The regulation of cultivated meat in Singapore and the US: lessons for Mexico

Julio J Copo Terrés
Arochi & Linder, Mexico City
jcopo@arochilindner.com

Marco Polo Rosas
Arochi & Linder, Mexico City
mrosas@arochilindner.com

Introduction

What is cultivated meat?

As defined by the Good Food Institute, cultivated meat is meat produced directly from animal cells, grown in bioreactors, using a cell culture medium that supplies basic nutrients, such as oxygen, amino acids, glucose, vitamins, fatty acids, inorganic salts and growth factors. These cells differentiate into muscle, fat and connective tissue to form a product that closely resembles conventional meat.

Why cultivated meat matters

The global population is expected to exceed 10 billion by 2080, with modest increases in life expectancy and affluence. As the population and incomes rise, so does the demand for animal protein. Yet, conventional livestock farming creates significant environmental pressure, being the largest user of land, the second largest consumer of crops and a major driver of deforestation, water scarcity, carbon emissions and biological waste. Meanwhile, industrial fishing contributes to marine ecosystem degradation and is one of the largest sources of plastic pollution.

Cultivated meat offers a promising alternative, with a markedly lower environmental footprint. It also addresses ethical concerns by eliminating the need for animals to be raised in inhumane conditions and avoiding slaughter altogether. It may also reduce public health risks associated with antibiotic resistance and zoonotic diseases, both of which are intensified by industrial animal agriculture.

Cultivated meat in Singapore

In December 2020, Singapore became the first country to authorise the commercial sale of cultivated meat, specifically chicken developed by the company, Eat Just. This historic approval, granted by the Singapore Food Agency (SFA), positioned Singapore as a global leader in food innovation, and marked a significant milestone in the country’s pursuit of food security, as a small, densely populated island, with limited arable land.

In this section, we examine Singapore’s regulatory approach to novel foods, with particular attention paid to the framework’s most distinctive features: the combination of scientific rigor and procedural flexibility.

The regulatory framework

The main legal document that sets out the safety standards for cultivated meat in Singapore are the Requirements for the Safety Assessment of Novel Foods and Novel Food Ingredients, published in November 2019, which, in summary, establishes the rules detailed below.

Novel foods are defined as foods or food ingredients without a history of safe use in Singapore or internationally. This includes:

• new food sources (eg, insects, microalgae, fungi);
• new production technologies (eg, cell cultivation, precision fermentation, 3D printing); and
• structurally modified materials (eg, nanomaterials or synthetic ingredients not having previously been consumed).

Before a novel food can be sold in Singapore, the company must submit a pre-market safety assessment to the SFA, which involves the submission of a technical dossier, including:

• a description of the product and production process;
• a description of all the constituents of the food, including background information, the identity and source of the cell lines, culture media, growth promoters and/or scaffolding material;
• the residue levels for non-food grade components and unintended metabolites;
• its anti-microbial resistance potential;
• its nutritional profile and composition;
• toxicological data, allergenicity and microbial safety information;
• dietary exposure estimates;
• in some cases, the results of toxicokinetic studies;
• hazard comparisons with traditional counterparts;
• traceability and labelling information; and
• genomic and proteomic analyses, if genetic modification is involved.

The data must be based on at least three non-consecutive production batches, representative of commercial-scale manufacturing, demonstrating its reproducibility.

Pre-packed cultivated meat labels must include clear qualifying terms, such as ‘cultured’ or ‘cell based’. Labels that might mislead the customer into thinking the product is conventional meat are prohibited.

The SFA stresses that ‘there is no one-size-fits-all approach to the testing of novel foods’ and that each request for approval must be considered individually, allowing for a flexible framework without the loss of scientific rigor and, therefore, fostering innovation without compromising public health.

Cultivated meat in the US

Although the US approved its first cultivated meat product after Singapore, it established its regulatory structure months earlier, in March 2019, with the publication of the Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species. This agreement outlines each agency’s responsibilities in regard to regulating animal cell-based food made from species under the US Department of Agriculture’s (USDA) jurisdiction.

The regulatory framework

According to the regulation cited above, the Food and Drug Administration (FDA) as part of the Department of Health and Human Services (HSS )and the USDA’s Food Safety and Inspection Service (FSIS) share the common goal of ensuring that human food produced from animal cell culture is not adulterated or misbranded, by conducting inspections, evaluating processes, coordinating their activities, sharing information with each other, specially when objectionable conditions are identified, and enforcing measures to prevent unsafe products from entering or staying on the market. The difference between their respective competencies is based on the stage of the process.

The FDA oversees initial cell line sourcing, cell bank development, cell proliferation and differentiation, manufacturing practices and facility conditions. These functions fall under the FDA’s authority granted by the Federal Food, Drug and Cosmetic Act.

The USDA’s FSIS takes over the regulatory oversight from the FDA after harvesting, according to which it is involved in regulating the subsequent processing activities, packaging, labelling and final product inspection. The FSIS’s activities are based on the provisions outlined in the Meat Inspection Act, Poultry Products Inspection Act and Egg Products Inspection Act.

Lessons for Mexico

The current state of research and entrepreneurship

Animal cell culture research has been developing in Mexico in recent years, particularly in the biomedical field. Researchers including Grissel Trujillo de Santiago, Mario Moisés Álvarez and Laura Palomares have made significant contributions to areas like tissue engineering, bioprocessing and recombinant protein production. However, most of this research remains focused on medical or pharmaceutical applications.

In the entrepreneurial sphere, Forma Foods has emerged as an early player in the cultivated meat space, using advanced 3D printing to create plant-based and potentially cell-cultured meat products. Nevertheless, no cultivated meat products are currently available on the Mexican market.

Gaps in the legal framework

Despite the growing scientific and commercial interest, the current legal framework in Mexico is not yet equipped to regulate cultivated meat or other novel food technologies. While there are several existing norms that govern food safety, none of them adequately address cultivated meat. Three of the most relevant regulations are:

• the Federal Animal Health Law, which is overseen by the National Service of Health, Safety and Agri-Food Quality (Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria or SENASICA), governs the conditions under which livestock is raised and processed to prevent the spread of diseases affecting both animal and human health. It also regulates the sanitary handling of animal-derived products, such as meat, dairy and eggs;
• the General Health Law, which oversees most aspects of public health, including food safety. It contains a definition of biotechnological products, which are described as ‘food […] products in whose production process living organisms or parts thereof are involved, modified through traditional techniques or genetic engineering’. However, this definition is too broad, as the production of most, if not all, food items involves living organisms and modifications to them made by humans. For example, raising livestock and crops involves animals and plants, which have been historically modified through selective breeding. As such, it fails to provide a useful legal category for regulating truly novel foods like cultivated meat; and
• the Regulation on the Sanitary Control of Products and Services, enforced by the Federal Commission for the Protection against Sanitary Risks (Comisión Federal para la Protección contra Riesgos Sanitarios or COFEPRIS), includes a narrower definition of biotechnological products: it only applies to those made using genetically modified organisms (GMOs) and, more specifically, transgenics. This is also problematic, as it excludes cultivated meat products developed using non-GMO cell lines, even though their production clearly involves advanced biotechnology and potential food safety concerns.

A more functional approach: novel foods

Rather than attempting to regulate cultivated meat according to existing definitions of ‘biotechnological products’, Mexico could follow the lead of jurisdictions like Singapore and the European Union, which regulate such products based on the concept of novel foods. Under this approach, foods are classified not by their production method, but by whether or not they have been used for human consumption to a significant degree over the past few decades.

This would allow regulators to focus on the risk profile and safety of the product, rather than being constrained by rigid definitions that may be over inclusive or too narrow. It would also allow for a more adaptive and scientifically grounded regulatory process.

Institutional cooperation

Mexico can also learn from the interagency cooperation frameworks established in the US, where the FDA and USDA share responsibility for regulating cultivated meat, with each agency overseeing different parts of the production process.

A similar model could be adopted in Mexico. SENASICA could draw on its expertise in animal health to ensure that source cells come from healthy animals and assist in inspecting final products for pathogens or toxins. Meanwhile, COFEPRIS could oversee the manufacturing process, the safety of the culture medium, facility conditions and labelling, ensuring compliance before the product reaches the consumer.

Conclusion

The regulation of cultivated meat demands a flexible, science-based approach. Singapore and the US offer valuable lessons in how to adapt existing institutions and foster interagency collaboration to safely bring novel foods to market.

Mexico can follow a similar path by adopting a novel foods framework, clarifying the roles of the relevant regulatory institutions and engaging with researchers and innovators. With the right regulatory strategy, it can support food innovation, protect public health and position itself as a regional leader in sustainable protein development.