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

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 ( Lc S) and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences. The food constituent, Lc S, 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 Lc S consumption on upper respiratory tract infections, that one human study did not support an effect of Lc S consumption on the immune response to influenza vaccination, and that there was a lack of evidence for an effect of Lc S 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 Lc S and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences.