The food enzyme catalase (hydrogen-peroxide:hydrogen-peroxide oxidoreductase; EC 1.11.1.6) is produced with the non-genetically modified Aspergillus niger strain CTS2093 by Shin Nihon Chemical Co., Ltd. In a previous evaluation, the Panel could not exclude safety concerns due to an insufficient margin of exposure (MoE). As a follow-up, the applicant updated the intended uses, conducted an in vitro micronucleus test using a new food enzyme batch and updated the homology search for allergenicity. In the present evaluation, the dietary exposure was calculated to be up to 0.032 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 (56 mg TOS/kg bw per day), the Panel derived an MoE of at least 1750. based on the new data, the revised MoE and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
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