2022年10月6日，歐盟食品安全局就一種β-半乳糖苷酶（β-galactosidase）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AE-LA生產的，旨在用于牛奶加工中的乳糖水解、發酵乳制品的生產、乳清加工和酶改性乳制品成分的生產。
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 galactohydrolase; EC 3.2.1.23) is produced with the non-genetically modified Aspergillus oryzae strain AE-LA by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used for lactose hydrolysis in milk processing, production of fermented milk products, whey processing and the manufacture of enzyme-modified dairy ingredients. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.651 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 1,656 mg TOS/kg bw per day, the highest dose tested. This results in a margin of exposure of at least 1,003. 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 is considered to be low. based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.
據了解，這種食品酶是由非轉基因米曲霉菌株AE-LA生產的，旨在用于牛奶加工中的乳糖水解、發酵乳制品的生產、乳清加工和酶改性乳制品成分的生產。
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 galactohydrolase; EC 3.2.1.23) is produced with the non-genetically modified Aspergillus oryzae strain AE-LA by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. The food enzyme is intended to be used for lactose hydrolysis in milk processing, production of fermented milk products, whey processing and the manufacture of enzyme-modified dairy ingredients. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.651 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 1,656 mg TOS/kg bw per day, the highest dose tested. This results in a margin of exposure of at least 1,003. 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 is considered to be low. based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns under the intended conditions of use.
