标题：Scientific Opinion on the substantiation of a health claim related to OXY 280 and reduction of body weight pursuant to Article 13(5) of Regulation (EC) No 1924/2006
摘要：Following an application from Actina, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Belgium, 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 OXY 280 and reduction of body weight. The food constituent that is the subject of the health claim, OXY 280, which is a powder composed of kidney bean, olive and rosemary extracts, is sufficiently characterised. The claimed effect, reduction of body weight, is a beneficial physiological effect for overweight subjects. One unpublished human intervention study was provided by the applicant as pertinent to the health claim. This randomised, double-blind, placebo-controlled study investigated the effect of OXY 280 vs placebo on body weight, BMI, and waist, hip and thigh circumferences in 60 overweight subjects. The Panel notes that the results of between-group comparisons with respect to changes in the outcome variables assessed in this study were not provided. The Panel considers that the data as analysed do not allow the evaluation of the effect of the food constituent on changes in body weight relative to the placebo, and that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel notes that no studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the consumption of OXY 280 and a reduction in body weight.
关键词：OXY 280; kidney bean; olive; rosemary; body weight; health claims
