• First step (preliminary evaluation of the notification): before a GMO is placed on the European Union market, a notification shall be submitted to the Competent Authority (CA) of the Member State where such a GMO is to be placed on the market for the first time. At the same time, the notifier must also submit copy of the notification throught the European Commission's ESFC platform. The CA carries out the preliminary evaluation of the notification and if it is positive, sends the summary of the dossier to the European Commission and to the competent authorities of the other Member States. The CA checks whether the notification fulfils the requirements of Article 13(2) of Directive 2001/18/EC (conformity check) and, if necessary, requests additional information from the notifier. If the notification is in conformity, the CA sends a copy of the notification to the Commission and to the other Member States. All communication between the CA, the European Commission and the Competent Authorities of the other Member States takes place throught the ESFC platform.
  • Second step (notification assessment report): within 90 days of the date of receipt of the notification, the CA 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 other Member States.
  • Third step (authorisation or rejection of the placing on the market): In case of a positive notification assessment report:
    • The CA shall give consent to the placing on the market to the notifier 60 days after the submission of the assessment report in case of absence of reasoned objections from Member States or the European Commission;
    • The CA shall give consent to the placing on the market to the notifier 105 days after the submission of the assessment report if reasoned objections from Member States or the European Commission have been resolved.

After 60 days from the submission of the assessment report, in case of reasoned and unresolved objections by the Member States or the European Commission, the CA shall adopt a decision on the basis of the decision adopted by the European Commission under the comitology procedure (Article 30, paragraph 2 of Directive 2001/18/EC): if the decision is favourable, the CA shall give the consent.

If the assessment report indicates that the GMO shall not be placed on the market, the CA shall immediately transmit the negative assessment report to the notifier and, within 105 days of receipt of the notification, to the European Commission.

The consent is valid for a maximum period of 10 years from the date on which the consent is issued.

 ENG 2001 18 Parte C

 

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