Calcium sulphate and reduction in body weight: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Mediconomics APS, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Denmark, 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 calcium sulphate and reduction in body weight. The Panel considers that the food constituent, calcium sulphate, is sufficiently characterised. A reduction in body weight is a beneficial physiological effect for overweight adults. The applicant submitted two human intervention studies investigating the effect of calcium sulphate on body weight. The Panel notes that no conclusions can be drawn from any of the human intervention studies submitted for the scientific substantiation of the claim and that no convincing evidence has been provided for a mechanism by which calcium sulphate could exert the claimed effect in vivo in humans. The Panel concludes that a cause and effect relationship has not been established between the consumption of calcium sulphate and a beneficial physiological effect on body weight under the proposed conditions of use.