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