欧盟评估转基因地衣芽孢杆菌菌株NZYM-AC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-AC生产的，旨在用于七种食品制造过程:加工谷物和其他谷物，以生产葡萄糖浆和其他淀粉水解产物，除烘焙、酿造产品和蒸馏酒精以外的谷物产品；加工水果和蔬菜以生产果汁和果汁以外的产品；精制糖和未精制糖的生产。

 

　　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 (1,4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM-AC by Novozymes A/S. The genetic modifications do not give rise to safety concerns and the production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in seven food manufacturing processes: processing of cereals and other grains for the production of glucose syrups and other starch hydrolysates, cereal-based products other than baked, brewed products and distilled alcohol; processing of fruits and vegetables for the production of juices and products other than juices; production of refined and unrefined sugars. Since the residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 0.167 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of concerns resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found with a respiratory allergen. The Panel considered that the risk of allergic reactions by dietary exposure 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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