We echoed the need to revise the European regulations on GMOs after the judgment of July 25, 2018 of the Court of Justice of the European Union ruling that all cultivated varieties resulting from techniques of genetic modification after 2001 are GMOs and must be subject to the provisions of Directive 2001/18 / EC and associated subsequent texts. The transposition into French law of this legal decision by the Council of State on February 7, 2020 followed the same logic by submitting the organisms obtained by means of techniques or methods of mutagenesis “called directed or genome editing” (or NBT, New Breeding Techniques), and “in vitro random mutagenesis techniques subjecting plant cells to chemical mutagens” to “obligations imposed on genetically modified organisms by this directive” (1).
These decisions have been criticized by the Group of Senior Scientific Advisers to the European Commission (the Scientific Advice Mechanism) which had stressed in November 2018 (2) in a public declaration that Directive 2001/18 / EC has become unsuitable due to advances in scientific knowledge and recent technical advances. This High Authority recommended that only the characteristics of the final product should be assessed, not the method on how to obtain it . Following this statement, the European citizen initiative named Grow scientific progress, initiated by a group of students from the University of Wageningen (Netherlands) of 8 different nationalities, requested a review of European regulations (petition closed in July 2020 (3)).
Recent statement of leaders of the German Greens Party to adapt European regulation to NBTs
In June 2020, more than twenty personalities of the German Greens party, just followed suit by signing a contribution entitled: “New Times, New Answers: Regulating the Law of genetic engineering in a modern way” (4). Kathtrin Zinkant, journalist from the Süddeutsche Zeitung (5) remarks among the signatories Katharina Fegebank, Hamburg senator (Senate Scholz II) and second mayor for science, research and equality, Anna Christmann, member of the German parliament the Bundestag since 2017 and spokesperson for technologies and innovation policies of the parliamentary group of his party Alliance90 /The Greens, his colleague the green deputy Kai Gehring as well as Hans-Josef Fell expert in renewable energies.
The signatories affirm that it is imperative to combine sustainability and new biotechnologies stemming from genetic engineering. For this, they formulate six proposals which emphasize that genetic engineering applied in human health is universally accepted and that applications in agriculture can also be part of sustainability with “appropriate supervision”.
The signatories stressed that these technologies could help Europe to quickly adapt to future challenges, most notably climate change. They also noted that the current regulations favor “monopoly structures in agriculture (6)”, which hinder public research, and they insisted on the need to have new rules to give public institutions and medium-sized enterprises an opportunity to use these new techniques.They conclude that the current European regulations on GMOs “no longer correspond to the current state of science” and that “the decisive factor is not the technology, but the result”, and advocate “a balanced technological assessment and prudent in dialogue with science” .
This analysis calls for an European adaptation of the regulations applied to GMOs for the approval of genome editing products (NBT). Many countries have already adopted such regulations. For instance, the new American SECURE Rule was published in the Federal Registrer on May 18, 2020. It indicates that plants genetically edited for minor modifications to the genome or the introduction of a gene known to belong to the plant’s genetic pool will be exempted from regulation applied to GMOs. In the United States, it is now the characteristics of the final NBT product that are evaluated, not the method of obtaining it. This will not only lead to drop approval costs but also to save time for R&D developments and to have a larger offer.
Will the call of the German Greens be decisive for moving the regulatory lines in the European Union? Over the past decade, more than 80% of patents on the most promising new genome editing technique, CRISPR, have been obtained by China and the United States(7). In this context, revising the European regulations on GMOs and exempting most NBT products from them is crucial for European and French agricultural independence.
(1) Conseil d’Etat, 7 février 2020, Organismes obtenus par mutagenèse .https://www.conseil-etat.fr/ressources/decisions-contentieuses/dernieres-decisions-importantes/conseil-d-etat-7-fevrier-2020-organismes-obtenus-par-mutagenese
(2) A scientific perspective on the regulatory status of products derived from gene editing and the implications for the GMO Directive – Statement of the Group of Senior Scientific Advisors – EU Publications Office, Published: 2019-06-04, https://op.europa.eu/en/publication-detail/-/publication/a9100d3c-4930-11e9-a8ed-01aa75ed71a1/language-en/format-PDF/source-94584603
(3) Grow scientific progress: crops matter! https://europa.eu/citizens-initiative/initiatives/details/2019/000012_en
(4) Anna Chritsman et al. 10 Juni 2020, Debattenbeitrag : Neue Zeiten, neue Antworten: Gentechnikrecht zeitgemäß regulieren, https://www.gruene.de/artikel/neue-zeiten-neue-antworten-gentechnikrecht-zeitgemaess-regulieren
(5) Kathtrin Zinkant, Haltung zur Gentechnik: Grüne fordern Umdenken, Süddeutsche Zeitung 10 Juni 2020 https://www.sueddeutsche.de/wissen/klimawandel-landwirtschaft-gruene-gentechnik-crispr-1.4932845
(6) I-e the 3 Majors Agrifood and Biotech Compagnies Corteva, ChemChina et Bayer. Ref Catherine Regnault-Roger, Des plantes biotech au service de la santé du végétal et de l’environnement, Fondation pour l’innovation politique, janvier 2020, p 18. http://www.fondapol.org/etude/des-plantes-biotech-au-service-de-la-sante-du-vegetal-et-de-lenvironnement/
(7) Catherine Regnault-Roger Gmos and genome edited organisms (Geos): regulatory and geopolitical challenges, Fondation pour l’innovation politique, 23 March 2020, 56p http://www.fondapol.org/en/etudes-en/gmos-and-genome-edited-organisms-geos-regulatory-and-geopolitical-challenges/
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