Technical meeting with applicants on recent developments on health claims applications

15 Junio 2009

Regulation (EC) No 1924/2006 harmonises the provisions that relate to nutrition and health claims and establishes rules governing the Community authorisation of health claims made on foods. In March 2007, the Commission requested European Food Safety Authority (EFSA) to provide scientific guidance for the preparation and the presentation of the application for health claim authorisation. On 6 July 2007, after public consultation, the EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) adopted an Opinion related to the scientific and technical guidance for the preparation and presentation of the application for authorisation of a health claim under Article 14, i.e. reduction of disease risk claims and claims referring to children’s development and health. The European Commission subsequently decided that this guidance should also apply to claims submitted under Article 18 of the Regulation, i.e. Article 13(5) claims which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data.

In the light of the experience gained with the evaluation of health claims applications, EFSA provided further guidance to applicants for the preparation and presentation of applications for Article 14 and 13.5 claims in the form of a document outlining answers to frequently asked questions (FAQ). A draft of this FAQ, which intended to complement the NDA Opinion on guidance published in 2007, was published on this page of the EFSA website for comments. In addition, a technical meeting with experts from industry/applicants for Article 14 and 13.5 health claims was held in Brussels on 15th June, 2009. Following this meeting the draft FAQ was revised and published on the EFSA website.

Objective of the meeting

The objective of the meeting was to have an exchange of views between experts from industry/applicants and experts from the NDA Panel and staff based on a draft FAQ for the preparation and the presentation of applications for health claim authorisation related to Article 14 and 13.5 claims.

Comments on the draft FAQ received by the 8 June were addressed at that meeting. These comments, as well as questions arising during the meeting, were taken into account in revising the draft FAQ.

Frequently Asked Questions (FAQ) related to the EFSA assessment of Article 14 and 13.5 health claims applications  

Outcome of Public Consultation on a draft Frequently Asked Questions document (FAQ) related to the EFSA assessment of health claims applications