Safety evaluation of the food enzyme subtilisin from the genetically modified Bacillus paralicheniformis strain...

The food enzyme subtilisin (serine endopeptidase; EC 3.4.21.62) is produced with the genetically modified Bacillus paralicheniformis strain AP-GKY by Kerry Ingredients & Flavours Ltd. The production strain met the requirements for the qualified presumption of safety (QPS). The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in six food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining five food manufacturing processes. It was estimated to be up to 7.99 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 subtilisin to known allergens was made and matches with three food, twenty respiratory and three contact allergens were found. The Panel considered that the risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded. 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.