據(jù)了解，這種食品酶是由非轉(zhuǎn)基因斐濟曲霉菌株NZYM-RE生產(chǎn)的，旨在用于八種食品制造過程：蒸餾酒精生產(chǎn)、釀造過程、烘焙過程、谷物加工、葡萄酒和葡萄酒醋生產(chǎn)、果汁生產(chǎn)中的水果和蔬菜加工、果汁以外產(chǎn)品的水果和蔬菜加工以及精煉橄欖油生產(chǎn)。

 

　　經(jīng)過評估，專家小組認為，在預(yù)期的使用條件下（蒸餾酒精生產(chǎn)除外），不能排除飲食暴露引起過敏反應(yīng)的風險，特別是在患有口腔過敏綜合征或?qū)δ竟线^敏的個體中。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問題。部分原文報道如下：

 

　　The food enzyme has two declared activities, endo-polygalacuronase ((1→4)-α-D-galacturonan glycanohydrolase; EC 3.2.1.15) and endo-1,3(4)-β-glucanase (3-(1→3;1→4)-β-D-glucan 3(4)-glucanohydrolase; EC 3.2.1.6) and is produced with the non-genetically modified Aspergillus fijiensis strain NZYM-RE by Novozymes A/S. The food enzyme was considered free from viable cells of the production organism. It is intended to be used in eight food manufacturing processes, i.e. distilled alcohol production, brewing processes, baking processes, cereal-based processes, wine and wine vinegar production, fruit and vegetable processing for juice production, fruit and vegetable processing for products other than juices and refined olive oil production. Since residual amounts of total organic solids (TOS) are removed during distilled alcohol production and refined olive oil production, dietary exposure was not calculated for these two processes. For the remaining six food manufacturing processes, dietary exposure was estimated to be up to 0.553 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 3,677 mg TOS/kg bw per day, the highest dose tested, resulting in a margin of exposure of at least 6,649. A search for similarity of the amino acid sequence of the food enzyme to known allergens was made and nine matches were found. The Panel considered that, under the intended conditions of use (other than distilled alcohol production), the risk of allergic reactions by dietary exposure to this food enzyme, particularly in individuals suffering from the oral allergy syndrome or sensitised to papaya, cannot be excluded. The Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.

 

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