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, Van Loveren Henk, Vernis Laurence, Aguilera Jaime, Andryszkiewicz Magdalena, Cavanna Daniele, Kovalkovičová Natália, Liu Yi
EFSA J. 2025 Jul 14;23(7):e9530. doi: 10.2903/j.efsa.2025.9530. eCollection 2025 Jul.
The food enzyme AMP deaminase (AMP aminohydrolase; EC 3.5.4.6) is produced with the non-genetically modified strain AE-DN by Amano Enzyme Inc. The food enzyme was free from viable cells of the production organism. It is intended to be used in the processing of yeast and yeast products. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.030 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 152 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 5067. A search for the homology of the amino acid sequence of the AMP deaminase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon 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AMP脱氨酶（AMP氨基水解酶；EC 3.5.4.6）由天野酶制剂公司使用非转基因菌株AE-DN生产。该食品酶不含生产生物的活细胞。它拟用于酵母和酵母产品的加工。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0.030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152毫克TOS/千克bw，这是测试的最高剂量，与估计的饮食接触量相比，得出的接触范围至少为5067。对AMP脱氨酶的氨基酸序列与已知过敏原进行了同源性搜索，未发现匹配项。专家小组认为，不能排除饮食接触该食品酶后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，在预期的使用条件下，这种食品酶不会引起安全问题。
