無極4註冊_歐盟評估一種普魯蘭酶的安全性

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無極4註冊_歐盟評估一種普魯蘭酶的安全性

    食品夥伴網訊  2022年6月14日,歐盟食品安全局就一種普魯蘭酶(pullulanase)的安全性評價發布意見。

 
  據了解,這種食品酶是由轉基因地衣芽孢桿菌菌株NZYM-LU生產的,旨在用於釀造工藝和澱粉加工,以生產葡萄糖漿和其他澱粉水解產物。
 
  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,評估小組得出結論,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 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 co nsidered 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 o nly 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 co nsidered necessary. The similarity of the amino acid sequence to those of known allergens was searched 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 low. ba sed on the data provided, the QPS status of the production strain and the absence of issues of co ncern arising from the production process, the Panel co ncluded that the food enzyme pullulanase produced with the genetically modified B. licheniformis strain NZYM-LU does not give rise to safety co ncerns under the intended co nditions of use.