• First step (preliminary evaluation of the notification): any person shell, before undertaking a deliberate release into the environment of a GMO for experimental purposes, submit a notification to the Italian Competent Authority (CA) following the procedure set out below. The notification shall include a technical dossier supplying all the information specified in Annex III of legislative decree 8 July 2003, no. 224, the environmental risk assessment and conclusions required in Annex II, section D of the legislative decree and, the risk assessment for agrobiodiversity if the experimentation concerns a plant species of agronomic interest. At the same time, the notifier must submit the summary of the notification information (SNIF) through the European Commission's ESFC¬†platform. Upon receiving the notification, the CA shall, 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, no. 224. If the preliminary evaluation of the notification is positive, the CA provides the summary of the notification available to the to the European Commission and transmit a copy of the complete notification to the Ministry of Health, to the Ministry of Agriculture, Food and Forestry Policies, to the Institute for Environmental Protection and Research (ISPRA) and to the regions and autonomous provinces concerned by the experimentation. The other Member States, having received the SNIF through the ESCF portal, have 30 days to submit any observations.
  • Second step (public consultation and ISPRA opinion): the CA carries out the public consultation by making available on the Italian BCH, for 30 days, the summary of the information of the notification, the environmental risk assessment and the conclusions required by annex II, section D of the legislative decree of 8 July 2003, no. 224. Within 60 days from the conclusion of the public consultation, ISPRA, taking into account the comments received during the public consultation, transmits its opinion to the CA.
  • Third step (authorization or rejection of the deliberate release into the environment): 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 rejection of authorization. The CA informs the concerned Regions and Autonomous Provinces of the final decision taken. The CA publishes the authorisation or rejection decision on the Italian BCH and on the ESFC platform.

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

The notifier may proceed with deliberate release into the environment for experimental purposes only after authorisation by the Italian Competent Authority and in compliance with all the conditions specified therein.

 ENG 224 2003 Titolo II

Public register of notifications submitted in Italy (see also GMO Register of the European Commission)

Submission procedure of notifications for the deliberate release of GMOs for experimental purposes