欧盟评估一种食品酶内切-1,3（4）-β-葡聚糖酶的安全性

 

　　据了解，这种食品酶是由非转基因Cellulosimicrobium funkei菌株AE-TN生产的，旨在用于烘焙过程和酵母加工中。

 

　　经过评估，专家小组认为，在预期的使用条件下，不能排除通过饮食接触引起过敏反应的风险，但这种情况发生的可能性很低。然而，由于在食品酶中存在生产菌株的活细胞，专家组得出结论，该食品酶不能被认为是安全的。部分原文报道如下：

 

　　The food enzyme endo-1,3(4)-β-glucanase (3-(1–3;1–4)-β-d-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) is produced with the non-genetically modified Cellulosimicrobium funkei strain AE-TN by Amano Enzyme Inc. The food enzyme was shown to contain viable cells of the production strain, which belongs to a species that has been implicated in opportunistic infections in humans. The food enzyme is intended to be used in baking processes and yeast processing. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 1.75 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 1,788 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1,022. A search for the 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 reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. However, due to the presence of viable cells of the production strain in the food enzyme, the Panel concluded that the food enzyme cannot be considered safe.

 

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