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Regulation of Genome Editing in Plant Biotechnology: European Union

  • Brigitte VoigtEmail author
  • Ansgar Münichsdorfer
Chapter

Abstract

Plants, animals and microorganisms obtained by any type of genome editing technology (SDN-1, SDN-2, SDN-3, ODM) are regulated through the EU’s GMO regime. A judgment of the European Court of Justice in July 2018 provided regulatory certainty about their GMO status. It ended more than a decade of legal debates.

The EU’s GMO regime is harmonised at the EU level and encompasses authorisation requirements regarding contained use, field trials and the placing on the market of GMOs as well as post-market monitoring, labelling, traceability and identity preservation obligations. Thus, GMOs are governed in a comprehensive, detailed and rigorous manner. In addition, GMOs are subject to widespread political and societal rejection.

The impossibility to distinguish certain genetic alterations induced by genome editing from those that are induced naturally or by traditional breeding techniques leads to problems as yet unresolved. It might hamper GMO authorisation, the EU’s zero tolerance policy for unauthorised GMOs and GM labelling.

It cannot be excluded that amendments to the GMO framework will be introduced in the aftermath of the European Court of Justice’s judgment. Without any, it will take several years until the first genome edited plants are commercially cultivated or imported.

Notes

Acknowledgment

The research for this article was conducted as part of the project “Genome editing in plant biotechnology – a science based legal analysis of regulatory problems” funded by the German Federal Ministry of Education and Research; principal investigator Professor Dr. Hans-Georg Dederer, University of Passau, Head of Chair of Constitutional and Administrative Law, Public International Law, European and International Economic Law.

The authors would like to thank their colleague Katharina Schreiber for her valuable research for Sect. 5.1 (“Introduction”). They would also like to thank the other team members, Sabrina Brzezinski, Clemens Dienstbier, Sebastian Graup and David Hamburger as well as the project coordinator Professor Dr. Dederer for their support.

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Authors and Affiliations

  1. 1.Faculty of LawUniversity of PassauPassauGermany

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