Regulation 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain (Regulation) came into force on 27 March 2021 across EU member states. The Regulation was prompted by the European Commission’s (Commission) fitness check of general food law and a European citizens’ initiative on pesticides. The European Food Safety Authority’s (ESFA) Executive Director, Bernhard Url, described the introduction of the Regulation as “a pivotal moment for the food safety system in the EU“.
The Regulation primarily amends Regulation 178/2002 on food law and food safety. The Regulation also amends eight other European acts on specific sectors insofar as transparency is concerned. Those sectors include genetically modified foods, food additives and novel foods. The core objectives of the Regulation are:
1. Increased Transparency
All scientific studies and data submitted to the EFSA will be disclosed to the public on its website with limited exceptions on the basis of confidentiality and commercial harm. The EFSA will also consult the public and stakeholders before preparing its scientific output.
2. Greater Reliability
More scientific evidence will be available to the EFSA during requests for authorisation and the EFSA will maintain a register of all authorisation studies commissioned by the industry. Regular audits will be carried out to ensure compliance by laboratories/studies with the relevant standards. In exceptional circumstances the Commission has the power to request the EFSA, to carry out further studies for verification purposes.
3. Enhanced Governance
Member states will play a more central role in the governance of the EFSA with representatives from all member states, the Commission, the European Parliament, civil society and industry groups on the EFSA’s Management Board. Experts appointed to the EFSA’s scientific panels will be drawn from nominees put forward by member states. Selection for appointments will be based on strict independence criteria.
4. Effective Risk Communication
The Regulation aims to ensure coherent communication throughout the risk assessment process. This will be achieved through a general plan on risk communication which is currently being developed by the Commission, EFSA and the EU Member States with the ultimate objective of ensuring better communication with stakeholders and the general public throughout the risk analysis process.
In keeping with the core values of transparency, independence, and scientific cooperation, the Regulation amends the authorisation application process throughout the planning, submission and renewal phases. The new processes will apply to applications that postdate the coming into operation of the Regulation (27 March 2021).
The EFSA describes the Regulation as one which will bolster its ability to carry our risk assessments in accordance with the highest transparency standards. Further information on the Regulation is available on the EFSA website.
To discuss the impact of the Regulation on your business please contact any member of our Food Beverage & Agribusiness group or your usual William Fry contact.
Contributed by Gerard James, Alexandra Drummy & Gail Nohilly