Ministero dell'Ambiente e della Sicurezza Energetica
- First step (preliminary evaluation of the notification): any person who would like to undertake a deliberate release of a GMO into the environment for experimental purposes must submit a notification to the Competent Authority (CA) of the Member State in whose territory the experimentation will take place. The notification shall include a technical dossier containing all the information required in Annex III of directive 2001/18/EC, the environmental risk assessment and the conclusions required in Annex II, Section D of the above directive. At the same time the notifier shall submit the Summary of Notification Information (SNIF) through the European Commission's ESFC platform.
- Second step (assessment of the notification and public consultation): the other Member States, upon receipt of the summary information of the notification through the ESFC platform, shall have 30 days to submit their comments. The CA concerned by the trial may also conduct a public consultation, which may extend the deadline of the procedure by no more than 30 days.
- Third step (authorization or rejection of the deliberate release into the environment): the CA, after examining the observations submitted by the other Member States, sends a reply to the notifier in which it specifies whether:
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- the notification is in compliance with Directive 2001/18/EC and therefore the release can take place;
- the release does not comply with Directive 2001/18/EC and therefore the notification is rejected.
The CA will also communicate this response to the notifier through the European Commission's ESFC platform.
The overall duration of the authorisation procedure is 90 days or up to 120 days if the CA conducts a public consultation.
Notifications submitted in the European Union under Part B of directive 2001/18/EC from 17 October 2002 to date for GM higher plants and GM organisms other than higher plants.