無極4註冊_歐盟評估一種食品酶葡糖氧化酶的安全

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無極4註冊_歐盟評估一種食品酶葡糖氧化酶的安全

   食品夥伴網訊  2022年3月4日,歐盟食品安全局就一種葡糖氧化酶(glucose oxidase)的安全性評價發布意見。
 
  據了解,這種食品酶是由轉基因黑麴黴菌株DP-Aze23生產的,旨在用於烘焙工藝、穀物加工和雞蛋加工中。
 
  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和誘發反應的風險,但這種情況發生的可能性很低。根據所提供的數據,評估小組得出結論,該食品酶在預期的使用條件下不會引起安全問題。部分原文報道如下:
 
  The food enzyme glucose oxidase (β-D-glucose:oxygen 1-oxidoreductase; EC 1.1.3.4) is produced with the genetically modified Aspergillus niger strain DP-Aze23 by Danisco US, Inc. The genetic modifications do not give rise to safety concerns. The food enzyme is co nsidered free from viable cells of the production organism and its DNA. It is intended to be used in baking processes, cereal-ba sed processes and egg processing. ba sed on the maximum use levels, dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.05?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 19.55?mg TOS/kg bw per day, the highest dose tested, which, when compared with the estimated dietary exposure, results in a margin of exposure above 380. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was found. The Panel co nsidered that, under the intended co nditions of use, 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 concerns, under the intended co nditions of use.