I. Introduction

The dawn of the 21^st century has witnessed remarkable innovations in the food industry, one of the most notable being the development of cultured meat.^[1] Also known as cultivated, lab-grown, in-vitro, or cell-cultured meat,^[2] this breakthrough represents a significant paradigm shift in food technology and production.^[3] Created by nurturing animal cells in a meticulously controlled setting, cultured meat presents a pioneering approach that may well transform the meat industry. Its importance extends beyond the mere advancement of technology; cultured meat has the potential to address some of the most pressing challenges of our time, including environmental sustainability, animal welfare, and food security.

The innovation of cultured meat emerges against the backdrop of increasing global concerns about the environmental impact of traditional livestock farming.^[4] Conventional meat production is resource-intensive, contributing to greenhouse gas emissions, land degradation, and water depletion. In contrast, cultured meat promises a more sustainable alternative, reducing the ecological impact associated with meat consumption.^[5] Furthermore, it offers a humane alternative to conventional meat, eliminating the need for animal slaughter and thus resonating with growing concerns among consumers interested in slaughter-free food.^[6] Additionally, cultured meat does not contain antibiotics, salmonella, heavy metals, or microplastics.

However, the path to integrating such innovative products into the market is fraught with regulatory challenges.^[7] The product's categorization is at the heart of the debate, as with every innovation in the food sector. Should cultured meat parallel conventional meat, be deemed a novel food, or warrant a distinct classification altogether? This determination is critical, as it dictates the nature and rigour of the legal requirements for market access. Moreover, the alternative protein industry raises concerns about food safety and quality.^[8] With cultured meat's origins in cell cultures rather than animal slaughter, there is a pressing need to recalibrate current food safety frameworks and inspection protocols to accommodate this new mode of production. Furthermore, crucial questions arise about regulating labelling and importing such products to ensure consumer trust and transparency.

The first lab-grown meat suitable for human consumption was produced at Maastricht University in 2013.^[9] Since then, companies worldwide have embraced this technology, and a few select countries have granted market access.^[10] Cell-based chicken nuggets were approved in Singapore in December 2020, and the US Food and Drug Administration (FDA) completed its voluntary pre-market consultation for the same product in November 2022.^[11] In Europe, the approach is markedly divergent, with the Netherlands committing sixty million Euros to cell-based meat research in 2022,^[12] contrasted by Italy's complete prohibition of such products in November 2023.^[13]

Switzerland presents a unique case study, as the company Aleph Farms filed the first Europe-wide application preceding a market access authorization request with Swiss authorities in July 2023.^[14] The Swiss regulatory approach to a novel technology such as cultured meat is pivotal in determining the trajectory of this innovation within the domestic market and, potentially, the European and global food industry more generally.^[15]

This paper aims to critically analyse the status of cultured meat within the Swiss legal framework, focusing on the challenges and opportunities presented by this innovative product in the context of food regulation. By examining the Swiss approach to cultured meat regulation, this paper seeks to contribute to the broader discourse on how legal systems can adapt to and facilitate emerging food technologies while safeguarding public health and consumer interests.

The paper unfolds as follows. It first delves into cultured meat technology, delineating the scientific underpinnings, biotechnological advancements, and production processes that distinguish it from conventional meat production. The paper then proceeds with the case study of the first market access authorization request filed in Switzerland in 2023, highlighting the company Aleph Farms and its context. The paper scrutinizes the Swiss food regulatory framework, analysing the existing food products taxonomy and the specific category of novel foods relevant to cultured meat. Finally, the paper examines the procedural mechanisms preceding market access authorization for such novel foods. It concludes by emphasizing the legal challenges beyond market access authorization, such as animal welfare, product labelling, and cultured meat importation.

II. Cultured meat technology

1. Production process

Cultured meat is predicated on the principles of tissue engineering applied to food production.^[16] Meat cultivation is based on a biotechnological process. It involves the following steps: the harvesting of stem cells, their cultivation and expansion, the guided differentiation within bioreactors, and the collection of the matured tissue for the final meat product.^[17]

The process begins with extracting stem cells or microsatellite cells from a living animal.^[18] Aleph Farms uses a "one-time collection" of a cow's fertilized eggs directly from its womb. These totipotent cells can replicate and differentiate into embryonic and extraembryonic cell types to construct a complete, viable organism.^[19] The fertilized eggs are left to grow for a short period before being differentiated into the "different types of cells that make up meat, like muscle and collagen-producing cells".^[20] Alternatively, some companies extract their stem cells from a biopsy done on the cow, which might be more invasive for the animal.^[21]

Then, under laboratory conditions, the cells are nurtured in a bioreactor, an apparatus designed to support a biologically active environment that is temperature-controlled, clean, and closed, allowing the cells to thrive. Aleph Farms describe their cell feed as containing "water, oxygen, nutrients and growth medium".^[22] Their growth medium comprises, more specifically, "carbohydrates, fats, amino acids, vitamins, minerals, and non-animal proteins" that mimic the natural growth conditions within an animal.^[23] Some growth mediums contain Fetal Bovine Serum (FBS) derived from a cow fetus' blood. FBS has been one of the controversial aspects surrounding cultured meat.^[24] However, Aleph Farms guarantees not to use "FBS or any other animal-based ingredients aside from angus cow cells".^[25]

Aleph Farms offers a "structured meat product", meaning that cells are structured into an appropriate configuration and need a scaffold.^[26] Technological advancements have allowed meat cultivation in three-dimensional forms, enhancing the resemblance to traditionally farmed meat. This development is similar to medical scientists' process of growing artificial organs. As the cells proliferate, they are guided to develop into muscle fibres and collagen, the primary constituents of meat, through a scaffolding structure that supports the tissue as it matures, thereby emulating the texture and structure of conventional meat.^[27] Aleph Farms uses a scaffolding structure made of soy and wheat. In this production stage, the specifics of the final meat product to be achieved (e.g., steak, filet, etc.) are considered to guide the growing process.

Finally, after a four-week process in the case of Aleph Farms,^[28] the cells will be ready for harvesting, compared to a minimum of seventy-four weeks for beef raised within standard animal agriculture, from fertilization to growing the beef to slaughter weight.^[29]

2. Taste and safety

The first ever lab-grown burger in 2013 passed the blind test of consumers, according to whom it tasted like meat and "not a soya copy".^[30] Blind tastes seem to be a successful exercise for cultured chicken, beef, pork, or fat.^[31] The cultured cells are exact copies of naturally occurring cells, which means the taste is similar. The taste is further engineered by selecting the more flavourful cells. The most challenging aspect is the texture and how the cells are structured to make it seem like meat.^[32] In 2023, the Netherlands became the first country to allow taste tests before regulatory approval.^[33]

Beyond taste, cultured meat raises consumer safety concerns. In early 2023, the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) published a report evaluating the current safety of food derived from cell-cultivated products. Potential hazards relate to four main categories: residues (whether physical, chemical, or biological) in the meat following the production process, microbial contamination, allergens, and risk of epigenetic drift.^[34] The report concluded that most of those risks already exist in conventionally produced food and that relevant risk-mitigating tools and food safety assessments are available. Over time, the genetic stability of the immortalized cells is probably the most extraordinary risk compared to conventional meat. Even though "several unanswered questions" remain, this uncertainty does not make cultured meat intrinsically dangerous.^[35] The literature highlights the importance of science-based harmonized legislation between countries to guarantee adequate food safety.^[36] The cultured meat industry calls for the implementation of standardized safety assessment methods. It suggests using techniques from conventional and novel foods, foods produced with biotechnology, and pharmaceuticals.^[37]

III. Switzerland: home to the first market access request

1. The company behind the request

In July 2023, the Israeli company Aleph Farms submitted its application for a consultation procedure on the novel food status of a "cultured meat product" to the Swiss Federal Food Safety and Veterinary Office (FSVO).^[38] This consultation procedure constitutes an initial administrative stage, which, if novel food status for this "cultured meat product" is recognized, will be followed by a substantive stage in view of obtaining regulatory approval and market access authorization. Aleph Farms' application to the Swiss FSVO is the first of its kind in Europe in the context of cultured meat market access authorization.

Aleph Farms was founded in Israel in 2017 and unveiled the "world's first cultivated thin-cut steak" in December 2018. This beef steak received market access authorization from the Israeli Health Ministry in January 2024. Aleph Farms defines itself as a "cellular agriculture company"^[39] and positions its product as a new category derived from cattle alongside beef and milk. Aleph Farms clearly states that its product is not vegetarian. However, company communications describe the product as "vegetarian-friendly and vegan-friendly" since it is produced "without slaughtering or inflicting harm" and it is "not harvested from an animal carcass".^[40]

Aleph Farms has an established connection to the Swiss meat market. In May 2019, the largest Swiss retail company, Migros, invested in Aleph Farms through its subsidiary "M-industry", which includes the "Micarna" group, Switzerland's leading meat, poultry, egg, and seafood producer, based on sales numbers.^[41] The amount of Migros' investment is not precisely known. Aleph Farms raised USD 11.7M during this round, with several other companies investing in the startup.^[42] Aleph Farms and Migros have developed a "go-to-market strategy" to commercialize and distribute the product Aleph Cuts in Switzerland.^[43] In 2021, Migros also invested in the Israeli startup "Supermeat", which specializes in producing cultured chicken meat.^[44] Furthermore, Migros developed "The Cultured Hub", a Swiss cultured meat startup incubator, together with the flavour manufacturer Givaudan and the technology group Bühler.^[45]

2. Beyond the request: some European context

Why was the first application for a consultation procedure on the novel food status of cultured meat filed in Switzerland, and not in the EU? While regulations are similar and even intertwined, including in the case of (novel) food law,^[46] the EU's internal market is much larger than the Swiss one. However, administrative and political considerations seem to have influenced the decision in favour of Switzerland.^[47]

The European Union Food Safety Authority (EFSA) has authorized novel foods from vegetal cultured cells as dietary supplements.^[48] However, no application for cultured meat has been submitted in the EU as of January 2024.^[49] Food industry stakeholders note that the EU is not a priority due to administrative obstacles, as the procedure lacks transparency and communication channels.^[50] The lengthy procedure was also mentioned.^[51] Although the EU refined its laws in 2018, it can still take up to three years for applications to be accepted and given permission to proceed.^[52] Furthermore, industry stakeholders have commented that "Europe is sending mixed messages",^[53] highlighting the stark difference between countries like the Netherlands and Germany on the one hand and Italy and France on the other hand.^[54]

In contrast, the Swiss FSVO offers application templates, which "provide clarity and transparency for producers", and it allows direct communication regarding the application.^[55] The timeframe between application and decision is usually between 6 and 19 months. Aleph Farms expects the procedure to take "between 12-24 months".^[56] Politically, the Swiss government has cautiously welcomed cultured meat. In response to a parliamentary motion calling for a ban on cultured meat, the Swiss Federal Council responded that it would be a "pointless and disproportionate measure" from the point of view of "consumer safety" and "research". It would harm "the Swiss economy if such products were imported and placed on the market by foreign companies, instead of being manufactured in Switzerland".^[57]

Following the market access authorization request from Aleph Farms, the Swiss FSVO is called upon to examine the application and decide. The question thus arises as to how Swiss food law apprehends the novel food technology of cultured meat.

IV. Positioning cultured meat in Swiss food law

1. Is it meat? Taxonomy of food product categories

The advent of cultured meat presents complex challenges concerning its categorization within the existing taxonomy of food products.^[58] This innovative product compels us to reconsider the fundamental definition of meat: Is the term appropriate if no live animal has been involved in the production process?Or should it be deemed a derivative product of animal origin? Alternatively, does it necessitate the establishment of a new "sui generis" food category? These are not merely academic inquiries; the classification of cultured meat has tangible repercussions for the legal framework governing food safety and the procedural intricacies of market access authorization.^[59]

Meat constitutes a product embedded with substantial cultural significance and connotations. In many countries, the connection between meat and animals' flesh/organs, "perceptions of naturalness, sustainability, religious perspectives, and affordability" is central to defining meat.^[60] According to some literature, "cultured meat in general is considered a technology product rather than meat", pointing towards a potential new food category.^[61] Other authors argue that cultured meat constitutes meat if the final product is indistinguishable from conventional meat from safety, taste, and nutritional perspectives.^[62]

The Federal Act on Foodstuffs and Utility Articles (Foodstuffs Act or FSA) is Switzerland's primary legislation governing foodstuffs.^[63] It relies on risk-based regulation, consumer protection, and food safety principles.^[64] Foodstuffs are "all substances or products that are intended or may reasonably be expected to be consumed by human beings in a processed, partly processed or unprocessed state" (Art. 4 FSA). For meat production, the Swiss Federal Council "determine(s) the animal species whose meat may be used as foodstuffs" (Art. 9 FSA). The Federal Department of Home Affairs (FDHA) Ordinance on Foodstuffs of Animal Origin (AFO) supplements the FSA.^[65]

Cultured meat is a foodstuff under the FSA, as it is "intended to be consumed by human beings". According to Art. 4 AFO, meat means all edible parts of animals belonging to the species listed in Art. 2 let. a to f (authors' translation). The definition of meat thus includes two criteria: (1) animals belonging to listed species and (2) being an edible part of such animals.

AFO's positive species list includes cattle, poultry, and more unusual species (Art. 2 let. a to m). Cultured meat can thus be considered meat under the AFO, pending the "edibility" criteria. Art. 5 let. a AFO states the rules regarding animal parts in mammals that are unfit for consumption, and thus may not be processed into foodstuffs, or passed on to the consumer (authors' translation). This negative list refers to various parts, including the entire urinary and genital system, except for the kidneys, bladder, and testicles. In the context of cultured meat, Aleph Farms starts its production process with a fertilized egg sourced from Lucy, an Angus cow. Therefore, the urinary and genital systems might be relevant. Questions arise about whether cultured meat is fit for consumption according to AFO:

Cultured meat thus matches the two criteria of Art. 4 AFO for meat. Based on this taxonomy, questions might arise regarding the type of meat and meat transformation it could be classified as, relevant for labelling and importing cultured meat products.

2. Novel foods: obligation to request market access authorization

Beyond the classification of cultured meat as a product of animal origin and meat, more specifically, the question of market access arises. Regulation of market access for foodstuffs in Switzerland distinguishes products and actors related to these products.

For foodstuffs of animal origin, any establishment that manufactures, transforms, processes, stores, or supplies food is subject to authorization from the competent cantonal enforcement authority (Art. 11 FSA; Art. 21 FUAO^[66]). This obligation is subject to various exceptions, such as for establishments whose activities are limited to primary production, establishments whose activities are limited to transportation, retail establishments whose activities are limited to the direct supply of food of animal origin to consumers, etc. (Art. 21 para. 2 FUAO).

For the products themselves, no general authorization regime is in place. Foodstuffs can, in principle, be placed on the market provided that they are safe (Art. 7 FSA; Art. 8 FUAO) and do not mislead consumers (Art. 18 FSA; Art. 12 FUAO).

However, this general regime applicable for foodstuffs is subject to exceptions. The Federal Council may introduce specific requirements (Art. 7 para. 5 FSA). For some products, the law imposes positive lists (e.g., Art. 4 para. 1 AFO: meat means all edible parts of animals belonging to the species listed in Art. 2 let. a to f), negative lists (e.g., Art. 5 let. a AFO: animal parts in mammals that are unfit for consumption), notification requirements (e.g., baby formula: Art. 11, 17, 27 SDRO)^[67] and authorization requirements (e.g., novel food: Art. 15 ff. FUAO; genetically modified organisms: Art. 30 ff. FUAO).

New types of products considered novel foods adhere to norms of a distinct regulatory framework. The FSVO has approved market access for insects as novel food since May 2017 for mealworms, crickets, and locusts.^[68] Despite their apparent nature as foods of animal origin, these species do not figure in the AFO, which gives novel foods an exceptional status among animal foodstuffs. The norms on novel food take precedence over the general regulatory framework applicable to food products of animal origin.

According to Swiss law, the definition of novel foods contains two elements.^[69] Art. 15 para. 1 FUAO defines novel foods as foodstuffs that have not been used for human consumption to a significant degree in Switzerland or any member state of the European Union before 15 May 1997 (authors' translation). Cultured meat matches this temporal criterion.

In addition, foodstuffs must belong to one of the novel food categories enumerated by the FUAO (Art. 15 para. 1 let. a to j). Two novel food categories among the enumerated list are particularly relevant to cultured meat: Art. 15 para. 1 let. e FUAO mentions foodstuffs consisting of, isolated from, or manufactured from animals or parts thereof, and let. f. foodstuffs consisting of, isolated from or manufactured from cell or tissue cultures derived from animals, plants, micro-organisms, fungi, or algae.

Genetically modified foodstuffs do not fall into the category of novel foods (Art. 15 para. 2 let. a). However, Aleph Farms states that they "do not genetically modify or immortalize" any cells used to cultivate steaks.^[70]

Art. 16 FUAO regulates the conditions under which novel foods may be placed on the market. The Federal Department of Home Affairs (FDHA) has either designated them in an ordinance as foodstuffs that may be placed on the market (Art. 16 let. a),^[71] or the FSVO has authorized them under Art. 17 (Art. 16 let. b).^[72]

Art. 17 FUAO specifies the market access authorization procedure. An authorization is granted if two cumulative conditions are met. The FSVO first determines whether the requirements for safety and non-deception of consumers stated in Art. 3 para. 1 are fulfilled (Art. 17 para. 1 let. a). Second, the new type of foodstuff, when it is intended to replace an existing foodstuff, does not differ from the old type to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer (Art. 17 para. 1 let. b) (authors' translation). This condition is highly relevant to cultured meat.

The formal requirements for the application for market access authorization are laid out in Art. 2 para. 2 of the FDHA Ordinance on Novel Foods^[73], which describes the necessary information to be submitted: let. a a proposal for a specific name; let. b a description; let. c composition and specifications; let. d where appropriate, methods of analysis; let. e scientific data proving that the new type of foodstuff meets the safety and non-deception requirements of Art. 17 para. 1 FUAO; let. f where applicable, the intended use and the conditions of use; let. g presentation and labelling; let. h the manufacturing process or multiplication or reproduction practices.

In practice, the application form submitted to the FSVO consists of two parts.^[74] Part A concerns the consultation procedure for determining the novel food status of a product. Aleph Farms' application is currently at this stage.^[75] Part B involves the documents for the application's substantive assessment. Documents relating to composition and specification, analytical methods, scientific data, intended use, and production process must be prepared and submitted following the "Administrative guidance on the submission of applications for authorization of a novel food pursuant to Art. 10 of Regulation (EU) 2015/2283".^[76] In general, documentation must be provided for each potential safety hazard, particularly the "composition of the novel food, its manufacturing process, its history of use, the results of animal and/or human studies".

This administrative guidance provides a "completeness checklist", recommending specific documents for each type of novel food. In the case of cultured meat, the applicant needs to specify the key steps of the production process; quality and safety assurance and standardization criteria; organ and tissue or part of the organism sourced; laboratory or culture collection sourced; information on the identity of cells; information on the handling of the sources, use of pesticides, antimicrobials, and antiparasitic agents; growth medium and culture conditions; qualitative and quantitative data on the composition, including impurities, byproducts, residues and contaminants; whether the novel food is intended to replace another food and if so, demonstration that the novel food does not differ in a nutritionally disadvantageous way; toxicological information; allergenicity. This list is completed in more detail by the "Guidance on the preparation and submission of an application for authorization of a novel food in the context of Regulation (EU) 2015/2283".^[77]

The purpose of these requirements is to guarantee safety and quality standards to protect consumers. The heart of the FSVO examination of Aleph Farms' application lies in the scientific data proving that cultured meat is safe and nutritionally equivalent to traditional meat. This examination ensures that the methods and substances used in the cell culturing process meet established food safety standards. Beyond the nutritional standards that must be similar to traditional meat, no regulatory benchmarks relate to texture, taste, and other quality parameters associated with meat products.

Without access to Aleph Farms' scientific data, it is difficult to predict the outcome of the current market access authorization procedure. Should cultured meat be classified as a novel food and authorized by the FSVO, a permit is issued. Such a permit can only be granted to individuals or entities with a domicile or registered office in Switzerland. Applicants established abroad must be represented in Switzerland; the representative submits the authorization request and undertakes to comply with the requirements (Art. 4 FUAO).

The authorization is granted for five years with no option of extension. If the conditions relating to food safety and the prohibition of deception remain fulfilled after this period, cultured meat will be included in the Annex to the FDHA Ordinance on Novel Foods following re-examination by the FSVO (art. 17 para. 2; Art. 16 let. a FUAO).

Considering that knowledge about the safety and quality of novel food might evolve due to evolving science and technology, Art. 19 FUAO specifies that any person who manufactures, processes, imports, or places on the market a novel food must communicate new knowledge on the safety of the food to the FSVO without delay and spontaneously.

For now, this novel food regulatory framework applies in Switzerland. In contrast, some countries, such as Singapore, have designed specific legal frameworks for the new foodstuff of cultured meat.^[78]

V. Conclusion

While promising, integrating cultured meat into the market mandates a multifaceted approach to regulation that ensures public health and consumer safety. Switzerland's encounter with the first market access authorization request for cultured meat in 2023 serves as a case study for Europe, illustrating the potential and pitfalls of navigating uncharted regulatory waters in the context of novel food technologies. The Swiss authorities' decision will impact how other authorities handle market access authorization for cultured meat, particularly in the EU.

The legal challenges of cultured meat extend far beyond the initial hurdle of market access authorization. These challenges encompass a range of complex issues that legal frameworks worldwide are only beginning to grapple with. Further research will be necessary to address regulatory issues such as animal welfare, product labelling, and importation and tariff quotas.

Cultured meat requires an initial harvest of animal cells. The extent to which this process must adhere to animal welfare laws needs to be clarified. Moreover, existing regulations require labelling to inform consumers about the nature and origin of meat products.^[79] The challenge with cultured meat is determining how it should be labelled to avoid deception, considering it is neither plant-based nor conventionally produced animal meat.

This ambiguity extends to the product nomenclature - should it be labelled simply as "steak" or more accurately as "cultured steak"? Further, there are implications for marketing terms such as "sustainable", prompting a debate on whether these descriptors and the claims they represent can be congruently applied to these novel products. Traditional meat producers may seek to differentiate their offerings with qualifiers like "natural" or "traditional". Finally, stringent importation barriers and tariffs insulate the Swiss meat market. Due to the global nature of food distribution and the fact that cultured meat is currently produced outside of Switzerland, the regulatory question arises of whether cultured meat falls under the existing importation and tariff quotas for meat, and if yes, under which category.

Beyond the regulatory issues surrounding market access for cultured meat, consumers' trust in this novel food product remains to be seen. The requirement of comprehensive labelling to empower consumers and ensure transparency and informed choice will play a critical role. Cost estimates for cultured meat are relatively high (63 USD/kg).^[80] Influenced by trust and price, consumers' attitudes^[81] will be the stepping stone in realizing the potential of this supposedly sustainable, animal-friendly novel product and the transition it may bring for agriculture and food systems.^[82]