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Лого на Европейската комисия
Public Health
Експертно становище

Synthetic Biology II - Risk assessment methodologies and safety aspects

Final Opinion


WG on Synthetic Biology
SCENIHR members: Theo Vermeire, Michelle Epstein, Philippe Hartemann, Ana Prokovya, Eduardo Rodriguez Farre, Luis Martinez Martinez
SCHER member: Teresa Fernandes
SCCS members: Qasim Chaudhry, Suresh Chandra Rastog
External experts: Rainer Breitling, James Bridges, 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
Doi: 10.2772/63529
Adopted on: 4 May 2015

Content of the opinion:

In Opinion I on synthetic biology (SynBio), the three non-food Committees of the European Union SCHER, SCENIHR, and SCCS answered the first 3 out of 11 questions from the European Commission on scope, definition and identification of the relationship between SynBio and genetic engineering, and the possibility of distinguishing the two.

In this second Opinion (Opinion II), the Scientific Committees (SCs) addressed the five subsequent questions focused on the implications of likely developments in SynBio on human and animal health and the environment and on determining whether existing health and environmental risk assessment practices of the European Union for Genetically Modified Organisms (GMOs) are also adequate for SynBio. Additionally, the SCs were asked to provide suggestions for revised risk assessment methods and risk mitigation procedures, including safety locks.

Because SynBio is a rapidly evolving technology, the SCs suggest that risk assessment of and methodology for SynBio must be revisited at regular intervals. Although it is outside the scope of the current mandate, some background considerations about the social, governance, ethical and security implications of SynBio are also provided.


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 and 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), SCCS (Scientific Committee on Consumer Safety), Synthetic Biology II - Risk assessment methodologies and safety aspects, Opinion, May 2015.


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