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

The food enzyme β-galactosidase (β-D-galactoside galactohydrolase, EC 3.2.1.23) is produced with the non-genetically modified Kluyveromyces lactis strain GD-YNL by Godo Shusei Co., Ltd. The food enzyme is intended to be used for the hydrolysis of lactose in milk processing, production of fermented milk products and whey processing. The food enzyme is also intended for lactose hydrolysis in milk products at home. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 54 mg TOS/kg body weight per day in European populations. As the production strain qualifies for the qualified presumption of safety approach of safety assessment and as no issue of concern raised from the production process, no toxicological studies other than assessment of allergenicity were necessary. A search for the 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 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.