欧盟评估转基因米曲霉菌株AR-183生产的内切多聚半乳糖醛酸酶的安全性

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    2023年2月26日，欧盟食品安全局就一种食品酶内切多聚半乳糖醛酸酶（endo-polygalacturonase）的安全性评价发布意见。

据了解，这种食品酶是由转基因米曲霉菌株AR-183生产的，旨在用于五种食品制造过程：果汁生产中的水果和蔬菜加工、果汁以外产品的水果和蔬菜加工、葡萄酒和葡萄酒醋的生产、作为调味制剂的植物提取物的生产以及咖啡脱脂。

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，尤其是对花粉过敏的个体。根据所提供的数据，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 endo-polygalacturonase (1→4)-α-d-galacturonan glycanohydrolase EC 3.2.1.15 is produced with the genetically modified Aspergillus oryzae strain AR-183 by AB ENZYMES GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme is free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juice, production of wine and wine vinegar, production of plant extracts as flavouring preparations and coffee demucilation. Since residual amounts of total organic solids (TOS) are removed by repeated washing or distillation, dietary exposure to the food enzyme TOS from coffee demucilation and from the production of flavouring extracts was considered not necessary. For the remaining three food processes, dietary exposure was estimated to be up to 0.087 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 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, resulted in a margin of exposure of at least 11,494. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and two matches with pollen allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to pollen allergens, 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.

关键词： 多聚半乳糖醛酸酶 花粉过敏 安全问题