Navigation path


Public Health (19-12-2014)

Public consultation on the Preliminary Opinion on Synthetic Biology II Risk assessment methodologies and safety aspects

The European Commission and its non-food Scientific Committees have launched a public consultation on the preliminary opinion on Synthetic Biology II– Risk assessment methodologies and safety aspects.

The consultation will run until 03/02/2015. Interested parties are invited to provide comments online on the scientific evidence of this preliminary opinion.

Synthetic Biology's application is full of exciting possibilities, from adapting crops to thrive in barren lands to growing new organs to save the lives of transplant recipients. And yet all unexplored scientific territories may pose potential risks, which is why the Scientific Committees, with this opinion address implications of likely developments in Synthetic Biology (SynBio) on human and non-human animal health and the environment and investigates whether existing health and environmental risk assessment practices of the European Union for Genetically Modified Organisms (GMOs) are adequate for SynBio.

In Opinion I on SynBio, the three Scientific Committees answered three 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 Opinion II, the SCs evaluate risk assessment methodology of contained use activities and activities involving the deliberate release of GMOs that are built on the principles outlined in Directives 2001/18/EC and 2009/41/EC and in the 'Guidance notes' published in Commission Decision 2000/608/EC.

As SynBio shares several methodologies and tools with genetic engineering, the framework for risk assessment of new SynBio developments may be addressed using current methodology used for GMO risk assessment. However, there are specific cases in which new approaches may be necessary and the opinion details these.

Though present risk assessment methodologies are appropriate for assessing potential risks of SynBio activities and products, the Scientific Committees suggest several improvements to ensure continued safety protection proportionate to risk, while enabling scientific and technological advances in the field of SynBio.

The Scientific Committees recommend 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.