The Long Journey of Cell-Based Meat across Singapore, the U.S. and Israel, Passing Through the European Union.
Heated Regulatory Debates – and More –.
By Giulia Formici
Navigating Ethical, Political, Economic, Environmental, and Legal Challenges Concerning Cell-Based Meat: Coordinates of the Journey.
2024 is undoubtedly expected to become a pivotal year for the future of cell-based meat. Just a few days ago, Aleph Farms got green light to market cell-based beef in Israel. Meanwhile, within the European Union (EU) context, a lively political debate is sparking, spurred by a note presented to the Council of the EU on January 22, 2024, by Austria, France, and Italy. This document strongly highlights the need for a comprehensive and in-depth discussion on the marketing of cell-based foods, accompanied by a resolute request for Commission intervention. This request is also intricately linked with the ongoing and open dialogue between Italy and the EU on the Italian legislation prohibiting the production and marketing of food and feed consisting of, isolated from or produced from cell culture and tissue culture (Law No. 172 of December 1, 2023).
All these recent developments allow to better understand not only the different policies and regulatory approaches characterizing the marketing of cultured meat, but also the significant attention scientific community, food business operators, agri-food producers’ associations as well as legislators, policymakers and institutions are dedicating to this innovative product.
In recent decades, the technical and scientific progress has paved the way to an innovative in vitro meat production method, starting from stem cells taken from the animal – often acquired through biopsy from a live animal –. These cells are then made to proliferate and differentiate in bioreactors, using cell culture and tissue engineering techniques, and in culture media containing growth factors of diverse origins, with the aim of obtaining fibers and tissues. The resulting product – named “synthetic”, “artificial”, “lab-grown” meat, but also “clean” or “slaughter-free” or even “cultured”, “cultivated” or “cell-based” meat, depending on the characteristics and potentialities emphasized – serves as an alternative source of animal protein.
The potential positive impacts of cell-based meat encompass improvements in animal welfare, by reducing the number of slaughtered animals, and a potential solution – albeit not the exclusive and definitive one – to the pressing challenge of food sustainability; this involves the need to develop food systems capable of simultaneously feeding a growing population – with a consequent increase in animal protein demand – while mitigating the impact of the agri-food sector on environment, biodiversity, and climate change. In fact, conventional livestock farming for meat production currently utilizes 30 percent of global land and 8 percent of water resources worldwide (Cheli et al., 2023), and the livestock supply chain contributes to 14.5 percent of global greenhouse gas emissions (FAO, 2016); considering these challenging data, cultured meat could lead to reduced land and water consumption, while the extent of emissions reduction strictly depend on the energy used, whether derived from fossil fuels or renewable sources (Cheli et al., 2023; Chriki&Hocquette, 2020). Furthermore, the cultured meat production process could contribute to lower antibiotic usage – thus mitigating the risks of antibiotic resistance – as well as to enrich meat with elements important for human health (such as vitamin B12), and to significantly decrease the threat of zoonoses (Post et al., 2020).
The studies and research currently available, however, are still quite limited, primarily because cultured meat, although authorized in some parts of the world – as the next paragraphs will show –, has not yet been produced on a large scale. As a consequence, the available collected data do not allow us to reach definitive conclusions. In particular, if we consider potential food safety issues, several scientific publications – including a comprehensive dossier recently published by the Food and Agriculture Organization of the United Nations (FAO, 2023) – emphasize the need to deeply evaluate aspects that involve: i) the implementation of production methods able to consider and face possible hazards, also with reference to long-term effects connected to this innovative production method; ii) the organoleptic properties and the “aspect” of cultured meat – the color, for example, or the capability to reproduce various meat cuts; iii) the development of culture media different from those of animal origin (Cheli et al., 2023).
While the scientific community continues its careful research activities in order to clearly detect strengths and weaknesses of this novel food, recent years have witnessed a lively political and legislative debate. This discussion not only addresses concerns related to consumers’ health, the costs and accessibility of cell-based meat, and potential socio-economic repercussions on existing agri-food supply chains – particularly those based on livestock – but also navigates sensitive ethical questions related to animal welfare as well as the interplay between innovative food products and cultural identity, which appears to be strictly linked to food and culinary traditions.
The following paragraphs offer a brief analysis of the latest and open regulatory debates on cultured meat. The journey starts in Israel, proceeds to Singapore and the U.S. and concludes by examining the EU and the ongoing dialogue with Italy.
Cell-Based Meat in Israel: The Novel Foods Regulation and the Recent Approval of Cultivated Beef.
In January 2024, Aleph Farms became the world’s first company to earn the authorization for the marketing of cultured beef in the territory of Israel; in fact, until now, only one type of cell-based meat, namely chicken, had been commercialized in Singapore and subsequently in the U.S. The authorization decision was issued by the Israeli Ministry of Health (MoH) and, specifically, by the National Food Service, following the pre-market approval procedure disciplined by the so-called Novel Foods regulation (Directive 004-08 of 2006, integrated by the Public Health Food Protection Law of 2015).
This provision defines as “novel” a food that was not significantly consumed in Israel before February 19, 2006, when the first regulatory framework on Novel Foods came into force, and that falls into specified categories, including “a novel primary molecular structure or has undergone an intentional alteration in its primary molecular structure, for which there is insufficient history of safe human consumption before February 2006; contain a genetically modified organism or a part thereof; contain a plant, animal, microorganism, fungi or algae, or derived from these, for whom there is insufficient history of safe human consumption; were manufactured in a process which was not used in Israel for the manufacturing of this specific food or food component, and this process has led to a substantial change in the composition of the food, its structure or components, and has affected its nutritional value, its metabolic qualities or the level of undesired substances in it” (FAO, 2022). After receiving an application from a food business operator, the National Food Service has to evaluate the food safety of the product, considering toxicology, allergens, and the microbiological safety of the entire production process. The evaluation also includes considerations concerning labeling and information that must be provided to consumers. Once an innovative food is authorized, it is subsequently added to the public list of Novel Foods.
The recent decision authorizing the marketing of cell-based beef, as reported in the Press Release issued by the Israeli Ministry of Foreign Affairs, has been hailed by Prime Minister Netanyahu as a “global breakthrough in the field of alternative protein and important news for food security, environmental protection and concern for animals”. In recent years, the Israeli government has closely monitored technological advancements in the agri-food sector, recognizing innovative foods as a potential solution to water scarcity, food insecurity and other long-standing sustainability issues affecting Israeli food system and linked to the peculiar geographical location, geopolitical situation, and territorial characteristics. It thus comes as no surprise that in 2022 the Israel Innovation Authority – an independent agency funded by public resources – allocated $18 million to finance the creation of an important consortium, involving public research institutions as well as private enterprises, and dedicated to promoting R&D of alternative animal proteins, with a specific emphasis on cell-based meat.
The Marketing of Cell-Based Meat in the Rest of the World: Singapore and U.S.
While Israel is currently the only country in the world having authorized the market entry of cultured beef, Singapore holds another significant global first: in this Asian country, cell-based chicken meat was first marketed in 2020, in the form of “chicken nuggets and processed shredded poultry products containing cell-based chicken” (FAO, 2022). This product underwent the pre-authorization procedure required for Novel Foods. According to the regulations introduced by the Singapore Food Agency (SFA) in 2019 (Novel Foods and Novel Food Ingredients), new foods are those lacking a “history of safe use.” This expression refers to substances that have been consumed as a significant part of the diet by a relevant population (e.g., the population of a country) for a period of at least 20 years without reported adverse human health effects (SFA, 2023). Food business operators interested in marketing Novel Foods are then required to prepare and submit to the SFA a complex scientific dossier, including studies proving the food safety of the product. The SFA will carry out a review of the submitted documentation and take the final decision on the authorization of the new food. Specific guidelines, containing a detailed list of data and studies necessary for the preparation of the application, are periodically updated by the SFA and, in particular, by the Novel Food Safety Expert Working Group, where specialized experts are involved. The presence of an effective and proactive dialogue between the SFA and interested food business operators – enabled by the promotion of Novel Food Virtual Clinics allowing early engagement since the initial product’s research and development phases – has facilitated the applications’ submissions related to cell-based foods. Following the initial authorization in 2020, this has led to further approvals of new formats of cultured chicken meat in 2021 and, more recently in 2023, of “serum-free media” for the production of cell-based meat (EDB Singapore, 2023). The profound interest in alternative protein sources manifested by Singapore’s public authorities appears to align with the broader “30 by 30” initiative aimed at strengthening the resilience of Singapore’s food system and reducing dependence on imports. The ambitious goal is to increase food production to cover at least 30% of national food demand by 2030. This project has led to substantial investments in innovation and research in the field of future foods, along with specific initiatives intended to support the re-training of agricultural workers and the creation of new professional roles.
Singapore is not the only country where cultured chicken meat is currently authorized: in 2023, in the U.S., Good Meat and Upside Foods companies obtained the approval for commercialization of cell-based chicken meat from both the Food and Drug Administration (FDA), on the basis of a “no questions letter”, and the U.S. Department of Agriculture (USDA). This landmark decision is the result of a long authorization process that, differently from the Israel of the EU ones, is not disciplined by a regulation concerning Novel Foods. Instead, it is governed by an inter-agency agreement established, in an anticipatory move, in 2019 by the FDA and USDA. According to this agreement, the FDA shall conduct risk assessments related to the initial phase of production (“cell collection, cell banks, and cell growth and differentiation”), based on a pre-market consultation opened by the food business operator, that is therefore required to submit precise documentation proving the food safety of the product. The USDA is responsible for the oversight of the further production, labeling, and packaging of the product (FDA, 2019). Notwithstanding the authorization of the first cell-based chicken meat, the political reactions recorded in certain U.S. States are paradigmatic examples of an ongoing and complex regulatory debate: in Florida, for example, the Proposed Bill HB 435, still discussed at the Florida House of Representatives, intends to impose a ban on the production and commercialization of cultured meat. In other States regulatory proposals are multiplying, aiming at establishing specific labeling requirements for cell-based foods/meat (see the Texas Senate Bill n. 664) or prohibiting to employ terms commonly associated with conventionally-produced meat – such as “meat”, “hamburger” etc. – to describe and name foods containing alternative proteins (see the House of Representatives Bill n. 2244 of Arizona).
Cultivated Meat in Italy and in the EU: An Ongoing Debate on Multiple Fronts.
While in the previously analyzed countries cell-based chicken or beef meat has already completed the authorization process, with food safety studies and assessments revealing no critical issues preventing its commercialization, the debate in the EU, both at the national and supranational levels, is still open, especially when it comes to the regulatory aspects.
The EU relevant provisions can be identified in the Novel Food Regulation (EU) 2015/2283 – which came into force on January 1, 2018, replacing the outdated first Regulation (EC) 258/97 –. According to this legislation, foods are considered “new” if they simultaneously meet two criteria, temporal and substantial: “novel food” means any food i) that was not used for human consumption to a significant degree within the Union before May 15, 1997 (marking the entry into force of the first Regulation on the matter), irrespective of the dates of accession of Member States to the Union, and ii) that falls under at least one of the categories outlined in Article 3. In particular, for what concerns us most, Article 3(2)(a)(vi) covers “food consisting of, isolated, or produced from cell or tissue cultures derived from animals” while Article 3(2)(a)(vii) includes food resulting “from a new production process not used for the production of food in the Union before May 15, 1997, involving significant changes in the composition or structure of the food.”
As a consequence, cell-based meat falls under the definition of Novel Foods and will therefore undergo a lengthy and detailed centralized pre-authorization procedure. In summary, applicants interested in marketing innovative foods must submit a scientific dossier to the Commission, containing data and scientific evidence demonstrating that the new food doesn’t pose a safety risk to human health. The Commission then informs all Member States about the application and submits the dossier to the European Food Safety Authority (EFSA), entrusted with the delicate task of publishing its opinion on the food safety of the product, based on a precise risk assessment. The subsequent risk management phase is handled by the Commission, which must prepare a draft implementing act to be submitted to the Standing Committee on Plants, Animals, Food and Feed (so-called PAFF Committee) (comitology).
It is important to highlight that EFSA’s opinion is not the sole element the Commission is called to evaluate: according to Article 12, paragraph 1, Regulation (EU) 2015/2283, the Commission should also take into account “any relevant provision of Union law, including the precautionary principle as referred to in Article 7 of Reg. EC 178/2002” as well as “any other legitimate factors relevant to the application under consideration”; these factors may include economic, social, ethical, and environmental considerations. The draft implementing act prepared by the Commission must be discussed and approved within the PAFF Committee, composed of Member States’ representatives, voting by qualified majority. In the case of a positive vote, the Novel Food will be included in the Novel Foods Union List, publicly accessible, and can therefore enter the European market.
So far, the Novel Foods authorization procedure has proven to be effective, leading to a substantial convergence of positions between EFSA, the Commission, and representatives of the Member States within the Committee regarding the approval of innovative foods: until now “decisions on Novel Food authorisations are systematically aligned to the outcome of the risk assessment, leaving limited room for debate on the non-scientific legitimate factors in risk management” (Volpato, 2022). However, the lively debate regarding cell-based meat and the different approaches manifested in the EU territory seem potentially capable of questioning the adequacy and effectiveness of the analyzed regulation, thus creating tensions between national and supranational governance levels as well as between scientific and political evaluations. Furthermore, even in the absence, so far, of cell-based meat authorization applications submitted to the Commission, this product has already been at the center of a lively debate in several Member States, showing different approaches and positions. In the Netherlands, for example, the Parliament approved a motion (Kamerstuk 274258, n. 383) aiming to enable the tasting of cultured meat, respecting specific conditions established by a code of conduct adopted by the government in July 2023. In France, on the contrary, a proposed law (Proposition de loi n. 1965) is currently under discussion before the National Assembly, with the purpose of prohibiting the production, marketing, and sale of the so-called viande de synthèse. In Italy, Law No. 172 of December 1, 2023 (Official Gazette No. 281, December 1, 2023) has been approved, containing “the prohibition of the production and marketing of foods and feeds consisting of, isolated, or produced from cell cultures or tissue culture derived from vertebrate animals, as well as on the prohibition of using the term ‘meat’ for processed products containing plant proteins”. This legislation, invoking the precautionary principle, established a general prohibition on the sale, possession, import, production for export, administration, or distribution of cell-based foods, including cultured meat. This provision, which caused various reactions by media, civil society and agri-food sector’s associations, has also raised doubts about its compatibility with EU law, particularly with the Regulation (EU) 2015/2283. Currently, as already seen, cultured meat is not authorized at the EU level; therefore, Italy's prohibition simply reinforces the existing marketing prohibition deriving from the implementation of the EU Novel Foods Regulation. Potential issues might nonetheless arise in the future if the EU Commission grants approval for cell-based products, following the Novel Foods authorization procedure. The dialogue between Italy and European institutions will thus become particularly crucial for the future of the Italian legislation on cultured meat. This dialogue began with the activation of the so-called TRIS (Technical Regulation Information System) procedure. The Directive EU 2015/1535, in particular, obliges Member States to notify any draft technical regulation related, among other things, to the circulation of industrial, agricultural, and fisheries products. The Commission will then have 90 days – extendable – to analyze the notified provisions and issue an opinion, also considering the compatibility with the EU law and the rules disciplining the functioning of the European single market. Following the notification, a so-called status quo period starts, during which the draft technical regulation cannot be definitively adopted by the notifying Member State (Article 6). It is within this regulatory framework that the Italian government notified – after parliamentary approval but before its entry into force – the national legislation prohibiting cell-based foods. On January 29, 2024, the Commission closed the abovementioned notification procedure, noting that the Italian legislation entered into force on December 16, 2023, during the status quo period. Recognizing the non-compliance of the standstill period provided for in the TRIS procedure, the Commission has consequently urged Italy “to inform it of the follow-up, also in light of the Court of Justice relevant case law”. This final reminder seems to refer to an extensive CJEU case law stating that the breach of the obligation to notify as well as the adoption of the law before the end of the standstill period “render the technical regulations concerned inapplicable”.
The developments that will follow the outcome of the described procedure certainly deserve close attention, especially in light of other recent events occurred within the Council of the EU. On January 22, 2024, Austria, France, and Italy, with the support of ten other Member States (Czech Republic, Cyprus, Greece, Hungary, Luxembourg, Malta, Poland, Romania, Slovakia, and Spain), submitted a note (5469/1/24) in preparation for the Agriculture and Fisheries Council scheduled for the following day. This note specifically addresses lab-grown artificial cell-based foods. The production of these foods, as affirmed, “represents a threat to primary farm-based approaches and genuine food production methods,” prompting the need for an in-depth discussion able to comprehensively address the challenges related to cell-based meat and to involve not only Member States and Commission but also stakeholders and citizens, before any decision is made regarding the authorization of such products. After highlighting ethical, economic, sustainability, social, and health-related questions, the note also stresses the importance to consider open legal issues, concerning the EU regulatory framework outlined by Regulation 2015/2283. In particular, the signatory States question whether “the current regulation on Novel Foods provides a suitable and comprehensive frame to assess the potential risks associated with these products while taking fully into account the precautionary principle”. This question thus suggests evaluating the adoption of a new and ad hoc legislation addressing the peculiarities of cell-based foods, which appear to be characterized by more controversial aspects if compared to other Novel Foods. In this possible path, however, the Commission intervention is considered crucial to promote “accurate and independent science-based information sharing” and provide a “fact-based impact assessment (...) prior to any authorization (...) that shall address ethical, economic, social and environmental questions, as well as nutrition, health safety, food sovereignty and animal welfare concerns”. The opportunity to initiate a public consultation on lab-grown meat is also emphasized, in order to give a voice to citizens/consumers and address the issues related to the name and labelling of cell-based foods.
The presentation of the aforementioned note has thus opened the doors to what appears to be an intense and delicate dialogue between Member States and European Institutions. During the Agriculture and Fisheries Council meeting on January 23, 2024, Stella Kyriakides, Commissioner for Health and Food Safety, addressed the issue by specifying that “on food safety, we are on very solid ground,” thanks to the pre-authorization procedure established by Regulation 2015/2283 and the risk assessment entrusted to EFSA. In this regard, it was highlighted that, despite no authorization request is currently submitted, the Commission has already invited EFSA to review and update the guidelines concerning the Novel Foods risk assessment, with the final aim of providing the “introduction of state-of-the-art provisions for the safety and nutritional assessment of lab-grown and cell-based foods”. While recognizing that ethical, socio-economic, and environmental issues and concerns “may be part of the decision-making process for Novel Foods authorisations”, Stella Kyriakides also acknowledged “that for the moment, data on lab-grown meat is scares and does not allow for meaningful assessments in key areas like emissions, environment or pricing”; for this reason, supporting R&D projects is crucial to “build the necessary knowledge-base on call-based food”.
This intervention, along with the presented note, marks the beginning of an articulated path that increasingly involves the supranational level, also posing important questions regarding the adequacy of the current EU discipline on Novel Foods. Observing the follow-up given to the request made by some Member States, along with the position the Commission will express regarding national prohibition choices, appears, therefore, of key relevance to understand the future of cultured meat in Europe.
Tasting the Future? The Challenging Regulatory Landscape and the Possible Next Steps
The previous paragraphs provided an overview of the different regulatory approaches and policies characterizing the marketing of cell-based meat – and more broadly, cell-based foods – worldwide. Ongoing political and regulatory discussions, also involving Countries different from those here analyzed – from Switzerland, to the United Kingdom, to China –, demand careful considerations that must first and foremost be based on the results of scientific research. Indeed, the scientific community is called upon to contribute to a better understanding of these innovative products and their impact on consumer health, through the preparation of increasingly precise risk assessments and hazard identifications. Alongside these primary research efforts, studies aimed at outlining the environmental and sustainability impacts – including economic and social aspects – of cultured meat reveal crucial. Considerations and studies concerning accessibility of the product, consumer perception, and accurate consumers’ informative, considering nutritional, environmental, and cultural aspects, are also of paramount importance. All these aspects must accompany and guide in-depth legal evaluations capable of facing, with a holistic vision, the challenges posed by the need to ensure food security, on one hand, and the necessity to preserve ecosystems, natural resources, and biodiversity, on the other hand, while ensuring a high standard of consumers’ health protection.
The case of cultured meat thus represents a paradigmatic example of how disciplining technological-scientific innovation must, more than ever, encourage legislative choices and solutions able not only to create a fruitful dialogue with sciences and scientific research but also to simultaneously serve and preserve the health of mankind as well as of the Planet.