欧盟评估转基因黑曲霉菌株DSM 29544生产的凝乳酶的安全性

2022年8月8日，欧盟食品安全局就一种凝乳酶（chymosin）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DSM 29544生产的，旨在用于奶酪生产和发酵乳制品生产的牛奶加工中。

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和诱发反应的风险，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 chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. 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 milk processing for cheese production and for production of fermented milk products. based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 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 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered 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.