EFSA completes evaluation of further 442 ‘general function’ health claims

EFSA’s NDA Panel[1] has published the outcome of the evaluations of a fourth series of ‘general function’ health claims[2] proposed for use on food products. The 442 claims assessed relate to health relationships in such areas as: protection against oxidative damage to body cells, contribution to either cognitive or bowel function; and maintenance of normal blood cholesterol levels. These opinions will help inform future decisions of the European Commission and EU Member States which are responsible for the authorisation of the claims. EFSA will finalise the evaluation of the remaining 600 ‘general function’ health claims which need to be assessed by June 2011.

“Experts on the Panel have completed the evaluation of about 80% of ‘general function’ health claims, excluding the so-called”botanical” claims, and are committed to finalising the remaining claims by the agreed deadline,” said Dr. Juliane Kleiner, Head of EFSA’s NDA Unit.

Claims evaluated with a favourable outcome include the relation between: walnuts and improved function of blood vessels; the antioxidant effects of polyphenols found in olive oil on LDL cholesterol; and the relation between caffeine and alertness and caffeine and increased physical endurance. The experts also conclude that a number of claims based on the replacement of certain nutrients were supported by sufficient scientific evidence including: the replacement of digestible starch by resistant starch to lower the increase of blood glucose levels after meals; the replacement of saturated fatty acids with mono- and polyunsaturated fatty acids to maintain normal blood cholesterol levels; as well as the role of a range of sugar replacers (e.g. xylitol or sorbitol) in maintaining tooth mineralisation or lowering the increase of blood glucose levels after meals.

As for previous evaluations, many of the unfavourable opinions in this series were linked to the poor quality of the information provided to EFSA. Information gaps included, for instance: the inability to identify the specific substance on which the claim is based; the lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of body functions; or the lack of precision regarding the health claim being made. In addition, some claims were outside the scope of the current legal framework.

EFSA and its scientific experts are pursuing dialogue with stakeholders to further explain their work and to provide applicants with additional guidance on preparing applications. Following consultations carried out in 2010, EFSA will launch three additional on-line consultations later this month on guidance for health claims related to: 1) bone, joint and oral health 2) oxidative damage and cardiovascular health, and 3) satiety, weight management and blood glucose concentrations.

• NDA opinions on “General function” health claims under Article 13

References

1. NDA – Panel dealing with Dietetic Products, Nutrition and Allergies.
2. ‘General function’ claims defined under Article 13.1 of the Regulation (EC) No 1924/2006 on nutrition and health claims made on food include: The role of a nutrient/substance in growth, development and the functions of the body; psychological and behavioural functions; slimming and weight control or reduction of hunger, increase of satiety or the reduction of available energy from the diet. These claims do not include those related to children’s development or health or disease risk reduction. The list of 4,637 claims was submitted to EFSA by the European Commission between July 2008 and March 2010.