Authorization procedure for the deliberate release into the environment of GMOs pursuant Part B of directive 2001/18/EC

  • First step (preliminary evaluation of the notification): any person must, before undertaking a deliberate release of a GMO, submit a notification to the Competent Autority (CA) of the Member State within whose territory the release is to take place. The notification shall include a technical dossier supplying the information specified in Annex III of the Directive 2001/18/EC necessary for carrying out the environmental risk assessment of the deliberate release of a GMO. The CA shall send to the European Commission, within 30 days of receipt of the notification, the summary of the notification information received. The Commission shall, at the latest 30 days following its receipt, forward this summary to the other Member States.

  • Second step (assessment of the notification): the Member States may, within 30 days, present observations to CA. The CA shall carry out a public consultation that shall not prolong the 90 days period, within the CA shall respond in writing to the notifier, by more than 30 days.

  • Third step (authorization of the deliberate release into the environment of the GMO or rejection of the notification): the CA having considered, where appropriate, any observations by other Member States, shall respond in writing to the notifier within 90 days of receipt of the notification by either:
    • indicating that it is satisfied that the notification is in compliance with directive 2001/18/EC and that the release may proceed;
    • or indicating that the release does not fulfil the conditions of directive and that notification is therefore rejected.

The overall period of the authorization procedure is 90 days or 120 days if the NCA proceeds to public consultation. 

Parte B EN

Notifications submitted in the European Union pursuant to Part B of directive 2001/18/EC:

■ From 17 October 2002 to date: of GM Plants and of other GMs than plants