This follows the Court of Justice of the European Union’s judgement of 25 July 2018 that organisms obtained using new techniques of directed mutagenesis (including those popularly known as ‘gene editing techniques’) are genetically modified organisms (GMOs) and are subject to the obligations of the corresponding legislation (Directive 2001/18/EC, the ‘GMO Directive’).
The advisors conclude that the GMO Directive should be revised to reflect current knowledge and scientific evidence, and as part of a broad dialogue with relevant stakeholders and the public at large.
Carlos Moedas, Commissioner for Research, Science and Innovation, said:
Gene-editing is a critical technology with an enormous potential to improve human health and preserve the environment. I therefore welcome the statement from our Chief Scientific Advisors which will contribute to a well-informed debate on the regulatory framework needed to maintain high levels of protection while enabling innovations that contribute to the environment and wellbeing. Their statement also provides a valuable input into our reflections on future proofing regulation so that our laws can keep up with our labs.
Vytenis Andriukaitis, Commissioner for Health and Food Safety, said:
The EU is a champion of the highest standards of food safety. As a scientist myself, I see great merit in keeping pace with innovations so that society can benefit from new science and technology. To make the best out of such developments, I encourage a broad reflection and discussion on how we, as a society, want to go forward with such issues as gene editing.
The Scientific Advice Mechanism was established in October 2015 to support the Commission with high quality, timely and independent scientific advice for its policy-making activities. Its Group of Chief Scientific Advisors comprises seven independent, eminent scientists, appointed in their personal capacities.
This is the second Statement the Scientific Advisors have delivered, in addition to its five Scientific Opinions and two Explanatory Notes. This statement draws in large part on the Advisors’ Explanatory Note on New Techniques in Agricultural Biotechnology, requested by Commissioner Andriukaitis and Commissioner Moedas on behalf of the College of European Commissioners and published in April 2017. In view of the strongly held and diverse views in this area, based on citizen’s values, beliefs and concerns, the European Group on Ethics in Science and New Technologies is currently working on the ethical issues raised by such technologies.
Upon a request from the Commission, the Scientific Advisors may make further contributions to the issues raised in their statement.
A Scientific Perspective on the Regulatory Status of Products Derived from Gene Editing and the Implications for the GMO Directive
Initial statement by the Group of Chief Scientific Advisors
- 13. november 2018
- Generaldirektoratet for Forskning og Innovation