世界熱議:歐盟評估轉(zhuǎn)基因里氏木霉菌株RF6197生產(chǎn)的內(nèi)切多聚半乳糖醛酸酶的安全性
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????2023年6月29日,歐盟食品安全局就一種內(nèi)切多聚半乳糖醛酸酶(endo-polygalacturonase)的安全性評價發(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RF6197生產(chǎn)的,旨在用于果汁生產(chǎn)中的水果和蔬菜加工、果汁以外產(chǎn)品的水果和蔬菜加工、葡萄酒和葡萄酒醋的生產(chǎn)、咖啡脫脂以及作為調(diào)味制劑的植物提取物的生產(chǎn)。
經(jīng)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反應的風險,尤其是對花粉過敏的個體。根據(jù)所提供的數(shù)據(jù),評估小組得出結(jié)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 endo-polygalacturonase ((1–4)-α-d-galacturonan glycanohydrolase; EC 3.2.1.15) is produced with the genetically modified Trichoderma reesei strain RF6197 by AB Enzymes GmbH. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. It is intended to be used in five food manufacturing processes: fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, production of wine and wine vinegar, coffee demucilation and production of plant extracts as flavouring preparations. Since residual amounts of the total organic solids (TOS) are removed during the coffee demucilation and the production of flavouring extracts, dietary exposure was calculated only for the remaining three food processes. It was estimated to be up to 0.156 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, resulted in a margin of exposure of at least 6,410. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and matches were found with a number of pollen allergens. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure, particularly in individuals sensitised to pollen cannot be excluded. 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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