Afssa - GMOs and regulation

GMO regulations ?
A European regulatory framework

GMOs are subject to EU-level regulation. In compliance with this framework, GMO safety for cultivation and/or for consumption by humans and animals is assessed before European marketing authorisation is granted.
Assessment is centralised on the EU level by the European Food Safety Authority which offers Member States the possibility to provide comments on the dossiers. In France, ANSES for the food aspects, and the High Council of Biotechnology for the environmental aspects, are both independent public bodies which participate in the assessment of GMO dossiers. When the assessment is complete, a decision is taken for each GMO by the European Commission after a vote by its 27 Member States.

On the European level, two main laws regulate GMOs

-Directive 2001/18/EC, regulating the deliberate release of GMOs into the environment, applies to two kinds of activity:
· experimental release of GMOs into the environment (e.g. for field testing);
· marketing of GMOs, e.g. cultivation, importing or processing of GMOs in industrial products.

- Regulation (EC) No. 1829/2003 which specifically regulates GMOs used in food and GMOs which may be used as a foodstuff ingredient. This law regulates marketing authorisation of all GMO-based products used in food or animal feed. It also sets out the methods for assessing, authorising and labelling these products.

European assessment

Before GMOs can be marketed, they undergo an assessment whose goal as concerns the health aspect is to demonstrate the safety of the GMO as compared to a traditional product. According to EU legislation, manufacturers must submit a marketing authorisation application providing the necessary elements for a scientific assessment of the risks in order to evaluate the safety of the GMO and of the foodstuffs or feedstuffs which are derived from it.
Once the assessment is conducted, the GMOs are granted authorisation, if necessary, by the European Commission by a Decision published in the Official Journal of the European Union.
In compliance with Regulation (EC) No.1829/2003, the European Food Safety Authority (EFSA) is in charge of assessing GMO marketing authorisation applications.

ANSES and the HCB, what scope of action?

In June 2008, under law 2008-595 concerning genetically modified organisms, the High Council of Biotechnology was created. The mission of this body is to "inform the Government on all issues relating to genetically modified organisms and any other biotechnology, and to give opinions relating to the assessment of risks for the environment and public health which may be posed by the contained use or deliberate release of genetically modified organisms, and opinions relating to biological monitoring of the national territory."
These provisions apply without affecting the jurisdiction exercised by the Agency, which remains in charge of assessing the health risks of GMOs used in or as food.

September 2012