Safety evaluation of the food enzyme bacillolysin from the genetically modified Bacillus amyloliquefaciens strain NPR

Abstract

The food enzyme bacillolysin (EC 3.4.24.28) is produced with the genetically modified Bacillus amyloliquefaciens strain NPR by DSM Food Specialties B.V. The production strain meets the requirements for the qualified presumption of safety (QPS) status. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in 10 food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated only for the remaining nine food manufacturing processes. It was estimated to be up to 6.450 mg TOS/kg body weight per day in European populations. Given the QPS status of the production strain and the absence of concerns resulting 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 bacillolysin to known allergens was made and no match was found. The Panel considered that the 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.