欧盟评估转基因地衣芽孢杆菌菌株NZYM-BC生产的α-淀粉酶的安全性

 

　　据了解，这种食品酶是由转基因地衣芽孢杆菌菌株NZYM-BC生产的，旨在用于生产葡萄糖浆和其他淀粉水解产物的淀粉加工、蒸馏酒精生产、酿造过程、谷物加工、精制和未精制糖生产以及果汁生产的水果和蔬菜加工。

 

　　经过评估，专家小组认为，在预期的使用条件下，不能排除饮食暴露引起过敏和诱发反应的风险，但这种情况发生的可能性很低。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 glucanhydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM-BC by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain was shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was free from viable cells of the production organism and its DNA. It is intended to be used in six food manufacturing processes, namely starch processing for the production of glucose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, cereal-based processes, refined and unrefined sugar production and fruit and vegetable processing for juice production. Since the residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated for these two food manufacturing processes. For the remaining four processes, the dietary exposure to the food enzyme–TOS was estimated to be up to 0.05 mg TOS/kg body weight per day in European populations. Genotoxicity tests did not raise safety concern. The similarity of the amino acid sequence of the food enzyme to those of known allergens was searched and one match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood was considered to be 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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