環球簡訊:歐盟評估非轉基因米曲霉菌株NZYM-NA生產的α-淀粉酶的安全性

(資料圖片僅供參考)

    2023年3月30日，歐盟食品安全局就一種α-淀粉酶（α-amylase）的安全性評價發布意見。

據了解，這種食品酶是由非轉基因米曲霉菌株NZYM-NA生產的，旨在用于七種食品制造過程：生產葡萄糖和麥芽糖糖漿及其他淀粉水解產物的淀粉加工、蒸餾酒精生產、釀造過程、烘焙過程、谷物加工、生產乳制品的植物加工以及生產果汁的水果和蔬菜加工。

經過評估，專家小組認為，在預期的使用條件下（蒸餾酒精生產除外），不能排除飲食暴露引起過敏反應的風險，但這種可能性被認為很低。根據所提供的數據，評估小組得出結論，這種食品酶在預期使用條件下不會引起安全問題。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 the non-genetically modified Aspergillus oryzae strain NZYM-NA by Novozymes A/S. It was considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: starch processing for the production of glucose and maltose syrups and other starch hydrolysates, distilled alcohol production, brewing processes, baking processes, cereal-based processes, plant processing for production of dairy analogues and fruit and vegetable processing for juice production. Since residual amounts of food enzyme–total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups and distillation, dietary exposure was not calculated for these processes. For the remaining five food manufacturing processes, dietary exposure was estimated to be up to 0.134?mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 1,862?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 13,896. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is 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.