Brussels, 06/11/2014 (Agence Europe) - The first submissions of dossiers for the renewal of authorisations of genetically modified foods are expected in 2016 in the EU. To help applicants in the preparation and submission of dossiers to it, the European Food Safety Authority (EFSA) has prepared new detailed guidance which was put out to public consultation on Wednesday 5 November. All stakeholders will have until 16 December to submit their comments.
The draft guidance document defines the information to be included in applications for the renewal of authorisations of genetically modified (GM) food and feed.
It sets out the requirements on information that applicants have to include, such as the identification of the GM food and feed to be renewed, the post-market monitoring reports, any other new information related to safety of the GM food and feed e.g. scientific papers, updated bioinformatics data, additional studies.
The guidance lays down data requirements to support the safety assessment of these renewal applications. It informs applicants and risk assessors on the steps to be followed for assessing the required data.
Under the terms of Regulation 1829/2003/EC, GM foods and feeds that have passed the risk assessment test and have received legal approval for marketing are authorised for a period of ten years. Companies wishing to renew an authorisation have to submit a dossier before expiry of the ten-year authorisation. Dossiers are submitted to EFSA for safety assessment before the risk managers (Commission, national authorities) take the decision on whether or not to renew authorisation. (AN)