Regulation of genetically modified organisms in the European Union

The regulation of genetically modified organisms in the European Union is varied.

In its regulations the European Union considers genetically modified organisms only to be food and feed for all intents and practical purposes, in difference to the definition of genetically modified organisms which encompasses animals.

The EU uses the precautionary principle demanding a pre-market authorisation for any GMO to enter the market and a post-market environmental monitoring. Both the European Food Safety Authority (EFSA) and the member states author a risk assessment. This assessment must show that the food or feed is safe for human and animal health and the environment "under its intended conditions of use".

As of 2010, the EU treats all genetically modified crops (GMO crops), along with irradiated food as "new food". They are subject to extensive, case-by-case, science-based food evaluation by the European Food Safety Authority (EFSA). This agency reports to the European Commission, which then drafts proposals for granting or refusing authorisation. Each proposal is submitted to the "Section on GM Food and Feed of the Standing Committee on the Food Chain and Animal Health". If accepted, it is either adopted by the EC or passed on to the Council of Agricultural Ministers. The Council has three months to reach a qualified majority for or against the proposal. If no majority is reached, the proposal is passed back to the EC, which then adopts the proposal.

The EFSA uses independent scientific research to advise the European Commission on how to regulate different foods in order to protect consumers and the environment. For GMOs, the EFSA's risk assessment includes molecular characterization, potential toxicity and potential environmental impact. Each GMO must be reassessed every 10 years. In addition, applicants who wish to cultivate or process GMOs must provide a detailed surveillance plan for after authorization. This ensures that the EFSA will know if risk to consumers or the environment heightens and that they can then act to lowed the risk or deauthorize the GMO.

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