20.5.2014 EN Official Journal of the European Union L 150/234 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 THE PARTIES TO THIS PROTOCOL, BEING Parties to the Convention on Biological Diversity, hereinafter referred to as ‘the Convention’, RECALLING that the fair and equitable sharing of benefits arising from the utilization of genetic resources is one of three core objectives of the Convention, and RECOGNIZING that this Protocol pursues the implementation of this objective within the Convention, REAFFIRMING the sovereign rights of States over their natural resources and according to the provisions of the Convention, RECALLING FURTHER Article 15 of the Convention, RECOGNIZING the important contribution to sustainable development made by technology transfer and cooperation to build research and innovation capacities for adding value to genetic resources in developing countries, in accordance with Articles 16 and 19 of the Convention, RECOGNIZING that public awareness of the economic value of ecosystems and biodiversity and the fair and equitable sharing of this economic value with the custodians of biodiversity are key incentives for the conservation of biological diversity and the sustainable use of its components, ACKNOWLEDGING the potential role of access and benefit-sharing to contribute to the conservation and sustainable use of biological diversity, poverty eradication and environmental sustainability and thereby contributing to achieving the Millennium Development Goals, ACKNOWLEDGING the linkage between access to genetic resources and the fair and equitable sharing of benefits arising from the utilization of such resources, RECOGNIZING the importance of providing legal certainty with respect to access to genetic resources and the fair and equitable sharing of benefits arising from their utilization, FURTHER RECOGNIZING the importance of promoting equity and fairness in negotiation of mutually agreed terms between providers and users of genetic resources, RECOGNIZING ALSO the vital role that women play in access and benefit-sharing and AFFIRMING the need for the full participation of women at all levels of policymaking and implementation for biodiversity conservation, DETERMINED to further support the effective implementation of the access and benefit-sharing provisions of the Convention, RECOGNIZING that an innovative solution is required to address the fair and equitable sharing of benefits derived from the utilization of genetic resources and traditional knowledge associated with genetic resources that occur in transboundary situations or for which it is not possible to grant or obtain prior informed consent, RECOGNIZING the importance of genetic resources to food security, public health, biodiversity conservation, and the mitigation of and adaptation to climate change, RECOGNIZING the special nature of agricultural biodiversity, its distinctive features and problems needing distinctive solutions, RECOGNIZING the interdependence of all countries with regard to genetic resources for food and agriculture as well as their special nature and importance for achieving food security worldwide and for sustainable development of agriculture in the context of poverty alleviation and climate change and acknowledging the fundamental role of the International Treaty on Plant Genetic Resources for Food and Agriculture and the FAO Commission on Genetic Resources for Food and Agriculture in this regard, MINDFUL of the International Health Regulations (2005) of the World Health Organization and the importance of ensuring access to human pathogens for public health preparedness and response purposes, ACKNOWLEDGING ongoing work in other international forums relating to access and benefit-sharing, RECALLING the Multilateral System of Access and Benefit-sharing established under the International Treaty on Plant Genetic Resources for Food and Agriculture developed in harmony with the Convention, RECOGNIZING that international instruments related to access and benefit-sharing should be mutually supportive with a view to achieving the objectives of the Convention, RECALLING the relevance of Article 8(j) of the Convention as it relates to traditional knowledge associated with genetic resources and the fair and equitable sharing of benefits arising from the utilization of such knowledge, NOTING the interrelationship between genetic resources and traditional knowledge, their inseparable nature for indigenous and local communities, the importance of the traditional knowledge for the conservation of biological diversity and the sustainable use of its components, and for the sustainable livelihoods of these communities, RECOGNIZING the diversity of circumstances in which traditional knowledge associated with genetic resources is held or owned by indigenous and local communities, MINDFUL that it is the right of indigenous and local communities to identify the rightful holders of their traditional knowledge associated with genetic resources, within their communities, FURTHER RECOGNIZING the unique circumstances where traditional knowledge associated with genetic resources is held in countries, which may be oral, documented or in other forms, reflecting a rich cultural heritage relevant for conservation and sustainable use of biological diversity, NOTING the United Nations Declaration on the Rights of Indigenous Peoples, and AFFIRMING that nothing in this Protocol shall be construed as diminishing or extinguishing the existing rights of indigenous and local communities, HAVE AGREED AS FOLLOWS: Article 1 Objective The objective of this Protocol is the fair and equitable sharing of the benefits arising from the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding, thereby contributing to the conservation of biological diversity and the sustainable use of its components. Article 2 Use of terms The terms defined in Article 2 of the Convention shall apply to this Protocol. In addition, for the purposes of this Protocol: (a) ‘Conference of the Parties’ means the Conference of the Parties to the Convention; (b) ‘Convention’ means the Convention on Biological Diversity; (c) ‘Utilization of genetic resources’ means to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology as defined in Article 2 of the Convention; (d) ‘Biotechnology’ as defined in Article 2 of the Convention means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use; (e) ‘Derivative’ means a naturally occurring biochemical compound resulting from the genetic expression or metabolism of biological or genetic resources, even if it does not contain functional units of heredity. Article 3 Scope This Protocol shall apply to genetic resources within the scope of Article 15 of the Convention and to the benefits arising from the utilization of such resources. This Protocol shall also apply to traditional knowledge associated with genetic resources within the scope of the Convention and to the benefits arising from the utilization of such knowledge. Article 4 Relationship with international agreements and instruments 1. The provisions of this Protocol shall not affect the rights and obligations of any Party deriving from any existing international agreement, except where the exercise of those rights and obligations would cause a serious damage or threat to biological diversity. This paragraph is not intended to create a hierarchy between this Protocol and other international instruments. 2. Nothing in this Protocol shall prevent the Parties from developing and implementing other relevant international agreements, including other specialized access and benefit-sharing agreements, provided that they are supportive of and do not run counter to the objectives of the Convention and this Protocol. 3. This Protocol shall be implemented in a mutually supportive manner with other international instruments relevant to this Protocol. Due regard should be paid to useful and relevant ongoing work or practices under such international instruments and relevant international organizations, provided that they are supportive of and do not run counter to the objectives of the Convention and this Protocol. 4. This Protocol is the instrument for the implementation of the access and benefit-sharing provisions of the Convention. Where a specialized international access and benefit-sharing instrument applies that is consistent with, and does not run counter to the objectives of the Convention and this Protocol, this Protocol does not apply for the Party or Parties to the specialized instrument in respect of the specific genetic resource covered by and for the purpose of the specialized instrument. Article 5 Fair and equitable benefit-sharing 1. In accordance with Article 15, paragraphs 3 and 7 of the Convention, benefits arising from the utilization of genetic resources as well as subsequent applications and commercialization shall be shared in a fair and equitable way with the Party providing such resources that is the country of origin of such resources or a Party that has acquired the genetic resources in accordance with the Convention. Such sharing shall be upon mutually agreed terms. 2. Each Party shall take legislative, administrative or policy measures, as appropriate, with the aim of ensuring that benefits arising from the utilization of genetic resources that are held by indigenous and local communities, in accordance with domestic legislation regarding the established rights of these indigenous and local communities over these genetic resources, are shared in a fair and equitable way with the communities concerned, based on mutually agreed terms. 3. To implement paragraph 1 above, each Party shall take legislative, administrative or policy measures, as appropriate. 4. Benefits may include monetary and non-monetary benefits, including but not limited to those listed in the Annex. 5. Each Party shall take legislative, administrative or policy measures as appropriate, in order that the benefits arising from the utilization of traditional knowledge associated with genetic resources are shared in a fair and equitable way with indigenous and local communities holding such knowledge. Such sharing shall be upon mutually agreed terms. Article 6 Access to genetic resources 1. In the exercise of sovereign rights over natural resources, and subject to domestic access and benefit-sharing legislation or regulatory requirements, access to genetic resources for their utilization shall be subject to the prior informed consent of the Party providing such resources that is the country of origin of such resources or a Party that has acquired the genetic resources in accordance with the Convention, unless otherwise determined by that Party. 2. In accordance with domestic law, each Party shall take measures, as appropriate, with the aim of ensuring that the prior informed consent or approval and involvement of indigenous and local communities is obtained for access to genetic resources where they have the established right to grant access to such resources. 3. Pursuant to paragraph 1 above, each Party requiring prior informed consent shall take the necessary legislative, administrative or policy measures, as appropriate, to: (a) Provide for legal certainty, clarity and transparency of their domestic access and benefit-sharing legislation or regulatory requirements; (b) Provide for fair and non-arbitrary rules and procedures on accessing genetic resources; (c) Provide information on how to apply for prior informed consent; (d) Provide for a clear and transparent written decision by a competent national authority, in a cost-effective manner and within a reasonable period of time; (e) Provide for the issuance at the time of access of a permit or its equivalent as evidence of the decision to grant prior informed consent and of the establishment of mutually agreed terms, and notify the Access and Benefit-sharing Clearing-House accordingly; (f) Where applicable, and subject to domestic legislation, set out criteria and/or processes for obtaining prior informed consent or approval and involvement of indigenous and local communities for access to genetic resources; and (g) Establish clear rules and procedures for requiring and establishing mutually agreed terms. Such terms shall be set out in writing and may include, inter alia: (i) A dispute settlement clause; (ii) Terms on benefit-sharing, including in relation to intellectual property rights; (iii) Terms on subsequent third-party use, if any; and (iv) Terms on changes of intent, where applicable. Article 7 Access to traditional knowledge associated with genetic resources In accordance with domestic law, each Party shall take measures, as appropriate, with the aim of ensuring that traditional knowledge associated with genetic resources that is held by indigenous and local communities is accessed with the prior and informed consent or approval and involvement of these indigenous and local communities, and that mutually agreed terms have been established. Article 8 Special considerations In the development and implementation of its access and benefit-sharing legislation or regulatory requirements, each Party shall: (a) Create conditions to promote and encourage research which contributes to the conservation and sustainable use of biological diversity, particularly in developing countries, including through simplified measures on access for non-commercial research purposes, taking into account the need to address a change of intent for such research; (b) Pay due regard to cases of present or imminent emergencies that threaten or damage human, animal or plant health, as determined nationally or internationally. Parties may take into consideration the need for expeditious access to genetic resources and expeditious fair and equitable sharing of benefits arising out of the use of such genetic resources, including access to affordable treatments by those in need, especially in developing countries; (c) Consider the importance of genetic resources for food and agriculture and their special role for food security. Article 9 Contribution to conservation and sustainable use The Parties shall encourage users and providers to direct benefits arising from the utilization of genetic resources towards the conservation of biological diversity and the sustainable use of its components. Article 10 Global multilateral benefit-sharing mechanism Parties shall consider the need for and modalities of a global multilateral benefit-sharing mechanism to address the fair and equitable sharing of benefits derived from the utilization of genetic resources and traditional knowledge associated with genetic resources that occur in transboundary situations or for which it is not possible to grant or obtain prior informed consent. The benefits shared by users of genetic resources and traditional knowledge associated with genetic resources through this mechanism shall be used to support the conservation of biological diversity and the sustainable use of its components globally. Article 11 Transboundary cooperation 1. In instances where the same genetic resources are found in situ within the territory of more than one Party, those Parties shall endeavour to cooperate, as appropriate, with the involvement of indigenous and local communities concerned, where applicable, with a view to implementing this Protocol. 2. Where the same traditional knowledge associated with genetic resources is shared by one or more indigenous and local communities in several Parties, those Parties shall endeavour to cooperate, as appropriate, with the involvement of the indigenous and local communities concerned, with a view to implementing the objective of this Protocol. Article 12 Traditional knowledge associated with genetic resources 1. In implementing their obligations under this Protocol, Parties shall in accordance with domestic law take into consideration indigenous and local communities’ customary laws, community protocols and procedures, as applicable, with respect to traditional knowledge associated with genetic resources. 2. Parties, with the effective participation of the indigenous and local communities concerned, shall establish mechanisms to inform potential users of traditional knowledge associated with genetic resources about their obligations, including measures as made available through the Access and Benefit-sharing Clearing-House for access to and fair and equitable sharing of benefits arising from the utilization of such knowledge. 3. Parties shall endeavour to support, as appropriate, the development by indigenous and local communities, including women within these communities, of: (a) Community protocols in relation to access to traditional knowledge associated with genetic resources and the fair and equitable sharing of benefits arising out of the utilization of such knowledge; (b) Minimum requirements for mutually agreed terms to secure the fair and equitable sharing of benefits arising from the utilization of traditional knowledge associated with genetic resources; and (c) Model contractual clauses for benefit-sharing arising from the utilization of traditional knowledge associated with genetic resources. 4. Parties, in their implementation of this Protocol, shall, as far as possible, not restrict the customary use and exchange of genetic resources and associated traditional knowledge within and amongst indigenous and local communities in accordance with the objectives of the Convention. Article 13 National focal points and competent national authorities 1. Each Party shall designate a national focal point on access and benefit-sharing. The national focal point shall make information available as follows: (a) For applicants seeking access to genetic resources, information on procedures for obtaining prior informed consent and establishing mutually agreed terms, including benefit-sharing; (b) For applicants seeking access to traditional knowledge associated with genetic resources, where possible, information on procedures for obtaining prior informed consent or approval and involvement, as appropriate, of indigenous and local communities and establishing mutually agreed terms including benefit-sharing; and (c) Information on competent national authorities, relevant indigenous and local communities and relevant stakeholders. The national focal point shall be responsible for liaison with the Secretariat. 2. Each Party shall designate one or more competent national authorities on access and benefit-sharing. Competent national authorities shall, in accordance with applicable national legislative, administrative or policy measures, be responsible for granting access or, as applicable, issuing written evidence that access requirements have been met and be responsible for advising on applicable procedures and requirements for obtaining prior informed consent and entering into mutually agreed terms. 3. A Party may designate a single entity to fulfil the functions of both focal point and competent national authority. 4. Each Party shall, no later than the date of entry into force of this Protocol for it, notify the Secretariat of the contact information of its national focal point and its competent national authority or authorities. Where a Party designates more than one competent national authority, it shall convey to the Secretariat, with its notification thereof, relevant information on the respective responsibilities of those authorities. Where applicable, such information shall, at a minimum, specify which competent authority is responsible for the genetic resources sought. Each Party shall forthwith notify the Secretariat of any changes in the designation of its national focal point or in the contact information or responsibilities of its competent national authority or authorities. 5. The Secretariat shall make information received pursuant to paragraph 4 above available through the Access and Benefit-sharing Clearing-House. Article 14 The access and benefit-sharing clearing-house and information-sharing 1. An Access and Benefit-sharing Clearing-House is hereby established as part of the clearing-house mechanism under Article 18, paragraph 3, of the Convention. It shall serve as a means for sharing of information related to access and benefit-sharing. In particular, it shall provide access to information made available by each Party relevant to the implementation of this Protocol. 2. Without prejudice to the protection of confidential information, each Party shall make available to the Access and Benefit-sharing Clearing-House any information required by this Protocol, as well as information required pursuant to the decisions taken by the Conference of the Parties serving as the meeting of the Parties to this Protocol. The information shall include: (a) Legislative, administrative and policy measures on access and benefit-sharing; (b) Information on the national focal point and competent national authority or authorities; and (c) Permits or their equivalent issued at the time of access as evidence of the decision to grant prior informed consent and of the establishment of mutually agreed terms. 3. Additional information, if available and as appropriate, may include: (a) Relevant competent authorities of indigenous and local communities, and information as so decided; (b) Model contractual clauses; (c) Methods and tools developed to monitor genetic resources; and (d) Codes of conduct and best practices. 4. The modalities of the operation of the Access and Benefit-sharing Clearing-House, including reports on its activities, shall be considered and decided upon by the Conference of the Parties serving as the meeting of the Parties to this Protocol at its first meeting, and kept under review thereafter. Article 15 Compliance with domestic legislation or regulatory requirements on access and benefit-sharing 1. Each Party shall take appropriate, effective and proportionate legislative, administrative or policy measures to provide that genetic resources utilized within its jurisdiction have been accessed in accordance with prior informed consent and that mutually agreed terms have been established, as required by the domestic access and benefit-sharing legislation or regulatory requirements of the other Party. 2. Parties shall take appropriate, effective and proportionate measures to address situations of non-compliance with measures adopted in accordance with paragraph 1 above. 3. Parties shall, as far as possible and as appropriate, cooperate in cases of alleged violation of domestic access and benefit-sharing legislation or regulatory requirements referred to in paragraph 1 above. Article 16 Compliance with domestic legislation or regulatory requirements on access and benefit-sharing for traditional knowledge associated with genetic resources 1. Each Party shall take appropriate, effective and proportionate legislative, administrative or policy measures, as appropriate, to provide that traditional knowledge associated with genetic resources utilized within their jurisdiction has been accessed in accordance with prior informed consent or approval and involvement of indigenous and local communities and that mutually agreed terms have been established, as required by domestic access and benefit-sharing legislation or regulatory requirements of the other Party where such indigenous and local communities are located. 2. Each Party shall take appropriate, effective and proportionate measures to address situations of non-compliance with measures adopted in accordance with paragraph 1 above. 3. Parties shall, as far as possible and as appropriate, cooperate in cases of alleged violation of domestic access and benefit-sharing legislation or regulatory requirements referred to in paragraph 1 above. Article 17 Monitoring the utilization of genetic resources 1. To support compliance, each Party shall take measures, as appropriate, to monitor and to enhance transparency about the utilization of genetic resources. Such measures shall include: (a) The designation of one or more checkpoints, as follows: (i) Designated checkpoints would collect or receive, as appropriate, relevant information related to prior informed consent, to the source of the genetic resource, to the establishment of mutually agreed terms, and/or to the utilization of genetic resources, as appropriate; (ii) Each Party shall, as appropriate and depending on the particular characteristics of a designated checkpoint, require users of genetic resources to provide the information specified in the above paragraph at a designated checkpoint. Each Party shall take appropriate, effective and proportionate measures to address situations of non-compliance; (iii) Such information, including from internationally recognized certificates of compliance where they are available, will, without prejudice to the protection of confidential information, be provided to relevant national authorities, to the Party providing prior informed consent and to the Access and Benefit-sharing Clearing-House, as appropriate; (iv) Check points must be effective and should have functions relevant to implementation of this subparagraph (a). They should be relevant to the utilization of genetic resources, or to the collection of relevant information at, inter alia, any stage of research, development, innovation, pre-commercialization or commercialization. (b) Encouraging users and providers of genetic resources to include provisions in mutually agreed terms to share information on the implementation of such terms, including through reporting requirements; and (c) Encouraging the use of cost-effective communication tools and systems. 2. A permit or its equivalent issued in accordance with Article 6, paragraph 3 (e) and made available to the Access and Benefit-sharing Clearing-House, shall constitute an internationally recognized certificate of compliance. 3. An internationally recognized certificate of compliance shall serve as evidence that the genetic resource which it covers has been accessed in accordance with prior informed consent and that mutually agreed terms have been established, as required by the domestic access and benefit-sharing legislation or regulatory requirements of the Party providing prior informed consent. 4. The internationally recognized certificate of compliance shall contain the following minimum information when it is not confidential: (a) Issuing authority; (b) Date of issuance; (c) The provider; (d) Unique identifier of the certificate; (e) The person or entity to whom prior informed consent was granted; (f) Subject-matter or genetic resources covered by the certificate; (g) Confirmation that mutually agreed terms were established; (h) Confirmation that prior informed consent was obtained; and (i) Commercial and/or non-commercial use. Article 18 Compliance with mutually agreed terms 1. In the implementation of Article 6, paragraph 3 (g) (i) and Article 7, each Party shall encourage providers and users of genetic resources and/or traditional knowledge associated with genetic resources to include provisions in mutually agreed terms to cover, where appropriate, dispute resolution including: (a) The jurisdiction to which they will subject any dispute resolution processes; (b) The applicable law; and/or (c) Options for alternative dispute resolution, such as mediation or arbitration. 2. Each Party shall ensure that an opportunity to seek recourse is available under their legal systems, consistent with applicable jurisdictional requirements, in cases of disputes arising from mutually agreed terms. 3. Each Party shall take effective measures, as appropriate, regarding: (a) Access to justice; and (b) The utilization of mechanisms regarding mutual recognition and enforcement of foreign judgments and arbitral awards. 4. The effectiveness of this article shall be reviewed by the Conference of the Parties serving as the meeting of the Parties to this Protocol in accordance with Article 31 of this Protocol. Article 19 Model contractual clauses 1. Each Party shall encourage, as appropriate, the development, update and use of sectoral and cross-sectoral model contractual clauses for mutually agreed terms. 2. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall periodically take stock of the use of sectoral and cross-sectoral model contractual clauses. Article 20 Codes of conduct, guidelines and best practices and/or standards 1. Each Party shall encourage, as appropriate, the development, update and use of voluntary codes of conduct, guidelines and best practices and/or standards in relation to access and benefit-sharing. 2. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall periodically take stock of the use of voluntary codes of conduct, guidelines and best practices and/or standards and consider the adoption of specific codes of conduct, guidelines and best practices and/or standards. Article 21 Awareness-raising Each Party shall take measures to raise awareness of the importance of genetic resources and traditional knowledge associated with genetic resources, and related access and benefit-sharing issues. Such measures may include, inter alia: (a) Promotion of this Protocol, including its objective; (b) Organization of meetings of indigenous and local communities and relevant stakeholders; (c) Establishment and maintenance of a help desk for indigenous and local communities and relevant stakeholders; (d) Information dissemination through a national clearing-house; (e) Promotion of voluntary codes of conduct, guidelines and best practices and/or standards in consultation with indigenous and local communities and relevant stakeholders; (f) Promotion of, as appropriate, domestic, regional and international exchanges of experience; (g) Education and training of users and providers of genetic resources and traditional knowledge associated with genetic resources about their access and benefit-sharing obligations; (h) Involvement of indigenous and local communities and relevant stakeholders in the implementation of this Protocol; and (i) Awareness-raising of community protocols and procedures of indigenous and local communities. Article 22 Capacity 1. The Parties shall cooperate in the capacity-building, capacity development and strengthening of human resources and institutional capacities to effectively implement this Protocol in developing country Parties, in particular the least developed countries and small island developing States among them, and Parties with economies in transition, including through existing global, regional, subregional and national institutions and organizations. In this context, Parties should facilitate the involvement of indigenous and local communities and relevant stakeholders, including non-governmental organizations and the private sector. 2. The need of developing country Parties, in particular the least developed countries and small island developing States among them, and Parties with economies in transition for financial resources in accordance with the relevant provisions of the Convention shall be taken fully into account for capacity-building and development to implement this Protocol. 3. As a basis for appropriate measures in relation to the implementation of this Protocol, developing country Parties, in particular the least developed countries and small island developing States among them, and Parties with economies in transition should identify their national capacity needs and priorities through national capacity self-assessments. In doing so, such Parties should support the capacity needs and priorities of indigenous and local communities and relevant stakeholders, as identified by them, emphasizing the capacity needs and priorities of women. 4. In support of the implementation of this Protocol, capacity-building and development may address, inter alia, the following key areas: (a) Capacity to implement, and to comply with the obligations of, this Protocol; (b) Capacity to negotiate mutually agreed terms; (c) Capacity to develop, implement and enforce domestic legislative, administrative or policy measures on access and benefit-sharing; and (d) Capacity of countries to develop their endogenous research capabilities to add value to their own genetic resources. 5. Measures in accordance with paragraphs 1 to 4 above may include, inter alia: (a) Legal and institutional development; (b) Promotion of equity and fairness in negotiations, such as training to negotiate mutually agreed terms; (c) The monitoring and enforcement of compliance; (d) Employment of best available communication tools and Internet-based systems for access and benefit-sharing activities; (e) Development and use of valuation methods; (f) Bioprospecting, associated research and taxonomic studies; (g) Technology transfer, and infrastructure and technical capacity to make such technology transfer sustainable; (h) Enhancement of the contribution of access and benefit-sharing activities to the conservation of biological diversity and the sustainable use of its components; (i) Special measures to increase the capacity of relevant stakeholders in relation to access and benefit-sharing; and (j) Special measures to increase the capacity of indigenous and local communities with emphasis on enhancing the capacity of women within those communities in relation to access to genetic resources and/or traditional knowledge associated with genetic resources. 6. Information on capacity-building and development initiatives at national, regional and international levels, undertaken in accordance with paragraphs 1 to 5 above, should be provided to the Access and Benefit-sharing Clearing-House with a view to promoting synergy and coordination on capacity-building and development for access and benefit-sharing. Article 23 Technology transfer, collaboration and cooperation In accordance with Articles 15, 16, 18 and 19 of the Convention, the Parties shall collaborate and cooperate in technical and scientific research and development programmes, including biotechnological research activities, as a means to achieve the objective of this Protocol. The Parties undertake to promote and encourage access to technology by, and transfer of technology to, developing country Parties, in particular the least developed countries and small island developing States among them, and Parties with economies in transition, in order to enable the development and strengthening of a sound and viable technological and scientific base for the attainment of the objectives of the Convention and this Protocol. Where possible and appropriate such collaborative activities shall take place in and with a Party or the Parties providing genetic resources that is the country or are the countries of origin of such resources or a Party or Parties that have acquired the genetic resources in accordance with the Convention. Article 24 Non-parties The Parties shall encourage non-Parties to adhere to this Protocol and to contribute appropriate information to the Access and Benefit-sharing Clearing-House. Article 25 Financial mechanism and resources 1. In considering financial resources for the implementation of this Protocol, the Parties shall take into account the provisions of Article 20 of the Convention. 2. The financial mechanism of the Convention shall be the financial mechanism for this Protocol. 3. Regarding the capacity-building and development referred to in Article 22 of this Protocol, the Conference of the Parties serving as the meeting of the Parties to this Protocol, in providing guidance with respect to the financial mechanism referred to in paragraph 2 above, for consideration by the Conference of the Parties, shall take into account the need of developing country Parties, in particular the least developed countries and small island developing States among them, and of Parties with economies in transition, for financial resources, as well as the capacity needs and priorities of indigenous and local communities, including women within these communities. 4. In the context of paragraph 1 above, the Parties shall also take into account the needs of the developing country Parties, in particular the least developed countries and small island developing States among them, and of the Parties with economies in transition, in their efforts to identify and implement their capacity-building and development requirements for the purposes of the implementation of this Protocol. 5. The guidance to the financial mechanism of the Convention in relevant decisions of the Conference of the Parties, including those agreed before the adoption of this Protocol, shall apply, mutatis mutandis, to the provisions of this Article. 6. The developed country Parties may also provide, and the developing country Parties and the Parties with economies in transition avail themselves of, financial and other resources for the implementation of the provisions of this Protocol through bilateral, regional and multilateral channels. Article 26 Conference of the parties serving as the meeting of the parties to this protocol 1. The Conference of the Parties shall serve as the meeting of the Parties to this Protocol. 2. Parties to the Convention that are not Parties to this Protocol may participate as observers in the proceedings of any meeting of the Conference of the Parties serving as the meeting of the Parties to this Protocol. When the Conference of the Parties serves as the meeting of the Parties to this Protocol, decisions under this Protocol shall be taken only by those that are Parties to it. 3. When the Conference of the Parties serves as the meeting of the Parties to this Protocol, any member of the Bureau of the Conference of the Parties representing a Party to the Convention but, at that time, not a Party to this Protocol, shall be substituted by a member to be elected by and from among the Parties to this Protocol. 4. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall keep under regular review the implementation of this Protocol and shall make, within its mandate, the decisions necessary to promote its effective implementation. It shall perform the functions assigned to it by this Protocol and shall: (a) Make recommendations on any matters necessary for the implementation of this Protocol; (b) Establish such subsidiary bodies as are deemed necessary for the implementation of this Protocol; (c) Seek and utilize, where appropriate, the services and cooperation of, and information provided by, competent international organizations and intergovernmental and non-governmental bodies; (d) Establish the form and the intervals for transmitting the information to be submitted in accordance with Article 29 of this Protocol and consider such information as well as reports submitted by any subsidiary body; (e) Consider and adopt, as required, amendments to this Protocol and its Annex, as well as any additional annexes to this Protocol, that are deemed necessary for the implementation of this Protocol; and (f) Exercise such other functions as may be required for the implementation of this Protocol. 5. The rules of procedure of the Conference of the Parties and financial rules of the Convention shall be applied, mutatis mutandis, under this Protocol, except as may be otherwise decided by consensus by the Conference of the Parties serving as the meeting of the Parties to this Protocol. 6. The first meeting of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be convened by the Secretariat and held concurrently with the first meeting of the Conference of the Parties that is scheduled after the date of the entry into force of this Protocol. Subsequent ordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be held concurrently with ordinary meetings of the Conference of the Parties, unless otherwise decided by the Conference of the Parties serving as the meeting of the Parties to this Protocol. 7. Extraordinary meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol shall be held at such other times as may be deemed necessary by the Conference of the Parties serving as the meeting of the Parties to this Protocol, or at the written request of any Party, provided that, within six months of the request being communicated to the Parties by the Secretariat, it is supported by at least one third of the Parties. 8. The United Nations, its specialized agencies and the International Atomic Energy Agency, as well as any State member thereof or observers thereto not party to the Convention, may be represented as observers at meetings of the Conference of the Parties serving as the meeting of the Parties to this Protocol. Any body or agency, whether national or international, governmental or non-governmental, that is qualified in matters covered by this Protocol and that has informed the Secretariat of its wish to be represented at a meeting of the Conference of the Parties serving as a meeting of the Parties to this Protocol as an observer, may be so admitted, unless at least one third of the Parties present object. Except as otherwise provided in this Article, the admission and participation of observers shall be subject to the rules of procedure, as referred to in paragraph 5 above. Article 27 Subsidiary bodies 1. Any subsidiary body established by or under the Convention may serve this Protocol, including upon a decision of the Conference of the Parties serving as the meeting of the Parties to this Protocol. Any such decision shall specify the tasks to be undertaken. 2. Parties to the Convention that are not Parties to this Protocol may participate as observers in the proceedings of any meeting of any such subsidiary bodies. When a subsidiary body of the Convention serves as a subsidiary body to this Protocol, decisions under this Protocol shall be taken only by Parties to this Protocol. 3. When a subsidiary body of the Convention exercises its functions with regard to matters concerning this Protocol, any member of the bureau of that subsidiary body representing a Party to the Convention but, at that time, not a Party to this Protocol, shall be substituted by a member to be elected by and from among the Parties to this Protocol. Article 28 Secretariat 1. The Secretariat established by Article 24 of the Convention shall serve as the secretariat to this Protocol. 2. Article 24, paragraph 1, of the Convention on the functions of the Secretariat shall apply, mutatis mutandis, to this Protocol. 3. To the extent that they are distinct, the costs of the secretariat services for this Protocol shall be met by the Parties hereto. The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, decide on the necessary budgetary arrangements to this end. Article 29 Monitoring and reporting Each Party shall monitor the implementation of its obligations under this Protocol, and shall, at intervals and in the format to be determined by the Conference of the Parties serving as the meeting of the Parties to this Protocol, report to the Conference of the Parties serving as the meeting of the Parties to this Protocol on measures that it has taken to implement this Protocol. Article 30 Procedures and mechanisms to promote compliance with this protocol The Conference of the Parties serving as the meeting of the Parties to this Protocol shall, at its first meeting, consider and approve cooperative procedures and institutional mechanisms to promote compliance with the provisions of this Protocol and to address cases of non-compliance. These procedures and mechanisms shall include provisions to offer advice or assistance, where appropriate. They shall be separate from, and without prejudice to, the dispute settlement procedures and mechanisms under Article 27 of the Convention. Article 31 Assessment and review The Conference of the Parties serving as the meeting of the Parties to this Protocol shall undertake, four years after the entry into force of this Protocol and thereafter at intervals determined by the Conference of the Parties serving as the meeting of the Parties to this Protocol, an evaluation of the effectiveness of this Protocol. Article 32 Signature This Protocol shall be open for signature by Parties to the Convention at the United Nations Headquarters in New York, from 2 February 2011 to 1 February 2012. Article 33 Entry into force 1. This Protocol shall enter into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification, acceptance, approval or accession by States or regional economic integration organizations that are Parties to the Convention. 2. This Protocol shall enter into force for a State or regional economic integration organization that ratifies, accepts or approves this Protocol or accedes thereto after the deposit of the fiftieth instrument as referred to in paragraph 1 above, on the ninetieth day after the date on which that State or regional economic integration organization deposits its instrument of ratification, acceptance, approval or accession, or on the date on which the Convention enters into force for that State or regional economic integration organization, whichever shall be the later. 3. For the purposes of paragraphs 1 and 2 above, any instrument deposited by a regional economic integration organization shall not be counted as additional to those deposited by member States of such organization. Article 34 Reservations No reservations may be made to this Protocol. Article 35 Withdrawal 1. At any time after two years from the date on which this Protocol has entered into force for a Party, that Party may withdraw from this Protocol by giving written notification to the Depositary. 2. Any such withdrawal shall take place upon expiry of one year after the date of its receipt by the Depositary, or on such later date as may be specified in the notification of the withdrawal. Article 36 Authentic texts The original of this Protocol, of which the Arabic, Chinese, English, French, Russian and Spanish texts are equally authentic, shall be deposited with the Secretary-General of the United Nations. IN WITNESS WHEREOF the undersigned, being duly authorized to that effect, have signed this Protocol on the dates indicated. DONE at Nagoya on this twenty-ninth day of October, two thousand and ten. ANNEX MONETARY AND NON-MONETARY BENEFITS 1. Monetary benefits may include, but not be limited to: (a) Access fees/fee per sample collected or otherwise acquired; (b) Up-front payments; (c) Milestone payments; (d) Payment of royalties; (e) Licence fees in case of commercialization; (f) Special fees to be paid to trust funds supporting conservation and sustainable use of biodiversity; (g) Salaries and preferential terms where mutually agreed; (h) Research funding; (i) Joint ventures; (j) Joint ownership of relevant intellectual property rights. 2. Non-monetary benefits may include, but not be limited to: (a) Sharing of research and development results; (b) Collaboration, cooperation and contribution in scientific research and development programmes, particularly biotechnological research activities, where possible in the Party providing genetic resources; (c) Participation in product development; (d) Collaboration, cooperation and contribution in education and training; (e) Admittance to ex situ facilities of genetic resources and to databases; (f) Transfer to the provider of the genetic resources of knowledge and technology under fair and most favourable terms, including on concessional and preferential terms where agreed, in particular, knowledge and technology that make use of genetic resources, including biotechnology, or that are relevant to the conservation and sustainable utilization of biological diversity; (g) Strengthening capacities for technology transfer; (h) Institutional capacity-building; (i) Human and material resources to strengthen the capacities for the administration and enforcement of access regulations; (j) Training related to genetic resources with the full participation of countries providing genetic resources, and where possible, in such countries; (k) Access to scientific information relevant to conservation and sustainable use of biological diversity, including biological inventories and taxonomic studies; (l) Contributions to the local economy; (m) Research directed towards priority needs, such as health and food security, taking into account domestic uses of genetic resources in the Party providing genetic resources; (n) Institutional and professional relationships that can arise from an access and benefit-sharing agreement and subsequent collaborative activities; (o) Food and livelihood security benefits; (p) Social recognition; (q) Joint ownership of relevant intellectual property rights.

Summary: Access to genetic resources and sharing of benefits arising from their utilisation (Nagoya Protocol) Access to genetic resources and sharing of benefits arising from their utilisation (Nagoya Protocol) SUMMARY OF: Nagoya Protocol Decision 2014/283/EU on the conclusion, on behalf of the EU, of 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 WHAT IS THE AIM OF THE PROTOCOL AND THE DECISION? The Nagoya Protocol is a protocol to the Convention on Biological Diversity (CBD), first signed by world leaders in 2010. The EU is a party to the CBD, together with 193 countries. The protocol aims to share out the benefits of using genetic resources in a fair and equitable way. The decision officially approves 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’ on behalf of the European Union (EU). Through this approval, the EU has become legally bound to the protocol, which is an important agreement on the international governance of biodiversity. KEY POINTS By approving the protocol on 16 May 2014, the EU contributed to the required 50 ratifications worldwide which enabled the Nagoya Protocol to come into force on 12 October 2014. As a result, the first meeting of the parties to the protocol (COP-MOP 1) took place at the biennial high-level meeting of the Convention on Biological Diversity (CBD) from 13-17 October 2014 in South Korea, at the same time as the 12th meeting of the Conference of the Parties to the CBD (COP 12). Access and benefit sharing The Nagoya Protocol implements the third aim of the CBD, access and benefit sharing (ABS), which focuses on the fair and equitable sharing of the benefits arising from the use of genetic resources, including by appropriate access to genetic resources and appropriate transfer of relevant technologies. Genetic resources are genetic materials of actual or potential value, from natural or cultivated stocks (e.g. seed banks or botanical gardens). These resources are typically used by a wide range of sectors in nature-based research and development as a basis for innovation, such as for new medicines, chemicals or cosmetics. The CBD recognises countries’ sovereign rights over their natural resources. ABS in the context of the Nagoya Protocol is based on this principle. Parties to the protocol have the authority to decide whether they wish to regulate access to their genetic resources and set out conditions for the sharing of benefits (e.g. through rules and procedures for prior informed consent and the negotiations of mutually agreed terms with the user of genetic resources). The Nagoya Protocol also applies to the use of traditional knowledge associated with genetic resources held by indigenous peoples and local communities. The protocol sets out mandatory rules on compliance for all parties, in order to monitor the use of genetic resources once they leave the provider country. The protocol will create greater legal certainty and transparency for both providers and users of genetic resources, whilst promoting benefit-sharing. The benefits generated and shared under the guidance of the protocol should contribute to support the conservation of biological diversity and the sustainable use of its components (the first and second aims of the CBD). Regulation (EU) No 511/2014, the access and benefit sharing regulation (ABS Regulation), which implements the compliance measures of the Nagoya Protocol at the EU level, entered into force on 9 June 2014 and has applied since the Nagoya Protocol itself entered into force for the EU, on 12 October 2014. Implementing Regulation (EU) 2015/1866 contains measures on specific aspects provided for in the ABS Regulation, in particular registered collections, best practices and monitoring of user compliance. It was adopted by the European Commission on 13 October 2015, and entered into force on 9 November 2015. DATE OF ENTRY INTO FORCE The protocol entered into force on 12 October 2014, 90 days after the date of deposit of the 50th instrument of ratification. BACKGROUND For more information, see: The Nagoya Protocol on Access and Benefit-sharing (Convention on Biological Diversity) Sharing nature’s genetic resources – ABS (European Commission). MAIN DOCUMENTS 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 (OJ L 150, 20.5.2014, pp. 234-249) Council Decision 2014/283/EU of 14 April 2014 on the conclusion, on behalf of the European Union, of 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 (OJ L 150, 20.5.2014, pp. 231-233) RELATED DOCUMENTS Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union (OJ L 150, 20.5.2014, pp. 59-71) Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices (OJ L 275, 20.10.2015, pp. 4-19) last update 20.11.2020


15.12.2009 EN Official Journal of the European Union L 328/27 COUNCIL REGULATION (EC) No 1217/2009 of 30 November 2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Community (codified version) THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular the third subparagraph of Article 37(2) thereof, Having regard to the proposal from the Commission, Having regard to the Opinion of the European Parliament (1), Whereas: (1) Regulation No 79/65/EEC of the Council of 15 June 1965 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Economic Community (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Regulation should be codified. (2) The development of the common agricultural policy requires that there should be available objective and relevant information on incomes in the various categories of agricultural holding and on the business operation of holdings coming within categories which call for special attention at Community level. (3) The accounts of agricultural holdings constitute the basic source of essential data for any assessment of incomes on agricultural holdings or study of their business operation. (4) The data collected should be obtained from agricultural holdings specially and suitably selected in accordance with common rules and be based on verifiable facts. Such data should reflect technical, economic and social conditions on the holdings involved, be taken from individual holdings, be available as quickly as possible, be based on uniform definitions, be presented in a common form and be usable at all times and in full detail by the Commission. (5) Those objectives can be attained only by means of a Community network for the collection of farm accountancy data (hereinafter referred to as ‘data network’), based on the farm accountancy offices existing in each Member State, enjoying the confidence of the parties concerned and relying on their voluntary participation. (6) In order to obtain accounting results that are sufficiently homogeneous at Community level, the returning holdings should be distributed among the various divisions and the various categories of holdings on the basis of a stratification of the field of survey based on the Community typology for agricultural holdings as established by Commission Regulation (EC) No 1242/2008 of 8 December 2008 establishing a Community typology for agricultural holdings (4). (7) The divisions of the data network should, as far as possible, be identical with those used for the presentation of other regional data that are essential in order to provide guidelines for the common agricultural policy. (8) For management reasons, the Commission should be authorised to amend the list of divisions of Member States, at the request of a Member State. (9) The field of survey of the data network should comprise all agricultural holdings of a certain economic size, irrespective of any outside work the operator may engage in. This field should be re-examined periodically in the light of the new Farm Structure Survey data. (10) Returning holdings should be selected in accordance with the rules laid down in the context of a selection plan aimed at obtaining a representative accounting sample of the field of survey. (11) In view of the experience gained, it is desirable that the main decisions concerning the selection of returning holdings, particularly the establishment of the selection plan, should be adopted at national level. Consequently, it is at that level that a body should be made responsible for this task. Those Member States which have several divisions should, however, be free to maintain regional committees. (12) The national liaison agency should play a key role in the management of the data network. (13) In selecting agricultural holdings and analysing and evaluating the data collected it is necessary to refer to data derived from other sources. (14) Farmers should be given an assurance that their accounts and all other individual details obtained pursuant to this Regulation will not be used for taxation purposes or for purposes other than those provided for in this Regulation or divulged by persons participating or having participated in the Community farm accountancy data network. (15) In order that it may satisfy itself as to the objectivity and relevance of the data collected, the Commission should be in a position to obtain all necessary details concerning the manner in which the bodies entrusted with the selection of agricultural holdings and the accountancy offices participating in the Community farm accountancy data network discharge their duties and, if necessary, to send experts to work on the spot with the collaboration of the competent national authorities. (16) The data network is a useful tool which enables the Community to develop the common agricultural policy and it serves, as a consequence, the Member States as well as the Community. The costs of the computerised systems on which the network relies and of studies and development activities of other aspects of the network, should therefore be eligible for Community financing. (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), HAS ADOPTED THIS REGULATION: CHAPTER I CREATION OF A COMMUNITY FARM ACCOUNTANCY DATA NETWORK Article 1 1. To meet the needs of the common agricultural policy, a Community network for the collection of farm accountancy data is set up (hereinafter referred to as the ‘data network’). 2. The purpose of the data network shall be to collect the accountancy data needed for, in particular: (a) an annual determination of incomes on agricultural holdings coming within the field of the survey defined in Article 5; and (b) a business analysis of agricultural holdings. 3. The data obtained pursuant to this Regulation shall, in particular, serve as the basis for the drawing up of reports by the Commission on the situation of agriculture and of agricultural markets as well as on farm incomes in the Community. The reports shall be submitted annually to the European Parliament and the Council, in particular for the annual fixing of prices of agricultural produce. Article 2 For the purposes of this Regulation, the following definitions shall apply: (a) ‘operator’ means the natural person responsible for the day-to-day management of an agricultural holding; (b) ‘category of holding’ means a group of agricultural holdings which belong to the same categories as regards the type of farming and economic size as defined in the Community typology for agricultural holdings established by Regulation (EC) No 1242/2008; (c) ‘returning holding’ means any agricultural holding making returns for the purposes of the data network; (d) ‘division’ means the territory of a Member State, or any part thereof as delimited with a view to the selection of returning holdings; a list of such divisions appears in Annex I; (e) ‘accountancy data’ means any technical, financial or economic data relating to an agricultural holding derived from accounts consisting of entries made systematically and regularly throughout the accounting year. Article 3 At the request of a Member State the list of divisions shall be amended in accordance with the procedure referred to in Article 18(2), provided that the request concerns the Member State's divisions. CHAPTER II DETERMINATION OF INCOMES ON AGRICULTURAL HOLDINGS Article 4 This Chapter shall apply to the collection of accountancy data for the purpose of making an annual determination of incomes on agricultural holdings. Article 5 1. The field of the survey referred to in Article 1(2)(a) shall cover the agricultural holdings having an economic size equal to, or greater than, a threshold expressed in euro corresponding to one of the lower limits of the economic size classes as defined in the Community typology. 2. To qualify as a returning holding, an agricultural holding shall: (a) have an economic size equal to, or greater than, a threshold to be determined in accordance with paragraph 1; (b) be farmed by a farmer holding accounts or willing and able to keep farm accounts and willing to allow the accountancy data from his holding to be made available to the Commission; (c) be representative, together with the other holdings and at the level of each division, of the field of survey. 3. The maximum number of returning holdings shall be 105 000 for the Community. 4. Detailed rules for the application of this Article, and in particular the threshold for the economic size and the number of returning holdings per division, shall be adopted in accordance with the procedure referred to in Article 18(2). Article 6 1. Each Member State shall set up a national committee for the data network (hereinafter referred to as ‘the National Committee’). 2. The National Committee shall be responsible for the selection of returning holdings. To this end, its duties shall, in particular, include approval of: (a) the plan for the selection of returning holdings, specifying in particular the distribution of returning holdings per category of holding and the detailed rules for selecting the said holdings; (b) the report on the implementation of the plan for the selection of returning holdings. 3. The chairman of the National Committee shall be appointed by the Member State from among the members of this Committee. The National Committee shall take its decisions unanimously. In the event of unanimity not being achieved, decisions shall be taken by an authority appointed by the Member State. 4. Member States which have several divisions may, for each of the divisions under their jurisdiction, set up a regional committee of the data network (hereinafter referred to as ‘the Regional Committee’). The Regional Committee shall, in particular, have the duty of cooperating with the liaison agency referred to in Article 7 in selecting the returning holdings. 5. Detailed rules for the application of this Article shall be adopted in accordance with the procedure referred to in Article 18(2). Article 7 1. Each Member State shall appoint a liaison agency whose duties shall be to: (a) inform the National Committee, the Regional Committees and the accountancy offices of the detailed rules of application concerning them and to ensure that those rules are properly implemented; (b) draw up and submit to the National Committee for its approval, and thereafter to forward to the Commission: (i) the plan for the selection of returning holdings, which shall be drawn up on the basis of the most recent statistical data, presented in accordance with the Community typology for agricultural holdings; (ii) the report on the implementation of the plan for the selection of returning holdings; (c) compile: (i) the list of returning holdings; (ii) the list of the accountancy offices willing and able to complete farm returns in accordance with the terms of the contracts provided for in Articles 10 and 15; (d) assemble the farm returns sent to it by the accountancy offices and to verify on the basis of a common inspection programme that they have been duly completed; (e) forward the duly completed farm returns to the Commission immediately after verification; (f) transmit to the National Committee, the Regional Committees and the accountancy offices the requests for information provided for in Article 17 and to forward the relevant answers to the Commission. 2. The detailed rules for the application of this Article shall be adopted in accordance with the procedure referred to in Article 18(2). Article 8 1. Each returning holding shall be the subject of an individual and anonymous farm return. 2. The accountancy data provided by each farm return shall be such that it is possible to: — characterise the returning holding by reference to the main elements of its factors of production; — assess the income of the holding in its various forms; — test by means of spot-checks the veracity of the information given. 3. The type of accountancy data to be given in a farm return, the form in which such data are to be presented and the definitions and instructions relating thereto shall be determined in accordance with the procedure referred to in Article 18(2). Article 9 A farmer whose holding is selected as a returning holding shall choose, from a list compiled for that purpose by the liaison agency, an accountancy office willing to complete the return for his holding in accordance with the terms of the contract provided for in Article 10. Article 10 1. A contract shall be concluded annually on the authority of the Member State between the competent authority designated by the latter and each accountancy office chosen as provided for in Article 9. Under this contract the accountancy office shall undertake, in consideration of a standard fee, to complete farm returns in a manner consistent with the provisions of Article 8. 2. The terms of the contract referred to in paragraph 1, which must be uniform in all Member States, shall be determined in accordance with the procedure referred to in Article 18(2). 3. Where the duties of an accountancy office are carried out by an administrative department, the latter shall be notified as to its duties through the normal administrative channels. CHAPTER III COLLECTION OF ACCOUNTANCY DATA FOR THE PURPOSE OF A BUSINESS ANALYSIS OF AGRICULTURAL HOLDINGS Article 11 This Chapter shall apply to the collection of accountancy data for the purpose of a business analysis of agricultural holdings. Article 12 In accordance with the procedure referred to in Article 18(2) the following shall be determined: — the subjects of the analyses referred to in Article 1(2)(b); — detailed rules concerning the selection and number of returning holdings, these being established according to the objectives of each particular analysis. Article 13 1. Each returning holding selected in accordance with the rules adopted pursuant to the second indent of Article 12 shall be the subject of a special farm return, which shall be individual to that holding and anonymous. This farm return shall include the accountancy data required under Article 8(2) and all such further accountancy items and details as each particular analysis may require. 2. The type of accountancy data to be given in a special farm return, the form in which such data are to be presented and the definitions and instructions relating thereto shall be determined in accordance with the procedure referred to in Article 18(2). 3. Special farm returns shall be completed by the various accountancy offices chosen as provided in Article 14. Article 14 A farmer whose holding is selected in accordance with the rules adopted pursuant to the second indent of Article 12 shall choose from a list compiled for the purpose by the liaison agency an accountancy office willing to complete the special return for his holding in accordance with the terms of the contract provided for in Article 15. Article 15 1. A contract shall be concluded on the authority of the Member State between the competent authority designated by the latter and each accountancy office chosen as provided for in Article 14. Under this contract the accountancy office shall undertake, in consideration of a standard fee, to complete special farm returns in a manner consistent with the provisions of Article 13. 2. The terms of the contract referred to in paragraph 1, which must be uniform in all Member States, shall be determined in accordance with the procedure referred to in Article 18(2). The supplementary terms which may be included in that contract by Member States shall be determined in accordance with the same procedure. 3. Where the duties of an accountancy office are carried out by an administrative department, the latter shall be notified as to its duties through the normal administrative channels. CHAPTER IV GENERAL PROVISIONS Article 16 1. It shall be prohibited to use for taxation purposes any individual accountancy data or other individual details obtained in implementation of this Regulation, or to divulge or use such data for purposes other than those provided for in Article 1. 2. It shall be prohibited for any person participating or having participated in the data network to divulge any individual accountancy data or any other individual details of which knowledge was acquired in the exercise of his duties or otherwise incidentally to such exercise. 3. Member States shall take all appropriate measures to penalise infringements of the provisions of paragraph 2. Article 17 1. The National Committee, the Regional Committees, the liaison agency and the accountancy offices shall be bound, within their respective areas of responsibility, to furnish the Commission with any information which the latter may request of them regarding the discharge of their duties under this Regulation. Such requests for information made to the National Committee, the Regional Committees or to the accountancy offices and the relevant answers shall be forwarded in writing through the liaison agency. 2. If the information supplied is inadequate or if such information fails to arrive in good time, the Commission may, with the collaboration of the liaison agency, send experts to work on the spot. Article 18 1. The Commission shall be assisted by the Community Committee for the Farm Accountancy Data Network (hereinafter referred to as the ‘Community Committee’). 2. Where reference is made to this paragraph Articles 4 and 7 of Decision 1999/468/EC shall apply. The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month. 3. The Community Committee shall be consulted for the purpose of: (a) verifying that the plans for the selection of returning holdings are in conformity with the provisions of Article 5; (b) analysing and evaluating the weighted annual results furnished by the data network, having regard in particular to data deriving from other sources, inter alia, from farm accounts and statistics generally and from national accounts. 4. The Community Committee may examine any other matter raised by its chairman, either on his own initiative or at the request of a representative of a Member State. It shall examine each year, in October, the trend of farm incomes in the Community, referring in particular to the updated results of the data network. It shall be kept regularly informed of the working of the data network. 5. The Chairman shall convene the meetings of the Community Committee. Secretarial services for the Community Committee shall be provided by the Commission. Article 19 1. Appropriations to be included in the general budget of the European Union, in the Commission section, shall cover: (a) those costs of the data network attributable to payment of fees to accountancy offices in consideration of their performance of the duties referred to in Articles 10 and 15; (b) all the costs of the computerised systems operated by the Commission for the reception, verification, processing and analysis of accountancy data supplied by the Member States. The costs referred to in point (b) include, where appropriate, the costs of disseminating the results of those operations and the costs of studies into, and development of, other aspects of the data network. 2. Costs in respect of the setting up and operation of the National Committee, Regional Committees and liaison agencies shall not be included in the Community budget. Article 20 Regulation No 79/65/EEC 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 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 Brussels, 30 November 2009. For the Council The President S. O. LITTORIN (1) Opinion of 20 October 2009 (not yet published in the Official Journal). (2) OJ 109, 23.6.1965, p. 1859/65. (3) See Annex II. (4) OJ L 335, 13.12.2008, p. 3. (5) OJ L 184, 17.7.1999, p. 23. ANNEX I List of divisions referred to in Article 2(d) Belgium 1. Vlaanderen 2. Bruxelles — Brussel 3. Wallonie Bulgaria 1. Северозападен (Severozapaden) 2. Северен централен (Severen tsentralen) 3. Североизточен (Severoiztochen) 4. Югозападен (Yugozapaden) 5. Южен централен (Yuzhen tsentralen) 6. Югоизточен (Yugoiztochen) However, Bulgaria may constitute a single division until 31 December 2009 Czech Republic Constitutes a single division Denmark Constitutes a single division Germany 1. Schleswig-Holstein 2. Hamburg 3. Niedersachsen 4. Bremen 5. Nordrhein-Westfalen 6. Hessen 7. Rheinland-Pfalz 8. Baden-Württemberg 9. Bayern 10. Saarland 11. Berlin 12. Brandenburg 13. Mecklenburg-Vorpommern 14. Sachsen 15. Sachsen-Anhalt 16. Thüringen Estonia Constitutes a single division Ireland Constitutes a single division Greece 1. Μακεδονία — Θράκη 2. Ήπειρος — Πελοπόννησος — Νήσοι Ιονίου 3. Θεσσαλία 4. Στερεά Ελλάς — Νήσοι Αιγαίου — Κρήτη Spain 1. Galicia 2. Asturias 3. Cantabria 4. País Vasco 5. Navarra 6. La Rioja 7. Aragón 8. Cataluña 9. Baleares 10. Castilla-León 11. Madrid 12. Castilla-La Mancha 13. Comunidad Valenciana 14. Murcia 15. Extremadura 16. Andalucía 17. Canarias France 1. Île de France 2. Champagne-Ardenne 3. Picardie 4. Haute-Normandie 5. Centre 6. Basse-Normandie 7. Bourgogne 8. Nord-Pas de Calais 9. Lorraine 10. Alsace 11. Franche-Comté 12. Pays de la Loire 13. Bretagne 14. Poitou-Charentes 15. Aquitaine 16. Midi-Pyrénées 17. Limousin 18. Rhône-Alpes 19. Auvergne 20. Languedoc-Roussillon 21. Provence-Alpes-Côte d'Azur 22. Corse Italy 1. Piemonte 2. Valle d'Aosta 3. Lombardia 4. Alto Adige 5. Trentino 6. Veneto 7. Friuli — Venezia Giulia 8. Liguria 9. Emilia — Romagna 10. Toscana 11. Umbria 12. Marche 13. Lazio 14. Abruzzi 15. Molise 16. Campania 17. Puglia 18. Basilicata 19. Calabria 20. Sicilia 21. Sardegna Cyprus Constitutes a single division Latvia Constitutes a single division Lithuania Constitutes a single division Luxembourg Constitutes a single division Hungary 1. Közép-Magyarország 2. Közép-Dunántúl 3. Nyugat-Dunántúl 4. Dél-Dunántúl 5. Észak-Magyarország 6. Észak-Alföld 7. Dél-Alföld Malta Constitutes a single division Netherlands Constitutes a single division Austria Constitutes a single division Poland 1. Pomorze and Mazury 2. Wielkopolska and Śląsk 3. Mazowsze and Podlasie 4. Małopolska and Pogórze Portugal 1. Norte e Centro 2. Ribatejo-Oeste 3. Alentejo e Algarve 4. Açores e Madeira Romania 1. Nord-Est 2. Sud-Est 3. Sud-Muntenia 4. Sud-Vest-Oltenia 5. Vest 6. Nord-Vest 7. Centru 8. București-Ilfov Slovenia Constitutes a single division Slovakia Constitutes a single division Finland 1. Etelä-Suomi 2. Sisä-Suomi 3. Pohjanmaa 4. Pohjois-Suomi Sweden 1. Plains of Southern and Central Sweden 2. Forest and mixed agricultural and forest areas of Southern and Central Sweden 3. Areas of Northern Sweden United Kingdom 1. England — north region 2. England — east region 3. England — west region 4. Wales 5. Scotland 6. Northern Ireland ANNEX II Repealed Regulation with list of its successive amendments Council Regulation No 79/65/EEC (OJ 109, 23.6.1965, p. 1859) 1972 Act of Accession, Annex I, Point II.A.4 and Annex II, Point II.D.1 (OJ L 73, 27.3.1972, p. 59 and p. 125) Council Regulation (EEC) No 2835/72 (OJ L 298, 31.12.1972, p. 47) Council Regulation (EEC) No 2910/73 (OJ L 299, 27.10.1973, p. 1) 1979 Act of Accession, Annex I, Points II.A. and II.G. (OJ L 291, 19.11.1979, p. 64 and p. 87) Council Regulation (EEC) No 2143/81 (OJ L 210, 30.7.1981, p. 1) Council Regulation (EEC) No 3644/85 (OJ L 348, 24.12.1985, p. 4) 1985 Act of Accession, Annex I, Point XIV(i) (OJ L 302, 15.11.1985, p. 235) Council Regulation (EEC) No 3768/85 (OJ L 362, 31.12.1985, p. 8) only point (2) of the Annex Council Regulation (EEC) No 3577/90 (OJ L 353, 17.12.1990, p. 23) only Annex XVI 1994 Act of Accession, Annex I, Point V.A.I (OJ C 241, 29.8.1994, p. 117) Council Regulation (EC) No 2801/95 (OJ L 291, 6.12.1995, p. 3) Council Regulation (EC) No 1256/97 (OJ L 174, 2.7.1997, p. 7) Council Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1) only point (1) of Annex II 2003 Act of Accession, Annex II, Point 6.A.1 (OJ L 236, 23.9.2003, p. 346) Council Regulation (EC) No 2059/2003 (OJ L 308, 25.11.2003, p. 1) Commission Regulation (EC) No 660/2004 (OJ L 104, 8.4.2004, p. 97) Commission Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1) only point 1 of Section A of Chapter 5 of the Annex Commission Regulation (EC) No 1469/2007 (OJ L 329, 14.12.2007, p. 5) ANNEX III CORRELATION TABLE Regulation No 79/65/EEC This Regulation Articles 1 and 2 Articles 1 and 2 Article 2a Article 3 Article 3 Article 4 Article 4 Article 5 Article 5 Article 6 Article 6(1)(a) Article 7(1)(a) Article 6(1)(b), first indent Article 7(1)(b)(i) Article 6(1)(b), second indent Article 7(1)(b)(ii) Article 6(1)(c), first indent Article 7(1)(c)(i) Article 6(1)(c), second indent Article 7(1)(c)(ii) Article 6(1)(e), (f) and (g) Article 7(1)(e), (f) and (g) Article 6(2) Article 7(2) Article 7 Article 8 Article 8 Article 9 Article 9 Article 10 Article 10 Article 11 Article 11 Article 12 Article 12 Article 13 Article 13 Article 14 Article 14 Article 15 Article 15 Article 16 Article 16 Article 17 Article 17 — Article 18 — Article 19 Article 18(1), (2) and (3) Article 20(1) and (2) Article 18(4) and (5) Article 21, first and second paragraphs Article 18(6) Article 21, third paragraph — Article 22 Article 19 Article 23 — — Article 20 — Article 21 Annex Annex I — Annex II — Annex III

Summary: Farm incomes and operations - EU statistics Farm incomes and operations - EU statistics The Farm Accountancy Data Network (FADN) enables the European Commission to collect data on the incomes and economic activities of agricultural holdings in the European Union in order to take informed decisions to shape the future common agricultural policy. ACT Council Regulation (EC) No 1217/2009 of 30 November 2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Community SUMMARY In order to ensure simple and convenient access for other institutions and the public to the annual analytical reports based on the FADN, reports covering selected sectors are published on a dedicated website. WHAT DOES THIS REGULATION DO? It sets out the rules for the collection of comparable farm accountancy data throughout the EU. These data are used to determine the annual incomes of agricultural holdings and for the business analysis of their activities. The data are collected every year based on a sample composed of more than 80,000 agricultural holdings. The process for collecting the accountancy data EU countries are responsible for surveys on their territory and each must appoint a liaison agency, which organises the data collection from different sources (such as farms and accounting offices) and electronically forwards the data to the Commission. A National Committee is responsible for the selection of returning holdings (i.e. the holdings taking part in the survey). Where an EU country is composed of several divisions, the National Committee may rely on regional committees. Farm return Each farm surveyed completes a return, which is a type of questionnaire. The data to be collected and delivered to the EC are identical for all EU countries, irrespective of their accounting practices and how they organise the data collection process. KEY POINTS Regulation (EU) No 1318/2013 amends Council Regulation (EC) No 1217/2009 (the FADN basic act) and introduces certain changes to the FADN rules. It gives the European Commission the power to adopt delegated and implementing acts. These delegated powers relate, among other things, to: the establishment of the list of FADN divisions (some EU countries represent a single division while some, particularly the larger ones, are broken down into smaller territorial units, such as regions or provinces), the rules for fixing economic size of returning holdings participating in the sample and for the plan for selecting the returning holdings, the main typology classification of EU agricultural holdings, the main groups of accountancy data to be collected and the general rules for data collection. As a result of this delegated power, Commission Delegated Regulation (EU) No 1198/2014 lays down rules supplementing some elements of Regulation (EC) No 1217/2009 (e.g. the correspondence between types of farming or the list of the main groups of accountancy data to be collected). As for the implementing powers, Commission Implementing Regulation (EU) 2015/220 lays down rules for the application of Council Regulation (EC) No 1217/2009. These include the detailed description of the group of accountancy data to be collected in each farm return and the economic thresholds applied in each country. According to Regulation (EC) No 1217/2009 the data are covered by strict confidentiality rules and can only be used to meet the needs of the common agricultural policy. For example, they cannot be used by authorities for tax or compliance purposes. Lastly, the regulation stipulates that the Commission is assisted by the Committee for the Farm Accountancy Data Network, composed of representatives of all EU countries. WHEN DOES THE REGULATION APPLY? Regulation (EC) No 1217/2009 entered into force in January 2010 while the amendment introduced by Regulation (EU) No 1318/2013 has applied since 1 January 2014. Further information is available from the European Commission’s Directorate-General for Agriculture and Rural Development website. REFERENCES Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EC) No 1217/2009 4.1.2010 - OJ L 328, 15.12.2009, pp. 27-38 Amending act(s) Entry into force Deadline for transposition in the Member States Official Journal Regulation (EU) No 1318/2013 20.12.2013 - OJ L 340, 17.12.2013, pp. 1-6 RELATED ACTS Commission Delegated Regulation (EU) No 1198/2014 of 1 August 2014 supplementing Council Regulation (EC) No 1217/2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Union (OJ L 321, 7.11.2014, pp. 2-6) Commission Implementing Regulation (EU) 2015/220 of 3 February 2015 laying down rules for the application of Council Regulation (EC) No 1217/2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Union (OJ L 46, 19.2.2015, pp. 1-106) last update 02.09.2015