欧盟评估非转基因黑曲霉菌株CCTCC M 2023236生产的含有三种酶活性的食品酶的安全性

 　　  2026年4月15日，欧盟食品安全局就一种含内切多聚半乳糖醛酸酶、果胶酯酶和果胶裂解酶活性的食品酶的安全性评价发布意见。 
　　据了解，这种食品酶是由非转基因黑曲霉菌株CCTCC M 2023236生产的，旨在用于6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。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 containing endo-polygalacturonase (1,4-α-d-galacturonan glycanohydrolase; EC 3.2.1.15), pectinesterase (pectin pectylhydrolase; EC 3.1.1.11) and pectin lyase (1,4-6-O-methyl-α-d-galacturonan lyase; EC 4.2.2.10) activities is produced with the non-genetically modified Aspergillus niger strain CCTCC M 2023236 by Suntaq International Limited. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in six food manufacturing processes. Dietary exposure was estimated to be up to 1.221 mg total organic solids (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 2000 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 1638. A search for the homology of the three amino acid sequences to known allergens was made and matches with 14 respiratory allergens were found. The Panel considered that under the intended conditions of use, a risk of allergic reactions upon dietary exposure 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.