Mullins Ewen, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian Crawford, Epstein Michelle M, Firbank Leslie George, Guerche Philippe, Hejatko Jan, Moreno Francisco Javier, Nogue Fabien, Rostoks Nils, Sanchez Serrano Jose Juan, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Casacuberta Josep, Zurbriggen Matias D, Fernandez Antonio, Gomez Ruiz Jose Angel, Gennaro Andrea, Papadopoulou Nikoletta, Lanzoni Anna, Naegeli Hanspeter
EFSA J. 2022 Jul 20;20(7):e07410. doi: 10.2903/j.efsa.2022.7410. eCollection 2022 Jul.
Synthetic biology (SynBio) is an interdisciplinary field at the interface of molecular engineering and biology aiming to develop new biological systems and impart new functions to living cells, tissues and organisms. EFSA has been asked by the European Commission to evaluate SynBio developments in agri-food with the aim of identifying the adequacy and sufficiency of existing guidelines for risk assessment and determine if updated guidance is needed. In this context, the GMO Panel has previously adopted an Opinion evaluating the SynBio developments in agri-food/feed and the adequacy and sufficiency of existing guidelines for the molecular characterisation and environmental risk assessment of genetically modified plants (GMPs) obtained through SynBio and reaching the market in the next decade. Complementing the above, in this Opinion, the GMO Panel evaluated the adequacy and sufficiency of existing guidelines for the food and feed risk assessment of GMPs obtained through SynBio. Using selected hypothetical case studies, the GMO Panel did not identify novel potential hazards and risks that could be posed by food and feed from GMPs obtained through current and near future SynBio approaches; considers that the existing guidelines are adequate and sufficient in some Synbio applications; in other cases, existing guidelines may be just adequate and hence need updating; areas needing updating include those related to the safety assessment of new proteins and the comparative analysis. The GMO Panel recommends that future guidance documents provide indications on how to integrate the knowledge available from the SynBio design and modelling in the food and feed risk assessment and encourages due consideration to be given to food and feed safety aspects throughout the SynBio design process as a way to facilitate the risk assessment of SynBio GMPs and reduce the amount of data required.
合成生物学是分子工程学与生物学交叉的跨学科领域，旨在开发新的生物系统，并赋予活细胞、组织和生物体新功能。欧盟委员会要求欧洲食品安全局（EFSA）评估合成生物学在农业食品领域的发展情况，以确定现有风险评估指南是否充分，并判断是否需要更新指南。在此背景下，转基因生物小组此前已通过一项意见，评估合成生物学在农业食品/饲料领域的发展情况，以及现有指南对通过合成生物学获得并将在未来十年上市的转基因植物（GMP）进行分子特征分析和环境风险评估的充分性和适用性。作为上述评估的补充，在本意见中，转基因生物小组评估了现有指南对通过合成生物学获得的转基因植物进行食品和饲料风险评估的充分性和适用性。通过选定的假设案例研究，转基因生物小组未发现通过当前及近期合成生物学方法获得的转基因植物的食品和饲料可能带来的新潜在危害和风险；认为现有指南在某些合成生物学应用中是充分的；在其他情况下，现有指南可能只是足够，因此需要更新；需要更新的领域包括与新蛋白质安全评估及比较分析相关的领域。转基因生物小组建议，未来的指导文件应就如何将合成生物学设计和建模中获得的知识整合到食品和饲料风险评估中提供指导，并鼓励在整个合成生物学设计过程中充分考虑食品和饲料安全方面，以此促进对合成生物学转基因植物的风险评估，并减少所需的数据量。
