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, Lunardi Simone, Andryszkiewicz Magdalena, Kovalkovicova Natalia, Liu Yi
EFSA J. 2025 Mar 10;23(3):e9286. doi: 10.2903/j.efsa.2025.9286. eCollection 2025 Mar.
The food enzyme aspergillopepsin I (EC 3.4.23.18) is produced with the non-genetically modified strain APTC 3C-290 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production organism. 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 processes, dietary exposure was calculated only for the remaining six food manufacturing processes. It was estimated to be up to 1.699 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 two repeated dose 90-day oral toxicity studies in rats. The two test items have been obtained by submerged culture and by solid state fermentation, respectively. The Panel used the lowest of the two no observed adverse effect levels (1600 mg TOS/kg bw per day, the highest dose tested of the batch obtained by submerged culture), which when compared with the estimated dietary exposure, results in a margin of exposure of at least 942. A search for the homology of the amino acid sequence of the aspergillopepsin I to known allergens was made and three matches with respiratory allergens and one match with a dermal allergen were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme 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.
食品酶曲霉胃蛋白酶I（EC 3.4.23.18）由日本新日化学有限公司使用非转基因菌株APTC 3C - 290生产。该食品酶不含生产生物体的活细胞。该食品酶拟用于八种食品制造工艺。由于在两种工艺中可去除食品酶总有机固体（TOS）的残留量，因此仅针对其余六种食品制造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1.699毫克TOS/千克体重（bw）。遗传毒性试验未表明存在安全问题。通过对大鼠进行两项重复剂量的90天口服毒性研究来评估全身毒性。这两种测试项目分别通过深层培养和固态发酵获得。专家小组采用了两个未观察到不良影响水平中的最低值（每天1600毫克TOS/千克bw，这是通过深层培养获得的批次的最高测试剂量），与估计的膳食暴露量相比，得出的暴露边际至少为942。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，发现与呼吸道过敏原匹配三项，与皮肤过敏原匹配一项。专家小组认为，不能排除膳食接触该食品酶时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，在预期使用条件下，这种食品酶不会引起安全问题。
