What is the EU approval process for GMOs?

The process for authorising a new GMO is based on the EU regulation on genetically modified food and feed (Reg (EU) No 1829/2003). Genetically modified (GM) foods can only be authorised in the European Union if they have passed a rigorous safety assessment. Applicants can apply for an authorisation by submitting a regulatory dossier with experimental data to the European Food Safety Authority (EFSA), which then evaluates the safety for human and animal health and the environment.  EFSA’s assessments are carried out by the GMO Panel, which is composed of independent scientific experts. The finalised EFSA risk assessment is the basis upon which the European Commission proposes a decision to Member States for the placing on the market of a GMO. The Commission’s draft decision is voted on under the EU’s usual qualified majority rules. In case the Standing Committee and the Appeal Committee do not manage to adopt the decision by qualified majority within a given time frame, it is up to the Commission to adopt the final decision and authorise the GMO.

The legislation also imposes a post-market monitoring of the environment for each authorised GMO. In addition, traceability and labelling obligations are imposed for any authorised GMO in order to provide consumers with information and freedom of choice.

For more information: check the European Commission’s infographic GMOs: EU decision-making process explained as well as EuropaBio’s infographics ‘What is the approval process for import of GMOs in the EU?’ and ‘EU Member States and GMOs: what they say and what they do