Safety evaluation of the food enzyme subtilisin from the genetically modified Bacillus licheniformis strain NZYM‐PD

strain NZYM-PD by Novozymes A/S. The production strain met the requirements for the Qualified Presumption of Safety (QPS) approach. The food enzyme is considered free from viable cells of the production strain and its DNA. It is intended to be used in the processing of cereals and other grains for the production of distilled alcohol. Since residual amounts of food enzyme-total organic solids are removed in this food manufacturing process, dietary exposure was not calculated. Given the QPS status of the production strain, the absence of concerns resulting from the food enzyme manufacturing process and the negligible dietary exposure under the intended use, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the subtilisin to known allergens was made and matches with 2 food allergens, 3 contact allergens and 20 respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme can be excluded for the production of distilled alcohol. 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.