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.
Ludwig Kraemer and Tade Spranger, for example, argue that with regard to their generation process, the aforementioned Directive can be clearly applied to organisms created through the use of CRISPR-Cas9. However, as the generated organisms in this result could have also originated with help of conventional breeding systems, the Opinion of the Federal Office of Consumer Protection and Food Safety (BVL) published on 28 February, 2017, came to the conclusion that the Directive cannot be applied to these organisms.
Further information:
Directive 2001/18/EG of the European Parliament and Council of Europe of 12. March 2001. Online Version
Legal opinion of Prof. Dr. Ludwig Kraemer. Online Version
Legal opinion of Prof. Dr. Tade Spranger. Online Version
Opinion of the BVL on the legal classification of new plant breeding systems, ODM and CRISPR-Cas9 in particular. Online Version
Further information on the the ECJ proceeding in Case C-528/16 can be found here:
Request for a preliminary ruling from the Conseil d’État (France) lodged on 17 October, 2016, Case C-528/16. Online Version
Court of Justice of the European Union: Press Release No. 04/18 of 18 January, 2018, Advocate General’s Opinion in Case C-528/16. 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
Full text of the ECJ judgement of 25 July, 2018 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
The position paper 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
European scientists unite to safeguard precision breeding for sustainable agriculture (2018). 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 Academy of Science and Engineering / Union of the German Academies of Sciences and Humanities (2015): Akademien nehmen Stellung zu Fortschritten der molekularen Züchtung und zum erwogenen nationalen Anbauverbot gentechnisch veränderter Pflanzen. 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)
Additionally, the German Federal Council tabled a bill that amends the Genetic Engineering Act (Gentechnikgesetz), also with regard to the application of new engineering techniques. This bill has drawn strong criticism from the parliamentary opposition and environmental organisations. The adoption of the bill failed in May 2017 as the German Federal Council and the German Government did not agree on proposals for amendments. The coalition agreement of the current German Federal Government announces that the ECJ’s decision will be implemented if necessary by European or national level regulations ensuring a precautionary approach and freedom of choice (cf. coalition agreement, p. 84).
The rejected bill can be found at: Drucksache 18/10459. Online Version (German)
Press Release of the German Bundestag, 26 January, 2017: "Gentechnikgesetz enttäuscht Bundesrat". Online Version (German)
Coalition agreement between CDU, CSU and SPD of the 19th legislative period, 12 March, 2018. Online Version (German)
For an introductory overview on the current status of 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
For more information see also the symposium "Brauchen wir eine neue Gentechnik‐Definition? Naturwissenschaftliche, ethische und rechtliche Perspektiven der Regulierung genom-editierter Pflanzen", hosted by the National Academy of the Sciences Leopoldina, the German Ethics Council and the German Research Foundation (14 February 2017):
Summary of the symposium Online Version (German)
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