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

The procedure is divided into three phases:

  • a first step of preliminary evaluation: anyone who wishes  to place on the Community market a GMO  for the first time in Italy, is required to give prior notice to the National Competent Authority (NCA) and to inform the competent ministries. On receipt and after the acknowledgement of the notification, the NCA shall carry out the preliminary evaluation, and send immediately the summary of the information contained in the notification to the European Commission, to the competent authorities of the other Member States, to the Regions and Autonomous Provinces of Trento and Bolzano. This summary shall be made available for public information on the Italian BCH.
  • a second step dedicated to the arrangement of the assessment report: within 90 days after receipt of the notification, the ANC shall prepare a draft assessment report according to the guidelines laid down in Annex VI of Legislative Decree n. 224/2003 and, after hearing the advice of the competent Ministries of Health and for the Agriculture, Food and Forestry Policies, prepare the assessment report that shall indicate whether or not the GMO may be placed on the market and under which conditions;
  • a third step in which the ANC the European Commission may authorize  the placing on the market of GMOs: when the assessment report indicates that the GMO may be placed on the market, the ANC shall give consent in writing:
    • after 60 days from the date of circulation of 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 the date of circulation of the assessment report to the Commission, if reasoned objections from the NCA of another Member State and/or from the Commission have been  resolved.

When the assessment report indicates that the GMO shall not be placed on the market, the NCA 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.

title III 224-2003 EN

 

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