How to apply for authorisation?
An application for authorising a GMO for food or feed uses must be submitted to a national authority through an electronic submission platform.
This electronic submission platform allows applicants to submit applications online and to follow them up from the submission until the outcome.
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:
- all relevant data, studies and analysis of the results (review under Article 12 of Implementing Regulation (EU) No 503/2013)
- purpose and scope
- monitoring plan
- labelling proposal
- detection method
- indication of confidential information
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 country which sends EFSA its Environmental Risk Assessment (ERA) report.
Guidance for the submission of application for authorisation of GMO for food and feed uses and for the renewal of the authorisation of GMO for food and feed uses are available at EFSA.
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 EU countries. The opinion is made available to the public.
Once EFSA publishes its risk assessment, the public has 30 days to comment on the Commission website for applications under Regulation (EC) 1829/2003.
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.