25.4.2007 EN Official Journal of the European Union L 108/1 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) 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, in the light of the joint text approved by the Conciliation Committee on 17 January 2007 (2), Whereas: (1) Community policy on the environment must aim at a high level of protection taking into account the diversity of situations in the various regions of the Community. Moreover, information, including spatial information, is needed for the formulation and implementation of this policy and other Community policies, which must integrate environmental protection requirements in accordance with Article 6 of the Treaty. In order to bring about such integration, it is necessary to establish a measure of coordination between the users and providers of the information so that information and knowledge from different sectors can be combined. (2) The Sixth Environment Action Programme adopted by Decision No 1600/2002/EC of the European Parliament and of the Council of 22 July 2002 (3) requires full consideration to be given to ensuring that the Community's environmental policy-making is undertaken in an integrated way, taking into account regional and local differences. A number of problems exist regarding the availability, quality, organisation, accessibility and sharing of spatial information needed in order to achieve the objectives set out in that programme. (3) The problems regarding the availability, quality, organisation, accessibility and sharing of spatial information are common to a large number of policy and information themes and are experienced across the various levels of public authority. Solving these problems requires measures that address exchange, sharing, access and use of interoperable spatial data and spatial data services across the various levels of public authority and across different sectors. An infrastructure for spatial information in the Community should therefore be established. (4) The Infrastructure for Spatial Information in the European Community (Inspire) should assist policy-making in relation to policies and activities that may have a direct or indirect impact on the environment. (5) Inspire should be based on the infrastructures for spatial information that are created by the Member States and that are made compatible with common implementing rules and are supplemented with measures at Community level. These measures should ensure that the infrastructures for spatial information created by the Member States are compatible and usable in a Community and transboundary context. (6) The infrastructures for spatial information in the Member States should be designed to ensure that spatial data are stored, made available and maintained at the most appropriate level; that it is possible to combine spatial data from different sources across the Community in a consistent way and share them between several users and applications; that it is possible for spatial data collected at one level of public authority to be shared between other public authorities; that spatial data are made available under conditions which do not unduly restrict their extensive use; that it is easy to discover available spatial data, to evaluate their suitability for the purpose and to know the conditions applicable to their use. (7) There is a degree of overlap between the spatial information covered by this Directive and the information covered by Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (4). This Directive should be without prejudice to Directive 2003/4/EC. (8) This Directive should be without prejudice to Directive 2003/98/EC of the European Parliament and of the Council of 17 November 2003 on the re-use of public sector information (5), the objectives of which are complementary to those of this Directive. (9) This directive should not affect the existence or ownership of public authorities' intellectual property rights. (10) The establishment of INSPIRE will represent significant added value for — and will also benefit from — other Community initiatives such as Council Regulation (EC) No 876/2002 of 21 May 2002 setting up the Galileo Joint Undertaking (6) and the Communication from the Commission to the European Parliament and the Council ‘Global Monitoring for Environment and Security (GMES): Establishing a GMES capacity by 2008 — (Action Plan (2004 to 2008))’. Member States should consider using the data and services resulting from Galileo and GMES as they become available, in particular those related to the time and space references from Galileo. (11) Many initiatives are taken at national and Community level to collect, harmonise or organise the dissemination or use of spatial information. Such initiatives may be established by Community legislation, such as Commission Decision 2000/479/EC of 17 July 2000 on the implementation of a European pollutant emission register (EPER) according to Article 15 of Council Directive 96/61/EC concerning integrated pollution prevention and control (IPPC) (7) and Regulation (EC) No 2152/2003 of the European Parliament and of the Council of 17 November 2003 concerning monitoring of forests and environmental interactions in the Community (Forest focus) (8), in the framework of Community funded programmes (for example Corine land cover, European Transport Policy Information System) or may emanate from initiatives taken at national or regional level. This Directive will not only complement such initiatives by providing a framework that will enable them to become interoperable, but it will also build upon existing experience and initiatives rather than duplicate the work that has already been done. (12) This Directive should apply to spatial data held by or on behalf of public authorities and to the use of spatial data by public authorities in the performance of their public tasks. Subject to certain conditions, however, it should also apply to spatial data held by natural or legal persons other than public authorities, provided that those natural or legal persons request this. (13) This Directive should not set requirements for the collection of new data, or for reporting such information to the Commission, since those matters are regulated by other legislation related to the environment. (14) The implementation of the national infrastructures should be progressive and, accordingly, the spatial data themes covered by this Directive should be accorded different levels of priority. The implementation should take account of the extent to which spatial data are needed for a wide range of applications in various policy areas, of the priority of actions provided for under Community policies that need harmonised spatial data and of the progress already made by the harmonisation efforts undertaken in the Member States. (15) The loss of time and resources in searching for existing spatial data or establishing whether they may be used for a particular purpose is a key obstacle to the full exploitation of the data available. Member States should therefore provide descriptions of available spatial data sets and services in the form of metadata. (16) Since the wide diversity of formats and structures in which spatial data are organised and accessed in the Community hampers the efficient formulation, implementation, monitoring and evaluation of Community legislation that directly or indirectly affect the environment, implementing measures should be provided for in order to facilitate the use of spatial data from different sources across the Member States. Those measures should be designed to make the spatial data sets interoperable, and Member States should ensure that any data or information needed for the purposes of achieving interoperability are available on conditions that do not restrict their use for that purpose. Implementing rules should be based, where possible, on international standards and should not result in excessive costs for Member States. (17) Network services are necessary for sharing spatial data between the various levels of public authority in the Community. Those network services should make it possible to discover, transform, view and download spatial data and to invoke spatial data and e-commerce services. The services of the network should work in accordance with commonly agreed specifications and minimum performance criteria in order to ensure the interoperability of the infrastructures established by the Member States. The network of services should also include the technical possibility to enable public authorities to make their spatial data sets and services available. (18) Certain spatial data sets and services relevant to Community policies that directly or indirectly affect the environment are held and operated by third parties. Member States should therefore offer third parties the possibility of contributing to the national infrastructures, provided that the cohesion and ease of use of the spatial data and spatial data services covered by those infrastructures is thereby not impaired. (19) Experience in the Member States has shown that it is important, for the successful implementation of an infrastructure for spatial information, that a minimum number of services be made available to the public free of charge. Member States should therefore make available, as a minimum and free of charge, the services for discovering and, subject to certain specific conditions, viewing spatial data sets. (20) In order to assist the integration of the national infrastructures into Inspire, Member States should provide access to their infrastructures through a Community geo-portal operated by the Commission, as well as through any access points they themselves decide to operate. (21) In order to make information from various levels of public authority available, Member States should remove the practical obstacles faced in that regard by public authorities at national, regional and local level when performing their public tasks that may have a direct or indirect impact on the environment. (22) Public authorities need to have smooth access to relevant spatial data sets and services during the execution of their public tasks. Such access can be hindered if it depends on individual ad hoc negotiations between public authorities every time access is required. Member States should take the necessary measures to prevent such practical obstacles to the sharing of data, using for example prior agreements between public authorities. (23) Where a public authority supplies another public authority in the same Member State with spatial data sets and services required for the fulfilment of reporting obligations under Community legislation relating to the environment, the Member State concerned should be free to decide that those spatial data sets and services shall not be subject to any charging. The mechanisms for sharing spatial data sets and services between government and other public administrations and natural or legal persons performing public administrative functions under national law should take into account the need to protect the financial viability of public authorities, in particular those that have a duty to raise revenue. In any event, any charges applied should not exceed the cost of collection, production, reproduction and dissemination together with a reasonable return on investment. (24) The provision of network services should be carried out in full compliance with the principles relating to the protection of personal data in accordance 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 (9). (25) Frameworks for the sharing of spatial data between public authorities upon whom the Directive imposes a duty to share should be neutral in respect of such public authorities within a Member State, but also in respect of such public authorities in other Member States and of the Community institutions. Since the Community institutions and bodies frequently need to integrate and assess spatial information from all the Member States, they should be able to gain access to and use spatial data and spatial data services in accordance with harmonised conditions. (26) With a view to stimulating the development of added-value services by third parties, for the benefit of both public authorities and the public, it is necessary to facilitate access to spatial data that extend over administrative or national borders. (27) The effective implementation of infrastructures for spatial information requires coordination by all those with an interest in the establishment of such infrastructures, whether as contributors or users. Appropriate coordination structures which extend to the various levels of government and take account of the distribution of powers and responsibilities within the Member States should therefore be established. (28) In order to benefit from the state of the art and actual experience of information infrastructures, it is appropriate that the measures necessary for the implementation of this Directive should be supported by international standards and standards adopted by European standardisation bodies in accordance with the procedure laid down in 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 (10). (29) Since the European Environment Agency set up by 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 (11) has the task of providing the Community with objective, reliable and comparable environmental information at Community level, and aims inter alia to improve the flow of policy-relevant environmental information between Member States and the Community institutions, it should contribute actively to the implementation of this Directive. (30) In accordance with point 34 of the Interinstitutional Agreement on better law-making (12), Member States are encouraged to draw up, for themselves and in the interests of the Community, their own tables illustrating, as far as possible, the correlation between this Directive and the transposition measures, and to make them public. (31) The measures necessary for the implementation of this Directive 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). (32) In particular, the Commission should be empowered to adapt the description of the existing data themes referred to in Annexes I, II and III. Since such measures are of general scope and are designed to amend non-essential elements of this Directive, they should be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (33) The Commission should also be empowered to adopt implementing rules laying down technical arrangements for the interoperability and harmonisation of spatial data sets and services, rules governing the conditions concerning access to such sets and services, as well as rules concerning the technical specifications and obligations of network services. Since such measures are of general scope and are designed to supplement this Directive 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. (34) Preparatory work for decisions concerning the implementation of this Directive and for the future evolution of Inspire requires continuous monitoring of the implementation of the Directive and regular reporting. (35) Since the objective of this Directive, namely the establishment of Inspire, cannot be sufficiently achieved by the Member States because of the transnational aspects and the general need within the Community to coordinate the conditions of access to, exchange and sharing of spatial information, 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 Directive does not go beyond what is necessary in order to achieve this objective, HAVE ADOPTED THIS DIRECTIVE: CHAPTER I GENERAL PROVISIONS Article 1 1. The purpose of this Directive is to lay down general rules aimed at the establishment of the Infrastructure for Spatial Information in the European Community (hereinafter referred to as Inspire), for the purposes of Community environmental policies and policies or activities which may have an impact on the environment. 2. Inspire shall build upon infrastructures for spatial information established and operated by the Member States. Article 2 1. This Directive is without prejudice to Directives 2003/4/EC and 2003/98/EC. 2. This Directive does not affect the existence or ownership of public authorities' intellectual property rights. Article 3 For the purposes of this Directive, the following definitions shall apply: 1. ‘infrastructure for spatial information’ means metadata, spatial data sets and spatial data services; network services and technologies; agreements on sharing, access and use; and coordination and monitoring mechanisms, processes and procedures, established, operated or made available in accordance with this Directive; 2. ‘spatial data’ means any data with a direct or indirect reference to a specific location or geographical area; 3. ‘spatial data set’ means an identifiable collection of spatial data; 4. ‘spatial data services’ means the operations which may be performed, by invoking a computer application, on the spatial data contained in spatial data sets or on the related metadata; 5. ‘spatial object’ means an abstract representation of a real-world phenomenon related to a specific location or geographical area; 6. ‘metadata’ means information describing spatial data sets and spatial data services and making it possible to discover, inventory and use them; 7. ‘interoperability’ means the possibility for spatial data sets to be combined, and for services to interact, without repetitive manual intervention, in such a way that the result is coherent and the added value of the data sets and services is enhanced; 8. ‘Inspire geo-portal’ means an Internet site, or equivalent, providing access to the services referred to in Article 11(1); 9. ‘public authority’ means: (a) any government or other public administration, including public advisory bodies, at national, regional or local level; (b) any natural or legal person performing public administrative functions under national law, including specific duties, activities or services in relation to the environment; and (c) any natural or legal person having public responsibilities or functions, or providing public services relating to the environment under the control of a body or person falling within (a) or (b). Member States may provide that when bodies or institutions are acting in a judicial or legislative capacity, they are not to be regarded as a public authority for the purposes of this Directive; 10. ‘third party’ means any natural or legal person other than a public authority. Article 4 1. This Directive shall cover spatial data sets which fulfil the following conditions: (a) they relate to an area where a Member State has and/or exercises jurisdictional rights; (b) they are in electronic format; (c) they are held by or on behalf of any of the following: (i) a public authority, having been produced or received by a public authority, or being managed or updated by that authority and falling within the scope of its public tasks; (ii) a third party to whom the network has been made available in accordance with Article 12; (d) they relate to one or more of the themes listed in Annex I, II or III. 2. In cases where multiple identical copies of the same spatial data set are held by or on behalf of various public authorities, this Directive shall apply only to the reference version from which the various copies are derived. 3. This Directive shall also cover the spatial data services relating to the data contained in the spatial data sets referred to in paragraph 1. 4. This Directive does not require collection of new spatial data. 5. In the case of spatial data sets which comply with the condition set out in paragraph 1(c), but in respect of which a third party holds intellectual property rights, the public authority may take action under this Directive only with the consent of that third party. 6. By way of derogation from paragraph 1, this Directive shall cover spatial data sets held by or on behalf of a public authority operating at the lowest level of government within a Member State only if the Member State has laws or regulations requiring their collection or dissemination. 7. The description of the existing data themes referred to in Annexes I, II and III may be adapted in accordance with the regulatory procedure with scrutiny referred to in Article 22(3), in order to take into account the evolving needs for spatial data in support of Community policies that affect the environment. CHAPTER II METADATA Article 5 1. Member States shall ensure that metadata are created for the spatial data sets and services corresponding to the themes listed in Annexes I, II and III, and that those metadata are kept up to date. 2. Metadata shall include information on the following: (a) the conformity of spatial data sets with the implementing rules provided for in Article 7(1); (b) conditions applying to access to, and use of, spatial data sets and services and, where applicable, corresponding fees; (c) the quality and validity of spatial data sets; (d) the public authorities responsible for the establishment, management, maintenance and distribution of spatial data sets and services; (e) limitations on public access and the reasons for such limitations, in accordance with Article 13. 3. Member States shall take the necessary measures to ensure that metadata are complete and of a quality sufficient to fulfil the purpose set out in point (6) of Article 3. 4. Rules for the implementation of this Article shall be adopted by 15 May 2008 in accordance with the regulatory procedure referred to in Article 22(2). These rules shall take account of relevant, existing international standards and user requirements, in particular with relation to validation metadata. Article 6 Member States shall create the metadata referred to in Article 5 in accordance with the following timetable: (a) not later than two years after the date of adoption of implementing rules in accordance with Article 5(4) in the case of the spatial data sets corresponding to the themes listed in Annexes I and II; (b) not later than five years after the date of adoption of implementing rules in accordance with Article 5(4) in the case of the spatial data sets corresponding to the themes listed in Annex III. CHAPTER III INTEROPERABILITY OF SPATIAL DATA SETS AND SERVICES Article 7 1. Implementing rules laying down technical arrangements for the interoperability and, where practicable, harmonisation of spatial data sets and services, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 22(3). Relevant user requirements, existing initiatives and international standards for the harmonisation of spatial data sets, as well as feasibility and cost-benefit considerations shall be taken into account in the development of the implementing rules. Where organisations established under international law have adopted relevant standards to ensure interoperability or harmonisation of spatial data sets and services, these standards shall be integrated, and the existing technical means shall be referred to, if appropriate, in the implementing rules mentioned in this paragraph. 2. As a basis for developing the implementing rules provided for in paragraph 1, the Commission shall undertake analyses to ensure that the rules are feasible and proportionate in terms of their likely costs and benefits and shall share the results of such analyses with the committee referred to in Article 22(1). Member States shall, on request, provide the Commission with the information necessary to enable it to undertake such analyses. 3. Member States shall ensure that all newly collected and extensively restructured spatial data sets and the corresponding spatial data services are available in conformity with the implementing rules referred to in paragraph 1 within two years of their adoption, and that other spatial data sets and services still in use are available in conformity with the implementing rules within seven years of their adoption. Spatial data sets shall be made available in conformity with the implementing rules either through the adaptation of existing spatial data sets or through the transformation services referred to point (d) of Article 11(1). 4. Implementing rules referred to in paragraph 1 shall cover the definition and classification of spatial objects relevant to spatial data sets related to the themes listed in Annex I, II or III and the way in which those spatial data are geo-referenced. 5. Representatives of Member States at national, regional and local level as well as other natural or legal persons with an interest in the spatial data concerned by virtue of their role in the infrastructure for spatial information, including users, producers, added value service providers or any coordinating body shall be given the opportunity to participate in preparatory discussions on the content of the implementing rules referred to in paragraph 1, prior to consideration by the Committee referred to in Article 22(1). Article 8 1. In the case of spatial data sets corresponding to one or more of the themes listed in Annex I or II, the implementing rules provided for in Article 7(1) shall meet the conditions laid down in paragraphs 2, 3 and 4 of this Article. 2. The implementing rules shall address the following aspects of spatial data: (a) a common framework for the unique identification of spatial objects, to which identifiers under national systems can be mapped in order to ensure interoperability between them; (b) the relationship between spatial objects; (c) the key attributes and the corresponding multilingual thesauri commonly required for policies which may have an impact on the environment; (d) information on the temporal dimension of the data; (e) updates of the data. 3. The implementing rules shall be designed to ensure consistency between items of information which refer to the same location or between items of information which refer to the same object represented at different scales. 4. The implementing rules shall be designed to ensure that information derived from different spatial data sets is comparable as regards the aspects referred to in Article 7(4) and in paragraph 2 of this Article. Article 9 The implementing rules provided for in Article 7(1) shall be adopted in accordance with the following timetable: (a) no later than 15 May 2009 in the case of the spatial data sets corresponding to the themes listed in Annex I; (b) no later than 15 May 2012 in the case of the spatial data sets corresponding to the themes listed in Annex II or III. Article 10 1. Member States shall ensure that any information, including data, codes and technical classifications, needed for compliance with the implementing rules provided for in Article 7(1) is made available to public authorities or third parties in accordance with conditions that do not restrict its use for that purpose. 2. In order to ensure that spatial data relating to a geographical feature, the location of which spans the frontier between two or more Member States, are coherent, Member States shall, where appropriate, decide by mutual consent on the depiction and position of such common features. CHAPTER IV NETWORK SERVICES Article 11 1. Member States shall establish and operate a network of the following services for the spatial data sets and services for which metadata have been created in accordance with this Directive: (a) discovery services making it possible to search for spatial data sets and services on the basis of the content of the corresponding metadata and to display the content of the metadata; (b) view services making it possible, as a minimum, to display, navigate, zoom in/out, pan, or overlay viewable spatial data sets and to display legend information and any relevant content of metadata; (c) download services, enabling copies of spatial data sets, or parts of such sets, to be downloaded and, where practicable, accessed directly; (d) transformation services, enabling spatial data sets to be transformed with a view to achieving interoperability; (e) services allowing spatial data services to be invoked. Those services shall take into account relevant user requirements and shall be easy to use, available to the public and accessible via the Internet or any other appropriate means of telecommunication. 2. For the purposes of the services referred to in point (a) of paragraph 1, as a minimum the following combination of search criteria shall be implemented: (a) keywords; (b) classification of spatial data and services; (c) the quality and validity of spatial data sets; (d) degree of conformity with the implementing rules provided for in Article 7(1); (e) geographical location; (f) conditions applying to the access to and use of spatial data sets and services; (g) the public authorities responsible for the establishment, management, maintenance and distribution of spatial data sets and services. 3. The transformation services referred to in point (d) of paragraph 1 shall be combined with the other services referred to in that paragraph in such a way as to enable all those services to be operated in conformity with the implementing rules provided for in Article 7(1). Article 12 Member States shall ensure that public authorities are given the technical possibility to link their spatial data sets and services to the network referred to in Article 11(1). This service shall also be made available upon request to third parties whose spatial data sets and services comply with implementing rules laying down obligations with regard, in particular, to metadata, network services and interoperability. Article 13 1. By way of derogation from Article 11(1), Member States may limit public access to spatial data sets and services through the services referred to in point (a) of Article 11(1) where such access would adversely affect international relations, public security or national defence. By way of derogation from Article 11(1), Member States may limit public access to spatial data sets and services through the services referred to in points (b) to (e) of Article 11(1), or to the e-commerce services referred to in Article 14(3), where such access would adversely affect any of the following: (a) the confidentiality of the proceedings of public authorities, where such confidentiality is provided for by law; (b) international relations, public security or national defence; (c) the course of justice, the ability of any person to receive a fair trial or the ability of a public authority to conduct an enquiry of a criminal or disciplinary nature; (d) the confidentiality of commercial or industrial information, where such confidentiality is provided for by national or Community law to protect a legitimate economic interest, including the public interest in maintaining statistical confidentiality and tax secrecy; (e) intellectual property rights; (f) the confidentiality of personal data and/or files relating to a natural person where that person has not consented to the disclosure of the information to the public, where such confidentiality is provided for by national or Community law; (g) the interests or protection of any person who supplied the information requested on a voluntary basis without being under, or capable of being put under, a legal obligation to do so, unless that person has consented to the release of the information concerned; (h) the protection of the environment to which such information relates, such as the location of rare species. 2. The grounds for limiting access, as provided for in paragraph 1, shall be interpreted in a restrictive way, taking into account for the particular case the public interest served by providing this access. In every particular case, the public interest served by disclosure shall be weighed against the interest served by limiting or conditioning the access. Member States may not, by virtue of points (a), (d), (f), (g) and (h) of paragraph 1, limit access to information on emissions into the environment. 3. Within this framework, and for the purposes of the application of point (f) of paragraph 1, Member States shall ensure that the requirements of Directive 95/46/EC are complied with. Article 14 1. Member States shall ensure that the services referred to in points (a) and (b) of Article 11(1) are available to the public free of charge. 2. By way of derogation from paragraph 1, Member States may allow a public authority supplying a service referred to in point (b) of Article 11(1) to apply charges where such charges secure the maintenance of spatial data sets and corresponding data services, especially in cases involving very large volumes of frequently updated data. 3. Data made available through the view services referred to in point (b) of Article 11(1) may be in a form preventing their re-use for commercial purposes. 4. Where public authorities levy charges for the services referred to in points (b), (c) or (e) of Article 11(1), Member States shall ensure that e-commerce services are available. Such services may be covered by disclaimers, click-licences or, where necessary, licences. Article 15 1. The Commission shall establish and operate an Inspire geo-portal at Community level. 2. Member States shall provide access to the services referred to in Article 11(1) through the Inspire geo-portal referred to in paragraph 1. Member States may also provide access to those services through their own access points. Article 16 Rules for implementation designed to amend non-essential elements of this Chapter by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 22(3), and shall in particular lay down the following: (a) technical specifications for the services referred to in Articles 11 and 12 and minimum performance criteria for those services, taking account of existing reporting requirements and recommendations adopted within the framework of Community environmental legislation, existing e-commerce services and technological progress; (b) the obligations referred to in Article 12. CHAPTER V DATA-SHARING Article 17 1. Each Member State shall adopt measures for the sharing of spatial data sets and services between its public authorities referred to in point (9)(a) and (b) of Article 3. Those measures shall enable those public authorities to gain access to spatial data sets and services, and to exchange and use those sets and services, for the purposes of public tasks that may have an impact on the environment. 2. The measures provided for in paragraph 1 shall preclude any restrictions likely to create practical obstacles, occurring at the point of use, to the sharing of spatial data sets and services. 3. Member States may allow public authorities that supply spatial data sets and services to license them to, and/or require payment from, the public authorities or institutions and bodies of the Community that use these spatial data sets and services. Any such charges and licenses must be fully compatible with the general aim of facilitating the sharing of spatial data sets and services between public authorities. Where charges are made, these shall be kept to the minimum required to ensure the necessary quality and supply of spatial data sets and services together with a reasonable return on investment, while respecting the self-financing requirements of public authorities supplying spatial data sets and services, where applicable. Spatial data sets and services provided by Member States to Community institutions and bodies in order to fulfil their reporting obligations under Community legislation relating to the environment shall not be subject to any charging. 4. The arrangements for the sharing of spatial data sets and services provided for in paragraphs 1, 2 and 3 shall be open to public authorities referred to in point (9)(a) and (b) of Article 3 of other Member States and to the institutions and bodies of the Community, for the purposes of public tasks that may have an impact on the environment. 5. The arrangements for the sharing of spatial data sets and services provided for in paragraphs 1, 2 and 3 shall be open, on a reciprocal and equivalent basis, to bodies established by international agreements to which the Community and Member States are parties, for the purposes of tasks that may have an impact on the environment. 6. Where the arrangements for the sharing of spatial data sets and services provided for in paragraphs 1, 2 and 3 are made available in accordance with paragraphs 4 and 5, these arrangements may be accompanied by requirements under national law conditioning their use. 7. By way of derogation from this Article, Member States may limit sharing when this would compromise the course of justice, public security, national defence or international relations. 8. Member States shall provide the institutions and bodies of the Community with access to spatial data sets and services in accordance with harmonised conditions. Implementing rules governing those conditions, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 22(3). These implementing rules shall fully respect the principles set out in paragraphs 1 to 3. CHAPTER VI COORDINATION AND COMPLEMENTARY MEASURES Article 18 Member States shall ensure that appropriate structures and mechanisms are designated for coordinating, across the different levels of government, the contributions of all those with an interest in their infrastructures for spatial information. These structures shall coordinate the contributions of, inter alia, users, producers, added-value service providers and coordinating bodies, concerning the identification of relevant data sets, user needs, the provision of information on existing practices and the provision of feedback on the implementation of this Directive. Article 19 1. The Commission shall be responsible for coordinating Inspire at Community level and shall be assisted for that purpose by relevant organisations and, in particular, by the European Environment Agency. 2. Each Member State shall designate a contact point, usually a public authority, to be responsible for contacts with the Commission in relation to this Directive. This contact point will be supported by a coordination structure, taking account of the distribution of powers and responsibilities within the Member State. Article 20 The implementing rules referred to in this Directive shall take due account of standards adopted by European standardisation bodies in accordance with the procedure laid down in Directive 98/34/EC, as well as international standards. CHAPTER VII FINAL PROVISIONS Article 21 1. Member States shall monitor the implementation and use of their infrastructures for spatial information. They shall make the results of this monitoring accessible to the Commission and to the public on a permanent basis. 2. No later than 15 May 2010 Member States shall send to the Commission a report including summary descriptions of: (a) how public sector providers and users of spatial data sets and services and intermediary bodies are coordinated, and of the relationship with the third parties and of the organisation of quality assurance; (b) the contribution made by public authorities or third parties to the functioning and coordination of the infrastructure for spatial information; (c) information on the use of the infrastructure for spatial information; (d) data-sharing agreements between public authorities; (e) the costs and benefits of implementing this Directive. 3. Every three years, and starting no later than 15 May 2013, Member States shall send to the Commission a report providing updated information in relation to the items referred to in paragraph 2. 4. Detailed rules for the implementation of this Article shall be adopted in accordance with the regulatory procedure referred to in Article 22(2). Article 22 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 23 By 15 May 2014 and every six years thereafter the Commission shall present to the European Parliament and to the Council a report on the implementation of this Directive based, inter alia, on reports from Member States in accordance with Article 21(2) and (3). Where necessary, the report shall be accompanied by proposals for Community action. Article 24 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 15 May 2009. When Member States adopt these 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 provisions of national law which they adopt in the field covered by this Directive. Article 25 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 26 This Directive is addressed to the Member States. Done at Strasbourg, 14 March 2007. For the European Parliament The President H.-G. PÖTTERING For the Council The President G. GLOSER (1) OJ C 221, 8.9.2005, p. 33. (2) Opinion of the European Parliament of 7 June 2005 (OJ C 124 E, 25.5.2006, p. 116), Council Common Position of 23 January 2006 (OJ C 126 E, 30.5.2006, p. 16) and Position of the European Parliament of 13 June 2006 (not yet published in the Official Journal). Decision of the Council of 29 January 2007 and legislative resolution of the European Parliament of 13 February 2007 (not yet published in the Official Journal). (3) OJ L 242, 10.9.2002, p. 1. (4) OJ L 41, 14.2.2003, p. 26. (5) OJ L 345, 31.12.2003, p. 90. (6) OJ L 138, 28.5.2002, p. 1. (7) OJ L 192, 28.7.2000, p. 36. (8) OJ L 324, 11.12.2003, p. 1. Regulation as amended by Regulation (EC) No 788/2004 (OJ L 138, 30.4.2004, p. 17). (9) 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). (10) OJ L 204, 21.7.1998, p. 37. Directive as last amended by the 2003 Act of Accession. (11) OJ L 120, 11.5.1990, p. 1. Regulation as last amended by Regulation (EC) No 1641/2003 of the European Parliament and of the Council (OJ L 245, 29.9.2003, p. 1). (12) OJ C 321, 31.12.2003, 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). ANNEX I SPATIAL DATA THEMES REFERRED TO IN ARTICLES 6(A), 8(1) AND 9(A) 1. Coordinate reference systems Systems for uniquely referencing spatial information in space as a set of coordinates (x, y, z) and/or latitude and longitude and height, based on a geodetic horizontal and vertical datum. 2. Geographical grid systems Harmonised multi-resolution grid with a common point of origin and standardised location and size of grid cells. 3. Geographical names Names of areas, regions, localities, cities, suburbs, towns or settlements, or any geographical or topographical feature of public or historical interest. 4. Administrative units Units of administration, dividing areas where Member States have and/or exercise jurisdictional rights, for local, regional and national governance, separated by administrative boundaries. 5. Addresses Location of properties based on address identifiers, usually by road name, house number, postal code. 6. Cadastral parcels Areas defined by cadastral registers or equivalent. 7. Transport networks Road, rail, air and water transport networks and related infrastructure. Includes links between different networks. Also includes the trans-European transport network as defined in Decision No 1692/96/EC of the European Parliament and of the Council of 23 July 1996 on Community Guidelines for the development of the trans-European transport network (1) and future revisions of that Decision. 8. Hydrography Hydrographic elements, including marine areas and all other water bodies and items related to them, including river basins and sub-basins. Where appropriate, according to the definitions set out in 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 (2) and in the form of networks. 9. Protected sites Area designated or managed within a framework of international, Community and Member States' legislation to achieve specific conservation objectives. (1) OJ L 228, 9.9.1996, p. 1. Decision as last amended by Council Regulation (EC) No 1791/2006 (OJ L 363, 20.12.2006, p. 1). (2) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No 2455/2001/EC (OJ L 331, 15.12.2001, p. 1). ANNEX II SPATIAL DATA THEMES REFERRED TO IN ARTICLES 6(A), 8(1) AND 9(B) 1. Elevation Digital elevation models for land, ice and ocean surface. Includes terrestrial elevation, bathymetry and shoreline. 2. Land cover Physical and biological cover of the earth's surface including artificial surfaces, agricultural areas, forests, (semi-)natural areas, wetlands, water bodies. 3. Orthoimagery Geo-referenced image data of the Earth's surface, from either satellite or airborne sensors. 4. Geology Geology characterised according to composition and structure. Includes bedrock, aquifers and geomorphology. ANNEX III SPATIAL DATA THEMES REFERRED TO IN ARTICLES 6(B) AND 9(B) 1. Statistical units Units for dissemination or use of statistical information. 2. Buildings Geographical location of buildings. 3. Soil Soils and subsoil characterised according to depth, texture, structure and content of particles and organic material, stoniness, erosion, where appropriate mean slope and anticipated water storage capacity. 4. Land use Territory characterised according to its current and future planned functional dimension or socio-economic purpose (e.g. residential, industrial, commercial, agricultural, forestry, recreational). 5. Human health and safety Geographical distribution of dominance of pathologies (allergies, cancers, respiratory diseases, etc.), information indicating the effect on health (biomarkers, decline of fertility, epidemics) or well-being of humans (fatigue, stress, etc.) linked directly (air pollution, chemicals, depletion of the ozone layer, noise, etc.) or indirectly (food, genetically modified organisms, etc.) to the quality of the environment. 6. Utility and governmental services Includes utility facilities such as sewage, waste management, energy supply and water supply, administrative and social governmental services such as public administrations, civil protection sites, schools and hospitals. 7. Environmental monitoring facilities Location and operation of environmental monitoring facilities includes observation and measurement of emissions, of the state of environmental media and of other ecosystem parameters (biodiversity, ecological conditions of vegetation, etc.) by or on behalf of public authorities. 8. Production and industrial facilities Industrial production sites, including installations covered by Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control (1) and water abstraction facilities, mining, storage sites. 9. Agricultural and aquaculture facilities Farming equipment and production facilities (including irrigation systems, greenhouses and stables). 10. Population distribution — demography Geographical distribution of people, including population characteristics and activity levels, aggregated by grid, region, administrative unit or other analytical unit. 11. Area management/restriction/regulation zones and reporting units Areas managed, regulated or used for reporting at international, European, national, regional and local levels. Includes dumping sites, restricted areas around drinking water sources, nitrate-vulnerable zones, regulated fairways at sea or large inland waters, areas for the dumping of waste, noise restriction zones, prospecting and mining permit areas, river basin districts, relevant reporting units and coastal zone management areas. 12. Natural risk zones Vulnerable areas characterised according to natural hazards (all atmospheric, hydrologic, seismic, volcanic and wildfire phenomena that, because of their location, severity, and frequency, have the potential to seriously affect society), e.g. floods, landslides and subsidence, avalanches, forest fires, earthquakes, volcanic eruptions. 13. Atmospheric conditions Physical conditions in the atmosphere. Includes spatial data based on measurements, on models or on a combination thereof and includes measurement locations. 14. Meteorological geographical features Weather conditions and their measurements; precipitation, temperature, evapotranspiration, wind speed and direction. 15. Oceanographic geographical features Physical conditions of oceans (currents, salinity, wave heights, etc.). 16. Sea regions Physical conditions of seas and saline water bodies divided into regions and sub-regions with common characteristics. 17. Bio-geographical regions Areas of relatively homogeneous ecological conditions with common characteristics. 18. Habitats and biotopes Geographical areas characterised by specific ecological conditions, processes, structure, and (life support) functions that physically support the organisms that live there. Includes terrestrial and aquatic areas distinguished by geographical, abiotic and biotic features, whether entirely natural or semi-natural. 19. Species distribution Geographical distribution of occurrence of animal and plant species aggregated by grid, region, administrative unit or other analytical unit. 20. Energy resources Energy resources including hydrocarbons, hydropower, bio-energy, solar, wind, etc., where relevant including depth/height information on the extent of the resource. 21. Mineral resources Mineral resources including metal ores, industrial minerals, etc., where relevant including depth/height information on the extent of the resource. (1) OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the Council (OJ L 33, 4.2.2006, p. 1).

Summary: The EU’s infrastructure for spatial information (Inspire) The EU’s infrastructure for spatial information (Inspire) SUMMARY OF: Directive 2007/2/EC establishing an infrastructure for spatial information in the European Community (Inspire) WHAT IS THE AIM OF THE DIRECTIVE? It lays down general rules setting up an infrastructure for spatial information* in Europe for the purposes of European Union (EU) environmental policies and for policies or activities which may have an impact on the environment. The European infrastructure builds on that of spatial information that is established and operated by EU countries. KEY POINTS The legislation applies to spatial data that: cover areas where EU countries have jurisdictional rights; exist in electronic format; are held by, or on behalf of, a public authority or another body using the network; relate to environmental information. EU countries are responsible for ensuring that metadata* are created for the various environmental spatial data* sets and services listed in the legislation. Depending on the subject, these must be established within 2 or 5 years of the rules coming into force. The European Commission, assisted by a committee, adopts the technical arrangements to ensure spatial data sets and services can work together and harmonises them where this can be put into practice. These implementing rules were to be adopted no later than 15 May 2009 or 15 May 2012, depending on the subject. EU countries must establish and operate a network with the following services: Discovery: to search for spatial data sets and services. View: to display, navigate, zoom in and out, pan or overlay viewable spatial data sets. Download: where this can be put into practice, to access directly and download copies of spatial data sets. Transformation: to transform spatial data sets to achieve interoperability. Public authorities must be able to link their spatial data sets and services to the national network. EU countries may limit public access to spatial data sets and services for various reasons, such as legal confidentiality, public security, intellectual property rights or protection of the environment. The Commission operates an EU Inspire geoportal. This gives access to the national networks. The legislation does not require the collection of new spatial data. Evaluation In August 2016, the Commission published its report on implementation of the INSPIRE Directive (2007/2/EC). Together with this report, it presented a detailed evaluation which was carried out in the context of its Regulatory Fitness (REFIT) programme. This evaluation has demonstrated that the INSPIRE directive is still largely fit-for purpose, but that further efforts are needed at EU and at EU country level to close the significant implementation gaps and to reap the benefits of the directive. Moreover, specific issues needing attention concern the data policy provisions (Article 17 of the directive) and requirements and use of some of the technical specifications in the implementing rules (including the streamlining of reporting). As a consequence, the Commission has issued a number of recommendations and actions which it will now implement in close collaboration with the EU countries in a Maintenance and Implementation Work Programme 2016-2020. FROM WHEN DOES THE DIRECTIVE APPLY? It has applied since 15 May 2007. EU countries had to incorporate it into national law by 15 May 2009. BACKGROUND For more information, see: ‘Inspire Directive’ on the European Commission's website. * KEY TERMS Infrastructure for spatial information: covers metadata, spatial data sets and spatial data services; network services and technologies; agreements on sharing, access and use; and coordination and monitoring mechanisms, processes and procedures. Metadata: information describing spatial data sets and spatial data services, making it possible to discover, inventory and use them. Spatial data: any data with direct or indirect reference to a specific location or geographical area, such as addresses, transport networks, elevation and land use. MAIN DOCUMENT 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, pp. 1-14) RELATED DOCUMENTS Commission Regulation (EC) No 1205/2008 of 3 December 2008 implementing Directive 2007/2/EC of the European Parliament and of the Council as regards metadata (OJ L 326, 4.12.2008, pp. 12-30). Successive amendments to Regulation (EC) No 1205/2008 have been incorporated into the basic text. This consolidated version is of documentary value only. Commission Decision 2009/442/EC of 5 June 2009 implementing Directive 2007/2/EC of the European Parliament and of the Council as regards monitoring and reporting (OJ L 148, 11.6.2009, pp. 18-26). 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) Commission Regulation (EC) No 976/2009 of 19 October 2009 implementing Directive 2007/2/EC of the European Parliament and of the Council as regards the Network Services (OJ L 274, 20.10.2009, pp. 9-18). See consolidated version. Commission Regulation (EU) No 268/2010 of 29 March 2010 implementing Directive 2007/2/EC of the European Parliament and of the Council as regards the access to spatial data sets and services of the Member States by Community institutions and bodies under harmonised conditions (OJ L 83, 30.3.2010, pp. 8-9) Commission Regulation (EU) No 1089/2010 of 23 November 2010 implementing Directive 2007/2/EC of the European Parliament and of the Council as regards interoperability of spatial data sets and services (OJ L 323, 8.12.2010, pp. 11-102). See consolidated version. Commission Regulation (EU) No 1088/2010 of 23 November 2010 amending Regulation (EC) No 976/2009 as regards download services and transformation services (OJ L 323, 8.12.2010, pp. 1-10) Commission Regulation (EU) No 102/2011 of 4 February 2011 amending Regulation (EU) No 1089/2010 implementing Directive 2007/2/EC of the European Parliament and of the Council as regards interoperability of spatial data sets and services (OJ L 31, 5.2.2011, pp. 13-34) Commission Regulation (EU) No 1253/2013 of 21 October 2013 amending Regulation (EU) No 1089/2010 implementing Directive 2007/2/EC as regards interoperability of spatial data sets and services (OJ L 331, 10.12.2013, pp. 1-267) Commission Regulation (EU) No 1311/2014 of 10 December 2014 amending Regulation (EC) No 976/2009 as regards the definition of an Inspire metadata element (OJ L 354, 11.12.2014, pp. 6-7) Commission Regulation (EU) No 1312/2014 of 10 December 2014 amending Regulation (EU) No 1089/2010 implementing Directive 2007/2/EC of the European Parliament and of the Council as regards interoperability of spatial data services (OJ L 354, 11.12.2014, pp. 8-16) 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, pp. 1-37) Directive 2010/40/EU of the European Parliament and of the Council of 7 July 2010 on the framework for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with other modes of transport (OJ L 207, 6.8.2010, pp. 1-13) 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, pp. 44-66) 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, pp. 135-145) last update 21.02.2017


30.6.2007 EN Official Journal of the European Union L 172/71 COMMISSION DIRECTIVE 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (Text with EEA relevance) (Codified version) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to 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 (1), and in particular Article 5 thereof, Whereas: (1) Commission Directive 93/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified. (2) The Community measures envisaged by this Directive are not only necessary but also indispensable for the attainment of the objectives of the internal market. These objectives cannot be achieved by Member States individually. Furthermore, their attainment at Community level is already provided for by Regulation (EC) No 1935/2004. (3) In order to achieve the objective laid down in Article 3(1) of Regulation (EC) No 1935/2004 in the case of regenerated cellulose film, the suitable instrument was a specific directive within the meaning of Article 5 of that Regulation. (4) Synthetic casings of regenerated cellulose should be the subject of specific provisions. (5) The method for determining the absence of migration of colouring matters should be established at a later stage. (6) Until criteria of purity and methods of analysis have been drawn up, national provisions should remain in force. (7) The establishment of a list of approved substances, accompanied by limits to the quantities to be used, is sufficient in principle in this specific case to achieve the objective laid down in Article 3(1) of Regulation (EC) No 1935/2004. (8) However, the bis(2-hydroxyethyl)ether (= diethyleneglycol) and ethanediol (= monoethyleneglycol) can migrate extensively to certain foodstuffs and therefore in order to avoid this possibility, as a preventive measure, it is more appropriate to lay down definitively the maximum authorised quantity of such substances in foodstuffs which have been in contact with regenerated cellulose film. (9) To protect the health of the consumer, direct contact between foodstuffs and the printed surfaces of regenerated cellulose film should be avoided. (10) The written declaration referred to in Article 16(1) of Regulation (EC) No 1935/2004 should be provided for in the event of professional use of regenerated cellulose film for materials and articles intended to come into contact with foodstuffs, except those which are, by their nature, intended for this use. (11) The rules to be applied to the regenerated cellulose films should be specific to the nature of the layer in contact with the foodstuff. Accordingly, the requirements for regenerated cellulose films coated with coatings consisting of plastics should be different from those provided for regenerated cellulose films uncoated or coated with coatings derived from cellulose. (12) Only authorised substances should be used in the manufacture of all the types of regenerated cellulose films, including regenerated cellulose films coated with plastics. (13) In the case of regenerated cellulose films coated with coatings consisting of plastics, the layer in contact with foodstuffs consists of a material similar to plastic materials and articles intended to come into contact with foodstuffs. Therefore it is appropriate that the rules provided for in Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs (4) apply also to such films. (14) In the interest of consistency of Community legislation, the verification of compliance of plastic-coated regenerated cellulose films with the migration limits set by Directive 2002/72/EC should be carried out according to the rules laid down in Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs (5) and Council Directive 85/572/EEC of 19 December 1985 laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (6). (15) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health. (16) This Directive should be 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 Annex III, Part B, HAS ADOPTED THIS DIRECTIVE: Article 1 1. This Directive is a specific directive within the meaning of Article 5 of Regulation (EC) No 1935/2004. 2. This Directive shall apply to regenerated cellulose film within the meaning of the description given in Annex I which is intended to come into contact with foodstuffs or which, by virtue of its purpose, does come into such contact and which either: (a) constitutes a finished product in itself; or (b) forms part of a finished product containing other materials. 3. This Directive shall not apply to synthetic casings of regenerated cellulose. Article 2 The regenerated cellulose films referred to in Article 1(2) shall belong to one of the following types: (a) uncoated regenerated cellulose film; (b) coated regenerated cellulose film with coating derived from cellulose; or (c) coated regenerated cellulose film with coating consisting of plastics. Article 3 1. Regenerated cellulose films referred to in Article 2(a) and (b) shall be manufactured using only substances or groups of substances listed in Annex II subject to the restrictions set out therein. 2. By way of derogation from paragraph 1, substances other than those listed in Annex II may be used when these substances are employed as colouring matter (dyes and pigments) or as adhesives, provided that there is no trace of migration of the substances into or onto foodstuffs, detectable by a validated method. Article 4 1. Regenerated cellulose film referred to in Article 2(c) shall be manufactured, prior to coating, using only substances or groups of substances listed in the first part of Annex II, subject to the restrictions set out therein. 2. The coating to be applied to the regenerated cellulose film referred to in paragraph 1 shall be manufactured using only substances or groups of substances listed in Annexes II to VI to Directive 2002/72/EC, subject to the restrictions set out therein. 3. Without prejudice to paragraph 1, materials and articles made of regenerated cellulose film referred to in Article 2(c) shall comply with Articles 2, 7 and 8 of Directive 2002/72/EC. Article 5 Printed surfaces of regenerated cellulose film shall not come into contact with the foodstuffs. Article 6 1. At the marketing stages other than the retail stages, materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 16(1) of Regulation (EC) No 1935/2004. 2. Paragraph 1 shall not apply to materials and articles made of regenerated cellulose film which by their nature are clearly intended to come into contact with foodstuffs. 3. Where special conditions of use are indicated, the material or article made of regenerated cellulose film shall be labelled accordingly. Article 7 Directive 93/10/EEC, as amended by the Directives listed in Annex III, Part A, is repealed, 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 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 in Annex IV. Article 8 This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union. Article 9 This Directive is addressed to the Member States. Done at Brussels, 29 June 2007. For the Commission The President José Manuel BARROSO (1) OJ L 338, 13.11.2004, p. 4. (2) OJ L 93, 17.4.1993, p. 27. Directive as last amended by Directive 2004/14/EC (OJ L 27, 30.1.2004, p. 48). (3) See Annex III, Part A. (4) OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive 2007/19/EC (OJ L 91, 31.3.2007, p. 17). (5) OJ L 297, 23.10.1982, p. 26. Directive as last amended by Commission Directive 97/48/EC (OJ L 222, 12.8.1997, p. 10). (6) OJ L 372, 31.12.1985, p. 14. Directive as last amended by Commission Directive 2007/19/EC. ANNEX I DESCRIPTION OF REGENERATED CELLULOSE FILM Regenerated cellulose film is a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides. ANNEX II LIST OF SUBSTANCES AUTHORISED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM NB: — The percentages in this Annex, first and second parts, are expressed in weight/weight (w/w) and are calculated in relation to the quantity of anhydrous uncoated regenerated cellulose film. — The usual technical denominations are given in square brackets. — The substances used shall be of good technical quality as regards the purity criteria. FIRST PART Uncoated regenerated cellulose film Denominations Restrictions A. Regenerated cellulose Not less than 72 % (w/w) B. Additives 1. Softeners Not more than 27 % (w/w) in total — Bis (2-hydroxyethyl) ether [= diethyleneglycol] Only for films intended to be coated and then used for foodstuffs which are not moist, namely which do not contain water which is physically free at the surface. The total amount of bis(2-hydroxyethyl)ether and ethanediol present in foodstuffs that have been in contact with film of this type may not exceed 30 mg/kg of the foodstuff. — Ethanediol [= monoethyleneglycol] — 1,3-butanediol — Glycerol — 1,2-propanediol [= 1,2 propyleneglycol] — Polyethylene oxide [= polyethyleneglycol] Average molecular weight between 250 and 1 200. — 1,2-polypropylene oxide [= 1,2 polypropyleneglycol] Average molecular weight not greater than 400 and free 1,3-propanediol content not greater than 1 % (w/w) in substance. — Sorbitol — Tetraethyleneglycol — Triethyleneglycol — Urea 2. Other additives Not more than 1 % (w/w) in total. First class The quantity of the substance or group of substances in each indent may not exceed 2 mg/dm2 of the uncoated film. — Acetic acid and its NH4, Ca, Mg, K and Na salts — Ascorbic acid and its NH4, Ca, Mg, K and Na salts — Benzoic acid and sodium benzoate — Formic acid and its NH4, Ca, Mg, K and Na salts — Linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and also behenic and ricinoleic acids and the NH4, Ca, Mg, K, Na, Al, Zn salts of these acids — Citric, d- and l-lactic, maleic, l-tartaric acids and their Na and K salts — Sorbic acid and its NH4, Ca, Mg, K and Na salts — Amides of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and also the amides of behenic and ricinoleic acids — Natural edible starches and flours — Edible starches and flours modified by chemical treatment — Amylose — Calcium and magnesium carbonates and chlorides — Esters of glycerol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and/or with adipic, citric, 12-hydroxystearic (oxystearin), ricinoleic acids — Esters of polyoxyethylene (8 to 14 oxyethylene groups) with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive — Esters of sorbitol with linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive — Mono-and/or di-esters of stearic acid with ethanediol and/or bis (2-hydroxyethyl) ether and/or triethylene glycol — Oxides and hydroxides of aluminium, calcium, magnesium and silicon and silicates and hydrated silicates of aluminium, calcium, magnesium and potassium — Polyethylene oxide [= polyethyleneglycol] Average molecular weight between 1 200 and 4 000. — Sodium propionate Second class The total quantity of the substances may not exceed 1 mg/dm2 of the uncoated film and the quantity of the substance or group of substances in each indent may not exceed 0,2 mg/dm2 (or a lower limit where one is specified) of the uncoated film. — Sodium alkyl (C8-C18) benzene sulphonate — Sodium isopropyl naphthalene sulphonate — Sodium alkyl (C8-C18) sulphate — Sodium alkyl (C8-C18) sulphonate — Sodium dioctylsulphosuccinate — Distearate of dihydroxyethyl diethylene triamine monoacetate Not more than 0,05 mg/dm2 of the uncoated film. — Ammonium, magnesium and potassium lauryl sulphates — N,N′-distearoyl diaminoethane, N,N′-dipalmitoyl diaminoethane and N,N′-dioleoyl diaminoethane — 2-heptadecyl-4,4-bis(methylene-stearate) oxazoline — Polyethylene-aminostearamide ethylsulphate Not more than 0,1 mg/dm2 of the uncoated film. Third class — Anchoring agent The total quantity of substances may not exceed 1 mg/dm2 of the uncoated film. — Condensation product of melamine-formaldehyde unmodified, or which may be modified with one or more of the following products: butanol, diethylenetriamine, ethanol, triethylenetetramine, tetraethylenepentamine, tri-(2-hydroxyethyl) amine, 3,3′-diaminodipropylamine, 4,4′-diaminodibutylamine Free formaldehyde content not greater than 0,5 mg/dm2 of the uncoated film. Free melamine content not greater than 0,3 mg/dm2 of the uncoated film. — Condensation product of melamine-urea-formaldehyde modified with tris-(2-hydroxyethyl)amine Free formaldehyde content not greater than 0,5 mg/dm2 of the uncoated film. Free melamine content not greater than 0,3 mg/dm2 of the uncoated film. — Cross-linked cationic polyalkyleneamines: (a) polyamide-epichlorhydrin resin based on diaminopropylmethylamine and epichlorhydrin; (b) polyamide-epichlorhydrin resin based on epichlorhydrin, adipic acid, caprolactam, diethylenetriamine and/or ethylenediamine; (c) polyamide-epichlorhydrin resin based on adipic acid, diethylenetriamine and epichlorhydrin, or a mixture of epichlorhydrin and ammonia; (d) polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, dimethyl adipate and diethylenetriamine; (e) polyamide-polyamine-epichlorhydrin resin based on epichlorhydrin, adipamide and diaminopropylmethylamine In accordance with Community directives and in their absence, with national legislation, pending the adoption of Community directives. — Polyethyleneamines and polyethyleneimines Not more than 0,75 mg/dm2 of the uncoated film. — Condensation product of urea-formaldehyde unmodified, or which may be modified with one or of the following products: aminomethylsulphonic acid, sulphanilic acid, butanol, diaminobutane, diaminodiethylamine, diaminodipropylamine, diaminopropane, diethylenetriamine, ethanol, guanidine, methanol, tetraethylenepentamine, triethylenetetramine, sodium sulphite Free formaldehyde content not greater than 0,5 mg/dm2 of the uncoated film. Fourth class The total quantity of substances may not exceed 0,01 mg/dm2 of the uncoated film. — Products resulting from the reaction of the amines of edible oils with polyethylene oxide — Monoethanolamine lauryl sulphate SECOND PART Coated regenerated cellulose film Denominations Restrictions A. Regenerated cellulose See first part. B. Additives See first part. C. Coating 1. Polymers The total quantity of substances may not exceed 50 mg/dm2 of the coating on the side in contact with foodstuffs. — Ethyl, hydroxyethyl, hydroxypropyl and methyl ethers of cellulose — Cellulose nitrate Not more than 20 mg/dm2 of the coating on the side in contact with foodstuffs; nitrogen content between 10,8 % (w/w) and 12,2 % (w/w) in the cellulose nitrate. 2. Resins The total quantity of substances may not exceed 12,5 mg/dm2 of the coating on the side in contact with foodstuffs and solely for the preparation of regenerated cellulose films with cellulose nitrate based coatings. — Casein — Colophony and/or its products of polymerization, hydrogenation, or disproportionation and their esters of methyl, ethyl or C2 to C6 polyvalent alcohols, or mixtures of these alcohols — Colophony and/or its products of polymerization, hydrogenation, or disproportionation condensed with acrylic, maleic, citric, fumaric and/or phthalic acids and/or 2,2 bis (4-hydroxyphenyl) propane formaldehyde and esterified with methyl ethyl or C2 to C6 polyvalent alcohols or mixtures of these alcohols — Esters derived from bis(2-hydroxyethyl) ether with addition products of betapinene and/or dipentene and/or diterpene and maleic anhydride — Edible gelatine — Castor oil and its products of dehydration or hydrogenation and its condensation products with polyglycerol, adipic, citric, maleic, phthalic and sebacic acids — Natural gum [= damar] — Poly-beta-pinene [= terpenic resins] — Urea-formaldehyde resins (see anchoring agents) 3. Plasticisers The total quantity of substances may not exceed 6 mg/dm2 of the coating on the side in contact with foodstuffs. — Acetyl tributyl citrate — Acetyl tri(2-ethylhexyl) citrate — Di-isobutyl adipate — Di-n-butyl adipate — Di-n-hexyl azelate — Dicyclohexyl phthalate Not more than 4,0 mg/dm2 of the coating on the side in contact with foodstuffs. — 2-ethylhexyl diphenyl phosphate (synonym: phosphoric acid diphenyl 2 ethylhexyl ester) The amount of 2-ethylhexyl diphenyl phosphate shall not exceed: (a) 2,4 mg/kg of the foodstuff in contact with this type of film; or (b) 0,4 mg/dm2 in the coating on the side in contact with foodstuffs. — Glycerol monoacetate [= monoacetin] — Glycerol diacetate [= diacetin] — Glycerol triacetate [= triacetin] — Di-butyl sebacate — Di-n-butyl tartrate — Di-isobutyl tartrate 4. Other additives The total quantity of substances may not exceed 6 mg/dm2 in the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs. 4.1. Additives listed in the first part Same restrictions as in the first part (however the quantities in mg/dm2 refer to the uncoated regenerated cellulose film, inclusive of the coating on the side in contact with foodstuffs). 4.2. Specific coating additives The quantity of the substance or group of substances in each indent may not exceed 2 mg/dm2 (or a lower limit where one is specified) of the coating on the side in contact with foodstuffs. — 1-hexadecanol and 1-octadecanol — Esters of linear fatty acids, saturated or unsaturated, with an even number of carbon atoms from 8 to 20 inclusive and of ricinoleic acid with ethyl, butyl, amyl and oleyl linear alcohols — Montan waxes, comprising purified montanic (C26 to C32) acids and/or their esters with ethanediol and/or 1,3 butanediol and/or their calcium and potassium salts — Carnauba wax — Beeswax — Esparto wax — Candelilla wax — Dimethylpolysiloxane Not more than 1 mg/dm2 of the coating on the side in contact with foodstuffs. — Epoxidised soya-bean oil (oxirane content 6 to 8 %) — Refined paraffin and microcrystalline waxes — Pentaerythritol tetrastearate — Mono and bis(octadecyldiethyleneoxide)-phosphates Not more than 0,2 mg/dm2 of the coating on the side in contact with foodstuffs. — Aliphatic acids (C8 to C20) esterified with mono- or di-(2-hydroxyethyl)amine — 2- and 3-tert.butyl-4-hydroxyanisole [= butylated hydroxyanisole — BHA] Not more than 0,06 mg/dm2 of the coating on the side in contact with foodstuffs. — 2,6-di-tert.butyl-4-methylphenol [= butylated hydroxytoluene — BHT] Not more than 0,06 mg/dm2 of the coating on the side in contact with foodstuffs. — Di-n-octyltin-bis(2-ethylhexyl) maleate Not more than 0,06 mg/dm2 of the coating on the side in contact with foodstuffs. 5. Solvents The total quantity of substances may not exceed 0,6 mg/dm2 of the coating on the side in contact with foodstuffs. — Butyl acetate — Ethyl acetate — Isobutyl acetate — Isopropyl acetate — Propyl acetate — Acetone — 1-butanol — Ethanol — 2-butanol — 2-propanol — 1-propanol — Cyclohexane — Ethyleneglycol monobutyl ether — Ethyleneglycol monobutyl ether acetate — Methyl ethyl ketone — Methyl isobutyl ketone — Tetrahydrofuran — Toluene Not more than 0,06 mg/dm2 of the coating on the side in contact with foodstuffs. ANNEX III PART A Repealed Directive with list of its successive amendments (referred to in Article 7) Commission Directive 93/10/EEC (OJ L 93, 17.4.1993, p. 27). Commission Directive 93/111/EC (OJ L 310, 14.12.1993, p. 41). Commission Directive 2004/14/EC (OJ L 27, 30.1.2004, p. 48). PART B List of time-limits for transposition into national law and application (referred to in Article 7) Directive Time-limit for transposition Date of application 93/10/EEC 1 January 1994 1 January 1994 (1) 1 January 1994 (2) 1 January 1995 (3) 93/111/EC — — 2004/14/EC 29 July 2005 29 July 2005 (4) 29 January 2006 (5) (1) In accordance with the first indent of Article 5(1) of Directive 93/10/EEC: ‘Member States shall permit, as from 1 January 1994, the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs complying with this Directive.’ (2) In accordance with the second indent of Article 5(1) of Directive 93/10/EEC: ‘Member States shall prohibit, as from 1 January 1994, the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs and which complies with neither this Directive nor Directive 83/229/EEC, other than film which Directive 92/15/EEC prohibits as from 1 July 1994.’ (3) In accordance with the third indent of Article 5(1) of Directive 93/10/EEC: ‘Member States shall prohibit, as from 1 January 1995, the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs and which does not comply with this Directive but did comply with Directive 83/229/EEC.’ (4) In accordance with Article 2(1)(a) of Directive 2004/14/EC: ‘Member States shall apply those provisions in such a way as to permit the trade in and use of regenerated cellulose film which is intended to come into contact with foodstuffs complying with this Directive, from 29 July 2005.’ (5) In accordance with Article 2(1)(b) of Directive 2004/14/EC: ‘Member States shall apply those provisions in such a way as to prohibit the manufacture and importation into the Community of regenerated cellulose film which is intended to come into contact with foodstuffs and which does not comply with the provisions of this Directive as from 29 January 2006.’ ANNEX IV Correlation table Directive 93/10/EEC This Directive Article 1(1) and (2) Article 1(1) and (2) Article 1(3), introductory wording, point (b) Article 1(3) Article 1a Article 2 Article 2 Article 3 Article 2a Article 4 Article 3 Article 5 Article 4 Article 6 Article 5 — Article 6 — — Article 7 — Article 8 Article 7 Article 9 Annex I Annex I Annex II Annex II Annex III — — Annex III — Annex IV

Summary: Regenerated cellulose film wrappers in contact with food Regenerated cellulose film wrappers in contact with food SUMMARY OF: Directive 2007/42/EC on materials and articles made of regenerated cellulose film that come into contact with food SUMMARY WHAT DOES THIS DIRECTIVE DO? It is a specific directive provided for by Regulation (EC) No 1935/2004 concerning materials and articles intended to come into contact with food. It defines regenerated cellulose film*. It lays down a list of substances authorised in the manufacture of regenerated cellulose film, as well as quantities not to be exceeded so as to protect consumers’ health. KEY POINTS Scope The directive applies to regenerated cellulose film — either in the form of a finished product in itself or part of a finished product containing other materials — which is intended to come into contact or placed in contact with food. It covers the following categories: 1.uncoated regenerated cellulose film; 2.coated regenerated cellulose film with coating derived from cellulose; or 3.coated regenerated cellulose film with coating consisting of plastics. It does not apply to synthetic casings of regenerated cellulose. List of authorised substances The directive’s Annex II lays down a list of substances authorised in the manufacture of regenerated cellulose film, along with restrictions of use. Regenerated cellulose films which are uncoated or coated with plastics may be manufactured with substances other than those specified in Annex II if they are used as colouring matter or as adhesives, provided that there is no trace of migration of the substances into or on to food. Regenerated cellulose films which are coated with plastics must comply with Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with foodstuffs. Printed surfaces of regenerated cellulose film must not come into contact with the foodstuffs. Marketing and labelling At the marketing stage, materials and articles made of regenerated cellulose film — which are intended to come into contact with foodstuffs — must be accompanied by a written declaration, in line with Regulation (EC) No 1935/2004. However, where such materials or articles are, by their nature, clearly intended to come into contact with foodstuffs, they are not subject to this obligation. Where special conditions of use are indicated, the material or article made of regenerated cellulose film must be labelled accordingly. FROM WHEN DOES THE DIRECTIVE APPLY? It entered into force on 20 July 2007. BACKGROUND Food Contact Materials — EU legislation European Union Reference Laboratories (EURL) — Food Contact Materials KEY TERM * Regenerated cellulose film: a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton. Regenerated cellulose film may be coated on one or both sides. ACT Commission Directive 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (OJ L 172, 30.6.2007, pp. 71-82) RELATED ACTS 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, pp. 4-17). The successive amendments and corrections to Regulation (EC) No 1935/2004 have been incorporated into the original text. This consolidated version is for reference only. Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, pp. 1-89). See consolidated version. last update 02.12.2015