GMO Cultivation Agreement Not Possible
20 July 2012
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
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
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
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
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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