Scientific Opinion on the substantiation of a health claim related to Bifidobacterium bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Lallemand Health Solutions, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Bifidobacterium bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract. The food constituent that is the subject of the claim is B. bifidum CNCM I-3426. The Panel considers that B. bifidum CNCM I-3426 is sufficiently characterised. The Panel considers that defence against pathogens in the upper respiratory tract is a beneficial physiological effect. The applicant provided one published human intervention study, one unpublished human intervention study (which was published during the evaluation of the claim) and one in vitro study as pertinent to the claimed effect. The Panel considers that no conclusions can be drawn from either of the human studies for the scientific substantiation of the claim. In the absence of evidence of an effect of B. bifidum CNCM I3426 on defence against pathogens in the upper respiratory tract in humans, the results of the in vitro study submitted cannot be used as a source of data for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of B. bifidum CNCM I-3426 and defence against pathogens in the upper respiratory tract.