Safety evaluation of the food enzyme β-galactosidase from the non-genetically modified Kluyveromyces lactis strain LAC-01

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 LAC-01 by Nagase (Europa) GmbH. The production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in two food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 2.133 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concern arising from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the β-galactosidase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but the likelihood 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.