Vast Majority of Second ‘General Function’ Health Claims Negatively Assessed by EFSA

Of the 416 health claims, just 9 were positively assessed, 14 were said to provide insufficient evidence, 125 were not characterised and 291 received a negative opinion.

25 Feb 2010 --- EFSA has published a second series of opinions on a list of ‘general function’ health claims compiled by Member States and the European Commission. Scientific experts on EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) assessed all available scientific data submitted to substantiate the 416 health claims. Of the 416, just 9 were positively assessed, 14 were said to provide insufficient evidence, 125 were not characterised and 291 received a negative opinion. These opinions have been sent to the European Commission and to Member States which will ultimately decide whether to authorise these claims or not.

Claims for probiotics and antioxidants were among the most high profile ingredients to incur negative opinions by EFSA. “Antioxidant claims reported in most of the cases to have antioxidant properties or an antioxidant content but did not provide actual evidence of an effect on the protection of DNA, proteins and lipids from oxidative damage - which would be considered to be a beneficial physiological effect (this effect is proven by studies among which human studies). In other cases no relevant studies were provided in support of the beneficial effect”, EFSA spokesperson Lucia de Luca told FoodIngredientsFirst.

De Luca explained that the claims that did pass related to:

• Vitamin D (immune system and muscle function)
• Potassium (blood pressure and muscle function)
• Guar gum and maintenance of blood cholesterol concentrations
• Generic claims on ingredients for meal replacement and weight control
• Melatonin and the alleviation of aspects related to jetlag

EFSA said that the evaluations of the NDA Panel were positive when there was sufficient scientific evidence available to support the claim, such as those related to vitamins and minerals. Experts issued unfavourable opinions on most of the claims in the second series due to the poor quality of the information provided to EFSA including:

• lack of information to identify the substance on which the claim is based, e.g. “probiotics”;
• lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body (e.g. food with “antioxidant properties”);
• lack of human studies with reliable measures of the claimed health benefit.

This is the second series of opinions on ‘general function’ health claims and the Panel is continuing its work on the remaining claims on the list. This phased approach has been adopted due to the very large number of claims received for evaluation and the requirement, for EFSA, to publish opinions soon after adoption in order to ensure transparency. In carrying out its work, EFSA combines similar claims (e.g. by substance and/or the benefit) in order to form coherent opinions.

“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 .

Until today EFSA has published the 125 opinions providing scientific advice for more than 900 “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. 

by Robin Wyers