There are two regulatory regimes but most recent applications have been made under the 2003 Regulation on genetically modified food and feed. Under this system, the European Food Safety Authority has six months to carry out a risk assessment, based on information supplied by the applicant, and give an official opinion. It can take longer if it needs to ask for more information.
The European Commission then has another three months to draft a proposal recommending authorisation. It can deviate from EFSA’s opinion but has to justify its decision.
The proposal is submitted to a committee of member-state representatives that needs a qualified majority to approve or reject the proposal. If it cannot reach a decision, the draft is submitted to the Council of Ministers. If the Council also fails to reach a qualified majority, the decision reverts to the Commission.
Authorisation lasts for ten years and post-market monitoring must be carried out during this period.
Before seed varieties can be marketed for cultivation they have to be placed on the national seed list of the countries they are to be sold in.
There may be several varieties of seed bearing the same GM trait. Each one has to undergo field trials prior to listing and once listed in one EU country, can be placed on the EU’s common catalogue and sold throughout the bloc.
Traceability and labelling
GMOs and food and feed products containing GMOs must be traceable throughout the food chain and final products labelled accordingly. Products with a low level of contamination - less than 0.9% - do not have to be labelled if the GM presence is "adventitious or technically unavoidable".
Coexistence procedures are designed to keep gene flow between crops to a minimum, giving EU farmers a choice between GM, conventional and organic crop production.
The Commission decided that it was up to member states to develop their own coexistence procedures and issued guidelines in 2003.
These guidelines state that the development process should be fair and transparent but also proportionate; that is not going beyond the measures necessary to comply with the 0.9% labelling threshold.
The separation distances needed between GM and conventional crops depends on the type of plant.