EFSA Approves One-Third of First ‘General Function’ Health Claims

Favourable outcomes related mainly to functions of vitamins and minerals, and also included dietary fibres, and fatty acids for maintenance of cholesterol levels, and sugar-free chewing gum for maintenance of dental health.

2 Oct 2009 --- EFSA has published its first series of opinions on the list of ‘general function’ health claims compiled by Member States and the European Commission. Experts on EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) evaluated the scientific evidence for more than 500 claims. The opinions will help inform future decisions of the European Commission and Member States concerning the authorisation of health claims.

The opinions provide scientific advice on 523 health claims relating to over 200 foods and food components such as vitamins and minerals, fibre, fats, carbohydrates, ‘probiotic’ bacteria, and botanical substances. For approximately one third of the claims the outcomes of the evaluations were favourable as there was sufficient scientific evidence to support the claims. These related mainly to functions of vitamins and minerals, and also included dietary fibres, and fatty acids for maintenance of cholesterol levels, and sugar-free chewing gum for maintenance of dental health. Almost half of the evaluations with unfavourable outcomes were owing to a lack of information on the substance on which the claim is based, for example ‘probiotic’ bacteria and botanical substances. Without clear identification of the substance in question, the Panel could not verify that the scientific evidence provided to EFSA related to the same substance for which the health benefits are claimed.

Commenting on these first results, Professor Albert Flynn, Chair of EFSA’s NDA Panel stated: “EFSA’s independent scientific advice will help ensure that the health claims made on foods are accurate and helpful to consumers in making healthy diet choices. The scientific opinions will inform future decisions of the Commission and Member States concerning the authorisation of health claims”.

EFSA has convened a meeting with experts from Member States and the European Commission on 6 October 2009 in Brussels to discuss the evaluation of the ‘general function’ claims. A briefing document prepared for discussion at the meeting explains EFSA’s approach to the evaluation of these claims.

Between July and December 2008 EFSA received from the European Commission a draft list with 4,185 claims to be evaluated. This list was the result of a consolidation process carried out by the Commission, after examining over 44,000 claims supplied by the Member States. The Panel is proceeding with the adoption and publication of scientific opinions on the outstanding claims on the list. EFSA is liaising with the European Commission in order to define a more precise timetable for completion of the work taking into account possible additional claims to be evaluated.

“General function” claims under Article 13.1 of the EC Regulation on nutrition and health claims refer to the role of a nutrient or substance in growth, development and body functions; psychological and behavioural functions; slimming and weight control, satiety or reduction of available energy from the diet. These claims do not include those related to child development or health or disease risk reduction.

In October 2009, EFSA published the first series of opinions providing scientific advice for more than 500 “general function” health claims on a draft list of 4,185 claims submitted to EFSA by the European Commission between July and December 2008. This list was the result of a consolidation process carried out by the Commission, after examining over 44,000 claims supplied by the Member States.

EFSA expects to complete its work within two years of receipt of the final list of submitted claims. EFSA will provide regular updates on its work and is liaising with the European Commission in order to define a more precise timetable taking into account possible additional claims to be evaluated.

In the light of the experience gained with the evaluation of Article 13.1 health claims, EFSA will provide an update to Member States and the European Commission on the evaluation status for these claims at a meeting on 6 October 2009. A briefing document prepared by the NDA Unit outlines and provides information on the main areas which will be discussed at the meeting.

The scientific references to be used in the evaluation of the list of claims were provided by Member States. They were either included in the access database or were sent to EFSA in separate files. In addition, full-text copies of references were provided directly to EFSA from stakeholders. The deadline for submission of these references was end of 2008.

For those health claims which have passed EFSA’s pre-screening, the references received have been combined into one consolidated list. Due to the large number of references (around 39,500 for 2,118 health claim entries) this list was divided into four parts, sorted by ID number of the entry of the claim.