Catalgine® bouffées de chaleur and reduction in the number of hot flushes


Catalgine® bouffées de chaleur, eicosapCatalgine® bouffées de chaleur, eicosapentaenoic acid, docosahexaenoic aentaenoic acid, docosahexaenoic acid, n-3 polyunsaturated fatty acids, hot flashes, peri-menopausal women, post-menopausal women, health claims.
First published in the EFSA Journal
13 January 2010
4 December 2009
Scientific Opinion

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.

Panel members at the time of adoption
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen.
Panel on Dietetic Products, Nutrition and Allergies
nda [at]
EFSA Journal 2010; 8(1):1422 [10 pp.].
Question Number
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Laboratoire vie et santé
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