欧盟评估非转基因米曲霉菌株NZYM-NA生产的α-淀粉酶的安全性

　　食品伙伴网讯  2023年3月30日，欧盟食品安全局就一种α-淀粉酶（α-amylase）的安全性评价发布意见。

 

　　据了解，这种食品酶是由非转基因米曲霉菌株NZYM-NA生产的，旨在用于七种食品制造过程：生产葡萄糖和麦芽糖糖浆及其他淀粉水解产物的淀粉加工、蒸馏酒精生产、酿造过程、烘焙过程、谷物加工、生产乳制品的植物加工以及生产果汁的水果和蔬菜加工。

 

　　经过评估，专家小组认为，在预期的使用条件下（蒸馏酒精生产除外），不能排除饮食暴露引起过敏反应的风险，但这种可能性被认为很低。根据所提供的数据，评估小组得出结论，这种食品酶在预期使用条件下不会引起安全问题。部分原文报道如下：

 

　　The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified Aspergillus oryzae strain NZYM-NA by Novozymes A/S. It was considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: starch processing for the production of glucose and maltose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, baking processes, cereal-based processes, plant processing for production of dairy analogues and fruit and vegetable processing for juice production. Since residual amounts of food enzyme–total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups and distillation, dietary exposure was not calculated for these processes. For the remaining five food manufacturing processes, dietary exposure was estimated to be up to 0.134?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 1,862?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 13,896. 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, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure 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.

 

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