Authorization procedure for the placing on the market of GMOs pursuant to Title III of the legislative decree 8 July 2003, n. 224

First step (preliminary examination): any person shall, before placing on the market a GMO for the first time in Italy, submit a notification to the Italian competent authority, informing at the same time the Ministry for Health, the Ministry for Agriculture, Food and Forestry Policies, the Ministry of Labour and Social Policies, the Ministry of Economic Development and the Ministry for University and Research. The CA shall, after receiving the notification, carry out a preliminary examination of the compliance of the notification with the provisions of the legislative decree of 8 July 2003, n. 224, and immediately forward the summary of the dossier to the European Commission, to the competent authorities of the other Member States, to the regions and autonomous provinces, and publish the summary of the dossier on the Italian BCH for public information.

Second step (assessment report): after the preliminary examination, the CA shall forward the notification to the Institute for Environmental Protection and Research (ISPRA). Within 75 days of the notification receipt, ISPRA shall send to the CA a proposal of assessment report established in accordance with the guidelines laid down in Annex VI of legislative decree of 8 July 2003, n. 224. The CA shall, on the basis of proposal of ISPRA, after consulting the Ministries of Health and Agriculture, Food and Forestry Policies, prepare an assessment report that specifies if the GMO may be placed on the market and under which conditions and forward it to the European Commission and to the notifier. The European Commission shall, wthin 30 days of its receipt, forward the assessment report to the competent authorities of the other Member States. 

Third step (consent to the placing on the market of the GMO): when the assessment report indicates that the GMO may be placed on the market, the CA shall give consent:

    • after 60 days from sending the assessment report to the European Commission, in the absence of reasoned objections from the CA of another Member State and/or from the European Commission;
    • after 105 days from sending the assessment report, if reasoned objections from the CA of another Member State and/or from the Commission have been resolved.

After 60 days from sending the assessment report, if reasoned objections from the CA of another Member State and/or from the Commission are not resolved, the CA shall take a decision in accordance with the decision adopted by the European Commission during the commitee procedure (article 30, paragraph 2, directive 2001/18/EC): if a favourable decision is taken, the CA shall give the consent to the placing on the market, shall trasmitt it to the notifier and shall inform the competent authorities of the other Member States and the European Commission.

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

The consent is published on the Italian BCH and is valid for a maximum period of 10 years starting from the date on which the consent is issued.

Until today no notification have been submitted for the placing on the market in Italy.

 

Titolo III EN 224 2003

Procedure for submitting a notification for placing on the market of GMOs