Scientific Opinion on the substantiation of a health claim related to Yestimun® and immune responses pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Abstract Following an application from Leiber GmbH submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Yestimun® and the initiation of appropriate innate and adaptive immune responses. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data. The Panel considers that the food, Yestimun®, which consists of (1,3)‐(1,6)‐β‐D‐glucans from brewer's yeast cell wall (100 % Saccharomyces cerevisiae ), is sufficiently characterised. The target population is adults. The Panel considers that the initiation of appropriate innate and adaptive immune responses is a beneficial physiological effect. In weighing the evidence the Panel took into account that in the one human intervention study conducted with Yestimun® from which scientific conclusions could be drawn for the scientific substantiation of the claim, no effects of Yestimun® were observed on any outcome that could imply a beneficial effect on the initiation of appropriate innate and adaptive immune responses, and that the evidence provided in the animal and in vitro studies does not predict an effect of Yestimun® on the initiation of appropriate innate and adaptive immune responses in humans. The Panel concludes that a cause and effect relationship has not been established between the consumption of Yestimun® and the initiation of appropriate innate and adaptive immune responses.