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

Abstract

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 TM . The Panel considers that the food, an aqueous extract from white kidney bean (Phaseolus vulgaris L.) standardised by its in vitro a-amylase inhibitory activity (GlycoLite TM ) 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 TM 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 TM on body weight when eating ad libitum. No evidence for a plausible mechanism by which GlycoLite TM 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 a-amylase inhibitory activity (GlycoLite TM ) and a reduction of body weight either under energy restriction or when eating ad libitum.

Response to comments on the Scientific Opinion of the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) on the scientific substantiation of a health claim related to GlycoLiteTM and helps to reduce body weight pursuant to Article 13.5 of Regulation (EC) No 1924/2006

“…On 15 May 2019, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) adopted a scientific opinion on the scientific substantiation of a health claim related to GlycoLite TM and helps to reduce body weight (EFSA NDA Panel, 2019)…”