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, Kovalkovičová Natália, Cavanna Daniele, Fernàndez-Fraguas Cristina, Lunardi Simone, Peluso Silvia, Liu Yi
EFSA J. 2025 Jul 14;23(7):e9561. doi: 10.2903/j.efsa.2025.9561. eCollection 2025 Jul.
The food enzyme aspergillopepsin I (EC 3.4.23.18) is produced with the non-genetically modified sp. strain AE-PRHF by AMANO ENZYME INC. The food enzyme was free from viable cells of the production organism. It is intended to be used in 15 food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in two processes, dietary exposure was calculated for the remaining 13 food manufacturing processes. It was estimated to be up to 2.172 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 2003 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 922. A search for the homology of the amino acid sequence of the aspergillopepsin I to known allergens was made and matches with three respiratory allergens and one injected allergen were 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.
食品酶曲霉胃蛋白酶I（EC 3.4.23.18）由天野酶制剂公司使用非转基因的曲霉属菌株AE-PRHF生产。该食品酶不含生产生物体的活细胞。它拟用于15种食品制造工艺。由于在两种工艺中可去除食品酶总有机固体（TOS）的残留量，因此针对其余13种食品制造工艺计算了膳食暴露量。据估计，欧洲人群的膳食暴露量高达每天2.172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2003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，得出的暴露边际至少为922。对曲霉胃蛋白酶I的氨基酸序列与已知过敏原进行了同源性搜索，发现与三种呼吸道过敏原和一种注射用过敏原匹配。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，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。
