EFSA launches public consultation on draft guidance for renewal of GM applications

Under European Union law, GM food and feed are authorised to be marketed in the European Union (EU) for a period of ten years. Applicants are required to submit a dossier for the renewal of that authorisation one year prior to the expiry date. These dossiers are submitted to EFSA for a safety assessment before risk managers make a decision on whether to renew the authorisation or not.

As the first submissions of dossiers for renewal are expected in 2016, EFSA has developed detailed guidelines to assist applicants in the preparation and the presentation of their dossiers.

The draft guidance describes mandatory data requirements such as: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 An umbrella term for biological studies that use computer programming as part of their methodology. Bioinformatics combines computer science, statistics, mathematics and engineering to study and process biological data. See also Transcriptomics, Proteomics and Metabolomics. data, additional studies).

Additionally, the guidance informs applicants and risk assessors on the steps to be followed for assessing the required data.

• Public consultation on the draft Guidance for Renewal Applications of Genetically Modified Food and Feed authorised under Regulation (EC) No. 1829/2003 - Extended deadline: 4 January 2015