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    歐盟評(píng)估轉(zhuǎn)基因枯草芽孢桿菌菌株AR-651生產(chǎn)的α-淀粉酶的安全性
    日期:2023-02-20  來(lái)源:食品伙伴網(wǎng)
       食品伙伴網(wǎng)訊  2023年2月17日,歐盟食品安全局就一種α-淀粉酶(α‐amylase)的安全性評(píng)價(jià)發(fā)布意見(jiàn)。
     
      據(jù)了解,這種食品酶是由轉(zhuǎn)基因枯草芽孢桿菌菌株AR-651生產(chǎn)的,旨在用于烘焙過(guò)程。
     
      經(jīng)過(guò)評(píng)估,專(zhuān)家小組認(rèn)為,在預(yù)期的使用條件下,不能排除飲食暴露引起過(guò)敏和誘發(fā)反應(yīng)的風(fēng)險(xiǎn),但這種情況發(fā)生的可能性很低。根據(jù)所提供的數(shù)據(jù),評(píng)估小組得出結(jié)論,這種食品酶在預(yù)期使用條件下不會(huì)引起安全問(wèn)題。部分原文報(bào)道如下:
     
      The food enzyme α-amylase (4-α-d-glucan glucanohydrolase; EC 3.2.1.1) is produced with the genetically modified Bacillus subtilis strain AR-651 by AB Enzymes. The genetic modifications do not give rise to safety concerns. The food enzyme is considered free from viable cells of the production organism and its DNA. It is intended to be used in baking processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.19?mg TOS/kg body weight (bw) per day in European populations. The production strain carries known antimicrobial resistance genes and consequently, it does not fully fulfil the requirements for the qualified presumption of safety (QPS) approach to safety assessment. However, considering the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. As no other concerns arising from the microbial source and its subsequent genetic modification or from the manufacturing process have been identified, the Panel considers that toxicological tests are not needed for the assessment of this food enzyme. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and three matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic sensitisation and elicitation reactions by dietary exposure cannot be excluded, but the likelihood for this to occur is considered to be low. based on the data provided, the Panel concludes that this food enzyme does not give rise to safety concerns, under the intended conditions of use.
     
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