Scientific Opinion on the substantiation of a health claim related Immunofortis® and strengthening of the baby’s immune system pursuant to Article 14 of Regulation (EC) No 1924/2006

Following an application from Danone Baby Nutrition, submitted pursuant to Article 14 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 related to Immunofortis® to naturally strengthen the baby’s immune system. The scope of the application was proposed to fall under a health claim referring to children’s development and health The Panel considered that the food constituent, Immunofortis®, a 9:1 mixture of short-chain galacto- and long-chain fructo-oligosaccharides, was sufficiently characterised. The target population consisted of infants who were not breastfed or who were partially breastfed and who were less than 12 months old. The Panel considered that a well-functioning immune system includes the initiation of appropriate adaptive immune responses and an appropriate defence against pathogens and was a beneficial physiological effect. In weighing the evidence, the Panel took into account that the one human intervention study investigating the effects of Immunofortis® on the incidence of atopic dermatitis and the overall cumulative incidence of infections had considerable limitations, that the evidence for an effect of Immunofortis® on the reduction of potentially pathogenic bacteria was inconsistent, that the evidence for an effect of Immunofortis® on immune function animal studies did not predict the occurrence of an effect in humans, and that the evidence presented in support of a biologically plausible mechanism by which Immunofortis® could exert the claimed effect was not convincing. The Panel concluded that the evidence provided was insufficient to establish a cause and effect relationship between the consumption of Immunofortis® and the claimed effect of initiation of appropriate immune responses including the defence against pathogens.