Scientific Opinion on the substantiation of a health claim related to Catalgine® bouffées de chaleur and contributes to the reduction in the number of hot flushes pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Abstract

Following an application from Laboratoire Vie et Sante submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim based on newly developed science and including proprietary data related to Catalgine® and contributes to the reduction in the number of hot flushes. Catalgine® bouffees de chaleur (also called OM3® menopause) is a dietary supplement made with concentrated wild fish oil that is sufficiently characterised. The reduction in the frequency of episodes of hot flushes is considered beneficial to the health of peri- and post-menopausal women. Two publications (three studies) were identified by the applicant as being pertinent to the claim. Two studies were uncontrolled with respect to the supplement. The third was a post-hoc analysis of a subsample of women participating in a randomised, placebo controlled intervention evaluating the effects of Catalgine® on psychological distress. A number of weaknesses in this study, including unsuccessful blinding and limited power, greatly limit its value as a source of data to substantiate the claimed effect. The Panel concludes that a cause and effect relationship has not been established between the consumption of Catalgine® bouffees de chaleur and the reduction in the frequency of episodes of hot flushes.