Revised safety evaluation of the food enzyme leucyl aminopeptidase from the non-genetically modified Aspergillus sp. strain AE-MB

Abstract

The food enzyme leucyl aminopeptidase (EC 3.4.11.1) is produced with the non-genetically modified Aspergillus sp. strain AE-MB by Amano Enzyme Inc. In a previous evaluation, the Panel concluded that the food enzyme could not be considered safe when used in five food manufacturing processes, due to insufficient margins of exposure estimated for all age groups. Subsequently, the applicant requested to withdraw one use, to include three additional food manufacturing processes, and to revise the use levels. In the present assessment, EFSA revised the safety evaluation of this food enzyme when used in a total of seven food manufacturing processes. The dietary exposure to the food enzyme–total organic solids (TOS) was calculated to be up to 0.367 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level reported in the previous opinion (183 mg TOS/kg bw per day, the lowest dose tested), the revised margin of exposure was at least 499. Having integrated new data into the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.