2024年4月17日，歐盟食品安全局就一種蛋白酶oryzin的安全性評價發(fā)布意見。
據(jù)了解，這種食品酶是由非轉(zhuǎn)基因赭曲霉菌株AE-P生產(chǎn)的，旨在用于九種食品制造過程。
經(jīng)過評估，專家小組認為，在預期的使用條件下，不能排除飲食暴露引起過敏反應的風險，別是對甜瓜過敏的人，但不會超過食用這種食品的風險。根據(jù)所提供的數(shù)據(jù)，評估小組得出結(jié)論，這種食品酶在預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 oryzin (EC 3.4.21.63) is produced with the non-genetically modified Aspergillus ochraceus strain AE-P by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in nine food manufacturing processes. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.1 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 1862 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 18,620. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 31 matches were found, including one food allergen (melon). The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to melon, cannot be excluded, but would not exceed the risk from consumption of this food. 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)基因赭曲霉菌株AE-P生產(chǎn)的，旨在用于九種食品制造過程。
經(jīng)過評估，專家小組認為，在預期的使用條件下，不能排除飲食暴露引起過敏反應的風險，別是對甜瓜過敏的人，但不會超過食用這種食品的風險。根據(jù)所提供的數(shù)據(jù)，評估小組得出結(jié)論，這種食品酶在預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 oryzin (EC 3.4.21.63) is produced with the non-genetically modified Aspergillus ochraceus strain AE-P by Amano Enzyme Inc. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in nine food manufacturing processes. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.1 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 1862 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 18,620. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 31 matches were found, including one food allergen (melon). The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to melon, cannot be excluded, but would not exceed the risk from consumption of this food. 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.
