Lambré Claude, Baviera José Manuel Barat, Bolognesi Claudia, Cocconcelli Pier Sandro, Crebelli Riccardo, Gott David Michael, Grob Konrad, Lampi Evgenia, Mengelers Marcel, Mortensen Alicja, Rivière Gilles, Steffensen Inger-Lise, Tlustos Christina, Van Loveren Henk, Vernis Laurence, Zorn Holger, Glandorf Boet, Herman Lieve, Aguilera Jaime, Andryszkiewicz Magdalena, Kovalkovicova Natalia, Liu Yi, di Piazza Giulio, de Sousa Rita Ferreira, Chesson Andrew
EFSA J. 2023 Jan 19;21(1):e07755. doi: 10.2903/j.efsa.2023.7755. eCollection 2023 Jan.
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non-genetically modified strain AE-LMH by Amano Enzyme Inc. The food enzyme is considered free from viable cells of the production organism. The food enzyme is intended to be used in baking processes, egg processing and the manufacture of enzyme-modified dairy ingredients (EMDI). Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.242 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 784 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 3,240. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood of such reactions 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）由天野酶制剂公司使用非转基因菌株AE-LMH生产。该食品酶被认为不含有生产生物体的活细胞。该食品酶拟用于烘焙工艺、蛋类加工以及酶改性乳制品成分（EMDI）的制造。据估计，欧洲人群通过膳食接触该食品酶的总有机固体（TOS）量高达每天0.242毫克TOS/千克体重（bw）。遗传毒性试验未引发安全担忧。通过对大鼠进行的90天重复剂量经口毒性研究评估了全身毒性。专家小组确定未观察到有害作用水平为每天784毫克TOS/千克bw，这是测试的最高剂量，与估计的膳食接触量相比，得出的接触界限至少为3240。对该食品酶的氨基酸序列与已知过敏原进行了相似性搜索，未发现匹配项。专家小组认为，在预期的使用条件下，不能排除通过膳食接触引发过敏反应的风险，但此类反应的可能性较低。根据所提供的数据，专家小组得出结论，在预期的使用条件下，这种食品酶不会引起安全担忧。
