Context

The Regulation aims to enable consumers to have greater confidence in the food safety approvals process by improving the transparency of EU risk assessments in the food chain and strengthening the reliability, objectivity and independence of studies used by the European Food Safety Authority (“EFSA”). It also reinforces the governance of EFSA, with each Member State being represented in its Management Board by July 2022.

Scope of the Regulation

The Regulation amends the General Food Law Regulation, as well as eight other acts dealing with specific sectors of the food chain, including GMOs, feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods.

The Regulation has four key objectives:

Ensure greater transparency of the EU’s risk assessment process in the food chain

• Enabling consumers to access the scientific studies and information submitted to EFSA by industry at the start of the risk assessment process.
• While protecting confidential information where justified following assessment by EFSA.

Increase the independence of scientific studies

• The Regulation requires that EFSA is informed of all studies commissioned by industry and carried out by laboratories, obliging businesses applying for authorisation to submit all relevant information including unfavourable studies. This requirement will enable EFSA to establish and monitor a common European Database for commissioned studies.
• The Regulation provides a mechanism by which companies can seek scientific advice from EFSA in advance of the submission of applications or notifications.
• It also gives the European Commission power to instruct EFSA to commission additional studies in order to verify evidence used in its risk assessment process and to perform fact-finding missions to ensure compliance of laboratories with the applicable standards.

Strengthen the governance of scientific cooperation

• The Regulation provides for representatives of all Member States on the EFSA Management Board.
• Member States now have an opportunity to increase EFSA’s scientific capacity and engage the best independent experts in EFSA’s work.

Develop comprehensive and effective risk communication

• A general plan for risk communication will be adopted, ensuring a comprehensive communication framework throughout the risk analysis process, combined with open dialogue amongst all interested parties.

The Regulation brings with it greater transparency and scientific rigor, with an increased administrative burden and responsibility being placed on applicants and EU-based CROs. Applicants will need to be mindful of the new transparency requirements and confidentiality provisions, as well as the impact that mandatory publication of scientific studies may have on innovation and new product development in the sector.

For further guidance on the Regulation, please contact Colin Kavanagh or Bridget McGrath in the Life Sciences Regulatory and Compliance Group or Deborah Spence and Danielle Conaghan in the Food and Agri Law Group.