2023年3月8日,歐盟食品安全局就一種食品酶內切多聚半乳糖醛酸酶(endo-polygalacturonase)的安全性評價發布意見。
據了解,這種食品酶是由轉基因黑曲霉菌株EPG生產的,旨在用于果汁生產中的水果和蔬菜加工。
經過評估,專家小組認為,在預期的使用條件下,不能排除飲食暴露引起過敏反應的風險,尤其是對木瓜或玉米過敏的個體,但這種風險不會超過食用木瓜或玉米的風險。此外,不能排除花粉過敏個體的口腔過敏反應。根據所提供的數據,小組得出結論,這種食品酶在預期使用條件下不會引起安全問題。部分原文報道如下:
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.
據了解,這種食品酶是由轉基因黑曲霉菌株EPG生產的,旨在用于果汁生產中的水果和蔬菜加工。
經過評估,專家小組認為,在預期的使用條件下,不能排除飲食暴露引起過敏反應的風險,尤其是對木瓜或玉米過敏的個體,但這種風險不會超過食用木瓜或玉米的風險。此外,不能排除花粉過敏個體的口腔過敏反應。根據所提供的數據,小組得出結論,這種食品酶在預期使用條件下不會引起安全問題。部分原文報道如下:
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.