据了解,这种食品酶是由非转基因戴尔根霉菌株CU634-1775生产的,旨在用于六种食品制造过程:烘焙过程、生产葡萄糖浆和其他淀粉水解产物的淀粉加工、果汁生产的水果和蔬菜加工、果汁以外产品的水果和蔬菜加工、酿造过程和蒸馏酒精生产。
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,但这种情况发生的可能性很低。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隐患。部分原文报道如下:
The food enzyme glucan-1,4-α-glucosidase (4-α-d-glucan glucohydrolase; EC 3.1.2.3) is produced with the non-genetically modified Rhizopus delemar strain CU634-1775 by Shin Nihon Chemical Co., Ltd. The food enzyme is free from viable cells of the production strain. It is intended to be used in six food manufacturing processes: baking processes, starch processing for production of glucose syrups and other starch hydrolysates, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, brewing processes and distilled alcohol production. As residual amounts of total organic solids (TOS) are removed by distillation and by the purification steps applied during the production of glucose syrups, dietary exposure was not calculated for these two food processes. For the remaining four food processes, dietary exposure to the food enzyme-total organic solids was estimated to be up to 1.238 mg TOS/kg body weight (bw) per day. Genotoxicity tests did not raise a safety concern. 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 1,735 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 1,401. In a search for the similarity of the amino acid sequence of the food enzyme to known allergens, a single match with a respiratory allergen was found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, 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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