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, Herman Lieve, Roos Yrjö, Andryszkiewicz Magdalena, Gomes Ana, Kovalkovicova Natalia, Liu Yi, Chesson Andrew
EFSA J. 2023 Oct 18;21(10):e08260. doi: 10.2903/j.efsa.2023.8260. eCollection 2023 Oct.
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the genetically modified strain FL108SC by Advanced Enzyme Technologies Ltd. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in an immobilised form for the production of modified fats and oils by interesterification. Genotoxicity tests did not raise safety concerns. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rodents. The Panel identified a no observed adverse effect level (NOAEL) at the highest dose of 774 mg TOS/kg body weight per day. As the food enzyme is used in an immobilised form and as any residual amounts of the food enzyme-total organic solids (TOS) are removed during the food manufacturing process, dietary exposure was not calculated. 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 a risk of allergic reactions upon dietary exposure cannot be excluded, but 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Advanced Enzyme Technologies Ltd.使用转基因菌株FL108SC生产。基因改造不存在安全问题。该食品酶不含生产生物体的活细胞及其DNA。它拟以固定化形式用于通过酯交换反应生产改性油脂。遗传毒性试验未引发安全问题。通过在啮齿动物中进行的重复剂量90天口服毒性研究评估了全身毒性。专家小组确定在最高剂量774毫克三酰甘油脂肪酶/千克体重/天时未观察到不良影响水平（NOAEL）。由于该食品酶以固定化形式使用，并且在食品制造过程中会去除食品酶总有机固体（TOS）的任何残留量，因此未计算膳食暴露量。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，不能排除膳食暴露时发生过敏反应的风险，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。
