Authorisation procedure for placing on the market of genetically modified food and feed pursuant regulation (EC) n. 1829/2003

First step (application for authorisation): to obtain the authorisation for placing on the market of genetically modified food and feed in the European Union an application shall be submitted to the competent authority of a Member State. Within 14 days of the receipt of the application, the AC shall make available the application the European Food Safety Authority (EFSA). The EFSA shall make the application available to the European Commission and to the other Member States and the summary of the dossier available to the public.

Second step (EFSA opinion): within 180 days of the receipt of the application for authorisation, the EFSA shall give its opinion and shall send it to the European Commission, to Member States and to the applicant. The EFSA shall make its opinion available to the public. The public may make comments to the European Commission within 30 days from such publication.

Third step (authorisation for placing on the market): within 90 days from the receipt of EFSA opinion, the European Commission shall submit to the Standing Committee on plants, animals, food and feed - Section genetically modified food and feed and environmental risk a draft of the decision to be taken in respect of the application, taking into account the opinion of the EFSA.
If the Standing Committee give a favorable opinion, the authorization for the placing on the market is granted, the Commission shall inform the applicant of its decision and published it on the Official Journal of the European Union.

If the Standing Committee give an unfavorable opinion, the application for authorisation is rejected.

If the Standing Committee give no opinion, the comitology procedure begins.

The authorization shall be valid for 10 years.

 Titolo III EN 224 2003

Applications submitted in the European Union pursuant regulation (EC) n. 1829/2003

Action Plan for capacity building for biosafety

Strengthening of human resources and institutional capacities in the field of biosafety.

During the COP-MPO 1, with the decision BS-I/5 – Annex 1 - was adopted the Action Plan for strengthening human resources and institutional capacities in the field of biosafety for the effective implementation of the Cartagena Protocol, subsequently revised during the COP-MOP 3, with the decision BS-III/3 – Annex.

The aim of the Action Plan is to facilitate and support, in a timely manner, the development and strengthening of capacities for the ratification and effective implementation of the Protocol at the national, subregional, regional and global levels, including the provision of financial services, technical and technological support to developing countries and countries with economies in transition.

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 Protection and 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