Scientific Opinion on the substantiation of health claims related to a combination of Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3 and maintenance of upper respiratory tract defence against pathogens (ID 931, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Abstract

The claimed effect, which is proposed for further assessment, is "supports the defence against pathogens in the upper respiratory tract resulting in a decrease in duration and severity of common cold symptoms". The proposed target population is the general adult population. The Panel considers that maintenance of upper respiratory defence against pathogens is a beneficial physiological effect.In the only human intervention study provided, the effect of consumption of the bacterial preparation on the incidence, severity and duration of common colds was assessed in healthy adults. The Panel notes that no information is provided about the validity of the questionnaire used to assess the incidence, severity or duration of respiratory tract infections, that the symptoms used for the diagnosis of common cold episodes are non-specific, and that the presence of one or more of these symptoms is not an appropriate measure of respiratory tract infections in the study population. The Panel also notes that no information has been provided in the publication about the use of rescue medication, which may have confounded the results. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.The Panel notes that no human intervention studies have been provided from which conclusions could be drawn for the scientific substantiation of the claim, and that the animal and in vitro studies which were provided cannot be used for the scientific substantiation of the claim as their results cannot predict the occurrence of an effect of a combination of Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3 in vivo in humans.On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3 and maintenance of upper respiratory tract defence against pathogens.