當(dāng)前快看:歐盟評(píng)估轉(zhuǎn)基因里氏木霉菌株RF6199生產(chǎn)的果膠裂解酶的安全性
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2022年12月8日,歐盟食品安全局就一種果膠裂解酶(pectin lyase)的安全性評(píng)價(jià)發(fā)布意見。據(jù)了解,這種食品酶是由轉(zhuǎn)基因里氏木霉菌株RF6199生產(chǎn)的。經(jīng)過評(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敏反應(yīng)的風(fēng)險(xiǎn),但這種可能性被認(rèn)為很低。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)引起安全問題。部分原文報(bào)道如下:
The food enzyme pectin lyase ((1-4)-6-O-methyl-α-D-galacturonan lyase; EC 4.2.2.10) is produced with the genetically modified Trichoderma reesei strain RF6199 by AB Enzymes GmbH. 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 six manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for fruit brandies, fruit and vegetable processing for products other than juices, wine and wine vinegar production, refined and unrefined sugar production and coffee bean demucilation. Foods obtained from fruit processing for fruit brandies and coffee bean demucilation, as well as refined sugars, were excluded from dietary exposure estimation. For the remaining four processes, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.2 mg TOS/kg body weight (bw) per day in European populations. 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 1,000 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 5,000. 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, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, but the likelihood of such reactions 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.
編輯:qysb005標(biāo)簽: 安全問題 過敏反應(yīng) 評(píng)估小組