欧盟评估非转基因黑曲霉菌株NZYM-BO生产的葡聚糖1，4-α-葡萄糖苷酶的安全性

 

　　据了解，这种食品酶是由非转基因黑曲霉菌株NZYM-BO生产的，旨在用于七种食品制造过程：烘焙过程、酿造过程、谷物加工、蒸馏酒精生产、果汁生产中的水果和蔬菜加工、乳制品类似物的生产以及生产葡萄糖浆和其他淀粉水解产物的淀粉加工。

 

　　经过评估，专家小组认为，在预期的使用条件下，不能排除饮食暴露引起过敏反应的风险（蒸馏酒精生产除外），但这种情况发生的可能性很低。根据所提供的数据，小组得出结论，该食品酶在预期的使用条件下不会引起安全隐患。部分原文报道如下：

 

　　The food enzyme glucan 1,4-α-glucosidase (4-α-d-glucan α-glucohydrolase; EC 3.2.1.3) is produced with the non-genetically modified Aspergillus niger strain NZYM-BO 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: baking processes, brewing processes, cereal-based processes, distilled alcohol production, fruit and vegetable processing for juice production, production of dairy analogues and starch processing for the production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by distillation and during starch processing, dietary exposure was not calculated for these two food manufacturing processes. For the remaining five food manufacturing processes, dietary exposure to the food enzyme–TOS was estimated to be up to 2.97?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 1,920?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 646. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure to this food enzyme cannot be excluded (except for distilled alcohol production), 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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