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The EU regulatory framework on genetically modified organisms (GMOs).
Transgenic Research ( IF 3 ) Pub Date : 2019-08-01 , DOI: 10.1007/s11248-019-00149-y
Chantal Bruetschy 1
Affiliation  

The European Union (EU) legislation on genetically modified organisms (GMOs) aims to ensure a high level of protection for human, animal and environmental health and a well-functioning EU internal market. The framework regulates the release of GMOs into the environment and their use as, or in, food and feed. It has three main pillars: pre-market authorisation based on a prior risk assessment, traceability and labelling. Within this legal framework, the EU has authorised the placing on the market of 118 GMOs so far. These have been obtained through long-standing techniques of genetic modification, namely transgenesis. Following the adoption of the GMO legislation, new techniques of genetic modification, including new mutagenesis techniques, have been developed, which have raised questions regarding the applicability of the GMO legislation and attracted a lot of attention from stakeholders and the general public. This article provides an overview of EU GMO legislation and implementation of the EU Court of Justice ruling on organisms obtained by mutagenesis techniques, issued in July 2018. It also updates on the recent initiatives by the European Commission and EU Member States on new developments in biotechnology. The manuscript is based on the author's contribution at the OECD Conference on Genome Editing, Applications in Agriculture, Implications for Health, Environment and Regulation held in Paris on 28-29 June 2018. It is complemented with updated information.

中文翻译:

欧盟有关转基因生物的监管框架。

欧盟(EU)有关转基因生物(GMO)的立法旨在确保对人类,动物和环境健康的高水平保护,以及运作良好的欧盟内部市场。该框架规范了转基因生物向环境的释放以及它们在食品和饲料中的使用。它具有三个主要支柱:基于事前风险评估的售前授权,可追溯性和标签。迄今为止,欧盟已在此法律框架内授权将118种转基因生物投放市场。这些已通过遗传修饰的长期技术获得,即转基因。随着转基因生物立法的通过,已开发出新的基因改造技术,包括新的诱变技术,这引起了有关转基因生物立法适用性的疑问,并引起了利益相关者和公众的广泛关注。本文概述了2018年7月发布的欧盟GMO立法以及欧盟法院关于通过诱变技术获得的生物的裁决的执行情况。它还介绍了欧盟委员会和欧盟成员国最近关于生物技术新发展的举措。该手稿基于作者在2018年6月28日至29日于巴黎举行的OECD关于基因组编辑,农业应用,对健康,环境和法规的影响的会议上的贡献。本文补充了最新信息。本文概述了欧盟GMO立法以及欧盟法院于2018年7月发布的关于通过诱变技术获得的生物的裁决的执行情况。它还介绍了欧盟委员会和欧盟成员国在生物技术新发展方面的最新举措。该手稿基于作者在2018年6月28日至29日于巴黎举行的OECD关于基因组编辑,农业应用,对健康,环境和法规的影响的会议上的贡献。本文补充了最新信息。本文概述了2018年7月发布的欧盟GMO立法以及欧盟法院关于通过诱变技术获得的生物的裁决的执行情况。它还介绍了欧盟委员会和欧盟成员国最近在生物技术方面的新举措。该手稿基于作者在2018年6月28日至29日于巴黎举行的OECD关于基因组编辑,农业应用,对健康,环境和法规的影响的会议上的贡献。本文补充了最新信息。
更新日期:2019-11-01
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