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. 2024 Dec 18;22(12):e9166. doi: 10.2903/j.efsa.2024.9166. eCollection 2024 Dec.
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified strain NZYM-AL by Novozymes A/S. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended conditions of use, this food enzyme did not give rise to safety concerns. Due to the implementation of a new methodology to estimate the dietary exposure to food enzymes in 2016, the European Commission requested EFSA to revise the exposure assessment of this food enzyme by using this new methodology. In this assessment, EFSA realigned the intended uses of this food enzyme to four food manufacturing processes. The dietary exposure was calculated to be up to 0.089 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (49.1 mg TOS/kg bw per day, the lowest dose tested), the Panel derived a margin of exposure of at least 552. Based on the revised exposure estimate, the margin of exposure calculated thereof and the previous evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the 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）由诺维信公司（Novozymes A/S）的转基因菌株NZYM-AL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，在预期使用条件下，该食品酶不存在安全问题。由于2016年实施了一种估计食品酶膳食暴露量的新方法，欧盟委员会要求欧洲食品安全局使用这种新方法对该食品酶的暴露评估进行修订。在此评估中，欧洲食品安全局将该食品酶的预期用途调整为四种食品制造工艺。经计算，欧洲人群的膳食暴露量高达每天0.089毫克三酰甘油脂肪酶/千克体重。将其与先前报告的未观察到不良反应水平（每天49.1毫克三酰甘油脂肪酶/千克体重，测试的最低剂量）相结合，专家小组得出的暴露限值至少为552。基于修订后的暴露估计值、由此计算出的暴露限值以及先前的评估，专家小组得出结论，在预期使用条件下，该食品酶不存在安全问题。
