EFSA Third Batch of General Function Claims Features High Number of Unfavorable Opinions

Favorable opinions related mainly to vitamins and minerals but also included claims on specific dietary fibres related to blood glucose control, bowel function or weight management; fatty acid claims related to brain function, vision or heart health; or claims related to live yoghurt cultures and lactose digestion.

Oct 20 2010 --- Scientific experts on EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) have adopted opinions on 808 ‘general function’ health claims taking into consideration all available scientific data. With this third series of opinions EFSA has assessed to date 1,745 claims from a list of 4,637 health claims compiled by Member States and the European Commission. These opinions have been sent to the European Commission and to Member States which are responsible for the authorisation of the claims. EFSA will finalise the evaluations of all ‘general function’ health claims (other than botanicals) by the end of June 2011.

Outcomes of the evaluations of 808 claims, addressed in 75 opinions, were favourable when there was sufficient scientific evidence to support the claims, EFSA said. These related mainly to vitamins and minerals but also included claims on specific dietary fibres related to blood glucose control, bowel function or weight management; fatty acid claims related to brain function, vision or heart health; or claims related to live yoghurt cultures and lactose digestion.

As for EFSA’s previous work on ‘general function’ health claims, scientific experts on EFSA’s NDA Panel issued unfavourable opinions on many of the claims in this series due to the poor quality of the information provided to EFSA. Information gaps included for instance: inability to identify the specific substance on which the claim is based (e.g. claims on “dietary fibre” without specifying the particular fibre); lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of body functions (e.g. claims on renal “water elimination”); lack of precision regarding the health claim being made (e.g. claims referring to terms such as “energy” and “vitality”); or lack of human studies with reliable measures of the claimed health benefit.

EFSA said it will pursue its dialogue with stakeholders to further explain how it is carrying out its work and to provide applicants with more detailed information on the preparation of health claims applications. EFSA is organising a series of consultations on specific topics to provide additional guidance to applicants, the first of which will be held on 2 December 2010, and will focus on health claims related to gut and immune functions.

EFSA said in a statement that it has been engaging regularly with stakeholders to outline and clarify where needed the process followed by the NDA Panel in the evaluation of claims, and has been providing guidance in this field since 2007 both through on-line consultations and the holding of scientific meetings. EFSA has also published briefing documents describing the procedures followed for the evaluation of Article 13.1 health claims to ensure the consistent assessment of claims, including the use of uniform scientific criteria.