Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to Lactobacillus fermentum ME-3 and decreasing potentially pathogenic gastro-intestinal microorganisms. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claim is Lactobacillus fermentum ME-3. The Panel considers that Lactobacillus fermentum ME-3 is sufficiently characterised. The claimed effect is “A probiotic lactic acid bacterium Lactobacillus fermentum ME-3 helps to strengthen the organism's defence ability. ME-3 supports digestion by increasing in the intestine the total number of useful lactobacilli which ensure the break-down of nutrients into compounds that can be easily absorbed”. The target population is assumed to be the general population. From the clarifications provided by Member States, the Panel assumes that the claimed effect refers to “increasing in the intestine the total number of useful lactobacilli” and “suppressing harmful bacteria in gut”. The Panel considers that the evidence provided does not establish that increasing numbers of intestinal microorganisms is a beneficial physiological effect. The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect. No human studies were provided which addressed outcomes related to the claimed effect. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus fermentum ME-3 and decreasing potentially pathogenic gastro-intestinal microorganisms.

Scientific Opinion on the substantiation of health claims related to Lactobacillus fermentum ME-3 and decreasing potentially pathogenic gastro-intestinal microorganisms (ID 3025) pursuant to Article 13(1) 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. - 9:4(2011). [10.2903/j.efsa.2011.2025]

Scientific Opinion on the substantiation of health claims related to Lactobacillus fermentum ME-3 and decreasing potentially pathogenic gastro-intestinal microorganisms (ID 3025) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

C.V. Agostoni
Primo
;
2011

Abstract

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to Lactobacillus fermentum ME-3 and decreasing potentially pathogenic gastro-intestinal microorganisms. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claim is Lactobacillus fermentum ME-3. The Panel considers that Lactobacillus fermentum ME-3 is sufficiently characterised. The claimed effect is “A probiotic lactic acid bacterium Lactobacillus fermentum ME-3 helps to strengthen the organism's defence ability. ME-3 supports digestion by increasing in the intestine the total number of useful lactobacilli which ensure the break-down of nutrients into compounds that can be easily absorbed”. The target population is assumed to be the general population. From the clarifications provided by Member States, the Panel assumes that the claimed effect refers to “increasing in the intestine the total number of useful lactobacilli” and “suppressing harmful bacteria in gut”. The Panel considers that the evidence provided does not establish that increasing numbers of intestinal microorganisms is a beneficial physiological effect. The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect. No human studies were provided which addressed outcomes related to the claimed effect. On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus fermentum ME-3 and decreasing potentially pathogenic gastro-intestinal microorganisms.
Lactobacillus fermentum ME-3 ; potentially pathogenic microorganisms ; health claims
Settore MED/49 - Scienze Tecniche Dietetiche Applicate
2011
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/165165
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