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