EU risk assessment model to be revised to increase transparency & sustainability

The European Parliament and the Council has reached an agreement on the European Commission's proposal to amend General Food Law Regulation.  The proposal 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 in order to ensure its long-term sustainability.

The agreement covers the review of the General Food Law Regulation and the amendment of eight 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.

The agreement stipulates that all studies and information supporting a request for a scientific output by EFSA are made public automatically when an application is validated or found admissible. This has to 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 independent and transparent risk assessment process are:

  • 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;
  • Consultations of stakeholders and of the general public on submitted studies to ensure EFSA's comprehensive access to existing evidence underpinning its risk assessment;
  • A specific procedure, including consultation of stakeholders and the general public on planned studies in the case of renewals of already authorised substances;
  • 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. Intellectual property rights, data exclusivity and data protection are to be guaranteed in line with the existing EU and national rules concerning intellectual property rights, which set out limitations on certain uses of the publicly disclosed documents or their content. EFSA are to ensure that clear undertakings are obtained to that effect, prior to disclosure of documents.

The changes will also affect the renewals of authorisations of substances that are already on the market. The applicant will have to notify in advance the studies it plans to carry out for the renewal request. EFSA will then launch a consultation of third parties regarding these planned studies, and will be able to provide advice to the applicant on the content of the submission dossier.

For more information please see website on transparency and sustainability of the EU risk assessment in the food chain:

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