2023年7月26日，歐盟食品安全局就一種菊粉酶（inulinase ）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)基因米曲霉菌株MUCL 44346生產(chǎn)的，旨在用于從菊苣根提取的菊粉中生產(chǎn)低聚果糖。
經(jīng)過(guò)評(píng)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(guò)敏反應(yīng)的風(fēng)險(xiǎn)，尤其是對(duì)番茄過(guò)敏的個(gè)體。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 inulinase (1-β-d-fructan fructanohydrolase; EC 3.2.1.7) is produced with the genetically modified Aspergillus oryzae strain MUCL 44346 by PURATOS NV. 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 the production of fructo-oligosaccharides (FOS) from inulin extracted from chicory roots. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.01 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 (NOAEL) of 100 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 10,000. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches were found with tomato allergens. 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 tomato, cannot be excluded. However, the likelihood of allergic reactions is expected not to exceed the likelihood of allergic reactions to tomato. As the prevalence of allergic reactions to tomato is low, also the likelihood of such reactions to occur to the food enzyme 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)基因米曲霉菌株MUCL 44346生產(chǎn)的，旨在用于從菊苣根提取的菊粉中生產(chǎn)低聚果糖。
經(jīng)過(guò)評(píng)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(guò)敏反應(yīng)的風(fēng)險(xiǎn)，尤其是對(duì)番茄過(guò)敏的個(gè)體。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 inulinase (1-β-d-fructan fructanohydrolase; EC 3.2.1.7) is produced with the genetically modified Aspergillus oryzae strain MUCL 44346 by PURATOS NV. 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 the production of fructo-oligosaccharides (FOS) from inulin extracted from chicory roots. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.01 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 (NOAEL) of 100 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 10,000. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches were found with tomato allergens. 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 tomato, cannot be excluded. However, the likelihood of allergic reactions is expected not to exceed the likelihood of allergic reactions to tomato. As the prevalence of allergic reactions to tomato is low, also the likelihood of such reactions to occur to the food enzyme 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.
