EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013. Scientific Opinion on the substantiation of a health claim related to Lactobacillus rhamnosus GG and maintenance of normal defecation during antibiotic treatment pursuant to Article 13(5) of Regulation (EC) No 1924/2006 : Lactobacillus rhamnosus GG and maintenance of normal defecation

Following an application from Fuko Pharma Ltd, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Finland, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Lactobacillus rhamnosus GG and maintenance of normal defecation during antibiotic treatment.

The food constituent, Lactobacillus rhamnosus GG, which is the subject of the health claim, is sufficiently characterised. The claimed effect proposed by the applicant is “help to maintain normal defecation during antibiotic treatment” and the target population proposed by the applicant is “healthy outpatient adults and children on oral antibiotic treatment”.

Maintenance of normal defecation during antibiotic treatment is a beneficial physiological effect. The Panel notes that the information submitted from five out of seven human intervention studies is insufficient to allow a full scientific evaluation, and that these studies have important methodological limitations.

No conclusions could be drawn from these studies for the scientific substantiation of the claim. The remaining two human intervention studies, from which conclusions could be drawn for the scientific substantiation of the claim, did not show an effect of Lactobacillus rhamnosus GG on the incidence of diarrhoea resulting from antibiotic treatment.

The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus rhamnosus GG and maintenance of normal defecation during antibiotic treatment. © European Food Safety Authority, 2013