Regulation of Genome Editing in Plant Biotechnology: European Union

Voigt, Brigitte; Münichsdorfer, Ansgar

doi:10.1007/978-3-030-17119-3_5

Regulation of Genome Editing in Plant Biotechnology: European Union

Brigitte Voigt³ &
Ansgar Münichsdorfer³

Chapter
First Online: 17 August 2019

595 Accesses
3 Citations

Abstract

Plants, animals and microorganisms obtained by any type of genome editing technology (SDN-1, SDN-2, SDN-3, ODM) are regulated through the EU’s GMO regime. A judgment of the European Court of Justice in July 2018 provided regulatory certainty about their GMO status. It ended more than a decade of legal debates.

The EU’s GMO regime is harmonised at the EU level and encompasses authorisation requirements regarding contained use, field trials and the placing on the market of GMOs as well as post-market monitoring, labelling, traceability and identity preservation obligations. Thus, GMOs are governed in a comprehensive, detailed and rigorous manner. In addition, GMOs are subject to widespread political and societal rejection.

The impossibility to distinguish certain genetic alterations induced by genome editing from those that are induced naturally or by traditional breeding techniques leads to problems as yet unresolved. It might hamper GMO authorisation, the EU’s zero tolerance policy for unauthorised GMOs and GM labelling.

It cannot be excluded that amendments to the GMO framework will be introduced in the aftermath of the European Court of Justice’s judgment. Without any, it will take several years until the first genome edited plants are commercially cultivated or imported.

Ansgar Münichsdorfer wrote Sect. 5.10 (“Liability”). Brigitte Voigt wrote the remaining sections. The final version of this Chapter was submitted on 01 February 2019 with minor updates in June 2019.

Consolidated versions of the EU legislation cited in this report can be accessed in all official EU languages at the website for European Union law EUR-Lex, https://eur-lex.europa.eu.

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Notes

1.
European Commission (2018a), pp. 1, 4. The main export destinations of agri-food products are the US (by far), China, Switzerland, Russia and Japan. Main importers into the EU regarding agri-food products are Brazil, the US, Argentina, Ukraine and China, European Commission (2018a), pp. 5–6; Eurostat (2018).
2.
The group of FAS Biotechnology Specialists in the European Union (2018), pp. 9–10.
3.
Until today, only six GM crops have obtained an approval for commercial cultivation in the EU (one only for seed production), the first in 1997. The MON810 maize line is the only one remaining. As for the other five, the approval expired, was withdrawn by the European Commission or annulled by the EU General Court. The most famous case is the GM potato “Amflora” developed by BASF. After an approval procedure which lasted almost 14 years, it was cultivated in the EU in 2010 and 2011. It was withdrawn from the EU market in the beginning of 2012. In 2013, the EU General Court overturned the permission. Cf. International Service for the Acquisition of Agri-biotech Applications (2017), p. 92; McEldowney (2015), p. 1; Schauzu (2011), pp. 60–61; Hunt (2011), pp. 140–141; Davison and Ammann (2017), pp. 16–17.
4.
Corresponding to about 300,000 acres. The group of FAS Biotechnology Specialists in the European Union (2018), p. 6.
5.
International Service for the Acquisition of Agri-biotech Applications (2017), pp. 3, 92; Canadian Biotechnology Action Network (2015), p. 9 (as of 2015).
6.
See Fig. 5.1 and text to n. 108.
7.
International Service for the Acquisition of Agri-biotech Applications (2016), p. 74; International Service for the Acquisition of Agri-biotech Applications (2017), p. 94.
8.
Davison and Ammann (2017), pp. 16–17; The group of FAS Biotechnology Specialists in the European Union (2018), p. 5; Baulcombe et al. (2014), p. 3; European Academies Science Advisory Council and German National Academy of Sciences Leopoldina (2013), pp. 11–12.
9.
Hartung and Schiemann (2014), pp. 744–745.
10.
EU register of GM food and feed, European Commission (n.d.-g). GM lines containing stacked events are counted separately. In terms of single transformation events, 44 events are currently approved for import. Only 62 approval decisions have been made for the currently authorised lines as some of these approvals authorise both a GM line containing stacked events and lines containing subcombinations of these events.
11.
European Commission (2015a).
12.
European Commission (2016), pp. 2, 5 (“The EU is 70% dependent on imports of protein-rich crops”); The group of FAS Biotechnology Specialists in the European Union (2018), pp. 9ff; Nábrádi and Popp (2011), pp. 10ff, 17ff; Masip et al. (2013), p. 319; Davison and Ammann (2017), p. 21. Soybean and soybean meal represent more than 60% of the EU’s total protein-rich feed materials and are to a very large extent derived from imports, European Commission (2016), p. 3; European Commission (2015a); de Visser et al. (2014), p. 2.
13.
The group of FAS Biotechnology Specialists in the European Union (2018), pp. 10, 12, 14. Slightly differing figures in European Commission (2016), p. 4.
14.
Tagliabue (2015), p. 57; Masip et al. (2013), p. 319; European Academies Science Advisory Council and German National Academy of Sciences Leopoldina (2013), p. 35.
15.
Cf. Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms [1990] OJ L117/15 (not in force any more).
16.
Plan and van den Eede (2010), p. 3; Schauzu (2011), p. 58; Devos et al. (2006), pp. 133–143.
17.
Directive 2001/18/EC, art. 1; Regulation (EC) No 1829/2003, art. 1.
18.
Regulation (EC) No 1829/2003, recitals 17, 20, 21, art. 1; Regulation (EC) No 1830/2003, recitals 4, 11, art. 1.
19.
Directive 2001/18/EC, art. 1; Regulation (EC) No 1829/2003, art. 1.
20.
Devos et al. (2012), p. 10771: “most stringent and wide-ranging regulations on GM products and commodities in the world”; Masip et al. (2013).
21.
Cf. the (somewhat differing) figures in Smart et al. (2017), pp. 182, 190–192; Hartung and Schiemann (2014), p. 744; The group of FAS Biotechnology Specialists in the European Union (2018), pp. 23; Lappin (2018b), p. 2; The Netherlands Commission on Genetic Modification (2009b), p. 21; McDougall (2011); Madre and Agostino (2017). Regarding the approval times for the most recent approvals cf. Jany (2018b) (in German). The procedure takes considerably longer than e.g. the petitions for determination of nonregulated status in the USA, cf. Smart et al. (2017), p. 192; Kalaitzandonakes et al. (2016), p. 226; Lucht (2015), p. 4257 (“on average, it takes at least 15 to 20 months longer than […] in the U.S., Brazil, and Canada”). With respect to the disruption of imports through asynchronous approvals cf. n. 229.
The legal timescales for GM food/feed applications (Regulation (EC) No 1829/2003, arts. 6(1), 7(1); 18(1), 19(1), 35(2); cf. Roïz (2014), pp. 2–3) and for commercial cultivation (Directive 2001/18/EC, arts. 13(1), 14(2), (4), 15(1), (3), 18) allow for a much shorter duration of the authorisation procedure, Jany (2018a) (in German). However, there are possibilities for delay, e.g. provisions to “stop the clock” whilst additional information is required from the applicant, cf. Regulation (EC) No 1829/2003, arts. 6(1), 18(1); Directive 2001/18/EC, arts. 14(4), 15(1), 18(1). Furthermore, the length of the community procedure (see n. 100) is not prescribed. Therefore, the actual timescale is much longer and unpredictable, cf. Lusser et al. (2011), p. 49; Jones (2015), p. 3.
22.
There is strong variation in the estimation of regulatory costs, OECD (2018b), p. 62, see e.g. the estimates in Hartung and Schiemann (2014), p. 744; Kalaitzandonakes et al. (2007); Tait and Barker (2011), p. 766; The Netherlands Commission on Genetic Modification (2009b), pp. 10, 20–21; Madre and Agostino (2017); Lusser et al. (2011), p. 49. Of course, costs vary with the crop, the introduced trait, the intended use and the studies performed by the variety developers, Kalaitzandonakes et al. (2007), pp. 509, 510; McDougall (2011), p. 23. The costs are estimated to be 25% higher than in the US, The Netherlands Commission on Genetic Modification (2009b), p. 21.
23.
Several GM maize varieties are in the pipeline for approval for commercial cultivation (some of them for more than a decade), see The group of FAS Biotechnology Specialists in the European Union (2017), p. 11.
24.
Regarding the step-by-step concept OECD (1986); Directive 2001/18/EC, recital 24; Dederer (2016b), pp. 143–147.
25.
In the EU Directives and Regulations, field trials are referred to as “Deliberate Release of GMOs for any other purpose than for placing on the market”, cf. Directive 2001/18/EC, part B (art. 5ff).
26.
Cf. Directive 2001/18/EC, recitals 23, 24; von Kries and Winter (2011), p. 33; Gross (2006), pp. 90–93.
27.
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms [2009] OJ L125/75.
28.
Winter (2016b), p. 182; Dederer (2016b), p. 144; Friant-Perrot (2010), p. 82.
29.
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 [2001] OJ L106/1.
30.
As a result, any release into the environment is governed by Directive 2001/18/EC.
31.
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [2003] OJ L268/1.
32.
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 [2004] OJ L136/1.
33.
Regulation (EC) No 1829/2003, art. 5(5). Still, the criteria for both regimes have to be met. Plan and van den Eede (2010), p. 8; Dederer (2016b), p. 147.
34.
Yusuf (2014), pp. 23, 36.
35.
Labelling: Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [2003] OJ L268/24, art. 4(6); Directive 2001/18/EC, art. 21; specific provisions for GM food/feed labelling in Regulation (EC) No 1829/2003, arts. 12ff and arts. 24ff; traceability: Regulation (EC) No 1830/2003 arts. 4(1)-(5) and 5.
36.
Directive 2001/18/EC, arts. 13(2)(e) and 20, annex VII; Council Decision 2002/811/EC of 3 October 2002 establishing guidance notes supplementing Annex VII to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC [2002] OJ L280/27.
37.
Cf. Directive 2001/18/EC, annex VII.
38.
Cf. Directive 2001/18/EC, art. 26a; further: European Commission (2010b).
39.
Cultivation: Directive 2001/18/EC, art. 23; cf. also the general safeguard clause for seed, Directive 2002/53/EC, art. 18; GM food: Regulation (EC) No 1829/2003, art. 34; cf. also the general safeguard clause for food, 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 [2002] OJ L31/1, arts. 53, 54. Further Norer and Preisig (2016), pp. 34–36.
40.
Directive 2001/18/EC, art. 26b; in detail Sect. 5.4 (“Regulatory Prerequisites for Activities Relating to Genome Edited Plants”), text to n. 108.
41.
Cf. the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), Introduction, art. 12.3, annex A(3)(a), obliging members to base their sanitary or phytosanitary measures on international standards, guidelines or recommendations. These international standards lead to a de facto harmonisation of GMO health risk assessments of all WTO members, cf. text to n. 127.
42.
Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Montreal, 29 January 2000, in force 11 September 2003, 2226 U.N.T.S. 208; 39 ILM 1027 (2000); UN Doc. UNEP/CBD/ExCOP/1/3. http://bch.cbd.int/protocol/text/. Accessed 22 August 2018 [hereinafter Cartagena Protocol].
43.
Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms [2003] OJ L287/ 1.
44.
Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety, Nagoya, 15 October 2010, in force 5 March 2018, UN Doc. UNEP/CBD/BS/COP-MOP/5/17. https://bch.cbd.int/protocol/NKL_text.shtml. Accessed 22 August 2018.
45.
The different types of site-directed nuclease techniques (SDN-techniques) are understood as defined in the standardised outline to this report:
- SDN-1: generation of site-specific random point mutations
- SDN-2: generation of site-specific desired point mutations using template DNA
- SDN-3: site-specific introduction of long stretches of donor DNA.
46.
Cf. further Devos et al. (2012), pp. 10770–10771; European Commission New Techniques Working Group (2011), para. 2.0.
47.
Cf. e.g. Regulation (EC) No 1829/2003, art. 2(5).
48.
Cf. Directive 2009/41/EC, arts. 2(b), 3, annex I, annex II part A. The only exception to that similarity is that Directive 2009/41/EC additionally excludes self-cloning from the scope of legislation, Directive 2009/41/EC, annex II part A(4); European Commission New Techniques Working Group (2011), para. 2.0.
49.
Cf. The Netherlands Commission on Genetic Modification (2009b), p. 3; Marchant and Stevens (2015), p. 234. All states party to the Cartagena Protocol have a process-based approach, Devos et al. (2012), p. 10770, but many approaches are not purely process-based, i.e. not only the method of production matters but also the genetic result.
50.
ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583; cf. also the press release, Court of Justice of the European Union (2018).
51.
ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583, paras. 38, 51, 54.
52.
Cf. ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583, para. 28 (“techniques/methods of mutagenesis such as those at issue in the main proceedings”); para. 23; Bobek (2018), para. 46 (“As […] explained by the referring court […] targeted mutagenesis methods applying new genetic engineering techniques have been devised, such as oligonucleotide-directed mutagenesis (ODM) or directed nuclease mutagenesis (SDN1)”; Conseil d’État, 3e et 8e ch., 3 oct. 2016, n°388649, ECLI:FR:CECHR:2016:388649.20161003, Confédération paysanne et autres, para. 23 (referral decision by the French Conseil d’État).
53.
Cf. also the description of directed mutagenesis used by the applicants in the proceedings before the French Conseil d’État, Conseil d’État, 3^e et 8^e ch., 3 oct. 2016, n°388649, ECLI:FR:CECHR:2016:388649.20161003, Confédération paysanne et autres, para. 23: “De nouvelles techniques, dites de mutagénèse dirigée ou d’édition du génome, consistent aujourd’hui, grâce au génie génétique, à provoquer une mutation précise dans un gène cible sans introduction de gène étranger.” (directed mutagenesis is understood as the induction of a precise mutation in a target gene without introduction of a foreign gene).
54.
Cf. text to n. 61ff.
55.
Cf. Lappin (2018b), p. 2.
56.
The Advocate General was of the opinion that the new directed mutagenesis techniques are “mutagenesis techniques” in the legal sense of the term and thus exempt from the EU’s GMO regulatory framework, cf. Bobek (2018), paras. 107, 86ff.
57.
The Court often follows this proposal, Craig and de Búrca (2015), p. 61.
58.
Cf. the overview in Eriksson (2018), p. 5.
59.
The legally binding effect on third parties is debated, cf. Craig and de Búrca (2015), pp. 465, 478; European Parliamentary Research Service (2017), p. 11.
60.
ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583, para. 25 no. 1.
61.
ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583, paras. 27–38, 54.
62.
Cf. e.g. European Commission New Techniques Working Group (2011), para. 4.1; Sprink et al. (2016), pp. 1497–1498; Custers (2016), p. 2; Callebaut (2015), pp. 20–22; 42–56.
63.
German Federal Office of Consumer Protection and Food Safety (2017), p. 6.
64.
ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583, para. 29.
65.
ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583, paras. 39ff, 54.
The Court gives two main reasons: First, it refers to a recital of the Directive (Directive 2001/18/EC, recital 17). Second, according to the Court, “the risks linked to the use of those new techniques/methods of mutagenesis might prove to be similar to those which result from the production and release of a GMO through transgenesis” as “the direct modification of the genetic material of an organism through mutagenesis makes it possible to obtain the same effects as the introduction of a foreign gene into that organism and […] the development of those new techniques/methods makes it possible to produce genetically modified varieties at a rate and in quantities quite unlike those resulting from the application of conventional methods of random mutagenesis.”
66.
ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583, para. 51.
67.
ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583, para. 51.
68.
Bobek (2018), paras. 68–78.
69.
Transgenesis refers to the introduction of genes derived from organisms which are sexually incompatible with the engineered plant, Voigt and Klima (2017), p. 320; Schaart et al. (2016), p. 439.
70.
Sprink et al. (2016), p. 1497.
71.
Cisgenesis refers to the introduction of genes derived from organisms which are sexually compatible with the engineered plant, Voigt and Klima (2017), p. 320; Schaart et al. (2016), p. 439.
72.
Intragenesis refers to the introduction of newly arranged genes derived from organisms that are sexually compatible with the engineered plant, Voigt and Klima (2017), p. 320; Schaart et al. (2016), p. 439.
73.
Apart from that, they might fall within the black list-catalogue, Directive 2001/18/EC, annex IA part 1, European Commission New Techniques Working Group (2011), para. 5.3.5 A; UK Advisory Committee on Releases to the Environment (2013b), p. 13.
74.
Directive 2009/41/EC, art. 4.
75.
Directive 2009/41/EC, art. 5, annex IV.
76.
Directive 2009/41/EC, arts. 6–9.
77.
Directive 2009/41/EC, arts. 7, 8.
78.
Directive 2009/41/EC, art. 9.
79.
Directive 2009/41/EC, art. 4(2),(3), annex III; Commission Decision 2000/608/EC of 27 September 2000 concerning the guidance notes for risk assessment outlined in Annex III of Directive 90/219/EEC on the contained use of genetically modified micro-organisms [2000] OJ L258/43.
80.
This risk assessment thus differs fundamentally in function and approach from the risk assessments for GMO field trials and placing on the market. It serves to determine which level of regulatory oversight is needed and is carried out by means of theoretical considerations based on the available knowledge. Risk assessments for field trials and any placing on the market, in contrast, aim at proving an organism’s safety with the highest possible certainty by generating data, mostly by performing studies.
81.
Directive 2009/41/EC, art. 4(4).
82.
Cf. Directive 2001/18/EC, arts. 6, 8, 9, annex V.
83.
Directive 2009/41/EC, art. 10(2), (3).
84.
Directive 2001/18/EC, art. 6(5); cf. Friant-Perrot (2010), p. 84; Plan and van den Eede (2010), p. 5.
85.
The application is called “notification” in the terminology of Directive 2001/18/EC, cf. art. 2(5).
86.
Directive 2001/18/EC, art. 6(2)(b).
87.
Directive 2001/18/EC, art. 2(8).
88.
Cf. Directive 2001/18/EC, art. 6(2)(a), annex III.
89.
Cf. Directive 2001/18/EC, art. 6(2)(b), annex II(C).
90.
E.g. by the United Nations Environment Programme (UNEP) or the Organisation for Economic Co-operation and Development (OECD), e.g. United Nations Environment Programme (1995), OECD (1986), pp. 24ff; OECD (2000b).
91.
Cf. Craig et al. (2008), p. 855.
92.
Directive 2001/18/EC, annex II(C.3).
93.
Cf. European Food Safety Authority (2010a), Devos et al. (2012), pp. 10789–10791.
94.
von Kries and Winter (2012), p. 573.
95.
Cf. Directive 2001/18/EC, art. 4.
96.
von Kries and Winter (2012), pp. 579–580; Craig et al. (2008), p. 854.
97.
Cf. European Commission (2000), summary no. 5.
98.
Cf. Directive 2001/18/EC, art. 12(1); Regulation (EC) No 1829/2003, arts. 5(5), 6(4)/arts. 17(5), 18(4) (food/feed); von Kries and Winter (2012), p. 572.
99.
Directive 2001/18/EC, arts. 13–15, 18–19, 28(1); Hartung and Schiemann (2014), p. 744; Devos et al. (2012), pp. 10775–10776.
100.
Cf. Directive 2001/18/EC, arts. 18(1), 30(2) (comitology procedure). In detail: The comitology procedure is the standard procedure for technical decisions. The European Commission issues a draft authorisation decision. A Committee composed of representatives of the member states adopts or rejects the decision by qualified majority. If the necessary majority cannot be reached (“no opinion”), the decision is referred to an appeal committee. In the event the necessary qualified majority cannot be reached in the appeal committee, either, the Commission adopts the final decision; cf. the infographic European Commission (2015b); cf. further Dederer (2016b), p. 150. In practice, a qualified majority is never reached, so the Commission takes all the final authorisation decisions, cf. European Commission (2015c), p. 3; Dederer (2016b), p. 150; Mühlböck and Tosun (2018), p. 387.
101.
Directive 2001/18/EC, arts. 13(2)(d), 15(4), 17; the data requirements are less burdensome than those for the initial authorisation, cf. Directive 2001/18/EC, art. 17(2).
102.
The application is called “notification” in the terminology of Directive 2001/18/EC, cf. art. 2(5).
103.
See text to n. 86ff as well as Tables 5.8 and 5.9.
104.
Directive 2001/18/EC, annex III B(II)(B)(2)(b).
105.
Directive 2001/18/EC, annex III B(II)(B)(4).
106.
Directive 2001/18/EC, art. 13(2)(a), annex III B(II)(B)(6); cf. further von Kries and Winter (2011), p. 34.
107.
Cf. Directive 2001/18/EC, art. 4; regarding the notion “adverse effects” cf. text to n. 96.
108.
Cf. Dederer (2016b), pp. 151–159; European Commission (n.d.-f).
109.
Cf. Directive 2001/18/EC, art. 26b. The aim of the opt-out possibility is to overcome member state obstructions of GMOs (deadlocks in the authorisation procedures of GMOs, invocation of safeguard clauses, overly restrictive coexistence measures etc.) by re-nationalising responsibilities, cf. Dederer (2016b), pp. 151–153. However, looking at recent authorisation decisions, it appears that this aim has not been reached, cf. Eriksson et al. (2018b). The conformity of the opt-out mechanism with EU law and WTO law is debated, cf. Dederer (2016b), pp. 159ff; Winter (2016a), pp. 132ff; Ferer (2016).
110.
Dederer (2016b), pp. 152ff.
111.
Cf. The group of FAS Biotechnology Specialists in the European Union (2017), p. 12.
112.
Wales, Scotland and Northern Ireland have opted out.
113.
European Commission (n.d.-j); The group of FAS Biotechnology Specialists in the European Union (2018), pp. 8–9; cf. also Fig. 5.1. Slovakia intends to opt out soon and is therefore already indicated as opted out in Fig. 5.1.
114.
Cf. the transitional measures laid down in Directive 2001/18/EC, art. 26c.
115.
McEldowney (2015).
116.
Cf. text to n. 269.
117.
Regulation (EC) No 1829/2003, art. 27.
118.
“Produced from GMOs “means” derived, in whole or in part, from GMOs, but not containing or consisting of GMOs”, Regulation (EC) No 1829/2003, art. 2(10). Food/feed is e.g. produced from GMOs if the GMOs have been destroyed during the production process (like highly refined oil). By contrast, products obtained from animals fed with GM feed are not produced “from”, but only produced “with” GMOs and therefore do not have to be authorised, Regulation (EC) No 1829/2003, recital 16. “The determining criterion is whether or not material derived from the genetically modified source material is present in the food or feed”, Regulation (EC) No 1829/2003, recital 16.
119.
Regulation (EC) No 1829/2003, art. 3(1).
120.
Regulation (EC) No 1829/2003, arts. 5ff/arts. 17ff (food/feed); cf. also the detailed description in European Food Safety Authority (2013), pp. 9ff.
121.
Directive 2001/18/EC, art. 6(3)(b), (c).
122.
Directive 2001/18/EC, art. 6(3)(c).
123.
Cf. Regulation (EC) No 1829/2003, arts. 7(3), 35(2) (comitology procedure), in detail see n. 100.
124.
Regulation (EC) No 1829/2003, arts. 7(5), 11/arts. 19(5), 23 (food/feed). The data requirements are less burdensome than those for the initial authorisation, cf. Regulation (EC) No 1829/2003, art. 11(2)/art. 23(2) (food/feed); Dederer (2016a), p. 108.
125.
Cf. Schauzu (2011), pp. 73ff; European Food Safety Authority (2011a), pp. 5ff.
126.
In particular the Codex Alimentarius principles and guidelines on foods derived from biotechnology (which are binding on the EU via World Trade Law, see text to n. 41), e.g. Codex Alimentarius Commission (2003b); Codex Alimentarius Commission (2003a), as well as the pertinent OECD guidelines, e.g. OECD (2000a); cf. also Regulation (EU) No 503/2013, recitals 9, 21.
127.
Cf. Schauzu (2011), p. 73; Paoletti et al. (2008), p. 77.
128.
Food: Regulation (EC) No 1829/2003, arts. 7(1), 4(1); slightly different regarding feed, Regulation (EC) No 1829/2003, arts. 19(1), 16(1); cf. further Dederer (2016a), pp. 101–102.
129.
Regulation (EC) No 1829/2003, art. 7(1)/art. 19(1) as well as n. 157.
130.
Apart from the authorisation for the placing on the market, other authorisation requirements of the EU medical law apply, i.e. manufacturing and clinical trial authorisations, cf. Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use [2001] OJ L311/67, art. 40(1); Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC [2014] OJ L158/1, art. 4.
131.
Regulation (EC) No 726/2004, art. 3(1), annex; cf. the regulatory flowchart in European Food Safety Authority (2009), p. 11.
132.
The peculiarities of substances produced by transgenic plants are taken into account in a special EMA guideline on the “quality of biological active substances produced by stable transgene expression in higher plants”, European Medicines Agency (2008).
133.
Regulation (EC) No 726/2004, arts. 5ff; cf. European Commission (n.d.-a).
134.
With the participation of the member states via a committee composed of member state representatives, Regulation (EC) No 726/2004, art. 10(2).
135.
Cf. Regulation (EC) No 726/2004, art. 12(1).
136.
Regulation (EC) No 726/2004, art. 14(1)-(3).
137.
Sparrow et al. (2013), pp. 4–6; the peculiarities of plant molecular farming are taken into account by the EFSA guidance document on the risk assessment of genetically modified plants used for non-food or non-feed purposes, cf. European Food Safety Authority (2009).
138.
E.g. industrial enzymes or raw materials for the production of biopolymers, biofuels, paper and starch, European Food Safety Authority (2009), p. 11.
139.
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC [2006] OJ L396/1 (REACH), art. 5; applies to both manufacturing (in quantities of one tonne or more per year) as well as placing on the market, including import, REACH, arts. 5, 6. Many substances that are obtained from natural sources and have not been chemically modified are exempt from registration if the substance does not have adverse properties such as persistence or toxicity, cf. REACH, annex V No. 8, 9. A registration is not needed for substances that are already registered, provided their identity can be established, REACH, art. 10(a)(ii) in conjunction with annex VI(2) (establishing identity is challenging for biological materials, they belong to what is called the UVCB-substrates—substances of unknown or variable composition, complex reaction products or biological materials, cf. REACH, recital 45). For more information on registration of substances refer to European Chemicals Agency (2017).
140.
Craig et al. (2008), p. 853; cf. also international guidelines, e.g. United Nations Environment Programme (1995), p. 5, Codex Alimentarius Commission (2003b), Section 3; cf. text to n. 41.
141.
This means that the authorisation decision is not taken by scientific bodies but by political institutions. Risk management includes weighing of different options, deciding on the acceptability of risks and other value-based decisions, cf. Devos et al. (2010), p. 557.
142.
Cf. Directive 2001/18/EC, annex II(B).
143.
Cf. Tzotzos et al. (2009), pp. 52ff; Eckerstorfer et al. (2014), p. 62; Devos et al. (2010), pp. 562–565; cf. also the risk assessment principles in the Cartagena Protocol, which the EU risk assessments respect (Cartagena Protocol, annex III and Secretariat of the Convention on Biological Diversity (2016); Directive 2001/18/EC, recital 13); with respect to food cf. the Codex Alimentarius principles and guidelines and pertinent OECD guidelines, cf. text to n. 41, 126.
144.
OECD (1993), pp. 11ff: “existing organisms used as food, or as a source of food, can be used as the basis for comparison when assessing the safety of human consumption of a food or food component that has been modified or is new”; further FAO/WHO (2000).
145.
European Food Safety Authority (2011a), pp. 5–6; European Food Safety Authority (2010a), pp. 11–13; Schauzu (2011), pp. 73ff.
146.
In fact, this comprises two tests: the test of difference to verify whether the GM plant is different from its comparator (apart from the genetic modification) and the test of equivalence to verify whether the characteristics are within the range of natural variation, cf. European Food Safety Authority (2011a), pp. 5–6, 12; European Food Safety Authority (2010a), p. 28; regarding the determination of the range of natural variation cf. European Food Safety Authority (2010b) as well as e.g. the OECD Consensus Documents, OECD Working Group on the Safety of Novel Foods and Feeds (2018), or the ILSI database, International Life Sciences Institute (2016), Ridley et al. (2004).
147.
Directive 2001/18/EC, annex II(B); European Food Safety Authority (2010a), p. 3.
148.
European Food Safety Authority (2010a), p. 10; UK House of Commons Science and Technology Committee (2015), p. 42; Baulcombe et al. (2014), p. 32.
149.
With respect to the uncertainty analyses to be provided by the applicant cf. the EFSA Guidance on Uncertainty Analysis in Scientific Assessments, European Food Safety Authority (2018a) as well as the EFSA document about the principles and methods behind EFSA’s Guidance on Uncertainty Analysis in Scientific Assessment, European Food Safety Authority (2018b).
150.
E.g. Directive 2009/41/EC, art. 10(3)(a) (contained use); Directive 2001/18/EC, art. 6(6),(7) (field trials), art. 15(1) (cultivation); Regulation (EC) No 1829/2003, art. 6(2)/art. 18(2) (food/feed).
151.
Craig et al. (2008), p. 854, Eckerstorfer et al. (2014), p. 62; UK House of Commons Science and Technology Committee (2015), Q411.
152.
The Netherlands Commission on Genetic Modification (2009b), p. 21; European Food Safety Authority (2011a).
153.
TFEU, art. 191(2); with respect to the European understanding of the precautionary principle cf. European Commission (2000).
154.
For instance, measures adopted should be proportional, non-discriminatory and consistent. They should consider the benefits and costs of action and lack of action and be re-examined after some time, European Commission (2000), para. 6.3.
155.
Winter (2016b), p. 189.
156.
Firstly, ethical committees can be consulted, Directive 2001/18/EC, art. 29; Regulation (EC) No 1829/2003, art. 33, e.g. the European Group on Ethics in Science and New Technologies. However, this only plays a marginal role in the authorisation decision in practice, Scott (2005), p. 118; Lee (2008), pp. 81–82. Secondly, the authorisation regime for marketing GM food and feed allows to take into account “other [that is non-safety related] legitimate factors” in the authorisation decision, Regulation (EC) No 1829/2003, arts. 7(1), 19(1). However, no authorisation decision has referred to “other factors” yet and their scope and role are highly debated, European Commission (2015c), pp. 3–4; Spök (2010), p. 32; Jack (2009), p. 230; Lee (2008), pp. 83ff; Dederer (2016a), p. 106; Dederer (2016b), p. 149; Scott (2005), pp. 118–119. Thirdly, some member states have included an ethical and/or socio-economic impact assessment in their national legislations regarding field trials/cultivation. They are of little impact in practice, cf. Spök (2010), pp. 31ff; Winter (2016b), p. 189. Fourthly, environmental risks can be balanced against environmental benefits (health risks do not allow for such a risk-benefit analysis), Dederer (2016a), p. 102.
157.
Dederer (2016b), pp. 148ff.
158.
Dederer (2016b), p. 152.
159.
Cf. the comitology procedure, n. 100.
160.
European Commission (2015c), p. 3.
161.
Winter (2016b), p. 183.
162.
Cf. in detail the report of the European Network of GMO Laboratories, European Network of GMO Laboratories (2019).
163.
Cf. Directive 2001/18/EC, art. 13(2)(a) in conjunction with annex IV(A)(7) (cultivation); Regulation (EC) No 1829/2003, art. 5(3)(i)/art. 17(3)(i) (food/feed); cf. in detail Regulation 503/2013, annex III; Regulation (EC) No 641/2004, annex I as well as the guidelines available at European Union Reference Laboratory for GM Food and Feed (2018), especially the guideline “Definition of minimum performance requirements for analytical methods of GMO testing”; cf. further international standards on methods for detection and identification, e.g. Codex Alimentarius Commission (2010), International Organisation for Standardisation (2005a, b, c, 2006). According to Kalaitzandonakes et al. (2007), p. 510, the requirement of detection and identification methods for authorisation is EU-specific.
164.
European Commission (2001).
165.
European Network of GMO Laboratories (2019), p. 5.
166.
Cf. Regulation (EC) No 1829/2003, art. 6(3)(d), annex(3)(d); European Union Reference Laboratory for GM Food and Feed (2017).
167.
European Network of GMO Laboratories (2019), 7–13; 17; European Commission Scientific Advice Mechanism Group of Chief Scientific Advisors (2018), p. 4. Likely, the minimum performance requirements for detection and identification methods will have to be changed, European Network of GMO Laboratories (2019), p. 1.
168.
Kahrmann et al. (2017), p. 180; The Greens/European Free Alliance in the European Parliament (2018a).
169.
“Detection” of a genetic modification means “that it is possible to determine the existence of a change in the genetic material of an organism”, Lusser et al. (2011), pp. 63–64.
170.
Lusser et al. (2011), pp. 69–70.
171.
Identification of a genetic modification means “that it is possible not only to detect the existence of a change in the genetic material of an organism [but also] to identify the genetic modification as one that has been intentionally introduced by a new technique”, Lusser et al. (2011), p. 64.
172.
European Network of GMO Laboratories (2019), pp. 9–10; Lusser et al. (2011), pp. 69–70; Hilscher et al. (2017a), pp. 32–33.
173.
Plant genomes are very diverse and dynamic. That means that they change at a rapid pace and that plant genomes differ a lot between two varieties, European Food Safety Authority (2012a), p. 12; European Network of GMO Laboratories (2019), p. 11; regarding the maize genome Jiao et al. (2017), p. 526.
174.
Lusser et al. (2011), pp. 165, 169; more precise Grohmann et al. (2019), pp. 4–5.
175.
Hilscher et al. (2017a), pp. 32–33; however, the linkage between the mutation and the background markers is broken up if the variety is used in further breeding programmes, Hilscher et al. (2017a), p. 33.
176.
However, it might be deemend sufficient that the genome edited line can be identified, because this also clarifies the origin of the event, Hilscher et al. (2017a), pp. 32–33.
177.
Ribarits et al. (2014), p. 186; Lusser et al. (2011), pp. 69–70.
178.
Cf. Eckerstorfer et al. (2014), p. 62.
179.
Eckerstorfer et al. (2014), p. 62.
180.
Cf. text to n. 147.
181.
It is criticised that in practice, the amount and type of information is not sufficiently flexible, especially when it comes to less data, UK House of Commons Science and Technology Committee (2015), Q411, Q413 [Professor Hails]; different opinion (appropriate amount of data) e.g. UK House of Commons Science and Technology Committee (2015), GMC0016 [Professor Perry] paras. 6, 7.
182.
A revision of the EFSA guidance documents is even envisaged for SDN-3, cf. text to n. 188, and is therefore even more necessary for SDN-1 and SDN-2.
183.
Cf. also Ribarits et al. (2014), pp. 188–189, Wasmer (2019), pp. 8–9: Some elements, e.g. environmental risks caused by gene transfer, should be reconsidered.
184.
European Food Safety Authority (2012a), pp. 17ff; European Food Safety Authority (2012b), p. 21; cf. also (with respect to cisgenesis) Prins and Kok (2010), p. 23: “Existing knowledge […] will, on a case-by-case basis, already be used within the current regulatory framework […]. […] no scientific basis for a general reduction of requirements”.
185.
European Food Safety Authority (2012b), p. 21; European Food Safety Authority (2012a), p. 19.
186.
E.g. in the section molecular characterisation or with respect to scrutiny for unintended effects, European Food Safety Authority (2012a), p. 18; European Food Safety Authority (2012b), p. 21.
187.
European Food Safety Authority (2012a), p. 18; EFSA guidance documents are regularly updated anyway, European Food Safety Authority (n.d.).
188.
Ricroch et al. (2017), pp. 178, 179; Modrzejewski et al. (2018), p. 5.
189.
Ricroch et al. (2017), p. 180.
190.
Callaway (2018), and King (2018).
191.
OECD (2018a), p. 5.
192.
OECD (2018a), p. 5; Nogué et al. (2015).
193.
Cibus™ (2017, 2018), Lombardo et al. (2016), pp. 52–53.
194.
Abbott (2015).
195.
Swedish Board of Agriculture (2015) (Sweden); UK Advisory Committee on Releases to the Environment (2011) (UK); German Federal Office of Consumer Protection and Food Safety (2015) (Germany; withdrawn in 2018, German Federal Office of Consumer Protection and Food Safety (2018)); further Abbott (2015); Madre and Agostino (2017); Eriksson (2018), pp. 2–4; Corporate Europe Observatory (2016c).
196.
Not known for certain, cf. Eriksson et al. (2017), p. 226. Cf. also the decisions by the Swedish and Finnish authorities that a GMO field trial authorisation is not required, Swedish Board of Agriculture (2015); Finnish Centre of Excellence in Molecular Biology of Primary Producers (2016).
197.
European Commission Directorate-General for Health and Food Safety (2015a); cf. also Abbott (2015). Once a binding interpretation of the GMO definition is issued at the EU level by the European Court of Justice, national interpretations are void. They are de facto also void if the European Commission issues non-binding interpretation guidance. Member states decisions that no field trial authorisation is required have no impact on the necessity of a marketing authorisation because marketing authorisations are issued at the EU level.
198.
Abbott (2015).
199.
Eriksson et al. (2017), p. 226.
200.
Cf. Corporate Europe Observatory (2018), and Greenpeace EU (2018).
201.
Cf. “Morineau et al. (2017)”; UK Advisory Committee on Releases to the Environment (2018), p. 2.
202.
Faure and Napier (2018), p. 3.
203.
Faure and Napier (2018), pp. 3–4; European Commission Joint Research Centre (2019a); Rothamsted Research (2019); European Commission Joint Research Centre (2019b); VIB (2019).
204.
There are no pending applications for placing GMOs obtained by genome editing on the market, yet, cf. European Commission (n.d.-g).
205.
See e.g. Sect. 5.4 (“Regulatory Prerequisites for Activities Relating to Genome Edited Plants”), text to n. 163ff, 179ff; Sect. 5.7 (“Low Level Presence”), text to n. 275ff; Sect. 5.8 (“Labelling”), text to n. 329ff; Sect. 5.10 (“Liability”), text to n. 374.
206.
Cf. text to n. 50–59.
207.
Lappin (2018b), p. 3; Andriukaitis (2018).
208.
Cf. text to n. 395–418.
209.
Cf. also the stakeholders’ positions on GEOs in general, n. 435–442.
210.
Laaninen (2016), p. 7; cf. the joint letter by environmental NGOs: EcoNexus et al. (2015); cf. the joint position paper by environmental NGOs and the organic sector: IFOAM EU Group (2017); cf. further GM Freeze (2016), Greenpeace (2015), GMWatch (2014), Steinbrecher (2015), and IFOAM EU Group (2015).
211.
Cf. Michalopoulos (2018), and IFOAM EU Group (2018).
212.
Note n. 441.
213.
Wolt et al. (2016), pp. 513–514; Laaninen (2016), p. 6; European Commission New Techniques Working Group (2011), para. 5.2.1.5 B; French Haut Conseil des Biotechnologies (2016a), pp. 95–96; European Seed Association (2017b), New Breeding Techniques Platform (2015b); cf. also the statements from the research and agricultural sectors listed in Stakeholder and Issue Mapping on New Breeding Techniques (2017). A frequent line of argumentation is: Organisms obtained by SDN-1, SDN-2 and ODM are similar to organisms resulting from traditional mutagenesis by radiation or chemical agents, which are not GMOs. Genome editing techniques even generate fewer unintended effects than traditional mutagenesis techniques, cf. European Commission New Techniques Working Group (2011), para. 5.2.1.5 B.
214.
Cf. Huang et al. (2016).
215.
Cf. e.g. the statements at Science Media Centre (2018), Clarke (2018), German Association of Biotechnology Industries (2018), and bioökonomie.de (2018).
216.
Cf. Lappin (2018a), pp. 4–5; European Seed Association (2017b), pp. 2–3.
217.
Cf. Michalopoulos (2018); cf. also text to n. 191.
218.
European Commission Scientific Advice Mechanism Group of Chief Scientific Advisors (2018), p. 6.
219.
Regarding the risks perceived by consumers cf. n. 463.
220.
See Sect. 5.8 (“Labelling”).
221.
With respect to the importance of consumer choice and personal control over exposure for the acceptance of new food technologies Frewer et al. (2011), p. 453; regarding the importance of labelling of GEOs to German focus groups participants Hopp et al. (2017), pp. 31–32; regarding British participants in a public dialogue van Mil et al. (2017), p. 87.
222.
Cf. also the past WTO dispute challenging the EU’s GMO policies, WTO Panel Report, European Communities - Measures Affecting the Approval and Marketing of Biotech Products (EC Biotech) (2006) WT/DS291/R; WT/DS292/R; WT/DS293/R.
223.
Cf. e.g. chapter 7 (Country Report on the USA); chapter 1 (Country Report on Argentina). Cf. also third countries’ disappointment regarding the European Court of Justice’s decision in Case C-528/16, e.g. U.S. Department of Agriculture (2018), stating that they “encourage the European Union to seek input from the scientific and agricultural communities, as well as its trading partners, in determining the appropriate implementation of the ruling.”
224.
Cf. Cantley (2007), p. 38.
225.
Cf. text to n. 328–329.
226.
Cf. Cantley (2007), p. 38; Paarlberg et al. (2004), p. 19; Beckmann et al. (2014), p. 385; Lezaun (2006), p. 502.
227.
See text to n. 275.
228.
Regarding “asynchronous GMO approvals” and “isolated foreign approvals” Stein and Rodríguez-Cerezo (2009), pp. 19–21; Beckmann et al. (2014), pp. 385–386.
229.
Cronin and Stone (2018) (“The world already has experienced the economic impact of asynchronous approvals for GMOs, when China and Europe rejected U.S. grain imports because a GMO crop was not approved in that country. However, the impact could be several times greater this time because there are so many gene-edited crops in the commercial development pipeline.”).
230.
Bruins (2018), p. 10.
231.
Regarding the situation of GM crop cultivation in the EU cf. text to n. 3–7.
232.
Cf. the experiences regarding GMOs, Paarlberg et al. (2004), pp. 5–6, 19.
233.
Lee (2008), pp. 234–240; regarding labelling and traceability e.g. Lezaun (2006), p. 501; Mansour and Key (2004), pp. 63–64; regarding the opt-out possibilities Dederer (2016b), pp. 163–164.
234.
In detail Dederer (2019); further Kahrmann et al. (2017), p. 182. Three examples:
1. (1)
  Many measures to restrict genome editing would qualify as measures to protect human, animal or plant life or health and thus as measures under the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), cf. SPS Agreement, art. 1.2 in connection with annex A. As such, they have to be based on a scientific risk assessment and need “sufficient scientific evidence” to be maintained, SPS Agreement, arts. 2.2, 5.1, 5.2; Alemanno (2013), pp. 292–293 (unless a risk assessment is not possible to perform, cf. SPS Agreement, art. 5.7). Do the EU risk regulation rules on GEOs withstand these procedural and material requirements? Is there “sufficient scientific evidence” that GEOs are risky? Are the extensive measures proportionate to the risk identified, cf. WTO Panel Report, Japan – Measures Affecting the Importation of Apples (2003) WT/DS245/R, para. 8.198? Is the huge discrepancy between the regulation of organisms developed through traditional breeding and the regulation of organisms developed through SDN-1, SDN-2 and ODM “inconsistent”, SPS Agreement, art. 5.5?
2. (2)
  Even more than regarding GMOs, it could be claimed that the different treatment of GEOs (which will mostly be produced outside the EU) and traditionally bred organisms is a discrimination of “like products”, cf. General Agreement on Tariffs and Trade 1994 (GATT 1994), Art. III:4 as well as Agreement on Technical Barriers to Trade (TBT Agreement), art. 2.1 (as far as applicable, cf. also art. 1.5). Could it be justified?
3. (3)
  Is there a “legitimate objective” for traceability, labelling and coexistence regulations within the meaning of the TBT Agreement, art. 2.2? Is it a legitimate objective to fulfil the consumers’ wish to know whether the product is genome edited/genetically modified or do consumers have to have a “good reason” for wanting to know it? Cf. Paarlberg et al. (2004), pp. 7, 14; Cheyne (2012), pp. 326–327, who further remarks that there is “great uncertainty about how a panel or the Appellate Body would resolve a dispute over existence and content of GMO labelling”.
235.
World Trade Organization Committee on Sanitary and Phytosanitary Measures (2018).
236.
World Trade Organization Committee on Sanitary and Phytosanitary Measures (2019), 3.1.5.
237.
U.S. Department of Agriculture (2019).
238.
Phillips and Flach (2017), p. 3.
239.
Sikkema (2018) (“No proposal in the GMO file is promising – one always opens Pandora’s box”); regarding the establishment of a trait-based system UK House of Commons Science and Technology Committee (2015), p. 41 (“very real possibility of ending up with the unsatisfactory GM regime simply being applied more generally to any novel crop”). The suspicion that attempts to deregulate genome editing could be counterproductive is underlined by calls for their tighter regulation, e.g. by the European parliamentary group The Greens/European Free Alliance, cf. the demand for an “enhanced” risk assessment for GEOs “to take into account the new set of risks linked to the gene editing techniques”, The Greens/European Free Alliance in the European Parliament (2018a).
240.
Cf. UK House of Commons Science and Technology Committee (2015), p. 41, Q424; cf. the politicisation of the GMO authorisation process, n. 157–160.
241.
Cf. UK House of Commons Science and Technology Committee (2015), Q424.
242.
Cf. e.g. Baulcombe et al. (2014), pp. 36–38, 41.
243.
UK House of Commons Science and Technology Committee (2015), pp. 32–35; European Plant Science Organisation (2017), p. 3.
244.
Cf. European Parliament (2014c), para. 32: “The European Parliament […] [n]otes that, with today’s technique-based plant-breeding legislation, it has proven difficult, after the event, to define what technique was used at the time of plant-breeding, which serves to confirm the difficulties posed by technique-based laws”.
245.
Marchant and Stevens (2015), pp. 236–237; UK House of Commons Science and Technology Committee (2015), p. 36. The initially foreseen mechanisms to deal with technological progress (update of the positive and negative lists of techniques in the GMO definition; simplified procedures and dossiers etc.) are (with very few exceptions) not used for political reasons, The Netherlands Government (2017), p. 2; text to n. 266.
246.
Tagliabue and Ammann (2018), p. 40 (“inconsistent”); Devos et al. (2012), p. 10771.
247.
Sprink et al. (2016), p. 1493.
248.
Cf. the overview of bodies wishing to move towards a trait-based system in UK House of Commons Science and Technology Committee (2015), p. 36 and Laaninen (2016), p. 5; examples of the statements in favour of a trait-based system are: European Academies Science Advisory Council (2015), p. 4; European Plant Science Organisation (2017); German National Academy of Sciences Leopoldina et al. (2015), p. 3; UK Advisory Committee on Releases to the Environment (2013a), p. 1; UK Biotechnology and Biological Sciences Research Council (2014), pp. 1, 4.
249.
Cf. UK House of Commons Science and Technology Committee (2015), p. 36; Tagliabue and Ammann (2018), p. 44.
250.
Cf. the statements in reaction to Case C-528/16, e.g. Prof Leyser or Prof Crute at Science Media Centre (2018).
251.
Pollack and Shaffer (2009), pp. 277–278; regarding the reasons for the continuance of the essential characteristics of GMO regulatory systems Pollack and Shaffer (2009), pp. 77–80.
252.
See n. 252.
253.
Cf. Dederer (2016b), p. 166; Hartung and Schiemann (2014), p. 750; UK House of Commons Science and Technology Committee (2015), Q543 [Lord de Mauley]; UK House of Commons Science and Technology Committee (2015), GMC0016 [Professor Perry] para. 8; The Netherlands Commission on Genetic Modification (2009b), p. 29.
254.
Eriksson and Ammann (2016), p. 3.
255.
Cf. UK House of Commons Science and Technology Committee (2015), p. 41; Marchant and Stevens (2015), p. 238; Hartung and Schiemann (2014), pp. 743–744.
256.
The Netherlands Government (2017); cf. further Phillips and Flach (2017).
257.
Cf. Phillips and Flach (2017), p. 3.
258.
Cf. e.g. Bioökonomierat (2018) (in German) aiming at an exemption for plants with genetic alterations up to 20 base pairs (not clear which legal amendments are envisaged).
259.
Cf. The Netherlands Government (2017), p. 2.
260.
The Netherlands Government (2017), pp. 2–3.
261.
ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583, paras. 48, 53.
262.
Cf. TFEU, art. 191(2); cf. also European Commission (2000), para. 5.1.2 (“An assessment of risk should be considered where feasible when deciding whether or not to invoke the precautionary principle.”). Cf. also van Heezik and Tuinzing-Westerhuis (2018) recommending such a risk evaluation due to the current political climate.
263.
Possibly, the studies that have already been carried out on hazards associated with the application of the various new breeding techniques in plants, animals and micro-organisms would be sufficient; cf. the EFSA study on cisgenesis, which concludes “that similar hazards can be associated with cisgenic and conventionally bred plants, while novel hazards can be associated with intragenic and transgenic plants.”, European Food Safety Authority (2012a), p. 20; cf. the studies analysing whether there are general differences in safety between organisms developed by the various new breeding techniques and traditionally bred organisms, e.g. European Commission Scientific Advice Mechanism High Level Group of Scientific Advisors (2017), pp. 17–19, 88–90 or the “Safety Issues” sections in Vogel (2012). The EU legislator enjoys a “wide measure of discretion” where complex technical assessments have to be made, cf. e.g. ECJ, Case T-177/13 TestBioTech eV and Others v Commission [2016] EU:T:2016:736, para. 77. It is therefore unlikely that the European Court of Justice would challenge the risk evaluation by the EU legislator. Cf. further Scott and Vos (2002), p. 254.
264.
Contained use: Directive 2009/41/EC provides the possibility to exempt GMMs with a high degree of familiarity and safety, Directive 2009/41/EC, art. 3(1)(b), annex II part B; Herdegen and Dederer (2009), para. 13, 22.
Field trials: Directive 2001/18/EC allows for the introduction of simplified procedures (“differentiated procedures”) for GMOs with a high degree of familiarity and safety, Directive 2001/18/EC, art. 7; Di Fabio and Kreiner (2003), pp. 714ff; Herdegen and Dederer (2015), para. 76.
Placing on the market: There are two possibilities: In the individual case, the applicant can request to provide less information on the marketing of the GMO, Directive 2001/18/EC, art. 13(2)(2) in conjunction with annex IV sec. B (cf. Table 5.10 sec. “Additional Information”); Herdegen and Dederer (2015), para. 114. On a general basis, Directive 2001/18/EC allows for the introduction of simplified dossiers for certain types of GMOs with a high degree of familiarity and safety, Directive 2001/18/EC, art. 16; Herdegen and Dederer (2015), para. 115; Di Fabio and Kreiner (2003), para. 92.
265.
All decisions are made by way of comitology procedures and thus involve a committee composed of member state representatives; cf. Directive 2009/41/EC, annex II part B, art. 20(2) regarding exemptions from Directive 2009/41/EC; cf. Directive 2001/18/EC, arts. 7(3),(4), 30(2) regarding differentiated procedures; cf. Directive 2001/18/EC, arts. 16(2), 30(3) regarding simplified dossiers for placing certain types of GMOs on the market.
266.
E.g. notification instead of authorisation or fast-track authorisation procedures. Regarding the case of cisgenic plants, the European Parliament called on the European Commission to “differentiate between cisgenic and transgenic plants and to create a different approvals process for cisgenic plants” in 2014, European Parliament (2014a), para. 31; Laaninen (2016), p. 7.
267.
Cf. also text to n. 179ff.
268.
Cf. text to n. 116.
269.
E.g. mutagenesis by chemicals or irradiation.
270.
ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583, para. 82.
271.
ECJ, Case C-528/16 Confédération paysanne and Others [2018] ECLI:EU:C:2018:583, para. 82.
272.
European Commission EU Science Hub (2016). From time to time, it is discussed to introduce a tolerance level for unauthorised GMOs in seed, cf. IG Saatgut (2016), p. 1.
273.
Commission Regulation (EU) No 619/2011 of 24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired [2011] OJ L166/9, art. 6, annex II(B)(2). Thereby, the EU wants to avoid problems of feed imports, Bergmann and Dederer (2012), para. 49. There has to be either an expired EU authorisation for the GM feed or both an authorisation in a third country and a pending application in the EU, Regulation (EU) No 619/2011, art. 2. This condition ensures that a risk assessment has been carried out. Cf. further Dederer (2016a), pp. 109–110.
274.
Cf. in detail the report of the European Network of GMO Laboratories, European Network of GMO Laboratories (2019), pp. 14–16.
275.
Cf. European Network of GMO Laboratories (2019), p. 17. Cf. also the US company Cibus claiming that its ODM herbicide-tolerant canola might have already entered the European market unnoticed, Cibus Europe (2015); Corporate Europe Observatory (2016c).
276.
Cf. Jones (2015), pp. 2–3.
277.
European Network of GMO Laboratories (2017), p. 5; Lusser et al. (2011), p. 68.
278.
European Network of GMO Laboratories (2019), p. 14. Cf. also the EU Official Controls Regulation, Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products [2017] OJ L95/1.
279.
Cf. Bartsch et al. (2018), pp. 43–55; cf. also European Commission Scientific Advice Mechanism High Level Group of Scientific Advisors (2017), pp. 19–20; Lusser et al. (2011), pp. 63–71; Ribarits et al. (2014), pp. 185–186.
280.
I.e. sequence of the mutation site and possibly of other sites in the genome.
281.
E.g. the Plant Genome Editing Database on which plant breeders can voluntarily provide information about plants that have been generated using the CRISPR/Cas9 technology, Plant Genome Editing Database (2018).
282.
Chapter 1 (Country Report on Argentina), n. 42. Cf. also the central register mentioned in Regulation (EC) No 1830/2003, art. 9(3), which also contains, where available, relevant information concerning GMOs that are not authorised in the EU. Cf. calls for a global public register of released genome edited organisms as part of the existing registry of the Biosafety Clearing House on Living Modified Organisms (LMOs), European GMO-Free Regions Network (2018). Regarding the difficulties of establishing a register of all released GEOs worldwide European Network of GMO Laboratories (2019), p. 16.
283.
Or characteristic proteins, metabolites etc. However, GMO screening for enforcement purposes is currently mainly performed with DNA-based analysis, Ribarits et al. (2014), p. 186.
284.
Cf. text to n. 172 (identification).
285.
The uniqueness of traditional GM transformation events is also only a probabilistic judgement (though, of course, one with a very high probability), Lezaun (2006), p. 511.
286.
Prima facie evidence in this case means that the authorities prove that it is improbable that the DNA sequence is not derived from genome editing. The developer can then prove the contrary, i.e. that it occurred naturally or through traditional breeding, e.g. by showing breeding protocols.
287.
For criminal sanctions, however, a higher standard of proof might apply.
288.
Cf. text to n. 175. The characteristic sequence can e.g. be composed of the sequence of the genetic modification and the sequence in its vicinity.
289.
European Network of GMO Laboratories (2019), pp. 1, 15, 17.
290.
As genomes differ between varieties of plant species (see n. 174), referring to a single reference genome is not possible. Pan-genome databases would have to be established, i.e. databases including variations between varieties.
291.
European Commission Scientific Advice Mechanism High Level Group of Scientific Advisors (2017), p. 19.
292.
Duensing et al. (2018), p. 4.
293.
Cf. Regulation (EC) No 178/2002, art. 3 no. 15, arts. 18, 11; IFS Food (2017), p. 75; Codex Alimentarius Commission (2006); International Organisation for Standardisation (2015), 8.5.2.
294.
Cf. Black et al. (2006), p. 368.
295.
E.g. confirmations by producers that the product is GM-free or that segregation measures have been applied.
296.
Cf., however, Jones (2015), p. 3, pointing to the “inherent frailties and temptations for misuse” of documentation.
297.
Heinemann (2014), pp. 167–168.
298.
The Netherlands Commission on Genetic Modification and Health Council of the Netherlands (2016), p. 46.
299.
Cf. also the example in German Federal Office of Consumer Protection and Food Safety (2017), p. 6.
300.
Cf. Beckmann et al. (2014), p. 386.
301.
Bruins (2018), p. 10; Cronin and Stone (2018).
302.
Cf. Jones (2015), p. 3 presuming that the EU might “turn a blind eye to the potential presence of unauthorised products”.
303.
Including import bans, Jones (2015), p. 3.
304.
Cf. Prof Huw Jones at Science Media Centre (2018); The Netherlands Commission on Genetic Modification and Health Council of the Netherlands (2016), pp. 46, 47; The Netherlands Commission on Genetic Modification (2009b), pp. 3–4. Cf. further text to n. 223ff.
305.
Regarding the EU’s GM labelling rules cf. e.g. Plan and van den Eede (2010), p. 12; Devos et al. (2012), pp. 10775, 10777–10778; The group of FAS Biotechnology Specialists in the European Union (2018), pp. 29–31.
306.
Masip et al. (2013), p. 317.
307.
Cf. Regulation (EC) No 1829/2003, recital 21; Devos et al. (2006), p. 144.
308.
Regarding the term “produced from GMOs” see n. 118.
309.
Regulation (EC) No 1829/2003, arts. 12ff, 24ff in conjunction with art. 15(1). The labelling requirement thus mirrors the authorisation requirement—the same food and feed that have to be authorised need to be labelled, cf. text to n. 118–119.
310.
See n. 118.
311.
Regulation (EC) No 1829/2003, art. 13/art. 25 (food/feed). Regarding the labelling of compound ingredients cf. Regulation (EC) No 1829/2003, art. 13(1)(b); cf. further The group of FAS Biotechnology Specialists in the European Union (2018), p. 30.
312.
Regulation (EC) No 1829/2003, art. 13(2),(3)/art. 25(2)(c),(3) (food/feed).
313.
In oils, for example, no recombinant DNA is detectable as the DNA is destroyed during the refining process, cf. Aparicio (2017), p. 81.
314.
Regulation (EC) No 1830/2003, art. 4(6); Lee (2008), p. 144.
315.
Regulation (EC) No 1830/2003, art. 4(6).
316.
The group of FAS Biotechnology Specialists in the European Union (2018), p. 29.
317.
Regulation (EC) No 1829/2003, art. 12(2)/art. 24(2) (food/feed); Regulation (EC) No 1830/2003, arts. 4(7), (8), 5(4); Directive 2001/18/EC, art. 21(3). According to Masip et al. (2013), p. 317 “The adventitious presence thresholds in the EU are the strictest in the world”.
318.
Cf. Regulation (EC) No 1830/2003, art. 4(7); Directive 2001/18/EC, art. 21(2); cf. further Devos et al. (2006), p. 142; Grossman (2010), pp. 141–146 and Norer and Preisig (2016), p. 54, also with respect to the ongoing discussion about the introduction of labelling thresholds. Cf. also European Seed Association (2012), pp. 1, 2, explaining that sampling and testing of seed differs widely between the member states (“patchwork of rules and practices”).
319.
The EU neither forbids nor regulates GMO-free labelling, European Commission Directorate-General for Health and Food Safety (2015b), p. 2.
320.
European Commission Directorate-General for Health and Food Safety (2015b), pp. 10ff.
321.
Most GM-free labels cover only food and feed, European Commission Directorate-General for Health and Food Safety (2015b), pp. 30ff; GM-free labels are mainly found on animal products, canned sweet corn and soybean products, The group of FAS Biotechnology Specialists in the European Union (2018), p. 31.
322.
Usually 0.9% or 0.1% for adventitious or technically unavoidable GM presence, European Commission Directorate-General for Health and Food Safety (2015b), pp. 33–34.
323.
European Commission Directorate-General for Health and Food Safety (2015b), pp. 10–47.
324.
European Commission Directorate-General for Health and Food Safety (2015b), pp. 2, 19–21.
325.
Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 [2007] OJ L189/1. It is replaced from 2021 on by Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 [2018] OJ L150/1. National, regional and private operator organic schemes partly apply stricter rules than the EU organic farming scheme with respect to GMOs, European Commission Directorate-General for Health and Food Safety (2015b), p. 19.
326.
Regulation (EC) No 834/2007, art. 9.
327.
Cf. Dederer (2016a), pp. 114–115; whether stricter thresholds for GM traces should be set in organic production is the subject of continuous debates, European Commission (2012), p. 9. However, the new Regulation (EU) 2018/848 also applies the 0.9% threshold, Regulation (EU) 2018/848, art. 30(4).
328.
European Commission (2016), p. 2; Sleenhoff and Osseweijer (2013), pp. 167, 168; Greenpeace (2005); The group of FAS Biotechnology Specialists in the European Union (2018), p. 29; except for consumers e.g. in the UK and Spain, The group of FAS Biotechnology Specialists in the European Union (2018), p. 41, below n. 443. Mandatory labelling is criticised for having a stigmatising effect, Sunstein (2017), pp. 1085–1087, Huffman and McCluskey (2014), p. 475, Peters and Lambert (2007), p. 159 (“message that genetic modification is harmful or bad”). Therefore, the reason why many consumers reject to buy GM labelled products is not only that they positively reject GMOs but also that some consumers are influenced by the label itself.
329.
Cf. The group of FAS Biotechnology Specialists in the European Union (2018), p. 41.
330.
Kahrmann et al. (2017), p. 180.
331.
Cf. e.g. Regulation (EC) No 1830/2003, art. 9(1). Admittedly, there are already products that do not allow for analytical controls, e.g. highly refined oil from GM plants, Davison and Ammann (2017), p. 22. Yet, the raw materials of the product can be tested.
332.
Currently, there are no unequivocal identification techniques for genome edited events, cf. the problem regarding the approval of these GEOs, text to 163ff. Control using several stretches of characteristic sequences in addition to the event might be possible, but could fail for progeny as progeny might have less or even none of these stretches due to crossing with other lines, cf. n. 176.
333.
European Network of GMO Laboratories (2019), p. 1; Brueller et al. (2012), pp. 126–127, 128; Ribarits et al. (2014), p. 187; Cotter et al. (2015), p. 12.
334.
The Netherlands Commission on Genetic Modification and Health Council of the Netherlands (2016), p. 46. Cf. also text to n. 299.
335.
European Commission (n.d.-b).
336.
Cf. Directive 2001/18/EC, art. 26a: “Member States may take appropriate measures to avoid the unintended presence of GMOs in other products.”; with respect to the coexistence measures adopted by the member states (as of 2009) European Commission (2009a), Beckmann et al. (2014), pp. 377–378.
337.
European Commission (2010b).
338.
Cf. the best practice documents by the European Coexistence Bureau, elaborated by technical working groups composed of member state experts, European Coexistence Bureau (n.d.).
339.
European Commission (2010b), annex 1.1.
340.
Cf. Beckmann et al. (2014), pp. 376–380; Dillen et al. (2016), pp. 64–65.
341.
Cf. the indicative catalogue of measures for coexistence at European Commission (2003), pp. 14–17; cf. European Commission (2009b), pp. 6–9; cf. also the overview of technical coexistence measures divided by production steps (seedbed preparation and start material—sowing—growing—harvest—post-harvest—storage, processing and transport) in Devos et al. (2012), p. 10778. In some countries, deviation from technical coexistence measures is possible provided that the neighbouring farmer consents, Schenkelaars and Wesseler (2016), p. 8. Registration and information responsibilities exist in almost all member states, Schenkelaars and Wesseler (2016), p. 7.
342.
Schenkelaars and Wesseler (2016), p. 7.
343.
Masip et al. (2013), pp. 312, 317 (“de facto moratorium”, “arbitrary”); Beckmann et al. (2014), pp. 384, 388.
344.
Schenkelaars and Wesseler (2016), p. 7.
345.
Spain has no national or regional coexistence regulations. GM farmers have to follow good agricultural practices and recommendations by the seed industry. The non-GM farmers are responsible themselves to adopt other necessary segregation measures, Schenkelaars and Wesseler (2016), p. 8; Guerrero (2017), p. 21; Asociación Nacional de Obtentores Vegetales (n.d.).
346.
Cf. Regulation (EC) No 1829/2003, art. 24(2),(3)—the labelling tolerance threshold for traces of authorised GM material of 0.9% only applies to traces that are adventitious or technically unavoidable (cf. text to n. 318–319). The operators must supply evidence that they have taken appropriate steps to avoid the presence of GM material. Contracts obliging suppliers from non-EU countries to take safety measures against GMO contamination is such an appropriate step, German Federal Ministry of Food and Agriculture and German Federal Office of Consumer Protection and Food Safety (2011), p. 5.
347.
E.g. liability for field trials or marketing without approval (as far as approval is required under Directive 2001/18/EC).
348.
E.g. liability for bodily injuries, damages to property and contamination of non-GMOs.
349.
Directive 2001/18/EC, art. 33; Regulation (EC) No 1829/2003, arts. 45(1), (2); Regulation (EC) No 1830/2003, arts. 11 (1), (2).
350.
German Genetic Engineering Act: Gesetz zur Regelung der Gentechnik (GenTG), (BGBl. 1993 I p. 2066). Last amended by law of 17.07.2017 (BGBl. 2017 I p. 2421), Sec. 39 (2); Decreto legislativo of 8 July 2003. n. 222 (GU n. 194 of 22-8-2003), art. 35.1.
351.
E.g. Austria, Belgium, Denmark, France, Hungary, the Netherlands and the Czech Republic, Beckmann et al. (2014), p. 380; European Commission (2009b), p. 8.
352.
ECJ, Case C-52/00 Commission v France [2002] ECR I-3827, paras. 16–24; ECJ, Case C-154/00 Commission v Greece [2002] ECR I-2879, paras. 12–20; ECJ, Case C-183/00 González Sánchez v Medicina Asturiana SA [2002] ECR I-3901, paras. 25–32; Riehm (2017), para. 47.
353.
Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products [1985] OJ L210/29 (Product Liability Directive), arts. 1ff; under the PLD three categories of ‘defects’ are recognised: Design defects, manufacturing defects, and warning defects, Brüggemeier (2015), para. 301; Hoffman and Hill-Arning (1994), pp. 6–7; Taschner and Frietsch (1990), Richtlinie Art. 6, para. 9. Accordingly, a GM variety is e.g. defective if it contains a potentially harmful trait, as is a food if it is erroneously processed from a GM variety not authorised for food use in the European Union, Koch (2010), para. 72.
354.
Product Liability Directive, art. 7(e); Brüggemeier (2015), paras. 324–325.
355.
Product Liability Directive, art. 15(1)(b); Luxembourg and Finland derogated from the development risk defence entirely, whereas Spain derogated with respect to food and pharmaceuticals, Koch (2010), para. 80, n.124; Giliker (2014), 334, n. 89. Moreover, Germany derogated from the defence with respect to GMOs, however, only concerning the liability of seed producers, GenTG. Sec. 37(2); Fedtke (2010), para. 40.
356.
Product Liability Directive, art. 9(b)(i), (ii).
357.
Product Liability Directive, art. 7(a); Brüggemeier (2015), paras. 319–320; Taschner and Frietsch (1990), Richtlinie Art. 7, para. 7.
358.
Kohler (2005), p. 575; Koch (2013), p. 410.
359.
European Commission (2009b), p. 5; Koch (2013), p. 407.
360.
van Dam (2013), p. 346, Bar (2000), para. 145; Koch (2010), para. 8.
361.
Koch (2010), paras. 45–47; regarding the different handling of alternative causation cf. Koziol (2007), pp. 387–389; Infantino and Zervogianni (2017), pp. 632–634; van Dam (2013), pp. 329–332; regarding cumulative causation, cf. Infantino and Zervogianni (2017), pp. 652–653; regarding supervening causation cf. Koch (2007), p. 501; Infantino and Zervogianni (2017), pp. 628–631.
362.
Ranging from “more likely than not”, e.g. in Italy, cf. Monti and Fusco (2010), para. 20 to almost “certainty”, e.g. in Austria, cf. Weissenbacher (2010), para. 18; see Koch (2010), paras. 36–37.
363.
Koch (2010), paras. 118–120, outlining that the length of objective periods of prescription, i.e. prescription commencing at the time of the harmful event independent of the victim’s knowledge, varies from 3 years in the Czech Republic to 30 years e.g. in Austria, Germany, and the Netherlands.
364.
Koch (2010), paras. 62–69; strict liability for classical damages in general applies in Finland, Hungary, Lichtenstein, Norway and Poland, strict liability only for the research and development stage in Austria (Sec. 79a Gentechnikgesetz) and Germany (GenTG, Sec. 32 (1), 37 (2)).
365.
European Commission (2010b), para. 2.5.
366.
Countries with such specific regulation are in particular Austria, Finland, France, Germany, Hungary, Norway, Poland, Slovakia and Switzerland, cf. Koch (2008a), paras. 156–183.
367.
Schenkelaars and Wesseler (2016), p. 8; Faure and Wibisana (2008), para. 75; Beckmann et al. (2014), p. 379; European Commission (2009b), p. 4.
368.
Cf. above Sect. 5.8 (“Labelling”).
369.
Beckmann et al. (2014), p. 380; Koch (2008b), para. 4; see e.g. discussion in Germany regarding GenTG, Sec. 36a, which refers to statutory labelling requirements only, but is still interpreted as uncertain by some, cf. Palme (2005), p. 256; Fedtke (2008), para. 40.
370.
Schenkelaars and Wesseler (2016), p. 8.
371.
Koch (2008a), para. 33–34; Bar (2000) no. 25; Bussani and Palmer (2005), pp. 123–125.
372.
Bar (2000), para. 32; Koch (2008a), para. 34.
373.
Cf. analysis in Koch (2008a), paras. 47–50, France and Denmark only require proof of cultivation of GMOs in the vicinity (and presence of GMOs on the claimant’s field) for compensation and thereby de facto apply an irrebuttable presumption of causation, cf. Ulfbeck (2008), para. 3; Taylor (2008), para. 6.
374.
European Commission (2009b), p. 5.
375.
Koch (2008a), para. 56.
376.
European Commission (2009b), p. 5; cf. the presentation of special liability regimes for GMO admixture in Europe by Koch (2008a), paras. 156–173: Strict liability is provided for in Austria, France (also within a special liability system, cf. art. 8 du Loi n°2008-595 du 25 juin 2008 relative aux organismes génétiquement modifiés, JORF n°0148 du 26 juin 2008, 10218), Finland (if qualified as environmental harm), Germany, Hungary, Luxemburg (Goergen (2010), para. 4), Norway, Poland, Slovakia.
377.
Koch (2008a), para. 59, drawing attention to the fact that the wording of the Belgium civil code is identical, but interpreted differently.
378.
Koch (2013), p. 409; Koch (2008a), para. 59.
379.
Koch (2008a), para. 67; Bar (1998), para. 531.
380.
Gordley (2010), p. 24; Bar (1998), paras. 531, 535–544; Koch (2008a), para. 69; except for the Netherlands which made liability between neighbours dependent on fault, Castillo and van Boom (2008), para. 32.
381.
Gordley (2010), pp. 23–24; Bar (1998), para. 533; Koch (2008a), para. 68.
382.
Bar (1998), para. 534; Koch (2008a), para. 69; Koch (2008b), para. 14.
383.
Koch (2008a), para. 69; Bar (1998), para. 534; different in Germany, where no distinction is made between GM and conventional cultivation as regards the customary character of farming (GenTG, Sec. 36a (3)), while any GMO admixture is legally defined as significant interference, GenTG, Sec. 36a (1).
384.
Beckmann et al. (2014), p. 380; European Commission (2009b), p. 5.
385.
Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004 on environmental liability with regard to the prevention and remedying of environmental damage [2004] OJ L143/56 (Environmental Liability Directive), art. 3(1)(a) in conjunction with annex III(11); Barns (2018), p. 5.
386.
Environmental Liability Directive, art. 1; Hinteregger (2008), para. 5/6.
387.
Environmental Liability Directive, art. 2(1)(a)-(c).
388.
European Commission (2002), pp. 19f; Duikers (2006), pp. 626–627; Meßerschmidt (2011), para. 16; Hinteregger (2008), para. 5/9.
389.
Environmental Liability Directive, art. 3(3).
390.
Environmental Liability Directive, art. 8(4)(a), (b); Bergkamp and van Bergeijk (2013), paras. 4.38–4.46; Barns (2018), pp. 6–7.
391.
e.g. Czech Republic, Greece, Italy, Malta, Portugal, Spain and the UK (with the exception of Scotland and Wales), cf. Goldsmith and Lockhart-Mummery (2013), para. 7.26; Bergkamp and van Bergeijk (2013), para. 4.47.
392.
Environmental Liability Directive, art. 8(4); Barns (2018), pp. 6–7.
393.
Environmental Liability Directive, art. 16(1); Hinteregger (2008), para. 5/7; Meßerschmidt (2011), para. 8.
394.
The European Commission is composed of one commissioner from each member state. Examples of functions are: Proposal of new laws, management of EU policies and allocation of EU funding, enforcement of EU law and international representation of the EU, cf. Consolidated version of the Treaty on European Union [2012] OJ C326/1 (TEU), art. 17; European Union (2018a), and European Commission (2018b).
395.
The European Parliament is directly elected. Examples of functions are: Adoption of EU laws together with the Council of the European Union, decision on international agreements, supervisory and budgetary functions, cf. TEU, art. 14; European Union (2018b).
396.
The Council of the European Union is composed of government ministers from each member state. Examples of functions are: Adoption of EU laws together with the European Parliament, coordination of EU policies, conclusion of agreements between the EU and other countries or international organisations and budgetary functions, cf. TEU, art. 16; European Union (2017).
397.
TEU, arts. 14(1)(1), 16(1)(1), 17(2); TFEU, arts. 289(1), 294; European Parliament (2017), pp. 11ff.
398.
Examples are: the strong role of the Commission in the GMO approval process—de facto, it takes the final authorisation decisions, see n. 100; the Commission’s guidance documents, e.g. on coexistence, text to n. 338–339; collection and dissemination of information and data on GMOs, cf. e.g. the GMO register, European Commission (n.d.-g) or various reports and studies; the enforcement of EU law through infringement procedures (TFEU, art. 258), e.g. when several member states did not implement Directive 2001/18/EC promptly, Poli (2006), p. 390.
399.
Bernauer and Aerni (2008), p. 188. From the various research projects on GMOs the Commission funded, it drew the conclusion that “GMOs […] are not per se more risky than e.g. conventional plant breeding technologies”, European Commission (2010a), p. 16.
400.
Cf. Valavanidis (2016), p. 30; Leroux (2016), Corporate Europe Observatory (2016a), p. 4; Fladung (2016), p. 474; text to n. 206, 209, 427–433.
401.
Lusser et al. (2011), and European Food Safety Authority (2012a, b).
402.
European Commission New Techniques Working Group (2011).
403.
European Commission Scientific Advice Mechanism High Level Group of Scientific Advisors (2017).
404.
Cf. European Commission (n.d.-h).
405.
High-level conference “Modern Biotechnologies in agriculture – Paving the way for responsible innovation”, 28 September 2017, Brussels, cf. European Commission (2017).
406.
Laaninen (2016), pp. 1, 2; Gene editing in legal limbo in Europe (2017); Corporate Europe Observatory (2016a), p. 13.
407.
Tagliabue and Ammann (2018), p. 51; O’Reilly (2017). This inaction despite the urgent need for regulatory clarification has been heavily criticised, cf. European Seed Association (2017b), p. 2.
408.
Cf. text to n. 486–488.
409.
Optimistic Purnhagen et al. (2018), p. 573. Cf. also Duensing et al. (2018), p. 2 (“during the hearing […] in the Case C-528/16 […], the Commission vaguely stated that they were preparing something about this ‘new’ problem.”).
410.
Bobek (2018), paras. 76–78.
411.
Fortuna (2019).
412.
The two largest groups, the Group of the European People’s Party (Christian Democrats) and the Group of the Progressive Alliance of Socialists and Democrats, do not have an official position on GEOs. Regarding established GMOs, the European People’s Party is conflicted. The Socialists and Democrats Group tends to reject GMOs, cf. e.g. Martin de la Torre, Victoria (2016). Members of the Group of the Alliance of Liberals and Democrats for Europe+Renaissance+USR PLUS and the European Conservatives and Reformists Group, i.e. the 3rd and 5th largest groups, initiated parliamentary reports stressing the potential of the new breeding techniques (see n. 415), cf. further Bruins (2017), McIntyre (2016). The Group of the Greens/European Free Alliance, i.e. the 4th largest group, reject GEOs. They call to be prudent and have always favoured the regulation of all GEOs as GMOs, The Greens/European Free Alliance in the European Parliament (2018b); The Greens/European Free Alliance in the European Parliament (2017). Regarding the composition of the EU Parliament 2019–2024 see European Parliament (2019). Regarding the position of the groups towards established GMOs cf. further the voting patterns of the European Parliament groups in a resolution concerning the placing on the market of the GMO Pioneer 1507 (European Parliament (2014b)), Mühlböck and Tosun (2015). Regarding the positions on established GMOs of the member state parties forming the European Parliament groups Wortmann (2015), pp. 14–23.
413.
Wortmann (2015), p. 3; n. 413.
414.
European Parliament (2016a), para. 32; European Parliament (2016b), paras. 27–28; European Parliament (2014c), paras. 7–8.
415.
European Parliament (2016a), para. 32; European Parliament (2016b), para. 27.
416.
Holland (2004), p. 5.
417.
The presidency rotates among the member states and is held for six months, TEU, art. 16(9).
418.
Council of the European Union (2019), p. 7; Fortuna (2019).
419.
Cf. the country overview in The group of FAS Biotechnology Specialists in the European Union (2017), pp. 50–51 as well as the “Innovative Biotechnologies” sections in the USDA Foreign Agricultural Service reports about the individual member states, The group of FAS Biotechnology Specialists in the European Union (2018), p. 53. Cf. further Madre and Agostino (2017); with respect to the Scandinavian countries Denmark, Finland, Norway and Sweden Eriksson et al. (2017); Stakeholder and Issue Mapping on New Breeding Techniques (2017) gives an overview of the political climate, positions of ministries and regulatory agencies in selected countries; cf. also the positions held by the national governments in Case C-528/16, Bobek (2018), paras. 71–75.
420.
UK House of Commons Science and Technology Committee (2015), p. 16; UK Government (2016); differing Wales, Scotland and Northern Ireland, cf. UK House of Commons Science and Technology Committee (2015), p. 17; The group of FAS Biotechnology Specialists in the European Union (2017), p. 50.
421.
Cf. The Netherlands Government (2017).
422.
The group of FAS Biotechnology Specialists in the European Union (2017), p. 50; cf. further the UK parliamentary written answer Eustice (2018) (“the Government’s view is that specific regulation of this technology is not required where the induced genetic change could have occurred naturally or been achieved through traditional breeding methods”) as well as the Netherlands’ proposal to exempt certain new plant breeding techniques from the GMO framework, The Netherlands Government (2017); Corporate Europe Observatory (2016a), p. 14.
423.
The group of FAS Biotechnology Specialists in the European Union (2017), pp. 50–51.
424.
GMWatch (2016).
425.
The group of FAS Biotechnology Specialists in the European Union (2017), p. 51; Eriksson et al. (2017), p. 229 (regarding Denmark and Norway, which is a member of the European Economic Area).
426.
With respect to the attitudes of the EU member states towards GMOs cf. the classification into adopters—conflicted—opposed in The group of FAS Biotechnology Specialists in the European Union (2018), pp. 41–42 and International Service for the Acquisition of Agri-biotech Applications (2017), p. 97; cf. also the member states’ positions in the Council of the European Union regarding GMO authorisation requests (pro GMOs—abstain—against GMOs), see the figure in Mühlböck and Tosun (2017) (before 2014, the Council was involved in the GMO approval process). Cf. further the overview of selected EU countries’ stance towards GMOs (UK, Germany, Poland, Spain) in Clancy (2017), pp. 28–29; 33–34; 36–40; 41–44.
427.
Cf. the strong plant research and breeding sectors in the Netherlands, Phillips and Flach (2017), Corporate Europe Observatory (2016a), p. 5; in Sweden, Eriksson et al. (2017), pp. 219, 225–226, Corporate Europe Observatory (2016a), p. 5; or in the UK, International Service for the Acquisition of Agri-biotech Applications (2016), p. 80 (“world leadership in plant science”), Sciencewise and Nuffield Council on Bioethics (2016), p. 11 (“global leadership in genome editing”).
428.
E.g. in Greece and Italy, Lee (2017), p. 1222; cf. also Austria aiming at the protection of Alpine biodiversity, Lee (2017), p. 1222.
429.
Cf. European Commission Directorate-General for Health and Food Safety (2018).
430.
European Commission Directorate-General for Health and Food Safety (2018).
431.
Cf. UK Department for Environment, Food and Rural Affairs (2019) and Downing and Coe (2018), pp. 71–72 regarding the ‘no deal’ scenario; cf. BBC News (2018) regarding the transition period in case a withdrawal agreement is reached.
432.
International Service for the Acquisition of Agri-biotech Applications (2016), p. 80. Regarding the UK’s future regulatory options for the regulation of GMOs and organisms obtained by new plant breeding techniques in general Border and Walker (2017), pp. 3–4 and Brookes (2018). In reaction to the ruling of the European Court of Justice in Case C-528/16 voices were raised in favour of a distinct regulation or at least interpretation of the GMO definition in the UK that is more favourable towards GEOs, cf. the open letter by the British research and agricultural sectors calling for a “science-based approach to regulation”, John Innes Centre et al. (2018).
433.
Potton and Webb (2017), pp. 6–9.
434.
Regarding the interests of the various stakeholders Hamburger (2018).
435.
Cf. GM Freeze (2016), Greenpeace (2015), GMWatch (2014), Steinbrecher (2015), Trans Atlantic Consumer Dialogue (2016); cf. also the joint letter by environmental NGOs: EcoNexus et al. (2015) and the joint position paper by environmental NGOs and other associations, IFOAM EU Group et al. (2017).
436.
Examples of position papers are IFOAM EU Group (2015), German Organic Food Production Alliance (2017), Agir pour l’Environnement et al. (2017).
437.
Cf. the position statements by European and national scientific organisations, e.g. European Plant Science Organisation (2017), European Academies Science Advisory Council (2015), German National Academy of Sciences Leopoldina et al. (2015), UK Biotechnology and Biological Sciences Research Council (2014). Plant scientists from the Netherlands, the UK and Sweden are amongst the most active in the debate and also receive high media coverage, Stakeholder and Issue Mapping on New Breeding Techniques (2017), executive summary. An example is a Swedish researcher who grows genome edited cabbage in his garden and served it to a journalist as the alleged world’s first CRISPR meal, Lawrence (2016), Callaway (2018).
438.
Cf. the communication initiative “Embracing the Power of Nature”, European Seed Association (n.d.); European Seed Association (2017a); cf. the New Breeding Techniques Platform, New Breeding Techniques Platform (2015a). Differing Helliwell et al. (2017), p. 2090, speaking of a “wait-and-see” strategy regarding the breeding/seed sector.
439.
Helliwell et al. (2017), p. 2090.
440.
Cf. e.g. Copa-Cogeca (2017) (European umbrella organisation of agricultural cooperatives “Copa-Cogeca”); Morgan (2017) (National Farmers Union, UK); French Haut Conseil des Biotechnologies (2016b), Annex 1, pp. 23–24, 102 (various agricultural cooperatives, France). There are also some farming cooperatives and associations sceptical or negatively disposed towards organisms developed through new breeding techniques, cf. e.g. French Haut Conseil des Biotechnologies (2016b), Annex 2, pp. 37ff, 102; Eriksson et al. (2017), p. 232 (regarding farmers associations in Norway, which is a member of the European Economic Area); German Syndicate of Traditional Agriculture (2016). Cf. further the sections on national associations in Stakeholder and Issue Mapping on New Breeding Techniques (2017).
441.
Cf. the overview of stakeholders’ opinions towards GMOs in The group of FAS Biotechnology Specialists in the European Union (2018), pp. 39–41.
442.
TNS Opinion & Social (2010a), pp. 13–17 (84% of the respondents have heard about GM food; 38% of those who have heard about GM food actively search for information on it).
443.
Including feelings of wariness, unease and uncertainty, Rollin et al. (2011), p. 100.
444.
Gaskell (2010), pp. 37–38; on average, the opponent/supporter-ratio regarding GM food was 3:1 in 2010, Gaskell (2010), p. 7. According to Rollin et al. (2011), p. 100 the “majority […] are undecided or feel that they don’t know enough to form a view”. There are “minorities with strongly positive or negative opinions”.
445.
Gaskell (2010), p. 38; TNS Opinion & Social (2010a), pp. 18; 28–29 (59% of the respondents do not think that GM food is safe for their health and that of their family). In spontaneous responses to the questions “What are all the things that come to your mind when thinking about possible problems or risks associated with food and eating”, 8% mentioned GMOs, which puts GMOs to the 7th place); in prompted responses, 66% of the respondents indicated that they are “very worried” or “fairly worried” about GMOs in food or drinks (putting GMOs to the 5th place), TNS Opinion & Social (2010b), pp. 19, 21.
446.
Gaskell (2010), pp. 39–40.
447.
European Commission Directorate-General for Health and Food Safety (2015b), pp. 48ff; Sleenhoff and Osseweijer (2013), pp. 166, 168–169; Lucht (2015), pp. 4258–4259; International Service for the Acquisition of Agri-biotech Applications (2017), pp. 97–98; European Academies Science Advisory Council and German National Academy of Sciences Leopoldina (2013), p. 30; The group of FAS Biotechnology Specialists in the European Union (2018), p. 40. This is particularly true for the UK, cf. UK House of Commons Science and Technology Committee (2015), Q437 [Professor Poppy].
448.
TNS Opinion & Social (2010a), pp. 18–32. Gaskell (2010), p. 40 shows that relatively high support of GM food amongst the population is found e.g. in the UK, the Czech Republic, Portugal and Spain (with more than 35% of respondents agreeing that GM food should be encouraged, UK at the top with 44%); countries with low support are e.g. Greece, France, Germany or Austria (23% or below agree that GM food should be encouraged).
449.
Traits offering consumer or environmental benefits and non-food use of GM crops are better accepted, The group of FAS Biotechnology Specialists in the European Union (2018), p. 40.
450.
Cf. Pollack and Shaffer (2009), pp. 73–74; Burchardi (2007), pp. 35–37.
451.
Pollack and Shaffer (2009), pp. 75–76; Devos et al. (2012), p. 10771; Paarlberg et al. (2004), p. 6.
452.
The group of FAS Biotechnology Specialists in the European Union (2018), pp. 39; Lucht (2015), pp. 4257–4258.
453.
Cf. Kuntz (2012).
454.
The group of FAS Biotechnology Specialists in the European Union (2018), pp. 39; Scholderer (2004), pp. 169, 220–221.
455.
The group of FAS Biotechnology Specialists in the European Union (2018), p. 43; examples: 86% of a random sample of German consumers have never heard of genome editing, German Federal Institute for Risk Assessment (2019), p. 7; 90% of the French people polled have not heard of CRISPR-Cas9, Institut d'études Opinion et Marketing (2016), p. 7.
456.
For Germany: German Federal Institute for Risk Assessment (2019), p. 9.
457.
Cf. Le Déaut and Procaccia (2017), p. 286. However, the media coverage differs widely between the member states, cf. the country sections in Stakeholder and Issue Mapping on New Breeding Techniques (2017).
458.
Sciencewise and Nuffield Council on Bioethics (2016), pp. 10–11; Malyska et al. (2016), pp. 530–531.
459.
Hamburger (2018), p. 6; Ishii and Araki (2016), p. 1508.
460.
This is also a result of focus groups on public opinions towards genome editing in Germany, Hopp et al. (2017), p. 21 (in German).
461.
Regarding the activation of existing attitudes in case of similarity of new technologies to existing ones in general Frewer et al. (2011), pp. 453, 454; with respect to genome editing Bruce (2017), p. 390.
462.
Cf. Cardello (2003), p. 218, explaining that new food technologies typically possess many factors that foster consumers’ perception of risk. This also applies to genome editing techniques: Consumers cannot judge (without a label) whether a food derives from genome edited plants by inspecting or using it—the perceived risk is unobservable; the technologies are new; the risks are—in the eyes of consumers and as propagated by some NGOs—uncertain and delayed, etc. On top, European consumers tend to be risk adverse regarding new technologies for food production, Pollack and Shaffer (2009), p. 73; Rollin et al. (2011), p. 100. Cf. also Hopp et al. (2017), pp. 27–29 showing that the participants in the focus groups tend to regard not only GM food but also genome edited food as unhealthy.
463.
Cf. the high financial expenditure and regulatory expertise that is necessary to go through the GMO authorisation process; cf. further Nuffield Council on Bioethics (2016), pp. 118–119; European Academies Science Advisory Council and German National Academy of Sciences Leopoldina (2013), p. 29; Malyska et al. (2016), p. 532; Stokstad (2018).
464.
Cf. the concern, mainly by NGOs and the political left, that the control over agriculture and foods is getting more and more into the hands of large agricultural companies (“corporate control”), instead of farmers and consumers (“food sovereignty”), Harriss and Stewart (2015), pp. 45, 54–55; Helliwell et al. (2017), pp. 2091–2092.
465.
As is the case for established GM crops, cf. n. 450. Cf. the acceptance criteria for GM applications (including genome editing applications) analysed in van Mil et al. (2017), pp. ii–iii. Examples of applications that found support amongst the participants in the public dialogue are the use of genome editing to produce cheaper medicines, to produce more nutritious crops to supplement dietary insufficiencies or to protect crops from damage, e.g. through late blight, van Mil et al. (2017), pp. 58, 81–90.
466.
Gaskell (2010), pp. 37–38; Gaskell et al. (2004), p. 193 (“the ‘Achilles heel’ of GM foods is not so much the misperception of the scientific risks, but rather the perceived absence of benefit for the consumer”); Lucht (2015), p. 4260. With respect to the importance of perceived benefits regarding the acceptance of a new technology in general Rollin et al. (2011), p. 100; Ronteltap et al. (2007), pp. 6–9. Stressing the importance of individual benefits (as distinguished from broader societal and environmental benefits) for individual acceptance Rollin et al. (2011), p. 105.
There are indications that more EU consumers would buy GM products if they delivered consumer benefits other than price reductions, European Commission Directorate-General for Health and Food Safety (2015b), pp. 49–50; King’s College London (2008), para. 5–6; with respect to quality being the leading purchasing factor for EU consumers when buying dairy products and meat, far ahead of price TNS Opinion & Social (2014), p. 58.
Cf. also the fear of NGOs that genome editing will only be used “to make rich people richer, not to make the world less hungry or more bio-diverse or more resilient to climate change”, Helliwell et al. (2017), p. 2092.
467.
Cf. Ricroch et al. (2017), pp. 170, 177 and Modrzejewski et al. (2018), p. 6 (in German) showing the share of the different breeding goals regarding genome editing applications in agriculture. Food quality plays an important role.
468.
Hilscher et al. (2017b), p. 8; APHIS Deputy Administrator Michael J. Firko (2015), Haun et al. (2014).
469.
Sánchez-León et al. (2017)
470.
Gaskell (2010), pp. 46–50; Lombardo and Zelasco (2016), p. 497.
471.
Gaskell (2010), p. 48 (72% of the respondents agree or tend to agree that transgenic crops are unnatural compared to 52% with respect to cisgenic crops). “Unnaturalness” is one of the main concerns associated with GM food in the EU, Gaskell (2010), pp. 7, 38, 46; Frewer et al. (2011), p. 448. However, there are different types of “unnaturalness” in consumer perception. Crossing species boundaries or more generally biological similarity is just one of them, Andersen et al. (2015), p. 431; Mielby et al. (2013), p. 478. In other terms, genome edited plants could still be perceived as unnatural because of their “unnatural” production process, Lucht (2015), p. 4270. Especially consumer and environmental NGOs reject the production process, Trans Atlantic Consumer Dialogue (2016), pp. 2, 4 Greenpeace (2015); cf. also Hopp et al. (2017), pp. 21–23 showing that the participants in the focus groups regard GEOs as equally unnatural as GMOs due to their unnatural production process.
472.
Cf. surveys indicating that EU consumers might accept genome edited products a bit better than traditional GM products, e.g. Shew et al. (2018), p. 74 (Belgium, France); Hopp et al. (2017), p. 38 (Germany).
473.
Cf. Bruce (2017), p. 388, explaining that early applications of genome editing might shape opinions towards the technique in general.
474.
E.g. Schwank et al. (2013), Osborn et al. (2015), Kaminski et al. (2016), Cyranoski (2016), van Diemen and Lebbink (2017); cf. also The Netherlands Commission on Genetic Modification (2014), p. 13.
475.
At the time of writing, the extent and orientation of societal involvement in genome editing issues differs between the EU member states, cf. the overview of selected countries in Le Déaut and Procaccia (2017), pp. 295ff (in French); cf. also Sciencewise and Nuffield Council on Bioethics (2016). Le Déaut and Procaccia (2017), p. 286 warn that inaction in terms of societal involvement bears the risk that the debate is taken over by the opponents of biotechnology as was the case in the GMO debate.
476.
Especially national governments favouring GEOs, e.g. of the UK and the Netherlands, Corporate Europe Observatory (2016b).
477.
Cf. the attempts to frame genome editing in a positive “innovation” or “naturalness” context instead of the GMO context, e.g. the communication initiative “Embracing the Power of Nature” or the term “plant breeding innovation” by the European Seed Association, European Seed Association (n.d.).
478.
Cf. text to n. 73.
479.
European Commission Joint Research Centre (n.d.); Holme et al. (2013), p. 404; Hou et al. (2014), p. 2; Halterman et al. (2016), p. 4.
480.
The intragenic potato “Modena”, European Food Safety Authority (2018c), Holme et al. (2013), p. 403.
481.
The German competent authorities have been asked whether apple trees obtained by accelerated breeding are GMOs but have not yet decided on that issue, German Federal Ministry of Food and Agriculture (2018) (in German).
482.
Grafting a non-GM scion onto a GM rootstock.
483.
Agro-infiltration sensu stricto, i.e. “non-germline tissues […] are agro-infiltrated in order to obtain localised expression”, European Commission New Techniques Working Group (2011), para. 5.5.2.
484.
Here defined as a technique, “in which an intermediate plant contains a transgene to accelerate the breeding process, but which is subsequently crossed out and only the null-segregants are used for further breeding”; also referred to as “fast breeding” or “rapid crop cycle breeding”, Schiemann and Hartung (2014), pp. 207–208.
485.
The understanding of Lusser et al. (2011), pp. 23–27 is adopted with regard to these techniques if not defined separately.
486.
Not legally binding, Craig and de Búrca (2015), pp. 109–110; Laaninen (2016), p. 2; Commission guidance documents nevertheless have practical effects or even a de facto binding effect, Snyder (1993), p. 32.
487.
Cf. text to n. 407–410.
488.
Defined as “changes in gene function that are mitotically and/or meiotically heritable and do not entail a change in DNA sequence”, cf. Nap and van Kessel (2011), p. 17; Riggs et al. (1996), p. 1.
489.
Cf. European Commission New Techniques Working Group (2011), para. 5.6.4 A; UK Advisory Committee on Releases to the Environment (2013b), pp. 25–26; Vogel (2012), pp. 27–28; The Netherlands Commission on Genetic Modification (2009a), pp. 4, 25; European Food Safety Authority (2015), p. 3.
490.
Cf. UK Advisory Committee on Releases to the Environment (2013b), p. 19.
491.
Cf. European Commission New Techniques Working Group (2011), para. 5.4.4.
492.
Cf. The Netherlands Commission on Genetic Modification (2009a), p. 25. However, most applications of SDNs for targeted gene expression regulation make use of transgenic plants, which are of course GMOs, cf. Hilscher et al. (2017a), pp. 21–22. The applications that are potentially non-GMOs are those inducing changes that are inherited (epigenetic changes), which allows the elimination of the inducer of the change, e.g. the transgene, cf. Nap and van Kessel (2011), p. 12.
493.
European Food Safety Authority (2015), p. 3; European Commission New Techniques Working Group (2011), para. 5.6.4 A; more cautious UK Advisory Committee on Releases to the Environment (2013b), p. 26; The Netherlands Commission on Genetic Modification (2006), p. 19.
494.
Cf. Vogel (2012), pp. 28, 34.
495.
It could be further distinguished whether the unintended alterations are induced by an “unnatural” breeding step, e.g. the intermediate integration of a transgene, or by a traditional breeding step, e.g. tissue culture.
496.
European Commission New Techniques Working Group (2011), para. 4.4.
497.
At the time of writing, no updated expert opinions on the GMO classification were available, yet.
498.
Process-based interpretation of the GMO definition, Directive 2001/18/EC, art. 2(2).
499.
Cf. European Commission New Techniques Working Group (2011), paras. 4.4, 4.5, 5.6.4 A; UK Advisory Committee on Releases to the Environment (2013b), pp. 16–17; The Netherlands Commission on Genetic Modification (2006), p. 14. In fact, there are several cases that might entail different legal treatment, e.g.
- stable integration of a transgene into the plant genome and subsequent crossing out (or other way of removal) (e.g. reverse breeding, accelerated breeding)
- transient introduction of a transgene into the cell, i.e. no integration into the genome and no capacity of autonomous replication (e.g. RdDM, Agro-infiltration)
- unnatural techniques not making use of DNA/RNA at all, e.g. delivery of zinc finger nucleases for epigenetic changes in protein form
cf. Rodriguez-Cerezo (2014), p. 9; German Central Committee on Biological Safety (2012), p. 6; European Commission New Techniques Working Group (2011), paras. 4.4, 4.5; The Netherlands Commission on Genetic Modification (2009a), p. 25.
500.
European Commission New Techniques Working Group (2011), para. 4.4. In fact, two lines of interpretation could be followed regarding the GMO definition: The strictly process-based interpretation, according to which any use of genetic engineering techniques results in GMOs and the less stringent process-based interpretation, according to which the end product has to have a genetic alteration (1) which has been induced by an unnatural technique (2), cf. Vogel (2012), p. 94. The wording of the GMO definition (“altered…in a way that does not occur naturally”) suggests the second interpretation. The judgment of the European Court of Justice in Case C-528/16 does not discuss this subject.
501.
“Plants that are negative segregants lack the transgenic event and can be produced, for example, by self-fertilisation of hemizygous GM plants, or from crosses between hemizygous GM plants and non-GM plants.”, European Food Safety Authority (2011b), p. 9 Examples of “negative segregant techniques” are reverse breeding and accelerated breeding.
502.
European Commission New Techniques Working Group (2011), paras. 4.4, 4.5, 5.6.4 A; German Central Committee on Biological Safety (2012), p. 6; more cautious French Haut Conseil des Biotechnologies (2016a), p. 98 (“should be exempt from risk assessment and could be considered to be a plant obtained by conventional breeding”); cf. also Vogel (2012), pp. 11–12.
503.
In legal terms, the use of a GM technique leads to a rebuttable GMO presumption. According to European Commission New Techniques Working Group (2011), para. 4.4 “[c]lear criteria would be needed to establish whether the ‘foreign’ genetic material is no longer present in the resulting organism”.
504.
Cf. also European Commission New Techniques Working Group (2011), para. 4.4.
505.
Lusser et al. (2011), p. 70; Ribarits et al. (2014), p. 186; Rodriguez-Cerezo (2014), p. 20; The Netherlands Commission on Genetic Modification (2006), p. 14.
506.
For example:
- Varieties of agricultural plant species: Directive 2002/53/EC, art. 3(1); Directive 2003/90/EC of 6 October 2003 setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species [2003] OJ L254/7, art. 1(1)
- Vegetable seed: Directive 2002/55/EC, art. 3(1);
- Fruit: Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production [2008] OJ L267/8, art. 7(2),(4);
- Vine: Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative propagation of the vine [1968] OJ L93/15, art. 5.
507.
The variety is clearly distinguishable on one or more important characteristics from any other registered variety, cf. Directive 2002/53/EC, art. 5(1).
508.
The plants of which the variety is composed are composed of identical plants, cf. Directive 2002/53/EC, art. 5(3).
509.
The variety maintains its essential characteristics over successive generations, cf. Directive 2002/53/EC, art. 5(2).
510.
For example: Varieties of agricultural plant species: Directive 2002/53/EC, art. 4(1); vegetable seed: Directive 2002/55/EC, art. 4(1). The same criteria are internationally relevant for variety protection, cf. e.g. International Union for the Protection of New Varieties of Plants (1991), art. 5ff.
511.
“Its qualities […] offer […] a clear improvement […] for cultivation or […] uses which can be made of the crops or the products derived therefrom”, Directive 2002/53/EC, arts. 4(1), 5(4); criteria the value is based on are yield, resistance to harmful organisms, response to the environment and quality characteristics, cf. Directive 2003/90/EC, annex III.
512.
Cf. e.g. regarding varieties of agricultural plant species Directive 2002/53/EC, art. 7(1).
513.
German Federal Plant Variety Office (2017), p. 24; Madre and Agostino (2017).
514.
Cf. Madre and Agostino (2017).
515.
For example: Varieties of agricultural plant species: Directive 2003/90/EC, art. 3(1); Directive 2002/53/EC, art. 3(1); vegetable seed: Directive 2002/55/EC, art. 3(2).
516.
For example: Varieties of agricultural plant species: Directive 2002/53/EC, arts. 16(1), 17; vegetable seed: Directive 2002/55/EC, arts. 3(3), 16(1), 17. Regarding the plant variety catalogues, databases and information systems see European Commission (n.d.-i).
517.
Example: Cereal seed: Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed [1966] OJ 125/2309, art. 3(1). Further European Commission (n.d.-d); Black et al. (2006), p. 368. With respect to the requirements for equivalence of seed produced in non-EU countries cf. European Commission (n.d.-c).
518.
Cf. Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC [2016] OJ L317/4. Comes into effect in December 2019, replacing the current Directive 2000/29/EC. Cf. the overview of the provisions of Regulation (EU) 2016/2031 in Schiffers (2017). Cf. further de Jong et al. (2018), pp. 255–256 describing the provisions of the EU’s Plant Health Regulation in the context of plants developed through new breeding techniques.
519.
Regulation (EU) 2016/2031, art. 71: “document, issued by a third country, which […] certifies that the plant, plant product or other object concerned complies with all of the following requirements [in the following specified]”.
520.
Regulation (EU) 2016/2031, arts. 71–74.
521.
Regulation (EU) 2016/2031, art. 78: “official label for movement of plants, plant products and other objects within the Union territory […] which attests compliance with all requirements […]”.
522.
Regulation (EU) 2016/2031, arts. 78ff.
523.
Regarding the different categories of pests see Regulation (EU) 2016/2031, arts. 3, 4, 6, 32, 36.
524.
Regulation (EU) 2016/2031, chapter II–V.
525.
Food: Regulation (EC) No 178/2002, art. 14; feed: Regulation (EC) No 178/2002, art. 15, Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC [2009] OJ L229/1, art. 4. Compliance is ensured by official controls, cf. also the EU Official Controls Regulation, Regulation (EU) 2017/625, harmonising the organisation of official controls.
526.
Regulation (EC) No 178/2002, art. 14(2).
527.
Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 [2015] OJ L327/1.
528.
So far, no decision has been made in this regard. The Novel Food definition includes several ambiguities, thus its interpretation is not straightforward.
529.
The legal term “propagating practice” probably includes breeding practices, cf. Voigt and Klima (2017), pp. 324–325.
530.
Regulation (EU) 2015/2283, art. 3(2)(a)(iv).
531.
E.g. foods for specific groups, cf. Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 [2013] OJ L181/35; European Commission (n.d.-e).
532.
Cf. Lappin (2018a), pp. 4–5; European Seed Association (2017b), pp. 2–3.
533.
Kalaitzandonakes et al. (2007), pp. 509, 511; Baulcombe et al. (2014), p. 34.
534.
The group of FAS Biotechnology Specialists in the European Union (2017), pp. 22–25.
535.
Hartung and Schiemann (2014), p. 745.
536.
Legislation and court cases are cited in footnotes and not included in the bibliography.

References

Legislation and court cases are cited in footnotes and not included in the bibliography.

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Acknowledgment

The research for this article was conducted as part of the project “Genome editing in plant biotechnology – a science based legal analysis of regulatory problems” funded by the German Federal Ministry of Education and Research; principal investigator Professor Dr. Hans-Georg Dederer, University of Passau, Head of Chair of Constitutional and Administrative Law, Public International Law, European and International Economic Law.

The authors would like to thank their colleague Katharina Schreiber for her valuable research for Sect. 5.1 (“Introduction”). They would also like to thank the other team members, Sabrina Brzezinski, Clemens Dienstbier, Sebastian Graup and David Hamburger as well as the project coordinator Professor Dr. Dederer for their support.

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Faculty of Law, University of Passau, Passau, Germany
Brigitte Voigt & Ansgar Münichsdorfer

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Brigitte Voigt
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Faculty of Law, University of Passau, Passau, Germany
Hans-Georg Dederer
Faculty of Law, University of Passau, Passau, Germany
David Hamburger

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Voigt, B., Münichsdorfer, A. (2019). Regulation of Genome Editing in Plant Biotechnology: European Union. In: Dederer, HG., Hamburger, D. (eds) Regulation of Genome Editing in Plant Biotechnology. Springer, Cham. https://doi.org/10.1007/978-3-030-17119-3_5

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DOI: https://doi.org/10.1007/978-3-030-17119-3_5
Published: 17 August 2019
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