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, Aguilera Jaime, Andryszkiewicz Magdalena, Daniele Cavanna Kyriaki Apergi, Fernàndez-Fraguas Cristina, Kovalkovicova Natalia, Peluso Silvia, di Piazza Giulio, Liu Yi, Chesson Andrew
EFSA J. 2024 May 15;22(5):e8780. doi: 10.2903/j.efsa.2024.8780. eCollection 2024 May.
The food enzyme -amylase (4--d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified microorganism strain AE-TA by Amano Enzyme Inc. The food enzyme is intended to be used in eight food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two food manufacturing processes, dietary exposure was calculated only for the remaining six processes. It was estimated to be up to 0.056 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme fulfils the requirements for the qualified presumption of safety approach to safety assessment. Consequently, in the absence of other concerns, the Panel considered that toxicological studies were not needed for the safety assessment of this food enzyme. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded (except for the production of distilled alcohol), 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微生物菌株AE-TA生产。该食品酶拟用于八种食品制造工艺。由于在两种食品制造工艺中可去除食品酶的残留量——总有机固体（TOS），因此仅针对其余六种工艺计算膳食暴露量。据估计，欧洲人群的膳食暴露量高达每天0.056毫克TOS/千克体重。该食品酶的生产菌株符合安全评估合格假定方法的要求。因此，在不存在其他问题的情况下，专家小组认为该食品酶的安全性评估无需进行毒理学研究。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，发现了与呼吸道过敏原的两个匹配项。专家小组认为，不能排除膳食接触该食品酶后发生过敏反应的风险（蒸馏酒精生产除外），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，该食品酶不会引起安全问题。
