Scientific Opinion on the substantiation of a health claim related to ethanol-water extract of Caralluma fimbriata (Slimaluma®) and helps to reduce waist circumference pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Gencor Pacific Inc. submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to ethanol-water extract of Caralluma fimbriata (Slimaluma^®) and “helps to reduce waist circumference”. Slimaluma^® is an ethanol-water extract of Caralluma fimbriata standardised by its content in pregnane glycosides that is sufficiently characterised. The reduction in body weight is considered a beneficial physiological effect. Two human intervention studies were considered as being pertinent to the claim. Neither of the studies provided reported a significant effect of ethanol-water extract of Caralluma fimbriata on weight loss in humans compared to a suitable control. The Panel concludes that a cause and effect relationship has not been established between the consumption of the ethanol-water extract of Caralluma fimbriata Slimaluma^® and a reduction in waist circumference.