据了解,这种食品酶是由转基因黑曲霉菌株EPG生产的,旨在用于果汁生产中的水果和蔬菜加工。
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,尤其是对木瓜或玉米过敏的个体,但这种风险不会超过食用木瓜或玉米的风险。此外,不能排除花粉过敏个体的口腔过敏反应。根据所提供的数据,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 endo-polygalacturonase ((1–4)-α-d-galacturonan glycanohydrolase; EC 3.2.1.15) is produced with the genetically modified Aspergillus niger strain EPG by DSM Food Specialties B.V. 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. It is intended to be used in fruit and vegetable processing for juice production. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.122 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate 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 1,014 mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, resulted in a margin of exposure at least 8,311. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and 38 matches were found, two of which are food allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded, in particular for individuals sensitised to papaya or maize, but that the risk will not exceed that of consumption of papaya or maize. In addition, oral allergy reactions cannot be excluded in pollen-sensitised individuals. 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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