据了解,这种食品酶是由转基因黑曲霉菌株NZYM-BR生产的,旨在用于生产葡萄糖浆和蒸馏酒精的淀粉加工中、/div>
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和诱发反应的风险,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--glucosidase (4--d-glucan glucohydrolase, EC 3.2.1.3) is produced with the genetically modified Aspergillus niger strain NZYM-BR by Novozymes A/S. 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. The food enzyme is intended to be used in starch processing for the production of glucose syrups and distilled alcohol. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups and by distillation, dietary exposure estimation was co
nsidered not necessary. 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 1,135 mg TOS/kg body weight (bw) per day, the highest dose tested. Similarity of the amino acid sequence of the food enzyme to those of known allergens was searched for and two matches were found. The Panel co
nsidered that under the intended co
nditions of use (other than distilled alcohol production) the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is co
nsidered to be low. ba
sed on the data provided, the Panel co
ncluded that this food enzyme does not give rise to safety co
ncerns under the intended co
nditions of use.
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