據(jù)了解，這種食品酶是由非轉(zhuǎn)基因里氏木霉菌株AR-256生產(chǎn)的，旨在用于七種食品制造過(guò)程：烘焙過(guò)程、谷物加工、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)、蒸餾酒精生產(chǎn)以及生產(chǎn)淀粉和麩質(zhì)部分的谷物處理。

 

　　經(jīng)過(guò)評(píng)估，專(zhuān)家小組認(rèn)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(guò)敏反應(yīng)的風(fēng)險(xiǎn)，尤其是對(duì)鮭魚(yú)過(guò)敏的人。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 cellulase (EC 3.2.1.4), endo-1,3(4)-β-glucanase (EC 3.2.1.6) and endo-1,4-β-xylanase (EC 3.2.1.8) is produced with the non-genetically modified Trichoderma reesei strain AR-256 by AB-Enzymes GmbH. The food enzyme is considered free from viable cells of the production organism. It is intended to be used in seven food manufacturing processes: baking processes, cereal-based processes, brewing processes, fruit and vegetable processing for juice production, wine and wine vinegar production, distilled alcohol production and grain treatment for production of starch and gluten fractions. Since the residual amounts of total organic solids (TOS) are removed during grain treatment and distilled alcohol production, dietary exposure was estimated for the remaining five processes and amounted up to 3.92 mg TOS/kg body weight (bw) per day. The toxicity studies were carried out with an endo-1,4-β-xylanase from T. reesei ■■■■■, considered by the Panel as a suitable substitute, because the genetic differences between the strains are well characterised and of no concern. Additionally, several strains derived from the production strain are considered safe by EFSA and the manufacturing of both food enzymes is similar. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by a repeated dose 90-day oral toxicity rat study. The no observed adverse effect level of 939 mg TOS/kg bw per day, the highest dose tested, compared with the estimated dietary exposure, resulted in a margin of exposure above 239. In the search for the similarity of the amino acid sequences to known allergens, one match (salmon) was found. The Panel considered that, under the intended conditions of use (except distilled alcohol production), the risk of allergic reactions by dietary exposure cannot be excluded, in particular for individuals sensitised to salmon. The Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.

 

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