Evaluation of existing guidelines for their adequacy for the molecular characterisation and environmental risk assessment of genetically modified plants obtained through synthetic biology.
Evaluation of existing guidelines for their adequacy for the molecular characterisation and environmental risk assessment of genetically modified plants obtained through synthetic biology.
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评估现有指南对通过合成生物学获得的转基因植物的分子表征和环境风险评估的适当性。
DOI：
10.2903/j.efsa.2021.6301
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发表时间：
2021-03
期刊：
影响因子：
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通讯作者：
Mullins E
中科院分区：
文献类型：
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作者：
EFSA Panel on Genetically Modified Organisms (GMO);Naegeli H;Bresson JL;Dalmay T;Dewhurst IC;Epstein MM;Firbank LG;Guerche P;Hejatko J;Moreno FJ;Nogue F;Rostoks N;Sanchez Serrano JJ;Savoini G;Veromann E;Veronesi F;Casacuberta J;De Schrijver A;Messean A;Patron N;Zurbriggen M;Alvarez F;Devos Y;Gennaro A;Streissl F;Papadopoulou N;Mullins E
合成生物学（SynBio）是工程学和生物学的交叉学科，旨在开发新的生物系统并赋予活细胞新的功能。欧盟委员会要求EFSA评估SynBio在农业食品中的发展，旨在确定现有风险评估指南的充分性，并确定是否需要更新指南。本意见的范围涵盖了通过SynBio获得的转基因植物的分子特征和环境风险评估，这些转基因植物旨在用于种植或食品和饲料目的。非食品科学委员会（2014年，2015年）以前对SynBio的工作被使用，并与EFSA委托进行的水平扫描练习的输出进行了补充，以确定与此职权范围相关的最现实和即将到来的SynBio案例。除了欧盟委员会非食品科学委员会先前确定的六个SynBio类别之外，地平线扫描没有确定其他部门/进展。这项工作确实表明，在不久的将来（下一个十年）进入市场的植物SynBio产品可能会使用现有的遗传修饰和基因组编辑技术将SynBio方法应用于其开发。此外，转基因生物小组（GMO）工作组选择了三个假设的SynBio案例研究，以进一步支持本科学意见的范围界定工作。通过使用选定的案例，GMO专家组得出结论，欧盟监管框架和现有EFSA指南的要求足以对未来10年将开发的SynBio产品进行风险评估，尽管具体要求可能不适用于所有产品。GMO小组承认，随着SynBio的发展，可能需要调整指导方针，以确保其充分和充分。本出版物链接到以下EFSA支持出版物文章：http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-2000/full
Synthetic Biology (SynBio) is an interdisciplinary field at the interface of engineering and biology aiming to develop new biological systems and impart new functions to living cells. EFSA has been asked by the European Commission to evaluate SynBio developments in agri‐food with the aim of identifying the adequacy of existing guidelines for risk assessment and determine if updated guidance is needed. The scope of this opinion covers the molecular characterisation and environmental risk assessment of such genetically modified plants obtained through SynBio, meant to be for cultivation or food and feed purposes. The previous work on SynBio by the non‐food scientific Committees (2014, 2015) was used and complemented with the output of a horizon scanning exercise, which was commissioned by the EFSA to identify the most realistic and forthcoming SynBio cases of relevance to this remit. The horizon scan did not identify other sectors/advances in addition to the six SynBio categories previously identified by the non‐food scientific committees of the European Commission. The exercise did show that plant SynBio products reaching the market in the near future (next decade) are likely to apply SynBio approaches to their development using existing genetic modification and genome editing technologies. In addition, three hypothetical SynBio case studies were selected by the working group of the Panel on Genetically Modified Organisms (GMO), to further support the scoping exercise of this Scientific Opinion. Using the selected cases, the GMO Panel concludes that the requirements of the EU regulatory framework and existing EFSA guidelines are adequate for the risk assessment of SynBio products to be developed in the next 10 years, although specific requirements may not apply to all products. The GMO Panel acknowledges that as SynBio developments evolve, a need may exist to adjust the guidelines to ensure they are adequate and sufficient. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-2000/full