欧盟发布转基因食品和饲料许可申请更新指南

       据欧盟食品安全局消息，6月18日欧盟食品安全局发布转基因食品和饲料许可申请更新指南。

    最新指南文件介绍了更新申请时的数据要求，应包含申请副件、上市后监控、上市后环境监控报告、系统性文献搜索和评估、最新生物信息学，以及其他授权期间由申请人完成或为代表的附加文件或研究。

    申请人需要评估收集的资料并就原先的评估报告是否继续有效发布结论。申请人还可以提议修订或者补充之前的授权许可条件，包括监控计划。

    部分原文报道如下：

    According to Articles 11（6） and 23（6） of Regulation （EC） No 1829/2003 on genetically modified food and feed, the European Food Safety Authority should publish detailed guidance to assist applicants in the preparation and presentation of their applications for the renewal of authorisations of that genetically modified food and feed. This guidance document describes the data requirements for renewal applications, which should contain a copy of the authorisation, post-market monitoring and post-market environmental monitoring reports, systematic search and evaluation of literature, updated bioinformatics and any additional documents or studies performed by or on behalf of the applicant during the authorisation period. The applicant is requested to assess the collected information and conclude whether the previous risk assessment remains valid. The applicant can also propose amending or complementing the original conditions of the authorisation, including the monitoring plan（s）。

    原文链接：<http://www.efsa.europa.eu/en/efsajournal/pub/4129.htm>