Increased transparency of the EU risk assessment in the food chain

On 13 June 2019, the Council formally adopted a new regulation regarding the transparency and sustainability of the EU risk assessment in the food chain. The Regulation, based on a proposal tabled by the European Commission, aims to strengthen the objectivity, reliability and independence of the studies used by the European Food Safety Authority (EFSA). The Regulation brings significant change to the food industry.

Background
The new Regulation (EU) 2019/1381 has been drafted and implemented as part of an evaluation of (EC) No. 178/2002 (the General Food Law Regulation) and as a response to the European Citizens’ Initiative on glyphosate, in which concerns were raised over the transparency of scientific studies in the food area. The adopted legislation principally amends the General Food Law Regulation, as well as introducing changes to eight legislative acts dealing with specific sectors of the food chain, including the GMO Regulation, the Additives Regulation and the Novel Food Regulation.

In the evaluation of the General Food Law Regulation, it was concluded that rules on confidentiality of EFSA’s documents and the fact that EFSA must primarily base its decisions on the studies presented by the applicant have led to a perceived lack of transparency and independence, which may adversely affect confidence in EFSA. The Commission also noted that there are deficiencies in EFSA’s ability to attract expertise and that the processing times are long, which may affect corporate competitiveness.

The main objectives of the Regulation are to promote transparency in the scientific assessment process and to explain how risk management decisions are made. Under the Regulation, the European Commission is required to adopt a plan for risk communication that will ensure a coherent risk communication strategy, as well as launching an open dialogue among all interested parties.

Disclosure of information
The Regulation requires disclosure of the information relied upon for and supporting a request for a scientific assessment by EFSA when an application is validated or found admissible. These requirements affect not only applications for new product authorisations but also renewals of authorisations for substances already on the market. Before submitting an authorisation application, the applicant will have to notify EFSA of any study commissioned. The notification shall include the title and the scope of the study, its start and planned completion dates, and the laboratory or testing facility that is carrying out the study. Non-compliance with the obligation to provide notification shall result in a temporary stop in the risk assessment process.

In order to ensure a more transparent and sustainable risk assessment process, the studies will become part of the EU’s register of commissioned studies. EFSA will manage a publicly accessible database that will contain detailed information of all studies commissioned or carried out by the food or feed industry. The information will be automatically published when the application is submitted, and European citizens will immediately have access to all studies and all information submitted by the industry.

In this way, the public and stakeholders will have access to key safety-related information assessed by EFSA, and EFSA will be able to cross-check whether all studies have been submitted and the information on the studies performed. Consequently, applicants will no longer be able to withhold unfavourable studies.

Confidential information
It will be possible to request that certain parts of the application be treated as confidential. Confidentiality requests will be assessed by EFSA. Information will only be protected in duly justified circumstances, and applicants will have to provide verifiable justification. It is the responsibility of the applicant to show that the disclosure of the information would significantly harm the commercial interests concerned. The Regulation specifies which types of information may be considered as confidential. For example, EFSA may grant confidential status with respect to manufacturing or the production process, to commercial links between the applicant and a producer or an importer, and to any commercial information revealing the business strategy of the applicant. Information that has been assigned confidential status shall only be disclosed in exceptional circumstances regarding the urgent need to protect human health or the environment.

When submitting a confidentiality request, the applicant shall provide a non-confidential and a confidential version of the information. The confidential information shall be clearly marked in the confidential version, and the parts of the non-confidential version where confidential information has been erased shall be clearly indicated. The non-confidential version will be published by EFSA without undue delay.

Intellectual property rights and personal data
In order to ensure transparency and the reliability of the risk assessment process, EFSA will make certain personal data public, including the name of the applicant. No other personal data will become publicly available unless this is necessary and in proportion to the purpose of ensuring the transparency independence. All processing of personal data will be carried out in accordance with existing EU and national legislation and regulations. Furthermore, EFSA will ensure that intellectual property rights will be guaranteed in line with the existing EU legislative framework, which sets out limitations on certain uses of publicly disclosed information.

Controls and audits
The Regulation also includes measures to ensure the objectivity and quality of the studies used by EFSA for its risk assessment. The European Commission will have the right to perform controls and audits to verify compliance by testing facilities to review whether they uphold relevant standards. The European Commission will additionally have the right to request EFSA to commission verification studies. Such studies will be financed by the EU but shall be commissioned only in cases of serious controversies or of conflicting results.

Conclusion
The focus of the Regulation is to explain how risk management decisions are made, to promote transparency within the assessment process and to increase confidence in EFSA. The Regulation obliges EFSA to publish scientific data, studies and other information supporting applications for regulated products at the beginning of the risk assessment process. Consequently, the public and stakeholders will have access to key safety-related information assessed by EFSA.

The Regulation brings significant change to the food industry. While intellectual property rights, duly justified confidential information and certain personal data will still be protected, the Regulation restricts the possibility to avail on the confidentiality and significantly extends the obligations for transparency. The regulation forces the food industry to plan its studies at an early stage and carefully consider the nature of the studies it commissions, as well as the information included.

The Regulation will become applicable on 27 March 2021.