Ensuring a path to market

Ensuring a path to market

The Good Food Institute Israel’s policy team works to advance clear regulatory frameworks for the approval of safe and healthy alternative protein products.

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Why is evidence-based regulation important for alternative proteins?

Credit: Kinoko-Tech

For alternative meat, seafood, eggs, and dairy to fulfill their potential to create a more sustainable, secure, and just food system, consumers need to be confident in them.

Producers who want to market cultivated meat and seafood and certain plant-based and fermented foods must first apply to regulatory authorities for product approval.

Most alternative proteins require pre-market approval with specific regulatory frameworks for novel foods and—in some cases—genetically modified foods.

Novel food regulations around the world

USA

Regulatory authority of cultivated products is shared between the Food and Drug Administration (FDA) and the Department of Agriculture (USDA), based on a formal agreement between the agencies. 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 labeling for land-based meats and catfish, while FDA will have jurisdiction over all other seafood products during the processing, packaging, and labeling stages.

The FDA is in the process of creating guidance regarding pre-market consultation during the pre-harvest phases and separate guidance regarding labeling for cultivated seafood products. The USDA is in the process of creating regulations on the labeling of cultivated terrestrial meats and catfish. The agencies have agreed to collaborate to develop harmonious labeling schemes. In the meantime, the USDA has an interim process for label pre-approval. 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. Those seeking to sell their products before the USDA finalizes their regulations can also submit their labels to the USDA for review and approval. Learn more about the latest on labeling for alternative proteins in the United States here.

Fermentation-enabled ingredients are regulated under the U.S. regulatory framework for ingredients and food additives. New ingredients and additives must be approved by FDA unless they are “generally recognized as safe” (GRAS) under the conditions of intended use. Once a company submits an ingredient GRAS notice to FDA, the agency can respond in one of two ways: it may inform the company that there is not enough information to determine that the ingredient is GRAS; or it may issue a “no questions letter.” While this letter is not an explicit approval of the product, it 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 and if it is approved, FDA will add the ingredient to its food additive regulations.

Credit: Wild Type

EUROPEAN UNION

In the European Union (EU), the Novel Foods Regulation (Regulation (EU) No 2015/2283) governs pre-market authorizations 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 must 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.

EFSA has published scientific guidance for preparing a novel food 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., labeling requirements and monitoring 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 it is expected to be at least 18 months and potentially up to three years. As of April 2022, no cultivated meat company had formally applied for pre-market authorization in the EU. (Learn more about the latest on labeling on alternative proteins in the EU here.)

SINGAPORE

In June 2022, Singapore was the first country in the world to have approved cultivated meat for sale. On December 1, 2020, the Singapore Food Agency (SFA) approved Eat Just Inc.’s cultivated chicken bites—making it the most advanced regulatory regime for cultivated meat.

The SFA has published guidance on its requirements for the safety assessment of novel foods, including 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 been edited or updated three times—most recently in April 2022—to clarify product tastings and sensory evaluations. SFA currently assesses applications on a case-by-case basis. Currently, SFA’s regulatory approvals are estimated to take between 9 and 12 months if all information in the required safety dossiers has been fulfilled.

On labeling, 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.

Read more: Singapore Food Agency’s Regulatory Leadership

Credit: Shiok Meats

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 creating industry standards and liaising with the regulator to foster consumer confidence.

Additionally, on the labeling front, in late 2021, Japan released regulations allowing plant-based companies to use terms such as meat, milk, and eggs on their labels, provided they use a modifier such as plant-based, dairy-free, or the ingredient name (e.g., oat milk).

UNITED KINGDOM

Following its exit from the EU, the UK no longer participates in the EU’s common food authorization procedures. Rather, the UK Food Standards Agency will regulate cultivated meat. The UK has indicated its will to create a distinct regulatory framework for cultivated meat.

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.

In December 2020, the Canadian Food Inspection Agency sought public input on plant-based meat labeling 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 labeling 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,” which is 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.


How are alternative proteins regulated in Israel, and how does GFI Israel support their advancement?

Some new foods in the alternative protein space, such as cultivated meat and precision fermentation dairy, must be authorized by regulators before they can be sold in Israel. The authorization process, under the responsibility of the National Food Service, includes a thorough and evidence-based assessment of the product’s safety and nutritional value and is estimated to take around 12 months.

To advance regulatory guidance and processes, in 2021, the National Food Service collaborated with the Israeli Innovation Authority on a two-year pilot program. In this program, four companies from various technologies were closely accompanied by representatives from the Food Service and IIA’s technological staff. The pilot served as a mutual education to aid the Food Service in better comprehending the processes and products associated with these technologies and adapting its guidelines accordingly. Simultaneously, the companies benefited from a clearer understanding of the Food Service’s approval requirements.

The pilot resulted in the publication of more robust and accurate guidelines for approving alternative proteins, with a commitment to publishing comprehensive approval guidelines in 2024. In addition, in April 2023, the Israeli Ministry of Health gave its first-ever regulatory approval for a precision-fermentation product made by Remilk to create dairy milk without the cow. In January 2024, Aleph Farms received regulatory approval in Israel for its beef cuts, making it the first regulatory approval for a cultivated product in Israel and the first in the world to approve cultivated beef.

Credit: Aleph Farms

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