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Synthetic Biology III - Risks to the environment and biodiversity related to synthetic biology and research priorities in the field of synthetic biology

Final Opinion

Cur síos

WG on Synthetic Biology
SCENIHR members: Theo Vermeire, Michelle Epstein, Philippe Hartemann, Ana Prokovya, Luis Martinez Martinez
SCHER member: Teresa Fernandes
SCCS members: Qasim Chaudhry, Suresh Chandra Rastog
External experts: Rainer Breitling, Camille Delebecque, Timothy Gardner, Katia Pauwels, James Philp, Markus Schmidt, Eriko Takano
Acknowledgement: Members of the Working Group are acknowledged for their valuable contribution to this Opinion.,,
On request from: European Commission
Adopted on: 27 November 2015

Content of the opinion:

In Opinion I on Synthetic Biology (SynBio), the three Scientific Committees SCHER, SCENIHR and SCCS answered three questions from the European Commission on the scope, definition and identification of the relationship between SynBio and genetic engineering and the possibility of distinguishing the two. The definition reads: Synthetic Biology is the application of science, technology and engineering to facilitate and accelerate the design, manufacture and/or modification of genetic materials in living organisms. In Opinion II, the three Scientific Committees addressed five questions focused on the implications of likely developments in SynBio for humans, animals and the environment and on determining whether existing health and environmental risk assessment practices of the European Union for Genetically Modified Organisms are adequate for SynBio. Additionally, the Scientific Committees were asked to provide suggestions for revised risk assessment methods and risk mitigation procedures including safety locks.

The current Opinion addresses specific risks to the environment from SynBio organisms, processes and products, partly in the context of Decision XI/11 of the Convention of Biodiversity (CBD) (CBD)(CBD)(CBD), identifies major gaps in knowledge to be considered for performing a reliable risk assessment and provides research recommendations resulting from gaps identified. The Scientific Committees confined the scope of their analysis to the foreseeable future, acknowledging that its findings should be reviewed and updated again after several years, depending on the development of the SynBio technology. Outside the scope of the current mandates are specific, thorough analyses of social, governance, ethical and security implications as well as human embryonic research..


Synthetic biology; biotechnology; bioengineering; genetic engineering; microbiology; molecular biology; regulatory framework; genetically modified organisms (GMO); risk assessment; risk assessment methodology; risk mitigation; genetic part libraries; minimal cells; designer chassis; protocells and artificial cells; xenobiology; DNA synthesis and genome editing; citizen science; Do-It-Yourself biology

Opinion to be cited as:

SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), SCHER (Scientific Committee on Health and Environmental Risks), SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), SCCS (Scientific Committee on Consumer Safety), Synthetic Biology III – Research priorities, Opinion, December 2015.


1 NOLLAIG 2021
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