Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Kluyveromyces lactis strain GAL.

Abstract

The food enzyme β‐galactosidase (β‐d‐galactoside galactohydrolase; EC 3.2.1.23) is produced with the non‐genetically modified Kluyveromyces lactis strain GAL by DSM Food Specialties B.V. It is intended to be used for the lactose hydrolysis in milk processing, production of fermented milk products and whey processing. It is also intended to be used for lactose hydrolysis in milk products at home. Dietary exposure to the food enzyme‐total organic solids (TOS) was estimated to be up to 10.78 mg TOS/kg body weight per day in European populations. As the production strain of K. lactis strain GAL qualifies for the Qualified Presumption of Safety (QPS) approach to safety assessment and no issue of concern arose from the production process, no toxicological data are required. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.