Regulation of GMO field trials in the EU and new genomic techniques: will the planned reform facilitate experimenting with gene-edited plants?

Q3 Agricultural and Biological Sciences
Tomasz Zimny
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引用次数: 1

Abstract

This study presents the possible consequences of maintaining the current regulatory regime of the experimental release of genetically modified higher plants in the EU for the products of new genomic techniques (NGTs). Currently, the experimental release is a crucial stage before the authorization of a product for the market. By analyzing the data on the performance of field trials in the EU (numbers, sizes, dominating countries) and comparing the present regulatory provisions with those of selected third countries (including new provisions adopted in the UK), this study shows that the current framework of GMO (genetically modified organisms) field trials is ill-fitted for breeding activities. Due to strict limitations placed on the operator of a field trial in the EU, easing the regulatory burdens on the authorization of certain NGT products for the market may not provide researchers (especially, plant breeders) the competitive position they need if the present legal conditions for carrying out GMO field trials with certain NGT products (especially, those that are considered GMOs covered by the EU GMO legislation) are not going to change as well.

欧盟对转基因作物田间试验的监管和新的基因组技术:计划中的改革会促进基因编辑植物的试验吗?
本研究提出了在欧盟维持转基因高等植物实验释放的现行监管制度对新基因组技术(NGTs)产品的可能后果。目前,试验发布是产品进入市场授权前的关键阶段。通过分析欧盟田间试验表现的数据(数量、规模、主导国家),并将目前的监管规定与选定的第三国的监管规定(包括英国采用的新规定)进行比较,本研究表明,目前的转基因生物(转基因生物)田间试验框架不适合育种活动。由于欧盟对田间试验经营者的严格限制,如果目前对某些转基因转基因产品(特别是欧盟转基因立法所涵盖的转基因生物)进行转基因田间试验的法律条件也不会改变,那么减轻某些转基因转基因产品上市授权的监管负担可能无法为研究人员(特别是植物育种者)提供他们所需的竞争地位。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BioTechnologia
BioTechnologia Agricultural and Biological Sciences-Plant Science
CiteScore
1.60
自引率
0.00%
发文量
8
审稿时长
8 weeks
期刊介绍: BIOTECHNOLOGIA – a high standard, peer-reviewed, quarterly magazine, providing a medium for the rapid publication of research reports and review articles on novel and innovative aspects of biotechnology, computational biology and bionanotechnology.
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