Safety evaluation of an extension of use of the food enzyme subtilisin from the genetically modified Bacillus licheniformis strain NZYM‐CB

Abstract The food enzyme subtilisin (EC 3.4.21.62) is produced with the genetically modified Bacillus licheniformis strain NZYM‐CB by Novozymes A/S. The safety of this food enzyme was evaluated previously and it did not give rise to safety concerns when used in six food manufacturing processes. Subsequently, the applicant has requested to extend its use to three additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of nine food manufacturing processes. As the food enzyme–total organic solids (TOS) are removed in two processes, the dietary exposure to the food enzyme–TOS was estimated for the remaining seven food manufacturing processes. It was calculated to be up to 1.391 mg TOS/kg body weight per day in European populations. Based on the revised dietary exposure and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.