欧盟评估转基因黑曲霉菌株NZYM-EN生产的纤维素酶的安全性

 　　  2025年10月30日，欧盟食品安全局就一种纤维素酶（cellulase）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-EN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，不能排除饮食暴露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，评估小组得出结论，这种食品酶在预期使用条件下不会引起安全问题。部分原文报道如下：
 
　　The food enzyme cellulase (4-(1,3;1,4)-β-d-glucan 4-glucanohydrolase, EC 3.2.1.4) is produced with the genetically modified Aspergillus niger strain NZYM-EN 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 0.018 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 1233 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 68,500. A search for the homology of the amino acid sequence of the cellulase 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.