EU Regulatory Bulletin contents
- BPR published
- National restrictions for GMOs
- Water pollution controls & pesticides
- Parallel trade in pesticides
- ETS & State Aid
- Nano & REACH
The Danish Presidency has concluded it is not possible "to achieve an agreement on proposals to allow national bans on the cultivation of EU-approved genetically modified crops."
The relevant legislation regulating Genetically Modified Organisms ("GMOs") is Directive 2001/18/EC. Under that Directive, 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 by the European Food Safety Authority ("EFSA") of the risks to human health and the environment.
There is a limited "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 at EU level, where they are able to provide scientific evidence justifying such measures.
A proposal was put forward by the European Commission to amend Directive 2001/18/EC, the aim of which was to provide for a legal basis within the EU legal framework to authorise Member States to restrict or prohibit the cultivation, in their territory, of GMOs that have been authorised at EU level.
The European Commission proposed to give member states the freedom to allow, restrict or ban the cultivation of GMOs on their territory with the exception of grounds based on a scientific assessment of health and environmental risks. The European Parliament amended the proposal, extending the right to impose cultivation bans on environmental grounds and by reference to socioeconomic impacts. The draft amendment was forwarded to the Council for further discussion
Danish Compromise and March Environment Council Meeting
As the Council was unable to reach a political agreement, the Danish Presidency prepared a compromise text. The compromise would allow two options for Member States to opt-out of the cultivation of an EU authorised GMO:
- Prior to the GMO authorisation procedure, a Member State could seek to reach an agreement with a company to exclude part or all of the relevant territory from its application for cultivation approval of a GMO; or
- After the GMO had received EU approval, a Member State would be able to restrict or ban cultivation on specific grounds, provided they did not conflict with EFSA's environmental risk assessment.
The Council met in March 2012 to discuss the Danish compromise text in relation to the draft amendment. Although a large majority of Member States were willing to accept the compromise, a small minority blocked the agreement. The reasons given varied between Member States but the main concerns were firstly. that the proposal was counter to internal market and WTO rules. The objectors argued that national authorities will face legal challenges if they block the use of any product that has been assessed and approved according to EU law, and secondly, it potentially undermined the position of EFSA.
Following the outcome of the Environment Council on 9 March 2012, the Danish Presidency undertook to consider options for a political agreement in the future.
Danish Presidency Progress Report
The Danish Presidency subsequently held informal consultations with delegations, in particular, the blocking minority in order to examine how a change in delegations' positions could possibly be achieved.
In light of the forthcoming Environment Council meeting on 12 June 2012, the Danish Presidency met with the Committee of Permanent Representatives in the European Union ("COREPER") at a Meeting on 31 May 2012 to consider the possibility of achieving a political agreement on the draft amendment.
Despite the fact that significant progress had been made, the Presidency, taking into account the outcome of the informal consultations and Member States' views at the COREPER meeting, concluded that a political agreement on the GMO dossier was not possible. Objectors had shrunk, but a core group of Belgium, France, Germany and the UK refused to change their stance.
The Danish Presidency had previously warned that the proposals would not be presented for a vote at the June meeting if there were signs of a repeat of the stalemate reached in March. This proved to be the case, and, instead of a vote, the Environment Council, on 12 June 2012, merely took note of the Danish Presidency progress report.
Future of the Proposal
A question has been raised over the future of the proposal as a consequence of the Danish Presidency's comments that the proposals are not currently on the work programme of the Cypriot government, which takes over the rotating six-month EU Presidency in July.
It remains to be seen what will now happen to registration times. Several applications for cultivation have been stalled in the EU system for many years. With regard to applications for import, approvals have been delayed in every case because Member States cannot reach the majority vote required to accept or reject them.
In a June update, European biotechnology industry association EuropaBio says that the number of GM crops in the EU backlog has reached an “all time record”. A total of 73 products are now in the registration system, of which 57 are awaiting a European Food Safety Authority decision on the safety assessment and 16 are awaiting further action from the Commission or Member States.
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