Zorn Holger, Barat Baviera José Manuel, Bolognesi Claudia, Catania Francesco, Gadermaier Gabriele, Greiner Ralf, Mayo Baltasar, Mortensen Alicja, Roos Yrjö Henrik, Solano Marize L M, Sramkova Monika, Van Loveren Henk, Vernis Laurence, Fernàndez-Fraguas Cristina, Andryszkiewicz Magdalena, Kovalkovicova Natalia, Marini Eleonora, Liu Yi
EFSA J. 2025 Jan 31;23(1):e9167. doi: 10.2903/j.efsa.2025.9167. eCollection 2025 Jan.
The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified sp. strain FUA by DSM Food Specialties B.V. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in four food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in the production of distilled alcohol, dietary exposure was calculated only for the remaining three food manufacturing processes. It was estimated to be up to 0.687 mg TOS/kg body weight (bw) per day in European populations. 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 2000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 2911. A search for the homology of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were found, one of which is also an oral allergen. Known sources of allergens were used in the food enzyme manufacturing process. The Panel considered that the 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α-淀粉酶（4-α-D-葡聚糖葡聚糖水解酶；EC 3.2.1.1）由帝斯曼食品特种产品有限公司使用非转基因的sp. 菌株FUA生产。该食品酶不含生产生物体的活细胞。该食品酶拟用于四种食品制造工艺。由于在蒸馏酒精生产过程中会去除食品酶总有机固体（TOS）的残留量，因此仅针对其余三种食品制造工艺计算膳食暴露量。据估计，欧洲人群每天的膳食暴露量高达0.687毫克TOS/千克体重（bw）。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2000毫克TOS/千克bw，这是测试的最高剂量，与估计的膳食暴露量相比，得出的暴露限值至少为2911。对该食品酶的氨基酸序列与已知过敏原进行了同源性搜索，发现与呼吸道过敏原匹配的有三种，其中一种也是口服过敏原。食品酶制造过程中使用了已知的过敏原来源。专家小组认为，不能排除膳食暴露引起过敏反应的风险，但可能性较低。根据提供的数据，专家小组得出结论，在预期的使用条件下，这种食品酶不会引起安全问题。
