Scientific Opinion on the substantiation of health claims related to Lactobacillus fermentum CECT5716 and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences (ID 916) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to Lactobacillus fermentum CECT5716 and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders. The food constituent that is the subject of the health claim is Lactobacillus fermentum CECT5716. The Panel considers that Lactobacillus fermentum CECT5716 is sufficiently characterised. The claimed effect is \u201cnatural defence/immune system\u201d. The target population is assumed to be the general population. From the clarifications provided by the Member States, the Panel assumes that the claimed effect refers to the maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences. The Panel considers that maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences is a beneficial physiological effect. In weighing the evidence, the Panel took into account that the only human study provided did not show an effect of Lactobacillus fermentum CECT5716 consumption on the maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences. On the basis of the data presented the Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus fermentum CECT5716 and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences