Guidance for risk assessment of food and feed from genetically modified plants EFSA Panel on Genetically Modified Organisms (GMO)
Guidance for risk assessment of food and feed from genetically modified plants EFSA Panel on Genetically Modified Organisms (GMO)
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DOI：
10.2903/j.efsa.2011.2150
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发表时间：
2011-05-01
期刊：
影响因子：
3.3
通讯作者：
Wal, Jean-Michel
中科院分区：
文献类型：
--
作者：
Andersson, Hans Christer;Arpaia, Salvatore;Wal, Jean-Michel
本文件提供了在关于转基因食品和饲料的第1829/2003号法规（EC）框架内提交的含有转基因植物、由转基因植物组成或由转基因植物生产的食品和饲料的风险评估的最新指南。建议的基因改造植物及衍生食物和饲料的风险评估策略，旨在采用适当的方法，将基因改造植物及衍生食物和饲料与其各自的比较物作比较。这种比较方法的基本假设是，传统种植的作物已经获得了消费者和/或驯养动物安全使用的历史。该文件就如何对转基因植物的相关特性进行比较分析提供了指导。该文件详述风险评估的不同组成部分：分子特性分析，提供有关基因插入物的结构和表现，以及预期性状的稳定性的资料;毒理学评估，探讨基因改造对基因改造植物和/或衍生食物和饲料造成的生物相关变化的影响;评估新蛋白质及源自转基因植物的全食物的潜在致敏性;进行营养评估，以评估源自转基因植物的食物及饲料在营养上是否对人类及/或动物并无不利。此外，该文件的每一节都具体阐述了对含有转化事件组合的转基因植物的要求，就如何确定该组合是稳定的以及在可能引起安全问题的事件之间没有发生相互作用提供了指导。该文件不包括转基因植物的环境风险评估，这是在一个独立的环境风险评估（ERA）的指导文件，由欧洲食品安全局转基因小组制定。
This document provides updated guidance for the risk assessment of food and feed containing, consisting or produced from genetically modified (GM) plants, submitted within the framework of Regulation (EC) No 1829/2003 on GM food and feed. The risk assessment strategy for GM plants and derived food and feed proposed seeks to deploy appropriate approaches to compare GM plants and derived food and feed with their respective comparators. The underlying assumption of this comparative approach is that traditionally cultivated crops have gained a history of safe use for consumers and/or domesticated animals. The document provides guidance on how to perform the comparative analysis of the relevant characteristics of the GM plant. The document addresses the details of the different components of the risk assessment: the molecular characterisation, which provides information on the structure and expression of the insert(s) and on the stability of the intended trait(s); the toxicological assessment, which addresses the impact of biologically relevant change(s) in the GM plant and/or derived food and feed resulting from the genetic modification; the assessment of potential allergenicity, of the novel protein(s) as well as of the whole food derived from the GM plant; the nutritional assessment to evaluate whether food and feed derived from a GM plant is not nutritionally disadvantageous to humans and/or animals. In addition every section of the document addresses specifically the requirements for GM plants containing a combination of transformation events, providing guidance on how to establish that the combination is stable and that no interactions occurs between the events that may raise safety concerns. The document does not cover the environmental risk assessment of GM plants which is addressed in a stand-alone environmental risk assessment (ERA) guidance document developed by the EFSA GMO Panel.