合成生物学(SynBio)是工程学和生物学界面的跨学科领域,旨在开发新的生物系统并赋予活细胞新的功能。欧盟委员会已要求EFSA评估SynBio在农业食品方面的发展,目的是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。本意见的范围包括通过SynBio获得的此类转基因植物的分子表征和环境风险评估,用于种植或食物和饲料的目的。非食品科学委员会先前关于SynBio的工作(2014年,2015年)被使用,并补充了地平线扫描练习的输出,这是由EFSA委托,以确定最现实的和即将到来的SynBio案件相关的这一职权范围。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/进步。这项研究表明,植物SynBio产品在不久的将来(未来十年)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,三个假设的SynBio案例研究由转基因生物(GMO)小组的工作组选择,进一步支持本科学意见的范围界定工作。使用选定的案例,GMO小组认为,欧盟监管框架和现有EFSA指南的要求足以对未来10年内开发的SynBio产品进行风险评估,虽然具体要求可能不适用于所有产品。GMO小组承认,随着SynBio开发的发展,可能需要调整准则,以确保它们足够和充分。
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.