Safety evaluation of an extension of use of the food enzyme glucose oxidase from the genetically modifiedstrain‐

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

Abstract The food enzyme glucose oxidase (β‐‐glucose:oxygen 1‐oxidoreductase; EC 1.1.3.4) is produced with the genetically modifiedstrain NZYM‐KP 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 one food manufacturing process. Subsequently, the applicant has requested to extend its use to include three additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of four food manufacturing processes. The dietary exposure was estimated to be up to 0.197 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 (341 mg TOS/kg bw per day), the Panel derived a margin of exposure of at least 1731. 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.