On 6 September 2019, Regulation (EU) No. 2019/1381 on transparency and sustainability of the EU risk assessment in the food chain was published, which include changes to the mandate of the European Food Safety Authority (EFSA). The Regulation is controversial as regards the confidentiality of industry studies.
Regulation (EC) No. 178/2002 of the European Parliament and of the Council lays down the general principles and requirements of food law, establishing the European Food Safety Authority (EFSA) and laying down procedures in matters of food safety.
For some time, there has been quite a pressure on EFSA concerning the way that the Authority is conducting risk assessments. Regulation (EU) No. 2019/1381 is a follow-up to the European Citizens' Initiative on glyphosate, especially concerns expressed in the initiative regarding the transparency of the scientific studies used to evaluate pesticides. Thus, the new Regulation is not only limited to EFSA’s pesticide opinions. It also follows a fitness check of the General Food Law, launched in 2014 and completed in January 2018 by the European Commission.
On 11 December 2018, the Plenary of the European Parliament adopted its final report on the Regulation for transparency and sustainability of the EU risk assessment in the food chain, which include changes to the mandate of the European Food Safety Authority (EFSA).
The new Regulation imposes an obligation on EFSA to publish industry studies at the beginning of the risk assessment process for product authorisations (‘without delay’). This mandatory publication raises a number of concerns as to wether the urge to increase transparency of the work of the EU authorities is more important than to keep the confidentiality of research.
The new rules are obliging manufacturers to make all scientific documents publicly available at the start of an risk assessment process, either pesticides, additives etc. The general concern is that very few manufacturers probably want to operate in the EU for research and development purposes in the future.
It will be possible to request that certain parts of the information submitted to EFSA to be treated as confidential. If this request is declined, the applicant will have the possibility of withdrawing the application.
Stakeholders have claimed that once the legislation has been implemented, non-EU competitors, e.g. from China, may easily and legally “seek inspiration” by means of checking the Internet for new product developments in the EU food sector. Furthermore, if the scientific studies submitted to EFSA have to be made publicly available at the start of a risk assessment, this is likely to give rise to interference in the work conducted by EFSA.
Consequently, the disclosure of confidential business information and the threat of rival companies might result in a decreased motivation for the industry to conduct scientific studies and research, which may ultimately damage the innovation of the European food market.
The Regulation enters into force by the end of September 2019 and it is applicable from 27 March 2021.
The Regulation aims to ensure transparency by allowing citizens to have automatic and immediate access to all safety related information submitted by industry in the risk assessment process. However, the purpose of securing transparency should not be at the cost of disclosing legitimate business information.
Furthermore, since scientific studies submitted to EFSA have to be made publicly available at the start of a risk assessment, this is likely to give rise to interference in the work conducted by EFSA, as stakeholders and the public in general may comment or submit information regarding a specific assessment, and, thus, potentially creating (even) longer case handling times and backlogs.
Click here to view the Regulation.