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The genome editing technique is covered by Directive 2001/18 - Comment on Advocate Bobek’s Opinion in case C-528/16

Ludwig Krämer

elni Review 2018, Issue 1, pp. 2-6. https://doi.org/10.46850/elni.2018.001

The question, whether or not plants that were obtained by genome editing are covered by Directive 2001/181 is at present the subject of proceedings before the Court of Justice of the European Union (CJEU). In this case, Advocate General (AG) Bobek has just issued his Opinion. He concluded that such plants are exempted from the provisions of the Directive, as genome editing is a form of mutagenesis, so that the exemption of Art. 3(1) of the Directive, read in conjunction with its Annex I B, applied. The application of the precautionary principle does not lead, in his opinion, to a different result.
The Opinion of the AG is not binding for the CJEU. However, it has a considerable weight, as it is the first factual and legal analysis of the case made by someone else than one of the Parties, and as the AG is an eminent lawyer with a rich professional experience and who is in rank equal to a judge at the CJEU.
This contribution argues that the Opinion of the AG comes to conclusions which are contrary to the wording and the purpose of Directive 2001/18, and that genome editing must be understood as being covered by the provisions of that Directive.

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  1. 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 - Commission Declaration, OJ 2001 L 106/1.
  2. Court of Justice of the European Union, 2018, Judgment of the Court (Grand Chamber) of 25 July 2018. Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt. Request for a preliminary ruling from the Conseil d'État. Reference for a preliminary ruling — Deliberate release of genetically modified organisms into the environment — Mutagenesis — Directive 2001/18/EC — Articles 2 and 3 — Annexes I A and I B — Concept of ‘genetically modified organism’ — Techniques/methods of genetic modification conventionally used and deemed to be safe — New techniques/methods of mutagenesis — Risks for human health and the environment — Discretion of the Member States when transposing the directive — Directive 2002/53/EC — Common catalogue of varieties of agricultural plant species — Herbicide-tolerant plant varieties — Article 4 — Acceptability of genetically modified varieties obtained by mutagenesis for inclusion in the common catalogue — Human health and environmental protection requirement — Exemption (Case C-528/16).
  3. Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms, OJ 1990 L 117/15.
  4. 97/98/EC: Commission Decision of 23 January 1997 concerning the placing on the market of genetically modified maize (Zea mays L.) with the combined modification for insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the herbicide glufosinate ammonium pursuant to Council Directive 90/220/EEC, OJ 1997 L 31/69.
  5. European Parliament, Report of the Committee on Environment, Public Health and Consumer Protection of 28 January1999, Opinion of the Committee on Research, Technological Development and Energy of 29 September 1998, document PE 227.836 /A 4-0024/99.
  6. World Trade Organization (WTO), Dispute Settlement on Approval and Marketing of Biotechnological Products, WT/Ds 291-293, United States, Canada and Argentina v. European Communities, Dispute Panel Report of 29 September 2006.
  7. Commission, Directive Amendment of Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, COM(1998) 85, OJ 1998 C139.
  8. Court of Justice of the European Union, 1979, Judgment of the Court of 20 February 1979. Rewe-Zentral AG v Bundesmonopolverwaltung für Branntwein. Reference for a preliminary ruling: Hessisches Finanzgericht - Germany. Measures heaving an effect equivalent to quantitative restrictions (Case 120/78).
  9. Court of Justice of the European Union, 1988, Judgment of the Court of 20 September 1988. Commission of the European Communities v Kingdom of Denmark. Free movement of goods - Containers for beer and soft drinks (Case 302/86).