Safety evaluation of a second extension of use of the food enzyme thermolysin from the non‐genetically modifiedstrain‐

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

Abstract The food enzyme thermolysin (EC. 3.4.24.27) is produced with the non‐genetically modifiedstrain AE‐TP by Amano Enzyme Inc. The safety of this food enzyme was evaluated previously, and it did not give rise to safety concerns when used in seven food manufacturing processes. Subsequently, the applicant has requested to extend its use to include one additional process and to revise the use levels. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of eight food manufacturing processes. Dietary exposure was calculated to be up to 0.930 mg Total Organic Solids (TOS)/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (700 mg TOS/kg bw per day), the Panel derived a margin of exposure of at least 753. 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.