Updated guidance: how to prepare a health claim application

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

The guidance applies to health claims related to a type of food, a food category or food constituents.

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 standardised 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 characterisation of the food or food constituent for which the claim is made.
  • Information to allow the characterisation 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  • Data – published and unpublished – to substantiate the health claim.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.

Stakeholder input

The new guidance is an update of the 2011 version and incorporates insights and lessons learned from several years of experience gained in evaluating health claims. Input received from stakeholders during an eight-week public consultation in summer 2016 was particularly valuable in shaping the updated guidance.

Background

The rules governing authorisation of health claims made on foods in the EU are covered by Regulation (EC) 1924/2006. According to the Regulation, health claims can be authorised for use in the EU only after a scientific assessment has been carried out by EFSA. For a detailed explanation of EFSA’s work on health claims, please see our topic page.

Media contacts