Genetically modified organisms (GMOs) and derived food and feed products are subject to a risk analysis and regulatory approval before they can enter the market in the European Union (EU). In this risk analysis process, the role of the European Food Safety Authority (EFSA), which was created in 2002 in response to multiple food crises, is to independently assess and provide scientific advice to risk managers on any possible risks that the use of GMOs may pose to human and animal health and the environment. EFSA's scientific advice is elaborated by its GMO Panel with the scientific support of several working groups and EFSA's GMO Unit. This review presents EFSA's scientific activities and highlights its achievements on the risk assessment of GMOs for the first 10 years of its existence. Since 2002, EFSA has issued 69 scientific opinions on genetically modified (GM) plant market registration applications, of which 62 for import and processing for food and feed uses, six for cultivation and one for the use of pollen (as or in food), and 19 scientific opinions on applications for marketing products made with GM microorganisms. Several guidelines for the risk assessment of GM plants, GM microorganisms and GM animals, as well as on specific issues such as post-market environmental monitoring (PMEM) were elaborated. EFSA also provided scientific advice upon request of the European Commission on safeguard clause and emergency measures invoked by EU Member States, annual PMEM reports, the potential risks of new biotechnology-based plant breeding techniques, evaluations of previously assessed GMOs in the light of new scientific publications, and the use of antibiotic resistance marker genes in GM plants. Future challenges relevant to the risk assessment of GMOs are discussed. EFSA's risk assessments of GMO applications ensure that data are analysed and presented in a way that facilitates scientifically sound decisions that protect human and animal health and the environment.

译文

:转基因生物(GMO)以及衍生的食品和饲料产品在进入欧盟(EU)市场之前,必须经过风险分析和监管批准。在此风险分析过程中,于2002年为应对多种食品危机而成立的欧洲食品安全局(EFSA)的职责是就使用GMO的任何可能风险进行独立评估并向风险管理者提供科学建议可能对人类和动物健康以及环境构成影响。 EFSA的GMO小组在多个工作组和EFSA的GMO部门的科学支持下,详细阐述了EFSA的科学建议。这篇综述介绍了EFSA的科学活动,并着重介绍了EFSA存在前10年在转基因生物风险评估方面所取得的成就。自2002年以来,欧洲食品安全局(EFSA)就转基因植物市场注册申请发布了69项科学意见,其中62项用于食品和饲料的进口和加工,六种用于种植,一种用于花粉(作为食品中或食品中),关于应用转基因微生物制成的产品的销售方面有19项科学见解。拟定了几项关于转基因植物,转基因微生物和转基因动物风险评估的指南,以及针对诸如上市后环境监测(PMEM)等特定问题的风险评估。 EFSA还应欧洲委员会的要求,就欧盟成员国援引的保障条款和紧急措施,PMEM年度报告,基于生物技术的新型植物育种技术的潜在风险,根据新的科学方法对先前评估的转基因生物进行评估提供了科学建议出版物,以及转基因植物中抗生素抗性标记基因的使用。讨论了与转基因生物风险评估有关的未来挑战。 EFSA对转基因生物的风险评估可确保对数据进行分析和呈现,从而促进科学合理的决策,从而保护人类和动物健康及环境。

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