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, Aguilera Jaime, Andryszkiewicz Magdalena, Cavanna Daniele, Liu Yi
EFSA J. 2025 Jul 14;23(7):e9546. doi: 10.2903/j.efsa.2025.9546. eCollection 2025 Jul.
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the genetically modified strain DSM 34125 by Chr. Hansen. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in four food manufacturing processes. Dietary exposure was estimated to be up to 0.039 mg total organic solids (TOS)/kg body weight per day in European populations. Given the qualified presumption of safety status of the production strain and the absence of concerns resulting from the food enzyme manufacturing process, toxicity tests were considered unnecessary by the Panel. A search for the homology of the amino acid sequence of the triacylglycerol lipase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but that the likelihood is low. Based on the data provided, 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）由科汉森公司通过基因改造菌株DSM 34125生产。基因改造不存在安全问题。该食品酶被认为不含有生产生物体的活细胞及其DNA。该食品酶拟用于四种食品制造工艺。据估计，欧洲人群的膳食暴露量高达每天0.039毫克总有机固体（TOS）/千克体重。鉴于生产菌株的安全合格推定状态以及食品酶制造过程不存在问题，专家小组认为无需进行毒性测试。对三酰甘油脂肪酶的氨基酸序列与已知过敏原进行了同源性搜索，未发现匹配项。专家小组认为，不能排除膳食暴露引起过敏反应的风险，但可能性较低。根据提供的数据，专家小组得出结论，在预期使用条件下，这种食品酶不存在安全问题。
