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首页> 外文期刊>EFSA supporting publications >Annual Report on preparatory support for the statistical evaluation of the comparative assessment of GM plant field trials and for the evaluation of toxicological studies for GM plant food/feed safety – Lot 1: Comparative statistical analysis (2017)
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Annual Report on preparatory support for the statistical evaluation of the comparative assessment of GM plant field trials and for the evaluation of toxicological studies for GM plant food/feed safety – Lot 1: Comparative statistical analysis (2017)

机译：关于转基因植物田间试验比较评估的统计评估和转基因植物食品/饲料安全毒理学研究评估的筹备支持年度报告–批次1：比较统计分析（2017年）

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摘要

To guide and assist applicants for the preparation and presentation of genetically modified (GM) plant market authorization applications, the GMO Panel of EFSA has developed guidance for the risk assessment of GM plants and derived food and feed, which describes principles, concepts, data requirements and issues to be considered when performing the risk assessment of GM plants and derived food and feed. The objective of this framework contract is to provide statistical support to the EFSA GMO Panel for the evaluation of GMO application dossiers with respect to the statistical analysis of collected data from field trials carried out for the comparative assessment according to the requirements described in the EFSA guidance on statistical considerations for the safety evaluation of GMOs and EFSA guidance on the risk assessment of food and feed from genetically modified plants (EFSA, 2011).This report describes the tasks performed in 2017 under this framework contract and their outcome. The evaluation of the statistical analysis of applications during 2017 fulfilled to a large extent the requirements described in the guidance documents. However, a few non‐compliances were reported for most of the applications evaluated and actions were undertaken.
机译：为指导和协助申请人准备和展示转基因植物市场授权申请，欧洲食品安全局GMO专家组已制定了有关转基因植物以及衍生食品和饲料风险评估的指南，其中描述了原理，概念，数据要求以及进行转基因植物以及衍生食品和饲料的风险评估时要考虑的问题。该框架合同的目的是向EFSA GMO专家组提供统计支持，以评估根据EFSA指南中描述的要求进行的用于比较评估的实地试验收集到的数据的统计分析。关于转基因生物安全性评估的统计考虑和欧洲食品安全局关于转基因植物食品和饲料风险评估的指南（欧洲食品安全局，2011年）。本报告介绍了2017年根据该框架合同执行的任务及其成果。 2017年对申请统计分析的评估在很大程度上满足了指导文件中所述的要求。但是，对于大多数评估的应用程序，都报告了一些不合规的情况，并采取了措施。

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