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歐盟發(fā)布轉(zhuǎn)基因食品和飼料許可申請(qǐng)更新指南

嘉峪檢測(cè)網(wǎng)        2015-07-01 17:57

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(qǐng)更新指南。

   

最新指南文件介紹了更新申請(qǐng)時(shí)的數(shù)據(jù)要求,應(yīng)包含申請(qǐng)副件、上市后監(jiān)控、上市后環(huán)境監(jiān)控報(bào)告、系統(tǒng)性文獻(xiàn)搜索和評(píng)估、最新生物信息學(xué),以及其他授權(quán)期間由申請(qǐng)人完成或?yàn)榇淼母郊游募蜓芯俊?/span>

   

申請(qǐng)人需要評(píng)估收集的資料并就原先的評(píng)估報(bào)告是否繼續(xù)有效發(fā)布結(jié)論。申請(qǐng)人還可以提議修訂或者補(bǔ)充之前的授權(quán)許可條件,包括監(jiān)控計(jì)劃。

   

部分原文報(bào)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>

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