Placing on the market of GMOs as or contained in products

At national level

In Italy the placing on the market of GMOs as or contained in products is regulated by Title III of Legislative Decree n. 224/2003 implementing Directive 2001/18/EC.

Authorization procedure for the placing on the market of GMOs pursuant to Title III of the Legislative Decree n. 224/2203

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

Notifications submitted in Italy: up to date no notification has been submitted under Title III of the Legislative Decree n. 224/2003 implementing Directive 2001/18/EC.

Regional registers relating to the location of GM crops: Article 30 of the Legislative Decree n. 224/2003 states that the Regions and the Autonomous Provinces of Trento and Bolzano shall establish public registers on which the locations of GMOs cultivation, authorized under Title III of the Legislative Decree n. 224/2203, are noted in order to allow, in particular, the monitoring of any potential adverse effect of such GMOs on the environment. Since until today in Italy the cultivation of GMOs has never been authorized, the regional registers have not been established.

 

At European level

The placing on the market of GMOs as or in products in the EU is regulated by Part C of Directive 2001/18/EC and by Regulation (EC) n. 1829/2003. In the past, the placing on the market of GMOs was regulated by Directive 90/220/EEC and by Regulation (EC) n. 258/97.

Authorization procedure for placing on the market of GMOs under the Directive 2001/18/EC, Part C

Authorization procedure for the placing on the market of GMOs under the Regulation (EC) n. 1829/2003.

Notifications submitted in the European Union:

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

Public consultation pursuant article 12 of legislative decree 8 July 2003, n. 224

Public consultation means the opportunity for any natural or legal person, institution, organization or association, of making comments or sending information on any notification submitted pursuant Title II of the legislative decree 8 July 2003, n. 224.

The following documents and information are made available for public consultation:

  • the synthesis of the dossier supplying information necessary to carry out the environmental risk assessment of the deliberate release of a GMO;
  • the environmental risk assessment;
  • any new information available on risks for human health and the environment.

Filling in the registration area below you will able to see documents and information on every new notification submitted.

To facilitate the public consultation a list has been done including central and local institutional authorities, trade associations and non-governmental organizations for environmental and consumer protection.

Upon request, any natural or legal person, institution, organization or association may be entered in the consultation list.

The members of the list will be advised at the beginning of any public consultation and will have the opportunity to provide comments during the public consultation period of 30 days.