GMO applications

Submission of regulated products applications by electronic means only

Applications for regulated products such as feed additives, food enzymes and health claims should now be submitted to the European Food Safety Authority (EFSA) by electronic means only. Electronic mediums such as CD ROMS, DVDs or USB keys can be used to submit technical dossiers, updates to applications and to respond to requests for additional information. >more…

Under European Regulation EC 1829/2003, GMOs and derived products must be evaluated by EFSA before they can be authorised in the EU. Applicants must submit an application for authorisation in line with European legislation and EFSA’s guidelines to the national competent authority of one of the Member States who then forwards the application to EFSA for its scientific risk assessment. EFSA’s Panel on Genetically Modified Organisms (GMO) carries out a detailed risk assessment to evaluate the safety of the GMO and derived food or feed. The Panel’s independent scientific advice is then used by the Commission and Member States when taking a decision on market approval.


Detailed information on the application procedure, including how to check the status, question number and deadlines, is available on the GMO pages of the Applications helpdesk section of this website. Guidance documents published by the GMO Panel are also essential reading for the preparation of GMO applications.