據(jù)了解，這種食品酶是由轉(zhuǎn)基因地衣芽孢桿菌菌株NZYM-BT生產(chǎn)的，旨在用于牛奶加工中乳糖的水解。

 

　　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(xiǎn)，尤其是對半乳糖苷酶或懸鈴木花粉的匹配過敏原敏感的個(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引起安全隱患。部分原文報(bào)道如下：

 

　　The food enzyme β-galactosidase (β-d-galactoside galactohydrolase; EC 3.2.1.23) is produced with the genetically modified Bacillus licheniformis strain NZYM-BT by Novozymes A/S. The genetic modifications do not give rise to safety concerns. The production strain has been shown to qualify for the qualified presumption of safety (QPS) status. 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 the hydrolysis of lactose. based on the assumption that all selected milk and milk products are enzymatically treated, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.34 mg TOS/kg body weight (bw) per day in European populations. Toxicological data were reported and were considered as supporting evidence of the safety of the food enzyme. 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 672 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 1,950. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and one match was 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, especially in individuals sensitised to galactosidase or to the matching allergen of pollen from Platanus. 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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