Directive 2015/412 - Amendment of Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory
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official title
Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory Text with EEA relevanceLegal instrument | Directive |
---|---|
Number legal act | Directive 2015/412 |
Original proposal | COM(2010)375 ![]() |
CELEX number71 | 32015L0412 |
Document | 11-03-2015 |
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Publication in Official Journal | 13-03-2015; OJ L 68 p. 1-8 |
Effect | 02-04-2015; Entry into force Date pub. +20 See Art 4 |
Deadline | 03-04-2019; Review |
End of validity | 31-12-9999 |
Transposition | 17-10-2002 |
13.3.2015 |
EN |
Official Journal of the European Union |
L 68/1 |
DIRECTIVE (EU) 2015/412 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 11 March 2015
amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,
Having regard to the proposal from the European Commission,
After transmission of the draft legislative act to the national parliaments,
Having regard to the opinion of the European Economic and Social Committee (1),
Having regard to the opinion of the Committee of the Regions (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1) |
Directive 2001/18/EC of the European Parliament and of the Council (4) and Regulation (EC) No 1829/2003 of the European Parliament and of the Council (5) establish a comprehensive legal framework for the authorisation of genetically modified organisms (GMOs), which is fully applicable to GMOs to be used for cultivation purposes throughout the Union as seeds or other plant-propagating material (‘GMOs for cultivation’). |
(2) |
Under that legal framework, GMOs for cultivation are to undergo an individual risk assessment before being authorised to be placed on the Union market in accordance with Annex II to Directive 2001/18/EC taking into account the direct, indirect, immediate and delayed effects, as well as the cumulative long-term effects, on human health and the environment. That risk assessment provides scientific advice to inform the decision-making process and is followed by a risk management decision. The aim of that authorisation procedure is to ensure a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, whilst ensuring the effective functioning of the internal market. A uniform high level of protection of health, the environment and consumers should be achieved and maintained throughout the territory of the Union. The precautionary principle should always be taken into account in the framework of Directive 2001/18/EC and its subsequent implementation. |
(3) |
Pursuant to the conclusions adopted by the Council on 4 December 2008 on Genetically Modified Organisms (‘2008 Council conclusions’), it is necessary to look for improvement of the implementation of the legal framework for the authorisation of GMOs. In this context, the rules on risk assessment should be, where needed, regularly updated to take account of continuous developments in scientific knowledge and analysis procedures, in particular regarding the long-term environmental effects of genetically modified crops as well as their potential effects on non-target organisms, the characteristics of receiving environments and the geographical areas in which genetically modified crops may be cultivated, and the criteria and requirements for assessing GMOs producing pesticides and herbicide tolerant GMOs. Therefore, the Annexes to Directive 2001/18/EC should be amended accordingly. |
(4) |
In addition to the authorisation for placing on the market, genetically modified varieties also need to comply with the requirements of Union law on the marketing of seed and plant propagating material, as set out in particular in Council Directives 66/401/EEC (6), 66/402/EEC (7), 68/193/EEC (8), 98/56/EC (9), 1999/105/EC (10), 2002/53/EC (11), 2002/54/EC (12), 2002/55/EC (13), 2002/56/EC (14), 2002/57/EC (15) and 2008/90/EC (16). Among those Directives, Directives 2002/53/EC and 2002/55/EC contain provisions which allow the Member States to prohibit, under certain well defined conditions, the use of a variety in all or in part of their... |
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- 2.OJ L 268, 18.10.2003, p. 1.
- 3.OJ L 268, 18.10.2003, p. 24.
- 4.AT, BG, IE, EL, CY, LV, LT, HU, LU, MT, NL, PL and SI.
- 5.Respective discussions took place at Council meetings of 2 March, 23 March and 25 June 2009.
- 6.Commission Recommendation of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming .
- 7.According to Article 26a(1) of Directive 2001/18/EC, 'Member States may take appropriate measures to avoid the unintended presence of GMOs in other products'.
- 8.Respective discussions took place at Council meetings of 2 March, 23 March and 25 June 2009.
- 9.14 for maize, one for soybean, one for sugar beet and one for potato.
- 10.'The economics of adventitious presence thresholds in the EU seed market', Kalaitzandonakes, Magnier; working paper, June 2007.
- 11.According to the 2006 Commission implementation report of Regulation (EC) No 1829/2003, the EU market shares of labelled GM food and feed products appear to be contrasted. Labelled GM feed products are much more placed on the market than GM food. This situation is mainly governed by factors that are not related to the legislative framework as such but by other elements including consumer demand, relative availability and costs of different commodities on the world market, and the policies of food producers and retailers.
- 12.Directives 2002/53/EC and 2002/55/EC.
- 13.OJ L 268, 18.10.2003, p. 24.
- 14.OJ L 268, 18.10.2003, p. 1.
- 15.OJ L 268, 18.10.2003, p. 24.
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- 17.OJ C , , p. .
- 18.OJ C , , p. .
- 19.OJ C , , p. .
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- 34.14 for maize, one for soybean, one for sugar beet and one for potato.
- 35.14 for maize, one for soybean, one for sugar beet and one for potato.
- 36.OJ L 106, 17.4.2001, p. 1.
- 37.OJ L 268, 18.10.2003, p. 1.
- 38.OJ L 268, 18.10.2003, p. 24.
- 39.AT, BG, IE, EL, CY, LV, LT, HU, LU, MT, NL, PL and SI.
- 40.Respective discussions took place at Council meetings of 2 March, 23 March and 25 June 2009.
- 41.Commission Recommendation of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming .
- 42.According to Article 26a(1) of Directive 2001/18/EC, 'Member States may take appropriate measures to avoid the unintended presence of GMOs in other products'.
- 43.Respective discussions took place at Council meetings of 2 March, 23 March and 25 June 2009.
- 44.14 for maize, one for soybean, one for sugar beet and one for potato.
- 45.'The economics of adventitious presence thresholds in the EU seed market', Kalaitzandonakes, Magnier; working paper, June 2007.
- 46.According to the 2006 Commission implementation report of Regulation (EC) No 1829/2003, the EU market shares of labelled GM food and feed products appear to be contrasted. Labelled GM feed products are much more placed on the market than GM food. This situation is mainly governed by factors that are not related to the legislative framework as such but by other elements including consumer demand, relative availability and costs of different commodities on the world market, and the policies of food producers and retailers.
- 47.Directives 2002/53/EC and 2002/55/EC.
- 48.OJ L 268, 18.10.2003, p. 24.
- 49.OJ L 268, 18.10.2003, p. 1.
- 50.OJ L 268, 18.10.2003, p. 24.
- 51.AT, BG, IE, EL, CY, LV, LT, HU, LU, MT, NL, PL and SI.
- 52.OJ C , , p. .
- 53.OJ C , , p. .
- 54.OJ C , , p. .
- 55.OJ L 106, 17.4.2001, p. 1.
- 56.OJ L 268, 18.10.2003, p. 1.
- 57.OJ L 125, 11.7.1966, p. 2298.
- 58.OJ L 268, 18.10.2003, p. 1.
- 59.OJ L 193, 20.7.2002, p. 12.
- 60.OJ L 193, 20.7.2002, p. 33.
- 61.OJ L 193, 20.7.2002, p. 60.
- 62.OJ L 193, 20.7.2002, p. 74.
- 63.OJ L 93, 17.4.1968, p. 15.
- 64.OJ L 226, 13.8.1998, p. 16.
- 65.OJ L 11, 15.1.2000, p. 17.
- 66.OJ L 267, 8.1.2008, p. 8.
- 67.OJ L 268, 18.10.2003, p. 1.
- 68.OJ L 204, 21.7.1998, p.
- 69.14 for maize, one for soybean, one for sugar beet and one for potato.
- 70.14 for maize, one for soybean, one for sugar beet and one for potato.
- 71.Deze databank van de Europese Unie biedt de mogelijkheid de actuele werkzaamheden (workflow) van de Europese instellingen (Europees Parlement, Raad, ESC, Comité van de Regio's, Europese Centrale Bank, Hof van Justitie enz.) te volgen. EURlex volgt alle voorstellen (zoals wetgevende en begrotingsdossiers) en mededelingen van de Commissie, vanaf het moment dat ze aan de Raad of het Europees Parlement worden voorgelegd.
- 72.EUR-lex provides an overview of the proposal, amendments, citations and legality.