Following an application from Cross Vetpharm Group UK Ltd, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the European Food Safety Authority (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 β-galactosidase from Kluyveromyces lactis in Colief® and a reduction of gastrointestinal discomfort.
The scope of the application was proposed to fall under a health claim referring to children’s development and health.
The food that is the subject of the health claim is ‘Colief®/lactase enzyme produced by controlled fermentation of Kluyveromyces lactis’. Ingested lactose is hydrolysed by lactase, an enzyme of the microvillus membrane of the enterocytes, into its components, glucose and galactose. The exogenous enzymes which are used to hydrolyse lactose are microbial β-galactosidases. The β-galactosidase which is the subject of the health claim is derived from the yeast Kluyveromyces lactis. The Panel considers that the food, β-galactosidase from Kluyveromyces lactis in Colief®, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect.……
