無極4_歐盟評估一種α-葡萄糖苷酶的安全性

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無極4_歐盟評估一種α-葡萄糖苷酶的安全性

    食品夥伴網訊  2022年4月28日,歐盟食品安全局就一種α-葡萄糖苷酶(α-glucosidase)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AE-TGU生產的,旨在用於烘焙過程、穀物加工、釀造過程和澱粉加工中,以生產葡萄糖糖漿和其他澱粉水解物。
 
  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,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隱患。部分原文報道如下:
 
  The food enzyme α-glucosidase (α-d-glucoside glucohydrolase; EC 3.2.1.20) is produced with the non-genetically modified Aspergillus niger strain AE-TGU by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. The food enzyme is intended to be used in baking processes, cereal-ba sed processes, brewing processes and starch processing for the 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 o nly calculated for the remaining three food processes. ba sed on the maximum use levels recommended, dietary exposure was estimated to be up to 0.64 mg TOS/kg body weight (bw) per day in European populations. 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 1,062 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1,650. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and no 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 co ncerns under the intended co nditions of use.