2025年7月14日，歐盟食品安全局就一種氨肽酶Y（aminopeptidase Y）的安全性評(píng)價(jià)發(fā)布意見。
據(jù)了解，這種食品酶是由轉(zhuǎn)基因里氏木霉菌株DP-Nyf80生產(chǎn)的，旨在用于3種食品生產(chǎn)過程。
經(jīng)過評(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)引起安全問題。部分原文報(bào)道如下：
The food enzyme aminopeptidase Y (EC 3.4.11.15) is produced with the genetically modified Trichoderma reesei strain DP-Nyf80 by Genencor International B.V. The genetic modifications do not give rise to safety concerns. Recombinant DNA was not detected under standard testing conditions. However, the absence of viable cells could not be excluded. The food enzyme is intended to be used in three food manufacturing processes. Dietary exposure was calculated to be up to 1.861 mg total organic solids (TOS)/kg body weight 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 1000 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 537. A search for the homology of the amino acid sequence of the aminopeptidase Y to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that 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)基因里氏木霉菌株DP-Nyf80生產(chǎn)的，旨在用于3種食品生產(chǎn)過程。
經(jīng)過評(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)引起安全問題。部分原文報(bào)道如下：
The food enzyme aminopeptidase Y (EC 3.4.11.15) is produced with the genetically modified Trichoderma reesei strain DP-Nyf80 by Genencor International B.V. The genetic modifications do not give rise to safety concerns. Recombinant DNA was not detected under standard testing conditions. However, the absence of viable cells could not be excluded. The food enzyme is intended to be used in three food manufacturing processes. Dietary exposure was calculated to be up to 1.861 mg total organic solids (TOS)/kg body weight 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 1000 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 537. A search for the homology of the amino acid sequence of the aminopeptidase Y to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme cannot be excluded, but that 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.
