無極4註冊_歐盟評估一種食品酶的安全性

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無極4註冊_歐盟評估一種食品酶的安全性

    食品夥伴網訊  2022年3月8日,歐盟食品安全局就一種非還原端α-l-阿拉伯呋喃糖苷酶(non-reducing end α-l-arabinofuranosidase)的安全性評價發布意見。

 
  據了解,這種食品酶是由轉基因里氏木黴菌株NZYM-GV生產的,旨在用於穀物處理,以生產澱粉和麵筋部分。
 
  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 non-reducing end α-l-arabinofuranosidase (α-l-arabinofuranoside non-reducing end α-l-arabinofuranosidase; EC 3.2.1.55) is produced with the genetically modified Trichoderma reesei strain NZYM-GV by Novozymes A/S. 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 grain treatment for the production of starch and gluten fractions. Since residual amounts of total organic solids (TOS) are removed by washing and purification steps applied during grain treatment, the estimation of a dietary exposure is co nsidered not necessary. 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 1,116?mg TOS/kg body weight per day, the highest dose tested. 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 co nsidered to be low. ba sed on the data provided and the removal of TOS during the grain treatment, the Panel co ncluded that this food enzyme does not give rise to safety co ncerns under the intended co nditions of use.