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


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.

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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.

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Correspondence to Martin Wasmer.

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

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Opinion articles are not peer reviewed, but concise commentary articles with a reference to recent occasions and/or developments in the fields of food, feed and commodities as well as crop protection products, veterinary drugs, genetic engineering and consumer protection. Please email us your comments, criticisms, or differing points of view to: jvl@bvl.bund.de. The editorial office reserves the right to reject and to edit and/or condense articles for publication.

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Wasmer, M., Robienski, J. Which organisms and technologies fall under the mutagenesis exemption of the European GMO-Directive?. J Consum Prot Food Saf 13, 323–327 (2018). https://doi.org/10.1007/s00003-018-1166-9

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