Transparency regulation

The Transparency Regulation became applicable on 27 March 2021. It amends the General Food Law Regulation and eight other legislative acts dealing with specific sectors of the food chain: GMOs (cultivation and for food/feed uses), feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods.

All scientific data, studies and other information supporting applications will be made public proactively, with the exception of duly justified confidential information. Confidentiality requests may only be submitted with respect to information falling within the closed positive lists of confidential items, set out in the Transparency Regulation. Applicants will have to substantiate their requests and provide verifiable justification that public disclosure of the relevant information would potentially harm their interests to a significant degree. Confidentiality requests will be mainly assessed by EFSA in the different sectoral authorisation processes, in accordance with the applicable Union provisions.

When the applicant submits a dossier, it should submit a non-confidential version and a confidential version of the submitted studies and other information.

When the application is validated or found admissible, EFSA will make the non-confidential version public, as submitted by the application, of the submitted studies and information. In parallel, within 10 weeks from the date of receipt, EFSA would assess the confidentiality claim. Once this assessment is completed, any additional data and information for which confidentiality requests has been considered as unjustified would also be made public.

Further information and resources

Further details are set out in EFSA’s Practical Arrangements on transparency and confidentiality.

To help stakeholders better understand and prepare for the new arrangements, the European Commission and EFSA have been producing a range of supporting materials such as video tutorials and holding a series of training sessions.