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    歐盟評(píng)估轉(zhuǎn)基因黑曲霉菌株AGN生產(chǎn)的天冬酰胺酶的安全性
    日期:2024-02-22  來(lái)源:食品伙伴網(wǎng)
       食品伙伴網(wǎng)訊  2024年2月20日,歐盟食品安全局就一種天冬酰胺酶(asparaginase)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)基因黑曲霉菌株AGN生產(chǎn)的,旨在用于防止食品加工中丙烯酰胺的形成。
     
      經(jīng)過(guò)評(píng)估,專家小組認(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 asparaginase (l-asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified Aspergillus niger strain AGN by DSM Food Specialties B.V. 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 to prevent acrylamide formation in food processing. The dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 1.434 mg TOS/kg body weight (bw) per day in European populations. The toxicity studies were carried out with an asparaginase from A. niger (strain ASP). The Panel considered this food enzyme as a suitable substitute for the asparaginase to be used in the toxicological studies, because the genetic differences between the production strains are not expected to result in a different toxigenic potential, and the raw materials and manufacturing processes of both food enzymes are comparable. 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 1038 mg TOS/kg bw per day, which, when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 724. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood is low. based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.
     
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