Schizophrenic stakes of GMO regulation in the European Union | Fieldfisher
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Schizophrenic stakes of GMO regulation in the European Union



Schizophrenic stakes of GMO regulation in the European Union

This text contains a summary of the item that will feature in the European Journal of Risk Regulation 2012/02.

For the long version : click here

After ten years of legislation, the Commission is proposing changes to bring about greater harmonization and flexibility to the GMO regime.

Directive 2001/18/2003

It is Directive 2001/18/EC regulating the release of GMOs on the European market, which is currently under review. The Directive allows GMOs to be placed on the market subject to a specific environmental risk assessment.  The final decision on the deliberate release rests with the Member State in charge of the request for authorisation. The procedure for the placement on the market of GMOs remains both national and European; however, faced with Member State objection, the Council may reject the opinion of the Committee by qualified majority. Finally, Article 23 of the Directive limits Member States in that they can only prevent the release of GMOs on their territory where they are able to provide scientific evidence justifying such measures.

The proposal of the European Commission

The Commission’s proposal suggests that the principle of subsidiarity is able to reconcile the freedom of Member States to decide whether or not to cultivate GMOs within a European authorisation system. It retains that EFSA should conduct the scientific assessment of the adverse effects on health and the environment which might arise from their deliberate release, but that Member States should be allowed to raise and prevent the cultivation of GMOs on other grounds. It should be noted that the cultivation and release of GM plants in Member State territory is a separate issue from authorisation for marketing and consumption of GMOs, which are not covered in the proposal.

Additionally, the Commission suggests that the measure should be based on Article 114 TFEU, which is the legal basis for harmonisation aimed at the establishment and functioning of the internal market. This is, in our opinion, correct as whilst the measure covers environmental matters, its main focus is the functioning of the internal market.

Parliament’s response

Members of the European Parliament disagreed with a number of points in the Commission’s proposal. The Parliament suggested Article 192 TFEU be adopted as the legal basis, which is the basis for harmonisation in the field of environment, as opposed to Article 114 TFEU and that Member States be allowed to also put forward scientific justifications for banning the cultivation of GMOs.

The compromise

The Parliament’s report was amended, emphasising the principle of proportionality and the importance of scientific grounds for authorisation decisions, although retaining the possibility for Member States to rely on “scientifically justified grounds relating to environmental impact”, and reference to Article 192 as the appropriate legal basis of the proposal. The draft amendment was forwarded to the Council and awaits (April 2012) a first reading Position.


These events highlight the struggle for power between the EU and the Member States, however, in our opinion, to ensure the European system is effective, the enforceability of the legislation on GMOs should remain “European” i.e harmonised. If Member States are allowed to restrict the cultivation of GMOs under any pretext, the regulatory system will crumble from within. This could ultimately hinder scientific innovation, which is essential for the EU to remain competitive in a global market.   

For more information please contact Claudio Mereu, Partner in the Competition & EU Regulatory Group at Field Fisher Waterhouse LLP.