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Public Health (16-06-2015)

Final Opinion - Synthetic Biology II - Risk assessment methodologies and safety aspects

Today, the European Commission and its non-food Scientific Committees1 publish their final Opinion on “Synthetic Biology II: Risk assessment methodologies and safety aspects”. This is the second of three scientific Opinions on Synthetic Biology (SynBio), concentrating on methodologies to asses possible risks to public health2.

The Opinion addresses SynBio’s implications for human and animal health as well as for the environment. It looks at whether the EU’s existing health and environmental risk assessment practices for Genetically Modified Organisms (GMOs) are adequate for SynBio. It also suggests revised risk assessment methods and risk mitigation procedures, including safety locks.

The Opinion finds that:

  • The current methodology used for GMO risk assessment can be extended to SynBio developments, given the similarities in methodologies and tools. However, there are specific cases in which new approaches may be necessary (detailed in the Opinion).
  • Present risk assessment methodologies are appropriate for assessing potential risks of SynBio activities and products. However, several improvements can be made to ensure continued safety protection proportionate to risk, while enabling scientific and technological advances in the field of SynBio. 
  • Safety locks currently available in genetic engineering are not yet sufficiently reliable for SynBio. 
  • A clear strategy for the analysis, development, testing and prototyping of applications based on new forms of bio-containment and additional layers of containment using orthogonal systems is recommended.

For more information:


1  Scientific Committee on Consumer Safety (SCCS), Scientific Committee on Health and Environmental Risks (SCHER), Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)

2 The first Opinion focused on an operational definition for SynBio,  and the third Opinion will cover requirements for further research.