Abstract
Abstract The food enzyme α‐amylase (4‐α‐d‐glucan glucanohydrolase, EC 3.2.1.1) is produced with the genetically modified Aspergillus niger strain NZYM‐MC 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 three food manufacturing processes. Subsequently, the applicant has requested to extend its use to include one additional process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of four 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 two food manufacturing processes. It was calculated to be up to 3.524 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1400 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 397. Based on the revised exposure estimation, the newly derived margin of 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.