欧盟评估转基因黑曲霉菌株NZYM-MR生产的‌脯氨酰寡肽酶的安全性

核心提示：2025年12月16日，欧盟食品安全局就一种食品酶‌脯氨酰寡肽酶（prolyl oligopeptidase）的安全性评价发布意见。……（世界食品网-www.shijieshipin.com）

　　 2025年12月16日，欧盟食品安全局就一种食品酶‌脯氨酰寡肽酶（prolyl oligopeptidase）的安全性评价发布意见。
　　据了解，这种食品酶是由转基因黑曲霉菌株NZYM-MR生产的，旨在用于3种食品生产过程。

　　经过评估，专家小组认为，在预期的使用条件下，不能排除通过饮食接触引起过敏反应的风险，但这种情况发生的可能性很低。根据所提供的数据，小组得出结论，该食品酶在预期的使用条件下不会引起安全问题。部分原文报道如下：

　　The food enzyme prolyl oligopeptidase (EC 3.4.21.26) is produced with the genetically modified Aspergillus niger strain NZYM-MR by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in three food manufacturing processes. Since residual amounts of food enzyme—total organic solids (TOS) are removed in one process, dietary exposure was calculated for the remaining two food manufacturing processes. It was estimated to be up to 0.557 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 1488 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 2671. A search for the homology of the amino acid sequence of the prolyl oligopeptidase 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.