Collection of Biosafety Reviews - Vol. 7

copertina vol 7

General introduction

  1. Generation of Genetically Modified Animals.
    Authors:
    Louis-Marie Houdebine, Biologie du Développement et Reproduction, INRA, France
    Martin Alfredo Lema, Biotech. Directorate of the Secretariat of Agriculture Livestock and Fisheries, Argentina
    Moisés Burachik, INDEAR (Agrobiotechnology Institute), Argentina
    Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
  2. Advances in the Development of Genetically Modified Animals.
    Authors: Louis-Marie Houdebine, Biologie du Développement et Reproduction, INRA, France Martin Alfredo Lema, Biotech. Directorate of the Secretariat of Agriculture Livestock and Fisheries, Argentina
    Moisés Burachik, INDEAR (Agrobiotechnology Institute), Argentina
  3. Food Safety Assessment of Products from Genetically Modified Animals.
    Authors: Louis-Marie Houdebine, Biologie du Développement et Reproduction, INRA, France Martin Alfredo Lema, Biotech. Directorate of the Secretariat of Agriculture Livestock and Fisheries, Argentina Moisés Burachik, INDEAR (Agrobiotechnology Institute), Argentina

National Competent Authorities

The Italian National Competent Authority (NCA) for the implementation of directive 2001/18/EC, pursuant to art.2 of Legislative Decree n. 224/2003, is the Ministry for Ecological Transition.

The NCA coordinates the administrative, technical and scientific activities arising from the implementation of the measures contained in Legislative Decree n. 224/2003, in agreement, within their respective powers, with the Ministers of Health, of Labour and Social Policies, for Agriculture, Food and Forestry Policies, of Production Activities and of Education, University and Research.

Until July 2012, the ANC has worked with the support of the Interministerial Commission for the Evaluation of GMOs release pursuant to art.6 of legislative Decree n. 224/2003.

Article. 12, paragraph 20, of Decree Law 6 July 2012, n. 95 "Urgent provisions for public spending review with invariance of services to citizens," has ordered the abolition of many boards operating in the public administration, including the Commission for the Evaluation of GMOs release.

The NCA pursuant to Directive 2001/18/EC is called to participate to environmental Risk Assessment for experimentation  end for marketing purposes of human medicinal products containing or consisting of GMOs pursuant to Regulation (EC) n. 726/2004, by submitting its own comments to the European Medicines Agency European (EMA).

The Italian NCA for the implementation of Title III bis of legislative Decree n. 224/2003 is the Ministry of Agricultural Food and Forestry Policies. 

The Italian NCA for the implementation of Regulation (EC) n. 1829/2003 is the Ministry of Health.

Authorization procedure for placing on the market of GMOs pursuant Part C of directive 2001/18/EC

First step (preliminary examination of the notification): before a GMO is placed on the market in the European Union, a notification shall be submitted to the competent authority of the Member State where such a GMO is to be placed on the market for the first time. After receipt of the notification, the AC shall immediately forward the summary of the dossier to the European Commission and the competent authorities of the other Member States. The AC shall, without delay, examine if the notification complies with the requirements of Article 13 (2) of Directive 2001/18 /EC and shall, if necessary, ask the notifier for additional information. If the notification is in accordance with article 13(2) of directive 2001/18/CE, the AC shall forward a copy of the notification to the European Commission which shall, within 30 days of its receipt, forward it to the competent authorities of the other Member States.

Second step (assessment report of the notification): within 90 days of the date of receipt of the notification, the AC shall prepare an assessment report and send it to the notifier. Not earlier than 15 days after sending the assessment report to the notifier and no later than 105 days after receipt of the notification, the CA shall send a copy of the assessment report to the Commission which, within 30 days of receipt, forward it 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 to the placing on the market and shall inform, within 30 days, the other Member States and the European Commission:

  • 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 (are raised and mantained), the CA shall adopt a decision in accordance with the decision adopted by the European Commission: 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. The decision is published.

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 shall be given for a maximum period of 10 years starting from the date on which the consent is issued.

200 18 CE parte C EN

Notifications authorized in the European Union pursuant directive 2001/18/EC