欧盟评估一种由纤维素酶、内切-1,3（4）-β-葡聚糖酶和内切-1,4-β-木聚糖酶组成的食品酶的安全性

 

　　据了解，这种食品酶是由非转基因里氏木霉菌株AR-256生产的，旨在用于七种食品制造过程：烘焙过程、谷物加工、酿造过程、果汁生产中的水果和蔬菜加工、葡萄酒和葡萄酒醋生产、蒸馏酒精生产以及生产淀粉和麸质部分的谷物处理。

 

　　经过评估，专家小组认为，在预期的使用条件下（蒸馏酒精生产除外），不能排除饮食暴露引起过敏反应的风险，尤其是对鲑鱼过敏的人。根据所提供的数据，小组得出结论，该食品酶在预期的使用条件下不会引起安全问题。部分原文报道如下：

 

　　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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