Controversy about genome editing in food and feed
Significant controversies arise from diverging interpretations of Directive 2001/18/EG. There is no consensus, for example, on if the concept of GMO should be understood as process oriented or result oriented. With process orientation the assessment's focus is on how the organism is manufactured, whereas with result orientation the assessment's focus is on the properties of the resulting organism.
This controversial issue was the subject of a judgement by the European Court of Justice (judgement of 25 July 2018). The French agricultural union Confédération paysanne, together with eight other associations, had brought an action against the French legislation in force until then, according to which organisms obtained by mutagenesis were exempt from the GMO Directive. The reason given was that mutagenesis processes, in contrast to transgenesis processes, caused changes in the organisms that could also occur naturally. The complaint related in particular to the mutagenesis methods newly developed since the adoption of the GMO Directive, with which targeted mutations could be obtained in vitro aimed at resistance to certain herbicides. The judgement of the European Court of Justice established that organisms obtained by mutagenesis are genetically modified organisms (GMOs) and are in principle subject to the obligations laid down in the GMO Directives. The (new) processes and methods of mutagenesis would result in a change to the genetic material of an organism that could not occur naturally. However, plant species obtained by mutagenesis techniques, which have been conventionally used in a number of applications and have a long safety record, are exempt from this obligation.
For an introductory overview on the discussion see for example
Sprink, T. / Eriksson, D. / Schiemann, J. / Hartung, F. (2016): Regulatory hurdles for genome editing: process- vs. product-based approaches in different regulatory contexts. In: Plant Cell Reports 35, 1493–1506. doi: 10.1007/s00299-016-1990-2 Online Version
Further information:
Directive 2001/18/EG of the European Parliament and Council of Europe of 12. March 2001. Online Version
Court of Justice of the European Union: Press Release No. 111/18 of 25 July, 2018, Judgment in Case C-528/16. Online Version
European Commission (2021): Study on the status of new genomic techniques under Union law and in light of the Court of Justice ruling in Case C-528/16 (Executive summary). Online Version
Position papers from members of a large number of European research organisations can be found here:
European Academies’ Science Advisory Council (EASAC) (2015): New breeding techniques. Online Version
Report of the Swiss ethical commission for biotechnology in the non-human sector (EKAH) (2018): Prevention in the environment. Ethical requirements for the regulation of new biotechnologies. Online Version (German)
Public Statement by European scientists (2019) Online Version (German)
National Academy of the Sciences Leopoldina / German Research Foundation / Union of the German Academies of Sciences and Humanities (2019): Towards a scientifically justified, differentiated regulation of genome edited plants in the EU (short version) Online Version
Critical positions and demands for an adaption of the legal situation are also expressed in Germany. See e.g.
Wissenschaftlerkreis Grüne Gentechnik e.V. / Verband Biologie, Biowissenschaften und Biomedizin in Deutschland (2018): Offener Brief an die Bundesministerin für Bildung und Forschung, Anja Karliczek und die Bundesministerin für Ernährung und Landwirtschaft, Julia Klöckner. Nach dem EuGH-Urteil zu Genome Editing – Die Politik ist am Zug. Online Version (German)
BUND e.V. (2021): Gemeinsames Positionspapier "Gentechnik auch in Zukunft streng regulieren!" von 94 Verbänden. Online Version (German)
On 5 July 2023, the EU Commission published a proposal for a new regulation on plants obtained by certain new genomic techniques and their food and feed. The proposal provides for the introduction of two different categories and corresponding regulations for NGT plants (new genomic techniques). The Category 1 NGT plants comprise simply edited plants that have been bred using new methods such as the CRISPR/Cas gene scissors and are considered equivalent to conventional plants. Authorisation procedures and field trials for these Category 1 NGT plants are to be facilitated in future. The criteria for Category 1 NGT plants were defined in an annex to the existing genetic engineering laws. The parliament is currently in negotiations with the member states to finalise the form of the law. The Category 2 NGT plants will then include all other genetically modified plants that cannot be considered equivalent to conventional plants. EU GMO legislation will continue to apply to these Category 2 NGT plants.
Proposal for a regulation of the EU parliament and of the council on plants obtained by certain new genomic techniques and their food and feed, and amending Regulation (EU) 2017/625. Online Version
Statement of the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) and the German National Academy of Sciences Leopoldina regarding the proposal of the European Commission for an EU regulation on plants obtained by new genomic techniques. Online Version
The status of genome editing is different in other countries. For example, in 2018, the U.S. Department of Agriculture issued a statement, clarifying that it will not regulate plants that could otherwise have been developed through traditional breeding techniques. This also includes new techniques of genome editing such as CRISPR-Cas9. The USDA said that it does not want to prevent innovation when there are no discernible risks.
U.S. Department of Agriculture (USDA) Statement on Plant Breeding Innovation (2018) Online Version