Info Session on Applications – Health claims – Technical meeting on the reporting of human studies submitted for the scientific substantiation of health claims

Around 170 participants from food business operators, consultants, academia, experts from EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA), EFSA staff, and other interested parties attended a meeting in Parma to discuss with EFSA and international experts the reporting of human studies submitted for the scientific substantiation of health claim.

The event was organised by EFSA's Nutrition (NUTRI) Unit in collaboration with the Applications Desk (APDESK) Unit, within the framework of the “EFSA Info Sessions on Applications”, aimed at increasing regular interaction between EFSA and its stakeholders.

Background

Under the framework of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, and based on experiences gained with the evaluation of health claims applications, EFSA has noted that regardless of the publication status (i.e. published articles, study reports of unpublished studies), the reporting of human studies (e.g. design, methodology, statistics and results) varies considerably, which can lead to delays in the review process (e.g. request of additional information to the originating source) or preclude a complete scientific evaluation (e.g. if the additional information requested is not available). Consistent reporting of human studies submitted for the scientific substantiation of health claims in a harmonised and standardised way would benefit both EFSA and its stakeholders.

Objective of the meeting

The objective of this meeting was to discuss with scientists the information required for a full scientific evaluation of human studies submitted for the scientific substantiation of health claims (i.e. the requirements for the compilation and reporting of human studies investigating the relationship between the consumption of the food/constituent for which the claim is requested and the claimed effect, which should be complete, unambiguous and well organised, to allow a full scientific evaluation by the NDA Panel).

The meeting gave insights on existing guidelines published by scientific societies, and provided an excellent opportunity for EFSA to engage, debate and challenge concepts related to health claim substantiation with experts from the scientific community and a wide range of stakeholders, with respect to:

• Improving the reporting of randomised trials
• Improving reporting for observational studies
• Improving reporting for systematic reviews and meta-analyses

EFSA will publish a report of the technical meeting that will collect and summarise the discussions.