欧盟评估来自一种米曲霉的α淀粉酶的安全性

　　2019年11月27日，欧盟食品安全局就来自米曲霉（Aspergillus oryzae）菌株DP‐Bzb41的α-淀粉酶（α-amylase）的安全性评价发布意见。

　　据了解，该种食品酶是由美国公司Danisco US Inc.使用米曲霉菌株DP‐Bzb41生产的，旨在用于食品烘焙和酿造工艺、蒸馏酒精生产和用于生产葡萄糖浆的淀粉加工中。经过评估，欧盟专家小组得出结论认为，在预期使用条件下，这种食品酶不会引起安全问题。 部分原文报道如下：

　　The food enzyme α‐amylase （4‐α‐d‐glucan glucanohydrolase, EC 3.2.1.1） is produced with a non‐genetically modified Aspergillus oryzae （strain DP‐Bzb41） by Danisco US Inc. （USA）。 The α‐amylase food enzyme is intended to be used in baking, brewing, distilled alcohol production and starch processing for the glucose syrup production. based on the maximum use levels for baking and brewing processes and individual data from the EFSA Comprehensive European Food Database, dietary exposure to the food enzyme-Total Organic Solids （TOS） was estimated to be up to 2.59 mg TOS/kg body weight （bw） per day. Since residual amounts of TOS are removed during distilled alcohol production and by the purification steps applied during starch processing, dietary exposure for these processes was not calculated. 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 （NOAEL） of 1,000 mg TOS/kg bw per day, the highest dose tested. Comparison with the estimated dietary exposure, results in a margin of exposure of at least 386. Similarity of the amino acid sequence to those of known allergens was searched and one match to respiratory allergen was found （an amylase from another strain of A. oryzae）。 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 below. 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.