8. The Challenge of Regulating Genetically Modified Organisms in the European Union: Trends and Issues

In 1990, the European Union (EU) did not exist. At that time, it was the ‘European Economic Community’ (EEC), which passed the two GMO directives (see fn. 2). In 1993, after the Maastricht Treaty (= Treaty on European Union of 7 February 1992 [hereinafter: TEU 1992]) went into force, the EEC was renamed (see Art. G[A]) (TEU 1992). It henceforth operated under the name ‘European Community’ (EC). In 2009, the EC was succeeded by the EU (Art. 1(3)(3) TEU). Thus, the EU of today is the successor of the EC and, thus, also of the EEC.

Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms, OJ L 117, 08.05.1990, p. 1; Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms, OJ L 117, 08.05.1990, p. 15.

See European Commission (ed.), Eurobarometer 73.1: Biotechnology, 2010 (Special Eurobarometer 341), in particular pp. 13 et seq., 73 et seq.

Concerning the risk discourse with regard to agricultural biotechnology see e.g. Baram and Bourrier (2011), pp. 3–8.

‘Genetic engineering’ is, very generally speaking, a three-step process. A gene is cut out of the DNA of a donor organism (step 1). This gene is inserted into a DNA molecule (step 2). That DNA molecule is the so-called ‘vector’. The function of the vector is to serve as a vehicle transferring the gene into the genome of another organism. The gene and the DNA molecule together form so-called ‘recombinant DNA’ (rDNA). Finally, the rDNA is inserted into a recipient organism (step 3). See e.g. Herdegen (2000), pp. 301–302.

In an infamous judgment of 1989, the Higher Administrative Court of Hesse declared that, concerning the need for regulation, the risks of genetic engineering were comparable at least to the risks of nuclear energy production. The Court concluded that the use of genetic engineering was not allowed until Parliament had passed a law endorsing the application of genetic engineering. See Verwaltungsgerichtshof Kassel, Juristenzeitung 1990, p. 89. As recently as 2013, the German Federal Constitutional Court held that ‘[t]he legislature was … entitled to regard … GMOs … as carrying a general risk. … The assumption of such a ‘basis risk’… is within the legislature’s prerogative of evaluation and does not require any empirical scientific evidence of the real danger potential of … GMOs and their descendants. For in a situation, … in which scientific knowledge is uncertain, the legislature is entitled to assess the potential dangers and the risks’ (BVerfGE 128, 1 (39)); English translation available at http://​www.​bundesverfassung​sgericht.​de/​SharedDocs/​Entscheidungen/​EN/​2010/​11/​fs20101124_​1bvf000205en.​html;jsessionid=​83FBC292BA593042​CF5FCC532EB35968​.​2_​cid394, para. 123).

Concerning these ‘products’, see fn. 5 and infra fn. 12.

See e.g. Dederer (1998), pp. 186–187.

For the ‘process approach’ versus ‘product approach’ debate, see e.g. Miller (1995), pp. 55 et seq.

For the early beginnings of genetic engineering, see the pioneering experiment described by Cohen et al. (1973), pp. 3240–3244.

See e.g. the US Coordinated Framework for Regulation of Biotechnology of 26 June 1986, 51 FR 23302, which still forms the basis of GMO regulation in the US (see http://​www.​aphis.​usda.​gov/​wps/​portal/​aphis/​ourfocus/​biotechnology/​sa_​regulations/​ct_​agency_​framework_​roles/​!ut/​p/​a0/​04_​Sj9CPykssy0xPLMn​Mz0vMAfGjzOK9_​D2MDJ0MjDzd3V2dD​Dz93HwCzL29jAyMT​PULsh0VAU1Vels!/).

See Dodet (1994), p. 475; Lunel (1995), p. 267; Teso (1993), p. 28. With regard to GMOs, any scientific risk assessment has to look not at the processes or techniques applied but at the products used in and resulting from the process of genetic engineering. The products that must be considered for the purposes of a science-based risk assessment of GMOs are the gene (to be transferred), the vector, the rDNA, the donor organism, the recipient organism and the resulting GMO (see also fn. 5). Whether these products present risks to human health or to the environment depends on their specific characteristics in the individual case. Admittedly, the risk assessment put forth in Art. 4(2), Annex III Directive 2009/41/EC and Arts. 4, 13, Annex II Directive 2001/18/EC is science based, and it considers relevant products and their specific properties. The problem, therefore, lies with the underlying normative assumption of the EU regulator that the process of genetic engineering as such is, by its very nature, inherently dangerous, posing a ‘basis risk’ (cf. the German Federal Constitutional Court’s reasoning in fn. 6) to human health and the environment.

For example, for over 20 years, the German Federal Ministry of Education and Research has spent over 100 million Euros to fund 300 projects, including 120 safety studies concerning GM plants. See Bundesministerium für Bildung und Forschung, Aktuelle Forschung liefert keine Belege für ökologische Schäden, Press release 041/2011 of 30 March 2011 (available at http://​www.​bmbf.​de/​_​media/​press/​pm_​20110330-041.​pdf). See also recital 21 Directive 2001/18/EC calling for such ‘systematic and independent research’.

Noted previously in and at fn. 12–13.

The term ‘GM food and feed’ refers to GMOs for food or feed use, food or feed containing or consisting of GMOs, food or feed produced from GMOs or food containing ingredients produced from GMOs (see Art. 3(1), 15(1) Regulation (EC) No. 1829/2003).

The Eurobarometer (fn. 3) survey of 2010 did not relate to the contained use of GMOs at all (except for the ethically sensitive issue of human gene therapy).

In particular, Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (OJ L 330, 5.12.1998, p. 13) significantly facilitated the notification requirements for the contained uses of GMOs. See, especially, recital 14 Council Directive 98/81/EC, which refers to the ‘considerable experience and knowledge of the risks associated with the contained use of GMMs’.

For more on the legal superstructure, see Dederer (2014).

Of course, Directive 2009/41/EC itself is not confined to contained uses of GMOs for research and development purposes. It also applies to industrial contained uses, e.g. for commercially producing drugs by means of GM bacteria (cf. also Annex IV Table II Directive 2009/41/EC).

Cf. also Annex IV Table I A Directive 2009/41/EC.

Cf. also Annex IV Table I B Directive 2009/41/EC.

Cf. also Annex IV Table I B Directive 2009/41/EC.

Art. 2(c), Annex IV Directive 2009/41/EC.

See Art. 2(c) Directive 2009/41/EC.

Cf. also recital 23 Directive 2001/18/EC.

Cf. also recital 25 Directive 2001/18/EC.

Cf. Art. 19(1) Directive 2001/18/EC.

Recital 24 Directive 2001/18/EC.

Admittedly, the Contained Use Directive only applies to genetically modified microorganisms (GMMs), see Arts. 1 and 2(a) Directive 2009/41/EC. However, most, if not all, EU member states extended their legal rules implementing the Contained Use Directive to all kinds of GMOs (see also Friant-Perrot (2010), p. 82). The member states were allowed to broaden the scope of application of the provisions set up by the Contained Use Directive because this Directive is based on Art. 192(1) TFEU (formerly Art. 175(1) TEC) and, thus, only provides for minimum standards, i.e. member states are permitted to adopt a higher level of environmental protection within their territory (see Art. 193 TFEU or ex Art. 176 TEC, respectively).

EU directives are generally not directly applicable within the EU member states (for exceptions, see the seminal decision ECJ Case 41/74, Van Duyn / Home Office, ECR 1974 p. 1337, para. 12). Thus, the Contained Use Directive and the Deliberate Release Directive had to be implemented through national law. In Germany, both directives have been implemented through the Law on Genetic Engineering (Gentechnikgesetz – GenTG), BGBl. 1993 I p. 2066.

Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed, OJ L 268, 18.10.2003, p. 1.

Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, OJ L 136, 30.4.2004, p. 1.

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, OJ L 309, 24.11.2009, p. 1.

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.

Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed, OJ 125, 11.7.1966, p. 2298.

Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed, OJ 125, 11.7.1966, p. 2309.

Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative propagation of the vine, OJ L 93, 17.4.1968, p. 15.

Council Directive 98/56/EC of 20 July 1998 on the marketing of propagating material of ornamental plants, OJ L 226, 13.8.1998, p. 16.

Council Directive 1999/105/EC of 22 December 1999 on the marketing of forest reproductive material, OJ L 11, 15.1.2000, p. 17.

Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed, OJ L 193, 20.7.2002, p. 12.

Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed, OJ L 193, 20.7.2002, p. 33.

Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes, OJ L 193, 20.7.2002, p. 60.

Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants, OJ L 193, 20.7.2002, p. 74.

Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production, OJ L 267, 8.10.2008, p. 8.

See Arts. 1, 4(1)(2), 12 Directive 2001/18/EC.

Cf. recital 28, Art. 26b Directive 2001/18/EC.

For GM food and feed, see Arts. 13, 25 Regulation (EC) No. 1829/2003; with regard to vegetable seed, see Art. 9(5)(2) Directive 2002/53/EC, Art. 9(5)(2), 31 Directive 2002/55/EC.

See, in particular, Art. 21 Directive 2001/18/EC.

See Art. 4(6) Regulation (EC) No. 1830/2003.

See Art. 4(1)–(5), Art. 5 Regulation (EC) No. 1830/2003.

For the sake of completeness, it should be mentioned that the EU’s regulatory framework for GMOs also sets rules concerning GMO exports (see Regulation (EC) No. 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms, OJ L 287, 5.11.2003, p. 1) and patenting (see Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, OJ L 213, 30.7.1998, p. 13).

For GM food and feed, see Art. 5(5)(a), Art. 6(4), Art. 17(5)(a), Art. 18 (4) Directive 2001/18/EC; for GM drugs, see Art. 6(2)(a)–(c), (3), Art. 31(2)(a)-(c), (3) Regulation (EC) No. 726/2004; for GM pesticides, see Art. 48(1) Regulation (EC) No. 1107/2009; for GM seeds, see e.g. with regard to vegetable seed Art. 4(4), Art. 7(4)(a)–(c) Directive 2002/53/EC, Art. 4(2), 7(4)(a)–(c) Directive 2002/55/EC.

See also recitals 18, 20, 27, Art. 12(1), (2) and (3)(3) Directive 2001/18/EC.

See e.g. with regard to vegetable seed Art. 3(1)(1) Directive 2002/53/EC, Art. 3(1), (2)(1) Directive 2002/55/EC.

See e.g. with regard to vegetable seed Art. 4(1) Directive 2002/53/EC, Art. 4(1) Directive 2002/55/EC.

See e.g. with regard to vegetable seed Art. 4(4), Art. 7(4)(b)(2) Directive 2002/53/EC, Art. 4(4), Art. 7(4)(b)(2) Directive 2002(55/EC.

See Arts. 4(1), 13 et seq. Directive 2001/18/EC. The Deliberate Release Directive authorises a specific crop plant line (e.g. a maize line) containing a particular transformation event. That event constitutes the specific genetic modification of the crop plant brought about by genetic engineering techniques.

See e.g. with regard to vegetable seed Art. 4(5) Directive 2002/53/EC, Art. 4(3) Directive 2002/55/EC.

In principle, the authorisation issued under the Food and Feed Regulation should extend to both food use and feed use (see Art. 27 Regulation (EC) No. 1829/2003).

Recital 33 Directive 2001/18/EC.

Dederer (2005), pp. 316–317.

31 March 2015.

http://​ec.​europa.​eu/​food/​dyna/​gm_​register/​index_​en.​cfm

For example, see the Opinion of the Scientific Panel on Genetically Modified Organisms on an application (reference EFSA-GMOUK-2004-04) for the placing on the market of glufosinate-tolerant genetically modified rice LLRICE62 for food and feed uses, import and processing, under Regulation (EC) No 1829/2003 from Bayer CropScience GmbH, The EFSA Journal (2007) 588, p. 1 et seq., at 2.

31 March 2015.

http://​gmoinfo.​jrc.​ec.​europa.​eu/​gmc_​browse.​aspx

For further information, see Herdegen and Dederer (2010), para. 1.

Dederer (2007), p. 189.

Regulations (EC) No. 1829/2003 and 1830/2003 became applicable on 18 April 2004. The first GM product approval was issued again on 19 May 2004 (see Commission Decision 2004/657/EC of 19 May 2004 authorising the placing on the market of sweet corn from genetically modified maize line Bt11 as a novel food or novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council, OJ L 300, 25.9.2004, p. 48).

European Commission (2006), pp. 6, 8.

Art. 13(1)(1) Directive 2001/18/EC, Arts. 4(2), 5(1), 17(1) Regulation (EC) No. 1829/2003.

Cf. fn. 57.

See supra in and at fn. 61.

Arts. 5(2), 17(2) Regulation (EC) No. 1829/2003.

Together with national competent authorities (see Arts. 6(3)(b) and (c), (4), 18(3)(b) and (c), (4) Regulation (EC) No. 1829/2003).

Cf. Arts. 6(3)(b), 18(3)(b) Regulation (EC) No. 1829/2003.

Cf. recital 33, Arts. 6(3)(c), (4), 18(3)(c), (4) Regulation (EC) No. 1829/2003.

Cf. Arts. 7(1), (3) and (4), 19(1), (3) and (4) Regulation (EC) No. 1829/2003.

For the distinction between risk assessment and risk management, see recital 32 Regulation (EC) No. 1829/2003.

Art. 7(1)(1), 19(1)(1) Regulation (EC) No. 1829/2003.

Art. 7(1)(1), 19(1)(1) Regulation (EU) No. 1829/2003.

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

Recital 19 Regulation (EC) No. 178/2002; see Dederer (2010a) p. 189 et seq.

See Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No. 1829/2003 as regards the possibility for the Member States to restrict or prohibit the use of genetically modified food and feed on their territory, COM(2015) 177 final, p. 3–4. According to the Commission, the rejection of an application based on other legitimate factors ‘could be legally defensible [only] if justified by overriding reasons of public interest of the same nature as those mentioned in Article 36 TFEU and related case-law of the Court of Justice … and by objectives of general interest referred to in Article 52(1) of the Charter of fundamental rights of the European Union and relevant Court’s case-law’ (op. cit., at 4 in fn. 6).

Recital 7 Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory (OJ L 68, 13.3.2015, p. 1).

See the Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No. 1829/2003 as regards the possibility for the Member States to restrict or prohibit the use of genetically modified food and feed in their territory, COM(2015) 177 final, p. 2–3.

Cf. Arts. 7(3), 19(3), 35(2) Regulation (EC) No. 1829/2003. Art. 35(2) Regulation (EC) No. 1829/2003 still refers to Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (OJ L 184, 17.7.1999, p. 23), which has been repealed by Art. 12(1) Regulation (EU) No. 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13). Instead, Arts. 5, 10 Regulation (EU) No. 182/2011 apply (Art. 13(1)(b), (c) Regulation (EU) No. 182/2011).

Arts. 5, 6 Regulation (EU) No. 182/2011.

See Arts. 7(3), 19(3) in connection with Art. 35(1) Regulation (EC) No. 1829/2003.

Art. 58(1)(1) Regulation (EC) No. 178/2002; Art. 3(2)(1) Regulation (EU) No. 182/2011.

Arts. 3(7)(1), 5(4)(2)(b) and (4)(3), 13(1)(c) Regulation (EU) No. 182/2011.

Art. 6(3)(2) Regulation (EU) No. 182/2011.

See the Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No. 1829/2003 as regards the possibility for the Member States to restrict or prohibit the use of genetically modified food and feed in their territory, COM(2015) 177 final, pp. 2, 10; see also Friant-Perrot (2010), p. 86.

See the Proposal for a Regulation of the European Parliament and of the Council amending Directive 2001/18/EC regarding the possibility that the member states will restrict or prohibit the cultivation of GMOs in their territory COM(2010) 375 final, p. 3.

Cf. WTO Panel Report WT/DS291/R; WT/DS292/R; WT/DS293/R, European Communities – Measures Affecting the Approval and Marketing of Biotech Products, para. 8.18.

For a brief description of these measures, see Schauzu (2011), pp. 59–62, 64–65.

Cf. WTO Panel Report WT/DS291/R; WT/DS292/R; WT/DS293/R, European Communities – Measures Affecting the Approval and Marketing of Biotech Products, paras. 8.21 et seq.

Art. 34 Regulation (EC) No. 1829/2003.

Art. 23 Directive 2001/18/EC.

See Art. 23(1) Directive 2001/18/EC, Art. 34 Regulation (EC) No. 1829/2003.

Concerning Germany, see http://​www.​bvl.​bund.​de/​SharedDocs/​Downloads/​08_​PresseInfothek/​mon_​810_​bescheid.​pdf?​_​_​blob=​publicationFile This safeguard measure has been upheld by the administrative courts (see Verwaltungsgericht Braunschweig, Order of 4 May 2009, 2 B 111/09, Gewerbearchiv 2009, p. 412; Oberverwaltungsgericht Lüneburg, Order of 28 May 2009, 13 ME 76/09, Natur und Recht 2009, p. 566). The claimant withdrew its action in the end (see Verwaltungsgericht Braunschweig, Order of 11 February 2010, 2 A 110/09).

Originally authorised by Commission Decision of 22 April 1998 concerning the placing on the market of genetically modified maize (Zea mays L., line MON 810), pursuant to Council Directive 90/220/EEC (98/2943/EEC), OJ L 131, 5.5.98, p. 32.

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Stellungnahme der ZKBS zur Risikobewertung von MON810 – Neue Studien zur Umweltwirkung von MON810, Kurzfassung, Az. 6788-02-13, 7 July 2009.

See Sec. 4(1)(1) GenTG.

Art. 114(5) TFEU.

Cf. their legal basis, which is Art. 114(1) TFEU.

Art. 114 (5) TFEU.

See e.g. Upper Austria’s (draft) law prohibiting the cultivation of GMOs, which was based on the TFEU’s derogation clause (Art. 114(5) TFEU), Court of First Instance, Joined Cases T-366/03 and T-235/04, Land Öberösterreich, ECR 2005, p. II-4005, paras. 36 et seq. This judgment was upheld by the ECJ, Joined Cases C-439/05 P and C-454/05 P, Land Oberösterreich, ECR 2007, p. I-7141, paras. 60 et seq.

Proposal for a Regulation of the European Parliament and of the Council amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory COM(2010) 375 final.

Recital 6 Directive (EU) 2015/412.

See Art. 26a Directive 2001/18/EC.

See recital 1 Directive (EU) 2015/412.

See Art. 22 Directive 2001/18/EC; recital 5 Directive (EU) 2015/412.

The date of entry into force of the Opt-Out Directive, i.e. Directive (EU) 2015/412 (cf. Art. 4 Directive (EU) 2015/412).

Art. 26b Directive 2001/18/EC.

Art. 26b(1)(1) Directive 2001/18/EC.

Art. 26b(2)(1) Directive 2001/18/EC.

Art. 26b(2)(2), (2)(3) Directive 2001/18/EC.

Art. 26b(3)(1) Directive 2001/18/EC.

See Art. 26b(3)(1) Directive 2001/18/EC.

See the wording (‘such as’) in Art. 26(3)(1) Directive 2001/18/EC.

Art. 26b(3)(2) Directive 2001/18/EC.

Art. 26b(3)(2) Directive 2001/18/EC.

Admittedly, basing an opt-out measure on public policy in combination with one or more other compelling grounds might give more weight to the public policy objectives pursued. That may be of importance for the requirement that opt-out measures be ‘proportional’ (Art. 26b(3)(1) Directive 2001/18/EC).

Art. 26b(3)(1) Directive 2001/18/EC.

Art. 26b(3)(2) Directive 2001/18/EC.

Art. 26b(3)(1)(a) Directive 2001/18/EC.

Art. 26b(3)(2) Directive 2001/18/EC.

Directive (EU) 2015/412.

Recital 14 Directive (EU) 2015/412.

EFSA Journal 2010; 8(11): 1879 (http://​www.​efsa.​europa.​eu/​de/​efsajournal/​doc/​1879.​pdf)

EFSA Journal 2010; 8(11): 1879 (fn. 131), p. 56.

EFSA Journal 2010; 8(11): 1879 (fn. 131), p. 56.

EFSA Journal 2010; 8(11): 1879 (fn. 131), p. 56.

See Art. 26b(3)(1) Directive 2001/18/EC, which expressly requires that opt-out measures be ‘proportional’. According to the ECJ’s case law, consistency (or coherence) is an element of the proportionality test. See e.g. ECJ Case C-42/07, Liga Portuguesa de Futebol Profissional and Bwin International, ECR 2009, p. I-7633, para. 61 and Dederer (2010b), pp. 198 et seq., at 199–200.

Art. 26b(3)(1)(f) Directive 2001/18/EC.

Recital 15 Directive (EU) 2015/214.

In Germany, seed purity can be guaranteed by so-called ‘closed production areas’, which may be established by the German States (‘Länder’) according to Sec. 29 Seed Commerce Law (Saatgutverkehrsgesetz – SaatG, BGBl. 2004 I p. 1673).

Art. 26b(3)(1)(d) Directive 2001/18/EC.

Recital 15 Directive (EU) 2015/412.

Report from the Commission to the European Parliament and the Council on socio-economic implications of GMO cultivation on the basis of Member States contributions, as requested by the Conclusions of the Environment Council of December 2008 (SANCO/10715/2011 Rev. 5 (POOL/E1/2011/10715/10715R5-EN.doc)).

Recital 15 Directive (EU) 2015/412.

Report (fn. 141), p. 8.

Report (fn. 141), p. 8.

Report (fn. 141), p. 8.

Art. 26b(3)(1)(e) Directive 2001/18/EC.

See para. 1.1 Commission Recommendation of 13 July 2010 on guidelines for the development of national co-existence measures to avoid the unintended presence of GMOs in conventional and organic crops (OJ C 200, 22.7.2010, p. 1; hereinafter: Commission Recommendation No. 2010/C 200/01).

See para. 1.1 Commission Recommendation No. 2010/C 200/01.

See para. 2.2 Commission Recommendation No. 2010/C 200/01.

Art. 26a(1) Directive 2001/18/EC.

Commission Recommendation No. 2010/C 200/01.

Para. 2.4 Commission Recommendation No. 2010/C 200/01.

Recital 15 Directive (EU) 2015/412.

Art. 26a Directive 2001/18/EC.

Commission Recommendation No. 2010/C 200/01.

Art. 26b(3)(1) Directive 2001/18/EC.

Recital 16 Directive (EU) 2015/412.

ECJ Case C-110/05, Commission v Italy, ECR 2009 p. I-519, para. 56.

ECJ Case C-110/05, Commission v Italy, ECR 2009 p. I-519, para. 57.

ECJ Case C-110/05, Commission v Italy, ECR 2009 p. I-519, para. 58.

ECJ Case C-142/05, Mickelsson and Roos, ECR 2009 p. I-4273, para. 26.

ECJ Case C-142/05, Mickelsson and Roos, ECR 2009 p. I-4273, para. 27.

ECJ Case C-142/05, Mickelsson and Roos, ECR 2009 p. I-4273, para. 28.

ECJ Case 120/78, Rewe / Bundesmonopolverwaltung für Branntwein, ECR 2009 p. 649, para. 8.

Art. 26b(3)(1) Directive 2001/18/EC.

Art. 26b(3)(1) Directive 2001/18/EC.

ECJ Case 34/79, Henn and Darby, ECR 1979 p. 3795, para. 15.

ECJ Case C-165/08, Commission v Poland, ECR 2009 p. I-6843, para. 53.

ECJ Case C-165/08, Commission v Poland, ECR 2009 p. I-6843, para. 52.

ECJ Case C-165/08, Commission v Poland, ECR 2009 p. I-6843, para. 58.

ECJ Case C-165/08, Commission v Poland, ECR 2009 p. I-6843, para. 59.

ECJ Case C-165/08, Commission v Poland, ECR 2009 p. I-6843, para. 54.

ECJ Case 302/86, Commission / Denmark, ECR 1988 p. 4607, para. 8.

Art. 26b(3)(1) Directive 2001/18/EC.

Recital 16 Directive (EU) 2015/412.

ECJ Case 181/73, Haegemann v Belgian State, ECR 1974 p. 449, para. 5.

Art. 26b(1)(1) Directive 2001/18/EC.

See WTO Panel Report WT/DS291/R; WT/DS292/R; WT/DS293/R, European Communities – Measures Affecting the Approval and Marketing of Biotech Products, paras. 7.429–7.430.

See Art. 1(2) and (3), Annex A(1)(1)(a)–(c) SPS Agreement.

See Art. 8 SPS Agreement.

OJ L 336, 23.12.1994, p. 40.

Art. 2(2) SPS Agreement.

Art. 5(1) SPS Agreement.

See the wording of Art. 26b(1)(1) Directive 2001/18/EC.

For an extensive discussion, see Dederer and Herdegen (2015).

See Art. 258 TFEU.

For the WTO membership of the EU, see Art. XI(1), Agreement Establishing the World Trade Organization (OJ L 336, 23.12.1994, p. 3) and Art. 1(3)(1) TEU. Of course, third-party states will claim that the EU member state adopting the contested opt-out measure violated WTO law. However, as in the past, the EU will always act as the respondent. For more on the member states’ loss of ‘their formal entitlement to be a party to the dispute settlement procedures of the World Trade Organization’ after the entry into force of the Treaty of Lisbon on 1 December 2009, see BVerfGE 123, 267 (419) (English translation available at http://​www.​bundesverfassung​sgericht.​de/​SharedDocs/​Entscheidungen/​EN/​2009/​06/​es20090630_​2bve000208en.​html;jsessionid=​0146DCA4180BBA9B​7352267F53C8F954​.​2_​cid394, para. 374).

Arts. 1(1), 2(1) Understanding on Rules and Procedures Governing the Settlement of Disputes (OJ L 336, 23.12.1994, p. 234).

Recital 8 Directive (EU) 2015/412.

Targeting Induced Local Lesions in Genomes.

Transcription Activator-Like Effector Nuclease.

Clustered Regularly Interspaced Short Palindromic Repeats.

CRISPR-associated.

Art. 2(2) Directive 2001/18/EC.

Annex I A Directive 2001/18/EC.

Art. 2(2) Directive 2001/18/EC.

E.g. conventional as well as organic cultivars are bred using irradiation and chemicals.

Annex I A Part 1(1) Directive 2001/18/EC.

Annex I A Part 1(1) Directive 2001/18/EC.

Doudna and Charpentier (2014).

See Annex I A Part 1 Directive 2001/18/EC.

See the wording (‘at least’) in Art. 2(2)(a) Directive 2001/18/EC and the wording (‘inter alia’) in Annex I A Part 1 Directive 2001/18/EC.

Art. 2(2) Directive 2001/18/EC.

German National Academy of Sciences Leopoldina et al. Academies issue statement on progress in molecular breeding and on the possible national ban on cultivation of genetically modified plants, 26 March 2015, p. 1, 3 (http://​www.​leopoldina.​org/​uploads/​tx_​leopublication/​2015_​03_​26_​Statement_​on_​Molecular_​Breeding_​final.​pdf)

Recital 17 Directive 2001/18/EC.

German National Academy of Sciences Leopoldina et al. (fn. 204), pp. 1, 3.

See the fears expressed in German National Academy of Sciences Leopoldina et al. (fn. 204), pp. 1, 3.

Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EC) No. 1829/2003 as regards the possibility for the Member States to restrict or prohibit the use of genetically modified food and feed on their territory, COM(2015) 177 final.

Amending Regulation (EC) No. 1829/2003 by inserting new ‘Article 34a. Restrictions or prohibitions by member states’.