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, Van Loveren Henk, Vernis Laurence, Cavanna Daniele, Liu Yi
EFSA J. 2025 Jul 10;23(7):e9559. doi: 10.2903/j.efsa.2025.9559. eCollection 2025 Jul.
The food enzyme β-galactosidase (β-d-galactoside galactohydrolase, EC 3.2.1.23) is produced with the genetically modified strain TOL by DSM Food Specialties B.V. 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 one food manufacturing process. Subsequently, the applicant has requested to extend its use to include two additional processes. In the present assessment, EFSA has updated the safety evaluation of this food enzyme when used in a total of three food manufacturing processes. The dietary exposure was calculated to be up to 3.144 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1038 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 330. Based on 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β-半乳糖苷酶（β-D-半乳糖苷半乳糖水解酶，EC 3.2.1.23）由帝斯曼食品特种产品公司使用转基因菌株TOL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，该食品酶在一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两种工艺。在本次评估中，欧洲食品安全局更新了对该食品酶在总共三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3.144毫克总有机硫/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1038毫克总有机硫/千克体重，测试的最高剂量）相结合，专家小组得出的暴露边际至少为330。基于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，该食品酶不会引发安全问题。
