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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.

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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  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).
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