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 Jan 29;23(1):e9225. doi: 10.2903/j.efsa.2025.9225. eCollection 2025 Jan.
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified strain LFS 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 one additional process. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of two food manufacturing processes. The dietary exposure was calculated to be up to 0.110 mg total organic solids (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 9436. 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.
食品酶三酰甘油脂肪酶（三酰甘油酰基水解酶，EC 3.1.1.3）由帝斯曼食品特种产品有限公司使用转基因菌株LFS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）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，申请人请求扩大其使用范围，将另一种工艺也涵盖在内。在本次评估中，欧洲食品安全局对该食品酶在总共两种食品制造工艺中的使用安全性评估进行了更新。经计算，欧洲人群的膳食暴露量高达每天0.110毫克总有机固体（TOS）/千克体重（bw）。将其与先前报告的未观察到不良反应水平（每天1038毫克TOS/千克bw，为测试的最高剂量）相结合，专家小组得出的暴露边际至少为9436。基于新数据、修订后的暴露边际以及先前的评估，专家小组得出结论，在修订后的预期使用条件下，这种食品酶不会引发安全问题。
