據(jù)了解，這種食品酶是由非轉(zhuǎn)基因曲霉屬菌株GD-FAL生產(chǎn)的，旨在用于牛奶加工中的乳糖水解。

 

　　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反應(yīng)的風(fēng)險，但這種可能性被認(rèn)為很低?；趯z傳毒性的其余關(guān)注、對大鼠進(jìn)行的90天重復(fù)劑量口服毒性研究的不足以及關(guān)于食品酶中缺乏生產(chǎn)菌株的活細(xì)胞的缺失數(shù)據(jù)，評估小組無法就該食品酶的安全性得出結(jié)論。部分原文報道如下：

 

　　The food enzyme β-galactosidase (EC 3.2.1.23) is produced with the non-genetically modified Aspergillus sp. strain GD-FAL by Godo Shusei Co., Ltd. The food enzyme is intended to be used in milk processing for the hydrolysis of lactose. The absence of viable cells of the production organism in the food enzyme was not demonstrated. based on the assumption that all milk/dairy products are enzymatically treated, dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.301 mg TOS/kg body weight per day in European populations. The data provided did not allow concerns of genotoxicity of the food enzyme to be excluded. The systemic toxicity could not be assessed in the absence of an appropriate repeated dose 90-day oral toxicity study. Consequently, a margin of exposure was not calculated. 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. based on the remaining concerns on genotoxicity, the inadequacies of the 90-day repeated dose oral toxicity study in rats and the missing data regarding the absence of viable cells of the production strain in the food enzyme, the Panel could not conclude on the safety of this food enzyme.

 

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