世界最資訊丨歐盟評估非轉基因乳酸克魯維酵母菌株AE-KL生產的β-半乳糖苷酶的安全性

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據了解，這種食品酶是由非轉基因乳酸克魯維酵母菌株AE-KL生產的，旨在用于牛奶加工（包括嬰兒配方奶粉）、發酵乳制品生產和低聚半乳糖生產中的乳糖水解。

經過評估，專家小組認為，在預期的使用條件下，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 β-galactosidase (β-d-galactoside galatohydrolase, EC 3.2.1.23) is produced with the non-genetically modified Kluyveromyces lactis strain AE-KL by Amano Enzyme Inc. As the production strain meets the requirements for a Qualified Presumption of Safety (QPS) approach to safety assessment and as no other issues of concern were identified, the Panel considered that toxicological tests were not needed for the assessment of this food enzyme. The food enzyme is intended to be used for lactose hydrolysis in milk processing (including infant formulae), production of fermented milk products and manufacture of galacto-oligosaccharides (GOS). The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 7.933 mg TOS/kg body weight (bw) per day in European populations. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. based on the QPS status of the production strain and the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.