GlycoLite™ and helps to reduce body weight: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from analyze & realize GmbH submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to GlycoLite™. The Panel considers that the food, an aqueous extract from white kidney bean (Phaseolus vulgaris L.) standardised by its in vitro α‐amylase inhibitory activity (GlycoLite™) which is the subject of the health claim, is sufficiently characterised. The claimed effect proposed by the applicant is ‘helps to reduce body weight’. The proposed target population is ‘overweight people from the age of 18 years who want to lose or manage their weight’. The Panel considers that a reduction in body weight is a beneficial physiological effect for overweight individuals. Two human intervention studies, carried out in the same centres and by the same research group, showed an effect of 3 g of GlycoLite™ on body weight when consumed daily for 12 weeks in the context of an energy restricted diet. The results have not been replicated in a different setting. One study of short duration and methodological limitations showed an effect of GlycoLite™ on body weight when eating ad libitum. No evidence for a plausible mechanism by which GlycoLite™ could exert a reduction in body weight in vivo in humans has been provided. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of an aqueous extract from white kidney bean (P. vulgaris L.) standardised by its in vitro α‐amylase inhibitory activity (GlycoLite™) and a reduction of body weight either under energy restriction or when eating ad libitum.