據(jù)了解，這種食品酶是由非轉(zhuǎn)基因Talaromyces cellulolyticus菌株NITE BP-03478生產(chǎn)的，旨在用于八種食品制造過(guò)程：烘焙過(guò)程、釀造過(guò)程、果汁生產(chǎn)中的水果和蔬菜加工、葡萄酒和葡萄酒醋生產(chǎn)、果汁以外產(chǎn)品的水果和蔬菜加工、精制橄欖油生產(chǎn)的水果和蔬菜加工、咖啡豆脫蛋白和淀粉生產(chǎn)中的谷物處理。

 

　　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)，特別是對(duì)花粉過(guò)敏的個(gè)體。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)引起安全問(wèn)題。部分原文報(bào)道如下：

 

　　The food enzyme containing endo-polygalacturonase ((1–4)-α-d-galacturonan glycanohydrolase; EC 3.2.1.15) and cellulase (4-(1,3;1,4)-β-d-glucan 4-glucanohydrolase; EC 3.2.1.4) activities is produced with the non-genetically modified Talaromyces cellulolyticus strain NITE BP-03478 by Meiji Seika Pharma Co., Ltd. It is intended to be used in eight food manufacturing processes: baking processes, brewing processes, fruit and vegetable processing for juice production, wine and wine vinegar production, fruit and vegetable processing for products other than juices, fruit and vegetable processing for refined olive oil production, coffee bean demucilation and grain treatment for starch production. Since residual amounts of total organic solids (TOS) are removed during three food processes (refined olive oil production, coffee bean demucilation and grain treatment for starch production), dietary exposure was not calculated for these food processes. For the remaining five food processes, dietary exposure was estimated to be up to 3.193 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 806 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 252. A search for the similarity of the amino acid sequences of the food enzyme to known allergens was made and six matches with pollen allergens were found. The Panel considered that, under the intended conditions of use, the risk of allergic reactions by dietary exposure cannot be excluded, especially in individuals sensitised to pollen. 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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