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

Galacto-oligosaccharides, fructo-oligosaccharides, Immunofortis®, infections, allergy, infants, infant formula
First published in the EFSA Journal
4 February 2010
4 December 2009
Scientific Opinion


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.

Panel members at the time of adoption

Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen. Five members of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests
Panel on Dietetic Products, Nutrition and Allergies
nda [at]
EFSA Journal 2010; 8(2):1430
Question Number
On request from
European Commission