What’s in a name? A meat by any other name would taste as sweet On how cultured meat could be labelled under European Union law
Image: Lindsey Benne Thesis Law & Technology - Pauline Gerth van Wijk, Snr: 2031763 Supervisors: Dr. jur. L.S. Reins and MML S. De Conca 19 June 2019 – Wordcount: 16151
Table of contents Table of contents ...... 2 Chapter 1 – Introduction ...... 4 1.1 Traditionally produced meat as a problem ...... 5 1.2 Cultured meat as a possible solution ...... 6 1.3 Cultured meat ready for consumption? ...... 6 1.4 Literature review...... 7 1.4.1 Consumer opinions ...... 7 1.4.2 Debate in the European Union ...... 8 1.4.4 Debate in the USA ...... 10 1.4.5 Conclusion on Literature Review ...... 11 1.5 The method and content of this thesis ...... 12 Chapter 2 Cultured meat compared to traditional meat ...... 13 2.1 Explaining the nature of cultured meat...... 13 2.1.1 The nature of the cultured meat ...... 13 2.1.2 The production method for cultured meat ...... 14 2.2 Differences from traditional meat...... 16 2.2.1 Difference in quality ...... 16 2.2.2 Difference in perception ...... 17 2.3 Conclusion ...... 18 Chapter 3 – European regulation on labelling and novel foods ...... 19 3.1 European food law ...... 19 3.2 The Novel Food Regulation ...... 20 3.2.1 Principles and objectives ...... 20 3.2.2 What is a novel food? ...... 21 3.2.3 Authorization of novel food including appropriate labelling ...... 22 3.2.4 Cultured meat in relation to the Novel Food Regulation ...... 22 3.3 Regulation on labelling and naming ...... 23 3.3.1 Principles and objectives ...... 24 3.3.3 General requirements to food information ...... 24 3.3.4 Specific requirements to food names...... 25 3.3.5 Meat as a legal name ...... 26
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3.4 Conclusion ...... 28 Chapter 4 Other cases of designating innovative foods and substitutions ...... 30 4.1 Plant-based alternatives to animal-based products ...... 30 4.1.1 The TofuTown case ...... 30 4.1.2 Implications for cultured meat ...... 32 4.2 Treatments of meat ...... 33 4.2.1 Implications for cultured meat ...... 34 4.3 Genetically modified food ...... 35 4.3.1 Implications for cultured meat ...... 36 4.4 Conclusion ...... 36 Chapter 5 Finding the proper name for cultured meat...... 38 5.1 Labelling cultured meat identically to traditional meat ...... 38 5.1.1 Cultured meat is meat ...... 39 5.1.2 Cultured meat is not really the same after all ...... 40 5.2 Banning meat-related terms for cultured meat ...... 41 5.2.1 Cultured meat as something other than meat ...... 41 5.2.2 Against banning meat-related terms for cultured meat ...... 42 5.3 Using meat-related terms with additional information ...... 43 5.3.1 Additional particulars as a middle ground ...... 43 5.3.2 Arguments against using additional particulars...... 44 5.3.3 Adding the additional particulars to the name or the label ...... 45 5.4 Conclusion ...... 46 Chapter 6 Conclusion ...... 47 Bibliography ...... 50 Legislation ...... 50 Cases, advisory opinions and documents ...... 51 Books, chapters or contributions within books, websites and articles ...... 51
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Chapter 1 – Introduction
In 2013, Mark Post presented a remarkable hamburger to the world: a hamburger made of meat which was artificially produced in a lab. It is a big innovation in the field of tissue engineering-based agriculture.1 There is no living animal involved beyond providing the initial cells. This technology promises all nutritious and culinary benefits of meat, without drawbacks like animal cruelty and great environmental harm. The technology could prove a leap for mankind in terms of sustainable Figure 1 Mark Post with cultured hamburger. development and food production. Photograph: David Parry/EPA As cultured meat is getting closer to being ready for consumers, debate on how it should be called is growing. The product has many names: cultured meat, artificial meat, lab-grown tissue, in vitro meat, clean meat, cellular agriculture, Frankenmeat, etcetera. One extreme argues that it should just be called ‘meat’ (or other applicable meat-related terms) without any qualifiers while the other extreme thinks it should not be referred to as meat at all.2 This thesis aims to give insight into this debate from the point of view of European Union Law. The product will be referred to as ‘cultured meat’ in this paper, because this appears as the most commonly used term in literature and distinguishes it from traditional meat. This is in no way a reflection on how the question of the labelling should be settled in the author’s opinion. It should further be noted that, unless explicitly stated otherwise, labelling is meant in the narrow sense, so as to mean solely the way a product is named, including a possible specific designation for the product other than the name. This does not include other types of information found on labels, such as the list of ingredients or the place of origin.
1 P Slade, 'If you build it, will they eat it? Consumer preferences for plant-based and cultured meat burgers' [2018] 125, Appetite 428-437 2 JL Greene and S Angadjivand, 'Regulation of Cell-Cultured Meat, updated 25 October 2018' [2018] 7(5700) Congressional Research Service, under labelling cell-cultured meat products; P Shapiro, 'Of diamonds and meat: Culturing a better future' (Food Safety News, 20 November 2018)
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1.1 Traditionally produced meat as a problem As long as humans have existed, they have consumed animals. Meat-based proteins have been a staple of our diet; animal products provide 33% of global protein consumption.3 However, meat is also problematic. The livestock sector is responsible for over 14% of greenhouse gas emissions.4 Moreover, livestock production is linked to land degradation, pollution, high use of fresh water and declines in biodiversity.5 These negative consequences are likely to increase, as it is projected that the demand for meat will drastically increase in the near future because of population growth and higher standards of living.6 Simultaneously, climate change could negatively affect meat production because of heat stress, water shortages or worse harvests leading to less animal feed.7 Meeting the increasing demand will therefore become more difficult. Traditionally produced meat also comes with health and safety concerns. Animals can carry and transfer diseases, which carries risks for farmers and consumers. Some diseases are combated by using antibiotics8. This is linked to an increase in antibiotic resistant viruses, which is a very serious risk for public health. Besides environmental problems, many consumers and some philosophers have ethical concerns about breeding animals for consumption.9 Animal cruelty is an unpleasant side- effect of livestock. Even though efforts are being made to improve animal welfare, for instance by introducing certifications for humane treatment of livestock, killing animals for consumption is arguably not ethically justifiable under any circumstance. 10
3 M M Rojas-Downing and others, 'Climate change and livestock: Impacts, adaptation, and mitigation' [2017] 15 Climate Risk Management 145-16315 Climate Risk Management 145-163 4 PJ Gerber and others, ‘Tackling climate change through livestock’ [2013] Food and Agriculture Organisation of the United Nations 15 5 Rojas-Downing and others (n 3) 6 OECD/FAO (2016), ‘Meat’, in OECD-FAO Agricultural Outlook 2016-2025, p. 107 7 Rojas-Downing and others (n 3) 8 Ibid 9 H G J Gremmen, ‘Ethics of livestock farming? Who cares?’ [2017] Inaugural lecture Wageningen University; WAJ Verbeke and J Viaene, 'Ethical challenges for livestock production: meeting consumer concerns about meat safety and animal welfare’ [2000] 12(12) Journal of Agricultural and Environment Ethics 141-151 10 Dierenbescherming ‘Beter Leven keurmerk’ (Dierenbescherming)
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1.2 Cultured meat as a possible solution Cultured meat, which is meat-like tissue produced in a laboratory with minimal involvement of animals, could offer a (partial) solution to the aforementioned problems. It is made by developing cell cultures, which originally stem from an animal, in vitro. Because only meat tissue is grown, instead of an entire animal, it is more efficient. This results in reduced use of resources. 11 It is generally thought that it will also decrease greenhouse gas emissions, although a recent study casts doubt.12 Because animals are virtually uninvolved, animal cruelty is much less prevalent, and the risk of transferable Figure 2 A simplified overview of cultured meat production diseases is probably lower.13 14
1.3 Cultured meat ready for consumption? While producing cultured meat is still too experimental and expensive for the large-scale consumer market, a restaurant in The Netherlands was ready to start serving it at the beginning of 2018.15 However, the NVWA, the Dutch Agency for consumer protection, put a stop to the initiative. The agency stated that even though cultured meat is an innovative product with potential, it should be classified as a ‘novel food’ under the European Novel
11 H Tumisto and A Roy, ‘Could cultured meat reduce environmental impact of agriculture in Europe?’ (Researchgate October 2012)
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Food Regulation (hereafter: NFR),16 which means it needs official approval by the European Commission before it can be made available to consumers.17 The NFR regulates the safety assessment and authorization of novel foods in the European internal market.18 It aims to protect human health and consumers’ interests.19 The NFR includes the following two relevant requirements: One aspect is that must be proven that a novel food does not pose a safety risk to human health.20 Another topic of debate is the requirement that the novel food must not be misleading towards consumers.21 The former is the most hotly debated, while the latter invites discussion over of how cultured should be labelled in The European Union. This thesis is concerned with this subject of labelling. Can cultured meat even be called ‘meat’, even though it does not come from the carcass of an animal? If the answer to that question is yes, should there be some kind of qualifier added to the product’s name or label, which indicates the lab-grown origin of the meat? Answering this question is further complicated by other Regulations and caselaw. However, if cultured meat is to be brought onto the European market, these questions will need to be addressed. The outcome is very relevant for companies aiming to bring cultured meat to the market, producers of traditional meat and, of course, consumers.
1.4 Literature review Most research pertaining to cultured meat is naturally concerned with ways cultured meat can be produced. This technical kind of literature is mostly beyond the scope of this legal thesis, as are aforementioned discussions about the safety and environmental impacts of cultured meat. This literature review focusses on regulation of cultured meat and specifically labelling.
1.4.1 Consumer opinions As labelling is closely linked to consumer information, it is relevant to have some insight into what consumers think about cultured meat and its name. There have been multiple studies of how consumers view cultured meat. The results show a mixed picture. One study among Dutch students suggests positive, but changeable attitudes towards cultured meat. 22
16 Regulation (EU) 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 2 327/1 [Novel Food Regulation] 17 Nederlandse voedsel- en warenautoriteit (NVWA), 'Kweekvlees mag worden verhandeld als het veilig is' (Nvwa.nl, 18 May 2018)
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Another study found that a quarter of respondents would surely try cultured meat, and two thirds might try it.23 On the flip side, some found most educated consumers were skeptical.24 Especially consumers’ doubts concerning health and taste might be relevant for the way cultured meat should be labelled. Focus groups in the EU reacted similarly negative; deeming cultured meat unnatural and risky.25 Another study shows that while openness to cultured meat varies greatly between different groups, the vast majority would prefer a traditional beef burger given the choice and only 11% would choose a cultured burger.26 This suggests on one hand that it might improve commercial viability to be labelled as just ‘meat’. On the other hand, people do care about whether their meat is produced artificially or not, and people might consider it be misleading if that is not mentioned. There have also been some studies on preferences of consumers regarding labelling, such as a survey performed by the Consumer Reports Advocacy.27 It found that almost half prefers ‘meat’ but accompanied by an explanation about how it is produced, while 40% preferred another label than meat. Just 5% favoured just ‘meat’. Another study found that the descriptors ‘slaughter-free’ and ‘craft’ made consumers most willing to try the product, while ‘slaughter-free’ and ‘cell-based’ were found most descriptive.28 It should be noted that these studies were conducted in the United States, where the sentiments concerning (lab grown) meat might differ. Additionally, a certain consumer preference does not automatically lead to similar regulation even though it might influence lawmakers.
1.4.2 Debate in the European Union In the European Union, the debate concerning cultured meat has so far primarily focused on whether it is a novel food under the NFR. As mentioned, the NVWA decided that it is.29 The European Commission backed that view in an answer to a Parliamentary Question on 8 October 2018, stating that cultured meat can be categorized as novel food.30 The debate around further legal issues, such as the proper designation of cultured meat, is starting to increase. There are currently three main publications. The first is an article from
23 W Verbeke and others, ‘Challenges and prospects for consumer acceptance of cultured meat’ [2015] 14 Journal of Integrative Agriculture 285-294 24 A Hocquette and others ‘Educated consumers don't believe artificial meat is the solution to the problems with the meat industry’ [2015] 14, Journal of Integrative Agriculture 273-284 25 Slade (n 1) par 1.2 26 Slade (n 1) 27 M Mccauley, 'Consumer Reports survey: Consumers want clear labelling to distinguish “lab grown meat” from conventional meat' (Consumer Reports Advocacy, 12 July 2018)
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2014 by Petetin, which examines European regulation of cultured meat.31 While the article is based on an old Regulation, Petetin’s brief discussion on labelling still contains relevant notions. The principle of consumer information still applies for instance, just like the general underlying dilemma she highlighted; not labelling the meat as lab-grown could accelerate a potential transition to cultured meat, which has environmental benefits, but at the same time it would seriously hinder consumer information. Petetin does not draw any further conclusions. A more recent article was published by Stephens and others.32 They note that Petetin fails recognize that cultured meat can be genetically modified (hereafter: GM), even though it does not always have to be. This distinction matters because the EU has a separate regulation for GM foods, including separate requirements for labelling.33 They further note several legal questions; such as which regulatory system will apply. As has now been officially confirmed, Stephen and others see the NFR as the most likely.34 The subject of labelling is primarily mentioned in terms of potential food fraud, namely attempts to pass cultured meat as traditional meat, and vice versa. While this is an interesting legal question, it is striking that the authors implicitly assume that cultured meat cannot be labelled as ‘meat’ in an unqualified manner. The third and most recent publication, is a research paper by Chatham House on the future of meat analogues in the European Union.35 This is the first paper to extensively discuss cultured meat in terms of labelling under current EU law, stating that “The legal, customary or descriptive name for cultured meat is likely to have a particularly marked impact on consumer demand”.36 They note that there has been no agreement on its proper name so far and that political debate about whether cultured meat can even be ‘meat’ is likely to emerge. However, they only briefly discuss legal arguments that could be used for or against a certain designation. This thesis will explore these more in depth. So far, the only authority to speak out on the issue designating cultured meat as ‘meat’ is The Dutch NVWA. 37 They have stated that meat does not fall under the scope of the European definition of meat which is ‘skeletal muscles of mammalian and bird species recognized as fit for human consumption with naturally included or adherent tissue (…)’.38 However, the statement is still debatable, as the basis for cultured meat actually is animal muscle cells.
31 L Petetin, 'Frankenburgers, Risks and Approval' [2014] 5(168) European Journal of Risk Regulation 32 N Stephens and others, 'Bringing cultured meat to market: Technical, socio-political, and regulatory challenges in cellular agriculture' [2018] 78(2018) Trends in Food Science & Technology 155-166 para. 5.3 33 See par 4.3 34 Stephens and others (n 32) para. 5.3; Answer to parliamentary question on 8 October 2018 35 Antony Froggatt and Laura Wellesley, ‘Meat Analogues Considerations for the EU’ (Research paper, 2019) Chatham House, ISBN 978 1 78413 312 2 36 Ibid 26 37 M van Dinther, 'Kweekvlees is hard op weg naar uw bord' (Volkskrant 31 March 2018)
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Most importantly, this is merely a statement to the press and not an official decision. This will only happen after an application has been made for cultured meat under the NFR. The proper designation under European Union law remains undecided for now. Some related debates on the proper designation of foods might shed light on the question of labelling cultured meat by drawing parallels. There has been a case of whether plant-based drinks can be referred to by dairy-related terms such as milk or butter.39 Another thing which has been extensively debated is how genetically modified foods should be labelled. This has now largely been settled in European legislation.
1.4.4 Debate in the USA The discussion on how cultured meat should be designated appears most prominent in the USA compared to the rest of the world. This might be attributed to the fact that only results in Dutch or English have been reviewed, but language barriers prevent a more global search. Schneider provided an in-depth legal analysis of in vitro meat under American Law ‘In vitro meat: Space travel, cannibalism, and federal regulation’.40 He examines existing mechanisms which are used for labelling, such as the Vermont requirements concerning ‘biotech seed’. This could translate to using ‘biotech meat’ for cultured meat or adding the information to the national information.41 He also proposes the possibility of voluntary labelling but admits this is not very likely. These kinds of solutions might be implemented in the EU as well and will discussed in chapter 4 and 5. Whether cultured meat is a ‘meat food product’ matters especially in the USA, because it determines whether it falls within the scope of the Federal Meat Inspection Act (FMIA). Sanchez of the Food and Drug Law Institute argued that cultured meat most likely does not fall under that category.42 However, in a formal agreement between the Food and Drug Authority (FDA) and Department of Agriculture (USDA) on who will oversee cultured meat production, this act is given as a basis for their authority.43 The FDA and USDA stated beforehand that new legislation is not necessary, but do not give clarity as to what its name should be.44 The new agreement doesn’t provide an answer either, but does indicate regulatory change might be needed after all.
39 Case C-422/16 Verband Sozialer Wettbeweb eV v TofuTown.com GmbH [2017] ECLI:EU:C: 2017:458 [Tofutown] 40 Z. Schneider In vitro meat: Space travel, cannibalism, and federal regulation. Houston Law Review. 2013;5(3):991 41 Ibid 2021 42 Sanchez A, ‘Laws and Regulations Concerning Cell-Cultured Meat and Cellular Agriculture’ (FDLI, February 2018)
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While there is no federal clarification, a few states have introduced legislation concerning the use of the term ‘meat’.45 These focus on limiting the use of the term if the product does not come directly from livestock, and often explicitly prevent cultured meat from being called ‘meat’. However, a federal decision could override these regulations. Lobbying from both proponents of cultured meat and the traditional agricultural sector is prominent in the debate.46 Finally, an article with a name similar to this thesis (A Burger by Any Other Name: Regulatory Challenges and Opportunities for Cell-cultured Meat) explores the question of what to call cultured meat in depth.47 The author points out that current definitions for meat are not made with cultured meat in mind, and that this makes it difficult to categorize the product. They show that cultured meat could arguably fit under these ill-fitting definitions. However, as this article exclusively examines USA law, it leaves the matter of regulating the labelling of cultured meat in the EU open.
1.4.5 Conclusion on Literature Review Cultured meat has been written on mostly from a technical and consumer acceptance perspective. The legal discussion is slowly starting, although official decisions have not been taken in the European Union. The primary comment on labelling cultured meat under current EU law, was made by the Dutch Agency for consumer protection, who stated that cultured meat does not fall under the definition of ‘meat’ used in the EU. However, this was not an official decision and is still up for debate. An interesting follow up question, if the statement of the NVWA is taken as legal truth, is what cultured meat can be labelled as, if not as ‘meat’. None of the articles discuss this question. The recent paper by the Chatham House does recognize the importance of labelling and mainly finds that the outcome of any coming debate is still uncertain. In short, there is neither a definitive decision nor an extensive analysis on the possible designations for cultured meat under European Law. While this thesis cannot provide a definitive answer, it will explore the labelling of cultured meat in depth. In the meantime, the debate is very active in the United States, although there is not definite conclusion either. Especially interesting is Schneider, who explores possible labelling, based on how food labelling is handled in other matters. However, as an American author, he just looks at US law. It is worth exploring what a similar analysis in the EU would bring.
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1.5 The method and content of this thesis The central question this thesis seeks to answer is: ‘How could cultured meat be labelled under European Union law?’ To answer the main question, the black letter method will primarily be used. This will include doctrinal research to determine whether current legislation is sufficient to answer this question. Because this is not entirely the case, some law reform research will be done for the gaps. Chapter 2y explores in depth what cultured meat is exactly, including how similar it is to traditional meat. This includes an examination of whether the differences could and should give rise to a different legal framework concerning the name and labelling of cultured meat. The European legal framework, especially concerning novel foods and labelling, will be discussed in the third chapter. How does the NFR work, what are labelling requirements for food products and how do these two relate? This chapter also considers briefly how these regulations relate to cultured meat. To give some further insights in to possible designations for cultured meat, the fourth chapter examines comparable cases concerning the labelling and legal names of other products. To illuminate how alternatives to animal-based products are viewed, the CJEU case on plant- based alternatives is examined in depth.48 Furthermore, there are already specific labelling requirements for meats that have undergone certain types of treatments. Similar requirements might be used for cultured meat. The labelling of genetically modified food will also be discussed, which is especially interesting as cultured meat can be GM as well. However, as being GM does not fundamentally influence whether cultured meat can be called meat, and the question of how GM should be labelled is already largely settled, this facet of labelling cultured meat will not be discussed in depth. The fifth chapter combines the information from the previous chapters to set out the different names and appurtenant labels which could be used for cultured meat and gives legal arguments pro and con.
48 Tofutown (n 39)
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Chapter 2 Cultured meat compared to traditional meat The exact nature of cultured meat and whether or not it is equivalent to the product it is intended to replace are important in determining the proper name for the product. How is cultured meat made, and how is it different from traditional meat? Are there any ethical issues with cultured meat? This chapter delves into these questions. This is relevant because the nature and specifics of a product play a significant role in labelling, and the extent to which cultured meat is the same as traditional meat will play a role in determining whether it can be labelled in the same manner.
2.1 Explaining the nature of cultured meat The starting point for determining a proper designation for cultured meat is determining what it actually is and how it is made.
2.1.1 The nature of the cultured meat There is no legal, European Definition of cultured meat. The FDA and USDA use the following description of cultured meat: “human food produced using animal cell culture technology, derived from cell lines of USDA-amenable species […]”.49 However that does not really clarify its nature. While there is no a definite demarcation of what cultured meat is, three main elements can be distilled from the literature which might illuminate its nature further.50 The first distinctive element is that cultured meat is nearly biologically equivalent to meat, or at least strives to so.51 The cells of cultured meat are actual muscle cells, just like in traditional meat. At the same time, it is questionable whether cultured meat can be truly biologically equivalent based on current technology, as replicating meat is a complex task. The second element is that cultured meat should be intended for human ingestion, at least to qualify as actual food.52 This is quite straightforward, but it does mean that cultured meat will be more strictly regulated than most products.53
49 Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species (n 43) 50 Froggatt and Wellesley (n 35) 7 51 Ibid; Stephens and others (n 32) par 2.1 and 2.2 52 Regulation (EC) 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 2 31/1 [General Food Law Regulation] art 1 53 European Commission, ‘FOOD SAFETY: OVERVIEW’ (European Commission, date unknown)
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What sets it apart from traditional meat is the third element: the production method of cultured meat. After all, cultured meat is virtually made without animal involvement. The process will be further explored in the next paragraph. There are other innovations on traditional meat, which are often mentioned together with cultured meat. Cultured meat can largely be distinguished from the three primary other innovations (namely plant-based meat alternatives, genetically modified meat and meat from cloned animals) using the aforementioned elements. These types of food have different properties and need separate review by the European Commission.54 Firstly, there are (plant- based) meat alternatives, which are made using plants and fungi. Unlike cultured meat, they are made without any kind of meat tissue and do not strive towards biological equivalence to meat.55 Secondly, meat can be genetically modified, which means that the animal has its genome altered. It differs from cultured meat in that it generally still requires an, artificially altered, animal to grow the meat. It is strictly regulated in the EU, and only certain types of genetic modifications are allowed.56 Genetic modification can be used in cultured meat, but not necessarily. 57 Combining the techniques would lead to additional legal questions, as only modification of plants have been approved in the EU so far, however that is a separate question from labelling.58 Thirdly, cloned animals can be used, which means genetically identical animals without genetic modification.59 As with genetically modified meat, this still typically requires a whole animal to grow meat.
2.1.2 The production method for cultured meat As the production method is an essential part of the nature of cultured meat, it is worth exploring more in depth. Cultured meat is produced using an innovative process within the field of tissue engineering-based agriculture, which muscle tissue from livestock is grown in laboratories.60 The process is still very much in development and a variety of techniques are employed. Companies are playing a substantial role in advancing the necessary technologies.61 Because they tend to limit the information to the public, it is unfortunately not possible to present a complete overview of the state of the art.
54 SPF Bonny and others, 'What is artificial meat and what does it mean for the future of the meat industry?' [2015] 14(2) Journal of Integrative Agriculture 256 55 Ibid 56 Theresa Papademetriou, ‘Restrictions on Genetically Modified Organisms: European Union’ (The Law Library of Congress, 9 June 2015) < https://www.loc.gov/law/help/restrictions-on-gmos/eu.php> accessed on 30 March 2019 57 I Datar and M Betti, ‘Possibilities for an in vitro meat production system’ [2010] 11(1) Innovative Food Science & Emerging Technologies, 13-22 58 European Food Safety Authority, ‘Genetically modified animals’ (European Food Safety Authority, date unknown) < https://www.efsa.europa.eu/en/topics/topic/genetically-modified-animals> accessed 3 May 2019 59 European Commission, 'Cloning' (European Commission, date unknown)
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Figure 3 Schematic overview of how cultured meat is produced62 The process begins with starting material of animal origin. It can either be procured from a live animal each time, or a cell line could be genetically modified to keep producing starting material.63 The starting material is combined some kind of growth medium, which includes nutrients, a growth-inducing protein and necessary vitamins, lipids and amino acids.64 It should be noted that this typically involves fetal calf serum but other, animal-free alternatives are being developed.65 The material is then placed in a bioreactor, which provides vital environmental conditions such as the right temperature and oxygen levels.66 Generally a scaffold is used to allow cell adhesion and the creation of a three dimensional meat product.67 So far, the process only produces tiny bits of muscle tissue and further processing is needed
62 K Mrunalini and others, ‘Cultured meat: state of the art and future’ Biomanufacturing Reviews, fig 1 63 M Post, ‘Cultured beef: Medical technology to produce food’ [2014] 49 Journal of the Science of Food and Agriculture 1039–1041; NJ Genovese and others, ‘Enhanced development of skeletal myotubes from porcine induced pluripotent stem cells’ [2017] 7 Scientific Reports 41833 64 Muhammad Sajid Arshad and others (n 60) par 4 65 Ibid; Niamh Michail, ‘Aleph Farms CEO on its 3D cultured beef: 'Unlike other companies, our meat grows together like real meat'’ (foodnavigator, 26 May 2018) < https://www.foodnavigator.com/Article/2018/05/02/Aleph-Farms-CEO-on-its-3D-cultured-beef-Unlike-other- companies-our-meat-grows-together-like-real-meat> accessed on 29 March 2019 66 Muhammad Sajid Arshad and others (n 61) par 4 67 Stephens and others (n 32) par 4.2.3
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to create a product that is ready for consumption. Other products can be made with similar techniques, like milk, leather, and eggs.68
2.2 Differences from traditional meat Cultured meat brings plenty of practical benefits, as listed by Mrunalini and others.69 Besides generally accepted advantages, such as a decrease in greenhouse gases, reduction in land use and improvement of animal welfare, they also note other interesting possibilities such as allowing people to eat exotic animals, currently banned for consumption, and aiding space settlements in food provision. However, the dissimilarities to traditional meat also have some more negative consequences. These will be discussed below.
2.2.1 Difference in quality It is difficult to say what the final product would be like as the technology is still developing, but it seems unlikely that cultured meat will not exactly biologically equivalent to traditional meat. Just like lab grown diamonds are almost too perfect in comparison to its natural counterpart, cultured meat will also be affected by not experiencing all circumstances traditional meat would.70 Meat is mainly composed of muscle cells, but it also includes some nerve, fat and blood cells. These contribute to the taste and texture of the food, and cultured meat largely lacks these.71 The taste of traditional meat is also affected by a complex interaction between different biological molecules, which does not occur in cultured meat. Even the colour of cultured meat is different as the muscle tissue turns out colourless or yellow instead of red or pink. 72 Replicating the vitamins (especially vitamin B12) and other micro-nutrients, which are necessary to provide the full range of nutritional benefits of traditional meat, is also difficult.73 Another issue is how the production method impacts the health risks surrounding meat. On one hand, the controlled environment of cultured meat can lead to fewer incidences of foodborne diseases and less risk of exposure to toxic substances such as pesticides and dioxins.74 On the other hand, the chemicals required for in vitro production might not be safe either and the process might lead to an increase in cancerous cells in meat.75 It should be noted that these cancerous cells would be dead at the moment of consumption, and unlikely to actually affect the human body, but this has not yet been conclusively proven. These
68 Stephens and others (n 32) 69 Mrunalini and others (n 62) table 1 70 Jean-Francois Hocquette, ‘Is in vitro meat the solution for the future?’ [2016] 120 Meat Science, 167–176 71 Ibid; Bhat Kumar and Fayas (n 14) 242 and 246 72 Ibid 73 Jean-Francois Hocquette (n 70) 74 Bhat Kumar and Fayas (n 13) 243 75 Jean-Francois Hocquette (n 70)
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potential health risks might call for additional labelling, depending on the outcome of a risk analysis. Developers are trying to solve these issues, for instance by adding different types of cells or adding food colouring. However, it is doubtful whether cultured meat will truly be biologically equivalent in the near future, especially as solutions need to be economically and practically feasible for mass production. 76 In general, it can be concluded that chances are slim of cultured meat being completely equivalent to its traditional counterpart, either on a visceral or a biological level. The differences will play a large part in determining whether cultured meat can be called meat.
2.2.2 Difference in perception Whether the public will accept cultured meat is a topic of extensive debate and research.77 Cultured meat can be perceived as unnatural, by both academics and the general public. 78 This is understandable given its highly artificial manufacturing. It can be argued that consumers should be aware of this “unnatural” production method when buying a product. The U.S. Cattlemen’s association are using this argument in their (seemingly successful) lobby to exclude cultured meat from being called meat.79 These feelings also relate to the phenomenon ‘neophobia’.80 The idea of cultured meat can evoke feelings of disgust and strangeness.81 This can be linked to findings that the public finds known or avoidable risks, such as smoking, more acceptable than poorly known and unavoidable risks, such as radioactivity.82 As a new technology, cultured meat will unavoidable carry new and possibly unknown risks. The higher content of cancerous cells, for instance, might lead some consumers to wish to avoid cultured meat altogether because it sounds repulsive and dangerous, regardless of whether the risks are scientifically acceptable.83 On the flipside, some consumers may wish to avoid traditional meat. A small but significant portion of the population does not eat meat at all and adheres to a vegetarian or vegan diet. They would be unwilling to consume traditional meat but at least some might be open to cultured meat if the process of that specific product excludes elements such as fetal calf
76 Michail (n 65); Bhat Kumar and Fayas (n 13) 242 and 246 77 See par 1.4.1 78 Bhat Kumar and Fayas (n 13) 242 79 The U.S. Cattlemen’s Association (n 46) 2 80 Froggatt and Wellesley (n 35) 13 81 Van der Weele and Driessen, ‘Emerging profiles for cultured meat; ethics through and as design’ [2013] 3(3): 647–662 Animals; WAJ Verbeke and J Viaene (n 9); M Siegrist and others, ‘Perceived naturalness and evoked disgust influence acceptance of cultured meat’[2018] 139:213-219 Meat sci. 82 Sylvy Bonny, ‘Why are most Europeans opposed to GMOs? Factors explaining rejection in France and Europe’ [2003] Electronic Journal of Biotechnology 83 Jean-Francois Hocquette (n 70); Paul L. Knechtges, Food Safety: Theory and Practice, (Jones & Bartlett Learning 2012) 417
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serum. Also, people who are enticed by the already mentioned benefits of cultured meat might prefer to buy cultured meat over the traditional kind.84 It seems quite clear that consumers would benefit from product names, or other forms of labelling, which makes a clear distinction between cultured and traditional meat. It would allow them to make an informed decision.
2.3 Conclusion This chapter explored what cultured meat is, and how similar it is to traditional meat. With regard to the nature of cultured meat, it sets out three main elements, namely:
- near biological equivalence to traditional meat; - being intended for human consumption, and; - being produced using tissue engineering-based agriculture. Especially the third element leads to some substantial differences between cultured and traditional meat, regarding its quality, nutritional value and potential health risks. How cultured meat will measure up will depend on technological development and choices, but it seems unlikely these dissimilarities will be done away with anytime soon. Additionally, consumers perception of cultured meat is different from traditional meat. While cultured meat strives for biological equivalence, it cannot be said to be truly the same as traditional meat. These differences might give rise to a necessity to clearly set cultured meat apart from traditional meat when presented to consumers.
84 Slade (n 1) 428-437
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Chapter 3 – European regulation on labelling and novel foods To assess which name could be given to cultured meat, it is important to understand the relevant legal framework. This chapter will explore the area of EU law concerned with food, and particularly novel foods and labelling of foods. The two main legal texts are the NFR and the Food Information to Consumers Regulation (hereafter: FIR).85 These will be explained in relation to cultured meat.
3.1 European food law European food law is a field of law that has grown piecemeal over the last decades and is now a significant part of EU law.86 It provides harmonized, strict legal standards for foodstuffs and how these can be presented, including labelling, advertising and marketing.87 Current food law is governed by principles as laid down in 2002 in the General Food Law Regulation.88 The general objectives of food law can be paraphrased as follows:
- to guarantee a high level of protection of human life and health and of consumers’ interests; - to guarantee fair practices in food trade, taking into account animal health and welfare, plant health and the environment; - to ensure free movement of food within the EU, and; - to facilitate global trade of safe, wholesome food.89 Simply put, the two main elements behind food law are food safety and trade.90 These lead to more specific principles relevant for labelling: risk communication, transparency, the precautionary principle and the protection of consumers’ interests.91 The precautionary principle is a widely used EU principle, detailed in art. 191 of the Treaty on the Functioning of the European Union (TFEU).92 It means that preventive decision-taking should take place in case of potential risk to human health, among other things, even if scientific uncertainty exists.93 This could, for instance, result in not allowing risky novel food,
85 Novel Food Regulation; Regulation on the provision of food information to consumers 86 Raymond O’Rourke, ‘European Food Law’ in Gabriela Steier and Kiran K. Patel (eds), International Food Law and Policy (Springer 2016) 407 87 Gunnar Sachs, ‘Introduction to European Food Law and Regulation’ in Gabriela Steier and Kiran K. Patel (eds), International Food Law and Policy (Springer 2016) 410-411 88 General Food Law Regulation 89 General Food Law Regulation art 5 90 O’Rourke (n 86) 408 91 General Food Law Regulation art 6-10 92 Treaty on the Functioning of the European Union [2016] OJ C 202, 7.6.2016 93 European Commission ‘Communication from the Commission on the precautionary principle’, Doc. 52000DC0001, accessed on 13 January 2019
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but also in taking preventative measures by informing the public. Labelling could play a role here. If cultured meat would be clearly designated as such, it can help consumers make their choice and would allow for easy recall actions in case of something going wrong. Consumer protection includes protection against fraudulent, deceptive or otherwise misleading practices, or in other words, the provision of proper information to consumers.94 Providing consumers with all relevant information also serves the functioning of the internal market, as it allows them to make informed choices. These protections are principally elaborated on in regulations on labelling and presentation of food and play a significant role in how a product can be called.95 Proper labelling can be part of dealing with potential risks related to certain food, as it allows consumers to make an informed decision.96 Finally, the European Food Safety Authority (EFSA) should be mentioned. It is an important player in EU food law with providing independent scientific advice and protecting consumers in relation to food and risks from the food chain.97
3.2 The Novel Food Regulation The NFR, also known as Regulation 2015/2283, has taken effect on January 1st of 2018. It regulates the placement of novel foods on the EU market. It utilizes pre-market approval requirements, which basically means that a new kind of food is banned until it is proven safe and in line with relevant regulations.98 It was preceded by a similar Regulation from 1997. 99 A relevant change is the removal of the substantial equivalence doctrine, as it might have been possible to claim cultured meat was substantially equivalent to traditional meat, which would have resulted in no additional labelling requirements.100
3.2.1 Principles and objectives As might be expected, the principles and objectives of the NFR are closely related to those set in the General Food Law Regulation. The harmonization of the requirements for assessing the safety of novel foods and the subsequent authorization, help ensure free movement and trade of food, because different national laws can create legal uncertainty and unfair
94 General Food Law Regulation art 8 95 Giorgio Rusconi, ‘Food Safety and Policy in the European Union’ in Gabriela Steier and Kiran K. Patel (eds), International Food Law and Policy (Springer 2016) 460 96 Dario Bevilacqua Introduction to Global Food-Safety Law and Regulation (Europa Law Publishing 2015) 115 97 Unknown, ‘European Food Safety Authority (EFSA)’ (European Union, 13 February 2019) < https://europa.eu/european-union/about-eu/agencies/efsa_en> accessed on 28 March 2019 98 Novel Food Regulation art 1; H Bremmers and B van der Meulen ‘The Problem of Food Waste: A Legal- Economic Analysis’ in Gabriela Steier and Kiran K. Patel (eds), International Food Law and Policy (Springer 2016) 407; European Commission ‘Novel Food’ (European Commission, date unknown) < https://ec.europa.eu/food/safety/novel_food_en> accessed on 28 March 2019 99 Regulation concerning novel foods and novel food ingredients [1997] OJ 2 043/1-6 [repealed] 100 Petetin (n 31) 180-182
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conditions for competition and hinder the working of the internal market.101 Considerations concerning food safety are also prioritized, as the Regulation establishes the most stringent risk assessments worldwide.102 The NFR itself states that it is in line with the principles of subsidiarity and proportionality nonetheless.103 As it aims at a high level of protection, it adopts the precautionary principle.104 Consumer protection is a related objective of the NFR and can be read into the objective to improve health and well-being of citizens, as well as benefit their social and economic interests.105 Just as in the General Food Law Regulation, that includes proper information. Especially interesting in relation to the possible environmental benefits of cultured meat, is the objective to improve the quality of the environment.106 The environmental benefits of cultured meat might be a basis to argue in favour of allowing the novel food without undue barriers. 107 As noted in the Chatham House paper, specific food policies could be used to either encourage or inhibit innovation by respectively encouraging and forcing businesses to innovate or by introducing or maintaining barriers to innovations.108 Allowing or banning certain nomenclature for cultured meat could be one of these encouragements or barriers. For instance, a name like ‘lab-grown material’ could put off even the most environmentally conscious consumer. This prevention of undue barriers would have to be balanced against the objective of providing consumers with all relevant information. 109
3.2.2 What is a novel food? To grasp the scope of NFR it is essential to understand what a ‘novel food’ is exactly. The legal definition of the second word is given in the General Food Law Regulation; it means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.110 Novel foods are a distinct category of food. Food is novel if it was not used for human consumption to a significant degree in the EU before 15 May 1997.111 The term ‘novel food’ is somewhat misleading; tried and true food can still be novel on the condition that it has been produced in a sufficiently novel way.112 Therefore, even if cultured meat is biologically equivalent to traditional meat, it will still be considered novel due to the innovative
101 Novel Food Regulation rec 1 102 P. Berry-Ottaway and S. Jennings ‘Continuing Legal Barriers to International Food Trade’ in Gabriela Steier and Kiran K. Patel (eds), International Food Law and Policy (Springer 2016) 103 Novel Food Regulation rec 42 104 Ibid rec 20 105 Ibid rec 2 106 Novel Food Regulation rec 20 and 29 107 Berry-Ottaway and Jennings (n 102) 190 108 Froggatt and Wellesley (n 35) 22 109 Petetin (n 31) 181 110 General Food Law Regulation art 2 111 Ibid rec 7 112 Ibid rec 7
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manufacturing techniques. 113 There has been some debate on whether cultured meat should fall under the scope of the NFR as this was unclear in the old Regulation. The legislator provided clarity in the current NFR, because it explicitly includes food from cell cultures derived from animals, which cultured meat is.114 Commentators have accepted this and it has been confirmed by both the NVWA and the European Commission. 115 This benefits producers of clean meat by giving them certainty on whether the NFR applies, although they might be unhappy about definitively having to go through the authorization process. 116
3.2.3 Authorization of novel food including appropriate labelling If a producer wants to bring a novel food to the EU market, they need to apply for authorization by the European Commission, although the process can also be initiated by the Commission itself.117 If the application is successful, the product is placed on the Union list, and is allowed to be brought to the entire EU market.118 The next question is under which conditions authorization is granted. The material conditions are found in art. 7 of the NFR:
- the food must not be a risk to human health, based on scientific research; - the food’s intended use is not misleading to the consumer, especially if the novel food is meant as a replacement for existing food; - if it is intended as a replacement, it should not be different in a way that is nutritionally disadvantageous when consumed normally.119 The second condition is most relevant in the context of naming cultured meat, because it concerns consumer information and labelling. An applicant has to provide all necessary information, among which is also a proposal for specific labelling requirements which do not mislead the consumer or a verifiable justification why those elements are not necessary. 120 Any specific labelling requirements will be added to the Union list, and the product can only be placed on the market in as far as it complies with the labelling requirements.121
3.2.4 Cultured meat in relation to the Novel Food Regulation Even though it is fairly certain the NFR applies and there are producers looking to bring their product to the market, an actual application for authorization has not been made yet. This
113 Stephens and others (n 32) 157 114 Novel Food Regulation rec 8 and art 3, under 2 (a) (vi) 115 Froggatt and Wellesley (n 35) 25, and Nederlandse voedsel- en warenautoriteit (NVWA) (n 17) 116 Kamsma (n 15) 117 Novel Food Regulation art 7 and 10 118 Ibid art 6 and Froggatt and Wellesley (n 35) 23 119 Novel Food Regulation, art 7 120 Ibid art 10 121 Ibid art 9 (3b) and art 6(2)
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might be attributed to the requirement to produce scientific evidence demonstrating the safety of the product, which takes time and money to produce.122 Food safety requirements are largely beyond the scope of this thesis, but it is still a prerequisite for the authorization to proceed. Despite that delay, an application is to be expected shortly, as there are already reports of a company planning to distribute cultured meat in 2021.123 Besides a proposal for a product-name, an applicant would have to include a proposal for labelling requirements, additional to those stemming from other legislation, or a justification of why this is not necessary.124 Based on art. 8 of the General Food Law Regulation, it can be deduced that it should prevent practices which are fraudulent, deceptive or otherwise misleading to the consumer. Recital 33 specifically refers to the FIR for general labelling requirements. Novel foods are required to comply with these, in addition to the possible specific requirements concerning food description, source, composition and conditions of intended use. Paragraph 2.3 discusses this Regulation further. The labelling should ensure sufficient information on the nature and safety of cultured meat. Whether the nature of cultured meat is fundamentally different from traditional meat, is debatable. Lastly, art. 9 requires the labelling to inform final customers of any characteristic or property which renders a novel food no longer equivalent to an existing food. This leads back to the question of whether cultured meat differs substantially from traditional meat. When a product should no longer be considered equivalent is unclear. However, the article suggests it has mainly to do with the composition and nutritional qualities of a food, or its intended use. It does not mention a difference in production method, which would be the main differentiating factor between cultured meat and its traditional equivalent. This suggests that additional labelling might not be required under the NFR. On the other hand, not mentioning the lab grown origins, might be considered misleading to consumers who care about the provenance of their food. This will be further explored in paragraph 3. If cultured meat is authorised by the Commission, it will be placed on the Union list. The placement includes the name and specifications of cultured meat as well as any specific labelling requirements.125 The name and labelling requirements on this list would be one way of regulating the labelling of cultured meat.
3.3 Regulation on labelling and naming For determining appropriate labelling and naming, the NFR relies heavily on the Regulation on the provision of food information to consumers (FIR). Moreover, even if the NFR would not require specific labelling, the FIR would still be applicable as it is concerned with general
122 Novel Food Regulation art 10(2e); Berry-Ottaway and Jennings (n 102) 190 123 S Musch, 'Mosa Meat wil in 2021 kweekvlees op Nederlandse markt brengen' (NRC, 17 July 2018)
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food labelling.126 The product designation, which is what this thesis in concerned with, is only one part of the food information and label, which also includes elements such as nutritional information and safety warnings. The FIR provides horizontal rules, which apply to all food. It is supplemented by vertical labelling rules, which apply to specific foods. 127 It is safe to say that both mass-produced cultured meat and traditional meat are food and fall under the scope of the FIR. The FIR targets food business operators at all stages of the production, distribution and sale of foods, as long as their activities concern the provision of information concerning food products.128
3.3.1 Principles and objectives Just like the NFR, the FIR falls under the General Food Law Regulation and aims to promote the free movement of safe and wholesome food in the internal market and while striving towards a high level of consumer protection.129 Proper consumer information, in particular labelling, enables consumers to make informed decisions, and prevents misleading practices.130 The information should preferably be easily understandable for the general public.131 It is the primary objective of the FIR to ensure that fair, clear and precise information is provided to consumers.132 An important principle is that the interest of the general public plays a role in whether certain information is mandatory.133 The principles of sustainability, proportionality and subsidiarity are very important and new requirements should only be made in accordance with them. These principles are important as they support the notion that labelling requirements for cultured meat should not be overly stringent.134
3.3.3 General requirements to food information Some basic food information on the label is mandatory. 135 One of these pieces of information is the name of the product.136 This is arguably the most important information to a potential consumer.137 There are also specific mandatory requirements for specific food groups. Interesting is art. 7 FIR, which concerns itself with food information that is misleading. This is obviously not allowed, as all information is required to be accurate, clear and easily
126 Sachs (n 87) 422 127 Aude Mahy and Nicola Conte-Salinas ‘European Food Labelling Law’ in Gabriela Steier and Kiran K. Patel (eds), International Food Law and Policy (Springer 2016) 505 128 Regulation on the provision of food information to consumers art 1 under 3 129 Regulation on the provision of food information to consumers, rec 2 and art 3 under 2 130 Mahy and Conte-Salinas (n 127) 516 131 Regulation on the provision of food information to consumers rec 37 and 41 132 Froggatt and Wellesley (n 35) 133 Regulation on the provision of food information to consumers rec 18 134 See par 3.2.1 135 Ibid art 6 136 Ibid art 9 (1a) 137 Food Standards Agency, ‘Product names – Introduction’ (Food Standards Agency UK, unknown) < https://labellingtraining.food.gov.uk/module2/overview_1.html> accessed 28 March 2019
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understandable. It should in particular not be misleading in terms of the method of production of a food. This is very relevant as the production is the controversial element of cultured meat. Furthermore, the information should be presented in a clear manner, and not be hidden.138 An example is the obligation for so called imitation foods (meaning foods that look similar to other foods but are made of different ingredients, such as “cheese-like” foods made with vegetable products) to be clearly labelled on the front of the pack in a prominent Figure 4 An example of labelling of font size and next to the brand name.139 140 processed cheese
3.3.4 Specific requirements to food names As laid down in art. 17 FIR, the name used for a food must be its legal name, if one exists. This refers to the name prescribed for a food by specific EU law or alternatively by law in the Member State the food is sold.141 For cultured meat, this would be the name on the Union List. One might be tempted to think this is the answer the question of what to call cultured meat, however that is unfortunately not true: the name on the Union list still needs to be decided. It should be noted that a legal name can also preclude foods that do not meet the definition to use that name. When the product lacks a legal name, the customary name - a name accepted by consumers in the member state or part of the member state where the food is sold, without any further explanation needed - can be used.142 Some examples of customary names are ‘Ceasar salad’ or ‘flapjack’. If that does not exist either, a descriptive name is utilized. As the term implies, this refers to a name that describes the food, possibly including its main ingredients or use.143 This might be a name like ‘sugar-free liquorice’ or ‘chocolate flavoured cake’. If cultured meat cannot be referred to in the same manner as traditional meat, it would make sense for the new name to be descriptive, as no existing legal name or customary name exists. Names protected as intellectual property, brand names or fancy names are not allowed as the name of the food.144 Art. 17 under 2 of the FIR is also relevant. It stipulates that the name should not be confusing as to the true nature of the food and it should distinguish it from other foods. If it might prove confusing, it has to be accompanied by other descriptive and clarifying information in close proximity to the name of the food. An omission would be deemed misleading. This happens
138 Regulation on the provision of food information to consumers art 13 139 Sachs (n 87) 427 140 (figure 4) Ci-Square, ‘Smoked Processed Cheese with Chili’ (Ci-Square, 2019) < http://ci- square.com/index.php?route=product/product&product_id=86> accessed 16 june 2019 141 Food Standards Agency (n 137) 142 Regulation on the provision of food information to consumers art 17 143 Food Standards Agency (n 137) 144 Regulation on the provision of food information to consumers art 17 (2)
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for instance in the case of food that has been concentrated, powdered or frozen.145 If the lab grown origin of cultured meat is deemed an integral part of the true nature of the food, this means that label should contain a very clear designation as cultured meat. Another possible factor in determining the proper name for cultured meat, is that Member States have some room to add their own legislation.146 This can happen if Union Law authorizes this or, more importantly, if something has not been specifically harmonized, on the condition that it doesn’t hinder the free movement of goods that are in conformity with the Regulation. There are hitherto no specific provisions for naming cultured meat, so Member States might have some room to legislate. However, it makes much more sense that any new provisions would be added to the Regulation or be provided for in other EU legislation, as this would provide harmonization.
3.3.5 Meat as a legal name Legal names for things like poultry, veal and beef can be found in EU regulations.147 These definitions use the term ‘meat’ but don’t really clarify what meat is; whether cultured meat can be considered ‘meat’ therefore also determines whether it can be called poultry, veal or beef. The FIR defines meat as ‘skeletal muscles of mammalian and bird species recognized as fit for human consumption with naturally included or adherent tissue (…)’.148 At first glance, this does not apply to cultured meat, which is why the NVWA stated that they doubt whether cultured meat can be called ‘meat’. However, cultured meat is usually comprised of muscle cells that can be found in mammalian and bird species, so it might be argued that it does fit that frame. ‘Skeletal muscles’ appears to be used primarily to rule out muscles that a generally perceived as organs, such as the tongue and heart. If the cultured meat is made of skeletal muscle cells, it could fit this definition. Additionally, while the Commission has stated that the term ‘meat’ should only be applied to products that meet the definition in the FIR, it does not seem like the FIR originally intended to provide an exclusionary definition of which products can be called meat.149 First of all, the definition is part of the list of
145 Regulation on the provision of food information to consumers Annex VI under 1 146 Ibid art 38 147 Mahy and Conte-Salinas (n 127) 512; Regulation No 1308/2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 [2013] OJ 2 347/671 [Regulation 1308/2013]; Regulation No 1750/2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and repealing Council Regulation (EC) No 820/97 [2000] OJ 2 204/1; Commission Regulation No 1825/2000 laying down detailed rules for the application of Regulation (EC) No 1760/2000 of the European Parliament and of the Council as regards the labelling of beef and beef products [2000] OJ 2 216/8 148 Froggatt and Wellesley (n 35) 28; Regulation on the provision of food information to consumers Annex VII part B, 17 149 V Andriukaitis on behalf of European Commission ‘Answer to parliamentary question on 19 July 2018’, E-002763/2018
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designations for ingredients, not whole food products. Secondly, the FIR does not say that the term ‘meat’ is exclusively reserved for things that fit the definition. ‘Meat’ is also defined in Regulation 1308/2013. It is interesting that this regulation is not part of EU food law, but rather of the Common Agricultural Policy.150 The Regulation is not aimed at consumer protection, but rather at the agricultural market. The rationale of regulating the sales description (the legal name of the food as meant in art. 17)151 for certain foods is consequently different: it is done because they are important elements for determining the conditions of competition.152 It seems odd to regulate the names of consumer products, in a Regulation that is not concerned with consumers, but that is what the European Union has decided. Meat is defined as ‘all carcases, meat on the bone or boned, and offal, whether or not cut, intended for human consumption, obtained from bovine animals aged less than 12 months, presented fresh, frozen or deep-frozen, whether or not wrapped or packed.’ It becomes immediately clear that this cannot be used as the general legal definition for ‘meat’ because it only applies to meat from bovine animals. That is because the definition is used exclusively for further regulating the sales descriptions of certain kinds of bovine meat. Regulation 1308/2013 as it is, does not provide a legal name for meat. The Commission does have a delegated power to change the sales descriptions and definitions, so that is something that could happen to better deal with cultured meat.153 The regulation as a whole is currently being updated.154 The proposal itself does not change anything with regards to meat, but a proposed amendment might add a legal name. The amendment adds a provision that meat-related terms and names will only be used for edible parts of animals, referring to a similar definition in Annex I of Regulation No. 853/2004 laying down specific hygiene rules for on the hygiene of foodstuffs.155 This definition of meat is different from the one used in the FIR, and it seems that the proponents of the amendment do not share the view of the Commission that there already exists a binding definition of ‘meat’. This is certainly a noteworthy discrepancy. The proposed amendment also regulates names for meat products and meat preparations. Meat preparations are defined as ‘fresh meat, including meat that has been reduced to fragments, which has had foodstuffs, seasonings or additives added to it or which has undergone processes that do not alter the internal muscle fibre structure of the meat enough
150 Regulation 1308/2013 151 Regulation 1308/2013 Annex VII 152 Regulation 1308/2013 rec 76 153 Regulation 1308/2013 Art 78(4) and art 227 154 Proposal for a Regulation of the European Parliament and of the Council amending Regulations (EU) No 1308/2013 establishing a common organisation of the markets in agricultural products, (EU) No 1151/2012 on quality schemes for agricultural products and foodstuffs, (EU) No 251/2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products, (EU) No 228/2013 laying down specific measures for agriculture in the outermost regions of the Union and (EU) No 229/2013 laying down specific measures for agriculture in favour of the smaller Aegean islands [2018] COM/2018/394 [Proposal Regulation] 155 Regulation No 853/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL [2004] L 139/55 [Regulation 853/2004]
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for the characteristics of fresh meat to be eliminated.’ ‘Meat products’ are ‘processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat.’ This includes the use of designations like sausage, steak and burger, which are all currently used for cultured meat products. The proposed provisions primarily target plant-based meat alternatives, like veggie burgers or tofu sausages. It seems likely that cultured meat could be considered a meat product, as it is a product resulting from the processing of meat (namely the starting material taken from a live animal), but this definition does not take cultured meat explicitly into account. This is unlike US proposals which generally explicitly exclude cultured meat in defining ‘meat’.156 The fact that the lawmakers in Europe do not appear interested in making a decision on the controversial issue is a shame, as this would have been the ideal opportunity to take charge in the debate. On the other hand, it might be for the best that the naming of cultured meat is not being explicitly regulated under a Regulation aimed at protecting the agricultural sector, rather than at consumer protection.
3.4 Conclusion This chapter has set out the current legal framework in the EU pertaining to naming cultured meat, which includes general food law, the NFR, the FIR and Regulation1308/2007. Several legal requirements can be found for naming and designating cultured meat. In general, consumer protection and improving the working of the internal market both call for providing consumers with reliable information about food. As cultured meat is a novel food, it will require authorization. Even though it can be argued that cultured meat is equivalent to traditional meat and would therefore not require to be explicitly labelled as different based on the NFR, not labelling it differently so could be considered misleading. Especially considering that labels, including a products name, should enable consumers to make an informed decision as to the product they are purchasing. At any rate, some kind of decision on the naming and designation of cultured meat has to be made as part of the NFR. This would be done by the Commission, based on a proposal by the applicant. The decision will likely be heavily informed by FIR, which sets out a broad ruleset for naming food products. It does not provide a specific answer to the question of how cultured meat should be regulated. It can be argued that it contains a definition of meat that does not fit cultured meat. Whether that is a convincing argument will be discussed in chapter 5. If legislators wish to lay down specific labelling requirements for cultured meat in legislation,
156 Keller and Heckman, ‘Arizona Legislators Join Cell-Cultured Meat Labelling Debate’ (National Law Review, 20 March 2019)
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instead of in a decision, this would be a plausible place to do so, as the FIR already contains some provisions for labelling certain kinds of meat products. Finally, a proposed update to Regulation 1308/2013 might heavily influence the designation of cultured meat, as it would add a legal name and definition of ‘meat’, that differs from the one found in the FIR. If this is implemented, cultured meat could only use meat-related terms, if it fits that definition. However, as the amendment has not been passed, it is to early to base any decisions on that. Specific regulations pertaining to labelling cultured meat could also be added to this Regulation, as it is currently being updated. However, the current proposal or amendments do not take cultured meat explicitly into account. This is probably a good thing, as Regulation 1308/2013 is not concerned with consumer protection. The main question remains: will cultured meat be allowed to use the terms associated with meat and if so, what additional information about its in vitro origin should be included in the label? These questions do not find a definite answer in the current legal framework, no matter which framework would be chosen, so the next chapter will provide some further insight by discussing related cases of designating innovative food.
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Chapter 4 Other cases of designating innovative foods and substitutions A better understanding of comparable cases concerning the naming, including appurtenant labelling, of innovative food, will help determining the proper designation for cultured meat. Firstly, the naming of plant-based alternatives for animal-based products is examined, as these bear close resemblance to cultured meat. Plant based meat substitutes are also using meat-related terms. If this is allowed, it would suggest cultured meat could use such terms as well. Secondly, some special treatments of meat, such as freezing or adding water, will be discussed. Information about these kinds of particulars are regulated in the FIR and might apply to cultured meat. Finally, genetically modified foods will be discussed. It is another form of innovative biotechnology and these foods suffer from the public perception of being risky and unnatural.157 Similar sentiments could play a role in regulating tissue-based agriculture. Of course, the solution found in one case does not automatically have to be applied to cultured meat. The examination includes a short analysis of the relevant differences between the cases and cultured meat, which might lead to different outcomes.
4.1 Plant-based alternatives to animal-based products Just like cultured meat, plant-based alternatives can be used as a substitution for traditional meat. They strive to a degree of visceral similarity, and often adopt the name of the animal- based product they seek to replace.158 As the alternatives have grown more popular, a serious debate has arisen over whether plant-based alternatives can use the terminology used for their traditional counterparts.159 2017 saw the TofuTown case by the CJEU giving clarity on the role of EU law.160 Additionally, some countries have sought to regulate plan-based meat alternatives specifically.
4.1.1 The TofuTown case This CJEU case is based on the German company TofuTown distributing plant-based foods such as ‘plant cheese’ and ‘tofu butter’. The main legal question is whether this infringes EU legislation on designations for milk and milk products, as set out in Regulation 1308/2013, or simply whether it is allowable to use regulated product names for new product types.161 The case is set in that framework, and not that of the FIR.
157 Bonny, ‘Why are most Europeans opposed to GMOs? Factors explaining rejection in France and Europe’ (n 82) 158 Stephens and others (n 32) par 2.2 159 Froggatt and Wellesley (n 35) 9 and 25-28 160 Tofutown (n 39) 161 Karin Verzijden, ‘The EU Tofutown case – don’t mess around with dairy product names’ (Food Health Legal, 31 July 2017) < http://foodhealthlegal.com/?p=889> accessed 30 March 2019
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The Court observed in principle that for the purposes of the marketing and advertising in question, the relevant legislation reserves the term ‘milk’ only for milk of animal origin, with a similar principle for products typically derived from milk.162 This leads the CJEU to deem the use of milk-related designations unlawful in this case, even if clarifying qualifiers, such as tofu or plant, are used.163 Consumer protection is given as a reason as the Court fears a likelihood of customers being confused by the dairy related terms. Even the fact that the plant-based nature is mentioned as part of the name does not change the verdict of the Court. 164 Seeing as plant-based alternatives have used dairy-related terms for a very long time, and this has become part of the normal discourse, it is rather doubtful that consumers would actually be confused.165 Another justification is that allowing the use of the terms could negatively affect the economic conditions for production, marketing and quality of traditional dairy products. Protecting these conditions is part of the aims of the Regulation. This justification makes some sense, as consumers might be more easily persuaded to substitute a dairy product, if they see a familiar name on the plant-based alternative. The ban on using dairy-related terms for plant-based foods that is created by this ruling, could be circumvented by an act from the Commission making an exemption, based on Regulation 1308/2013. This would dependent on their discretion, and so far no efforts have been made.166 Moreover, the Committee on Agriculture and Rural Development, is doubling down on the ban in an update of the Regulation. Part of the previously mentioned amendment is a further tightening of the protection of milk-related terms.167 Dairy-related designations for plant- based alternatives could not even be evoked accompanied by an expression such as ‘style’, ‘imitation’, ‘flavour’, “substitute” or similar.168 This case provides a basis for enforcement authorities to prohibit further use of strictly regulated product names for plant-based substitutes.169 Partly based on the TofuTown case, France passed an amendment banning the use of designations associated with animal products to market food products which are wholly plant-based, or at least a significant
162 Tofutown (n 39) 163 Ibid 164 Ibid, 44 165 Examples: ‘Soy Milk’ (Wikipedia) < https://en.wikipedia.org/wiki/Soy_milk> accessed on 4 May 2019; ‘Soy yoghurt’ (Wikipedia) < https://en.wikipedia.org/wiki/Soy_yogurt > accessed on 4 May 2019 166 Verzijden (n 161); Regulation 1308/2013 art 78(3) 167 See par 3.3.5 168 Amendment on Proposal Regulation ‘Compromise 41’ Working document - COM (2018) 394 - 2018/0218 (COD) 169 Verzijden (n 161)
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part.170 The German authority is seeking to clarify what plant-based substitutes can be called and stresses the importance of its visceral similarity to the animal-based product.171
4.1.2 Implications for cultured meat So, how does this relate to cultured meat? First of all, the Court does note that meat and its substitutes are subject to a different ruleset.172 While meat is also part of Regulation 1308/2013 and is regulated by art. 78 (2) and Annex VII, the provisions on which the judgement is based, it is regulated different from milk. ‘Milk’ can exclusively mean products which match the given definition, which means that it is a legal name.173 ‘Meat’ is only defined for use within the annex itself, and it does not provide a definition Figure 5 an example of labelling that would not be allowed 174 intended for general use. Currently under the amendment meat is not a legal name, only certain types of meat, and it is therefore unlikely that calling cultured meat would be disallowed under a similar reasoning as in the TofuTown case. This is also why ‘veggie burgers’ and ‘soy sausages’ are still available to the public. However, as the amendment that seeks to further regulate the term ‘milk’, also contains a provision constituting a legal name for ‘meat’, this might change in the future.175 The fact that products made with tissue engineering-based agriculture are (nearly) biologically equivalent and do use animal cells as a starting material – which means that it can be argued that it is actually of animal origin – might lead to the interpretation that these products do fit under the definitions for milk- or meat-products, unlike plant-based substitutes. 176
170 Assemblée Nationale de France, ‘Amendment No CE2044’ (Assemblee nationale 13 April 2018) ,
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4.2 Treatments of meat Current EU legislation already implements some special rules in regard to indicating additional information about the nature of certain meats.177 These are so called mandatory particulars accompanying the name of the food and are listed in Annex VI of the FIR. It concerns information about the physical condition or a specific treatment of the product and will help consumers make an informed choice.178 This obligation can be based on a general rule that the name of a product must include particulars about its physical condition or treatment, if omission could mislead consumers. Additionally, the Regulation regulates certain specific cases. For instance, the name of a product which has been frozen has to include the designation ‘defrosted’.179 This framework is also used to provide information to consumers about irradiated food – food which has been exposed to ionizing radiation to kill bacteria or delay ripening – as the FIR demands a clear statement of this process on the label. 180 This allows consumers who wish to avoid the perceived risk of this biotechnology to avoid the product. There are also some particular requirements for meat:
- containing certain added proteins, must indicate their presence in the name; - containing over 5% added water, while having the appearance of a cut, joint, slice, portion or carcase of meat, must indicate its presence in the name, and; - that gives the impression of being a whole piece of meat, while actually being formed, must bear the following indication: ‘formed meat’.181
Figure 6 Dutch label of tenderloin with added water, as listed on the list of ingredients Photograph: IJsbrand Velzeboer It should be noted that it depends on what kind of particulars must be provided, whether they must be mentioned in the products name, or just somewhere on the label.
177 Food Information to Consumers Regulation art 17(5) and Annex VI part A 178 Food Information to Consumer Regulation, Annex VI, part A, 1 and Wieke Huizing Edinger, ‘Promoting Educated Consumer Choices. Has EU Food Information Finally Matured?’ J Consum Policy (2016) 39:9–22 179 Food Information to Consumer Regulation, Annex VI, part A, 2 180 Berry-Ottaway and Jennings (n 102) 194-195 181 Food Information to Consumer Regulation, Annex VI, part A
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4.2.1 Implications for cultured meat The general obligation to include particulars to the name, so as not to mislead customers, could apply to cultured meat. It could very well be argued that producing the meat in vitro, is a specific treatment which the product has undergone, and which is pertinent to proper consumer information. On the other hand, it could be argued that treatment refers to things being done to a product and not so much the production method of the product. Assuming, the obligation does actually apply, an addition to the specific obligations mentioned in Annex VI might be a pathway for legislators wishing to clarify, additional requirements for adding particulars to the name, or label, of cultured meat. Depending on the requirements, demanding additional particulars on the label is a very effective way of informing consumers about the nature of the food they are purchasing. It would be very likely that the exact content of these requirements would be highly politicized.182 Lobby groups could try to influence the debate, just like the US Cattlemen Association is doing in the United States.183 Which descriptors could be used? How prominent should it be? Should it be an obligatory part of the name or can the particulars be placed elsewhere on the label? It will be important to keep the objective of labelling requirements, namely to properly inform consumers so as to allow them to make informed decisions, clearly in mind. Two guidelines helping to achieve this, are that the labelling should not be so technical that the average consumer will not understand them, and that the additions should serve an informational rather than a discouraging purpose.184 It might also be helpful to commission independent market research to better understand consumer attitudes towards cultured meat and its labelling amongst EU citizens.185
182 Froggatt and Wellesley (n 35) 33-34 183 The U.S. Cattlemen’s Association (n 46) 184 Schneider (n 40) 2021 185 Froggatt and Wellesley (n 35) 34
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4.3 Genetically modified food Labelling of GM food is doubly relevant for cultured meat. Firstly, it can provide a template for how to deal with labelling biotechnologically engineered food and secondly, some cultured meat also involves genetic modification and will thus have to adhere to the rules.
Figure 7 Attitudes towards GM in the European Union in 2010
The European Union has a strict policy pertaining to novel GM food.186 This is hardly surprising as citizens have a highly sceptical attitude towards this type of technology, as shown in Figure 4. 187 The legislation includes vertical rules for labelling genetically modified organisms (hereafter: GMO).188 It is laid down in a Directive and a Regulation, with similar rules.189 The legislation regarding labelling is widely accepted as a good policy by farmers, retailers and NGO’s alike, which is quite impressive considering the controversial nature of GMO’s.190
186 Bremmers and van der Meulen (n 62) 555-556 187 Eurobarometer, ‘Special Eurobarometer – Biotechnology Report’ [2010] TNS Opinion & Social, Par 2.1.1. 188 Mahy and Conte-Salinas (n 127) 513 189 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 - Commission Declaration [2001] OJ 2 106/1; 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 2 268/1 [Genetically Modified Food Regulation] 190 Papademetriou (n 56) par II
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Food consisting of GMOs, or containing GMOs, is assigned a unique identifier and label so as to ensure traceability and enable consumers to make informed choices.191 The ingredient list on the label of GM food must include the phrase “genetically modified” or “produced from genetically modified [name of the organism]” for the concerned ingredients.192 When the product does not possess a list of ingredients, the same phrase must appear on the Figure 7 Example of labelling of GMO ingredient label.193
4.3.1 Implications for cultured meat What is interesting about labelling regulation for GM food, is that it is actually not that stringent. The information concerning the genetically modified nature of a food (or ingredient used in a food), only has to appear on the list of ingredients in principal. It does not have to be mentioned in the products name This is not a particularly prominent placement, especially considering the very controversial nature of the technology. Perhaps this could be used as an argument why information about the use of in vitro technology could also just be provided as part of the label. Especially as cultured meat seems less controversial for consumers than GM food. Labelling rules comparable to GM food would leave producers of cultured meat more room to decide how to present the information.
4.4 Conclusion This chapter has explored three different cases concerning innovative foods and their names and appurtenant labelling. They offer three different types of solutions, which could be implemented for cultured meat. The first is the most extreme: banning the use of the term ‘meat’ for cultured meat completely, just like plant-based dairy products cannot be called milk. The second allowing for more nuance, by only requiring an additional particular about the cultured nature of the product being part of the product name. This is how the labelling of meat which has undergone certain treatments of meat are currently regulated. Finally, as seen in both GM food and radiated food, the information could be provided on the ingredient
191 Idem 192 Genetically Modified Food Regulation art 13; 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 - Commission Declaration [2001] OJ 2 106/1, art 13(f) 193 (figure 7) Genetic Literacy Project, ‘How are GMOs labeled around the world?’ (Genetic Literacy Project, 2016)
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list or other part of the label, independent from the product name. Each solution has pro’s and con’s and will probably be up for extensive debate. Each of these solutions concerning naming and labelling products has required some explicit decisions, by either the Commission, the CJEU or the legislator. It would make sense that this would also happen for cultured meat.
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Chapter 5 Finding the proper name for cultured meat As seen in previous chapters, the current legal situation does not unambiguously point to one way of labelling cultured meat under European Union law. As the amendment concerning Regulation 1308/2013 has not been passed and there have been no attempts to lay down specific labelling requirements in any Regulations or Decisions, it seems most likely that the proper designation of cultured meat will be decided as part of its approval under the NFR. This means current legislation will not be changed, and only a decision as part of the Union list will be added. The Commission will have to make a decision or the product name and any specific labelling requirements in order to authorize cultured meat for European markets. This will be based on a proposal from the applicant and will be informed by the General Food Law Regulation, the FIR and any use of the term ‘meat’ in current legislation, such as Regulation 1308/2013. The ways of labelling cultured meat can be divided into three approaches. Firstly, one could consider labelling cultured meat in the same manner as traditional meat. Secondly, cultured meat could be banned from using meat-related terms at all, in which case another designation would need to be found. Lastly, there is a compromise between these extremes: namely allowing meat-related designations with some kind of added particular on the label. This last option has two variants: either the information could be added somewhere on the label, or it could be added to the name of the product itself. This chapter analyses each of these approaches, including arguments pro and contra, in order to give some pointers as to which could be considered the most appropriate. This, of course, does not necessarily mean that cultured meat will in fact be labelled that way. That decision is up to the European Union.
5.1 Labelling cultured meat identically to traditional meat This approach allows for cultured meat to be labelled in much the same way as traditional meat and existing regulation concerned with labelling meat would apply. So if the cultured meat would be frozen as part of the production, its label would have to include the designation ‘defrosted’.194 This would also mean that if the cultured meat is made to look like a whole piece of meat (like a steak) it would need to be indicated as ‘formed meat’. Cultured meat is composed of individual cells, stuck together after all.195 Designations such as ‘beef’, ‘veal’ ‘poultrymeat’, which are protected under Regulation 1308/2013, could be used, as long as the animal from which the starting material is taken fits
194 Food Information to Consumer Regulation, Annex VI, part A, 2 195 Food Information to Consumer Regulation, Annex VI, part A
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the criteria. So, if the starting material is taken from poultry, it can be designated as poultry meat.
5.1.1 Cultured meat is meat The NFR only demands specific labelling requirements in as far as the food is not equivalent to existing food.196 The main argument in favour of this approach is that cultured meat is equivalent traditional meat. After all, it is made from the same primary component (muscle cells), it serves the same purpose and the way it should be used is the same. A new production method does not necessarily make a food substantially different. The product name can arguably also be ‘meat’ as none of the current definitions of meat in EU law, explicitly rule out cultured meat. As cultured meat is the result of processing meat (albeit only a few cells of meat) it could be categorized as a ‘meat product’.197 It would fit the given definition of “processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat”. Similarly, it is made from cells which find their origin as skeletal muscle of mammalian and bird species.198199 Moreover, it could be argued that the customary name for products made from animal muscle cells, meant for human consumption, is meat. An additional advantage of this approach to labelling, is that current legislation would be sufficient; no new provisions are necessary. It is generally recognized that EU legislation is already very complicated and adding more provisions would only complicate it further. Of course, that is not to say that new rules should always be avoided; only if there is no good reason for adding them. Labelling cultured meat, the same as traditional meat would have the advantage of simplicity. Not requiring a specific name or label, will place the least amount of barrier to cultured meat. It is against the objectives of the NFR to unduly hinder novel foods, especially if they can contribute to the quality of the environment.200 The environmental benefits of cultured meat might be a basis to argue against special requirements for labelling. 201 Allowing widely accepted, meat related terms could also help consumer acceptance, because it takes time and effort to make consumers adapt to new products. Finally, the NFR, FIR and General Food Law Regulation all state that any requirements should be proportional. Regulating the way cultured meat can be called, should only be done if there is a good reason to do so, and be done in a way that is the least intrusive. Allowing cultured meat to fall under the requirements of meat products, would give producers the most
196 Novel Food Regulation art 9(3b) 197 Regulation 853/2004 198 It should be noted that the interpretation that cultured meat falls within the current definition of meat is not uncontested. This will be further discussed in paragraph 5.1.2. 199 Regulation on the provision of food information to consumers Annex VII part B, 17 200 Novel Food Regulation, rec 20 and 29 201 Berry-Ottaway and Jennings (n 102) 190
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room to decide how prominently they want to advertise the lab-grown origin of cultured meat, if at all.
5.1.2 Cultured meat is not really the same after all The strongest argument against labelling cultured meat identically to traditional meat, is the fact that cultured meat is not really equivalent to traditional meat. Unless the producers of cultured meat have some breakthroughs, it cannot be said that a piece of cultured meat is truly biologically equivalent to a piece of traditional meat. Cultured meat is different in composition, taste and nutritional value. The NFR specifically points out that additional labelling requirements should be included in order to inform consumers of any specific characteristic or food property, such as the composition, nutritional value or nutritional effects, which renders a novel food no longer equivalent to an existing food.202 Not including such information for cultured meat could be considered misleading to consumers.203 They would be unable to actively choose whether they want to consume cultured meat. This is further backed up by art 17 FIR which states that a name should not be confusing as to the nature of the food. Additionally, the FIR considers that food information should not be misleading as to the method of production.204 Not disclosing that cultured meat is lab grown, could definitely be considered misleading. A related factor is the precautionary principle and the possible unforeseen effects on health cultured meat could have, as a wholly new product. Not having specific labelling would meant that cultured meat could not easily be retracted in case of some sort of unforeseen emergency. On the flipside, it is possible that traditional meat would need to be recalled because of some disease in livestock, while cultured meat remains safely consumable. Not labelling would make it difficult to make use of the distinction. Besides physical (dis)similarities, it should also be noted that most market research indicates that a substantial group of people is sceptical about cultured meat.205 It is unlikely that people would react favourably to a system in which they cannot cultured meat from its traditional counterpart, especially seeing how controversial GMO’s are. An American study found that only 5% of people thought meat should be labelled as ‘meat, without any further explanation’.206 The facts that the two products are physically different with different risk profiles and consumers do not appear to view cultured meat and traditional meat as interchangeable, mean that it is unlikely that cultured meat will be labelled identical to traditional meat. Not even
202 Novel Food Regulation art 9(3) 203 See par. 1.4.5 204 Regulation on the provision of food information to consumers art 7 205 See par. 1.4.5 206 Mccauley (n 27) 4
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the producers of cultured meat themselves appear to believe that this approach is realistic, at least not in the short term.207
5.2 Banning meat-related terms for cultured meat Now the approach of labelling cultured meat the exact same way as traditional meat has been found implausible, it is time to consider the other extreme: not allowing the use of meat- related terms for cultured meat at all. This approach would be most likely, if a legal name is found for ‘meat’ and cultured meat does not meet the definition. That would leave the question of what it can be called instead. This name could be included as part of the labelling requirements for cultured meat in the Union list of authorised novel foods.208
5.2.1 Cultured meat as something other than meat The most compelling argument supporting this approach would be the interpretation that cultured meat does not fall within the definitions of ‘meat’ as used in Union law. The NVWA has already informally stated that they do not believe cultured meat meets the definition of ‘skeletal muscles of mammalian and bird species recognized as fit for human consumption with naturally included or adherent tissue’ as used for ‘meat’ in the FIR.209 The idea that only products that fit this definition can be called ‘meat’ is backed up by the Commission.210 Additionally, cultured meat is factually different from traditional meat. Calling it by a different name would prevent any confusion on the part of consumers. About 40 percent of consumers in the USA also prefers this type of labelling, according to a recent study.211 A final supporting argument against calling cultured meat ‘meat’ is the protection of the economic conditions for the production and marketing and the quality of agricultural products. This consideration would be especially important if cultured meat would be regulated under Regulation 1308/2013, as this is explicitly mentioned as an objective of this Regulation.212 If cultured meat would become widely accepted as a substitute for traditionally produced meat, this would probably harm those who produce traditional meat. Using familiar meat-related terms, would facilitate consumers in making the transition from cultured meat towards cultured products. Preventing this kind of diffusion between animal products and their possible replacement, has informed the proposed amendment banning the use of meat- and dairy related terms for plant-based alternatives. It is certainly possible that a similar approach will be taken for regulating cultured meat. Even though the protection of agricultural products is not an explicit objective of the NFR, it is certainly plausible that this
207 Paul Shapiro, ‘Clean Meat and Cell-Based Meat: What’s in a Name?’ ( Medium, 10 September 2018) < https://medium.com/@PaulShapiro/clean-meat-and-cell-based-meat-whats-in-a-name-d4366431deb7> accessed 5 May 2019 208 Novel Food Regulation art 6(2) 209 Van Dinther (n 37) 210Andriukaitis on behalf of European Commission ‘Answer to parliamentary question on 19 July 2018’ (n 149) 211 Mccauley (n 27) 4 212 Regulation 1308/2013 Rec 64
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argument will influence legislators. Lobby from the meat industry has already proven quite effective in the USA, so that might happen in Europe as well.213
5.2.2 Against banning meat-related terms for cultured meat The statement by the NVWA that cultured meat does not meet the definition used in the FIR and could therefore not be referred to as ‘meat’, is not an official decision and is somewhat questionable. Firstly, the definition does not appear to be intended to create a legal name as meant in art 17 FIR. It is used in reference to the list of ingredients, not the name of a whole product. This is unlike the way the term ‘milk’ is explicitly reserved for traditional milk from an animal.214 Another clue that ‘meat’ should currently not be considered a legal name, is the fact that the amendment to Regulation 1308/2007 proposes to add exactly such a legal name and definition.215 Secondly, it can be argued that as the starting material of cultured meat is actually the skeletal muscle of an animal, it does fit the definition (as long as the animal is a mammal or bird). Cultured meat is made from muscle tissue of animal origin and it is recognized as fit for human consumption. While not allowing meat-related terms could be argued to prevent consumer confusion or misleading practices, the opposite can be argued just as well. Cultured meat has thus far been referred to in popular media as some sort of meat (i.e. cultured meat, clean meat, lab-grown burger), so consumers might already link the product to meat related terms. The same study that indicated that ca. 40 percent of consumers preferred labelling with a different term than meat, also found that well over half of consumers preferred labelling including a meat-related term. Additionally, only 18% found ‘something without the words meat, beef, pork etc.’ the most accurate way to identify cultured meat.216 Moreover, some people are allergic to meat. Not labelling cultured meat as meat might lead to accidental consumption, as consumers might be unaware the product consists of (cultured) meat. This directly contradicts the labelling requirement for novel that labelling should include implications for the health of specific people.217 Finally, as already mentioned: there is a lack of a good alternative term. This is would pose a practical regulatory challenge as a name is necessary for approval of cultured meat under the NFR. Based on the FIR, this new name would need to be descriptive.218 Finding such a descriptive name that does not include meat-related terms would be difficult. While plant- based alternatives for meat can fall back on a plant related term, this does not work for cultured meat, as it is constituted of muscle cell (which are usually referred to as meat if meant for consumption). Regulators might try to avoid the difficult question of what to call
213 Amanda Pampuro,’The Beef Over What to Call Lab Meat I Starting to Sizzle’ (Courthouse News Service, 26 April 2019) accessed 13 May 2019
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cultured meat, by not explicitly regulate how cultured meat can be called, but rather add a binding definition of meat that excludes cultured meat. This is largely the approach which has been taken in some American states.219 However, as a product name is a necessary part of the NFR procedure this approach would not work in the EU. The Commission needs to decide on a name for cultured meat. While banning the use of meat-related terms for cultured meat, appears more likely than the first approach, as the NVWA indicated leaning this way, it still does not seem like the most logical or probable way of dealing with the issue. There is currently no legally binding definition of meat, nor a definition that explicitly excludes cultured meat. If the legislator would wish to exclude cultured meat from the term ‘meat’ it would have made sense to do so explicitly as part of the amendment adding a legal name and definition for meat. They have refrained from doing so thus far, which seems to be a good thing in terms of consumer information. Moreover, banning meat-related terms makes naming cultured meat very challenging.
5.3 Using meat-related terms with additional information The final approach is a synthesis between the two extremes which have been discussed: it is to designate cultured meat with meat-related terms, but also require additional information on the label to clarify that it is different from traditional meat. This method is similar to how certain treatments of meat should be mentioned on the label.220 There are two ways to do so, broadly speaking. The first is to just require the information somewhere on the products packaging, or perhaps on the ingredient list. The product name could still be the same as its traditional counterpart. The second way is to include an indication of the cultured nature in the product name; which could lead to product names like ‘cultured chicken wings’ or ‘cell- based hamburger’. Both methods will be discussed, after considering general arguments pro and contra additional particulars.
5.3.1 Additional particulars as a middle ground The approach of using additional particulars to clarify the cultured nature of cultured meat, takes into account the ambiguous relationship between cultured meat and its traditional counterpart: cultured meat can neither definitively be said to be the same as traditional meat nor to not be meat at all. It fits with the current legal framework, as both the NFR and the FIR point to adding additional information to the label in order to make sure consumer are properly informed.221 It also fits with the General Food Law Regulation because laws that requires additional particulars for cultured meat, will provide a basis for consumers to make informed choices.222
219 Keller and Heckman (n 45) 220 See par 4.2 221 Novel Food Regulation art 9 (3a); Regulation on the provision of food information to consumers art 17 222 General Food Law Regulation, art 8
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This approach will allow consumers to make an informed decision about whether or not they wish to purchase cultured meat. Both consumers wishing to avoid cultured meat and those seeking it out, will be enabled in their preferences. It also fits best with the kind of designation currently being used for cultured meat. Because it clearly distinguishes between the two kinds of meat, it will still give some protection to traditional agricultural products.
5.3.2 Arguments against using additional particulars There are also things to be said against just requiring additional information on the label of cultured meat, mostly by proponents of the other two approaches to designating cultured meat. An argument that is easily done away with is that this approach does require additional provisions in order to regulate labelling, unlike labelling cultured meat the same way as traditional meat. Although this is true, it has already been mentioned that adding provisions is not a bad thing if they are useful. They provisions would probably initially be part of the NFR approval process but could also be codified more generally in the FIR, as is done for other treatments of meat which must be mentioned on the label. Another downside of using added particulars to clarify the lab grown origin of cultured meat, is that it might put people of wanting to consume the product. This would hinder the acceptance of the product. While it would be important not to word the additional information in an unnecessarily alarmist way, as previously noted by Schneider, the fact that consumers would choose not to buy meat if they know that it is cultured is really only an added reason for informing them.223 Convincing people to substitute traditional meat for cultured meat might have environmental benefits, but it does not fit the ideals of the free market and consumer protection to fool them into choosing it. On the other side, opponents of the use of meat-related terms for cultured meat, might feel that allowing so would be confusing to consumers even with added information. In the TofuTown case, the CJEU found the additions to the product names that clarified that the product was made from plants, was not sufficient to allow for the use of dairy-related terms.224 However, it is important to note that naming cultured meat is fundamentally different from naming plant-based alternatives to meat. Cultured meat is still consists of the same general material as meat, while plant-based “meat” is only viscerally similar. As discussed, it appears that using a name for cultured that does not involve meat-related terms at all, would only be more confusing to consumers. In terms of consumer information, using meat related terms with additional particulars appears superior. While some might argue that the existing legal name and definition for ‘meat’ prevents cultured meat from using that word, I would argue that the current definition in the FIR does not explicitly exclude cultured meat.225
223 Schneider (n 40) 2021 224 Tofutown (n 39) 225 See par 5.2.2
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It can also be argued allowing anything but traditional meat to called by meat-related terms would do injury to the marketing of traditional meat, which is not in line with one of the goals of Regulation 1308/2013.226 However, as stated before it seems more likely that the regulation will take place under the NFR and FIR, which have no such considerations. Even if cultured meat would be regulated under Regulation 1308/2013, it should be noted that benefitting agricultural products is not a binding principle. It is merely mentioned in a recital as a possible beneficial side-effect of applying standards for marketing. In conclusion, none of the arguments against using a meat-related term with an additional particular for cultured meat is very convincing. This is why I consider this route the most legally sound and the most plausible. The next question is how exactly this should be done
5.3.3 Adding the additional particulars to the name or the label As previously mentioned, the additions informing consumers of the lab grown origin of cultured meat, could be required to be part of the product name, or just be added somewhere on the label. The former solution would provide consumers more directly with information, while just adding it somewhere on the package is more discrete. There is not really a clear indication of which kind should be used in which cases. Currently, cultured meat products are always referred to by a name including an indicator of its lab-grown origin. However, this is at least partly due to the novelty of the product. Cultured meat is newsworthy because of how it is created. This reason will fade once cultured meat becomes an established product. Seeing how controversial technologies like GMO only need to be mentioned on the ingredient list or somewhere else on the label, it could be argued that this should suffice for cultured meat as well. On the other hand, whether or not the information should be part of the product name will also be dependent on how similar cultured meat will be to traditional meat. As long as the in vitro process produces yellowy burgers with little taste and a lack of certain nutrients, it makes a lot of sense to clearly distinguish the product from regular burgers. The FIR or NFR do not provide any clear direction of which would be appropriate, so the decision will be up to the Commission, as part of the NFR process. As the differences between cultured meat and traditional meat are substantial, it would make sense that if it would be an added particular on the label, it would have to be added on a prominent place. The next question is how the additional information should be formulated. This will of course depend on the language of the Member State, but the general principles will apply overall. The FIR provides some useful guidelines in this case. The first, and most important criterion is that the information contributes to a high level of protection of consumers’ health and interests by providing a basis for final consumers to make informed choices and to make safe use of food, with particular regard to health, economic, environmental, social and ethical considerations.227 The lowest threshold is that the information is not misleading, for instance by misrepresenting the characteristics of the product or claiming attributes which the food
226 Regulation 1308/2013 rec 64 227 Regulation on the provision of food information to consumers art 3 (1)
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does not possess.228 It should also be accurate, clear and easy to understand for consumers.229 This would exclude vague euphemisms or overly technical terms. Additionally, brand names and names protected by intellectual property are ruled out.230 There are many different terms used to denote cultured meat in English, of which ‘cultured’, ‘fake’, ‘lab-grown’ and ‘clean’ appear the most commonly used descriptors.231 While some terms are unlikely candidates, as the cultured meat sector would never propose or accept an overtly negative term like ‘fake meat’, and the term ‘clean meat’ can hardly be called descriptive, there is no clear winner. Doing consumer research similar to what has been done in the USA, in the EU might help determine which name would fit the criteria of the FIR best.232 While the FIR or NFR do not explicitly call for such research, they also do not prohibit it. Moreover, the General Food Law Regulation calls for public consultation if any provisions for labelling cultured meat are made.233
5.4 Conclusion This chapter delved into the questions whether cultured meat should be allowed to use meat- related terms and whether there should be any additional particulars should be added to the name or label of cultured meat. Although these questions cannot be answered with complete certainty, as this is up to the Commission to decide as part of the Authorisation under the NFR, I have argued that a designation including meat related terms and further clarifying information on the cultured nature of the food is the most in line with European food law, including the NFR and the NFR. This approach fits best with the ambiguous relation between traditional- and cultured meat and provides consumers with clear information on the product they are purchasing. Whether the appurtenant information should be part of the product name or just be mentioned on the label, is not clear cut and will at least partly depend on how similar cultured meat will be to traditional meat. Finally, the exact terms to be used to distinguish cultured meat cannot be said based on this legal research. While the NFR, and primarily the FIR give some guidelines and further consumer research could help determine which terms people actually find descriptive, it will be up to the legislator to make a final decision.
228 Idem art 7 (1) 229 Idem art 7 (2) 230 Idem art 17 (2) 231 Shapiro (n 207) 232 Szejda (n 28) 233 General Food Law Regulation art 9
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Chapter 6 Conclusion
Cultured meat is gaining ever more attention, and as several groups are trying to bring it to European markets, it is only a question of time before authorisation under the NFR will be requested. A major question that needs to be answered in order to put cultured meat on the Union list of approved novel foods, is what to call cultured meat and if any additional particulars about its nature should be added to the label. As cultured meat is quite unlike any existing product and there is no consensus on how to refer to it, this is not an easy question. It is only made more difficult by the fact that current legislation on labelling, and specifically labelling meat is not made with cultured meat in mind. While some literature exists on labelling cultured meat under EU law, none have fundamentally adressed whether cultured meat fits any current definition of meat. There have also been no concrete proposals on how to legally call cultured meat. This thesis has set out to answer this question. Although some debate has taken place, it is clear by now that cultured meat falls under the scope of the NFR. Part of the approval is finding a product name and determining any necessary labelling requirements. It should be noted that it would also be possible to include labelling requirements in the FIR, but that would likely only happen after the authorisation. Because cultured meat will not be allowed on the market before this approval, a legally appropriate designation will not be relevant until then. What the name and labelling requirements should be, is up for decision by the Commission, although the FIR and General Food Law Regulation will provide some guidance. I have set out to argue which direction that decision should probably take. First of all, the claim that cultured meat should not be referred to as any kind of meat, seems legally shaky. It is primarily based on the idea that cultured meat would not fit the definition of ‘meat’ as laid down in the FIR. However, as the definition has not been made with the possibility of cultured meat in mind, it does not explicitly include or exclude cultured meat. An update of Regulation 1308/2013 might provide a different definition of meat, which is similarly ambiguous of whether it includes cultured meat. The legislator has truly missed an opportunity to act expeditiously and provide for this coming innovation. It would be commendable for the legislator to provide an unambiguous legal name and definition for meat that also explicitly takes cultured meat into account (either by in- or excluding it). As long as no such clarification has been made, cultured meat will have to be judged based on existing provisions, which are ambiguous. While plant-based alternatives are made of fundamentally different material, cultured meat is made from the same muscle cells as traditional meat. Moreover, I have argued that precluding meat-related terms would only detract from proper consumer information. Therefore, it would be more in line with the objective of the FIR to allow labelling that includes meat-related words. It will be interesting to see whether the Commission will take a similar view. On the other hand, labelling cultured meat in the exact same manner as regular meat would not be logical either. Cultured meat is not truly substantially equivalent to traditional meat,
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as it is different in terms of appearance, taste, nutrition and safety risks. Moreover, not providing information about the production of a food product can be considered misleading. As is often the case, it is the happy medium between these extremes that appears most fruitful: namely to allow a name including meat-related terms, but only if it includes a clear indication that the products is cultured. Whether this indicator should be part of the product name or can be placed elsewhere on the label too, would depend on what would be considered proportionate. As long as cultured meat differs substantially from traditional meat, it appears to make most sense to include it in the product name. What the indicator of the cultured meat should be, is also up for debate and somewhat arbitrary. What is clear is that it should be descriptive, accurate understandable to consumers, not a brand name or other name that is protected by intellectual property. Obviously, it should also not be misleading. As determining which terms would fit that description, it makes sense to do some consumer research in order to determine which terms are most acceptable to people. Such research could also include questions on whether consumers prefer the indication as part of the name or as part of the label. Anyone looking to apply for authorisation of cultured meat under the NFR, might be wise to include such research in order to back up their proposed term (done by an independent research institution of course). When an actual application for approval of cultured meat is submittedl, it will become definitively clear what the specifications of the product truly are and how similar it is to traditional meat. As this information is not yet available, this thesis has had to settle for more broad assumptions of what cultured meat is like. As labelling is a tricky subject that heavily relies on the exact specifications of the food, this is not ideal. It is very well possible that cultured meat will include some form of GM technology. This would mean that the product will also need to conform the GM regulation, which includes some labelling requirements. As these requirements are not particularly strict (an indication on the list of ingredients can be sufficient) it does not seem that this will be much of an issue. However, it might be worth exploring more in depth, for those wishing to bring GM cultured meat to European markets. This thesis has been concerned with cultured meat, as this has been the most highly publicized and debated form of cultured product. However, there are plenty of other types of products of animal origin, such as leather, milk and eggs, that could be made using a similar process. A proper labelling would need to be found for each of these products. It will be interesting to see whether a similar approach will be taken for all of these products, or that the fact that the labelling of leather and milk is regulated separately, will lead to vastly different outcomes. A final critical note is that this research is almost exclusively based on literature and decisions in Dutch and English. As both the French and Germans are actively debating what exactly should constitute meat, it is very plausible this has also included cultured meat. However, language barriers have prevented me from investigating these debates in depth.
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To conclude, there is currently no clear way cultured meat can be labelled under EU law, but it is to be expected that the Commission will provide clarity in the near future as part of the authorisation process for cultured meat under the NFR. I have recommended that they allow the labelling of cultured meat with meat-related terms, but also require additional information on the label to clarify that it is different from traditional meat. Cultured meat is coming however it will be called, but giving cultured meat the right name can very well make it or break it.
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