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Published online by Cambridge University Press: 03 December 2021
Various methods of genetic modification have been applied to plant breeding as an integral part of agriculture. This article examines a method of targeted mutagenesis – CRISPR-Cas9 – and its dysregulation in the European Union (EU). It provides clarity for food business operators relating to the traceability and labelling of food products induced using this biotechnology. In addition, it outlines policy recommendations to improve the regulation of such food products in the EU.
1 M Jinek et al, “A Programmable Dual-RNA-Guided DNA Endonuclease in Adaptive Bacterial Immunity” (2012) 337 Science 816 <https://www.sciencemag.org/lookup/doi/10.1126/science.1225829> (last accessed 7 December 2020).
2 PD Hsu, ES Lander and F Zhang, “Development and Applications of CRISPR-Cas9 for Genome Engineering” (2014) 157 Cell 1262, p 7 <https://linkinghub.elsevier.com/retrieve/pii/S0092867414006047> (last accessed 20 July 2020).
3 ibid, p 4.
4 Y Demirci, B Zhang and T Unver, “CRISPR/Cas9: An RNA-Guided Highly Precise Synthetic Tool for Plant Genome Editing” (2018) 233 Journal of Cellular Physiology 1844 <http://doi.wiley.com/10.1002/jcp.25970> (last accessed 7 December 2020); WA Ansari et al, “Genome Editing in Cereals: Approaches, Applications and Challenges” (2020) 21 International Journal of Molecular Sciences 4040, p 11 <https://www.mdpi.com/1422-0067/21/11/4040> (last accessed 25 January 2021).
5 K Yin, C Gao and J-L Qiu, “Progress and Prospects in Plant Genome Editing” (2017) 3 Nature Plants 17107, p 5 <http://www.nature.com/articles/nplants2017107> (last accessed 7 December 2020).
6 European Network of GMO Laboratories (ENGL), “Detection of food and feed plant products obtained by new mutagenesis techniques”, 26 March 2019 (JRC116289) <https://gmo-crl.jrc.ec.europa.eu/doc/JRC116289-GE-report-ENGL.pdf≥ p 14 (last accessed 14 August 2020).
7 PM Poortvliet et al, “On the Legal Categorisation of New Plant Breeding Technologies: Insights from Communication Science and Ways Forward” (2019) 10 European Journal of Risk Regulation 180 <https://www.cambridge.org/core/product/identifier/S1867299X19000102/type/journal_article> (last accessed 20 July 2020).
8 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 2 106/1 (Deliberate Release Directive).
9 Case C-528/16, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt [2018] EU:C:2018:583 [54].
10 Regulation (EC) No 1829/2003 of the European Parliament and the Council of 22 September 2003 on genetically modified food and feed [2003] OJ 2 268/1, Arts 5(3)(i) and 17(3)(i); Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 [2013] OJ 2 157/1, Annex III; Regulation (EC) No 641/2004 Annex I.
11 General Food Law, Arts 19(1) and (3).
12 feednavigator.com, “ECJ Ruling on Gene Editing: ‘A Missed Opportunity for Agricultural Innovation in the EU’” (feednavigator.com) <https://www.feednavigator.com/Article/2018/07/26/ECJ-ruling-on-gene-editing-A-missed-opportunity-for-agricultural-innovation-in-the-EU> (last accessed 8 February 2021); K Purnhagen and J Wesseler, “EU Regulation of New Plant Breeding Technologies and Their Possible Economic Implications for the EU and Beyond” (2020) Applied Economic Perspectives and Policy aepp.13084, p 9 <https://onlinelibrary.wiley.com/doi/10.1002/aepp.13084> (last accessed 2 December 2020).
13 See further: H Bremmers and K Purnhagen (eds), Regulating and Managing Food Safety in the EU: A Legal-Economic Perspective (1st edn, New York, Springer International Publishing 2018) pp 69, 217–45, 308, 361–72; G Steier and KK Patel (eds), International Food Law and Policy (1st edn, New York, Springer International Publishing 2016) pp 451–60, 1334–35; I Härtel (ed.), Handbook of Agri-Food Law in China, Germany, European Union: Food Security, Food Safety, Sustainable Use of Resources in Agriculture (1st edn, New York, Springer International Publishing 2018) pp 80–81, 525–33; R Norer (ed.), Genetic Technology and Food Safety (1st edn, New York, Springer International Publishing 2016) pp 20–28, 34–37; JD Graham and S Hsia, “Europe’s Precautionary Principle: Promise and Pitfalls” (2002) 5 Journal of Risk Research 371 <http://www.tandfonline.com/doi/abs/10.1080/1366987021058580> (last accessed 8 July 2020); SO Hansson, “How Extreme Is the Precautionary Principle?” (2020) 14 NanoEthics 245 <http://link.springer.com/10.1007/s11569-020-00373-5> (last accessed 31 March 2021); A de Boer, “Scientific Assessments in European Food Law: Making It Future-Proof” (2019) 108 Regulatory Toxicology and Pharmacology 104437, p 2 <https://linkinghub.elsevier.com/retrieve/pii/S0273230019302016> (last accessed 9 July 2020); J Leinen, “Risk Governance and the Precautionary Principle: Recent Cases in the Environment, Public Health and Food Safety (ENVI) Committee” (2012) 3 European Journal of Risk Regulation 169 <https://www.cambridge.org/core/product/identifier/S1867299X00002014/type/journal_article> (last accessed 17 June 2021); L Petetin, “The Precautionary Principle and Non-Scientific Factors in the Regulation of Biotech Foods” (2017) 8 European Journal of Risk Regulation 106 <https://www.cambridge.org/core/product/identifier/S1867299X16000180/type/journal_article> (last accessed 23 July 2020); R von Schomberg, “The Precautionary Principle: Its Use Within Hard and Soft Law” (2012) 3 European Journal of Risk Regulation 147 <https://www.cambridge.org/core/product/identifier/S1867299X00001987/type/journal_article> (last accessed 17 June 2021); MD Adams, “The Precautionary Principle and the Rhetoric behind It” (2002) 5 Journal of Risk Research 301 <http://www.tandfonline.com/doi/abs/10.1080/13669870210139798> (last accessed 8 July 2020); S Vezzani, “The International Regulatory Framework for the Use of GMOs and Products Thereof as Food Aid” (2018) 9 European Journal of Risk Regulation 120, pp 124–26 <https://www.cambridge.org/core/product/identifier/S1867299X17000587/type/journal_article> (last accessed 17 June 2021); J Davison and K Ammann, “New GMO Regulations for Old: Determining a New Future for EU Crop Biotechnology” (2017) 8 GM Crops & Food 13 <https://www.tandfonline.com/doi/full/10.1080/21645698.2017.1289305> (last accessed 17 June 2021); GC Leonelli, “GMO Authorisations and the Aarhus Regulation: Paving the Way for Precautionary GMO Governance?” (2019) 26 Maastricht Journal of European and Comparative Law 505 <http://journals.sagepub.com/doi/10.1177/1023263X19855081> (last accessed 17 June 2021); C MacMaoláin, Irish Food Law: European, Domestic and International Frameworks (Oxford, Hart Publishing 2019) pp 146–61.
14 Case C-528/16, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt, supra, note 9, para 47.
15 B Voigt and A Münichsdorfer, “Regulation of Genome Editing in Plant Biotechnology: European Union” in H-G Dederer and D Hamburger (eds), Regulation of Genome Editing in Plant Biotechnology (New York, Springer International Publishing 2019) p 183 <http://link.springer.com/10.1007/978-3-030-17119-3_5> (last accessed 1 December 2020).
16 General Food Law, Arts 18(3) and (4).
17 JRC116289, supra, note 6, p 15.
18 Purnhagen and Wesseler, supra, note 12, p 9; Voigt and Münichsdorfer, supra, note 15, p 137.
19 Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard to organic production, labelling and control [2008] OJ 2 250/1.
20 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 2 189/1 (Organic Regulation).
21 Organic Regulation, Arts 3 and 4.
22 Organic Regulation, Arts 5–7.
23 Purnhagen and Wesseler, supra, note 12, p 9.
24 In the EU, the controversy regarding the AstraZeneca vaccine rollout is the most recent manifestation of a company suffering severe reputational damage as a result of contractual discrepancies. The domino effect of a party in a supply chain reneging on their contractual obligations can be detrimental to multiple actors; “Martin Welcomes EU Decision to Withdraw Article 16 in Row over AstraZeneca Vaccine in Northern Ireland” (Irish Independent) <https://www.independent.ie/irish-news/martin-welcomes-eu-decision-to-withdraw-article-16-in-row-over-astrazeneca-vaccine-in-northern-ireland-40030300.html> (last accessed 14 February 2021); “Prospects for Game-Changing AstraZeneca Vaccine Become Increasingly Clouded” (Irish Times) <https://www.irishtimes.com/business/health-pharma/prospects-for-game-changing-astrazeneca-vaccine-become-increasingly-clouded-1.4470349> (last accessed 14 February 2021).
25 Reg 889/2008, Art 66(1).
26 A list of control bodies has been collated by the Directorate General of the European Commission for Agriculture and Rural Development: <https://ec.europa.eu/agriculture/ofis_public/actor_cbeu/ctrl.cfm?targetUrl=home> (last accessed 10 December 2020).
27 General Food Law, Arts 18(2) and (3); Organic Regulation, Art 29(2).
28 Reg 889/2008, Art 66(2).
29 Reg 889/2008, Art 63(2)(a).
30 Reg 889/2008, Art 63(1).
31 Reg 889/2008, Art 81.
32 Reg 889/2008, Art 63(3)(a)(b)(c)(f).
33 Reg 889/2008, Art 63(1)(a)(b)(c).
34 Reg 889/2008, Art 63(1)(b).
35 Reg 889/2008, Art 63(2)(c).
36 Reg 889/2008, Art 26(5)(a)(b)(c).
37 Reg 889/2008, Arts 26(5)(d) and (2).
38 Reg 889/2008, Art 26(3).
39 Reg 889/2008, Arts 30 and 34.
40 Reg 889/2008, Art 31(1).
41 Reg 889/2008, Art 31(1)(a).
42 Reg 889/2008, Art 31(1)(b)(c)(d).
43 Reg 889/2008, Art 31(1).
44 Reg 889/2008, Art 34.
45 Reg 889/2008, Art 34.
46 Reg 889/2008, Art 31(2)(a)(b)(c).
47 Reg 889/2008, Art 83.
48 Reg 889/2008, Art 83.
49 Reg 889/2008, Art 84(a).
50 Reg 889/2008, Art 84(b)(i).
51 Reg 889/2008, Art 84(b)(ii).
52 Reg 889/2008, Art 85.
53 Reg 889/2008, Arts 70–89.
54 Reg 889/2008, Art 70(1)(b).
55 Reg 889/2008, Art 70(1)(c).
56 Reg 889/2008, Art 80.
57 Reg 889/2008, Art 80.
58 Reg 889/2008, Art 86(a)(b).
59 Reg 889/2008, Art 82(1).
60 Reg 889/2008, Art 82(1).
61 Reg 889/2008, Arts 82(2) and 83.
62 Organic Regulation, Art 27(5)(a).
63 Organic Regulation, Art 27(5)(b)(i)(ii)(iii).
64 Organic Regulation, Art 27(6)(a).
65 Organic Regulation, Art 32(1)(a)(b).
66 Organic Regulation, Art 32(1)(c); Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries [2008] OJ 2 334, Art 6.
67 Organic Regulation, Art 32(2).
68 Organic Regulation, Art 32(2).
69 Organic Regulation, Art 33(1)(a)(b).
70 Organic Regulation, Arts 33(2) and (3).
71 Reg 1235/2008, Art 7.
72 Reg 1235/2008, Art 10.
73 Organic Regulation, Art 33(1)(c).
74 Organic Regulation, Arts 33(2) and (3); Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods (GL 32 – 1999, Rev. 1 – 2001) <http://www.fao.org/docs/eims/upload/230124/cxg_032e.pdf> (last accessed 18 October 2020); Organic Regulation, Art 33(3).
75 Organic Regulation, Art 33(2).
76 Organic Regulation, Art 33(1)(d).
77 European Court of Auditors, The Control System for Organic Products Has Improved, but Some Challenges Remain. Special Report No 04, 2019. (Publications Office 2019) p 37 <https://data.europa.eu/doi/10.2865/217286> (last accessed 17 December 2020).
78 ibid, p 30.
79 Organic Regulation, Art 27(5)(e).
80 Regulation (EC) No 889/2008, Art. 92(a)(1); Commission Regulation (EC) No 1235/2008 of 8 December 2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for imports of organic products from third countries [2008] OJ 2 334, Art 15.
81 foodnavigator.com, “EU Launches Electronic Tracking System for Organic Imports” (foodnavigator.com) <https://www.foodnavigator.com/Article/2017/04/19/EU-launches-electronic-tracking-system-for-organic-imports> (last accessed 14 February 2021).
82 H Willer et al, The World of Organic Agriculture Statistics and Emerging Trends 2020 (2020) p 145 <http://www.fibl.org/fileadmin/documents/shop/5011-organic-world-2020.pdf> (last accessed 3 February 2021).
83 European Court of Auditors, supra, note 77, p 37.
84 “EC Study on New Genomic Techniques” <https://ec.europa.eu/food/plants/genetically-modified-organisms/new-techniques-biotechnology/ec-study-new-genomic-techniques_en> (last accessed 6 September 2021); “Gmo_mod-Bio_ngt_eu-Study.Pdf” <https://ec.europa.eu/food/system/files/2021-04/gmo_mod-bio_ngt_eu-study.pdf> (last accessed 6 September 2021); G Fortuna and N Foote, “Commission Reopens Gene Editing’s Box amid Sustainability Claims” ( www.euractiv.com , 29 April 2021) <https://www.euractiv.com/section/agriculture-food/news/commission-reopens-gene-editings-box-amid-sustainability-claims/> (last accessed 6 September 2021).
85 New GM methods are constantly trialled in the EU. See further: European Medicines Agency “Genome Editing EU-IN Horizon Scanning Report.Pdf” p 4 <https://www.ema.europa.eu/en/documents/report/genome-editing-eu-horizon-scanning-report_en.pdf> (last accessed 6 September 2021).
86 Consolidated version of the Treaty on the Functioning of the European Union [2012] OJ 1 326/47, Art 290.
87 Regulation (EC) 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 2 268/24, Art 4(4).
88 General Food Law, Arts 18(3) and (4).
89 E Waltz, “With a Free Pass, CRISPR-Edited Plants Reach Market in Record Time” (2018) 36 Nature Biotechnology 6 <http://www.nature.com/articles/nbt0118-6b> (last accessed 17 December 2020).
90 E Castellari et al, “Food Processor and Retailer Non-GMO Standards in the US and EU and the Driving Role of Regulations” (2018) 78 Food Policy 26, p 35 <https://linkinghub.elsevier.com/retrieve/pii/S0306919218301088> (last accessed 29 November 2020).
91 Organic Regulation, Art 23(3).
92 Organic Regulation, Arts 23(1), (6), 23(4) and 25(1).
93 Reg 889/2008, Art 26(4)(c).
94 Organic Regulation, Art 23(4).
95 Organic Regulation, Art 23(3).
96 Organic Regulation, Recitals 9 and 10, Arts 9 (1), 25(3) and 69.
97 Organic Regulation, Recital 10; Deliberate Release Directive, Arts 21(1) and (3); Reg 1829/2003, Recital 29, Arts 12(1) and 24.
98 R Ferreira, F David and J Nielsen, “Advancing Biotechnology with CRISPR/Cas9: Recent Applications and Patent Landscape” (2018) 45 Journal of Industrial Microbiology & Biotechnology 467, p 475 <https://academic.oup.com/jimb/article/45/7/467-480/5996688> (last accessed 25 February 2021).
99 A Churi and S Taylor, “Continuing CRISPR Patent Disputes May Be Usurped by Its Potential Role in Fighting Global Pandemics” (2020) 39 Biotechnology Law Report 184, p 188 <https://www.liebertpub.com/doi/10.1089/blr.2020.29180.ac> (last accessed 25 February 2021).
100 Directorate General Internal Market, Industry, Entrepreneurship and SMEs, “Final Report of the Expert Group on the Development and Implications of Patent Law in the Field of Biotechnology and Genetic Engineering” (2016) 114, 124 <https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwjylZXSsfryAhWOQEEAHZp5AigQFnoECB8QAQ&url=https%3A%2F%2Fec.europa.eu%2Fdocsroom%2Fdocuments%2F18604%2Fattachments%2F1%2Ftranslations%2Fen%2Frenditions%2Fnative&usg=AOvVaw3mIaad8erOMRToQaBPqSpm> (last accessed 12 September 2021); European Commission, “COMMISSION STAFF WORKING DOCUMENT Study on the Status of New Genomic Techniques under Union Law and in Light of the Court of Justice Ruling in Case C-528/16” (2021) 42, 43 <https://ec.europa.eu/food/system/files/2021-04/gmo_mod-bio_ngt_eu-study.pdf> (last accessed 12 September 2021).
101 General Food Law, Art 17(1); Reg 1830/2003, Art 3(3).
102 Deliberate Release Directive, Art 33; Reg 1829/2003, Arts 45(1) and (2); Reg 1830/2003, Arts 11(1) and (2).
103 General Food Law, Arts 17 and 19.
104 Reg 889/2008, Art 91(1).
105 Reg 889/2008, Art 91(2).
106 JRC116289, supra, note 6, p 9.
107 Organic Regulation, Recital 10, Art 9(1).
108 Organic Regulation, Art 9(2).
109 Organic Regulation, Art 9(2).
110 A Varacca and C Soregaroli, “Identity Preservation in International Feed Supply Chains” (2016) 15 EuroChoices 38, p 38 <http://doi.wiley.com/10.1111/1746-692X.12118> (last accessed 27 August 2020).
111 ibid.
112 Waltz, supra, note 91.
113 Organic Regulation, Art 2(a).
114 Case C-528/16, Confédération paysanne and Others v Premier ministre and Ministre de l’agriculture, de l’agroalimentaire et de la forêt [2018] EU:C:2018:583, Opinion of AG Bobek, para 62; D Eriksson et al, “A Welcome Proposal to Amend the GMO Legislation of the EU” (2018) 36 Trends in Biotechnology 1100 <https://linkinghub.elsevier.com/retrieve/pii/S0167779918301367> (last accessed 3 March 2021).
115 G Tagliabue, “The EU Legislation on ‘GMOs’ between Nonsense and Protectionism: An Ongoing Schumpeterian Chain of Public Choices” (2017) 8 GM Crops & Food 57, pp 58, 60, 63 <https://www.tandfonline.com/doi/full/10.1080/21645698.2016.1270488> (last accessed 22 April 2021).
116 “BSE Crisis in 1990s Caused Havoc in Industry” (Irish Independent) <https://www.independent.ie/business/farming/bse-crisis-in-1990s-caused-havoc-in-industry-31296502.html> (last accessed 22 April 2021).
117 “Horsemeat Scandal: The Essential Guide” (The Guardian, 15 February 2013) <http://www.theguardian.com/uk/2013/feb/15/horsemeat-scandal-the-essential-guide> (last accessed 22 April 2021).
118 S Charlebois et al, “Comparison of Global Food Traceability Regulations and Requirements: Global Food Traceability Regulations…” (2014) 13 Comprehensive Reviews in Food Science and Food Safety 1104, p 1111 <http://doi.wiley.com/10.1111/1541-4337.12101> (last accessed 16 February 2021).
119 Reuters Staff, “Bayer, BASF to Pursue Plant Gene Editing Elsewhere after EU Ruling” (Reuters, 27 July 2018) <https://www.reuters.com/article/us-eu-court-gmo-companies-idUSKBN1KH1NF> (last accessed 7 April 2021); PAC Hundleby and WA Harwood, “Impacts of the EU GMO Regulatory Framework for Plant Genome Editing” (2019) 8 Food and Energy Security e00161, p 3 <https://onlinelibrary.wiley.com/doi/abs/10.1002/fes3.161> (last accessed 20 July 2020).
120 Organic Regulation, Art 23(3).
121 JE Hobbs, WA Kerr and PWB Phillips, “Identity Preservation and International Trade: Signaling Quality across National Boundaries” (2001) 49 Canadian Journal of Agricultural Economics/Revue canadienne d’agroeconomie 567, p 576 <http://doi.wiley.com/10.1111/j.1744-7976.2001.tb00327.x> (last accessed 15 February 2021).
122 Reg 889/2008, Art 66(1).
123 General Food Law, Arts 18(2) and (3).
124 E Nuijten, M Messmer and EL van Bueren, “Concepts and Strategies of Organic Plant Breeding in Light of Novel Breeding Techniques” (2016) 9 Sustainability 18, p 4 <http://www.mdpi.com/2071-1050/9/1/18> (last accessed 23 July 2020).
125 T Ruttink et al, “Knowledge-Technology-Based Discovery of Unauthorized Genetically Modified Organisms” (2010) 396 Analytical and Bioanalytical Chemistry 1951, p 1956 <http://link.springer.com/10.1007/s00216-009-3218-6> (last accessed 17 December 2020); N Kalaitzandonakes, R Maltsbarger and J Barnes, “Global Identity Preservation Costs in Agricultural Supply Chains” (2001) 49 Canadian Journal of Agricultural Economics/Revue canadienne d’agroeconomie 605, p 607 <http://doi.wiley.com/10.1111/j.1744-7976.2001.tb00330.x> (last accessed 11 November 2020); Varacca and Soregaroli, supra, note 112, p 40; J Bovay and JM Alston, “GMO Food Labels in the United States: Economic Implications of the New Law” (2018) 78 Food Policy 14, pp 14, 23 <https://linkinghub.elsevier.com/retrieve/pii/S0306919218301295> (last accessed 25 February 2021).
126 TR Abbott et al, “Development of CRISPR as a Prophylactic Strategy to Combat Novel Coronavirus and Influenza” (Bioengineering 2020) preprint <http://biorxiv.org/lookup/doi/10.1101/2020.03.13.991307> (last accessed 23 April 2021); “How MRNA Technology Could Upend the Drug Industry” (Time) <https://time.com/5927342/mrna-covid-vaccine/> (last accessed 23 April 2021).
127 Hobbs et al, supra, note 123, p 575.
128 “Big Pharma Lobby’s Self-Serving Claims Block Global Access to Vaccines” (Corporate Europe Observatory) <https://corporateeurope.org/en/2021/04/big-pharma-lobbys-self-serving-claims-block-global-access-vaccines> (last accessed 23 April 2021); “Could Waiving Covid-19 Vaccine Patents Save the World?” (France 24, 16 April 2021) <https://www.france24.com/en/europe/20210416-could-waived-covid-19-patents-save-the-world> (last accessed 23 April 2021).
