欧盟评估转基因乳酸克鲁维酵母菌株CIN生产的凝乳酶的安全性

2022年8月11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乳酸克鲁维酵母菌株CIN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，特别是对雪松花粉过敏源过敏的个体。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 Kluyveromyces lactis strain CIN by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its recombinant DNA. It is intended to be used in milk processing for cheese production and for the production of fermented milk products. Dietary exposure was estimated to be up to 0.73 mg total organic solids (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 1,000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1,300. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and four matches were found. The Panel considered that under the intended conditions of use the risk of allergic sensitisation and elicitation reactions by dietary exposure, although unlikely, cannot be excluded, particularly for individuals sensitised to cedar pollen allergens. 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.