Safety evaluation of an extension of use of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM‐AL

Abstract The food enzyme triacylglycerol lipase (EC 3.1.1.3) is produced with the genetically modified Aspergillus oryzae strain NZYM‐AL 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 four food manufacturing processes. Subsequently, the applicant has requested to extend its use to include six additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of ten food manufacturing processes. As the food enzyme‐total organic solids (TOS) are removed in one food manufacturing process, the dietary exposure to the food enzyme–TOS was estimated for the remaining nine processes to be up to 0.093 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (49.1 mg TOS/kg bw per day, the lowest dose tested), the Panel derived a margin of exposure of at least 528. Based on the new data, the revised 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.