Applications for authorisation to market a GM food are processed at EU level as outlined in Regulation (EC) No 1829/2003. Authorisation is only possible following a positive risk assessment by the European Food Safety Authority (EFSA). This scientific evaluation is followed by a risk management decision by the EU, under a regulatory procedure ensuring close cooperation between the Commission and Member States and is valid for 10 years (renewable). The Commission has prepared an infographic explaining the decision-making process for GMOs authorisation.
Article 4(2) of Regulation (EC) No 1829/2003 provides that no GM food is to be placed on the EU market unless it is covered by an authorisation granted in accordance with that Regulation. Article 4(3) of the same Regulation specifies that no GM food may be authorised unless it has been adequately and sufficiently demonstrated that it does not have adverse effects on human health, animal health or the environment, that it does not mislead the consumer or the user, and that it does not differ from the food it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for humans or animals.
See the list of applications for assessment by EFSA.