Published online by Cambridge University Press: 20 January 2017
This piece critically analyses the development of a novel food technology: the Frankenburger, a type of cultured/in vitro meat (or ‘shmeat’, which stands for ‘sheet of meat’). It assesses the risks raised by cultured meat as well as the role it could play to alleviate environmental and food security concerns. The article argues that the current EU regulatory structures for cultured meat, and for novel foods more generally, ought to be strengthened. There is a necessity to transfer and develop food innovations in partnerships with all the relevant stakeholders (the public, scientists, the food industry, policy-makers and regulators). Including interested parties from the inception of a technology as well as within the decision-making process would provide a supporting framework for cultured meat.
1 Mark Brown, “‘Frankenburger’: It May Be What's for Dinner in 2035”, Chicago Sun Times, 5 August 2013, available at http://www.suntimes.com/news/brown/21751235-452/frankenburger-it-may-be-whats-for-dinner-in-2035.html (last accessed on 1 April 2014).
2 Cultured meat falls under the scope of the Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning Novel Foods and Novel Food Ingredients, OJ 1997 L 43/1 (Novel Foods Regulation).
3 And to a certain extent with nanotechnology and its derived foods.
4 Winston Churchill, “Fifty Years Hence” Strand, December 1931, available at http://teachingamericanhistory.org/library/document/fifty-years-hence/ (last accessed on 1 April 2014).
5 Michael Specter, “Test-Tube Burgers: How Long Will it Be Before You Can Eat Meat that Was Made in a Lab?”, New Yorker, 23 May 2011, available at http://www.newyorker.com/reporting/2011/05/23/110523fa_fact_specter (last accessed on 1 April 2014).
6 Benjaminson, Morris A. et al., “In Vitro Edible Muscle Protein Production System (MPPS): Stage 1, Fish”, 51 Acta Astronautica (2002), pp. 879 et sqq., at p. 881CrossRefGoogle ScholarPubMed. See also, Schneider, Zachary, “In Vitro Meat – Space Travel, Cannibalism, and Federal Regulation”, 50 Houston Law Review (2013), pp. 991 et sqq., at p. 998.Google Scholar
7 Steve Connor, “Special Report: ‘In Vitro’ Beef – It's the Meat of the Future”, Independent, 28 July 2013, available at http://www.independent.co.uk/news/science/special-report-in-vitro-beef--its-the-meat-of-the-future-8735104.html (last accessed on 1 April 2014). See also, Schneider, “In Vitro Meat - Space Travel, Cannibalism, and Federal Regulation”, supra note 6, at p. 998.
8 Giles Sheldrick, “Try the ‘Frankenburger’: £250,000 Test-Tube Burger Made Using Stem Cells”, Express, 5 August 2013, available at http://www.express.co.uk/news/uk/419837/Try-the-Frankenburger-250-000-test-tube-burger-made-using-stem-cells (last accessed on 1 April 2014).
9 Alok Jha, “Synthetic Meat: How the World's Costliest Burger Made it on to the Plate”, The Guardian, 5 August 2013, available at http://www.theguardian.com/science/2013/aug/05/synthetic-meat-burger-stem-cells (last accessed on 1 April 2014).
10 Sheldrick, “Try the Frankenburger”, supra note 8.
11 Glenn, Linda MacDonald and D’Agostino, Lisa, “The Moveable Feast Legal, Ethical, and Social Implications of Converging Technologies on Our Dinner Tables”, 4 Northeastern University Law Journal (2012), pp. 111 et sqq., at p. 122.Google Scholar
13 For more on cultured meat, see: The In Vitro Meat Consortium, “Primer on Technology”, available at http://invitromeat.org/content/view/30/51/ (last accessed on 1 April 2014); and The In Vitro Meat Consortium, “Why In Vitro Meat?”, available at http://invitromeat.org/content/view/12/55/ (last accessed on 1 April 2014).
14 See e.g., Schneider, “In Vitro Meat – Space Travel, Cannibalism, and Federal Regulation”, supra note 6, at p. 997. As a result, animal cloning as well as its regulation have the potential to offer insights in cultured meat and its regulation.
15 Scott Gottlieb and Matthew B. Wheeler, “Genetically Engineered Animals and Public Health: Compelling Benefits for Health Care, Nutrition, the Environment, and Animal Welfare”, Biotechnology Industry Organization, (2011), at p. 21. For more on the AAS, see Council for Agricultural Science and Technology (CAST), “The Science and Regulation of Food from Genetically Engineered Animals” (2011); and Homer, Michael B., “Frankenfish… It’s What's for Dinner: The FDA, Genetically Engineered Salmon, and the Flawed Regulation of Biotechnology”, 45 Columbia Journal of Law & Social Problem (2011), pp. 83 et sqq. 93.Google Scholar
16 Gottlieb and Wheeler, “Genetically Engineered Animals and Public Health”, supra note 15, at p. 20.
17 Food and Agriculture Organization, “Livestock's Long Shadow” (2006), available at http://www.fao.org/docrep/010/a0701e/a0701e00.HTM (last accessed on 1 April 2014), at p. 4.
19 Tuomisto, Hanna L. and de Mattos, M. Joost Teixeira, “Environmental Impacts of Cultured Meat Production”, 45 Environmental Science & Technology (2011), pp. 6117 et sqq., at p. 6117CrossRefGoogle ScholarPubMed. Confirmed in Hanna L. Tuomisto and Avijit G. Roy, “Could Cultured Meat Reduce Environmental Impact of Agriculture in Europe?”, presentation held at 8th International Conference on “LCA in the Agri-Food Sector”, Rennes (France), 2-4 October 2012.
20 Connor, “Special Report: ‘In Vitro’ Beef”, supra note 7.
21 The ‘food versus fuel’ debate highlights the dilemma addressing the risks of using farmland and crops for the production of biofuels to the detriment of the food supply. Two reports link higher food prices to increased biofuel demands. See Food and Agriculture Organization, “State of Food and Agriculture 2012” (2012), available at http://www.fao.org/docrep/017/i3028e/i3028e.pdf (last accessed on 1 April 2014), at p. 100; and Organisation for Economic Co-operation and Development and Food and Agriculture Organization, “The OECD-FAO Agricultural Outlook 2013-2022” (2013), available at http://www.oecd.org/site/oecd-faoagriculturaloutlook/ (last accessed on 1 April 2014), at p. 9. See also, Wes Harrison, R., “The Food versus Fuel Debate: Implications for Consumers”, 41 Journal of Agricultural and Applied Economics (2009), pp. 493 et sqq. CrossRefGoogle Scholar; and, Tenenbaum, David J., “Food vs. Fuel: Diversion of Crops Could Cause More Hunger”, 116 Environmental Health Perspectives (2008), pp. A254 et sqq.CrossRefGoogle ScholarPubMed
22 Nuffield Council on Bioethics, “Genetically Modified Crops: The Ethical and Social Issues” (1999), available at http://www.nuffieldbioethics.org/gm-crops (last accessed on 1 April 2014), at p. 131.
23 See e.g., MacDonald Glenn and D’Agostino, “The Moveable Feast Legal, Ethical, and Social Implications of Converging Technologies on Our Dinner Tables”, supra note 11, at p. 123.
24 PETA is now ‘eager to move on to yet more innovative ways to combat animal suffering in the meat industry’. See PETA, “PETA’s ‘In Vitro’ Chicken Contest”, available at http://www.peta.org/features/vitro-meat-contest/ (last accessed on 1 April 2014). See also, George Walker, B., “Double Trouble: Competing Federal And State Approaches to Regulating the New Technology of Cloned Animal Foods, and Suggestions for the Future”, 14 Journal of Technology Law & Policy (2009), pp. 29 et sqq., at p. 48Google Scholar; John Schwartz, “PETA's Latest Tactic: $1 Million for Fake Meat”, New York Times, 21 April 2008, available at http://www.nytimes.com/2008/04/21/us/21meat.html?_r=0 (last accessed on 1 April 2014).
25 Food Standards Agency, “Emerging Food Technologies: Novel Protein Sources as Food” (2011), at p. 1.
26 Food and Agriculture Organization, “Livestock's Long Shadow”, supra note 17, at p. 17.
28 See e.g., Golden Rice Project, “Golden Rice Is Part of the Solution”, available at http://goldenrice.org/ (last accessed on 1 April 2014). Golden rice is a type of GM rice that contains betacarotene. In countries where rice is a dietary staple, this rice may reduce the incidence of blindness caused by vitamin-A deficiency.
29 UK Government Office for Science, “Foresight Report on The Future of Food and Farming: Challenges and Choices for Global Sustainability” (2011), at p. 167. In the conclusions of the report, a more cautious approach seems to be given to new technologies, such as genetically modified organisms (GMOs) and animal cloning, to think very carefully about the impact of such technologies on the public, farmers and other stakeholders along the food chain.
30 Connor, “Special Report: ‘In Vitro’ Beef”, supra note 7.
31 Animal cloning raises the same concern. See e.g., the UK National Standing Committee on Farm Animal Genetic Resources, “Statement on Cloning of Farm Animals” (2011), available at http://archive.defra.gov.uk/fangr/documents/100914-cloning-statement.pdf (last accessed on 1 April 2014), at p. 1.
32 Schneider, “In Vitro Meat – Space Travel, Cannibalism, and Federal Regulation”, supra note 6, at p. 1024.
33 Specter, “Test-Tube Burgers”, supra note 5. See also, UK National Ecosystem Assessment, “The UK National Ecosystem Assessment: Synthesis of the Key Findings” (2011), available at http://uknea.unep-wcmc.org/Resources/tabid/82/Default.aspx (last accessed on 1 April 2014); His Royal Highness Prince Charles declared that ‘the land needs the presence of feeding animals and their droppings for the cycle to be complete, so that soils and grassland areas stay productive’. See Joanna Blythman, “Miracle? No, the New Frankenburger Turns my Stomach”, Daily Mail, 5 August 2013, available at http://www.dailymail.co.uk/debate/article-2385137/Miracle-No-new-Frankenburger-turns-stomach.html (last accessed on 1 April 2014).
34 Public acceptance will be the focus of section III.
35 Christina Agapakis, “Steak of the Art: The Fatal Flaws of In Vitro Meat”, Discover, 24 April 2012, available at http://blogs.discovermagazine.com/crux/2012/04/24/steak-of-the-art-the-fatal-flaws-of-in-vitro-meat/#.Uwdrds4UDGd (last accessed on 1 April 2014).
36 Fisher, Elizabeth, Risk Regulation and Administrative Constitutionalism (Oxford: Hart Publishing, 2010), at p. 8 Google Scholar. This expanding rupture in the causality chain is paralleled with the increase use of the precautionary principle in the regulatory process as the precautionary principle aims at preventing future hazard when scientific uncertainty is present.
37 To evaluate the possible risks created by such foods, risk analyses are to be undertaken. A risk analysis is a three-tier process: the risk has to be assessed, then managed, as well as being communicated to all stakeholders. At the end of a risk analysis, decisionmakers are, arguably, able to decide about the position to adopt and which type of regulation is desirable. See Codex Alimentarius Commission, “Procedural Manual” (2010), at p. 86. It is the same process for analysing the safety of biotech foods, see Codex Alimentarius Commission, “Principles for the Risk Analysis of Foods Derived from Modern Biotechnology” (2008), at p. 1.
38 For more on risk regulation, see: Baldwin, Robert (ed.), Law and Uncertainty: Risks and Legal Processes (Berlin: Kluwer, 1997)Google Scholar; Fisher, Risk Regulation and Administrative Constitutionalism, supra note 36; Hood, Christopher et al., The Government of Risk: Understanding Risk Regulation Regimes (Oxford: OUP 2001)CrossRefGoogle Scholar; Lee, Robert G., “Look at Mother Nature on the Run in the Twenty First Century: Responsibility, Research and Innovation”, 1 Transnational Environmental Law (2012), pp. 105 et sqq. CrossRefGoogle Scholar; O’Malley, Pat, Risk, Uncertainty and Government (London: Cavendish Press, 2004)Google Scholar; Steele, Jenny, Risks and Legal Theory (Oxford: Hart Publishing, 2004)Google Scholar; and Sunstein, Cass R., Laws of Fear: Beyond the Precautionary Principle (Cambridge: CUP, 2005).CrossRefGoogle Scholar
39 Beck, Ulrich, Risk Society: Towards a New Modernity (London: Sage, 1992), at p. 22.Google Scholar
40 See e.g., Sarewitz, Daniel, “How Science Makes Environmental Controversies Worse”, 7 Environmental Science and Policy (2004), pp. 385 et sqq, at p. 386CrossRefGoogle Scholar; and Jasanoff, Sheila, “Biotechnology and Empire: The Global Power of Seeds and Science”, 21 OSIRIS (2006), pp. 273 et sqq, at p. 283.CrossRefGoogle Scholar
41 Reynolds, Glenn H., “Nanotechnology and Regulatory Policy: Three Futures”, 17 Harvard Journal of Law & Technology (2003), pp. 179 et sqq, at p. 186 (referring to nanotechnology).Google Scholar
42 The precautionary principle will be developed to a greater extent in section IV.1.
43 Thompson, Dorothea K., “Small Size, Big Dilemma: The Challenge of Regulating Nanotechnology”, 79 Tennessee Law Review (2012), pp. 621 et sqq., at p. 662.Google Scholar
45 For more on the regulation of biotech foods, see Bodiguel, Luc and Cardwell, Michael (ed.), The Regulation of Genetically Modified Organisms: Comparative Approaches (Oxford: OUP, 2010)CrossRefGoogle Scholar; and Lee, Maria, EU Regulation of GMOs: Law, Decision-making and New Technology (Cheltenham: Edward Elgar, 2008).CrossRefGoogle Scholar
46 MacDonald Glenn and D’Agostino, “The Moveable Feast Legal, Ethical, and Social Implications of Converging Technologies on Our Dinner Tables”, supra note 11, at p. 124.
47 John Vidal, “Lab-Grown Burgers Cannot Provide a Secure Future for Africa”, The Guardian, 6 August 2013, available at http://www.theguardian.com/global-development/poverty-matters/2013/aug/06/lab-grown-burgers-stem-cell-africa (last accessed on 1 April 2014). For similar arguments in relation to how small-scale agriculture constitutes a more suitable alternative to reduce hunger and poverty, see the World Bank, “World Development Report: Agriculture for Development” (2008); and Communication from the EU Commission, An EU Policy Framework to Assist Developing Countries in Addressing Food Security Challenges, COM (2010) 127.
48 John Vidal, “Lab-Grown Burgers Cannot Provide a Secure Future for Africa”, supra note 47.
49 Alok Jha, “Synthetic Meat: How the World's Costliest Burger Made it on to the Plate”, supra note 9.
50 Jasanoff, “Biotechnology and Empire”, supra note 40, at p. 288. See also, Birhanu, Fikremarkos Merso, “Genetically Modified Organisms in Africa: Regulating a Threat or an Opportunity?”, in Bodiguel, Luc and Cardwell, Michael (ed.), The Regulation of Genetically Modified Organisms: Comparative Approaches (Oxford: OUP, 2010), pp. 227 et sqq.CrossRefGoogle Scholar
51 Jasanoff, “Biotechnology and Empire”, supra note 40, at p. 290.
53 Sustainable intensification of crop production is one of the strategic objectives of the Food and Agriculture Organisation. See FAO, “Stategic Framework 2010-2019” (2009), available at http://www.fao.org/uploads/media/C2009K5864EnglishStrategicFr_1.pdf (last accessed on 1 April 2014). See generally on sustainable intensification: Tara Garnett and H. Charles J. Godfray, “Sustainable Intensification in Agriculture: Navigating a Course Through Competing Food System Priorities” (Food Climate Research Network and the Oxford Martin Programme on the Future of Food, 2012); UK Government Office for Science, “Foresight Report”, supra note 29; and the UK Royal Society, “Report on Reaping the Benefits: Science and the Sustainable Intensification of Global Agriculture” (2009).
54 Department of Agriculture, Food and the Marine, “Irish Consumer and Industry Acceptance of Novel Food Technologies: Research Highlights, Implications and Recommendations” (2013), at p. 19.
55 Ibid, at p. 21.
57 Ibid, at p. 19.
58 Ibid, at p. 21.
60 58% of the respondents to a 2005 eurobarometer opposed GM food while 42% did not. See George Gaskell et al., “Europeans and Biotechnology in 2005: Patterns and Trends” (May 2006), at p. 20. In a 2008 eurobarometer on Europeans’ attitudes towards animal cloning, a majority of EU consumers said that it was ‘unlikely that they would buy meat or milk from cloned animals, even if a trusted source stated that such products were safe to eat’. See Gallup Organization, “Europeans’ Attitudes Towards Animal Cloning” (October 2008), at p. 39.
62 See e.g., Chang, Howard F., “Risk Regulation, Endogenous Public Concerns, and the Hormones Dispute: Nothing to Fear but Fear Itself?”, 77 Southern California Law Review (2003–2004), pp. 743 et sqq.Google Scholar; and Echols, Marsha A., “Food Safety Regulation in the European Union and the United States: Different Cultures, Different Laws”, 4 Columbia Journal of European Law (1998), pp. 525 et sqq.Google Scholar; and Howse, Robert, “Democracy, Science, and Free Trade: Risk Regulation on Trial at the World Trade Organisation”, 98 Michigan Law Review (2000), pp. 2329 et sqq.CrossRefGoogle Scholar
63 Jasanoff, “Constitutional Moments in Governing Science and Technology”, supra note 61, at p. 635.
64 Sunstein, Laws of Fear (2005), supra note 38, at p. 54.
66 See e.g., Christoforou, Theofanis, “The Regulation of Genetically Modified Organisms in the European Union: the Interplay of Science, Law and Politics”, 41 Common Market Law Review (2004), pp. 637 et sqq.Google Scholar
67 Sunstein, Cass R., “The Laws of Fear”, 115 Harvard Law Review (2002), pp. 1119 et sqq., at p. 1120CrossRefGoogle Scholar. Also, for Beck, ‘reflexivity is excluded from the social and political interactions between experts and social groups over modern risks, because of the systematic assumption of realism in science’. Beck, Risk Society: Towards a New Modernity, supra note 39, at p. 4.
68 Sunstein, “The Laws of Fear” (2002), supra note 67, at p. 1120.
69 Brom, Frans W.A., “Food, Consumer concerns, and Trust: Food Ethics for a Globalizing Market”, 12 Journal of Agricultural and Environmental Ethics (2000), pp. 127 et sqq., at p. 131CrossRefGoogle Scholar. See also, Bratspies, Rebecca, “Some Thoughts on the American Approach to Regulating Genetically Modified Organisms”, 16 Kansas Journal of Law and Public Policy (2007), pp. 393 et sqq., at p. 395.Google Scholar
70 In the EU in the 1990s, three food scares occurred concomitantly: the bovine spongiform encephalopathy (BSE) scandal, GMO imports from the US to the EU, and recombinant bovine somatotropin (rBST).
71 This has led to an enduring public mistrust of institutional declarations (both at national and EU levels) in food and public health on food scares, which was reignited with national and EU support for GM foods. For more on the relationship between institutions, public (confidence) and science, see Ferrari, Matteo, Risk Perception, Culture, and Legal Change: A Comparative Study of Food Safety in the Wake of the Mad Cow Crisis (Farnham: Ashgate, 2009)Google Scholar; Packer, Richard, The Politics of BSE (London: Palgrave Macmillan, 2007)Google Scholar; and European Environment Agency, “Late Lessons from Early Warnings: The Precautionary Principle 1896–2000” (2002), available at http://www.eea.europa.eu/publications/environmental_issue_report_2001_22 (last accessed on 1 April 2014), at p. 157.
72 Bratspies, “Some Thoughts on the American Approach to Regulating Genetically Modified Organisms”, supra note 69, at p. 395.
73 Specter, “Test-Tube Burgers”, supra note 5.
75 See e.g., Marsden, Terry et al., The New Regulation and Governance of Food (London: Routledge, 2010).Google Scholar
76 Jasanoff, “Biotechnology and Empire”, supra note 40, at p. 283.
77 See e.g. for an explanation and a critique: Wynne, Brian, “Public Understanding of Science Research: New Horizons or Hall of Mirrors”, 1 Public Understanding of Science (1992), pp. 37 et sqq.CrossRefGoogle Scholar; and Wynne, Brian, “The Public Understanding of Science”, in Jasanoff, Sheila et al. (ed.), The Handbook of Science and Technology Studies (London: Sage, 1995), pp. 361 et sqq Google Scholar. For another critique, see Yearley, Steven, “Computer Models and the Public's Understanding of Science: A Case-Study Analysis”, 29 Social Studies of Science (1999), pp. 845 et sqq.CrossRefGoogle Scholar
78 Chang, “Risk Regulation, Endogenous Public Concerns, and the Hormones Dispute”, supra note 62, at p. 752.
79 See section III.
80 European Commission, “Science in Society in FP7”, available at http://ec.europa.eu/research/science-society/index.cfm?fuseaction=public.topic&id=1321&lang=1 (last accessed on 1 April 2014); European Commission, “Why ‘Science in Society’?”, available at http://ec.europa.eu/research/science-society/index.cfm?fuseaction=public.topic&id=1223 (last accessed on 1 April 2014); CORDIS, “Ethical, Legal and Social Aspects of the Life Sciences and Technologies of the Fourth RTD Framework Programme 1994-1998”, available at http://cordis.europa.eu/elsa-fp4/src/about.htm (last accessed on 1 April 2014); and CORDIS, “Science and Society in FP6”, available at http://cordis.europa.eu/science-society/fp6.htm (last accessed on 1 April 2014).
82 See Articles 12 and 169 Consolidated Version of the Treaty on the Functioning of the European Union (TFEU)  C115/47. Article 169 on consumer protection stipulates that ‘in order to promote the interests of consumers and to ensure a high level of consumer protection, the Union shall contribute to protecting the health, safety and economic interests of consumers as well as to promoting their right to information, education and to organise themselves in order to safeguard their interests’. This interest in consumer protection and information originates in the Council Resolution of 14 April 1975 on a Preliminary Programme of the European Economic Community for a Consumer Protection and Information Policy OJ 1975 C92/1.
83 European Communities, “EU Consumer Policy Strategy 2007–2013” (2007), at p. 7. The strategy was established by Communication of 13 March 2007 from the Commission to the Council, the European Parliament and the European Economic and Social Committee, EU Consumer Policy Strategy 2007–2013, COM(2007) 99.
84 Communication of 25 May 2012 from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions, A European Consumer Agenda – Boosting Confidence and Growth, COM(2012) 225; and a Proposal of the European Parliament and of the Council for a Regulation on a Consumer Programme 2014–2020, COM(2011) 707.
85 European Communities, “EU Consumer Policy Strategy 2007–2013”, supra note 83, at p. 7. This policy is also in line with the Europe 2020 Strategy, which calls for citizens to be empowered to play a full role in the single Market. See Communication of 3 March 2010 from the Commission, Europe 2020: A European Strategy for Smart, Sustainable, and Inclusive Growth, COM(2010) 2020, at p. 20.
86 See section III.
87 Bodiguel, Luc and Cardwell, Michael, “Genetically Modified Organisms and the Public: Participation, Preferences, and Protest”, in Bodiguel, Luc and Cardwell, Michael (ed.), The Regulation of Genetically Modified Organisms: Comparative Approaches (Oxford: OUP, 2010), at p. 11.CrossRefGoogle Scholar
88 See section III.
90 Nowotny, Helga et al., Re-Thinking Science: Knowledge and the Public in an Age of Uncertainty (Cambridge: Polity, 2001), at p. 166.Google Scholar
91 Co-production highlights the simultaneous production of technical and social order as well as the interconnectedness of politics, science and social order. See generally on co-production: Jasanoff, Sheila (ed.), States of Knowledge: The Co-production of Science and the Social Order (London: Routledge, 2006)Google Scholar. See also, Daniel Sarewitz, “How Science Makes Environmental Controversies Worse”, supra note 40, at p. 386.
92 Jasanoff, “Constitutional Moments in Governing Science and Technology”, supra note 61, at p. 637.
96 Yearley, “Computer Models and the Public's Understanding of Science”, supra note 77, at p. 845.
97 Otherwise public discontent grows. See e.g., Petetin, Ludivine, “Consumer Preferences and Biotech Foods in EU and US Law”, 1 EU Agrarian Law (2012), pp. 27 et sqq. Google Scholar
98 This is further expanded in section V.
99 European Commission, White Paper on Food Safety COM(1999) 719.
100 European Commission Directorate-General for Press and Communication, From Farm to Fork: Safe Food for Europe's Consumers (Office for Official Publications of the European Communities, 2004).
101 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the General Principles and Requirements of Food Law, establishing the European Food Safety Authority and laying down Procedures in Matters of Food Safety OJ 2002 L31/1.
102 Regulation 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the Provision of Food Information to Consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 OJ 2011 L304/18.
103 Articles 6(2) and 22(2) and (3) GFL.
104 Article 7(4) Novel Foods Regulation. Generally, the precautionary principle is a cornerstone of EU environmental law and policymaking. See Article 191(2) TFEU. For a detailed examination on the role of the precautionary principle, see e.g., Fisher, Elizabeth et al (eds), Implementing the Precautionary Principle: Perspectives and Prospects (Cheltenham: Edward Elgar, 2006)CrossRefGoogle Scholar; Freestone, David and Hey, Ellen (eds), The Precautionary Principle and International Law: The Challenge of Implementation (The Hague: Kluwer Law International, 1996)Google Scholar; O’Riordan, Timothy et al. (eds), Re-interpreting the Precautionary Principle (London: Cameron and May, 2001)Google Scholar; de Sadeleer, Nicolas, “The Precautionary Principle in EC Health and Environmental Law”, 12 European Law Journal (2006), pp. 139 et sqq.CrossRefGoogle Scholar; De Sadeleer, Nicolas (ed.), Environmental Principles: From Political Slogans to Legal Rules (Oxford: OUP, 2007)Google Scholar; Salmon, Naomi, “A European Perspective on the Precautionary Principle, Food Safety and the Free Trade Imperative of the WTO”, 27 European Law Review (2002), pp. 138 et sqq.Google Scholar; and Stokes, Elen, “The Role of Risk Assessment in Precautionary Intervention: A Comparison of Judicial Trends in the EC and WTO”, 4 Journal for European Environmental Planning Law (2007), pp. 455 et sqq.CrossRefGoogle Scholar
105 For Sunstein, the precautionary principle is ‘paralysing because it forbids an activity that could be beneficial at low-level’ as it can give ‘rise to substitute risks, in the form of hazards that materialize, or are increased, as a result of regulation’ and this is why he urges to recourse to a cost-benefit analysis tool for the assessment and management of risks as an alternative to the precautionary principle’. Respectively, Sunstein, Laws of Fear (2005), supra note 38, at pp. 30, 32 and 130.
106 European Commission, Communication from the Commission on the Precautionary Principle COM(2000) 1, at p. 12. For more on the communication, see McMahon, Joseph A., EU Agricultural Law (Oxford: OUP, 2007), at 6.83Google Scholar; and Button, Catherine, The Power to Protect: Trade, Health and Uncertainty in the WTO (Oxford: Hart Publishing, 2004), at p. 129 Google Scholar. For its critique, see Bergkamp, Lucas, “Understanding the Precautionary Principle (Part II)”, 10 Environmental Liability (2002), pp. 67 et sqq., at p. 72.Google Scholar
107 Communication on the Precautionary Principle, supra note 106, at p. 2.
108 Joined cases T-74/00, T-76/00, T-83/00, T-84/00, T-85/00, T- 132/00, T-137/00 and T-141/00, Artegodan GmbH and Others v. Commission of the European Communities  ECR II-4945, at para. 184.
109 Case T-13/99, Pfizer Animal Health SA v. Council of the European Union  ECR II-3305.
110 Bovine somatotrophin, a bovine growth hormone, is a naturally occurring hormone produced in the mammary gland of cattle. In the 1980s, scientists developed a synthetic recombinant bovine somatotropin (rBST), which increases cows’ milk production.
111 Council Directive 96/22/EC concerning the Prohibition on the Use in Stockfarming of certain Substances having a Hormonal or Thyrostatic Action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC OJ 1996 L125/3, as amended by Directive 2003/74/EC of the European Parliament and of the Council amending Council Directive 96/22/EC concerning the Prohibition on the Use in Stockfarming of certain Substances having a Hormonal or Thyrostatic Action and of ßagonists OJ 2003 L262/17. In contrast in the US, the Food and Drug Administration approved the application of rBST in 1993. See Food and Drug Administration, Interim Guidance on Voluntary Labeling of Milk and Milk Products From Cows That Have Not Been Treated With Recombinant Bovine Somatotropin (1994) 59 Fed Reg 6279. The US and Canada challenged the EU ban on rBST and its resulting products in the World Trade Organization case: EC-Hormones case. See EC-Hormones: Measures Concerning Meat and Meat Products WT/DS26/AB/R, WT/DS48/AB/R, 16 January 1998.
112 Report of the Scientific Committee on Animal Health and Animal Welfare, Report on Animal Welfare Aspects of the Use of Bovine Somatotrophin (10 March 1999).
113 Opinion of the Scientific Committee on Veterinary Measures Relating to Public Health, Assessment of Potential Risks to Human Health from Hormone Residues in Bovine Meat and Meat Products (30 April 1999).
114 See e.g., Vogel, David, The Politics of Precaution: Regulating Health, Safety, and Environmental Risks in Europe and the United States (Princeton: Princeton University Press, 2012), at p. 43 CrossRefGoogle Scholar; and Gray, George et al., “Beef, Hormones and Mad Cows”, in Wiener, Jonathan B. et al. (ed.), The Reality of Precaution: Comparing Risk Regulation in the United States and Europe (London: Earthscan, 2011), at p. 65 Google Scholar. Moreover, in the EC-Hormones case, the European institutions relied on EU consumer anxieties to ban the use of rBST, see EC-Hormones, para. 10.
115 See the Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on Genetically Modified Food and Feed, OJ 2003 L 268/1 (Food and Feed Regulation); and 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, OJ 2003 L 268/24.
117 Ibid, at p. 99. Although this article refers to nanotechnology, cultured meat raises similar issues. See also, Bratspies, “Some Thoughts on the American Approach to Regulating Genetically Modified Organisms”, supra note 69, at p. 395; and Stokes, Elen and Bowman, Diana M., “Looking Back to the Future of Regulating New Technologies: The Cases of Nanotechnologies and Synthetic Biology”, 2012 European Journal of Risk Regulation (2012), pp. 235 et sqq. CrossRefGoogle Scholar
118 Lee, EU Regulation of GMOs, supra note 45, at p. 12.
119 Foods from GEAs will fall under the scope of the Food and Feed Regulation and Regulation 1830/2003. Cloned foods are regulated under the Novel Foods Regulation – as already mentioned.
120 Article 1(2) (e) and (f) Novel Foods Regulation.
121 Ibid, Article 4.
122 Ibid, Article 6.
123 Like cultured meat, cloned foods could benefit from the simplified procedure existing under the Novel Foods Regulation as no difference exists between cloned and conventional foods. See e.g., Petetin, Ludivine, “The Revival of Modern Agricultural Biotechnology by the UK Government: What Role for Animal Cloning?”, 6 European Food and Feed Law Review (2012), pp. 296 et sqq. Google Scholar
124 Ibid, at p. 305.
125 OECD, “Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles” (1993), at p. 11.
126 Ibid, at p. 10.
127 Ghisleri, Lucia Roda et al., “Risk Analysis and GM foods: Scientific Risk Assessment”, 4 European Food and Feed Law Review (2009), pp. 235 et sqq., at p. 247.Google Scholar
128 Millstone, Erik et al., “Beyond Substantial Equivalence”, 401 Nature (1999), pp. 525 et sqq. , at p. 526CrossRefGoogle Scholar. For Strauss, substantial equivalence is ‘an unscientific concept, however, that has never been properly defined or provided with a legal standard for implementation’. See Strauss, Debra M., “The International Regulation of Genetically Modified Organisms: Importing Caution into the U.S. Food Supply”, 61 Food and Drug Law Journal (2006), pp. 167 et sqq., at p. 174.Google ScholarPubMed
129 McGarity, Thomas O., “Seeds of Distrust: Federal Regulation of Genetically Modified Plants”, 35 University of Michigan Journal of Law Reform (2002), pp. 403 et sqq., at p. 429.Google Scholar
130 For more criticism of substantial equivalence, see Mae-Wan Ho and Ricarda A. Steinbrecher, “Fatal Flaws in Food Safety Assessment: Critique of the Joint FAO/WHO Biotechnology and Food Safety Report”, 2 Environmental & Nutritional Interactions (1998), available at http://www.psrast.org/fao96.htm (last accessed on 1 April 2014); McGarity, “Seeds of Distrust”, supra note 169, at p. 429; and Andrew Apel, “Substantial Equivalence and the Precautionary Principle: a Challenge to Risk” (AgBioWorld, September 2000), available at http://www.agbioworld.org/newsletter_wm/index.php?caseid=archive&newsid=721 (last accessed on 1 April 2014).
132 Article 3(4) Novel Foods Regulation.
133 Ibid, Article 5.
134 Food Standards Agency, “Emerging Food Technologies”, supra note 25, at p. 2.
135 For more on the UK policy of cloned foods, see Petetin, “The Revival of Modern Agricultural Biotechnology by the UK Government”, supra note 123, at p. 296 et sqq.
136 Article 8(1)(a) Novel Foods Regulation.
137 Schneider, “In Vitro Meat – Space Travel, Cannibalism, and Federal Regulation”, supra note 6, at p. 1025.
138 Article 8(1)(c) Novel Foods Regulation.
139 See section III.
140 Case C-236/01, Monsanto Agricoltura Italia SpA and Others v. Presidenza del Consiglio dei Ministri and Others  ECR I 8105. For comments of the case, see Dabrowska, Patrycja, “GM Foods, Risk, Precaution and the Internal Market: Did Both Sides Win the Day in the recent Judgment of the European Court of Justice?”, 5 German Law Journal (2004), pp. 151 et sqq. Google Scholar; and Fernandez, Ruby R., “Monsanto and the Requirement for Real Risks in GM Food Regulation”, 28 International & Comparative Law Review (2006), pp. 335 et sqq. Google Scholar
141 Monsanto case, para. 19.
142 The Novel Foods Regulation along with the Directive 2001/18 on the Deliberate Release into the Environment of Genetically Modified Organisms were at the centre of the EU de facto moratorium on the approval of GMOs – which led to the WTO EC-Biotech case and the establishment of the Food and Feed Regulation and Regulation 1830/2003. See Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the Deliberate Release into the Environment of Genetically Modified Organisms and repealing Council Directive 90/220/EEC OJ 2001 L 106/1; and EC-Biotech: Approval and Marketing of Biotech Products, WT/DS291/R, WT/DS292/R and WT/DS293/R, 29 September 2006. For more on the EC-Biotech case, see Conrad, Christiane R., “The EC–Biotech Dispute and Applicability of the SPS Agreement: Are the Panel's Findings Built on Shaky Ground?”, 6 World Trade Review (2007), pp. 233 et sqq. CrossRefGoogle Scholar; and Prevost, Denise, “Opening Pandora's Box: The Panel's Findings in the EC-Biotech Products Dispute”, 34 Legal Issues of Economic Integration (2007), pp. 67 et sqq.Google Scholar
143 See for instance, the reactions in 2003 of the Environment Commissioner Wallström and the Health and Consumer Protection Commissioner Byrne after the European Parliament adopted its second reading opinion on the Food and Feed Regulation and Regulation 1830/2003 in Europa, “Wallström and Byrne Welcome EP Acceptance of a Trustworthy and Safe Approach to GMOs and GM Food and Feed” (2006), available at http://europa.eu/rapid/press-release_IP-03-935_en.htm?locale=EN (last accessed on 1 April 2014).
144 Stokes, “Nanotechnology and the Products of Inherited Regulation”, supra note 116, at p. 93.
145 See generally on regulatory regimes and new technologies: Brownsword, Roger, Rights, Regulation, and the Technological Revolution (Oxford: OUP, 2008)CrossRefGoogle Scholar; and Brownsword, Roger and Yeung, Karen (ed.), Regulating Technologies: Legal Futures, Regulatory Frames and Technological Fixes (Oxford: Hart Publishing, 2009).Google Scholar
146 Proposal for a Regulation of the European Parliament and of the Council on Novel Foods, COM(2007) 872.
147 Ibid, Article 3(2)(a)(iii).
148 Ibid, at p. 7 and Articles 1 and 19.
149 Euractiv, “Novel Foods Review Stumbles over Cloning”, 29 March 2011, available at http://www.euractiv.com/cap/novel-foods-review-stumbles-clon-news-503610 (last accessed on 1 April 2014). See also, Petetin, “The Revival of Modern Agricultural Biotechnology by the UK Government”, supra note 123, at p. 296 et sqq.
150 Proposal for a Regulation of the European Parliament and of the Council on Novel Foods, COM(2013) 894, at p. 7.
151 Ibid, Articles 9 and 10.
152 Ibid, Article 2(a)(i): a novel food means a ‘food to which a new production process not used for food production within the Union before 15 May 1997 is applied, where that production process gives rise to significant changes in the composition or structure of the food which affect its nutritional value, the way it is metabolised or the level of undesirable substances’. This appears to be a broad definition and could aim at covering any future novel food to avoid regulatory gaps.
153 Ibid, at p. 6. This proposal is complemented by a Proposal for a Directive on Animal Cloning for Farming Purposes which also provisionally bans such practices. See Proposal for a Directive of the European Parliament and of the Council on the Cloning of Animals of the Bovine, Porcine, Ovine, Caprine and Equine Species kept and reproduced for Farming Purposes, COM(2013) 892.
154 See section III.
155 Proposal for a Regulation of the European Parliament and of the Council amending Directive 2001/18/EC as regards the Possibility for the Member States to Restrict or Prohibit the Cultivation of GMOs in their Territory, COM(2010) 375. In February 2011, in a staff working document, the EU Commission provided an indicative list of grounds that could be relied upon by member states. They relate to the public interest, such as public morals (including religious and ethical concerns); public order; avoiding GMO presence in other products; social policy objectives; and cultural policy. See Commission Staff Working Document Complementary Considerations on Legal Issues on GMO Cultivation Raised in the Opinions of the Legal Service of the Council of the European Union of 5 November 2010 and of the Legal Service of the European Parliament of 17 November 2010, SEC(2011) 184, at p. 2. In 2012, the EU member states, nonetheless, failed to reach an agreement on the proposal.
156 Paradise, Jordan and Fitzpatrick, Ethan, “Synthetic Biology: Does Re-Writing Nature Require Re-Writing Regulation?”, 117 Penn State Law Review (2012), pp. 53 et sqq., at p. 56.Google Scholar
157 See e.g., Van Eenennaam, Alison L. et al., “Is Unaccountable Regulatory Delay and Political Interference Undermining the FDA and Hurting American Competitiveness?”, 3(13) Food and Drug Policy Forum (2013), pp. 865 et sqq., at p. 14Google Scholar; and CAST, “The Science and Regulation of Food from Genetically Engineered Animals”, supra note 15, at p. 7.
158 Nathan Gray, “Lab-Grown Meat: Too Revolutionary for Industry Backing?”, Foodnavigator.com, 6 August 2013, available at http://www.foodnavigator.com/Science-Nutrition/Lab-grown-meat-Too-revolutionary-for-industry-backing (last accessed on 1 April 2014).
159 Connor, “Special Report: ‘In Vitro’ Beef”, supra note 7.
160 Gray, “Lab-Grown Meat: Too Revolutionary for Industry Backing?”, supra note 158.
161 Andrew C. Revkin, “Bring on the ‘Frankenburger”, New York Times (The Opinion Pages), 5 August 2013, available at http://dotearth.blogs.nytimes.com/2013/08/05/bring-on-the -frankenburger/?partner=rss&emc=rss&_r=0 (last accessed on 1 April 2014).
162 The programme ‘Science and Society’ evolved into the ‘Science in Society’ programme to now RRI. RRI could be summarised as ‘Science for Society, with Society’. See also, the Europe 2020 Strategy and the Horizon 2020 Strategy for the Framework Programme (which itself implements the EU 2020 flagship ‘Innovation Union’ initiative aiming at securing Europe's global competiveness); and Hilary Sutcliffe, “A Report on Responsible Research and Innovation” (2011).
164 See e.g., Ravetz, Jerome R., Scientific Knowledge and its Social Problem (Oxford: Clarendon, 1971).Google Scholar
165 Jasanoff, “Technologies of Humility”, supra note 95, at p. 243.
166 Van Est, “The Broad Challenge of Public Engagement in Science – Commentary”, supra note 94, at p. 646.
168 Green, Anthony P. et al., “Accelerating Innovation: The Nanotechnology Institute”, 8 Nanotechnology Law & Business (2011), pp. 176 et sqq., at p. 176.Google Scholar
169 Ibid, at p. 177. For more on nanotechnology, see Kesan, “Transferring Innovation”, supra note 167, at p. 2169; and Reynolds, “Nanotechnology and Regulatory Policy”, supra note 41, at p. 179.
170 Kesan, “Transferring Innovation”, supra note 167, at p. 2201.
171 See Rebecca Trager, “BASF Pulls Out of Europe over GM Hostility”, 18 January 2012, available at http://www.rsc.org/chemistryworld/News/2012/January/basf-pull-out-gm-crops-biotech.asp (last accessed on 1 April 2014).