Journal of Consumer Protection and Food Safety

, Volume 13, Issue 3, pp 323–327 | Cite as

Which organisms and technologies fall under the mutagenesis exemption of the European GMO-Directive?

  • Martin WasmerEmail author
  • Jürgen Robienski
Opinion article


The European GMO-Directive’s (2001/18/EC) mutagenesis exemption may exempt organisms produced by genome editing from the legal obligations of the Directive, according to the recently published opinion of the Advocate General of the Court of Justice of the European Union (CJEU). We analyse his opinion and assess that the caveat in Art. 3(1) i.c.w. Annex 1B does not allow the use of nucleic acid vector constructs and CRISPR’s sgRNA. This represents an obstacle for genome editing in plants and animals, since most current setups use vectors. However, alternatives are under way.


Site-directed mutagenesis Genome editing GMO Directive 2001/18/EC CJEU C-528/16 New breeding techniques 



This article was written as part of the collaborative project Ethical, Legal and Social Aspects of Genome Editing in Agriculture (ELSA-GEA), funded by the German Federal Ministry of Education and Research (grant number 01GP1613D). Special thanks to Prof. Marcel Weber’s group at the Department of Philosophy of the University of Geneva for hosting Martin Wasmer as visiting researcher.

Compliance with ethical standards

Conflict of interest

This work was been funded by the German Federal Ministry of Education and Research (Grant No. 01GP1613D).


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Copyright information

© Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) 2018

Authors and Affiliations

  1. 1.Centre for Ethics and Law in the Life SciencesLeibniz Universität HannoverHannoverGermany
  2. 2.Département de PhilosophieUniversité de GenèveGenèveSwitzerland

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