欧盟评估来黑曲霉菌株的α淀粉酶的安全性

　　近日，欧盟食品安全局发布关于来自非基因黑曲霉（菌株DP‐Azb60）的α-淀粉酶（alpha‐amylase）安全性的评估结果。

　　据了解，食品酶α-淀粉酶（4‐α‐d‐glucan glucanohydrolase； EC 3.2.1.1）是由Danisco US 公司用非转基因黑曲霉（菌株DP‐Azb60）生产的。这种食品酶不含生产生物体的活细胞，旨在用于烘焙过程。经过评估，专家小组得出结论，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 alpha‐amylase （4‐α‐d‐glucan glucanohydrolase； EC 3.2.1.1） is produced with a non‐genetically modified Aspergillus niger （strain DP‐Azb60） by Danisco US Inc. The food enzyme is free from viable cells of the production organism. The α‐amylase is intended to be used in baking processes. based on the maximum use levels, dietary exposure to the food enzyme-total organic solids （TOS） was estimated to be up to 0.503 mg TOS/kg body weight （bw） per day. Genotoxicity tests with the food enzyme did not indicate a genotoxic 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 （NOAEL） at the highest dose of 1,000 mg TOS/kg bw per day that, compared with the estimated dietary exposure, results in a sufficiently high margin of exposure （of at least 1,988）。 Similarity of the amino acid sequence to those of known allergens was searched and one match was found to Asp o 21, an alpha‐amylase from Aspergillus oryzae. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions upon dietary exposure to this food enzyme cannot be excluded, but the likelihood is considered 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.