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

Following an application from Laboratoire Vie et Santé 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® bouffées 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® bouffées de chaleur and the reduction in the frequency of episodes of hot flushes.