Lambré Claude, Barat Baviera José Manuel, Bolognesi Claudia, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lampi Evgenia, Mengelers Marcel, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Roos Yrjö, Liu Yi, Marini Eleonora, di Piazza Giulio, Chesson Andrew
EFSA J. 2024 Apr 10;22(4):e8697. doi: 10.2903/j.efsa.2024.8697. eCollection 2024 Apr.
The food enzyme -glucosidase (-d-glucoside glucohydrolase; EC 3.2.1.20) is produced with the non-genetically modified strain AE-TGU 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 four food manufacturing processes. Subsequently, the applicant 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 seven food manufacturing processes. The dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.693 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1062 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 1532. Based on the data provided for the previous evaluation and the revised margin of exposure, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.
食品酶β-葡萄糖苷酶（β-D-葡萄糖苷葡糖水解酶；EC 3.2.1.20）由天野酶制剂公司使用非转基因菌株AE-TGU生产。此前已对该食品酶进行了安全性评估，欧洲食品安全局（EFSA）在评估中得出结论，该食品酶在四种食品制造工艺中使用时不会引发安全问题。随后，申请人请求将其使用范围扩大至另外三种工艺。在本次评估中，EFSA对该食品酶在总共七种食品制造工艺中的使用进行了安全性评估更新。据估计，欧洲人群通过膳食摄入该食品酶总有机固体（TOS）的量最高可达每天0.693毫克TOS/千克体重（bw）。将此摄入量与先前报告的未观察到不良影响水平（每天1062毫克TOS/千克bw，为所测试的最高剂量）相结合，专家小组得出的暴露边际至少为1532。根据先前评估提供的数据以及修订后的暴露边际，专家小组得出结论，在修订后的预期使用条件下，该食品酶不会引发安全问题。
