Scientific Opinion on the substantiation of a health claim related to Prolibra and “helps to reduce body fat while preserving lean muscle” pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Glanbia Nutritionals plc, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Prolibra and “helps to reduce body fat while preserving lean muscle” in the context of energy restriction for weight loss. Prolibra was described by the applicant as a partially hydrolysed whey protein isolate containing whey protein, peptides and milk minerals. The applicant denoted the peptides contained in Prolibra as “weight loss peptides” and claims that these particular peptides contribute to the specificity of Prolibra in relation to the claimed effect. The Panel notes that, while a specific fraction (i.e. the peptide fraction) of Prolibra , is claimed to play a role on the claimed effect (i.e. “helps to reduce body fat while preserving lean muscle” in the context of energy restriction for weight loss), the information provided by the applicant was insufficient to characterise these peptides and thus the food constituent (i.e. Prolibra ) for which the claim is made. The Panel considers that the food, Prolibra , which is the subject of the health claim, is not sufficiently characterised in relation to the claimed effect. The Panel concludes that a cause and effect relationship cannot be established between the consumption of Prolibra and “helps to reduce body fat while preserving lean muscle” in the context of energy restriction for weight loss.