Following an application from Gencor Pacific Inc. submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to ethanol-water extract of Caralluma fimbriata (Slimaluma®) and “helps to reduce body fat”. Slimaluma® is an ethanol-water extract of Caralluma fimbriata standardised by its content in pregnane glycosides that is sufficiently characterised. The reduction in body weight is considered a beneficial physiological effect. A double blind, placebo controlled, randomised trial in humans investigating the effects of Slimaluma® on body fat was considered as being pertinent to the claim. No statistically significant differences in body fat changes between the experimental and placebo groups were reported. The Panel concludes that a cause and effect relationship has not been established between the consumption of the ethanol-water extract of Caralluma fimbriata Slimaluma® and a reduction in body fat
Scientific Opinion on the substantiation of a health claim related to ethanol-water extract of Caralluma fimbriata (Slimaluma®) and helps to reduce body fat pursuant to Article 13(5) of Regulation (EC) No 1924/2006 / C.V. Agostoni, J.L. Bresson, S. Fairweather Tait, A. Flynn, I. Golly, H. Korhonen, P. Lagiou, M. Løvik, R. Marchelli, A. Martin, B. Moseley, M. Neuhäuser Berthold, H. Przyrembel, S. Salminen, Y. Sanz, S. Strain, S. Strobel, I. Tetens, D. Tomé, H. van Loveren, H. Verhagen. - In: EFSA JOURNAL. - ISSN 1831-4732. - 8:5(2010). [10.2903/j.efsa.2010.1603]
Scientific Opinion on the substantiation of a health claim related to ethanol-water extract of Caralluma fimbriata (Slimaluma®) and helps to reduce body fat pursuant to Article 13(5) of Regulation (EC) No 1924/2006
C.V. AgostoniPrimo
;
2010
Abstract
Following an application from Gencor Pacific Inc. submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to ethanol-water extract of Caralluma fimbriata (Slimaluma®) and “helps to reduce body fat”. Slimaluma® is an ethanol-water extract of Caralluma fimbriata standardised by its content in pregnane glycosides that is sufficiently characterised. The reduction in body weight is considered a beneficial physiological effect. A double blind, placebo controlled, randomised trial in humans investigating the effects of Slimaluma® on body fat was considered as being pertinent to the claim. No statistically significant differences in body fat changes between the experimental and placebo groups were reported. The Panel concludes that a cause and effect relationship has not been established between the consumption of the ethanol-water extract of Caralluma fimbriata Slimaluma® and a reduction in body fat
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