Following the approval by the European Parliament on 17 April 2019, the Council has formally adopted on 13 June 2019 a new Regulation on the transparency and sustainability of the EU risk assessment in the food chain. This new Regulation mainly amends the General Food Law Regulation (178/2002). It aims at increasing the transparency of the EU risk assessment in the food chain, on strengthening the reliability, objectivity and independence of the studies used by European Food Safety Authority (EFSA), and revisiting the governance of EFSA.

The Regulation stipulates that all studies and information supporting a request for a scientific output by EFSA are to be made public. This will be done at the very early stage of the risk assessment process, in an easily accessible electronic format with the possibility to search, download and print the studies. Confidential information will be protected in duly justified circumstances. Confidentiality claims will be assessed by EFSA.

Other measures which will also ensure a more robust, independent and transparent risk assessment process are particularly:

• A notification obligation for applicants and laboratories when studies are commissioned and creation of a database of commissioned studies: This will provide a mechanism by which EFSA will be able to double-check whether all studies commissioned by an applicant in the context of its application for an authorisation, have been submitted;
• Consultation of stakeholders and of the general public on submitted studies to ensure EFSA’s comprehensive access to existing evidence underpinning its risk assessment;
• Pre-submission advice on the applicable rules and the required content of an application dossier, to be provided by EFSA upon request to potential applicants;
• Fact-finding missions by the Commission to ensure the compliance of laboratories/studies with standards;
• Possibility for the Commission to ask EFSA to commission studies in exceptional circumstances to verify evidence used in its risk assessment process.

The new Regulation is expected to be published in the Official Journal in September 2019 and will become applicable 18 months later.