据了解,这种食品酶是由转基因地衣芽孢杆菌菌株NZYM-LU生产的,旨在用于酿造工艺和淀粉加工,以生产葡萄糖浆和其他淀粉水解产物。
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,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 pullulanase (pullulan 6-α-glucanohydrolase, EC 3.2.1.41) is produced with the genetically modified Bacillus licheniformis strain NZYM-LU by Novozyme A/S. The genetic modifications did not give rise to safety concerns. The production strain has been shown to qualify for the qualified presumption of safety (QPS) status. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in brewing processes and in starch processing for production of glucose syrups and other starch hydrolysates. Since residual amounts of total organic solids (TOS) are removed by the purification steps applied during the production of glucose syrups, dietary exposure was calculated only for the brewing processes. It was estimated to be up to 0.59 mg TOS/kg body weight (bw) per day in European populations. Given the QPS status of the production strain and the lack of hazards resulting from the food enzyme manufacturing process, toxicological studies were not considered necessary. The similarity of the amino acid sequence to those of known allergens was searched and no match was found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is low. based on the data provided, the QPS status of the production strain and the absence of issues of concern arising from the production process, the Panel concluded that the food enzyme pullulanase produced with the genetically modified B. licheniformis strain NZYM-LU does not give rise to safety concerns under the intended conditions of use.
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