欧盟评估一种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‐KE生产的，旨在用于淀粉加工中，用于生产葡萄糖浆和其他淀粉水解物，以及生产蒸馏酒精。

 

　　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 α‐amylase (4‐α‐d‐glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM‐KE by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. The α‐amylase is intended to be used in starch processing for the production of glucose syrups and other starch hydrolysates, and distilled alcohol production. Since residual amounts of the food enzyme are removed by the purification steps applied during the production of glucose syrups and distillation, no dietary exposure was calculated. 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 at the highest dose of 1,100 mg TOS/kg body weight (bw) per day. 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, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood is 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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