Authorization procedure for the deliberate release of GMOs into the environment for any purpose other than placing on the market in Italy (Title II of legislative decree 8 July 2003, no. 224)

  • First step (submission and preliminary evaluation of the notification): any person must, before undertaking a deliberate release into the environment of a GMO for experimental purposes, submit a notification to the Italian Competent Authority (AC). The notification shall include a technical dossier supplying all the information specified in Annex III of legislative decree 8 July 2003, n. 224, to carry out the environmental risk assessment of the deliberate release into the environment of the GMO. The CA shall, after receiving the notification, within 15 days, carry out a preliminary evaluation of the compliance of the notification with the provisions of the legislative decree of 8 July 2003, n. 224, send the summary of the notification information format (SNIF) to the European Commission and transmit a copy of the notification to the Ministry of Health, to the Ministry of Agriculture, Food and Forestry Policies, to the Institute for Environmental Research (ISPRA) and to the regions and autonomous provinces concerned. The European Commission shall send the summary of the notification information to the Member States which may, within 30 days, present observations.

  • Second step (public consultation and ISPRA opinion): the AC shall carry out a public consultation making available the summary of the notification information format on the Italian BCH for 30 days. Within 60 days of the conclusion of the public consultation, ISPRA shall, taking into account the comments received during the public consultation, send its opinion to the AC.

  • Third step (consent to the deliberate release in the environment of the GMO or motivated refusal): within 15 days from the receipt of the opinion of ISPRA, the CA shall, after consulting the Ministries of Health and Agriculture, Food and Forestry Policies, inform the notifier that the deliberate release into the environment of the GMO may proceed, requiring specific conditions, or communicate to the notifier the reasons for the refusal of authorization. The CA shall inform the European Commission, the Member States and the regions and autonomous provinces concerned of the final decision taken. The CA shall publish the consent or the refusal of the authorization on the Italian BCH.

The period of time for the authorization procedure is 120 days.

The notifier may proceed with the release only when he has received the consent of the Italian CA, and in conformity with any conditions required in the consent.

224 titolo II EN