欧盟评估非转基因塔宾曲霉菌株AE-CN生产的过氧化氢酶的安全性

 

　　据了解，这种食品酶是由非转基因塔宾曲霉菌株AE-CN生产的，旨在用于五种食品生产过程：烘焙产品的生产、蛋和蛋制品的加工、果汁以外的水果和蔬菜产品的生产、奶酪的生产和鱼卵的生产。

 

　　经过评估，专家小组认为，在预期的使用条件下，不能排除通过饮食接触引起过敏反应的风险，但这种情况发生的可能性很低。由于遗传毒性研究的结果，并且没有证明生产菌株中没有活细胞，专家组无法确定食品酶的安全性。部分原文报道如下：

 

　　The food enzyme catalase (hydrogen-peroxide:hydrogen-peroxide oxidoreductase; EC 1.11.1.6) is produced with the non-genetically modified Aspergillus tubingensis strain AE-CN by Amano Enzyme Inc. The absence of viable cells of the production organism in the food enzyme was not demonstrated. The food enzyme is intended to be used in five food manufacturing processes: production of baked products, processing of egg and egg products, production of fruit and vegetable products other than juices, production of cheese and production of fish roes. The dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.325 mg TOS/kg body weight (bw) per day in European populations. The results of the in vitro genotoxicity studies indicated the presence of a clastogenic agent in the food enzyme which could not be dismissed due to limitations in the in vivo studies. 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 323 mg TOS/kg bw per day, the highest dose tested. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. Because of the results of the genotoxicity studies, and as the absence of viable cells from the production strain was not demonstrated, the Panel was unable to establish the safety of the food enzyme.

 

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