Niveau juridique : Union européenne
Texte de la question (disponible en anglais, allemand
Synthetic biology is the next generation of genetic engineering techniques and represents an extreme version of earlier genetic engineering techniques used to produce GMO plants, animals, micro-organisms and foodstuffs. Among other things, synthetic biology allows for the production of entirely novel organisms, and of novel traits that cannot be produced using conventional breeding techniques.
None of the EU institutions have, to our knowledge, an official position on synthetic biology, or even an official definition of the term. This despite the fact formal discussions on the issue of synthetic biology were initiated in 2015 in the framework of the Convention on Biological Diversity (the Cartagena and Nagoya protocols). The Commission and the EU Presidency are taking part in these discussions, which aim to provide a definition of synthetic biology, and to elaborate guidelines for risk assessments of the different techniques the term applies to.
In the light of the above, the Commission is asked to answer the following:
1. What is its negotiating mandate in these discussions, and on what basis — official positions, texts or reports — is it relying on for this task?
2. Has the European Food Safety Authority been given any mandate in this regard?
3. How does it plan to inform Parliament and civil society about this issue, and involve them in the debates regarding it, and how does it intend to use their participation to formulate an EU position?
1. The EU position for the negotiations at the thirteenth meeting of the Conference of the Parties to the Convention on Biological Diversity (CBD COP13) will be determined on the basis of the Council conclusions to be adopted under the Slovak Presidency in October 2016.
2. The European Food Safety Authority has not been given a mandate to work on Synthetic biology. However, the Commission mandated its Scientific Committees(1) which have issued three opinions on Synthetic biology:
— Final Opinion on Synthetic Biology I: Definition(2),
— Final Opinion on Synthetic Biology II: Risk assessment methodologies and safety aspects(3),
— Final Opinion on Synthetic Biology III: Risks to the environment and biodiversity related to synthetic biology and research priorities in the field of synthetic biology(4).
3. The Commission welcomes views from Members of the European Parliament and stakeholders and will regularly inform them through ad-hoc meetings during the CBD COP13.
(1) The Scientific Committee on Health and Environmental Risks, the Scientific Committee on Emerging and Newly Identified Health Risks and the Scientific Committee on Consumer Safety.