The European Food Safety Authority (EFSA) is launching a public consultation on its new draft guidance that defines the information to be included in applications for the renewal of authorisations of genetically modified (GM) food and feed. The guidance lays down data requirements to support the safety assessment of these renewal applications. EFSA is inviting all stakeholders and interested parties to comment on the document through an online public consultation by 16 December 2014.
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The draft guidance describes mandatory data requirements such as: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 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- Public consultation on the draft Guidance for Renewal Applications of Genetically Modified Food and Feed authorised under Regulation (EC) No. 1829/2003