Lambré Claude, Barat Baviera José Manuel, 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, Andryszkiewicz Magdalena, Liu Yi, Lunardi Simone, Nielsen Elsa, Nørby Karin, Chesson Andrew
EFSA J. 2023 Jan 18;21(1):e07756. doi: 10.2903/j.efsa.2023.7756. eCollection 2023 Jan.
The food enzyme triacylglycerol lipase (EC 3.1.1.3) is produced with the non-genetically modified strain AE-N by Amano Enzyme Inc. It is considered free from viable cells of the production organism. The food enzyme is intended to be used in an immobilised form in the modification of fats and oils by interesterification. Since residual amounts of total organic solids (TOS) are removed during refinement of the fats and oils, dietary exposure was not calculated. Genotoxicity tests did not indicate 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 1,806 mg TOS/kg body weight (bw) per day, the highest dose tested. 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 for this to occur 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（EC 3.1.1.3）由天野酶制剂公司使用非转基因菌株AE-N生产。该食品酶被认为不含有生产菌株的活细胞。这种食品酶旨在以固定化形式用于油脂的酯交换改性。由于在油脂精炼过程中会去除总有机固体（TOS）的残留量，因此未计算膳食暴露量。遗传毒性试验未表明存在安全问题。通过对大鼠进行为期90天的重复剂量口服毒性研究来评估全身毒性。专家小组确定未观察到有害作用水平为每天1806毫克TOS/千克体重（bw），这是测试的最高剂量。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，不能排除因膳食暴露引起过敏反应的风险，但发生这种情况的可能性较低。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问题。
