The national ambassadors of the Twenty-Eight EU Member States (Coreper) adopted on Wednesday 12 December the Council's position, the so-called 'general approach', on the regulation on the transparency of EFSA's risk assessments of certain substances (pesticides, food additives, GMOs, etc.).
The European Parliament had just given its opinion on this revision of Regulation 178/2002, proposed in April, following the European citizens' initiative 'Stop Glyphosate' (see EUROPE 12158, 12157).
“Our objective is to grant people greater access to scientific studies while at the same time strengthening the scientific base of risk management.” says Austrian Minister Elisabeth Köstinger, President of the EU Environment Council. According to her, “I believe we have struck a balance between transparency and protection of innovation in the European agro-food industry.”
The political agreement will be formally adopted on 17 December. It remains close to the spirit of the Commission's proposal, but it improves the basic text so as to increase the clarity of legal requirements for industry.
In order to guarantee more transparency about scientific studies, all supporting data and information linked to an application for authorisation (the applicant) will be made public by EFSA, unless the applicant requested confidential treatment for this information, but “after the assessment of the validity of the application”. The applicant bears the burden of proving that the disclosure of the information “significantly harms its interests”.
If the applicant disagrees with EFSA's results of the validity of its confidentiality claim, they can file a confirmatory request. In the period during which the confirmatory request is assessed, the information cannot be made public.
Under the Council general approach, all potential applicants will be obliged to notify the studies they commission or carry out to support future applications. The Commission will be able to request EFSA to commission its own verification studies “in exceptional circumstances”.
Member States will encourage national experts to apply to participate in EFSA’s Scientific Panels. Risk communication by the Commission and EFSA towards member states and public stakeholders will be improved.
The agreement does not include any decision concerning the budget of EFSA, as negotiations on the EU's 2021-2027 budget are ongoing. The Commission proposed an additional €62.5 million per year after 2020 (see EUROPE 12036). (Original version in French by Aminata Niang)