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, Liu Yi, de Nijs Roos Anna, di Piazza Giulio
EFSA J. 2024 Jul 31;22(7):e8948. doi: 10.2903/j.efsa.2024.8948. eCollection 2024 Jul.
The food enzyme α-amylase (4-α-d-glucan glucanohydrolase i.e. EC 3.2.1.1) is produced with the non-genetically modified strain AE-AMT by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that the food enzyme 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 three additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of ten food manufacturing processes. As the food enzyme-total organic solids (TOS) are removed from the final foods in one food manufacturing process, the dietary exposure to the food enzyme-TOS was estimated only for the remaining nine processes. The dietary exposure was calculated to be up to 0.049 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (230 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 4694. Based on the data provided for the previous evaluation and the revised margin of exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
食品酶α-淀粉酶（4-α-D-葡聚糖葡聚糖水解酶，即EC 3.2.1.1）由天野酶制剂公司使用非转基因菌株AE-AMT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，该食品酶在七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对该食品酶在总共十种食品制造工艺中的使用安全性评估进行了更新。由于在一种食品制造工艺中，食品酶中的总有机固体（TOS）会从最终食品中去除，因此仅对其余九种工艺中食品酶-TOS的膳食暴露量进行了估算。经计算，欧洲人群的膳食暴露量最高可达每天0.049毫克TOS/千克体重（bw）。将此暴露量与先前报告的未观察到不良影响水平（每天230毫克TOS/千克bw，即测试的最高剂量）相结合，专家小组得出的暴露限量至少为4694。基于先前评估提供的数据以及本次评估中修订后的暴露限量，专家小组得出结论，该食品酶在预期使用条件下不会引发安全问题。
