Scientific Documents

Bimuno^TM and support of the immune system - Scientific substantiation of a health claim related to Bimuno^TM and support of the immune system pursuant to Article 13(5) of Regulation (EC) [1]

Summary (78 KB)

Opinion (122 KB)

Summary

Following an application from Clasado Limited submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Bimuno^TM and support of the immune system.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.

The food supplement, Bimuno^TM, a β-galacto-oligosaccharide mixture, that is the subject of the health claim is sufficiently characterised.

The claimed effect is “supports the immune system by helping to increase the natural killer cell and phagocyte activity”. The target population is elderly people. From the evidence provided, it has not been established that changes in natural killer cells and phagocytes are beneficial to human health. The Panel considers that supporting the immune system is beneficial to human health.

The applicant identified one randomised, double-blind, placebo-controlled, crossover study in 44 elderly healthy subjects as being pertinent to the health claim. Primary outcomes were counts of faecal bifidobacteria that were found to be increased significantly in the Bimuno^TM group. Immune parameters such as phagocytosis, natural killer (NK) cell activity and cytokine production were secondary outcomes. The applicant did not provide any evidence that the observed changes in counts of faecal bifidobacteria, NK cell activity, production of inflammatory cytokines and phagocytosis activity constitute beneficial changes in the immune system. The Panel considers this study as having limited relevance for the substantiation of the claimed effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of Bimuno^TM and support of the immune system.