Technical meeting with stakeholders on recent developments related to health claims

Health claims evaluation under Regulation (EC) No 1924/2006

Briefing document(244.03 KB)

Background
Regulation (EC) No 1924/2006[1] harmonises the provisions that relate to nutrition and health claims and establishes rules governing the Community authorisation of health claims made on foods. Up to now the EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) has adopted and published 63 scientific opinions related to children and disease risk reduction health claim applications (Article 14 health claims) and 22 opinions related to health claim applications based on newly developed science and/or proprietary data (Article 13.5 health claims). Out of the over 4,600 general function health claims (Article 13.1 health claims) submitted to EFSA via the Member States/European Commission, the NDA Panel has evaluated 937 claims and published them in respective opinions.

In the light of the experience gained with the health claims evaluations, EFSA provided in 2009 further advice and organised two meetings with various stakeholders. For health claim applications (Article 14 and 13.5 health claims) EFSA provided additional advice to applicants in form of a frequently asked question document (FAQ). The draft FAQ was subject to public consultation and discussed at a meeting with applicants in June 2009 before its finalisation and publication in September 2009. In order to update Member States and the European Commission on the evaluation of Article 13.1 health claims, EFSA held a meeting with them in October 2009. To this end a draft briefing document was prepared and discussed at the meeting, which was updated after the meeting and published in December 2009.

In order to ensure continuous discussion and information exchange with stakeholders EFSA is organising this meeting. EFSA has prepared a draft updated and combined briefing document for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims which will serve as a basis for discussion at the meeting.

Participants and all interested parties are invited to submit comments on the briefing document to nutrition.conference [at] efsa.europa.eu. Please write “Comments on the briefing document” in the email subject. Comments should be sent before the meeting takes place.

Objective of the meeting
The objective of the meeting is to provide an update on EFSA’s health claims evaluations and to have an exchange of views between experts from food industry/applicants, Member States, European Commission, NDA Panel members and EFSA staff. Topics to be discussed will include

• General conditions for substantiation of claims
• Scientific criteria for substantiation of claims
• Pertinent studies for substantiation
• Totality of the available scientific evidence
• Characterisation of food/constituent
• Beneficial physiological effects
• Risk factors for disease risk reduction claims
• Target population
• Procedural aspects

Structure of the meeting
The meeting will be organised in a way that provides for interactive exchange of expert views.
Experts from EFSA’s NDA Panel and staff from EFSA’s NDA Unit will provide an update on key issues related to the scientific substantiation of health claims and in relation to procedural aspects of health claims applications and Article 13 health claims. There will be an opportunity for an exchange of views on questions/comments arising during the meeting. Member State experts, officials from the European Commission and experts from food industry will be invited to contribute to the meeting. Registered attendees will be asked prior to the meeting to submit questions/comments to be addressed at the meeting. An updated briefing document for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims will be published after the meeting together with a summary report of the meeting.

Scientific coordinator
Dr. Juliane Kleiner
European Food Safety Authority (EFSA)
Tel. +39 0521 036 411