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 further advance the sector 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.
As of June 2022, Singapore is the first and only country to have approved cultivated meat for sale in the world. On December 1, 2020, SFA approved Eat Just Inc.’s cultivated chicken bites—making it the most advanced regulatory regime for cultivated meat at present.
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 and fermentation-enabled products. Since SFA’s first publication of its novel foods framework in 2019, it has edited or updated it three times—most recently in April 2022, to increase clarity on product tastings and sensory evaluations. SFA currently assesses applications on a case-by-case basis.
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.
Currently, SFA’s regulatory approvals are estimated to take between 9 – 12 months, if all information in the required safety dossiers has been fulfilled.
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.
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), a collaboration between industry, government, and academia was also launched to create rules specifically for cultivated meat, egg, and dairy products in order to smoothen their pathway to commercialisation in Japan. JACA is led by the Center for Rulemaking Strategy (CRS) at Tama University, a Japanese think tank that comprises some of the biggest food companies, startups, research institutions, and government agencies in Japan. CRS’s focus is to design rules—law, industrial standards, self-regulation guidelines, etc.—for emerging technologies. 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 formalised guidance for cultivated meat within the existing regulatory framework.
Additionally, on the labelling front, in late 2021, Japan released regulations 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 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. The group reportedly aims to finalise regulations in 2023 by leveraging a draft guideline that was written several years ago by the cellular agriculture community. As of July 2022, MFDS is awaiting comments on the draft guideline. The Ministry of Agriculture, Food, and Rural Affairs is also involved in this process.
Australia and New Zealand share a joint food regulatory framework and agency, Food Standards Australia New Zealand (FSANZ). FSANZ has yet to develop regulatory settings for cultivated products, as it intends to accumulate company applications under its pre-existing novel foods framework to assess the specific frameworks that need to be developed for cultivated products.
FSANZ develops food standards governing the composition, production, handling, promotion, sale, and transport of food. Under FSANZ’s “novel foods” regulation, cultivated meat and seafood manufacturers must apply for pre-market approval. This requires a safety assessment by FSANZ of the production process, likely lasting 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. Additionally, all foods in Australia and New Zealand are covered by the bi-national Food Standards Code, which details requirements for food safety, identification, labelling, handling, and treatment. Qualifiers on plant-based meat, and potentially cultivated meat in the future, are allowed under subsection 1.1.1-13(4) of the FSC. 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 Inquiry Committee’s final report recommends, among other things, that the Australian Government develop a mandatory regulatory framework for the labelling of plant-based protein products.
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 India, cultivated and fermentation-based protein products will be regulated under the Approval of Non-Specified Food and Food Ingredients Regulations in India. In September 2021, India’s food regulatory body, the Food Safety and Standards Authority of India (FSSAI), released a call for public comment regarding an amendment to the Non-Specified Food Regulations that would substantially modify the requirements for the application process for obtaining a pre-market approval of alternative proteins. These include, among other things, timelines for the application process, post-market surveillance on relevant safety parameters, and compulsory animal testing to support health benefit claims.
In December 2021, the FSSAI amended the Food Products Standards and Food Additives Regulations to define “analogues in the dairy context,” specifically stating that such analogues are not considered milk, milk products, or composite milk products. This amendment requires dairy analogues to declare their ingredients and for conventional dairy products to display a newly proposed dairy logo.
In 2016, Thailand published an informal notification and framework on novel foods.
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. The USDA will regulate 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.
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.” Additionally, FDA is in the process of creating guidance regarding pre-market consultation during the pre-harvest phases and separate guidance regarding labelling for cultivated seafood products. USDA is in the process of creating regulations on the labelling of cultivated terrestrial meats and catfish. The agencies have agreed to work together to develop harmonious labelling schemes. In the meantime, USDA has set forth an interim process for label pre-approval. Cultivated meat companies should engage with FDA’s Center for Food Safety and Applied Nutrition to discuss safety approvals for cultivated meat or seafood. Those seeking to sell their products before USDA finalises its regulations can also submit their labels to USDA for review and approval. (Learn more about the latest on labelling for alternative proteins in the US here.)
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 recognized as safe” (GRAS) under the conditions of intended use. A company may submit a notice to the FDA that its 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 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 FDA for approval. If the FDA approves the petition, it will add the ingredient to its food additive regulations.
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.)
Novel foods and ingredients are regulated by the novel foods framework by Israel’s National Food Service (NFS) under the Ministry of Health. NFS will consider 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.
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.
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.
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.
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 meat, but they have not yet produced formal guidance on safety regulations.
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