Safety evaluation of an extension of use of the food enzyme pullulanase from the genetically modifiedstrain‐

Source: PubMed Central Open Access, NCBI / U.S. National Library of Medicine

Abstract The food enzyme pullulanase (pullulan 6‐α‐glucanohydrolase, EC 3.2.1.41) is produced with the genetically modifiedstrain NZYM‐LU 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 two food manufacturing processes. Subsequently, the applicant has requested to extend its use to include three additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of five food manufacturing processes. As the food enzyme–Total Organic Solids (TOS) are removed from the final foods in two processes, the dietary exposure to the food enzyme–TOS was estimated for the remaining three food manufacturing processes. It was calculated to be up to 1.394 mg TOS/kg body weight per day in European populations. Based on the revised exposure estimation 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.