Reposted from Regulatory Update | 17 May 2013
By Ansis Helmanis, RegLink
The European Commission’s three Scientific Committees have been requested to provide a joint scientific opinion on the relationship of Synthetic Biology (SB) to genetic modification of organisms, its implications for human and animal health and the environment, and the major gaps in knowledge necessary for performing a reliable risk assessment.
Synthetic Biology is the term used to describe the creation of biological systems that do not exist in nature using engineering principles to better understand life processes, to generate and assemble functional modular components, and to develop novel applications or processes, such as products that produce, absorb or detect chemical substances of interest.
In December 2008, an expert working group was established by EU Member States to analyze a number of technologies, including synthetic genomics, to determine whether their use would produce a genetically modified organism as defined by the EU’s directives on the deliberate release of genetically modified organisms (Directive 2001/18/EC) and on contained use of genetically modified micro-organisms (Directive 2009/41/EC).
The Working Group’s report, finalized in December 2011, concluded that synthetic genomics (and more generally synthetic biology) is evolving so quickly and with such potential for new developments as compared to gene modification that the subject was too broad to discuss in the limited context of the Working Group.
The three EU Scientific Committees now asked to develop a joint scientific opinion are the Committee on Emerging and Newly Identified Health Risks (SCENIHR), the Committee on Consumer Safety (SCCS) and the Committee on Health and Environmental Risks (SCHER).