What is the approval process for GMOs in the European Union?

Every GMO released in the environment for research or marketing purposes needs a special authorization.  Some major principles of the EU legal framework are the following :

1. The risk assessment is done on a case-by-case, step-by-step, and use-by-use basis. This means that attention is paid to the peculiarities of each individual GM product, depending on the interaction between its novel trait and a given environment, and considering its intended uses (food, feed, cultivation, processing etc.). The step-by-step approach means that GMOs are marketed only after they have been carefully evaluated in a contained environment, followed by experimental field releases.
    

2. Post-release monitoring, traceability and labelling : as a general provision of the precautionary principle, monitoring plans need to be approved before issuing the marketing consent and the traceability of the product on the market is ensured by labelling and administrative records throughout the food chain. Marketing approvals are first granted for a maximum of 10 years.
    

3. Public information : in the course of the approval process, information is provided to the public, via abstracts of the technical dossiers submitted by the applicants, via opinion papers published by the EFSA and via the web sites of national authorities and of the European Commission in-house research Center (JRC of Ispra).
    

4. Subsidiarity : although the aim is the promote the European market via common rules, member states may be requested to develop national answers to questions raised by GMOs. This is true for the « co-existence issue », which refers to the need to provide the farmers with a practical choice between conventional, organic and GM crop production, with minimal adverse economical effect. Considering the diversity of crop and land management practices across Europe, legislators estimated that the member states were in a better position to identify the effective and justified measures for achieving this co-existence objective, and the Commission only provided guidelines via a Recommandation on that issue (2003/556/EC).
    

5. Compliance with the international trade rules : The EU regulation is in line with the international trade requirements of WTO (it is clear, transparent and non discriminatory) and with the transboundary movement rules of the UN Cartagena Protocol on Biosafety.

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