Zorn Holger, Barat Baviera José Manuel, Bolognesi Claudia, Catania Francesco, Gadermaier Gabriele, Greiner Ralf, Mayo Baltasar, Mortensen Alicja, Roos Yrjö Henrik, Solano Marize L M, Sramkova Monika, Van Loveren Henk, Vernis Laurence, Cavanna Daniele, de Sousa Rita Ferreira, Liu Yi
EFSA J. 2024 Oct 7;22(10):e9040. doi: 10.2903/j.efsa.2024.9040. eCollection 2024 Oct.
The food enzyme β-glucosidase (β-d-glucoside glucohydrolase, EC 3.2.1.21) is produced with the non-genetically modified strain AE-GLY 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 has requested to extend its use to include three additional processes and to revise the use levels. 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 was calculated to be up to 0.206 mg total organic solids (TOS)/kg body weight (bw) per day in European populations. Using the no observed adverse effect level reported in the previous opinion (943 mg TOS/kg bw per day), the Panel derived a margin of exposure of at least 4578. Based on the previous evaluation, the assessment of the new data 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 3.2.1.21）由天野酶制剂公司使用非转基因菌株AE-GLY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）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，并修订使用水平。在本次评估中，欧洲食品安全局更新了该食品酶在总共七种食品制造工艺中使用时的安全性评估。经计算，欧洲人群的膳食暴露量高达每天0.206毫克总有机固体（TOS）/千克体重（bw）。根据上一份意见报告的未观察到不良影响水平（每天943毫克TOS/千克bw），专家小组得出的暴露边际至少为4578。基于之前的评估、新数据的评估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。
