• First step (preliminary evaluation of the notification): Any person who intends to place a GMO on the market, for the first time in Italy, shall submit a notification to the Italian Competent Authority (CA), following the procedures set out below. The notification must include all the information listed in Article 16, paragraph 3 of legislative decree 8 July 2003, no. 224, including the Summary of Notification Information (SNIF). At the same time, the notifier must also present the notification through the ESFC platform of the European Commission. The CA carries out the preliminary assessment of the notification and if it is positive, sends the SNIF to the European Commission, to the competent authorities of other Member States and to the Italian Regions and Autonomous Provinces. The CA publishes the SNIF and the environmental risk assessment on the Italian BCH for public information.
    All communication between the CA, the European Commission and the Competent Authorities of other Member States is done through the ESFC platform.
  • Second step (notification assessment report): after the preliminary assessment, the CA sends the notification to the Institute for Environmental Protection and Research (ISPRA). Within 75 days from the receipt of the notification, ISPRA transmits to the CA a proposal of assessment report in accordance with the guidelines of Annex VI of the legislative decree July 8, 2003, no. 224. The CA, on the basis of the assessment proposed by ISPRA, and after consulting the Ministries of Health and of Agricultural, Food and Forestry Policies, elaborates the notification assessment report that specifies if the GMO can be placed on the market or not and under which conditions, and sends it to the notifier. At the same  time the CA sends the entire notification and assessment report to the European Commission and to the competent authorities of the other Member States.
  • Third step (authorization or rejection of the placing on the market): if the assessment report is positive:
    • the CA shall give consent to the placing on the market to the notifier 60 days after the submission of the notification assessment report in case of absence of reasoned objections from Member States or from the European Commission;
    • the CA shall give consent to the placing on the market to the notifier 105 days after the submission of the notification assessment report if reasoned objections from Member States or from the European Commission have been resolved.

After 60 days from the submission of the assessment report, in case of reasoned and unresolved objections from Member States or from the European Commission, the CA shall adopt a decision on the basis of the decision adopted by the European Commission under the comitology procedure (Article 30, paragraph 2 of Directive 2001/18/EC): if the Commission’s decision is positive, the CA shall give the authorisation.

If the assessment report indicates that the GMO shall not be placed on the market, the CA immediately transmits the negative assessment report to the notifier and within 105 days of receipt of the notification, to the European Commission.

The authorisation decision is published in the Italian BCH. The authorisation is valid for a maximum period of 10 years from the date of authorisation.

To date, no notifications for the placing on the market of GMOs have been submitted in Italy.

ENG 224 2003 Titolo III 

 

Submission procedure of notifications for placing on the market of GMOs as or contained in products

Notifications authorised in the European Union under Part C of Directive 2001/18/EC