Cultivated meat is gaining momentum—and pathways for regulatory approval
As cultivated meat moves closer to—and enters—markets globally, various countries are using existing novel food regulations or developing new ones to assess the new products. To bolster the cultivated meat industry around the globe, we’re sharing where several key regions currently stand with cultivated meat regulation. With a clear picture of their region’s current regulatory landscape, entrepreneurs and nascent cultivated meat companies can better understand the possible regulatory pathways to bring their product to market approval in their area.
Australia-New Zealand
Australia and New Zealand share a joint food regulatory framework and a joint food regulatory agency, Food Standards Australia New Zealand (FSANZ). FSANZ develops food standards governing the composition, production, handling, promotion, sale, and transport of food. Under FSANZ’s “novel food” regulation, cultivated meat and seafood manufacturers must apply to have their products included in the schedule of approved novel foods if they wish to make sales in either country. This requires a safety assessment by FSANZ of the production process, likely lasting at least 14 months. The safety assessment must establish with reasonable certainty that “no harm will result from the intended use of the food.”
In assessing the risk of harm, FSANZ is required to use the best available scientific evidence. At the same time, the enforcement of the code lies with the government of each participating jurisdiction (that is, of New Zealand and of each Australian state and territory). As a result, those governments ultimately also may have a voice in cultivated meat and seafood approvals.
Cultivated meat and seafood companies are recommended to engage with FSANZ as a next step to familiarize the regulator with their production process and relevant safety issues and controls.
Canada
In Canada, cultivated meat and seafood are characterized as “novel foods” requiring the submission of detailed information in an application for premarket approval. The required information for the novel food submission includes evidence that the food is safe for consumption, including molecular characterization, nutritional composition, toxicology and allergenicity, and types and levels of chemical contaminants.
A three-part approval is required: (i) a letter of no objection for human food use through the novel food assessment process, (ii) a premarket assessment for new animal feed (due to the possibility of supply chain crossover, and regardless of whether the product is intended for use as animal feed), and (iii) an environmental assessment under the New Substances Notification regulations. Companies may not market their products in Canada until they have all three approvals.
Cultivated meat produced with the use of genetic engineering (GE) will likely be considered “genetically modified,” defined broadly to include any “change [to] the heritable traits of a plant, animal or microorganism by means of intentional manipulation.” This definition encompasses traditional methods such as conventional breeding and mutagenesis, as well as more recent methods such as rDNA technology or gene-editing (and is not restricted to interspecies transfer of genetic material).
For cultivated meat produced using GE techniques, certain additional information may be required in the novel food application, including documentation of the nutrient makeup to gauge whether it is nutritionally comparable to the unmodified meat or seafood analog; evidence that the food does not contain toxins or allergens introduced through genetic modification, and that the possibility of any such introduction is remote; and evidence that levels of undesirable substances associated with the conventional analog have not increased in the GE version.
Companies should engage with Health Canada’s Food Directorate to discuss the nature and content of a novel food submission for cultivated meat or seafood.
United States
U.S. regulators have advanced rapidly to create a regulatory framework specific to foods cultured from animal cells.
On November 16, 2018, the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) announced their intent to implement a joint regulatory framework for cultivated meat as follows. FDA will oversee cell collection, cell banks, and all cultivation inputs and processes including cell growth and differentiation, up through the moment of “harvest” from the bioreactors. USDA will then oversee the further processing and labeling of food products derived from the cells of livestock and poultry. (FDA retains jurisdiction over cultivated seafood, excepting catfish, through processing and labeling.) This regulatory framework is intended to leverage both FDA’s experience regulating cell-culture technology and living biosystems and USDA’s expertise in regulating livestock and poultry products for human consumption.
On March 7, 2019, FDA and USDA released a formal agreement describing their respective oversight roles and responsibilities under this framework and how they will collaborate to regulate the production of cultivated meat and its entry into commerce. The agreement is a significant step forward in providing a clear and predictable regulatory framework for cell-based meat and signals that USDA and FDA will work together to ensure that cell-based meat and poultry products are safe and accurately labeled. The agreement does not discuss seafood, which generally is under FDA’s sole purview, but does provide that “USDA-FSIS shall not inspect activities solely regulated by HHS-FDA and shall rely on the HHS-FDA regulatory process for information regarding such activities.” Additionally, it suggests that the labeling requirements for cell-based meat, poultry, and seafood will be consistent.
Since then, USDA and FDA have formed three interagency working groups on cultivated meat, and have confirmed the framework of the formal agreement in a joint webinar titled “Roles and Responsibilities for Cultured Animal Cell Human and Animal Food Products.” The agencies continue to work to refine the technical details of this framework, to include robust collaboration and information sharing between the agencies to permit each to carry out its role.
Companies should engage with FDA’s Center for Food Safety and Applied Nutrition to discuss safety approvals for cultivated meat or seafood.
European Union
In the EU, the Novel Foods Regulation (Regulation (EU) No 2015/2283) governs pre-market authorizations for foods produced from animal cell or tissue culture. However, if genetic engineering is used in the production of cultivated meat, the Regulation on genetically modified food and feed (Regulation (EC) 1829/2003) might apply instead.
Applications under the Novel Foods Regulation need to be addressed to the European Commission and its Directorate-General for Health and Food Safety. The European Food Safety Authority (EFSA) usually conducts a risk assessment and gives a scientific opinion on the safety and nutritional aspects of the product. If that opinion is positive, final approval rests with the European Commission and representatives from all EU member states.
In the risk assessment stage, the European Food Safety Authority (EFSA) assesses the information submitted by the applicant about the compositional, nutritional, toxicological and allergenic properties of the novel food as well as information on respective production processes, and the proposed uses. To help applicants prepare their dossier for submission, EFSA has published a scientific Guidance for the preparation of a novel foods application and an accompanying administrative guidance document with completeness checklists.
After the risk assessment, the European Commission considers EFSA’s opinion and, if the opinion is positive, drafts an implementing act that lays out the specific conditions of use — e.g., specific labelling requirements and monitoring arrangements after placing the product on the market — under which the product is approved, i.e., is put on the Union list of novel foods. The implementing act then needs to be adopted by a Committee representing all EU member states.
The length of the entire novel foods approval process for cultivated meat and seafood is hard to estimate but expected to be at least 18 months and potentially up to three years. As of May 2021, no cultivated meat company had yet formally applied for pre-market authorization in the EU.
United Kingdom
With its exit from the EU, the UK is no longer participating in the EU’s common food authorization procedures. As of May 2021, any cultivated meat companies wanting to sell their products in the UK need to apply for authorization to the UK Food Standards Agency (FSA). But the UK retained relevant EU law and the substance of the risk assessment of both novel foods and genetically modified food authorizations remains the same as in the EU. The FSA provides guidance on how to submit an application.
The most substantial difference between the UK and EU regulatory approval concerns the final approval decision. In the UK, it will be government ministers taking the decision as opposed to the EU, where final approval is governed by the, likely more elaborate and possibly more time consuming, committee procedure involving the European Commission and representatives from all 27 EU member states.
Asia Pacific
Two jurisdictions in the APAC region are making notable progress in creating a regulatory environment favourable to cellular agriculture and cultivated food products: Singapore and Japan.
Singapore
The Singapore Food Agency (SFA) has published guidance on its requirements for the safety assessment of novel foods, including specific requirements on the information to be submitted for approval of cultivated meat products. SFA currently assesses applications on a case-by-case basis.
On December 1, 2020, SFA approved the sale of Eat Just Inc.’s cultivated chicken bites pursuant to this framework—the first such approval in the world. SFA is currently in conversation with other local cultivated meat and seafood startups, including Shiok Meats and Ants Innovate, about potential approval of their products, and is very open to working with companies from the early R&D and product development stages.
Japan
In theory, cultivated meat (depending on the production method) already falls within the existing regulatory regime in Japan and might not require a premarket assessment or approval. At the same time, the Japanese government is working to develop a specific regulatory framework to properly shape the market while ensuring food safety and consumer acceptance. Industry groups are being formed to create industry standards and liaise with the regulator to create a process to foster consumer confidence. Two significant related developments are discussed below.
The first is a government initiative. In April 2020 the Ministry of Agriculture, Forestry and Fisheries (MAFF) launched the Food Tech Research Group, including over 100 companies. It aims to foster the food industry and strengthen Japan’s food security through technology. The group has met to share industry information, to understand structural challenges that startups and established companies are facing in the food technology field, and to enable the development of appropriate policies. The group’s focus is not limited to cultivated meat, and it is anticipated that the group will dive deeper into various food technology subfields to identify priority issues to be addressed.
The second important initiative is that of the Japan Association for Cellular Agriculture (JACA), a collaboration between industry, government, and academia to create rules for cultivated meat, egg, and dairy products in order to contribute to their commercialization in Japan.
JACA is led by the Center for Rulemaking Strategy (CRS) at Tama University, a Japanese think tank, and comprises 30 companies, including some of the major food companies in Japan. CRS’s focus is to design rules (law, industrial standards, self-regulation guidelines, etc.) for emerging technologies and important concepts to be implemented into Japanese society.
With past members, it has successfully created a range of domestic rules and institutions through the Liberal Democratic Party’s parliamentary group on rulemaking strategy in fields including blockchain technology, hydrogen energy, and economic statecraft. Unlike the Food Tech Research Group, JACA’s primary focus is on cultivated meat. JACA has held regular meetings to discuss potential regulatory frameworks, and a number of international cultivated meat companies have joined the collaboration. The group is currently working towards formalized guidance for cultivated meat within the existing regulatory framework. More information (as of October 28, 2020) is available here.
Today, the cultivated meat regulatory landscape varies across the globe. But, in recognition of advancing food technology, many countries are actively establishing regulatory pathways to bring these products to market. If you are an entrepreneur curious about the process for getting cultivated meat approved in your region, or if you have updated information on the regulatory requirements in the regions covered here, reach out to GFI.
Reach out to GFI about cultivated meat regulation
If you are an entrepreneur curious about the process for getting cultivated meat approved in your region, or if you have updated information on the regulatory requirements in the regions covered in our blog post, reach out to GFI.
Header image courtesy of Higher Steaks.
