歐盟評估非轉基因解淀粉芽孢桿菌菌株BA生產的α-淀粉酶的安全性

(資料圖)

據了解，這種食品酶是由非轉基因解淀粉芽孢桿菌菌株BA生產的，旨在用于六種食品制造過程：烘焙過程、釀造過程、蒸餾酒精生產、生產葡萄糖漿和其他淀粉水解產物的淀粉加工、乳制品類似物的生產和大米膳食的生產。

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 microorganism Bacillus amyloliquefaciens strain BA by HBI Enzymes Inc. The enzyme under assessment is intended to be used in six food processes: baking processes, brewing processes, distilled alcohol production, starch processing for the production of glucose syrups and other starch hydrolysates, production of dairy analogues and production of rice-based meals. Since residual amounts of total organic solids (TOS) are removed during distillation and during the production of glucose syrups and other starch hydrolysates, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 4.805 mg TOS/kg body weight (bw) per day in European populations. The applicant did not provide sufficient data to demonstrate that the production strain meets the qualified presumption of safety (QPS) criteria, or proof of absence of viable cells and DNA from the production organism in the food enzyme. Therefore, the Panel was not able to conclude on the safety of the microbial source. A margin of exposure could not be calculated in the absence of toxicological studies. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were 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 could not conclude on the safety of this food enzyme, under the intended conditions of use.