Scientific Opinion on the substantiation of a health claim related to Lactobacillus casei strain Shirota and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2010;8(10):1860 [15 pp.].
doi
10.2903/j.efsa.2010.1860
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. One member 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.
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.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
the Competent Authority of The Netherlands following an application from Yakult Europe B.V.
Question Number
EFSA-Q-2010-00137
Adopted
7 October 2010
Published in the EFSA Journal
18 October 2010
Last Updated
16 June 2011. This version replaces the previous one/s.
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Following an application from Yakult Europe B.V., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data related to Lactobacillus casei strain Shirota (LcS) and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences. The food constituent, LcS, which is the subject of the health claim, is sufficiently characterised. The Panel considers that maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences is a beneficial physiological effect. The applicant identified a total of 12 references as being pertinent to the health claim. These included nine human intervention trials and three animal studies. In weighing the evidence, the Panel took into account that there was no human study from which conclusions could be drawn for an effect of LcS consumption on upper respiratory tract infections, that one human study did not support an effect of LcS consumption on the immune response to influenza vaccination, and that there was a lack of evidence for an effect of LcS consumption on the immune system that could relate to the defence of the upper respiratory tract against pathogens. The Panel concludes that a cause and effect relationship has not been established between the consumption of LcS and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences.

Keywords
Lactobacillus casei, fermented milk product, upper respiratory tract infections, health claims
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Number of Pages
15