Safety evaluation of an extension of use of the food enzyme mannan endo-1,4-β-mannosidase from the non-genetically modified Aspergillus niger strain AE-HCM

The food enzyme mannan endo-1,4-β-mannosidase (1,4-β-d-mannan mannanohydrolase; EC 3.2.1.78) is produced with the non-genetically modified microorganism Aspergillus niger strain AE-HCM by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in three food manufacturing processes. Subsequently, the applicant requested to extend its use to include ten additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of 13 food manufacturing processes. As the food enzyme–total organic solids (TOS) are not carried into the final foods in one food manufacturing process, the dietary exposure to the food enzyme–TOS was estimated for the remaining 12 processes. The dietary exposure was calculated to be up to 0.586 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (728 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 1242. 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.