欧盟评估非转基因解淀粉芽孢杆菌菌株NZYM-WR生产的α-淀粉酶的安全性

 

　　据了解，这种食品酶是由非转基因解淀粉芽孢杆菌菌株NZYM-WR生产的，旨在用于九种食品生产过程:加工谷物和其他谷物以生产焙烤产品、非焙烤的谷物基产品、葡萄糖浆和其他淀粉水解产物、蒸馏酒精和酿造产品；精制糖和未精制糖的生产，基于植物的牛奶类似物和奶制品的生产；加工水果和蔬菜以生产果汁和果汁以外的水果和蔬菜产品。

 

　　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，但这种可能性被认为很低。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 α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the non-genetically modified Bacillus amyloliquefaciens strain NZYM-WR by Novozymes A/S. The production strain met the requirements for the qualified presumption of safety (QPS) approach. The food enzyme is intended to be used in nine food manufacturing processes: processing of cereals and other grains for the production of baked products, cereal-based products other than baked, glucose syrups and other starch hydrolysates, distilled alcohol and brewed products; production of refined and unrefined sugar, production of plant-based analogues of milk and milk products; processing of fruits and vegetables for the production of juices and fruit and vegetable products other than juices. Since residual amounts of total organic solids (TOS) are removed during two processes, a dietary exposure was calculated only for the remaining seven food manufacturing processes. Exposure was estimated to be up to 0.450 mg TOS/kg body weight per day in European populations. As the production strain qualified for the QPS approach and no issues of concern arose from the production process of the food enzyme, the Panel considered that toxicological studies were unnecessary. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and one match with a respiratory allergen was found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded (except for distilled alcohol production), but the likelihood is 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.

 

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