EUR-Lex - 32004R0870 - EN Avis juridique important | 32004R0870 Council Regulation (EC) No 870/2004 of 24 April 2004 establishing a Community programme on the conservation, characterisation, collection and utilisation of genetic resources in agriculture and repealing Regulation (EC) No 1467/94 (Text with EEA relevance) Official Journal L 162 , 30/04/2004 P. 0018 - 0028 Council Regulation (EC) No 870/2004of 24 April 2004establishing a Community programme on the conservation, characterisation, collection and utilisation of genetic resources in agriculture and repealing Regulation (EC) No 1467/94(Text with EEA relevance)THE COUNCIL OF THE EUROPEAN UNION,Having regard to the Treaty establishing the European Community, and in particular Article 37 thereof,Having regard to the proposal from the Commission,Having regard to the opinion of the European Parliament,Having regard to the opinion of the European Economic and Social Committee,Whereas:(1) Biological and genetic diversity in agriculture is essential to the sustainable development of agricultural production and of rural areas. The necessary measures should therefore be taken to conserve, characterise, collect and utilise the potential of that diversity in a sustainable way to promote the aims of the common agricultural policy (CAP).(2) The conservation and sustainable use of genetic resources in agriculture also contributes to the aims of the Convention on Biological Diversity approved by the Community by Council Decision 93/626/EEC(1) and the related Community biodiversity strategy which includes an action plan for biodiversity conservation and the protection of genetic resources in agriculture. It is also a major objective of the FAO's Global Plan of Action for the Conservation and Sustainable Utilisation of Plant Genetic Resources for Food and Agriculture and of the International Treaty on Plant Genetic Resources for Food and Agriculture, which the Commission and the Member States signed on 6 June 2002.(3) The wide range of activities carried out in the Member States (by a public sector body or natural or legal persons) and by various international organisations and programmes such as FAO, the European Cooperative Programme for Crop Genetic Resources Networks (ECP/GR), the Consultative Group on International Agricultural Research (CGIAR), the Global Forum on Agricultural Research (GFAR), the Agricultural Research for Development (ARD) regional and subregional organisations supported by the Community, the European Regional Focal Point (ERFP) of National Coordinators for the Management of Farm Animal Genetic Resources, the European Forest Genetic Resources Programme (Euforgen) and the related commitments of the ongoing Ministerial Conference on the protection of forests in Europe (MCPFE) to which the Community is signatory call for an effective information exchange and close coordination between the Community main actors and with the relevant organisations throughout the world with regard to the conservation, characterisation, collection and utilisation of genetic resources in agriculture so as to enhance their positive impact on agriculture.(4) The work undertaken on the conservation, characterisation, collection and utilisation of genetic resources in agriculture can help maintain biological diversity, improve the quality of agricultural products, contribute to increase diversification in rural areas and reduce inputs and agricultural production costs by promoting a sustainable agricultural production and contributing to the sustainable development of rural areas.(5) The ex situ and in situ conservation of genetic resources in agriculture (including in situ/on-farm conservation and development) should be promoted. This should cover all plant, microbial and animal genetic resources that are or could prove useful for agriculture and rural development, including forest genetic resources, in line with the needs of the CAP, with a view to conserving genetic resources and increasing the use of under-utilised breeds and varieties in agricultural production.(6) Knowledge of the genetic resources available in the Community, their origins and their characteristics still needs to be improved. Relevant information on existing facilities and activities implemented at national or regional level regarding the conservation, characterisation, collection and utilisation of genetic resources in agriculture in each Member State should be gathered and made available to the other Member States and at Community, as well as at international level, particularly the developing countries, in accordance with the international Treaties and Agreements.(7) Development of decentralised, permanent and widely accessible web-based inventories collecting such knowledge and ensuring its availability at Community and international level should be promoted, with particular reference to the ongoing efforts to develop an inventory of ex situ collections held in European gene banks (the EPGRIS - European Plant Genetic Resources Information Infrastructure "EURISCO", funded by the fifth framework programme).(8) The Community should complement and promote the efforts made in the Member States for the conservation and sustainable use of biological diversity in agriculture. Added value at Community level should be promoted by concerting existing actions and supporting the development of new trans-border initiatives involving the conservation, characterisation, collection and utilisation of genetic resources in agriculture.(9) Provision should therefore be made for measures that complement or go beyond the scope, as regards beneficiaries and/or eligible actions for funding of Council Regulation (EC) No 1257/1999 of 17 May 1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF)(2).(10) In order to contribute to the achievement of those aims, a Community programme was established under Council Regulation (EC) No 1467/94 of 20 June 1994 on the conservation, characterisation, collection and utilisation of genetic resources in agriculture(3), for a period of five years. That programme terminated on 31 December 1999 and should be replaced by a new Community programme. Regulation (EC) No 1467/94 should therefore be repealed.(11) Selection and implementation of measures under the new Community programme should take into account research, technological development and demonstration activities supported either at national level or under the framework programmes of the European Community for research, technological development and demonstration activities. The marketing of seed and plant propagating material to be utilised under the new programme should be without prejudice to Council Directives 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed(4), 66/402/EEC of 14 June 1966 on the marketing of cereal seed(5), 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative propagation of the vine(6), 92/33/EEC of 28 April 1992 on the marketing of vegetable propagating and planting material, other than seed(7), 92/34/EEC of 28 April 1992 on the marketing of fruit plant propagating material and fruit plants intended for fruit production(8), 98/56/EC of 20 July 1998 on the marketing of propagating material of ornamental plants(9), 1999/105/EC of 22 December 1999 on the marketing of forest reproductive material(10), 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species(11), 2002/54/EC of 13 June 2002 on the marketing of beet seed(12), 2002/55/EC of 13 June 2002 on the marketing of vegetable seed(13), 2002/56/EC of 13 June 2002 on the marketing of seed potatoes(14), 202/57/EC of 13 June 2002 on the marketing of seed oil and fibre plants(15).(12) The Agreement on the European Economic Area (EEA Agreement) provides that the countries of the European Free Trade Association participating in the European Economic Area (EFTA/EEA countries) should, inter alia, strengthen and broaden cooperation within the framework of the Community's activities in the field of conservation, characterisation, collection and utilisation of genetic resources in agriculture.(13) For the better implementation of the Community programme, a work programme for the period 2004 to 2006 should be set out detailing the relevant financial provisions to be applied.(14) For the purposes of implementing and monitoring the Community programme, the Commission should be able to use the assistance of scientific and technical advisors.(15) The Community contribution should all be financed through heading 3 (Internal policies) of the financial perspective.(16) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(16),HAS ADOPTED THIS REGULATION:Article 1ObjectivesWith a view to achieving the aims of the CAP, and to implementing the commitments taken at international level, a Community programme is hereby established for the period 2004 to 2006 to complement and promote, at Community level, the work undertaken in the Member States for the conservation, characterisation, collection and utilisation of genetic resources in agriculture.Article 2Scope1. This Regulation shall apply to plant, microbial and animal genetic resources which are or could be of use in agriculture.2. No support may be granted under this Regulation:(a) for commitments eligible under Title II, Chapter VI, of Regulation (EC) No 1257/1999, as specified pursuant to Article 14 of Commission Regulation (EC) No 445/2002 of 26 February 2002 laying down detailed rules for the application of Council Regulation (EC) No 1257/1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF)(17).(b) for activities eligible under the framework programme of the European Community for research, technological development and demonstration activities.Article 3DefinitionsFor the purpose of this Regulation, the following definitions shall apply:(a) "plant genetic resources" means those of agricultural crops, horticultural crops, medicinal plants and aromatics, fruit crops, forest trees and wild flora which are or could be of use in the field of agriculture;(b) "animal genetic resources" means those of farm animals (vertebrates and invertebrates) and wild fauna which are or could be of use in the field of agriculture;(c) "genetic material" means any material of plant, microbial or animal origin, including reproductive and vegetative propagating material, containing functional units of heredity;(d) "genetic resources for agriculture" means any genetic material of plant, microbial or animal origin of actual or potential value for agriculture;(e) "in situ conservation" means the conservation of genetic material in ecosystems and natural habitats and the maintenance and recovery of viable populations of species or feral breeds in their natural surroundings and, in the case of domesticated animal breeds or cultivated plant species, in the farmed environment where they have developed their distinctive properties;(f) "in situ/on-farm conservation" means "in situ conservation and development" at the level of the farm;(g) "ex situ conservation" means the conservation of genetic material for agriculture outside their natural habitat;(h) "ex situ collection" means a collection of genetic material for agriculture maintained outside their natural habitat;(i) "biogeographic region" means a geographic region with typical characteristics regarding the composition and structure of the fauna and flora.Article 4Eligible actions1. The Community programme referred to in Article 1 shall comprise targeted actions, concerted actions and accompanying actions, as specified in Articles 5, 6 and 7.2. All actions carried out under the programme shall be in conformity with Community legislation on the phytostanitary, and animal health and zootechnical rules, on the marketing of seed and propagating material and on the common catalogue and shall take into account:(a) other activities undertaken at Community level;(b) relevant international processes, developments and agreements, in particular as regards:- the Convention on Biological Diversity,- the International Treaty on Plant Genetic Resources for Food and Agriculture,- the FAO's Global Plan of Action for the Conservation and Sustainable Utilisation of Plant Genetic Resources for Food and Agriculture and other actions undertaken within the framework of FAO,- the European Plant Conservation Strategy and the relevant resolutions of the Ministerial Conferences on the Protection of Forests in Europe,- the Global Strategy for the Management of Farm Animal Genetic Resources, and- programmes implemented under international frameworks such as the European Cooperative Programme for Crop Genetic Resources Networks (ECP/GR), the European regional focal point (ERFP) of national coordinators for the management of farm animal genetic resources, European Forest Genetic Resources Programme (Euforgen) and the Consultative Group on International Agricultural Research (CGIAR).Article 5Targeted actionsThe targeted actions shall include:(a) actions promoting the ex situ and in situ conservation, characterisation, collection and utilisation of genetic resources in agriculture;(b) the establishment of a European decentralised, permanent and widely accessible web-based inventory of genetic resources currently conserved in situ including in situ/on-farm genetic resources conservation activities;(c) the establishment of a European decentralised, permanent and widely accessible web-based inventory of the ex situ collections (gene banks) and in situ facilities (resources) and databases currently available or being developed on the basis of national inventories;(d) the promotion of regular exchanges of technical and scientific information, in particular on the origins and individual characteristics of available genetic resources, among competent organisations in the Member States.The actions referred to in point (a) shall be transnational, taking into account, if appropriate, biogeographic regional aspects and promote or complement, at Community level, work implemented at regional or national level. They may not involve aid to maintain nature protection areas.Article 6Concerted actionsThe concerted actions shall promote the exchange of information on thematic issues for the purpose of improving the coordination of actions and programmes for the conservation, characterisation, collection and utilisation of genetic resources in Community agriculture. They shall be transnational.Article 7Accompanying actionsThe accompanying actions shall include information, dissemination and advisory actions involving the organisation of seminars, technical conferences, meetings with non-governmental organisations (NGOs) and other relevant stakeholders, training courses and the preparation of technical reports.Article 8Work programme1. The Commission shall ensure the implementation of the Community programme on the basis of a work programme covering the period 2004 to 2006 established in accordance with the procedure referred to in Article 15(2) and subject to the availability of budgetary allocations.2. The actions co-financed under the Community programme shall have a maximum duration of four years.Article 9Selection of actions1. The Commission shall, within the work programme referred to in Article 8 and on the basis of calls for proposals for actions published in the C series of the Official Journal of the European Union, select the actions to be financed under the Community programme.2. The calls for proposals shall cover the actions and areas referred to in Articles 5, 6 and 7 and in Annex I. The content of the calls for proposals shall be established in accordance with the procedure referred to in Article 15(2) and in compliance with the relevant Articles under Title VI of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities(18).3. Proposals for actions referred to in Articles 5, 6 and 7 may be submitted by a public sector body or any natural or legal person who is a national of a Member State and established in the Community, including gene banks, non-governmental organisations, breeders, technical institutes, experimental farms, gardeners and forest owners. Bodies or persons established in third countries may also submit proposals where this is provided for in Article 10.4. The following criteria shall be taken into account for the assessment of the proposals:(a) relevance to the objectives of the Community programme, as defined in Article 1;(b) technical quality of the proposed work;(c) ability to carry out the action successfully and to ensure its efficient management, assessed in terms of resources and competences and including the organisational arrangements laid down by the participants;(d) European added value and potential contribution to Community policies.5. Proposals for actions to be financed under the Community programme shall be selected on the basis of independent expert assessment. The independent experts shall be invited by the Commission in compliance with Article 57(2) of Regulation (EC, Euratom) No 1605/2002 and with Article 178 of Commission Regulation (EC, Euratom) No 2342/2002 of 23 December 2002 laying down detailed rules for the implementation of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities(19).6. If necessary, detailed rules for the application of this Article shall be adopted in accordance with the procedure referred to in Article 15(2).Article 10Participation of third countriesThe Community programme shall be open to the participation of:(a) EFTA/EEA countries in accordance with the conditions established in the EEA Agreement;(b) associated countries, in accordance with the conditions laid down in the respective bilateral agreements establishing the general principles for their participation in Community programmes.Article 11Grant agreement1. After adoption of the selected actions, the Commission shall conclude grant agreements with the participants in these actions in compliance with the relevant Articles under Title VI of Regulation (EC, Euratom) No 1605/2002. The grant agreements shall set out detailed criteria for the reporting, dissemination, protection and exploitation of the results of the actions.2. The Commission shall take the necessary steps, in particular by means of technical, administrative and accounting checks at the premises of the beneficiaries, to verify that the information and supporting documents supplied are accurate, and that all the obligations laid down in the grant agreement have been fulfilled.Article 12Technical assistance1. In compliance with Article 57(2) of Regulation (EC, Euratom) No 1605/2002, the Commission may call on the assistance of scientific and technical experts for the implementation of the Community programme, including technical advice with regard to the preparation of calls for proposals, evaluation of technical and financial reports, monitoring, reporting and information purposes.2. A service contract shall be signed as a result of a call for tender procedure in the field of public procurement in compliance with the relevant Articles under Title V of Regulation (EC, Euratom) No 1605/2002.Article 13Community contribution1. The Community contribution to the actions referred to in Article 5 shall not exceed 50 % of the total cost of the action.2. The Community contribution to the actions referred to in Articles 6 and 7 shall not exceed 80 % of the total cost of the action.3. A Community contribution of up to 100 % of the total cost of the assistance referred to in Article 9(5) (assessment of proposals), Article 12 (technical assistance) and Article 14 (evaluation of the Community programme) shall be allocated.4. The financial perspective heading 3 "Internal Policies" shall contribute to the funding of actions and assistance undertaken under the Community programme in application of this Regulation.5. An indicative breakdown of the funds allocated to the Community programme is given in Annex II.Article 14Evaluation of the Community programmeAt the end of the Community programme, the Commission shall appoint a group of independent experts to report on the implementation of this Regulation, to assess the results and to make appropriate recommendations. The group's report, together with the Commission's comments, shall be submitted to the European Parliament, the Council and the European Economic and Social Committee.Article 15Committee procedure1. The Commission shall be assisted by a Committee on the conservation, characterisation, collection and utilisation of genetic resources in agriculture (hereinafter referred to as the 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 Committee shall adopt its Rules of Procedure.4. The Committee shall be informed on a regular basis on the implementation of the Community programme.Article 16RepealRegulation (EC) No 1467/94 shall be repealed, without prejudice to the contractual obligations of parties which have entered into contracts arising out of that Regulation.Article 17Entry into forceThis Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Luxembourg, 24 April 2004.For the CouncilThe PresidentJ. Walsh(1) OJ L 309, 13.12.1993, p. 1.(2) OJ L 160, 26.6.1999, p. 80. Regulation as last amended by Regulation (EC) No 583/2004 (OJ L 91, 30. 3.2004, p. 1).(3) OJ L 159, 28.6.1994, p. 1. Regulation as amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).(4) OJ P 125, 11.7.1966, p. 2298/66. Directive as last amended by Directive 2003/61/EC (OJ L 165, 3.7.2003, p. 23).(5) OJ P 125, 11.7.1966, p. 2309/66. Directive as last amended by Directive 2003/61/EC.(6) OJ L 93, 17.4.1968, p. 15. Directive as last amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 1).(7) OJ L 157, 10.6.1992, p. 1. Directive as last amended by Regulation (EC) No 806/2003 (OJ L 122, 16.5.2003, p. 1).(8) OJ L 157, 10.6.1992, p. 10. Directive as last amended by Regulation (EC) No 806/2003.(9) OJ L 226, 13.8.1998, p. 16. Directive as last amended by Regulation (EC) No 806/2003.(10) OJ L 11, 15.11.2000, p. 17.(11) OJ L 193, 20.7.2002, p. 1. Directive as last amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council.(12) OJ L 193, 20.7.2002, p. 12. Directive as amended by Directive 2003/61/EC.(13) OJ L 193, 20.7.2002, p. 33. Directive as last amended by Regulation (EC) No 1829/2003 of the European Parliament and of the Council.(14) OJ L 193, 20.7.2002, p. 60. Directive as last amended by Directive 2003/61/EC.(15) OJ L 193, 20.7.2002, p. 74. Directive as last amended by Directive 2003/61.(16) OJ L 184, 17.7.1999, p. 23.(17) OJ L 74, 15.3.2002, p. 2. Regulation as last amended by Regulation (EC) No 963/2003 OJ L 138, 5.6.2003, p. 32).(18) OJ L 248, 10.9.2002, p. 1.(19) OJ L 357, 31.12.2002, p. 1.ANNEX ICOMMUNITY PROGRAMME: ELIGIBLE ACTIONS AND AREAS1. Eligible actions and areasThe Community programme concerns the conservation, characterisation, evaluation, collection, documentation, development and utilisation of genetic resources that currently occur within the territory of the Community. Eligible organisms are plants (seed-bearing plants), animals (vertebrates and certain invertebrates) and micro-organisms.The programme covers material that is actively growing and material that is dormant (seeds, embryos, semen and pollen). Ex situ, in situ and on farm collections are covered. All types of material are eligible including cultivars and domestic breeds, local breeds, breeders' material, genetic type collections, and wild species.Priority will be given to species which are, or which may reasonably be expected to become significant in agriculture, horticulture or forestry in the Community.Preference will be given to the use of genetic resources for:(a) diversification of production in agriculture;(b) improved product quality;(c) sustainable management and use of natural and agricultural resources;(d) improved quality of the environment and the countryside;(e) identification of products for new uses and markets.When collections are recorded and new collecting is undertaken, steps will be taken within the programme to ensure that the traditional regional experience and knowledge of the users (farmers, horticulturists) on methods of cultivation, specific uses, processing, taste, etc., are also included. The latter information should not be recorded as narrative but, as far as possible, in a standardised manner allowing documentation and easy retrieval of the data in a relational database system.All actions carried out under the programme shall be in conformity with Community legislation on the marketing of seed and propagating material and on the common catalogue, as well as with phytosanitary and the animal health and zootechnical rules in force in the Community.Appropriate steps, in accordance with the aims of the CAP and in conformity with Community international commitments, should be taken to promote the dissemination and exploitation of any results of work in the field of the conservation, characterisation, evaluation, collection, documentation, development and utilisation of genetic resources in agriculture which could contribute to the achievement of those aims and commitments. The main objective is to provide an efficient and practical support to the actual and future end users of genetic resources in the Community.2. Excluded actions and areasThe following actions are specifically not eligible for Community financial support under this programme: theoretical studies, studies to test hypotheses, studies to develop tools or techniques, work involving untested techniques or "model" systems and all other research activities. Such actions are eligible for consideration under the Community research and technological development framework programmes. Adaptation of existing methods for the purpose of an activity within the Regulation might, however, be considered eligible for support under the Community programme.Actions that are eligible for support under the framework programme of the European Community for research, technological development and demonstration activities may not be supported.No support may be granted under this programme for commitments that are already under way in the Member States and/or eligible under Title II, Chapter VI, of Regulation (EC) No 1257/1999 as specified under Article 14 of Regulation (EC) No 445/2002. However, actions leading to synergy between Regulation (EC) No 1257/1999 and this programme should be encouraged.Actions involving lower animals, lower plants and micro-organisms, including fungi, are only eligible when these are reared or cultivated on land and when they are or could be of use in agriculture, including organisms which are suited for use as biological control agents in agriculture in its widest sense. Exception will be made in the specific case of defined gene-for-gene relationships between parasite or symbiont and host, and where both organisms are to be conserved. Collecting and acquisition of material is subject to the priorities stipulated above.3. Types of actionsThe implementation of the Community programme for the conservation, characterisation, evaluation, collection, documentation, development and utilisation of genetic resources in agriculture includes targeted actions, concerted actions and accompanying actions. The following actions shall be promoted:3.1. Targeted actionsActions aiming at the ex situ, in situ and on-farm conservation, characterisation, evaluation, collection, documentation, development and utilisation of genetic resources in agriculture are intended to support or complement, at Community level, work implemented at regional or national level. They shall be transnational (taking, where appropriate, into account also biogeographic regional aspects). These actions may not involve aid to maintain nature protection areas.The actions should add value (spreading knowledge, increasing use, improving methodologies, exchange between Member States) to the agri-environmental schemes for endangered species, provenance, cultivars or breeds already funded at national or regional level (e.g., characterisation of genetic diversity and distance between the respective breeds, utilisation of local products, coordination and search of commonalties between scheme managers).These actions must, as a general rule, be carried out by participants established within the Community and funded through the present facility, in partnership, when appropriate, with organisations from other regions of the world. Priority is to be given to actions providing for the participation of two or more unconnected participants established in different Member States. Participation by NGOs and other stakeholders in the field of in situ/on-farm conservation should be promoted.The dissemination and exchange of European genetic resources should be promoted with a view to increasing the use of under-utilised species but also the use of a broad diversity of genetic resources in sustainable agricultural production.For plant genetic resources, a European decentralised, permanent and widely accessible web-based network of national inventories of the ex situ collections (gene banks), in situ facilities (resources) and databases on the basis of national inventories is currently available or being developed in the framework of the EPGRIS initiative. The development of national inventories of ex situ collections held in European countries, and a European search catalogue (EURISCO) should be established and further improved and inventories of in situ resources (genetic reserves or gene conservation units) should be developed.A European decentralised, permanent and widely accessible web-based inventory of forest genetic resources, including in situ resources (genetic reserves or gene conservation units) and ex situ collections should be established on the basis of national inventories and taking into consideration the activities of the Euforgen-networking programme.For animal genetic resources maintained on farms, efforts should concentrate on a European network of national inventories of administrative aspects (origin and status of funding, state of breeds and their endangerment, location of herdbooks, etc.) which should be managed in conformity with DAD-IS, the information system for the Global Strategy for the Management of Farm Animal Genetic Resources (AnGR).For ex situ conservation of animal genetic resources (semen, embryos) a web-based network of national inventories and a European search catalogue for minimum passport data should be developed. The inventory is to consist principally of the establishment, regular updating and regular publication of the facilities (storage and conservation) for genetic resources in agriculture collected in the Community, and the listing of current work on the conservation, characterisation, evaluation, collection, documentation, development and utilisation of those genetic resources. Minimum passport data of individual accessions may be included.For microbial genetic resources, a web-based network of national inventories of ex situ and in situ resources should be established, in the framework of the European Biological Resource Centre Network (EBRCN).Regular exchanges of information between competent organisations in the Member States, in particular on the origins and individual characteristics of available genetic resources, shall be promoted. This will help establish a network of national inventories which will provide a guide to collections of conserved genetic resources and associated activities in the Community. The aims of the network of national inventories are to support the Community and national activities and encourage the widest possible knowledge and use of preserved material.Expenditure on the capacity building of NGOs, the establishment and monitoring of the inventories, regular exchanges of information between competent organisations in the Member States and the preparation of regular publications and reports, is to be covered from the total appropriations earmarked for the implementation of the programme.3.2. Concerted actionsConcerted actions are devoted to improve the coordination at Community level, mainly through the organisation of seminars and the preparation of reports, of individual (national, regional, local) actions for the conservation, characterisation, evaluation, collection, documentation, development and utilisation of genetic resources in agriculture that are already being carried out in the Member States. In particular, they should promote exchanges of information among the Member States and the Member States and the Commission on thematic issues and on specific local (on-farm), regional, or national actions and programmes (carried out or planned under the authority of Member States or by bodies not under their authority), including also actions which are or may be carried out under Regulation (EC) No 1257/1999, Council Regulations (EEC) No 2081/92 of 14 July 1992 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs(1) and (EEC) No 2082/92 of 14 July 1992 on certificates of specific character for agricultural products and foodstuffs(2)or Council Directive 98/95/EC of 14 December 1998 amending, in respect of the consolidation of the internal market, genetically modified plant varieties and plant genetic resources, Directives 66/400/EEC, 66/401/EEC, 66/402/EEC, 66/403/EEC, 69/208/EEC, 70/457/EEC and 70/458/EEC on the marketing of beet seed, fodder plant seed, cereal seed, seed potatoes, seed of oil and fibre plants and vegetable seed and on the common catalogue of varieties of agricultural plant species(3), for the purposes of coordinating these initiatives with each other, with measures to be undertaken at Community level and with relevant international processes, developments and agreements. Concerted actions could also involve coordination activities on thematic issues (specific crop or animal genetic resources) through specialised technical groups. The concerted actions shall be transnational.3.3. Accompanying actionsSpecific accompanying actions shall include information, dissemination and advisory actions involving:- the organisation of seminars, technical conferences, workshops, occasional meetings with NGOs and other interested bodies and relevant stakeholders,- training courses and mobility schemes for specialists,- preparation of technical reports,- the promotion of the utilisation of results by the market (users).4. Targeted actions: more details about eligible areas4.1. Crop genetic resources1) Development of a web-based, permanent and widely accessible network of national inventories on crop genetic resources (in situ and ex situ); maintenance and further improvement of EURISCO.2) Information exchange on methods, techniques and experiences of on-farm activities, including utilisation and marketing concepts that may promote the use of under-utilised crops and contribute to the diversification of agriculture.3) Inventory and documentation of in situ resources of wild crop relatives that are used or potentially useful for food and agriculture.4) Establishment, maintenance and improvement of web-based European Central Crop Databases (ECCDBs) with characterisation and evaluation data and linked to the network of national inventories and to the EURISCO catalogue for the passport level data.5) Establishment and coordination of permanent European ex situ collections based upon the existing national or institutional ex situ collections, implementing concepts for sharing of responsibilities for the conservation of crop genetic resources among European countries.6) Establishment and coordination of a European network of conservation and demonstration fields/gardens of endangered and under-utilised crop genetic resources.7) Characterisation and evaluation of crop genetic resources that could be of interest for European agriculture.8) Collecting, in conformity with international law and obligations, of crop genetic resources that could be of interest for European agriculture.4.2. Forest genetic resources1) Establishment of a web-based, permanent and widely accessible network of national inventories on forest genetic resources that are used or potentially useful for sustainable forest management in Europe.2) Information exchange on methods, techniques and experiences on forest genetic resources conservation and management.3) Assessment and development of best operational management practices for forest genetic resources and integration of related activities into national forest programmes.4) Establishment of European networks of representative genetic reserves or gene conservation units for relevant target species in order to improve conservation and characterisation at European level.5) Evaluation of forest genetic resources at species and provenance level (including evaluation of trials in the case of existing provenance experiments) that could be of value for sustainable forest management in Europe.6) Establishment and coordination of collections to promote the use of genetic resources for afforestation, reforestation, rehabilitation and tree improvement purposes at the European level.7) Collecting of forest genetic resources that could be of interest at the European level.4.3. Animal genetic resources1) Establishment of a web-based, permanent and widely accessible European network of national inventories of animal genetic resources ex situ and in situ/on-farm taking into account activities within the framework of the European National Coordinators for Animal Genetic Resources and linked to the FAO/DAD-IS system.2) Development of European-wide standardised and comparable criteria to identify the national priorities for action in the field of sustainable conservation and utilisation of Animal Genetic Resources and related requirements for international cooperation.3) Establishment of European cryo-conserves for animal genetic resources based upon national or institutional cryo-conserves.4) Characterisation and evaluation of animal genetic resources (species and breeds) used or potentially useful for food and agriculture.5) Establishment of a standardised European performance testing regime for animal genetic resources in agriculture, and documentation of characteristics of endangered farm animal breeds and populations.6) Establishment and coordination of a European-wide network of "Ark farms", rescue-stations and farm animal parks for endangered European farm animal breed.7) Development of common cross-national breeding programmes for endangered breeds and populations. Establishment of rules for the exchange of information, genetic material and breeding animals.8) Development of strategies which support the enhancement of profitability of local breeds in order to develop links between local breeds and their typical products, to identify and to promote the value of local breeds for their environmental services (e.g. landscape conservation, agro-ecosystems management) and for their contribution to the multifunctional character of agriculture (e.g. maintenance of rural cultural diversity, rural development and tourism, etc.).9) Development of strategies which promote the utilisation of under-utilised animal genetic resources that could be of interest on a European level.(1) OJ L 208, 24.7.1992, p. 1. Regulation as last amended by Regulation (EC) No 806/2003.(2) OJ L 208, 24.7.1992, p. 9. Regulation as last amended by Regulation (EC) No 806/2003.(3) OJ L 25, 1.2.1999, p. 1.ANNEX IIINDICATIVE FINANCIAL BREAKDOWN FOR THE COMMUNITY PROGRAMME>TABLE>

Summary: Conservation, characterisation, collection and utilisation of genetic resources in agriculture Conservation, characterisation, collection and utilisation of genetic resources in agriculture The European Union is complementing and encouraging Member States' efforts on the conservation and sustainable utilisation of biodiversity in agriculture by financing a number of measures under a Community programme for 2004-06. ACT Council Regulation (EC) No 870/2004 of 24 April 2004 establishing a Community programme on the conservation, characterisation, collection and utilisation of genetic resources in agriculture, and repealing Regulation (EC) No 1467/94 SUMMARY During the period 2004-06, the Commission is implementing a Community programme covering plant, microbial and animal genetic resources * which are or could be of use in agriculture. The amount allocated to the programme is 10 million. The Commission selects the actions to be part-financed under the programme on the basis of calls for proposals and following evaluation by independent experts. Proposals may be submitted by a public sector body or any natural or legal person who is a national of a Member State and established in the Community, in an EFTA/EEA country, or in an associated country in accordance with the conditions stipulated in a bilateral agreement. The actions, which may last for a maximum of four years, may be of three types: targeted actions, part-financed up to a maximum of 50% of their total cost and including:- transnational actions promoting the ex situ and in situ conservation *, characterisation, collection and utilisation of genetic resources in agriculture;- the establishment of a European decentralised, permanent and widely accessible web-based inventory of genetic resources currently conserved in situ including in situ/on-farm genetic resources conservation activities;- the establishment of a European decentralised, permanent and widely accessible web-based inventory of the ex situ collections (gene banks) and in situ resources;- the promotion of regular exchanges of technical and scientific information among competent organisations in the Member States; concerted actions, part-financed up to a maximum of 80% of their total cost, transnational in character and promoting the exchange of information on thematic issues for the purpose of improving the coordination of actions and programmes in the sphere concerned; accompanying actions, part-financed up to a maximum of 80% of their total cost and comprising information, dissemination and advisory actions, training courses and the preparation of technical reports. Once an action has been approved, the Commission will conclude a grant agreement with the participants setting out detailed criteria for the reporting, dissemination, protection and exploitation of the results of the action. The Commission is assisted by a Committee on the conservation, characterisation, collection and utilisation of genetic resources in agriculture. The Commission may also call on the assistance of scientific and technical experts for the implementation of the programme. At the end of the programme, the Commission will appoint a group of independent experts to report on the implementation of the Regulation, to assess the results and to make appropriate recommendations. The group's report will be submitted to the European Parliament, the Council and the European Economic and Social Committee. Key terms used in the act "Plant genetic resources" means those of agricultural crops, horticultural crops, medicinal plants and aromatics, fruit crops, forest trees and wild flora which are or could be of use in agriculture. "Genetic material" means any material of plant, microbial or animal origin, including reproductive and vegetative propagating material, containing functional units of heredity. "In situ "Ex situ References Act Entry into force Deadline for transposition in the Member States Official Journal Regulation (EC) No 870/2004 7.5.2004 - OJ L 162 of 30.4.2004 See also For further information, please consult the website of the European Commission Directorate-General for Agriculture. Last updated: 17.03.2005


EUR-Lex - 32004R0065 - EN Avis juridique important | 32004R0065 Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms Official Journal L 010 , 16/01/2004 P. 0005 - 0010 Commission Regulation (EC) No 65/2004of 14 January 2004establishing a system for the development and assignment of unique identifiers for genetically modified organismsTHE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Regulation (EC) No 1830/2003, of the European Parliament and of the Council, of 22 September 2003, concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC(1), and in particular Article 8 thereof,Whereas:(1) Regulation (EC) No 1830/2003 lays down a harmonised framework for the traceability of genetically modified organisms, hereinafter "GMOs", and of food and feed products produced from GMOs through the transmission and holding of relevant information by operators for such products at each stage of their placing on the market.(2) Under that Regulation, an operator placing on the market products containing or consisting of GMOs is required to include, as part of that relevant information, the unique identifier assigned to each GMO as a means of indicating its presence and reflecting the specific transformation event covered by the consent or authorisation for placing that GMO on the market.(3) Unique identifiers should be developed in accordance with a particular format in order to ensure consistency both at Community and international level.(4) The consent or authorisation granted for the placing on the market of a given GMO under Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC(2) or other Community legislation should specify the unique identifier for that GMO. Moreover, the person applying for such consent should ensure that the application specifies the appropriate unique identifier.(5) Where, prior to the entry into force of this Regulation, consents have been granted for the placing on the market of GMOs under Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms(3), it is necessary to ensure that a unique identifier is or has been developed, assigned and appropriately recorded for each GMO covered by those consents.(6) In order to take account of and maintain consistency with developments in international fora, it is appropriate to have regard to the formats for unique identifiers established by the Organisation for Economic Cooperation and Development (OECD), for use in the context of its BioTrack product database and in the context of the Biosafety clearing house established by the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.(7) For the purposes of the full application of Regulation (EC) No 1830/2003, it is essential that this Regulation apply as a matter of urgency.(8) The measures provided for in this Regulation are in accordance with the opinion of the Committee set up under Article 30 of Directive 2001/18/EC,HAS ADOPTED THIS REGULATION:CHAPTER I SCOPEArticle 11. This Regulation shall apply to genetically modified organisms, hereinafter "GMOs", authorised for the placing on the market in accordance with Directive 2001/18/EC or other Community legislation, and applications for placing on the market under such legislation.2. This Regulation shall not apply to medicinal products for human and veterinary use authorised under Council Regulation (EEC) No 2309/93(4), or applications for authorisation under that Regulation.CHAPTER II APPLICATIONS FOR THE PLACING ON THE MARKET OF GMOsArticle 21. Applications for the placing on the market of GMOs shall include a unique identifier for each GMO concerned.2. Applicants shall, in accordance with the formats set out in the Annex, develop the unique identifier for each GMO concerned, following consultation of the OECD BioTrack product database, and the Biosafety clearing house, to determine whether or not a unique identifier has already been developed for that GMO in accordance with these formats.Article 3Where consent or authorisation is granted for the placing on the market of a GMO:(a) the consent or authorisation shall specify the unique identifier for that GMO;(b) the Commission, on behalf of the Community, or, where appropriate, the competent authority that has taken the final decision on the original application shall ensure that the unique identifier for that GMO is communicated as soon as possible, in writing, to the Biosafety clearing house;(c) The unique identifier for each GMO concerned shall be recorded in the relevant registers of the Commission.CHAPTER III GMOs FOR WHICH CONSENT FOR THEIR PLACING ON THE MARKET HAS BEEN GRANTED PRIOR TO THE ENTRY INTO FORCE OF THIS REGULATIONArticle 41. Unique identifiers shall be assigned to all GMOs in respect of which, prior to the entry into force of this Regulation, consent has been granted under Directive 90/220/EEC for their placing on the market.2. Relevant consent holders or where appropriate the competent authority that has taken the final decision on the original application shall consult the OECD BioTrack product database, and the Biosafety clearing house, to determine whether or not a unique identifier has already been developed for that GMO in accordance with the formats set out in the Annex.Article 51. Where, prior to the entry into force of this Regulation, consent has been granted for the placing on the market of a GMO and where a unique identifier has been developed for that GMO in accordance with the formats set out in the Annex, paragraphs 2, 3 and 4 shall apply.2. Each consent holder, or where appropriate the competent authority that has taken the final decision on the original application, shall within 90 days following the date of entry into force of this Regulation, communicate the following, in writing, to the Commission:(a) the fact that the unique identifier has already been developed in accordance with the formats set out in the Annex;(b) the details of the unique identifier.3. The unique identifier for each GMO concerned shall be recorded in the relevant registers of the Commission.4. The Commission, on behalf of the Community, or, where appropriate, the competent authority that has taken the final decision on the original application shall ensure that the unique identifier for that GMO is communicated as soon as possible, in writing, to the Biosafety clearing house.Article 61. Where, prior to the entry into force of this Regulation, consent has been granted for the placing on the market of a GMO but where a unique identifier has not been developed for that GMO in accordance with the formats set out in the Annex, paragraphs 2, 3, 4 and 5 shall apply.2. Each consent holder or, where appropriate, the competent authority that has taken the final decision on the original application, shall develop a unique identifier for the GMO concerned in accordance with the formats set out in the Annex.3. The consent holder shall, within 90 days following the date of entry into force of this Regulation, communicate the details of the unique identifier, in writing, to the competent authority granting consent, which in turn shall immediately transmit these details to the Commission.4. The unique identifier for each GMO concerned shall be recorded in the relevant registers of the Commission.5. The Commission, on behalf of the Community, or, where appropriate, the competent authority that has taken the final decision on the original application shall ensure that the unique identifier for that GMO is communicated as soon as possible, in writing, to the Biosafety clearing house.CHAPTER IV FINAL PROVISIONArticle 7This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union.This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 14 January 2004.For the CommissionMargot WallströmMember of the Commission(1) OJ L 268, 18.10.2003, p. 24.(2) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003.(3) OJ L 117, 8.5.1990, p. 15. Directive as last amended by Directive 2001/18/EC.(4) OJ L 214, 24.8.1993, p. 1.ANNEXFORMATS FOR UNIQUE IDENTIFIERSThe Annex below defines the format for the unique identifier for plants in Section A and for micro-organisms and animals in Section B.SECTION A1. Overall formatThis Annex provides details as to the format to be used for unique identifiers for GMOs pending or authorised for the placing on the market under Community legislation. The format consists of three components comprising a number of alphanumeric digits and providing reference to the applicant/consent holder, transformation event and a means for verification.The format comprises nine alphanumeric digits in total. The first component represents the applicant/consent holder and comprises two or three alphanumeric digits. The second component comprises five or six alphanumeric digits and represents the transformation event. The third component provides for verification and is represented by a final numerical digit.The following provides an example of a unique identifier developed using this format.>PIC FILE= "L_2004010EN.000802.TIF">or>PIC FILE= "L_2004010EN.000803.TIF">The following sections provide guidance as to how the three individual components of the unique identifier should be developed.2. Applicant/consent holder componentThe first two or three alphanumeric digits represent the applicant/consent holder (for example, the first two or three letters of the applicant/consent holder organisation name), followed by a dash, such;>PIC FILE= "L_2004010EN.000804.TIF">or>PIC FILE= "L_2004010EN.000805.TIF">Applicants may already have assigned alphanumeric digits to indicate their identity and these appear in the applicant's code table within the OECD BioTrack product database. These applicants should continue to use these digits.Any new applicant that is not identified within the database will not be permitted to use the existing codes listed in the applicant's code table within the database. The new applicant Should inform the national authorities, which should update the OECD BioTrack product database by including a new code (digits) that will be designed to identify the new applicant in the code table.3. Transformation event componentThe second set of five or six alphanumerical digits should represent the specific transformation event(s), which is the subject of the application for the placing on the market and/or consent, such as:>PIC FILE= "L_2004010EN.000806.TIF">or>PIC FILE= "L_2004010EN.000807.TIF">Clearly, an individual transformation event may occur in different organisms, species and varieties and the digits should be representative of the specific event in question. Again, applicants should, prior to formulating unique identifiers, consult the OECD BioTrack product database in terms of the unique identifiers that have been assigned to similar transformation events of the same organism/species in order to provide consistency and to avoid duplication.Applicants should develop their own internal mechanism to avoid applying the same designation (digits) to a "transformation event" if used in a different organism. Where similar transformation events are developed by two or more organisations, the "applicant information" (see section 2) should enable applicants to generate a unique identifier for their own product, while at the same time ensuring its uniqueness from those generated by other applicants.As regards new GMOs compromising more than one transformation event (often referred to as stacked-gene transformation events), applicants or consent holders should generate a novel unique identifier for such GMOs.4. Verification componentThe final digit of the unique identifier is for verification, which shall be separated from the rest of the unique identifier digits by a dash, such as:>PIC FILE= "L_2004010EN.000901.TIF">or>PIC FILE= "L_2004010EN.000902.TIF">The verification digit is intended to reduce errors by ensuring the integrity of the alphanumeric identifier, entered by the users of the database.The rule to calculate the verification digit is as follows. The verification digit is made up of a single numerical digit. It is calculated by adding together the numerical values of each of the alphanumerical digits in the unique identifier. The numerical value of each of the digits is from>PIC FILE= "L_2004010EN.000903.TIF">to 9 for the numerical digits (>PIC FILE= "L_2004010EN.000904.TIF">to 9) and 1 to 26 for the alphabetical digits (A to Z) (see sections 5 and 6). The total sum, if made up of several numerical digits, will be further calculated by adding the remaining digits together using the same rule, in an iterative process, until the final sum is a single numerical digit.For example, the verification digit for the code CED-AB891 is calculated as follows:>TABLE>Therefore, the final unique identifier then becomes - CED-AB891-6.5. Form of digits to be used in the unique identifier>PIC FILE= "L_2004010EN.000905.TIF">6. Form of alphabetic characters to be used, plus numerical equivalents for calculating verification digit.>PIC FILE= "L_2004010EN.001001.TIF">SECTION BThe provisions of section A of this Annex shall apply to micro-organisms and animals unless another format for a unique identifier is adopted internationally and endorsed at Community level.

Summary: Genetically modified organisms — unique identifiers Genetically modified organisms — unique identifiers SUMMARY OF: Commission Regulation (EC) No 65/2004 on unique identifiers for genetically modified organisms SUMMARY WHAT DOES THE REGULATION DO? The regulation establishes a unique identifier*, similar to a barcode, specific to each genetically modified organism* (GMO) brought to market. This is a key element in the traceability* and labelling of food and animal feed derived from GMOs, aiming to improve consumer choice and provide safeguards to health and the environment. KEY POINTS For consistency with developments in international fora, a unique identifier format is used by the Organisation for Economic Cooperation and Development BioTrack database and by the Biosafety Clearing-House of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. For each new application for the authorisation of a GMO to be put on the market, the applicant must check in the databases to make sure that an identifier has not already been assigned before creating a unique identifier in the prescribed format. Where authorisation is granted for a GMO to be put on the market, the unique identifier is then communicated to the Biosafety Clearing-House by the European Commission and recorded in the EU register of authorised GMOs. All GMOs authorised before the regulation came into force have been assigned unique identifiers under the regulation. The format of the unique identifier is defined in the annex to the regulation, and consists of nine alphanumeric digits. The first two or three digits represent the company or organisation name. The second component of five or six digits represents the transformation event* and the final component is a single verification digit, all separated by a dash, for example: MON-00603-1. FROM WHEN DOES THE REGULATION APPLY? It applies from 16 January 2004. BACKGROUND For more information, see ‘Traceability and labelling’ on the European Commission’s website. KEY TERMS * Unique identifier: a 9-digit alphanumeric code specific to a GMO enabling it to be readily identified on a product’s labelling. * Genetically modified organisms: plants or animals bred to give higher yield or resist disease, through modification of their cellular and genetic make-up. * Traceability: the ability to track GMOs, and products produced from GMOs, at all stages of the production and distribution chain, facilitating accurate labelling. * Transformation event: a term used to differentiate genetically engineered (transformed) crop varieties and other organisms. ACT Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (OJ L 10, 16.1.2004, pp. 5-10) RELATED ACTS Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation (OJ L 102, 7.4.2004, pp. 14-25). Successive amendments to Commission Regulation (EC) No 641/2004 have been incorporated into the original text. This consolidated version is of documentary value only. Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (OJ L 268, 18.10.2003, pp. 24-28). See consolidated version. last update 12.04.2016