The Regulation on the transparency and sustainability of European Union (EU) risk assessment in the food chain has been adopted by the European Parliament and the Council and is awaiting publication in the Official Journal of the European Union (OJEU). The intent of the new Regulation is to increase the transparency of risk assessments in the food chain in the EU and to strengthen the reliability, objectivity, and independence of the studies used by the European Food Safety Authority (EFSA). This article focuses on the aspects that may impact business operators in the food-contact sector below, given that it will amend, among others, the EU’s Framework Regulation (EC) No. 1935/2004 on food-contact materials and articles intended to come into contact with food.
Business operators and EU laboratories and testing facilities carrying out testing to support a petition dossier for a food-contact substance to the EFSA will be required to notify such studies without delay to the EFSA for inclusion in a database. This obligation may apply to laboratories and other testing facilities located in third countries insofar as set out in relevant agreements and arrangements. The notification should include:
- Title and scope of the study;
- Testing facility carrying out the study; and
- Commencement and planned completion dates of the study.
Importantly, applications or petitions for food-contact substances to the EFSA shall not be considered valid or admissible if studies supporting the petition dossier were not previously notified to the EFSA unless a valid justification for non-notification of such studies is provided.
Certain information in the petition dossier may be maintained confidential upon request to EFSA with verifiable justification (i.e., if the disclosure is demonstrated to potentially harm the applicant’s interests to a significant degree). However, the non-confidential version of the petition dossier will be made public by the EFSA without delay when an application is validated or found admissible (i.e., at the initial stage of the risk assessment process). The Regulation sets out a detailed procedure to be followed in the situation where the petitioner disagrees with the EFSA’s assessment of what information may be maintained as confidential and identifies the following as details that may be marked as confidential in a petition dossier:
- Manufacturing/production process, except for information that is relevant to the safety assessment
- Commercial links between a producer/importer/petitioner
- Commercial information revealing sourcing/market shares/business strategy of the petitioner
- Quantitative composition, except for information relevant to the safety assessment
- Descriptions of starting substances/mixtures used to manufacture the substance subject to the authorization, the composition of the mixtures, materials and articles in which the petitioner intends to use the substance, the manufacturing methods of these mixtures, materials and articles, impurities and migration test results, except for information relevant to the safety assessment
- Trademark under which the substance/mixture is to be marketed as well as the trade name of the mixtures, materials and articles in which it shall be used
Furthermore, if requested, EFSA will provide pre-submission advice on the relevant provisions and required content of a petition or notification. However, the EFSA staff providing pre-submission advice will not be involved in any preparatory scientific or technical work directly or indirectly relevant to the application or notification. A summary of pre-submission advice will be made public once the application is considered valid or admissible.
According to the European Commission, the new Regulation is expected to be published in the OJEU on September 6, 2019. It will enter into force 20 days after publication and it will apply 18 months after that (i.e., by the end of March 2021).