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Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) claiming “healthy and balanced digestive system” (ID 1371, 4228), increasing numbers of gastro-intestinal microorganisms (ID 864, 1371, 3073, 4228) and decreasing potentially pathogenic gastro-intestinal microorganisms (ID 864, 1371, 3073, 4228) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

EFSA Journal 2010;8(10):1767 [15 pp.]. doi:10.2903/j.efsa.2010.1767
  EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Panel Members 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. Acknowledgment The Panel wishes to thank for the preparatory work on this scientific opinion: The members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. The members of the Claims Sub-Working Group on Gut/Immune: Maria Carmen Collado, Miguel Gueimonde, Daisy Jonkers, Martinus Løvik, Bevan Moseley, Maria Saarela, Seppo Salminen, Yolanda Sanz, Stephan Strobel, Daniel Tomé and Hendrik van Loveren. Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2008-1651 , EFSA-Q-2008-2108 , EFSA-Q-2008-3805 , EFSA-Q-2008-4938 Adopted: 30 April 2010 Published: 19 October 2010 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

No abstract available

Summary

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 various food(s)/food constituent(s) and “healthy and balanced digestive system”, increasing numbers of gastro-intestinal microorganisms 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.

“Healthy and balanced digestive system”

The claimed effects are “intestinal flora”, “digestive health” and “ingestion of cheese containing probiotic culture Lb. paracasei NFBC 338 positively influences the healthy balance of the gut microflora”. The target population is assumed to be the general population. In the context of the proposed wording the Panel assumes that the claimed effects refer to maintenance of, or contribution to, a healthy and balanced digestive system, which is not sufficiently defined.

The Panel considers that the claimed effects are general and non-specific and do not refer to any specific effect on health as required by Regulation (EC) No 1924/2006.

Increasing numbers of gastro-intestinal microorganisms

The claimed effects are “gut health”, “intestinal flora”, “digestive health” and “ingestion of cheese containing probiotic culture Lb. paracasei NFBC 338 positively influences the healthy balance of the gut microflora”. The target population is assumed to be the general population. In the context of the proposed wording, the Panel assumes that the claimed effects refer to an increase in the number of “good” bacteria that are considered to be beneficial. The Panel considers that the evidence provided does not establish that increasing numbers of gastro-intestinal microorganisms is a beneficial physiological effect.

The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this opinion and a beneficial physiological effect related to increasing numbers of gastro-intestinal microorganisms.

Decreasing potentially pathogenic gastro-intestinal microorganisms

The claimed effects are “gut health”, “intestinal flora”, “digestive health” and “ingestion of cheese containing probiotic culture Lb. paracasei NFBC 338 positively influences the healthy balance of the gut microflora”. The target population is assumed to be the general population. In the context of the proposed wording, the Panel assumes that the claimed effects refer to changes in the number of gastro-intestinal microorganisms. The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.

No human studies that investigated the effects of the food(s)/food constituent(s) on outcomes related to potentially pathogenic gastro-intestinal microorganisms have been provided.

The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) evaluated in this opinion and decreasing potentially pathogenic gastro-intestinal microorganisms.

Keywords

Microbiota, potentially pathogenic microorganisms, health claims