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Scientific Opinion on the substantiation of a health claim related to a combination of bifidobacteria (Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum) and decreasing potentially pathogenic intestinal microorganisms pursuant to Article 14 of Regulation (EC) No 1924/2006

EFSA Journal 2009; 7(12):1420 [8 pp.]. doi:10.2903/j.efsa.2009.1420
  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 Miguel Gueimonde and the members of the Working Group on claims for the preparation of this opinion: 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. Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: Töpfer GmbH Question number: EFSA-Q-2009-00224 Adopted: 04 December 2009 Published: 21 December 2009 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Following an application from Töpfer GmbH submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to a combination of bifidobacteria (Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum) and decreasing potentially pathogenic intestinal microorganisms. The scope of the application was proposed to fall under a health claim referring to children’s development and health. The food constituent that is the subject of the proposed claim, a combination of Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, has not been sufficiently characterised. The claimed effect is “establishment of a natural, beneficial bifidobacterial dominance in the large intestine, which can lead to a suppression of harmful bacteria and thereby to a better health status”. The target population is infants and children aged between 0 to 36 months. The Panel considers that decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health. The applicant identified a total of 34 publications considered as being pertinent to the health claim. In weighing the evidence, the Panel notes that the strains that are the subject of the health claim have not been sufficiently characterised and that from the evidence provided it cannot be established that the strains used in the studies are the same strains that are the subject of the claim.

 

© European Food Safety Authority, 2009

Summary

Following an application from Töpfer GmbH submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to a combination of bifidobacteria (Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum) and decreasing potentially pathogenic intestinal microorganisms.

The scope of the application was proposed to fall under a health claim referring to children’s development and health.

The food constituent that is the subject of the proposed claim is a combination of Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum. The Panel considers that the food constituent, the combination of Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, which is the subject of the health claim, has not been sufficiently characterised.

The claimed effect is “establishment of a natural, beneficial bifidobacterial dominance in the large intestine, which can lead to a suppression of harmful bacteria and thereby to a better health status”. The target population is infants and children aged between 0 to 36 months. The Panel notes that aspects of the term “health status” are not sufficiently defined and do not allow an in depth scientific analysis of the claimed effect. The gastrointestinal tract is populated with a large number of microorganisms and it normally acts as an effective barrier against generalised systemic infections. It is not possible to provide the exact numbers of bacterial groups that would constitute a beneficial microbiota. However, the Panel considers that decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.

The applicant identified a total of 34 publications considered as being pertinent to the health claim: 13 randomised controlled trials, 6 observational studies, and 15 non-human studies.

The Panel notes that 11 randomised controlled trials provided insufficient identification of the bacterial strains used to establish that they were the same strains which are the subject of the health claim. In addition, the 6 human observational studies did not use the combination of bifidobacteria which is subject of the health claim. The Panel considers that no scientific conclusions can be drawn from these studies for substantiation of the claim.

Two randomised controlled trials were performed in infants with the combination of bifidobacteria which is the subject of the health claim. The Panel notes that the identity of the strains used in these studies cannot be ascertained and thus from the evidence provided it cannot be established that the strains used in these studies are the same strains that are the subject of the health claim. The Panel considers that no scientific conclusions can be drawn from these studies for the substantiation of the claim.

The applicant submitted 15 in vitro and animal studies performed with one or more of the following strains: Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis and Bifidobacterium longum. These studies were related to pathogen adhesion, inhibition of adhesion, production of antibacterial substances and passive protection in mice. The Panel notes that from the evidence provided it cannot be established that the strains used in these studies are the same strains that are the subject of the health claim. Therefore no scientific conclusions can be drawn from these studies for the substantiation of the claim.

In weighing the evidence, the Panel notes that the strains that are the subject of the health claim have not been sufficiently characterised and that from the evidence provided it cannot be established that the strains used in the studies are the same strains that are the subject of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of the combination of Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum and decreasing potentially pathogenic intestinal microorganisms in infants and children aged between 0 and 36 months.

Keywords

Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, bifidobacteriapotentially pathogenic intestinal microorganisms, health claims.