Fourteen per cent of the world’s greenhouse emissions is estimated to come from raising livestock, and ethical concerns are rife at different stages of livestock production (eg. live animal exports, slaughter practices, the use of hormones). Health implications are also involved in the consumption of animals, from the novel coronavirus through to non-infectious diseases caused by over-consumption of saturated animal fat. Breakthrough research in alternatives to farmed meat has seen several start-up tech companies promising to bring alternatives to market as early as 2022. Alternatives to farmed meat may be an important lever to encourage people to eat less meat but there is an equal if not more pressing need for regulators outline a clear framework for such alternatives. This howtoregulate article examines the existing regulatory environment for alternatives to farmed meat and suggest regulatory techniques that aim to encourage safer and faster take-up in the market.
A. Questions of substance for regulating alternatives to farmed meat
I. Defining meat
1. Meat is defined in most national food regulatory frameworks, however, alternatives to farmed meat challenge these traditional definitions despite theoretically being “biologically equivalent” products to the livestock versions. Alternatives to farmed meat go by many names such as clean meat, cultured meat or cultivated meat. Such alternatives can be animal-based or plant-based. Plant-based alternatives to meat are already on the market (eg. BeyondMeat). This howtoregulate article focusses on animal-based alternatives which have not yet been approved under any national food regulation. The earliest claims we have seen is from Israeli start-up, Future Meat Technologies, claiming to have meat on the market by 2022.
2. Animal-based alternatives to farmed meat are produced using cellular agriculture which “encompasses a set of technologies to manufacture products typically obtained from livestock farming, using culturing techniques to manufacture the individual product”. Although cellular agriculture is yet to enjoy a universally-agreed definition or a definition of all the products that fall under it, there is some agreement that it can be divided into two types: “tissue engineering-based” and “fermentation-based cellular agriculture”, grouped by the production method used. For the purposes of this howtoregulate article we focus on tissue-engineered meat and use the general term of “cultured meat”.
3. Cultured meat is an in-vitro culture of animal cells (collected from the animal via a small biopsy under anaesthesia) through tissue engineering, it does not require animal slaughter. Through tissue engineering, “biological equivalence” is produced by “targeting molecularly and genetically identical material that delivers viscerally equivalent eating or usage experiences”1. In-vitro culture of animal cells are grown in a controlled laboratory environment to mimic specific cuts or parts of meat that would be traditionally sold in the market. Tissue engineering does not involve genetic modification but genetically modified foods are regulated separately under most national food regulation and has more requirements to satisfy before it is assessed as safe.
4. Regulatory definitions are closely followed by industry groups because such definitions can include or exclude products which affect the economic interests of food producers. By analysing the existing definitions of meat in various jurisdictions, we see that the current definitions for meat and the technical definitions for cultured meat do not align. This may present an unfair barrier for cultured meat to be regulated and promoted in different markets, particularly given its health and climate benefits. An example where meat definitions were debated was the EU proposal to ban the veggie burger (the ban did not pass) on the grounds that a plant-based protein may not use meat-related terms such as “burger”. This example highlights the importance of clarity of definition and the need for a modern definition or interpretative approach.
5. Currently, the United States Department of Agriculture (USDA) defines meat as “any carcass, part thereof, meat or meat food product under one or more of the following circumstances.” Similarly, the European Union (EU) regulations define meat as “the edible parts of animals,.. including blood” of domestic and game animals, while meat products are defined as “processed products resulting from the processing of meat or from the further processing of such processed products,” such that “the product no longer has the characteristics of fresh meat.”
6. Similarly, the term ‘meat product,’ which encompasses a larger range of meat-based products is defined by the USDA as “product[s] capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats.” However, this definition excludes “products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry.”
7. In the EU, cultured meat would be regulated by the Novel Food Regulation (EU Regulation No 2015/2283) because “food consisting of, isolated from, or produced from a cell culture or tissue culture from animals, plants, micro-organisms, fungi or algae is considered one of the novel food categories listed in the regulation.”2 Leaving the question of labelling cultured meat as “meat” to the side (see above EU ban the veggie burger example) the EU Novel Food Regulation provides that “where a novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally less advantageous for the consumer”. This definition focusses on the nutritional value, which is arguably advantageous to cultured meat because it is less fatty.
(a) Would cultured meat be considered meat under the current definitions?
8. Examining the definitions of meat outlined above, it would be fair to claim that cultured meat is not meat, as it is not an ‘edible part’ of an animal given the tissue engineering that is involved in its production. Biologically, however, if a muscle is regenerated in a laboratory environment through cell proliferation, is it not still a muscle? This poses larger questions of the fate and identity of an extracted cell that is then grown in a lab and may rely heavily on the consensus in the scientific community.
(b) Would cultured meat be considered a meat product under the current definitions?
9. As a meat product is generally considered food that is made in part by a form of meat, it is possible that cultured meat will fit more closely with the definition of a meat product. That being said, cultured meat will generally only require the extraction of specific cells from a living animal, which means that it does not align with the meat product definition that dictates and implies that a significant proportion of the meat product is to come from a carcass and in a significant proportion of the final product.
10. This quick examination of cultured meat in the context of existing definitions of meat or meat products highlights the issue with potentially outdated definitions. It seems that a logical next step would be to consider alternative methods for defining meat, as the continuing research and development of alternative meats is challenging the boundaries and traditional conceptions of meat in general. Noting that definitions are a starting point for all regulation, regulators may need to consider separate categories for novel tissue engineered foods, or at the extreme, redefine and spearhead a paradigm shift in how meat is defined.
II. Reflecting safety and ethical concerns in food regulation
11. Conventional meat is regulated at almost all levels of production:
- Land clearing for livestock farming is regulated by both environmental legislation and land laws that regulate activities that are permitted on different types of land.
- Livestock farming is regulated by many laws related to safety of feed given to livestock, animal health, animal anti-cruelty, hormones.
- Livestock transport is regulated for anti-cruelty, animal safety.
- Livestock slaughter is regulated for animal and human safety, human and animal hygiene, animal anti-cruelty, various religious credentials, credentials of employees.
- Meat processing, production, packaging, labelling, cold transport, cold storage, handling at points of sale are all subject to regulation.
12. If we take a look at cultured meat, many steps of the production would follow the same regulatory course as farmed meat:
- Extent to which land use is required for the small number of livestock required to collect cells from, comply with existing regulation.
- The farming methods used to raise such livestock would comply with the same regulations as other conventional meat livestock.
- Veterinarian conditions for the anaesthesia and biopsy of collected cells, comply with existing regulation although a verification system would need to be established to ensure that the animals are treated well. For example this would be critical where cultured meat claim that no animal was harmed in the production of the meat.
- The safety and quality conditions of the in-vitro growing process would require regulating, to ensure safety, quality and consistency.
- The processing, production, packaging, labelling, cold transport, cold storage, handling at points of sale of cultured meat would be similar to the regulation of traditional meat.
13. Through a negative lens, alternative proteins can often be seen as “fake meat,” with unknown health implications due to the rapidly increasing technology and the negative associations made with genetic and tissue engineering when it comes to cultivated meat in particular. Similar to the fear of genetically modified organisms (GMO) and its health effects for consumption, the aspect of genetic engineering in cultured meat, or plant-based alternative proteins has caused concerns for the average consumer. It can be noted that there are current measures in place when other new food technologies are introduced to the market. For instance, both the US Food and Drug Authority (FDA) and the UK Food Standards Agency (FSA) both consider a number of criteria before a novel nutritional substance or food ingredient is considered Generally Recognised as Safe (GRAS), before they can be used in the manufacture of consumed substances.
14. Similarly, in the United States Code under Agriculture (Title 7), there is a provision that has proactively funded and supported research to identify and monitor the potential, mainly environmental, risks of biotechnology and genetically engineered animals, plants, and other organisms into an environment before they were introduced. That said, it is important to acknowledge the time lag associated with preemptive research and risk assessments that may not be able to match the growing research and development of alternative proteins or even appease the current concerns regarding these products.
15. Another barrier to the widespread acceptance of cultured meat is the ethical implications of genetically engineered plants and animals. The ethical implications of producing meat from a cell source of animals have raised concerns on the animals’ rights, as the cell harvesting procedures can be invasive, and the nonconsensual extraction and widespread use of these animal cells has been ethically problematic for animal rights groups. Additionally, the introduction and potential of in vivo meat production has been seen as alarming to some who see the development of the technology to be open to all types of animals, such as endangered species, extinct animals, and even humans.3 In the alternative, when comparing the fate of an animal raised in mass production farming with that of an animal under anaesthesia for a biopsy to collect cells, one could argue that the latter may have a better quality of life.
16. Cultured meat promises huge benefits for the environment because take-up at scale could see the slow-down of deforestation for livestock farming, reduction in methane gas production as demand for livestock reduces and more smaller-scale farming with improved quality of life conditions of the animals. Consumer safety is always the key focus of food regulation but to what extent, assuming safety proven, should food regulation consider ethical concerns of animal health and environmental benefits to encourage such food producers.
17. Labelling of cultured meat would have a profound impact on the take-up of the products in the market. The labelling of plant-based meat is already a contentious issue between farmed meat producers and alternative meat producers and so regulators will need to steer a course based on fairness and science.
18. On the one hand cultured meat is biologically equivalent to livestock meat, the difference being the muscle for steak is grown and matured on the animal whereas in cultured meat the muscle is grown outside of the animal. Arguably, a cut of steak grown outside of the animal that is biologically equivalent to a cut of steak from a farmed animal should be equally labelled as such. Much of this will turn on the importance of what is understood by biological equivalent.
19. Another aspect to labelling is that cultured meat can be engineered to have less fat than its livestock equivalent and as such consideration needs to be given as to how to approach labelling. Furthermore, additives can be introduced to the cultured meat to make it more nutritionally healthy, which could make the cultured meat less biologically equivalent if that were the regulatory basis on which a meat definition was based.
B. International food frameworks and standard setting bodies
I. Codex Alimentarius (“International Food Code”)
1. The Codex Alimentarius (Codex) is a collection of standards, guidelines and codes of practice adopted by the Codex Alimentarius Food Commission, to harmonise international food standards. The Commission is a joint intergovernmental body of the Food and Agriculture Organisation of the United Nations (FAO) and the World Health Organisation (WHO) with 188 Member Countries and one Member Organisation (EU). Codex standards ensure that food is safe and can be traded. The 188 Codex members have negotiated science based recommendations in all areas related to food safety and quality. Codex standards and related texts are voluntary in nature and need to be transposed into national legislation or regulations in order to be enforceable. The reference made to Codex food safety standards in the World Trade Organisation’s Agreement on Sanitary and Phytosanitary Measures highlights the authority of Codex, its broad appeal and adoption.
2. Codex standards cover the following themes:
- Novel coronavirus (COVID-19)
- Animal feed
- Antimicrobial resistance
- Nutritional and labelling
- Pesticides, including maximum residue limits of a pesticide residue that is legally tolerated in or on food or feed when pesticides are applied correctly in accordance with Good Agricultural Practice.
3. Cultured meat is likely to fall under the theme of biotechnology and the role of these body of standards is to outline the risk assessment aspect of food safety. Risk assessment includes a safety assessment, which is designed to identify whether a hazard, nutritional or other safety concern is present, and if present, to gather information on its nature and severity. The safety assessment should include a comparison between the food derived from modern biotechnology and its conventional counterpart focusing on determination of similarities and differences. Codex has developed texts relevant to labelling of foods derived from modern biotechnology. The following six standards are covered under biotechnology:
- Principles for the Risk Analysis of Foods Derived from Modern Biotechnology.
- Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants.
- Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombiant-DNA Microorganisms.
- Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals.
- Guidelines on Performance Criteria and Validation of Methods for Detection, Identification and Quantification of Specific DNA Sequences and Specific Proteins in Foods.
- Compilation of Codex texts relevant to the labelling of foods derived from modern biotechnology.4
II. World Trade Organisation (WTO)
4. The WTO’s Agreement on the Application of Sanitary and Phytosanitary Measures (the “SPS Agreement”) entered into force with the establishment of the WTO on 1 January 1995. It concerns the application of food safety and animal and plant health regulations. The SPS Agreement recommends that member states follow international guidelines and standards where they exist and also allows member countries to set their own guidelines and regulations, so long as they are based on scientific evidence and are able to raise the health and hygiene standards above the international standards. The international standards that are referred to in the agreement are divided up in to different sources of dispute: food safety standards set by Codex, animal health by OIE (World Organisation for Animal Health), and plant health by IPPC (International Plant Protection Convention, under the UN Food and Agriculture Organisation).
C. Pre-market (ex-ante)
1. Food regulation always involves strict controls at the pre-market stage to ensure that food is safe for consumers. In regulating meat several regulatory bodies are involved such as the traditional food body, health (both human and animal) and agriculture (animal livestock). Where novel foods are concerned, particularly in jurisdictions that do not have a mature novel foods regulatory pathway, it can be confusing for food business operators to know where to submit their product applications and who conducts the verification for various stages of their food production. Verification is an important pre-market regulatory tool and jurisdictions must be clear about what needs to be verified. The two approaches for verifying conformity is to verify the result, that is the final product, or verify the production, both the actual production process and its quality. Where food is concerned it is common that both the final product and the actual production process and its quality is verified for conformity.
I. Designating the correct regulatory authority
2. In some jurisdictions there may be overlap in the regulatory responsibilities of different bodies and where novel foods such as cultured meat are concerned this is the case in some jurisdictions. In the United States, for instance, the USDA and FDA came to a joint agreement in 2019 to collaboratively undertake the regulation of cultured meats. Given the specific role of each body in regulating and inspecting food and agricultural products, the USDA and FDA have taken joint and compartmentalised responsibilities in the regulation of cultured meats, as seen in Table 1.
Table 1. USDA, FDA, and Joint Responsibilities in the oversight of cultured meat. FSIS (Food Safety and Inspection Service)
|Oversee establishments for cell harvest from livestock or poultry, and the appropriate labels and USDA marks of inspection, particularly in accordance with FSIS regulations and HACCP verification
Oversee product testing and review to ensure products are unadulterated and properly labeled
Ensuring that the food products derived from cultured cells are pre-approved and verified through inspection
Developing additional requirements necessary to ensure the safety and accuracy of labelling cell culture-based food products
Conducting necessary enforcements to ensure that misbranded, mislabeled, or adulterated products do not enter the market, or removed from the market upon confirmation.
At harvest of cells from live animals, help coordinate the transfer of regulatory oversight from each body, with a focus on eligibility of harvested cells to be processed into meat or poultry products
Share information with each body, and notify each body if “objectionable conditions are identified” that may lead to the production of adulterated products
Work collaboratively with each body to address conditions for harvesting of cells as well as post-harvesting activities.
|Evaluate production materials and processes, including the oversight of tissue collection, cell lines, cell banks, and other components of cell proliferation
Oversee initial cell collection and the development and maintenance of qualified cell banks for food production purposes
Oversee proliferation and differentiation of cells
Ensure production complies with the current Good Manufacturing Practices and preventative regulations
Develop additional requirements necessary for cell bank and cell culturing facilities to ensure the cell culture process is safe and produces unadulterated products
Conducting inspections or follow up activities, including enforcement actions if necessary that cell bank and cell culture facilities are in compliance with regulations
Adapted and summarised from US FDA.
II. Verification Processes
(a) Pre-market authorisation
3. The EU requires a verification process for cultured meat food producers to verify the safety of their product before it is introduced to the market. Additionally, like all novel food products, cultured meat is subject to a pre-market authorisation, including a safety assessment conducted by the European Food Safety Authority (EFSA).5
4. “Food business operators” are required to pass a specific authorisation process (Novel Food Regulation 2015/2283). Food business operators submit an online application including scientific evidence that demonstrates that the products do not pose a safety risk to human health and a proposal for the conditions for specific labelling requirements of the specific product (Articles 4 and 7 of Novel Food Regulation). Article 10(2) lists the particulars the application must include:
- the name and address of the applicant;
- the name and description of the novel food;
- the description of the production process(es);
- the detailed composition of the novel food;
- scientific evidence demonstrating that the novel food does not pose a safety risk to human health;
- where appropriate, the analysis method(s); and
- a proposal for the conditions of intended use and for specific labelling requirements which do not mislead the consumer or a verifiable justification why those elements are not necessary.
The product may be subject to a safety assessment by EFSA to determine the effects on human health (Paragraph 23 and Article 11 of Novel Food Regulation).
5. Of all the jurisdictions researched for this howtoregulate article, Singapore has provided the most detailed Guidance on Safety Assessment of Novel Foods that the competent authority, Singapore Food Agency (SFA), will consider in approving novel food applications. It specified that for cultured meat in particular it:
“(c) For cultured meat
11. Cultured meat refers to meat developed from animal cell culture. The process to produce cultured meat involves growing the selected cell lines (or stem cells) in a bioreactor. The cells are grown in a suitable growth media, and subsequently onto a “scaffold” to produce products resembling meat muscle.
12. SFA notes that the science for producing cultured meat is still at an early stage. SFA currently requires the following information to be submitted for the safety assessment of cultured meat. Information required may change based on the developments on the science of producing cultured meat.
(i) A description of the overall manufacturing process.
(ii) Characterisation of the cultured meat product, including nutritional composition, and comparison of residual growth factors against levels in published literature.
(iii) Information related to the cell lines used, including: a. Identity and source of cell lines. b. Description of methods used for selection and screening of cells. c. Information on how the cell lines are prepared and banked following their extraction from animals. d. Description of the modifications and adaptions made to the cell lines, and how these relate to the expression of substances that may result in food safety risk.
(iv)Information related to the culture media used, including: a. Composition of media, including identities and purity of all added substances. Companies should indicate whether the purity of individual substances used in culture media comply with specifications recommended by the Joint FAO/WHO Expert Committee on Food Additives (JECFA, British Pharmacopoeia, European Pharmacopoeia or Food Chemical Codex). b. Clarification on whether the culture media remains in the finished cultured meat product, or is removed completely. Where culture media is removed completely, companies should provide information demonstrating removal.
(v) Information related to the scaffolding materials, if used, including: a. Identities and purity of scaffolding materials used.
(vi)Information on how your company ensures the purity and genetic stability of cell culture during the manufacturing process. a. Where genetic differences between starter cell lines and finished cultured meat are observed, companies should investigate the differences to determine whether these would result in food safety risks (e.g. upregulation of metabolite production).
(vii) Safety assessment covering possible hazards arising from the manufacturing of the cultured meat.
(viii) Other relevant studies to support safety such as digestibility assays, allergen profiling, genetic sequencing, etc.
(vii) Safety assessment covering possible hazards arising from the manufacturing of the cultured meat.
(viii) Other relevant studies to support safety such as digestibility assays, allergen profiling, genetic sequencing, etc.”6
The Guidance also states that it will consider any safety assessment reports conducted by food safety authorities in major developed countries (Australia, Canada, New Zealand, Japan, the EU and the US)7.
6. Israel also has a pre-market authorisation process outlined in its novel food regulation framework [Article 18 Public Health (Food) Protection Law 2015 (Hebrew)]. In this process, novel foods are identified by three different categories:
- Food in which the molecular primary structure has been modified or originating from a Genetically Modified Organism (GMO),
- Food which contains isolates from plants, animals, microorganisms, fungi or algae that have not been traditionally consumed or considered safe to consume in Israel (and does not appear on the list of edible plants, fungi and algae),
- Foods that have undergone a change in nutritive value.
The safety assessment required is modelled on the EU assessment, and Israel’s regulation accepts the assessments of the safety bodies of the EU, US, Canada, Japan and the Australian and New Zealand body. In order for any of these novel foods to be approved to enter the market, the manufacturer must submit an online application, which is then subject to approval by the National Food Service and Ministry of Health. The administrative procedures to register a new food are here (in Hebrew).
7. The joint competent regulatory authority in Australia and New Zealand, Food Standards Australia and New Zealand (FSANZ) has stated that its regulation the Food Standards Code is equipped to deal with foods produced by new technologies such as cultured meat. Like the EU and Israel, cultured meat must comply with the standards in the Code and require pre-market approval under the novel food regulation (Standard 1.5.1). Section 1.5.1—2 of Definitions, Subsection 1 provides that novel foods such as cultured meat require assessment of the public health and safety consideration, including:
- the potential for adverse effects in humans; or
- the composition or structure of the food; or
- the process by which the food has been prepared; or
- the source from which it is derived; or
- patterns and levels of consumption of the food; or
- any other relevant matters.
As cultured meat can be produced using a variety of techniques, FSANZ has stated that depending on the composition, cultured meats need to comply with the following standards:
- Novel foods – foods without a history of traditional human consumption in Australia and New Zealand (as above);
- Processing aids – substances used to produce foods but which serve no technological function in the final food for sale;
- Food additives – substances that serve a technological function in the final food for sale;
- Foods produced using gene technology;
- Vitamins and minerals;
- Labelling that indicates the true nature of the food;
- Definition of cell based meat; and
- Food Safety requirements.
(b) Tissue collection and cell culture
8. The US FDA has not yet outlined detailed requirements for tissue collection and cell culture but it has stated that “products derived from cultured animal cells will involve a thorough pre-market consultation process and inspections of records and facilities…[and compliance with] facility registration and FDA’s Current Good Manufacturing Practices and preventive control requirement”8. Key elements of the Good Manufacturing Practices includes:
Hazard analysis: all the known or reasonably expected biological, chemical, and physical hazards, intentional or unintentional, are identified, and if hazards are found the facility must have preventative controls for said hazards.
Preventative Controls: facilities must have a written preventative control method that is implemented to ensure that the food is unadulterated through the various hazards identified. This involves process, food allergen, sanitation controls among other hazard controls.
Oversight and Management of Preventative Controls: facility must have a way to provide oversight and monitor that the preventative controls are being met.
Supply Chain Program: manufacturers must have a risk-based supply chain program for any product for which a hazard is identified and requires preventative control
Recall Plan: in the instance that a hazard is identified in a product, the facility must have a plan to perform a recall of the product, involving a notification plan for the public and stakeholders.
9. The US FDA states that pre-market consultation process includes evaluating the production process and produced biological material, including tissue collection, cell lines and cell banks, manufacturing controls, and all components and inputs. Although it has yet to outline specific requirements for tissue collection and cell culture it advocates for a consultative process and encourages early engagement via email:
The FDA encourages firms working on the culture of animal cells for food use to contact the agency early in the development phase to begin discussions. The FDA believes that both the agency and individual firms will benefit from ongoing discussions as the firms make technical and strategic decisions and as the agency begins to implement the consultation process.
After a successful pre-market safety consultation, the FDA intends to conduct routine inspections on an ongoing basis, as well as other oversight activities at cell banks and facilities where cells are cultured, differentiated, and harvested.
10. In conducting inspections and other oversight activities, the FDA will use the results of the pre-market consultation and a thorough assessment of production records maintained by the facility. Should FDA inspections uncover areas of noncompliance, the agency will take appropriate action. The FDA also will ensure that labelling of cell cultured products derived from animal species not subject to USDA jurisdiction is truthful and not misleading, consistent with coordinated FDA and USDA-FSIS principles for product labelling and claims.
11. During the cell harvesting stage, when cells are removed from a sealed growth environment and prepared for traditional food processing, the FDA and USDA-FSIS will work together to coordinate the transfer of regulatory oversight to USDA-FSIS. USDA-FSIS will carry out inspections at establishments where cells derived from livestock and poultry are harvested. These establishments will be required to have USDA grants of inspection and meet the USDA-FSIS regulatory requirements, including:
- File an Application for Inspection (Form for Meat, Poultry, Egg Products and Import Inspections and a Form for Registration of Meat Handlers)
- Facilities must meet Regulatory Performance Standards
- Establishment Sanitation
- Hazard Analysis and Critical Control Points systems (HACCP Principles).
12. USDA-FSIS inspectors will review batch records produced during cell culturing and verify compliance with applicable USDA-FSIS regulatory requirements (Federal Meat Inspection Act) during product processing, packaging, and labelling to verify the cellular products are safe, wholesome, unadulterated, and truthfully labeled. If cells are shipped to other establishments for further processing into human food products, these establishments also will be subject to USDA-FSIS inspection.
13. USDA-FSIS inspection of cell harvest and processing will occur at a frequency of at least once per shift (which is the same frequency for processing traditional meat and poultry products). Once verification is complete the products receive the USDA mark of inspection. Finally, the USDA-FSIS will ensure that cell-based products are labeled truthfully and consistent with coordinated FDA and USDA-FSIS principles for product labelling and claims. Under the requirements of the Federal Meat Inspection Act and Poultry Products Inspection Act, all labelling of human food products made from the cultured cells of livestock or poultry must by pre-approved by FSIS.
III. Recognition of foreign certificates and authorisations
14. The Handbook: How to regulate? has a useful summary on recognition of foreign certificates and authorisations, the first two paragraphs of which has been reproduced below for ease of reading.
15. The recognition of foreign certificates and approvals can be decided unilaterally or in conjunction with the state whose certificates or approvals shall be recognised. To reduce unnecessary burden for the exporting industry, it can be useful to negotiate with trade partners bilaterally on the recognition of certificates and approvals. The negotiations can lead to formal or informal bilateral agreements.
16. As formal bilateral agreements tie up a lot of resources and are not easy to manage, an empowerment for the relevant public authority to decide upon the recognition of foreign certificates by regulatory acts. The empowerment should not be limited to the case of mutual recognition. According to theories of free trade, it is advantageous in all cases to recognise foreign certificates and approvals provided that these fulfil the same requirements and are based on an equal or higher level of stringency as the domestic certificates and approvals. Furthermore, if the domestic industry exports more to the third country than vice versa, the domestic industry will profit more from the recognition of the foreign certificates than the industry of the third country. It can substantially reduce costs by applying only for the certificate or the approval of the third country. The only necessary condition is that the certificate or the approval must be based on an assessment that is at least of an equivalent level of stringency as requested by domestic law.
17. These jurisdictions permit submission of safety assessments of novel foods from foreign food regulatory authorities:
IV. Online automation
18. The EU, the US FDA, the UK FSA, the Israel Healthy Body, India Food Body? the Australian Food body and the New Zealand Food body all have automated their novel food registration systems. Any form of automation that can be introduced into any regulatory framework reaps significant benefits in terms of processing and review of registration. Although the upfront cost of online automation can be expensive the ongoing costs are minimal and would most likely require less human resources for processing of registrations which can be a significant ongoing cost for the limited resourced jurisdiction. In low-income countries, particular development partners could assist in funding such a system.
D. Placing on the market
1. Registration of establishments, listing of food producer’s business and a list of food products they make are a core part of a basic food regulatory framework.
The UK requires registration of all food businesses, meat establishments,
New Zealand requires all food importers to be registered as a food importer. A food importer must: be a resident of New Zealand (within the meaning of the Income Tax Act 2007) and have a New Zealand Customs Client Code.
Singapore’s Food Agency requires food establishments to apply for a licence to operate a food processing establishment, coldstores and slaughter-house, and a pre-requisite of registration with the Accounting and Corporate Regulatory Authority under the Business Registration Act (Cap. 32); or in the case of a company, incorporated or registered under the Companies Act (Cap. 50)
2. The US Federal Title 21 – Food and Drugs (21CFR130.8 Food Standards General) requires Standards of Identity for several special foods. In short, for several special foods to be labelled as a certain food (milk, chocolate, bread, ketchup etc.), they must follow a set of guidelines which includes required ingredients and in what proportion, along with the different manufacturing processes involved in a given food. This requirement prevents manufacturers from incorrectly labelling and claiming that their product was a special product when in fact it was adulterated in some form.
3. In addition to the Standard of Identity, all food labels must go through a Generic Label Approval which requires manufacturers to submit a sample of the proposed label for approval by the FSIS.
4. India’s Food Safety and Standards (FSS) Act also includes general guidelines preventing mislabeling of foods to consumers, stating that labels “shall not contain any statement, claim, design, or device which is false or misleading… concerning the food products contained in the package or concerning the quality or the nutritive value implying medicinal or therapeutic claims, or in relation to the origin” of the labeled food product. The FSS Act also states that business operators have the responsibility to ensure that labels are clear and is not misleading.
5. Singapore’s Sale of Food Act and the Singapore Food Regulations outline the food labelling requirements, which are based on the standards set by the Codex Alimentarius Commission. All pre-packed food products for sale in Singapore must be labelled according to the general labelling requirements of the Food Regulations. Some pre-packed food products (e.g. special purpose foods, foods with nutrition or health claims, etc.) are required to meet additional labelling requirements. The SFA has collaborated with local institutions of higher learning as SFA’s appointed food labelling consultants, who are experts that can assist food businesses for a fee.
II. Cultural and religious labelling
6. As a broad definition, religious labelling and certification involves a third party that certifies that a given food in the market is suitable for certain religious groups to consume given the specific dietary restrictions. Most commonly seen in the market is Halal or Kosher certifications. Halal certifications, for example, are issued by the Muslim authority in the given or exporting country where the food is certified to be and have been produced in accordance to Islamic Law. Similarly, Kosher certifications are issued by a Rabbinic agency or a Kosher certification agency, which verifies that the ingredients, derivates, tools, of the final product are free of non-Kosher substances. This is then reflected through labelling in packaging where foods are generally certified to be Halal or Kosher, to take the two examples.
7. Relatedly, cultured meat may perhaps be considered for the aforementioned religious certifications. In an article published in the Journal of Religious Health, the Halal status of cultured meat in general was said to be dependent on the source cell and the medium used in culturing the meat. Essentially, if the extracted cell comes from a Halal slaughtered animal, with no blood or serum used in the cultivation process, it will likely fall under the Halal certification. The Kosher status of cultivated meat is similar to this.
III. Import controls
8. The other important aspect of a basic food regulation is import control, particularly for those jurisdictions that opt for a reliance system in pre- and post-market regulation. Australia and New Zealand are a good example of two jurisdictions that have decided to harmonise their regulatory systems for food imports. The Trans-Tasman Mutual Recognition Arrangement (TTMRA) is a non-Treaty arrangement between the Australian (Commonwealth), state and territory governments of Australia and the Government of New Zealand, under the Trans-Tasman Mutual Recognition Act 1997. The TTMRA enables mutual recognition for food produced or imported into one country meets that country’s food standards and may be legally sold in the other country. In practice, this means that most food exported to Australia from New Zealand is not assessed for compliance with Australian food standards, and vice versa.
9. Both countries share food standards (the joint regulatory authority is Food Standards Australian and New Zealand) and imported food control systems which are designed to protect public health and safety to a high level. This means that under the TTMRA most risk food and all surveillance food from New Zealand are not subject to the requirements of the Imported Food Control Act 1992 (the Act). However, Australian biosecurity requirements still apply to food from New Zealand (Australia is known for its strict biosecurity requirements) and products such as beef, beef products etc are still inspected and tested. In order to be exempt from inspection under the provisions of the Act, food imported from New Zealand must comply with the TTMRA principles whereby the food:
- must be grown, harvested and produced in or imported into New Zealand
- must comply with New Zealand food laws, and
- must be labelled at the point of sale with the importers name and business address in Australia or New Zealand.
10. For all other foreign food imports they are subject to the Imported Food Control Act 1992 and the Imported Food Control Regulations 2019. Under this legislation imported food is inspected and controlled using a risk-based border inspection programme called the Imported Food Inspection Scheme, which is administered by the Department of Agriculture, Water and the Environment (DAWE). There are three classifications for foods coming into Australia that inform Australia’s food inspection scheme:
Risk food – After conducting a risk assessment, FSANZ provides advice to DAWE on foods that pose a medium to high risk to public health. These are known as ‘risk foods’, which are inspected and tested against a pre-determined list of potential hazards including microbial and chemical hazards.
Surveillance food – All other foods that are not risk foods are in this category as they are considered to pose a low risk to public health and safety. Foods in this category are normally inspected at a lower rate than risk-categorised food. However, this inspection rate is increased if a surveillance food fails inspection.
Compliance agreement food – Food importers are able to enter into a Food Import Compliance Agreement with DAWE. This arrangement offers food importers an alternative to inspection and testing of their products at the border. The agreement is an assurance-based regulatory arrangement undertaken through formal recognition and audit of and importer’s food safety management system by DAWE.
11. The Food Standards Australia New Zealand Act 1991 requires FSANZ to provide risk assessment advice to DAWE on foods that pose a medium to high risk to public health and safety. In addition to advice provided on risk category foods, FSANZ also provides risk assessment advice to the DAWE in response to formal requests. FSANZ may also provide advice in other circumstances such as in response to a national food safety incident. FSANZ is responsible for inspecting and sampling imported foods to ensure they comply with the Food Standard Code.
12. Australia negotiates Food Import Compliance Agreements with food importers, which means their food products are not required to be inspected on entering Australia. Holders of a Food Import Compliance Agreement have documented food management safety systems in place to manage the safety of the food they import. These businesses are regularly audited by the DAWE.
13. The US applies an equivalence process for eligible export countries, whereby the US FSIS determines whether its inspection system achieves the same level of public health protection. Once an export country is deemed eligible meat and poultry products imported from the cultured less of livestock and poultry will be deemed safe for the US market. Additionally, the foreign food safety inspection system must provide standards equivalent to the US FSIS to ensure other non-food safety requirements (such as accurate labelling, and assurance that meat and poultry products are not economically adulterated) are met. Imports of meat and poultry products made from the cultured cells of livestock and poultry will also be subject to all of the other FSIS requirements for imports, including labelling requirements and re-inspection by FSIS at an official import establishment. These imports also will be subject to applicable requirements of the USDA Animal and Plant Health Inspection Services and US Customs and Border Protection.
E. Post-market (ex-post)
1. Generally, much of the novel food regulation reviewed for this article did not require food business’ to establish post-market monitoring as a condition of approval. Evidently, post-market monitoring should not replace any steps in the pre-market safety assessment.10 Nevertheless, it is common that many food business’ do monitor consumer views of their food for both safety and marketing purposes. The need for any post-market mechanisms for safety is reduced by the strict verification work done at the pre-market stage through inspections at facilities, reviewing of batch records and oversight of quality management systems for packaging. Most regulatory authorities have empowerments to investigate adverse situations that arise and documentation collected at the pre-market stage is reviewed to determine what went wrong and what remedial action is required.
2. Post-market monitoring is important for ensuring that cultured meat do not trigger disproportionate or unjustified side-effects. Noting that cultured meat is not yet on the market, good post-market monitoring may be useful to learn quickly when adverse situations arise. Food business’ could be required to establish a 24 hour call-free line, included on the label of cultured meat, so that consumers can advise of any adverse affects from the meat. Food business’ could be required to conduct a study of consumers of cultured meat to measure level of consumption and nutrient levels, particular on measurements based on assumptions at the pre-market safety assessment. Where food authorities wish to receive independent consumer information about cultured meat it could establish its own call-free lines or establish a website where consumers could give their feedback directly.
3. The EU’s Novel Food Regulation indicates no specific post-market measures, but reserves the right to implement post-market requirements, which may involve the “identification of the relevant food business operators”11. Canada’s Guidelines for the Safety Assessment of Novel Foods provides at paragraph 3.5 that “Post-market monitoring may be an appropriate risk management measure in specific circumstances”.
Most food regulatory authorities operate a consumer complaint portal:
Australia and New Zealand, FSANZ;
USDA Meat, Poultry and Processed Egg Products; and
UK FSA has categories for complaints eg. food poisoning, food product, labelling, poor food safety, which depending on the categories has complaint prompts for consumers and businesses.
1. Understandably much of the basic food and meat regulation reviewed did not provide for a broad range of enforcement beyond the competent food or agricultural regulatory authority. Much of the enforcement work was carried out at the pre-market stage through inspections by the competent regulatory authority. Ongoing quality management reviews?
2. Voluntary surveillance by third parties could be a useful enforcement mechanism and in religious and cultural labelling organisation such surveillance does occur. Entrusted public utility associations, other associations or simply competitors can fill in the gap. They may exert intense surveillance in their own interests provided they have a powerful tool to enforce legal compliance. One way to achieve this is to give them the right to sue at court, which can be useful in middle- to high-income countries but probably more difficult in low-income countries.
3. Ensuring competent regulatory authorities have the right empowerments can provide flexibility in enforcement, where specific enforcement measures are not proscribed by regulation. Please see the Handbook: How to regulate? about how to approach empowerments generally but also the two-part empowerments articles have specific lists of empowerments: Empowerments (Part I): typology and Empowerments (Part II): checklist.
Several jurisdictions recognise the benefits that cultured meats can provide for a healthier and sustainable life and planet evidenced by the level of government financial investment in the industry: the US, EU, Japan,Singapore, Australia. Some of them have updated or clarified their novel food regulations to make clear the regulatory pathway for approval: US, Singapore and Australia, with Canada’s “4.3 Novel Foods Derived from Animals (Under Development)”. Given the promising benefits of cultured meat, jurisdictions that have not yet updated their food regulation might raise a few preliminary questions that would help them design their respective regulatory frameworks:
What is the cultural perception of cultured meat in that jurisdiction? Does cultured meat fall “naturally” under the term “meat”? Is it perceived as positive or not?
To what extent does the jurisdiction wish to protect or incentivise small scale livestock farming, to avoid that farmers of large scale livestock farming have no viable economic alternative other than to lose their income? If this goal prevails, the regulator is likely to establish hurdles rather than facilitating the introduction of cultured meat. The regulator might then also choose a definition and make labelling requirements that deter from buying cultured meat, eg by denying the use of the term “meat” or even requiring to label “not meat” in a culture where “meat” is cherished; or, in the extreme case, even simply ban cultured meat.
To what extent do they wish to promote cultured meat, eg because of its environmental benefits? If this goal prevails, the regulator will aim to reduce hurdles as much as possible and even reduce regulation to the strict minimum: safety. The regulator will also update the definition of the legal term “meat” to include cultured meat to facilitate the marketing in a culture that is sceptical of cultured meat.
To what extent is transparency for consumers necessary and desired? If there is little necessity and the regulator wishes to promote cultured meat, the regulator might avoid the obligation to label the product as “just” cultured meat, in particular where the population is sceptical towards cultured meat.
Does the jurisdiction have its own technical competence to assess the safety of cultured meat? If not, it might wish to focus on surveilling the hygiene and cold transport and storage of cultured meat, recognising approvals from other jurisdictions and establishing administrative cooperation with foreign competent authorities in order to get fair access to their safety alerts, information on withdrawals of approvals etc.
These are just some of the preliminary questions out of many more that would emerge in a structured analysis of the novel food regulatory framework in a given jurisdiction, following the method outlined in the Handbook: How to regulate?. The optimisation of novel food regulation with the regulatory techniques mentioned in this article and that of the Handbook depends very much on the answers to these preliminary questions. In particular there is a need for clarity on the goals and the objectives (which make the goals more concrete).
This article was written by Valerie Thomas and Shin Won Kim, on behalf of the Regulatory Institute, Brussels and Lisbon.
1 Stephens, Neil et al. “Bringing cultured meat to market: Technical, socio-political, and regulatory challenges in cellular agriculture.”Trends in food science & technology vol. 78 (2018), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6078906/.
3 J applied psychology article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4419201/.
4Codex standard under the theme of biotechnology http://www.fao.org/fao-who-codexalimentarius/thematic-areas/biotechnology/en/.
5Answer given by Commissioner Andriukaitis on behalf of the European Commission 8 Oct 2018 to question reference: E-004200/2018, https://www.europarl.europa.eu/doceo/document/E-8-2018-004200-ASW_EN.html.
6 Guidance Information on Safety Assessment Assessment of Novel Foods, paragraph 6, v, ii on page 3,https://www.sfa.gov.sg/docs/default-source/food-import-and-export/guidance-on-safety-assessment-of-novel-foods-(22nov2019).pdf.
7 Guidance Information on Safety Assessment Assessment of Novel Foods, paragraph 6, v, ii on page 2,https://www.sfa.gov.sg/docs/default-source/food-import-and-export/guidance-on-safety-assessment-of-novel-foods-(22nov2019).pdf.
8 US FDA “Overview of the pre-market consultation process and oversight activities”, https://www.fda.gov/food/food-ingredients-packaging/foods-made-cultured-animal-cells.
9 US FDA New Dietary Ingredient Revised Draft Guidance – August 2016 p. 69, paragraph 4. What documentation of an new dietary ingredient’s history of use should I submit? https://www.fda.gov/media/99538/download.
10 Hepburn, P. et al, “The application of post-market monitoring to novel foods”, Food and Chemical Toxicology 46 (2008) 9-33, p. 28,http://www.ask-force.org/web/Food/Hepburn-Application-Post-Market-Monitoring-2008.pdf.