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, de Nijs Roos Anna, Andryszkiewicz Magdalena, Cavanna Daniele, Liu Yi
EFSA J. 2025 Jan 29;23(1):e9223. doi: 10.2903/j.efsa.2025.9223. eCollection 2025 Jan.
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non-genetically modified strain AE-LAYH (B) 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 six food manufacturing processes. Subsequently, the applicant has requested to revise the use levels for three food manufacturing processes. In this assessment, EFSA updated the dietary exposure assessment of this food enzyme when used in six food manufacturing processes at the revised use levels. 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 for the remaining five processes. It was calculated to be up to 0.220 mg TOS/kg body weight (bw) per day in European populations. Based on the new data, the revised exposure estimation 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）由天野酶制剂公司使用非转基因菌株AE-LAYH (B) 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，该食品酶在六种食品制造工艺中使用时不会引发安全问题。随后，申请人请求修订三种食品制造工艺的使用水平。在本次评估中，欧洲食品安全局更新了该食品酶在六种食品制造工艺中按修订后的使用水平使用时的膳食暴露评估。由于在一种食品制造工艺中食品酶的总有机固体（TOS）会从最终食品中去除，因此对其余五种工艺中食品酶-TOS的膳食暴露进行了估计。经计算，欧洲人群每天的膳食暴露量高达0.220毫克TOS/千克体重（bw）。基于新数据、修订后的暴露估计以及之前的评估，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。
