欧盟评估一种由内切多聚半乳糖醛酸酶和纤维素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Talaromyces cellulolyticus菌株NITE BP-03478生产的，旨在用于八种食品制造过程：烘焙过程、酿造过程、果汁生产中的水果和蔬菜加工、葡萄酒和葡萄酒醋生产、果汁以外产品的水果和蔬菜加工、精制橄榄油生产的水果和蔬菜加工、咖啡豆脱蛋白和淀粉生产中的谷物处理。

 

　　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，特别是对花粉过敏的个体。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) and cellulase (4-(1,3;1,4)-β-d-glucan 4-glucanohydrolase; EC 3.2.1.4) activities is produced with the non-genetically modified Talaromyces cellulolyticus strain NITE BP-03478 by Meiji Seika Pharma Co., Ltd. It is intended to be used in eight food manufacturing processes: baking processes, brewing processes, fruit and vegetable processing for juice production, wine and wine vinegar production, fruit and vegetable processing for products other than juices, fruit and vegetable processing for refined olive oil production, coffee bean demucilation and grain treatment for starch production. Since residual amounts of total organic solids (TOS) are removed during three food processes (refined olive oil production, coffee bean demucilation and grain treatment for starch production), dietary exposure was not calculated for these food processes. For the remaining five food processes, dietary exposure was estimated to be up to 3.193 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 806 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 252. A search for the similarity of the amino acid sequences of the food enzyme to known allergens was made and six matches with pollen allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, especially in individuals sensitised to pollen. 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.

 

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