欧盟拟更新QPS生物制剂列表

 

    QPS列表名为安全合理推定列表，可为欧盟专家组提供统一、通用的预评估方案。专家组评估了定义明确的生物制剂的安全性，以及资料的完整性。

 

    2016年4月至9月期间，共计57种生物制剂被提交至欧盟食品安全局，其中34种生物制剂仍符合QPS要求无需进行进一步风险评估，13种因风险评估不到位或资料提交不全不予纳入QPS列表，荧光假单胞菌等3种生物制品不符合QPS要求。

 

    经安全合格评定，将史密斯芽孢杆菌新增到允许添加到食品和饲料中的QPS-推荐生物制剂列表。

 

    部分原文报道如下：

 

    EFSA was requested to assess the safety of a broad range of biological agents in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety （QPS） assessment was developed to provide a harmonised generic pre-assessment to support safety risk assessments performed by EFSA's Scientific Panels. The safety of unambiguously defined biological agents （at the highest taxonomic unit appropriate for the purpose for which an application is intended） and the completeness of the body of knowledge were assessed.

 

    原文链接：http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4663/full