Abstract
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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References
Bobek M (2018) Reference for a preliminary ruling in the Case C-528/16. Opinion of Advocate General Bobek delivered on 18 January 2018. Confédération paysanne, Réseau Semences Paysannes, Les Amis de la Terre France, Collectif vigilance OGM et Pesticides 16, Vigilance OG2 M, CSFV 49, OGM dangers, Vigilance OGM 33, Fédération Nature & Progrès vs. Premier ministre, Ministre de l’agriculture, de l’agroalimentaire et de la forêt. (Request for a preliminary ruling from the Conseil d’État (Council of State, France)). ECLI:EU:C:2018:20
BVL (2017) Stellungnahme zur gentechnikrechtlichen Einordnung von neuen Pflanzenzüchtungstechniken, insbesondere ODM und CRISPR-Cas9. BVL - Bundesamt für Verbraucherschutz und Lebensmittelsicherheit. https://www.bvl.bund.de/SharedDocs/Downloads/06_Gentechnik/gentechnikrechtlichen%20Einordnung%20von%20neuen%20Pflanzenz%C3%Bcchtungstechniken.pdf?__blob=publicationFile&v=8. Accessed 10 Sept 2017
Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. http://eur-lex.europa.eu/eli/dir/2001/18/oj. Accessed 1 Mar 2018
Econ. & Soc. Comm. (1979) Opinion of the Economic and Social Commitee on the proposal for a Council Directive establishing safety measures against the conjectural risks associated with recombinant DNA work. Official Journal of the European Communities 247(2): 3–7. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=uriserv:OJ.C_.1979.247.01.0007.01.ENG Accessed 3 Mar 2018
Griebsch T (2018) Anwendbarkeit des Gentechnikgesetzes auf nach CRISPR/Cas9 verändertes Saatgut. Natur Recht 40:92–100. https://doi.org/10.1007/s10357-018-3293-6
Kahrmann J, Bömeke O, Leggewie G (2017) Aged GMO legislation meets new genome editing techniques. EurUP 15:176–182
Martin EA, Hine R (2014) Recombinant DNA. In: A dictionary of biology, 6th ed. Oxford University Press, Oxford. eISBN: 9780191726507
Ostertag A (2006) GVO-Spuren und Gentechnikrecht: die rechtliche Beurteilung und Handhabung von ungewollten Spuren gentechnisch veränderter Organismen in konventionell und ökologisch erzeugten Produkten. Nomos, Baden-Baden
Podevin N, Davies HV, Hartung F et al (2013) Site-directed nucleases: a paradigm shift in predictable, knowledge-based plant breeding. Trends Biotechnol 31:375–383
Robienski J, Wasmer M (2018) Produkte gezielter Mutagenese sind keine GVOs gemäß Art. 3 i.V.m. Anhang I B der Richtlinie 2001/18/EG. J Verbrauch Lebensm. https://doi.org/10.1007/s00003-017-1147-4
Ronellenfitsch M (2016) GenTR/BioMedR, 95. Aktualisierung, Dezember 2016 (Ronellenfitsch). In: Recht der Gentechnik und Biomedizin: GenTR/BioMedR: EG-Recht, Gesetze, Verordnungen, Formulare, ZKBS-Empfehlungen, Beschlüsse des LAG, Richtlinien, Empfehlungen und Stellungnahmen von Institutionen und Vereinigungen., erste Ausgabe 1997. C.F. Müller, Heidelberg, pp 32–46
Singleton P, Sainsbury D (2006) Mutagenesis. In: Dictionary of microbiology and molecular biology. 3rd ed. Wiley, Chichester (West Sussex, UK)
Sprink T, Metje J, Hartung F (2015) Plant genome editing by novel tools: TALEN and other sequence specific nucleases. Curr Opin Biotechnol 32:47–53. https://doi.org/10.1016/j.copbio.2014.11.010
Voss U (2006) Die Novelle der Freisetzungsrichtlinie - Richtlinie 2001/18/EG. Nomos, Baden-Baden
Woo JW, Kim J, Kwon SI et al (2015) DNA-free genome editing in plants with preassembled CRISPR-Cas9 ribonucleoproteins. Nat Biotechnol 33:1162–1164. https://doi.org/10.1038/nbt.3389
Acknowledgements
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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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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DOI: https://doi.org/10.1007/s00003-018-1166-9