欧盟评估一种由内切多聚半乳糖醛酸酶和内切-1,3（4）-β-葡聚糖酶组成的食品酶的安全性

 

　　据了解，这种食品酶是由非转基因斐济曲霉菌株NZYM-RE生产的，旨在用于八种食品制造过程：蒸馏酒精生产、酿造过程、烘焙过程、谷物加工、葡萄酒和葡萄酒醋生产、果汁生产中的水果和蔬菜加工、汁以外产品的水果和蔬菜加工以及精炼橄榄油生产。

 

　　经过评估，专家小组认为，在预期的使用条件下（蒸馏酒精生产除外），不能排除饮食暴露引起过敏反应的风险，特别是在患有口腔过敏综合征或对木瓜过敏的个体中。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 has two declared activities, endo-polygalacuronase ((1→4)-α-D-galacturonan glycanohydrolase; EC 3.2.1.15) and endo-1,3(4)-β-glucanase (3-(1→3;1→4)-β-D-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) and is produced with the non-genetically modified Aspergillus fijiensis strain NZYM-RE by Novozymes A/S. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes, i.e. distilled alcohol production, brewing processes, baking processes, cereal-based processes, wine and wine vinegar production, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices and refined olive oil production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and refined olive oil production, dietary exposure was not calculated for these two processes. For the remaining six food manufacturing processes, dietary exposure was estimated to be up to 0.553 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 3,677 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 6,649. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and nine matches were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure to this food enzyme, particularly in individuals suffering from the oral allergy syndrome or sensitised to papaya, cannot be excluded. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

 

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