GMO authorisations for food and feed

GMO authorisations for food and feed

The process for authorisation of GM for food and feed in the EU takes place under Regulation (EC) No 1829/2003.

How to apply for authorisation?

An application for authorising a GMO for food or feed uses must be submitted to a national authority. The application under Regulation (EC) 1829/2003 must also comply with the requirements set out in Commission Implementing Regulation (EU) No 503/2013 on applications for authorisation of genetically modified food and feed. It must include:

The national authority acknowledges receipt of the application within 14 days.

It then sends the application to the European Food Safety Agency (EFSA) for a risk assessment. EFSA makes the application summary available to the public.

If the application also covers cultivation, EFSA delegates the environmental risk assessment to an EU Member State which sends EFSA its Environmental Risk Assessment (ERA) report.

Risk assessment

EFSA assesses the risks the GMO may present to the environment, human health and animal safety in the EU.

EFSA's GMO Panel carries out the risk assessment. It may give recommendations on labelling or conditions of the use and sale.

Normally, EFSA performs the risk assessment within six months of receiving the application and issues a scientific opinion published in the EFSA Journal. This process can take longer if EFSA has to request additional information from the applicant in order to complete the assessment.

EFSA submits its opinion to the European Commission and to the Member States. The opinion is made available to the public.

Public consultation

Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Regulation (EC) 1829/2003.

Final decision

Within three months of receiving EFSA's opinion, the Commission proposes to Member State to grant or refuse the authorisation. If the Commission proposal differs from EFSA’s opinion, it must be explained why.

Authorisations are valid for a maximum of 10 years (renewable).

National representatives approve the Commission’s proposal by qualified majority in the Standing Committee on Plants, Animals, Food and Feed.

If the Committee does not approve or reject the proposal by a qualified majority, the Commission may summon an Appeal Committee.

If the Appeal Committee fails to reach an opinion by a qualified majority, the Commission has to take the responsibility for the final decision.