Scientific Opinion on the substantiation of a health claim related to fermented milk containing Lactobacillus casei DN-114 001 plus yoghurt symbiosis (Actimel®), and reduction of Clostridium difficile toxins in the gut of patients receiving antibiotics and reduced risk of acute diarrhoea in patients receiving antibiotics pursuant to Article 14 of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2010;8(12):1903 [17 pp.].
Possible conflict of interest
Five members of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
doi
10.2903/j.efsa.2010.1903
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.
Acknowledgements

The Panel wishes to thank 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 for the preparatory work on this scientific opinion and EFSA staff: Wolfgang Gelbmann for the support provided to this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of France following an application from Danone Produits Frais France
Question Number
EFSA-Q-2009-00776
Adopted
12 November 2010
Published in the EFSA Journal
8 December 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Following an application from Danone Produits Frais France submitted pursuant to Article 14 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 related to a fermented milk drink Actimel® containing Lactobacillus casei (Lc) DN-114 001 and reduction of the presence of Clostridium difficile toxins in the gut which reduces the incidence of acute diarrhoea. The Panel considers that the food constituent, Actimel®, which is the subject of the health claim, is sufficiently characterised. The Panel considers that reducing the risk of Clostridium difficile diarrhoea by reducing the presence of C. difficile toxins is a beneficial physiological effect. In total the applicant indicated seven publications on human studies, three unpublished human studies, eight published and one unpublished non-human studies to be pertinent for the claimed effect. In weighing the evidence, the Panel took into account that human and animal studies showed partial survival of Lc DN-114 001 during its gastrointestinal passage, that one human intervention study with Actimel® which showed a statistically significant risk reduction for CDAD had considerable limitations, that there were only limited data on the effect of Actimel® on the reduction C. difficile toxins (the risk factor) in humans, that one study which showed an inhibitory effect of Lc DN-114 001 on the growth of C. difficile in vitro does not predict the occurrence of an effect against C. difficile in humans, that five further human studies do not support the proposed mechanisms by which Actimel® could exert the claimed effect, and that the evidence provided from a further two animal and three in vitro studies does not establish that effects of Actimel® or Lc DN-114 001 in these model systems related to immune function and infection can predict the occurrence of such effects in humans. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of Actimel® and a reduction of the risk of C. difficile diarrhoea by reducing the presence of C. difficile toxins.

Keywords
Actimel®, Lactobacillus casei DN-114 001, Streptococcus thermophilus, Lactobacillus delbrueckii subsp. bulgaricus, yoghurt, fermented milk, microbiota, intestine, Clostridium difficile toxin, risk reduction, elderly, diarrhoea, antibiotic treatment.
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Number of Pages
17