General food law and transparency

Date:  9 June 2020

An evaluation of the general food law (Regulation (EC) No 178/2002) found out that risk communication is not considered to be effective enough overall effecting consumers' confidence in the outcome of the risk analysis process. It was therefore considered essential to increase the confidence of consumers, the general public or other interested parties by increasing the transparency of the risk assessment process.

Therefore, the European Parliament and the European Union have decided on new rules on the transparency and sustainability of the EU risk assessment in the food chain last year, in June 2019. These rules are laid down in Regulation (EU) 2019/1381 resulting also in an amendment of further regulations as the above mentioned regulation (EU) 178/2002 referring to general food law and the Regulation (EU) 1107/2009 referring to the placing of plant protection products on the European market.

This new EU regulations includes/incorporates the notification of studies, the pre-submission advice by Authority, the consultation of 3rd parties and the public access to information.

As of 27 March 2021, studies that might be relevant for the submission of an application at EU-level for a new active substance or for the renewal of an active substance have to be notified to the Authority (EFSA). This obligation to notify such studies applies to the applicant, to the laboratory (if EU-located) and other testing facilities carrying out these studies and the information about these notified studies will be made public only when a corresponding application has been made and is publicly available.

Up to current knowledge, the following information has to be provided to Authority by:

1) applicant or notifier:

      • the title and the scope of any study commissioned
      • as well as the laboratory or testing facility carrying out that study, and its
      • starting and planned completion dates
2) laboratories or other testing facilities:
      • the title and the scope of any study commissioned by business operators
      • its starting and planned completion dates
      • the name of the business operator who commissioned such a study

When an application will be made to the Authority including studies that had not been notified or excluding studies that had been notified, the application will considered as non-valid or non-admissible unless a sound justification is provided. Such an application can be re-submitted six months after the studies have been notified. In case studies are not fully included, the applicable time limits within which the Authority is required to deliver its scientific output shall be suspended.

Upon request, the Authority should provide advice to a potential applicant upon request, before an application or notification is formally submitted.

In case applications for renewal of an authorisation or an approval are planned, the potential applicant for the renewal shall notify the planned studies including information on study design and compliance to regulation. Following such notification, the Authority is asked to launch a consultation of stakeholders and the public on the intended studies for renewal, including on the proposed design of studies.

Confidentiality may be granted by Authority where the disclosure of such information is demonstrated to potentially harm interests to a significant degree as for instance for the manufacturing or production process, commercial links between a producer or importer, commercial information revealing sourcing, market shares or business strategy or quantitative composition of the subject matter of the request, except for information which is relevant to the assessment of safety.

Dörte Goertz