2023年11月24日，歐盟食品安全局就一種α-淀粉酶（α‐amylase）的安全性評(píng)價(jià)發(fā)布意見(jiàn)。
據(jù)了解，這種食品酶是由轉(zhuǎn)基因地衣芽孢桿菌菌株NZYM-AC生產(chǎn)的，旨在用于七種食品制造過(guò)程:加工谷物和其他谷物，以生產(chǎn)葡萄糖漿和其他淀粉水解產(chǎn)物，除烘焙、釀造產(chǎn)品和蒸餾酒精以外的谷物產(chǎn)品；加工水果和蔬菜以生產(chǎn)果汁和果汁以外的產(chǎn)品；精制糖和未精制糖的生產(chǎn)。
經(jīng)過(guò)評(píng)估，專(zhuān)家小組認(rèn)為，在預(yù)期的使用條件下（蒸餾酒精生產(chǎn)除外），不能排除飲食暴露引起過(guò)敏和誘發(fā)反應(yīng)的風(fēng)險(xiǎn)，但這種情況發(fā)生的可能性很低。根據(jù)所提供的數(shù)據(jù)，評(píng)估小組得出結(jié)論，這種食品酶在預(yù)期使用條件下不會(huì)引起安全問(wèn)題。部分原文報(bào)道如下：
The food enzyme α-amylase (1,4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM-AC by Novozymes A/S. The genetic modifications do not give rise to safety concerns and the production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in seven food manufacturing processes: processing of cereals and other grains for the production of glucose syrups and other starch hydrolysates, cereal-based products other than baked, brewed products and distilled alcohol; processing of fruits and vegetables for the production of juices and products other than juices; production of refined and unrefined sugars. Since the residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 0.167 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of concerns resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found with a respiratory allergen. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), 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.
據(jù)了解，這種食品酶是由轉(zhuǎn)基因地衣芽孢桿菌菌株NZYM-AC生產(chǎn)的，旨在用于七種食品制造過(guò)程:加工谷物和其他谷物，以生產(chǎn)葡萄糖漿和其他淀粉水解產(chǎn)物，除烘焙、釀造產(chǎn)品和蒸餾酒精以外的谷物產(chǎn)品；加工水果和蔬菜以生產(chǎn)果汁和果汁以外的產(chǎn)品；精制糖和未精制糖的生產(chǎn)。
經(jīng)過(guò)評(píng)估，專(zhuān)家小組認(rèn)為，在預(yù)期的使用條件下（蒸餾酒精生產(chǎn)除外），不能排除飲食暴露引起過(guò)敏和誘發(fā)反應(yīng)的風(fēng)險(xiǎn)，但這種情況發(fā)生的可能性很低。根據(jù)所提供的數(shù)據(jù)，評(píng)估小組得出結(jié)論，這種食品酶在預(yù)期使用條件下不會(huì)引起安全問(wèn)題。部分原文報(bào)道如下：
The food enzyme α-amylase (1,4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus licheniformis strain NZYM-AC by Novozymes A/S. The genetic modifications do not give rise to safety concerns and the production strain meets the requirements for the qualified presumption of safety (QPS) approach. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in seven food manufacturing processes: processing of cereals and other grains for the production of glucose syrups and other starch hydrolysates, cereal-based products other than baked, brewed products and distilled alcohol; processing of fruits and vegetables for the production of juices and products other than juices; production of refined and unrefined sugars. Since the residual amounts of total organic solids (TOS) are removed during two processes, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 0.167 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of concerns resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found with a respiratory allergen. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded (except for distilled alcohol production), 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.
