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A scientific perspective on the regulatory status of products derived from gene editing and the implications for the GMO Directive
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A scientific perspective on the regulatory status of products derived from gene editing and the implications for the GMO Directive

Statement by the Group of Chief Scientific Advisors

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On 25 July 2018, the Court of Justice of the European Union ('the Court') decided that organisms obtained by the new techniques of directed mutagenesis are genetically modified organisms (GMOs), within the meaning of the Directive 2001/18/EC on the release of genetically modified organisms into the environment ('GMO Directive'), and that they are subject to the obligations laid down by the GMO Directive. New techniques of directed mutagenesis include gene editing such as CRISPR/Cas9 methodologies. The legal status of the products of such techniques was uncertain, because it was unclear whether they fell within the scope of the GMO Directive. These techniques enable the development of a wide range of agricultural applications and the ethical, legal, social and economic issues of their use are discussed intensively. The European Commission’s Group of Chief Scientific Advisors (the ‘Chief Scientific Advisors’) recognises the complex nature of these debates, which touch upon people’s beliefs, values, and concerns, as well as the underpinning science. The mandate of the Chief Scientific Advisors is to provide scientific advice to the European Commission. Therefore, following our explanatory note on ‘New Techniques in Agricultural Biotechnology’ (SAM, 2017a), we have examined the GMO Directive taking into account current knowledge and scientific evidence.
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ISBN 978-92-79-97286-7
DOI 10.2777/407732
Katalognummer KI-06-18-301-EN-N
ISBN 978-92-79-97282-9
DOI 10.2777/10874
Katalognummer KI-06-18-301-EN-C
PDF
ISSN ISBN 978-92-79-97286-7 DOI 10.2777/407732 Katalognummer KI-06-18-301-EN-N
Papir
ISSN ISBN 978-92-79-97282-9 DOI 10.2777/10874 Katalognummer KI-06-18-301-EN-C
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