Locations
EU Regulatory Bulletin contents
- Biocides: scope of definition
- Pesticides: data sharing
- Dangerous Preparations Directive recast
- REACH: substance evaluation
- GMO: cultivation opt-out
Member States fail to agree on GMO cultivation opt-out compromise
Plans to allow Member States to block the cultivation of approved genetically modified organisms (GMOs) on their territory have stalled again after a minority of Member States rejected a compromise proposal put forward by the Danish EU Presidency, maintaining their original objection that the plans conflict with the EU's internal market rules on free trade.
Current EU Law
1. The release of GMOs into the environment and the marketing of GMOs is currently regulated by Directive 2001/18/EC(1). As the law currently stands a GMO can only be put on the market in the EU after it has been tested and authorised on the basis of a detailed procedure, involving a scientific assessment of the risks to human health and the environment.
2. Regulation 1829/2003/EC(2) requires an application for authorisation to be made to national authorities, who in turn convey the application to the European Food Safety Authority ("EFSA"). EFSA performs the risk assessment and delivers its opinion. Based on EFSA's opinion, the European Commission, together with representatives of Member States, will decide whether to grant the final authorisation decision.
3. There is a "safeguard clause" that enables Member States to restrict or prohibit, provisionally, the use and/or sale in their territory of a GMO that has been authorised for placing on the market. However, Member States recourse to this safeguard is limited to preventing the release of GMOs in their territory where they are able to provide scientific evidence justifying such measures.
Proposed Amendment
4. On 13 July 2010, in an attempt to address persistent opposition from European public opinion to the release of GMOs and their use in agriculture, the European Commission proposed to give member states the freedom to allow, restrict or ban the cultivation of GMOs on part or all of their territory with the exception of grounds based on a scientific assessment of health and environmental risks(3).
5. The proposal did not purport to change the substance of the existing authorisation system, and maintained the aim of ensuring the free circulation of genetically modified products.
6. In response, the European Parliament adopted a draft amendment to Directive 2001/18/EC but went against the Commission's proposal. The European Parliament backed Member States' right to cultivation bans based on environmental grounds and by reference to socioeconomic impacts.
7. The draft amendment was forwarded to the Council for further discussion.
Opposition to the Draft Amendment
8. The main objection to the draft amendment is the concern that the plans conflict with the EU's internal market rules on free trade.
9. Under the proposal, a Member State whose population does not wish to grow GMOs is able to resist the Commission's request to lift national cultivation bans. This could restrict trade and ultimately hinder scientific innovation and may, depending on the criteria used to justify the ban, contravene Member States' commitments under World Trade Organisation ("WTO") law.
10. Other objections raised are the potential fears over "comingling" – where GMOs grown in one country can mix with non-GMOs in a neighbouring country, and over the exact role the Commission will play in the process.
Danish Presidency Compromise
11. The Danish presidency put forward a compromise in attempt to deal with some of these concerns. The compromise would allow for two options for Member States to opt-out of the cultivation of an EU authorised GMO.
12. Firstly, prior to the GMO authorisation procedure, a Member State could ask a company to adjust the geographical scope of its application for cultivation approval of a GMO. Should an agreement be reached, the company would submit an application for authorisation that excluded part or all of the relevant territory.
13. The Second option would arise in the event that an agreement with the relevant company could not be agreed. After the GMO had received EU authorisation (based on the same scientific risk assessment carried out at EU level as before), the country would be able to restrict or ban cultivation on specific grounds, provided they did not conflict with the environmental risk assessment.
14. The Commission had originally limited the eligible criteria for bans, but the Danish compromise widens these to include local environment risks and socio-economic concerns (such as risk of cross-contamination).
Environmental Council Meeting
15. The Council met in March 2012 to discuss the draft amendment. Although a large majority of Member States were willing to accept the compromise, Belgium, France, Germany and the UK were joined by Bulgaria, Cyprus, Ireland, Slovakia and Spain in refusing to back the plan.
16. These Member States were still unhappy about the second option, believing that a Member State's ability to opt out from allowing cultivation of an EU authorised product would run counter to internal market rules and possibly risk falling foul of the WTO.
17. France and Germany have vigorously opposed the move, claiming the second phase would undermine the position of EFSA, and the UK are concerned it would mean a move away from a "science-based" decision-making process.
18. However, the Danish proposal provides that Member States can only ban cultivation of a GMO "provided that such a decision is in conformity with EU law, proportional and non-discriminatory and does not conflict with the environmental risk assessment" from EFSA. As such, the Member States' refusal has been met with criticism from some quarters. EU Health Commissioner John Dalli stated that, "the main reason for dissent has been a repetition of what was said before" and that the environmental concerns raised had "already been taken care of" in Denmark's proposal.
19. French Liberal MEP Corinne Leparge, who was responsible for drafting the Parliament amendment, went further, accusing the Member States blocking the Danish proposal as being "hypocritical", as they themselves had "enacted safeguard clauses against cultivation" of GMOs. She alleged that, "a huge majority of European citizens are opposed to GMOs, and most countries wanted to prevent their cultivation on their territory".
20. The Danish proposal also clarifies the Commission's role in the process. The Commission would give its view on a Member State's opt-out request within three months but that Member State would not be obliged to take this into account. Some countries, such as France and the Czech Republic are concerned about the possible implications of this if a Member State ignored the Commission's opinion. However, Commission officials have confirmed that while its comments can or cannot be taken into consideration, if it finds that a Member State has acted outside the legal framework, it would launch infringement proceedings.
Conclusion
21. The Danish proposal would appear to be a step in the right direction from the draft amendment as proposed by the European Parliament. The limiting of a Member State's right to opt out of cultivating an authorised EU GMO, so that any opt-out must not conflict with the EFSA risk assessment means that whilst Member States maintained some prerogative in this area, a European coherence and regulation system was present whereby the reason for authorising a GMO is scientific and not political. Providing Member States greater flexibility to opt-out of cultivation, whilst at the same time using and relying on a proper risk assessment at an EU level will assist in restoring public confidence in GMOs rather than simply banning them altogether to appease public opinion, as to do so would be ignoring their potential great benefits.
22. The Danish presidency plans to review the Member States' refusals before holding another vote in June. It remains to be seen whether the remaining minority Member States will agree to the new measures as for now the two opposing views within the EU seem worlds apart.
(1) Directive 2001/18/EC of the European Parliament and the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC, OJ L 106, 17 April 2001, p1.
(2) Regulation 1829/2003 of the European Parliament and of the Council of 22 September 2003 concerning genetically modified food and feed, OJ L 268, 18 October 2003, p. 1
(3) Commission proposal of 13 July 2010 for a regulation of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit for cultivation of GMOs on their territory, C(2010) 380 final, C(2010) 4822 final.
