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
EFSA J. 2025 Jun 18;23(6):e9489. doi: 10.2903/j.efsa.2025.9489. eCollection 2025 Jun.
The food enzyme mannan endo-1,4-β-mannosidase (1,4-β-d-mannan mannanohydrolase; EC 3.2.1.78) is produced with the non-genetically modified microorganism strain AE-HCM 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 three food manufacturing processes. Subsequently, the applicant requested to extend its use to include ten additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of 13 food manufacturing processes. As the food enzyme-total organic solids (TOS) are not carried into the final foods in one food manufacturing process, the dietary exposure to the food enzyme-TOS was estimated for the remaining 12 processes. The dietary exposure was calculated to be up to 0.586 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (728 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 1242. Based on the new data, the revised 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.
食品酶甘露聚糖内切-1,4-β-甘露糖苷酶（1,4-β-D-甘露聚糖甘露水解酶；EC 3.2.1.78）由天野酶制剂公司使用非转基因微生物菌株AE-HCM生产。此前已对这种食品酶进行了安全性评估，欧洲食品安全局（EFSA）得出结论，该食品酶在三种食品制造工艺中使用时不会引起安全问题。随后，申请人请求将其使用范围扩大到另外十种工艺。在本次评估中，EFSA更新了该食品酶在总共13种食品制造工艺中使用时的安全性评估。由于在一种食品制造工艺中食品酶的总有机固体（TOS）不会带入最终食品中，因此对其余12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高达每天0.586毫克TOS/千克体重（bw）。将其与先前报告的未观察到不良影响水平（每天728毫克TOS/千克bw，测试的最高剂量）相结合，专家小组得出的暴露边际至少为1242。基于新数据、修订后的暴露边际和先前的评估，专家小组得出结论，在修订后的预期使用条件下，这种食品酶不会引起安全问题。
