歐盟評估來自一種米曲霉的α淀粉酶的安全性

　　2019年11月27日，歐盟食品安全局就來自米曲霉（Aspergillus oryzae）菌株DP‐Bzb41的α-淀粉酶（α-amylase）的安全性評價發布意見。

　　據了解，該種食品酶是由美國公司Danisco US Inc.使用米曲霉菌株DP‐Bzb41生產的，旨在用于食品烘焙和釀造工藝、蒸餾酒精生產和用于生產葡萄糖漿的淀粉加工中。經過評估，歐盟專家小組得出結論認為，在預期使用條件下，這種食品酶不會引起安全問題。 部分原文報道如下：

　　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.