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, Roos Yrjö, Andryszkiewicz Magdalena, Liu Yi, Lunardi Simone, Nielsen Elsa, Nørby Karin, Chesson Andrew
EFSA J. 2023 Jan 16;21(1):e07753. doi: 10.2903/j.efsa.2023.7753. eCollection 2023 Jan.
The food enzyme glucan 1,4-α-glucosidase (4--d-glucan glucohydrolase; EC 3.2.1.3) is produced with the non-genetically modified strain AE-G by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. The applicant proposed the use of the food enzyme in baking processes, coffee processing and manufacture of enzymatically modified dairy ingredients (EMDI). The Panel considered only the baking processes as the relevant intended use of this food enzyme. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.94 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 a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,868 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1,987. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one 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 is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns when used in baking processes under the intended conditions of use.
食品酶葡聚糖1,4-α-葡糖苷酶（4-α-D-葡聚糖葡糖水解酶；EC 3.2.1.3）由天野酶制剂公司使用非转基因菌株AE-G生产。该食品酶不含生产生物体的活细胞。申请人提议将该食品酶用于烘焙过程、咖啡加工以及酶法改性乳制品配料（EMDI）的生产。专家小组仅将烘焙过程视为该食品酶的相关预期用途。据估计，欧洲人群通过饮食接触该食品酶的总有机固体（TOS）最高可达每天0.94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1,868毫克TOS/千克bw，这是所测试的最高剂量，与估计的饮食接触量相比，得出的接触范围至少为1,987。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，发现了一个匹配项。专家小组认为，在预期使用条件下，不能排除因饮食接触而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，该食品酶用于烘焙过程时不会引发安全担忧。
