Safety evaluation of the food enzyme urease from the non-genetically modified Limosilactobacillus reuteri strain 48/72

Abstract

The food enzyme urease (urea amidohydrolase EC 3.5.1.5) is produced with the non-genetically modified Limosilactobacillus reuteri strain 48/72 by Nagase (Europa) GmbH. The food enzyme is intended to be used in brewing processes for the production of Japanese sake. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.009 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme fulfils the requirements for the Qualified Presumption of Safety approach to safety assessment. As no other concerns arising from the manufacturing process have been identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. 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 notes that the food enzyme contains a known allergen. Therefore, allergenicity cannot be excluded. Based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use, except for individuals sensitised to the identified allergen.