EFSA Update Health Claim Application Advice

01 Feb 2017 --- EFSA has updated its advice for applicants on how to prepare and present a health claim application. The guidance presents a standardized format for a well-structured application and also details the kind of information and data applicants need to submit in support of their claim.

The new guidance applies to health claims related to a type of food, a food category or food constituents, and is an update of the 2011 version. The EFSA say it incorporates insights and lessons learned from several years of experience gained in evaluating health claims.

The update is aligned with EFSA’s 2016 general scientific guidance on health claim applications, which outlines the evaluation process and gives applicants a better understanding of the assessment criteria.

Valeriu Curtui, head of EFSA’s Nutrition Unit, said: “We expect the updated guidance to increase the efficiency of evaluating health claims once applicants adhere to the new application format.”

New format to present data Applicants are advised to use the standardized format when preparing and presenting their health claim application.

In addition to the required administrative and technical information, an application dossier must include the following:

• Data on the characterization of the food or food constituent for which the claim is made.
• Information to allow the characterization of the claimed effect.
• Data – published and unpublished – to substantiate the health claim.

The guidance further clarifies how to present this information, applying a defined order of the type of data and study designs applicable to specific applications.

The document also identifies the key issues to be addressed when substantiating a health claim.