Published online by Cambridge University Press: 19 December 2019
On July 25, 2018, the Court of Justice of the European Union (CJEU, the Court) rendered its judgment in the case C-528/16, Confédération paysanne and Others. It is a landmark decision in that the Court essentially decided that genome-edited organisms are “genetically modified organisms” (GMOs) governed by the EU's regulatory framework on GMOs without exception.
1 Case C-528/16, Confédération paysanne and Others, ECLI:EU:C:2018:583 [hereinafter CJEU Judgment].
2 In accordance with Article 267(1)(b), (3) TFEU, which lays down the obligation of national courts whose decisions cannot be appealed any more to refer questions on the interpretation of secondary EU law to the CJEU for a preliminary ruling.
3 Article D. 531-2 of the Environmental Code.
4 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, OJ L 106, 17.4.2001, p. 1.
5 See Article D. 531-2 in conjunction with Article L. 532-2 of the Environmental Code, which implement Article 3(1) in conjunction with Annex I B(1) of the GMO Directive.
6 Conseil d'État, 3e et 8e ch., 3 oct. 2016, n°388649, Confédération Paysanne, ECLI:FR:CECHR:2016:388649.20161003 [hereinafter Conseil d'État decision].
7 Id. ¶ 23.
8 Id. More specifically, the Conseil d'État referred only to “SDN1.” Regarding the different variants, i.e., SDN1, SDN2, and SDN3 of site-directed nuclease mutagenesis, see, e.g., European Commission, New Techniques in Agricultural Biotechnology 58–59 2017, https://ec.europa.eu/research/sam/index.cfm?pg=agribiotechnology.
9 Conseil d'État decision ¶ 23.
10 Id.
11 Id.
12 Id. ¶ 28.
13 Id.
14 CJEU Judgment ¶¶ 23, 28, 29, 47, 48, 53.
15 Id. ¶ 48.
16 See CJEU Rules of Procedure art. 64(2)(d), 70.
17 CJEU Statute arts. 16(2)(1)–(2).
18 Opinion of Advocate General Bobek, Case C-528/16, ECLI:EU:C:2018:20 [hereinafter AG Opinion].
19 CJEU Judgment ¶ 26.
20 GMO Directive, art. 2(2).
21 On this debate, see, e.g., Thorben Sprink, Dennis Eriksson, and Joachim Schiemann et al., Regulatory Hurdles for Genome Editing: Process- vs. Product-Based Approaches in Different Regulatory Contexts, 35 Plant Cell Reports 1493, 1494 (2016).
22 CJEU Judgment ¶¶ 38, 54. See supra note 8 regarding the meaning of “SDN1.”
23 GMO Directive, art. 3(1) in conjunction with Annex I B(1).
24 CJEU Judgment ¶ 42.
25 GMO Directive, art. 1.
26 Supra in and at notes 9–13. See CJEU Judgment ¶¶ 23–24, 47–48.
27 CJEU Judgment ¶ 51.
28 AG Opinion ¶¶ 98–107.
29 CJEU Judgment ¶ 55.
30 Council Directive 2002/53/EC of 13 June 2002 on the Common Catalogue of Varieties of Agricultural Plant Species, OJ L 193, 20.7.2002, p. 1.
31 CJEU Judgment ¶ 68.
32 Id. ¶ 69.
33 Id. ¶ 82.
34 GMO Directive, Annex IV(A)(7); see also Annex IIIA(II)(A)(6)–(7), (II)(C)(2)(f)–(g), (V)(A)(3), Annex IIIB(I)(B)(5), (II)(B)(5).
35 See World Trade Organization, Committee on Sanitary and Phytosanitary Measures, International Statement on Agricultural Applications of Precision Biotechnology, Oct. 30, 2018 (G/SPS/GEN/1658/Rev.2).
36 World Trade Organization, Members Discuss Precision Biotechnology as a Tool for Agricultural Biotechnology, November 1–2, 2018, https://www.wto.org/english/news_e/news18_e/sps_01nov18_e.htm.