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, Cavanna Daniele, Aguilera Jaime, Andryszkiewicz Magdalena, Kovalkovicova Natalia, Marini Eleonora, Pesce Francesco, di Piazza Giulio, Liu Yi
EFSA J. 2025 Apr 8;23(4):e9334. doi: 10.2903/j.efsa.2025.9334. eCollection 2025 Apr.
The food enzyme glucan 1,4-α-glucosidase (4-α-d-glucan α-glucohydrolase; EC 3.2.1.3) is produced with the non-genetically modified strain AGME 1415 by ENMEX SA de CV, a Kerry Company. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in seven 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 five processes. It was estimated to be up to 7.143 mg TOS/kg body weight 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 body weight (bw) per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 280. A search for the homology of the amino acid sequence of the glucan 1,4--glucosidase to known allergens was made and one match with a respiratory allergen was found. The Panel considered that a risk of allergic reactions by dietary exposure to the food enzyme cannot be excluded, but that 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1,4-α-葡聚糖苷酶（4-α-D-葡聚糖α-葡糖苷水解酶；EC 3.2.1.3）由嘉利公司旗下的ENMEX SA de CV采用非转基因菌株AGME 1415生产。该食品酶被认为不含有生产微生物的活细胞。它拟用于七种食品制造工艺。由于在两种食品制造工艺中会去除食品酶中的残留总量有机固体（TOS），因此仅针对其余五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7.143毫克TOS/千克体重。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。专家小组确定未观察到有害作用水平为每天2000毫克TOS/千克体重（bw），这是测试的最高剂量，与估计的膳食暴露量相比，得出的暴露边际至少为280。对1,4-α-葡聚糖苷酶的氨基酸序列与已知过敏原进行了同源性搜索，发现与一种呼吸道过敏原存在一个匹配项。专家小组认为，不能排除因膳食接触该食品酶而发生过敏反应的风险，但可能性较低。根据所提供的数据，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。
