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, Gomes Ana, Liu Yi, Rainieri Sandra, Chesson Andrew
EFSA J. 2022 Aug 3;20(8):e07463. doi: 10.2903/j.efsa.2022.7463. eCollection 2022 Aug.
The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified strain AE-AMT by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in starch processing for maltotriose production. Since residual amounts of total organic solids (TOS) are removed by purification steps applied during starch processing, the estimation of a dietary exposure is considered unnecessary. 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 at the highest dose of 230 mg TOS/kg body weight (bw) per day. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and nine matches were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is considered 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α-淀粉酶（4-α-D-葡聚糖葡聚糖水解酶；EC 3.2.1.1）由天野酶制剂公司使用非转基因菌株AE-AMT生产。该食品酶不含生产生物体的活细胞。它旨在用于淀粉加工以生产麦芽三糖。由于在淀粉加工过程中应用的纯化步骤可去除总有机固体（TOS）的残留量，因此认为无需估计膳食暴露量。遗传毒性试验未表明存在安全问题。通过对大鼠进行的为期90天的重复剂量口服毒性研究评估了全身毒性。专家小组确定在最高剂量为每天230毫克TOS/千克体重（bw）时未观察到不良影响水平。对该食品酶的氨基酸序列与已知过敏原的氨基酸序列进行了相似性搜索，发现了9个匹配项。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致敏和激发反应的风险，但可能性较低。根据提供的数据，专家小组得出结论，该食品酶在预期的使用条件下不会引起安全问题。
