今日快看!歐盟評(píng)估非轉(zhuǎn)基因黑曲霉菌株AS 29-286生產(chǎn)的α-淀粉酶的安全性
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????2023年6月30日,歐盟食品安全局就一種食品酶α-淀粉酶(α-amylase)的安全性評(píng)價(jià)發(fā)布意見(jiàn)。據(jù)了解,這種食品酶是由非轉(zhuǎn)基因黑曲霉菌株AS 29-286生產(chǎn)的,旨在用于七種食品制造過(guò)程:烘焙過(guò)程、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、蒸餾酒精生產(chǎn)、生產(chǎn)麥芽糊精的淀粉加工、釀造過(guò)程和非葡萄酒醋生產(chǎn)。
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),小組得出結(jié)論,該食品酶在預(yù)期的使用條件下不會(huì)引起安全隱患。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 non-genetically modified Aspergillus niger strain AS 29-286 by Shin Nihon Chemical Co., Ltd. The food enzyme is considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: baking processes, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices, distilled alcohol production, starch processing for the production of maltodextrins, brewing processes and non-wine vinegar production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and starch processing for the production of maltodextrins, dietary exposure was calculated only for the remaining five food manufacturing processes. It was estimated to be up to 2.158 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 1,774 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 822. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and four matches with respiratory allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions upon 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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