Novel food regulations around the world

Regulatory frameworks for granting approval continue to play the most crucial role in determining the path to market for novel smart protein products—fermentation-derived and cultivated meat. Cultivated meat products have already received regulatory approvals for sale in three countries—Singapore, the U.S., and Israel. Other countries are following suit, with Australia & New Zealand (NZ), the U.K., and Switzerland actively reviewing applications from cultivated meat companies. Notably, Australia has already completed the safety assessment for Vow’s cultivated quail, concluding the product safe for consumption. South Korea also amended its regulatory framework to invite applications from cultivated meat companies.

It is not just cultivated meat that has been gaining momentum—the use of precision fermentation and biomass fermentation technologies to manufacture ingredients that improve the taste and texture of plant-based and cultivated meat, eggs, and dairy has also received regulatory approvals in several countries, including India.

Fermentation technology (both biomass and precision fermentation) offers opportunities in scaleup and manufacturing. Regulatory approvals for mycelium-based biomass fermentation products and precision fermentation products like Remilk’s animal-free dairy in countries like Singapore, the US, Israel, and Canada are paving the way for wider consumer access. 

The Food Safety and Standards Authority of India (FSSAI)—the apex food regulatory body in India—is at the forefront of driving forward innovative food categories such as smart protein while ensuring consumer safety. In India, fermentation-based protein products are regulated under the Approval of Non-Specified Food and Food Ingredients Regulations (NSF Regulations). Under the NSF Regulations, the companies are required to apply for prior approval from the Food Authority before beginning the manufacturing, production, or import of a non-specified food (including novel) product. After seeking prior approval, the food business operator may apply for licensing to get the product to the consumers. So far, under its Non-Specified Foods regulations, the FSSAI has granted pre-market approvals for ACME’s mycoprotein, Perfect Day’s precision fermentation-derived non-animal whey protein, Reliance’s biomass fermentation-derived algae protein, and Nature’s Fynd’s biomass fermentation-derived Fy Protein (Nutritional Fungal Protein derived from Fusarium str. flavolapis).

Below is a summary of notable regulatory progress for novel smart protein products in Asia and around the world.

Singapore

Singapore treats cultivated meat as a novel food requiring pre-market authorisation. In 2020, the Singapore Food Agency (SFA) became the first regulatory body to green-light the sale of a cultivated meat product, approving GOOD Meat’s cultivated chicken for use as an ingredient in the company’s chicken bites. SFA has since approved additional cultivated meat products from GOOD Meat, including at the beginning of 2023. In October 2022, Singapore became the first country to approve a gas-fermented microbe-based protein called Solein, created by Finnish startup Solar Foods. And, in early 2023, SFA approved the use of serum-free media in the production of GOOD Meat’s existing products, which will allow the company to further scale up production and reduce costs. More recently, in 2024, SFA approved cultivated quail from Vow Foods. 2024 also marked another milestone – GOOD Meat’s cultivated meat product became available for retail in Singapore in first such instance globally. 

SFA’s novel food regulatory framework approves cultivated meat and fermentation-derived products and ingredients on a case-by-case basis, based on safety assessments that companies submit which describe potential food safety risks, information on inputs and manufacturing processes, and risk management procedures. Cultivated meat is required to comply with the chemical, microbiological, and labelling requirements under Singapore’s broader food regulations and must also include qualifying terms on their labels to differentiate them from conventional meat. The Singapore Food Agency (SFA) has published guidance on its requirements for the safety assessment of novel foods, including specific guidance on cultivated meat, foods produced by biomass fermentation, and functional ingredients produced through precision fermentation. SFA strongly encourages companies interested in selling alternative protein products in Singapore to contact the agency early in the R&D and commercialisation planning process. The regulatory approvals take approximately nine to 12 months once all required information is submitted to the agency. Since SFA’s first publication of its novel foods framework in 2019, it has been updated multiple times (most recently in July 2023).

In 2024, The Fatwa Committee of the Majlis Ugama Islam Singapura (MUIS) announced that the consumption of cultivated meat is permissible as halal under certain conditions.

On labelling, SFA requires companies selling pre-packed alternative proteins to label the product packaging with suitable qualifying terms such as “plant-based” or “made from plants” to indicate their true nature. SFA has indicated that this will also apply to cultivated meat products once they are available in pre-packed form.

 ¹Solar Foods recently set up a production factory in Vantaa, Finland, set to commercially produce 160 tonnes annually of the company’s flagship protein, Solein.

United States

In 2023, the United States became the second country in the world to grant regulatory approvals to two cultivated chicken products to enter the market.  After successfully completing the US Food and Drug Administration’s (FDA) pre-market safety evaluation, the US Department of Agriculture (USDA) issued grants of inspection to UPSIDE Foods and GOOD Meat–indicating that their production facilities satisfied regulatory standards, and their products could be sold in the United States. 

Regulatory jurisdiction of cultivated products is shared between the Food and Drug Administration (FDA) and the Department of Agriculture (USDA) pursuant to a formal agreement between the agencies. The FDA oversees cell collection and banking, and all cultivation inputs and processes up through the moment of biomass “harvest” of the cultivated product from the bioreactors. The USDA regulates processing as well as packaging and labelling for terrestrial meats and catfish while the FDA will have jurisdiction over all other seafood products during the processing, packaging, and labelling stages.

The USDA and the 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 USDA has set forth an interim process for label pre-approval but is in the process of setting guidance for the same. Cultivated meat companies should engage with the FDA’s Center for Food Safety and Applied Nutrition to discuss safety approvals for cultivated meat or seafood. 

Fermentation-enabled ingredients are regulated under the U.S. regulatory framework for ingredients and food additives. New ingredients and additives must be approved by the FDA unless they are “generally recognised as safe” (GRAS) under the conditions of intended use.  In recent years, multiple fermentation companies (e.g. Perfect Day, Remilk, Impossible Foods, Nature’s Fynd) have obtained “no questions” letters from the FDA for their ingredients, meaning the FDA does not object to the companies’ view that their ingredients are generally recognised as safe. In April 2022, ENOUGH (formerly 3F BIO Ltd.) received a no questions letter from the FDA regarding their ABUNDA® mycoprotein. If a company does not believe its ingredient is already GRAS, it must submit a food additive petition to the FDA for approval. If the FDA approves the petition, it will add the ingredient to its food additive regulations.

Australia – New Zealand

Australia and New Zealand share a joint food regulatory framework and agency—Food Standards Australia New Zealand (FSANZ). All foods in Australia and New Zealand are governed by the bi-national Food Standards Code (FSC), which details requirements for food safety, identification, labelling, handling, and treatment. Companies can seek pre-market approval via an application to amend the FSC to list the food or ingredient in the table in section S25 – 2. Food Standards Australia New Zealand (FSANZ) provides guidelines on what information needs to be provided for different types of pre-market approval. Cultivated meat is regulated under Standards 1.1.1 and 1.5.1 in the FSC. Novel food applications are subject to a statutory assessment which includes a pre-market safety assessment. If approved, the food will be listed on the table, and the manufacturer will be permitted to sell the product as long as it complies with any specified conditions. 

The enforcement of the code lies with the government of each participating jurisdiction—that is, of New Zealand and each Australian state and territory. As a result, those governments ultimately may also have a voice in cultivated meat and seafood approvals. 

In 2024, FSANZ assessed a cultivated quail submission by Australian startup Vow Foods. After scrutinising the application and conducting a safety assessment, FSANZ made an initial assessment that Vow’s cell-cultured quail does not present safety concerns. The novel food assessment was open for public comment with a deadline of Feb 5, 2024. Full approval is anticipated in 2024. Most recently, Cauldron Fern was granted approval from the Office of the Gene Technology Regulatory to produce limited-scale production trials of protein ingredients up to 10,000 litre batches. Cauldron’s proprietary hyper-fermentation technology approval is a first of its kind in Australia.

South Korea

South Korea has recently amended the legislation concerning the pre-market approval for novel foods, i.e., Ministry of Food and Drug Safety (New Food Materials – Temporary recognition of foods), and included ingredients from cell and microbial cultures within its ambit. To obtain a temporary recognition of standards of food, an applicant has to prepare and submit an application with data. South Korea followed this development by announcing regulatory free zones, formally titled the Gyeongbuk Cell-Cultivated Foods Regulatory-Free Special Zone (RFSZ), to foster cultivated meat R&D.

In 2022, the Ministry of Food and Drug Safety (MFDS) formed a discussion group with industry players to better understand the cellular agriculture production process from cell media to the finished product. In 2023, the North Gyeongsang Province in South Korea led an MOU to form a national cellular agriculture cluster with 28 signatories, including city governments, academia, and corporations.

Israel

Novel foods and ingredients are regulated under the novel foods framework by Israel’s National Food Service (NFS), which is part of the Ministry of Health (MoH). NFS considers company applications on a case-by-case basis. However, as the existing novel foods framework is generic, the Israeli Innovation Authority and the Food Safety Authority surveyed alternative protein companies to determine what additional safety criteria requirements are needed for regulatory approval for future applications. 

Israel’s Ministry of Health granted its first formal regulatory approval to Remilk’s cow-free milk. In 2024 Aleph Farm’s cultivated beef also received regulatory approval by the MoH. The regulatory approval grants permission to produce and market the product in Israel, subject to specific directions for labelling and marketing provided by the MoH, and the completion of a Good Manufacturing Practices (GMP) inspection for Aleph’s pilot production facility. The NFS website gives an overview of the application for novel food registration in Israel and the link to the application portal. 

United Kingdom

Although the United Kingdom is no longer part of the European Union, it has thus far retained the same regulatory processes for novel foods. The placing of novel foods on the market in the UK must be in accordance with the assimilated Regulation (EU) 2015/2283. As in the European Union, novel plant-based, fermented, and cultivated meat products will require premarket authorisation, and companies must apply for authorisation from the UK Food Standards Agency (FSA) using these guidelines. In 2023, the FSA and Food Standards Scotland (FSS) launched a new system for businesses to make applications for regulated products such as novel foods. The most substantial difference between UK and EU regulatory approval lies in the final decision-making process. While the European Commission and representatives from all 27 EU member states determine approval in the EU, in the UK, this responsibility rests with UK government ministers. In 2023, FSA also commissioned Deloitte to undertake a review of the novel food regulations and published the review, showing a proactive approach to evolving with the industry.

In 2023, FSA also issued a ‘Guidance for businesses on cell-cultivated products and the authorisation process’. The Guidance also includes a report commissioned by FSA and FSS on the ‘Identification of hazards in meat products manufactured from cultured animal cells’. The purpose was to inform the risk assessment process for authorising cultivated meat products. Aleph Farms, Ivy Farms and Vital Meat have submitted applications for approval of cultivated meat products and ingredients. The FSA is reportedly planning to start conducting safety tests for cultivated meat in 2024 and has issued a call for scientists to work alongside to pilot a ‘sandbox’ testing project, which will enable them to assess the novel proteins for human consumption.

European Union

In the European Union (EU), the Novel Foods Regulation (Regulation (EU) No 2015/2283) governs pre-market authorisations for foods produced from animal cell or tissue culture, fermentation-enabled ingredients, and some plant-based foods. 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 EFSA assesses the safety and nutritional value of the product. To help applicants prepare their dossier for submission, EFSA has published scientific guidance for the preparation of a novel foods application and an accompanying administrative guidance document with completeness checklists. In 2023, EFSA held a scientific colloquium on the safety of cell culture-derived food to ensure its preparedness for scientific evaluations in this area.

After the risk assessment, once EFSA publishes a positive scientific opinion, the European Commission considers EFSA’s opinion and 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. A committee of delegates from all 27 EU member states makes the final approval decision.

In the EU, once regulators approve a novel food product, it can be sold across all 27 EU countries, plus Iceland, Liechtenstein, Norway, and Switzerland. (Switzerland acknowledges approvals under the EU’s novel foods process but has a separate framework for genetically modified foods.) 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. 

In 2023, the European Commission approved MycoTechnology’s novel food application for FermentIQ. In 2024, EFSA  issued a draft guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283. In the document, EFSA specifically laid the requirements for foods consisting of, isolated from, or produced from cell culture or tissue culture derived from animals.

As of April 2024, no cultivated meat company had yet formally applied for pre-market authorisation in the EU. The Swiss regulator has received one application for approval of cultivated meat products by Aleph Farms. Learn more about the latest on labelling of alternative proteins in the EU here.

Thailand

In 2016, Thailand published an informal notification and framework on novel foods. Thailand held its first cultivated meat regulatory roundtable coordinated by the National Center for Genetic Engineering and Biotechnology (BIOTEC) to support the Food and Drug Administration to develop a national regulatory framework for the sale of cultivated meat, targeted for 2024. Thailand is currently in the process of developing a regulatory framework for cultivated meat led by the National Center for Genetic Engineering and Biotechnology (BIOTEC). 

China

In December 2021, China’s Ministry of Agriculture and Rural Affairs included cultivated meat in its five-year plan, which provides a blueprint for strengthening innovation in “frontier and cross-disciplinary technologies” and clear guidelines for the development of the protein industry and related technologies. China has yet to announce how the country plans to regulate cultivated meat.  

In late 2022, government officials from the United States and China’s National Centre for Food Safety Assessment (CFSA) met to discuss cultivated meat regulation at a virtual event hosted by the AgFood Future Center of Excellence and the Agriculture Food Partnership. At this event, CFSA indicated that it would be actively promoting the safety assessment of cultivated meat. CFSA established a special group to focus on the regulatory framework for cultivated meat in China starting in 2023. 

Japan

Japan’s Ministry of Agriculture, Forestry, and Fisheries (MAFF) has declared alternative proteins an “important sector.” 

In theory, cultivated meat—depending on the production method—already falls within the existing regulatory regime in Japan and might not require a pre-market assessment or approval. However, the Japanese government is working to develop a specific regulatory framework for cultivated products to ensure food safety and increase consumer acceptance. Industry groups are being formed to create industry standards and liaise with the regulator to foster consumer confidence. 

In April 2020, MAFF launched the Food Tech Research Group, a public-private group comprising over 150 companies to support the food industry and strengthen Japan’s food security through technology.

The Japan Association for Cellular Agriculture (JACA), a collaboration between industry, government, and academia, was also launched to create rules specifically for cultivated meat, egg, and dairy products to smoothen their pathway to commercialisation in Japan. JACA has held regular meetings to discuss potential regulatory frameworks, and several international cultivated meat companies have joined the collaboration. The group is currently working towards formalised guidance for cultivated meat within the existing regulatory framework.

Additionally, in 2021, Japan prepared a QnA document regarding the labelling of plant-based foods allowing plant-based companies to use terms such as meat, milk, and eggs on their labels, provided that they use a modifier such as plant-based, dairy-free, or ingredient name (e.g., oat milk).

In June 2022, Japan’s Health, Labour, and Welfare Ministry mobilised a group of researchers to investigate the safety of cultivated meat as part of an effort to equip Japan’s Food Sanitation Law with clear rules for regulating the industry. This expert panel plans to release a cultivated meat food safety report aimed at reducing the risk of toxicity during cultivation and addressing the sector’s anticipated impact on public health based on present cultivated meat regulations abroad.

In 2023, the Prime Minister of Japan announced plans to develop a cultivated meat industry as an important part of reducing the country’s carbon footprint. The Asia-Pacific Society for Cellular Agriculture (APAC-SCA) and the Japan Association for Cellular Agriculture (JACA) signed an MOU to coordinate regional regulatory development.

Canada

The Food Directorate oversees the regulation of cultivated meat, which is considered a “novel food.” Producers must apply for premarket approval before selling their products. The approval process includes three parts: (i) a letter of no objection for human food use through the novel food assessment process, (ii) a premarket assessment for new animal feed (regardless of whether the product is intended for use as animal feed), and (iii) an environmental assessment.

Health Canada explicitly acknowledges Cellular Agriculture as an emerging technology and has laid the safety assessment procedure, statutory and regulatory requirements beyond novel food safety assessment, and the labelling of products containing ingredients produced by cellular agriculture methods. In 2022, Health Canada notified that it has no objection to Impossible Foods Inc. soy leghemoglobin (LegH).  In 2024, Remilk became the first company producing animal-identical protein to receive Health Canada’s No Objection Letter. In 2023, Nature’s Fynd’s Fy Protein had also received approval from Health Canada to commercialise its novel fermented fungi called Fy.

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.

Brazil

On December 18, 2023, the Brazilian Health Regulatory Agency (Anvisa) published the Resolution of the Board of Directors RDC 839/2023 which provides for safety proof and authorisation for the use of novel foods and ingredients. The main point of innovation in RDC 839/2023 for alternative proteins is the inclusion of foods obtained from precision fermentation and cell culture (cultivated meat) in the definition of Novel Foods. This article from Souto Correa gives a short overview of the new framework in English, and this article from Jota co-written by GFI Brazil provides the impacts of the RDC on alternative proteins (in Portuguese).

---

This information was last updated on June 1, 2024.

---

---