重點聚焦!歐盟評估一種食品酶內(nèi)切-1,3(4)-β-葡聚糖酶的安全性
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2023年2月22日,歐盟食品安全局就一種食品酶內(nèi)切-1,3(4)-β-葡聚糖酶(endo-1,3(4)-β-glucanase)的安全性評價發(fā)布意見。據(jù)了解,這種食品酶是由非轉(zhuǎn)基因Cellulosimicrobium funkei菌株AE-TN生產(chǎn)的,旨在用于烘焙過程和酵母加工中。
經(jīng)過評估,專家小組認為,在預期的使用條件下,不能排除通過飲食接觸引起過敏反應的風險,但這種情況發(fā)生的可能性很低。然而,由于在食品酶中存在生產(chǎn)菌株的活細胞,專家組得出結(jié)論,該食品酶不能被認為是安全的。部分原文報道如下:
The food enzyme endo-1,3(4)-β-glucanase (3-(1–3;1–4)-β-d-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) is produced with the non-genetically modified Cellulosimicrobium funkei strain AE-TN by Amano Enzyme Inc. The food enzyme was shown to contain viable cells of the production strain, which belongs to a species that has been implicated in opportunistic infections in humans. The food enzyme is intended to be used in baking processes and yeast processing. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 1.75 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 1,788 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 1,022. 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 for this to occur is low. However, due to the presence of viable cells of the production strain in the food enzyme, the Panel concluded that the food enzyme cannot be considered safe.
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