今日報丨歐盟評估轉(zhuǎn)基因黑曲霉菌株DSM 29544生產(chǎn)的凝乳酶的安全性
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2022年8月8日,歐盟食品安全局就一種凝乳酶(chymosin)的安全性評價發(fā)布意見。據(jù)了解,這種食品酶是由轉(zhuǎn)基因黑曲霉菌株DSM 29544生產(chǎn)的,旨在用于奶酪生產(chǎn)和發(fā)酵乳制品生產(chǎn)的牛奶加工中。
經(jīng)過評估,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和誘發(fā)反應(yīng)的風(fēng)險,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),評估小組得出結(jié)論,這種食品酶在預(yù)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 chymosin (EC 3.4.23.4) is produced with the genetically modified Aspergillus niger strain DSM 29544 by Chr. Hansen. 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 milk processing for cheese production and for production of fermented milk products. based on the maximum use levels, dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.09 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 84.1 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure above 930. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and two 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 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.