Genetically Modified Organisms (GMOs): Changes to the authorisation process for cultivation

09 September 2014

Article by Katy Orford, National Assembly for Wales Research Service

Image from Flikr by iplaylens  Licensed under the Creative Commons

Image from Flikr by iplaylens Licensed under the Creative Commons

In 2010 the EU Commission set out a proposal for a Regulation to revise the current system for authorisation of GMO cultivation. The aim of the proposal was to grant Member States more flexibility to restrict or prohibit GMO cultivation based on ethical and moral criteria as well as the existing scientific risk assessment. These proposals are subject to the co-decision procedure where both the Council and European Parliament have to reach an agreement.

The Commission’s proposal had been stalled due to Member States’ concern but the proposal has recently been revisited following complications associated with the authorisation of maize 1507. Indeed, the Council of Ministers has indicated that it expects to enter into trilogue negotiations with the European Parliament on the text of the final proposal in the coming autumn.

The current process

GMOs are authorised for cultivation at EU level following an application by a bio-tech company with the resulting decision applying to all EU countries. The legislative process involves scientific risk assessment, public consultation and a final decision where Member States may approve or reject the Commission’s proposal by qualified majority. Member States have often failed to reach a majority resulting in a stale-mate within the Council. If this is the case and the crop is approved following scientific risk assessment the Commission should grant authorisation. In recent years the Commission has failed to come to a decision following a lack of agreement by Member States which has led to action being taken by bio-tech companies in the European courts e.g. in the case of maize 1507.

A ‘safe guard clause’ (Article 23 of the Directive 2001/18) exists allowing Member States to restrict or prohibit the cultivation or use of a GMO product that has been authorised but only if they can provide new scientific evidence proving the product is a danger to the environment or human health within the territory.

The proposed changes in legislation

In July 2010 the Commission published a draft proposal for a Regulation revising Directive 2001/18. This revision would provide a legal basis for Member States to approve or reject GMO cultivation based on grounds other than scientific. Possible grounds suggested by the Commission included ‘public morals’ including religious, philosophical and ethical concerns, ‘social policy objectives’ including the preservation of certain farming types to maintain jobs, and ‘cultural policy’. This Regulation would allow Member States to prohibit GMO cultivation in part or all of their territory without having to use the safe guard clause (though health and environmental concerns would continue to be raised under the clause). The Commission hopes this will lead to more crops being approved for authorisation by the Council.

These proposals are subject to the co-decision procedure where both the Council and European Parliament have to reach an agreement.

The status of the proposed Regulation

The initial proposals were met with opposition with France and Germany concerned that it could result in fragmentation of the EU’s internal market and cause problems with the World Trade Organisation.

In March 2012 in a debate on the proposals at the Environment Council no agreement could be made due to blocking of the proposal by a minority of Member States delaying the decision making process. However, in 2014 the Greek Presidency of the Council began to revive discussions which led to a vote and adoption of the compromise text at the Environment Council on 12 June 2014. This included several proposed amendments to the Commission’s original proposal.

The European Parliament

The European Parliament adopted a negotiation position on the Commission’s original proposals in July 2011 however following the recent European elections and the amount of time passed since the Parliament adopted its negotiation position it may decide to revisit its original response. Whether it will chose to do so will become clear over the next few months.

For further information:

Research Service, Research Note,

Genetically Modified Organisms (GMOs): The authorisation process for cultivation, July 2014

European Commission,

Questions and Answers on EU’s policies on cultivation and imports of GMOs, 6 November 2013