2023年2月26日，歐盟食品安全局就一種食品酶內(nèi)切多聚半乳糖醛酸酶（endo-polygalacturonase）的安全性評價發(fā)布意見。
據(jù)了解，這種食品酶是由轉(zhuǎn)基因米曲霉菌株AR-183生產(chǎn)的，旨在用于五種食品制造過程：果汁生產(chǎn)中的水果和蔬菜加工、果汁以外產(chǎn)品的水果和蔬菜加工、葡萄酒和葡萄酒醋的生產(chǎn)、作為調(diào)味制劑的植物提取物的生產(chǎn)以及咖啡脫脂。
經(jīng)過評估，專家小組認(rèn)為，在預(yù)期的使用條件下，不能排除飲食暴露引起過敏反應(yīng)的風(fēng)險，尤其是對花粉過敏的個體。根據(jù)所提供的數(shù)據(jù)，小組得出結(jié)論，這種食品酶在預(yù)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 endo-polygalacturonase (1→4)-α-d-galacturonan glycanohydrolase EC 3.2.1.15 is produced with the genetically modified Aspergillus oryzae strain AR-183 by AB ENZYMES GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juice, production of wine and wine vinegar, production of plant extracts as flavouring preparations and coffee demucilation. Since residual amounts of total organic solids (TOS) are removed by repeated washing or distillation, dietary exposure to the food enzyme TOS from coffee demucilation and from the production of flavouring extracts was considered not necessary. For the remaining three food processes, dietary exposure was estimated to be up to 0.087 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 a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,000 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 11,494. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with pollen allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to pollen allergens, cannot be excluded. 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)基因米曲霉菌株AR-183生產(chǎn)的，旨在用于五種食品制造過程：果汁生產(chǎn)中的水果和蔬菜加工、果汁以外產(chǎn)品的水果和蔬菜加工、葡萄酒和葡萄酒醋的生產(chǎn)、作為調(diào)味制劑的植物提取物的生產(chǎn)以及咖啡脫脂。
經(jīng)過評估，專家小組認(rèn)為，在預(yù)期的使用條件下，不能排除飲食暴露引起過敏反應(yīng)的風(fēng)險，尤其是對花粉過敏的個體。根據(jù)所提供的數(shù)據(jù)，小組得出結(jié)論，這種食品酶在預(yù)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 endo-polygalacturonase (1→4)-α-d-galacturonan glycanohydrolase EC 3.2.1.15 is produced with the genetically modified Aspergillus oryzae strain AR-183 by AB ENZYMES GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juice, production of wine and wine vinegar, production of plant extracts as flavouring preparations and coffee demucilation. Since residual amounts of total organic solids (TOS) are removed by repeated washing or distillation, dietary exposure to the food enzyme TOS from coffee demucilation and from the production of flavouring extracts was considered not necessary. For the remaining three food processes, dietary exposure was estimated to be up to 0.087 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 a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1,000 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 11,494. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with pollen allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to pollen allergens, cannot be excluded. 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.
