Novel Food Regulations Around the World

Regulatory approvals are an essential element for market access, but few standardised best practices or technical recommendations for consistent international regulation have been established, and current frameworks for alternative proteins lag behind consumer demand for novel foods like cultivated and plant-based meats and fermentation-enabled proteins. 

At GFI APAC, we firmly believe that a strong regulatory framework is critical to advance the sector further and maximise its potential to improve food security, mitigate environmental degradation, and alleviate global poverty. That’s why we work directly with regulators, policymakers, and other key stakeholders to increase clarity and transparency on novel foods regulations, and facilitate knowledge sharing between nations as they seek to build out forward-looking novel food frameworks. We have put together a summary of notable regulatory progress taking place in Asia and around the world. With a clearer picture of the current regulatory landscape for alternative proteins, industry players can better shape their strategies and plans, based on a deeper understanding of possible regulatory pathways to seek pre-market approval.

Singapore

Singapore was the first country on Earth to approve a cultivated meat product for sale. On December 1, 2020, the Singapore Food Agency (SFA) approved Eat Just Inc.’s cultivated chicken bites. 

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 and fermentation-enabled products. SFA first published its novel foods framework in 2019 and frequently updates it to increase clarity on product tastings and sensory evaluations. SFA currently assesses applications on a case-by-case basis. Regulatory approvals are estimated to take between 9 – 12 months, if all information in the required safety dossiers has been fulfilled. 

This milestone has since led to many subsequent market developments, including the world’s first regulatory approval of an industrial co-manufacturing platform to produce cultivated meat for commercial sale. 

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.

In October 2022, Singapore again made headlines by becoming the first country to grant approval for a gas-fermented microbe-based protein called Solein, created by Finnish startup Solar Foods. 

In 2023, Singapore became the first country in the world to give regulatory approval for serum-free media for cultivated meat, with GOOD Meat (Eat Just) receiving approval from SFA. In 2024, the Fatwa Committee of the Majlis Ugama Islam Singapura (MUIS), a statutory board of the Ministry of Culture, Community and Youth, announced that the consumption of cultivated meat is permissible as halal under certain conditions.

Read more: Singapore Food Agency’s Regulatory Leadership

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.  

On labelling, in June 2021, the Chinese Institute of Food Science and Technology implemented voluntary standards, “The Group Standard for Plant-Based Meat Products,” which provides definitions, categorisation, basic regulatory requirements, and labelling rules for plant-based foods. 

In 2022, China’s President Xi Jinping mentioned protein diversification at the Two Sessions to support national food security, and the nation’s first-ever five-year plan for the bioeconomy called for exploring alternative proteins as novel foods.

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.

India

In India, cultivated and fermentation-based protein products will be 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 manufacturing, producing, or importing a non-specified food (including novel) product. After seeking prior approval, the food business operator may apply for Central Licensing to get the product to the consumers. In 2022, the Food Safety and Standards Authority of India (FSSAI) modified the regulations to substantially update the requirements for the application process for obtaining a pre-market approval of alternative proteins.

In 2022, under its Approval for Non-Specified Food and Food Ingredients Regulations, the FSSAI granted prior approval (pre-market approval) to two alternative protein products: mycoprotein derived from Fusarium venenatum and Perfect Day’s non-animal derived whey protein, which utilises precision fermentation.  In 2023, the FSSAI also granted prior approval to Reliance’s algal protein powder that utilises biomass fermentation under the NSF Regulation.

The FSSAI does not permit the use of dairy terms for plant-based dairy products. In 2021, the Delhi High Court passed an injunction order in a pending set of writ petitions directing FSSAI to not take coercive steps against plant-based dairy companies that are using dairy terms to market their products. For more details, refer to GFI India’s State of the Industry Report on Smart Protein in India.

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 with the aim of ensuring food safety and increasing 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) was formed through a collaboration between industry, government, and academia, and launched to create rules specifically for cultivated meat, egg, and dairy products to smoothen their pathway to commercialisation in Japan. JACA became independent in December 2022 and is currently working towards formalised guidance for cultivated meat within the existing regulatory framework.

On labelling, Japan released regulations in late 2021 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 the 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. In 2023, 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.

South Korea

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. 

In 2024, The Ministry of Food and Drug Safety of Republic of Korea started to accept applications for regulatory approval of cultivated meat.

Thailand

In 2016, Thailand published an informal notification and framework on novel foods. 

In 2023,  the National Center for Genetic Engineering and Biotechnology (BIOTEC) coordinated Thailand’s first cultivated meat regulatory roundtable. BIOTEC is developing a national regulatory framework for the sale of cultivated meat, with implementation targeted for 2024. 

Australia-New Zealand

Australia and New Zealand share a joint food regulatory framework and agency, Food Standards Australia New Zealand (FSANZ). FSANZ regulates cultivated meat products under its pre-existing novel foods framework. Cultivated meat is regulated under Standards 1.1.1 and 1.5.1 in the Australia New Zealand Food Standards Code (the Code). Anyone wanting to sell a novel food or a food containing a novel food ingredient must apply to FSANZ for the Code to be amended to list the food or ingredient in the table at section S25 – 2. 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.

Under FSANZ’s novel foods regulations, a safety assessment of the production process will likely last at least 14 months. 

However, it should also be noted that 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 may also have a voice in cultivated meat and seafood approvals.

Labelling qualifiers on plant-based meat, and potentially cultivated meat in the future, are allowed under subsection 1.1.1-13(4) of the Code. In 2021, the Australian Parliament sought public comments on the “Definitions of Meat and Other Animal Products” to consider the topic of plant-based product labelling. The politicised Inquiry Committee’s final report recommended, among other things, that the Australian government develop a mandatory regulatory framework for the labelling of plant-based protein products, a recommendation not pursued by the new government following the election of 2022, and considered unnecessary by industry, which subsequently developed voluntary guidelines. In 2024, FSANZ assessed a cultivated quail submission by Australian startup Vow Foods as safe, inviting public submissions on the application. Full approval is anticipated in 2024.

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. 

On 17 January 2024, the MOH announced the world’s first regulatory approval of a cultivated beef product, produced by local company Aleph Farms. The regulatory approval grants permission to produce and market its product in Israel, subject to specific directions for labelling and marketing provided by the MOH, and the completion of a Good Manufacturing Practices inspection for its pilot production facility.

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.

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. As of April 2022, no cultivated meat company had yet formally applied for pre-market authorisation in the EU. (Learn more about the latest on labelling on alternative proteins in the EU here.)

United Kingdom

Following its exit from the EU, the UK no longer participates in the EU’s common food authorisation procedures. Rather, the UK Food Standards Agency (FSA) will regulate cultivated meat. The UK adopts the same approach as the EU with respect to risk assessments and authorisations for novel foods and genetically modified foods. The UK has indicated it may create a distinct regulatory framework for cultivated meat.

The most substantial difference between the UK and EU regulatory approval is the final approval decision. UK government ministers, not the European Commission and representatives from all 27 EU member states, decide on the final approval in the UK.

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 will oversee cell collection and banking and all cultivation inputs and processes up through the moment of biomass “harvest” of the cultivated product from the bioreactors for all cultivated food products. During the harvest process, FDA helps to coordinate the transfer of regulatory oversight to USDA to regulate processing as well as packaging and labelling for livestock meats, poultry, and catfish, while the FDA will have jurisdiction over all other seafood products and game meat during the processing, packaging, and labelling stages.

In early 2023, GOOD Meat became the second company after UPSIDE Foods to complete the FDA pre-market consultation process. In June 2023, both UPSIDE Foods and GOOD Meat obtained landmark grants of inspection and label approvals from the USDA. Having completed both FDA and USDA regulatory approval processes, the companies lawfully are permitted to sell their cultivated chicken products in the United States, marking a decisive moment in the history of food and agriculture.

FDA is in the process of creating guidance for the industry regarding the pre-market consultation process, and separate guidance regarding labelling for cultivated seafood products. For the pre-market consultations that have been completed so far, the FDA has published the nonproprietary portions of the companies’ submissions as well as an FDA-authored scientific memorandum explaining how it evaluated the submissions. Cultivated meat and seafood companies should engage with FDA’s Center for Food Safety and Applied Nutrition to discuss what information they will need to provide the FDA to demonstrate the safety of their products. USDA is also in the process of creating regulations on the processing and labelling of cultivated livestock meats, poultry, and catfish. The agencies have agreed to work together to develop harmonious labelling schemes. In the meantime, USDA has set forth an interim process to pre-approve cultivated meat labels. Those seeking to sell their products before USDA finalises its regulations can submit their labels to USDA for review and approval on a case-by-case basis. (Learn more about the latest on labelling for alternative proteins in the US here.) 

Neither FDA nor USDA has published labelling requirements for cultivated meat or seafood products, but both agencies have solicited public comments on labelling and nomenclature. 

Fermentation-enabled ingredients are regulated under the US 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. The GRAS pathway is used for ingredients that a company or food producer believes are already generally recognised as safe among qualified experts under their conditions of intended use. A company may submit a notice to the FDA that it has self-affirmed an ingredient is GRAS. FDA can respond in one of two ways: it may inform the company that there is not enough information available to determine that the ingredient is GRAS, or it may issue a “no questions letter.” Such a letter is not an explicit approval of the product but indicates that the FDA does not question the company’s conclusion that its ingredient is GRAS. 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.

Canada

The Food Directorate oversees the regulation of cultivated meat, which is considered a “novel food.” Producers must apply for pre-market 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 pre-market assessment for new animal feed (regardless of whether the product is intended for use as animal feed), and (iii) an environmental assessment.

On labelling, in December 2020, the Canadian Food Inspection Agency government sought public input on plant-based meat labelling in Canada. The Final Guidelines require plant-based meat product labels to use the phrase “simulated” followed by the meat or poultry type and the phrase “contains no meat” or “contains no poultry” in close proximity to the common name, using a similar text size or having the same prominence. Additional guidelines include nutrition labelling requirements for specifying added vitamins and minerals. For traditional plant proteins like tofu and black bean burgers (i.e., products that replace the occasion but not the experience of meat), a “contains no meat” declaration is optional, but the label must still “truthfully and accurately” describe the product.

Cultivated meat produced using genetic engineering 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.” For cultivated meat produced using genetic engineering techniques, certain additional information may be required in the novel food application.

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

The Brazilian Health Regulatory Agency (ANVISA) oversees food regulation and labelling. Brazil’s food safety authorities have taken steps to begin analysing their alternative protein regulatory landscape, including food safety and labelling of cultivated meats. In 2023, Brazilian regulatory bodies opened the main frameworks for public consultation, signalling a major step toward formal adoption and implementation. On 18 December 2023, ANVISA published the Resolution of the Board of Directors (RDC 839/2023), providing safety proof and authorisation for using 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. The article from Souto Correa gives a short overview of the new framework in English, and this article from Jota and co-written by GFI Brazil, provides for the impacts of the RDC for alternative proteins (in Portuguese).

Get in touch

GFI APAC’s expert-led team works with startups to provide clarity on existing regulatory frameworks and also works with regulators and policymakers to help refine their own national standards. Interested parties are encouraged to contact us to initiate those discussions so that we can support your ambitions.