欧盟评估一种α-葡萄糖苷酶的安全性

 

　　据了解，这种食品酶是由转基因黑曲霉菌株AE-TGU生产的，旨在用于烘焙过程、谷物加工、酿造过程和淀粉加工中，以生产葡萄糖糖浆和其他淀粉水解物。

 

　　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，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-glucosidase (α-d-glucoside glucohydrolase; EC 3.2.1.20) is produced with the non-genetically modified Aspergillus niger strain AE-TGU by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in baking processes, cereal-based processes, brewing processes and starch processing for the production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was only calculated for the remaining three food processes. based on the maximum use levels recommended, dietary exposure was estimated to be up to 0.64 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 1,062 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1,650. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no 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 for this to occur 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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