欧盟评估转基因地衣芽孢杆菌菌株NZYM-AY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-AY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，以及蒸馏酒精生产。

 

　　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 (4-α-d-glucan glucanhydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM-AY by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in starch processing for the production of glucose syrup and other starch hydrolysates, and distilled alcohol production. Since residual amounts of total organic solids are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure estimation was considered unnecessary. The production strain of the food enzyme fulfils the requirements for the qualified presumption of safety (QPS) approach to safety assessment. As no other concerns arising from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. A search for 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 sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. based on the data provided, the Panel concluded that this food enzyme did not give rise to safety concerns under the intended conditions of use.

 

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