The European Transparency Regulation: a new framework for risk assessment and food safety
In effect since 27 March 2021, REGULATION (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019, known as the "Transparency Regulation", aims to improve the transparency and sustainability of European Union risk assessment in the food chain. Below is an overview of the main changes introduced by this regulation and its implications for businesses, civil society representatives and national health agencies such as ANSES.
What is the Transparency Regulation changing?
Regulation (EU) 2019/1381 is improving the transparency of EU risk assessment in the food chain, as well as the reliability, objectivity and independence of the studies used by the European Food Safety Authority (EFSA). It is also reinforcing the governance of EFSA, with each Member State being represented in its Management Board as of July 2022.
Based on a European Commission proposal from April 2018, the Transparency Regulation amends the pre-existing regulatory framework, i.e. the General Food Law Regulation (Regulation (EC) No 178/2002), as well as eight legislative acts dealing with specific sectors:
- plant protection products;
- novel foods;
- food contact materials;
- food additives, enzymes and flavourings, including smoke flavourings;
- feed additives;
- genetically modified organisms (cultivation and food/feed uses).
Why are these changes occurring?
In the 1990s, especially following the mad-cow crisis, the need to better guarantee the safety of food and feed in the European Union led the European Commission to develop a "farm to fork" approach. Adopted in 2002, Regulation (EC) No 178/2002 laid down the general principles and requirements of food law, establishing EFSA and laying down procedures in matters of food safety.
As part of its "smart regulation" policy, the Commission initiated a regulation improvement programme that focused on this General Food Law Regulation in particular. Adopted on 20 June 2019 by the European Parliament and the Council, Regulation (EU) 2019/1381 builds on the conclusions of the General Food Law Regulation audit completed in January 2018 while following up on a European Citizens' Initiative on pesticides. The Transparency Regulation entered into force on 27 March 2021.
How does the Transparency Regulation enhance risk assessment and the independence of scientific studies?
The new regulation enables citizens to access the scientific studies and information submitted to EFSA by industry. It stipulates that these studies and this information shall be published from the start of the risk assessment process, in an easily accessible electronic format, and that studies shall be available to be searched through, downloaded and printed. Confidential information shall be protected in duly justified cases and requests for confidential treatment shall be assessed by EFSA.
The Transparency Regulation also includes public consultations in the process of assessing authorisation applications for regulated products. The consultation of stakeholders and the public with regard to submitted studies aims to provide EFSA with full access to the evidence available when it is conducting its risk assessments. A specific consultation procedure is provided for renewal applications for authorised substances.
The regulation ensures that EFSA is informed of all studies commissioned by industry and carried out by laboratories in order to guarantee that businesses applying for authorisations submit all relevant information. It also gives the European Commission the power to ask EFSA to commission further studies to verify the evidence used in its risk assessment process.
The Transparency Regulation also modifies the mode of governance of EFSA by adding representatives of all Member States to its Management Board. Work is in progress to increase the participation of Member States in the drafting of EFSA's Opinions and to provide everyone with easier access to information on the assessment and management of food-related risks.
ANSES: a stakeholder in the implementation of the Transparency Regulation
ANSES acts as a French reference partner for EU health agencies and authorities. It serves as EFSA's National Focal Point for France and represents France within EFSA's Advisory Forum, whose members are national agencies for the assessment of risks related to food and feed safety, plant health, and animal health and welfare. ANSES also contributes to the implementation of European regulations involving Member States and EFSA, for example with regard to the assessment of plant protection active substances and products; its role and contributions are specific to each of these regulations.
As part of these European commitments, and because strengthening trust in scientific activities relating to health risks is one of its priorities, ANSES is supporting and contributing to the implementation of the new orientations of the Transparency Regulation.