Scientific Opinion on the substantiation of a health claim related to beta‐galactosidase from Streptococcus thermophilus and reduction of gastrointestinal discomfort pursuant to Article 14 of Regulation (EC) No 1924/2006

Abstract Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, 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 beta‐galactosidase from Streptococcus thermophilus and reduction of gastrointestinal discomfort. According to the applicant, the food constituent which is the subject of the claim is beta‐galactosidase from Streptococcus thermophilus . Streptococcus thermophilus is added to infant formulae in the production process for fermentation purposes and the live organisms are inactivated after the fermentation process. The Panel considers that the food constituent, beta‐galactosidase from Streptococcus thermophilus , under the conditions of use proposed by the applicant, is sufficiently characterised. The claimed effect proposed by the applicant is “reduction of gastro‐intestinal discomfort”. The target population proposed by the applicant is infants and young children. The Panel considers that reduction of gastrointestinal discomfort is a beneficial physiological effect. No human studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the consumption of beta‐galactosidase which is produced by Streptococcus thermophilus (subsequently inactivated) during fermentation of an infant formula and reduction of gastrointestinal discomfort.