2025年5月19日，歐盟食品安全局就一種食品酶普魯蘭酶（pullulanase）的安全性評(píng)價(jià)發(fā)布意見(jiàn)。
據(jù)了解，這種食品酶是由非轉(zhuǎn)基因肺炎克雷伯菌菌株AE-PUL生產(chǎn)的，旨在用于八種食品生產(chǎn)過(guò)程。
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)。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 pullulanase (pullulan 6-α-glucanohydrolase, EC 3.2.1.41) is produced by Amano Enzymes Inc. with the non-genetically modified Klebsiella pneumoniae strain AE-PUL, a known human pathogen. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in 10 food manufacturing processes. Since residual amounts of food enzyme—total organic solids (TOS) are removed in two processes, dietary exposure was calculated only for the remaining eight food manufacturing processes. It was estimated to be up to 0.075 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 0 124 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1653. A search for the homology of the amino acid sequence of the pullulanase to known allergens was made and matches with two food allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme 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，這種食品酶是由非轉(zhuǎn)基因肺炎克雷伯菌菌株AE-PUL生產(chǎn)的，旨在用于八種食品生產(chǎn)過(guò)程。
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)。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 pullulanase (pullulan 6-α-glucanohydrolase, EC 3.2.1.41) is produced by Amano Enzymes Inc. with the non-genetically modified Klebsiella pneumoniae strain AE-PUL, a known human pathogen. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in 10 food manufacturing processes. Since residual amounts of food enzyme—total organic solids (TOS) are removed in two processes, dietary exposure was calculated only for the remaining eight food manufacturing processes. It was estimated to be up to 0.075 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 0 124 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1653. A search for the homology of the amino acid sequence of the pullulanase to known allergens was made and matches with two food allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme 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.
