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據(jù)歐盟食品安全局消息，6月18日歐盟食品安全局發(fā)布轉(zhuǎn)基因食品和飼料許可申請更新指南。
最新指南文件介紹了更新申請時的數(shù)據(jù)要求，應(yīng)包含申請副件、上市后監(jiān)控、上市后環(huán)境監(jiān)控報告、系統(tǒng)性文獻搜索和評估、最新生物信息學(xué)，以及其他授權(quán)期間由申請人完成或為代表的附加文件或研究。
申請人需要評估收集的資料并就原先的評估報告是否繼續(xù)有效發(fā)布結(jié)論。申請人還可以提議修訂或者補充之前的授權(quán)許可條件，包括監(jiān)控計劃。
部分原文報道如下：
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）。
原文鏈接：<http://www.efsa.europa.eu/en/efsajournal/pub/4129.htm> |
