| 1 | The barriers and drivers of a safe market introduction of cultured meat: A qualitative study | Ketelings et al. (2021) | The Netherlands | The lack of sufficient research on hazard and risk characterization constitutes a significant barrier. It is recommended to conduct genetic stability assays for starter cell lines and to perform residual testing for culture medium and serum. | Compliance with EFSA guidelines under Novel Food or GMO regulations is required. Global regulatory inconsistencies need addressing for smoother market entry. | Certain areas of cultured meat research require more attention from researchers to ensure the highest level of safety. Overall, the lack of in-depth research related to hazard and risk characterization of cultured meat is considered the biggest barrier in introducing a safe product to the market. |
| 2 | Scientific, sustainability and regulatory challenges of cultured meat | Post et al. (2020) | The Netherlands | Essential to use serum-free medium and optimize biomaterials and genetic stability assays for starter cell lines and residual testing for culture medium and serum, are key safety concerns. Additionally, ensuring high-volume cell production in industrial bioreactors using a serum- free medium and establishing clear regulatory pathways are essential for the safe commercialization of cultured meat. | FDA and USDA–FSIS: FDA oversees early cell development; USDA–FSIS manages final production and labeling. Agencies collaborate but have separate roles. Regulations: Cultured meat is regulated under Novel Foods or GMO legislation, with a framework in place since 1997 and updated in 2018. | Key safety findings for cultured meat include insufficient research on hazard and risk characterization, necessitating genetic stability assays and residual testing for culture medium and serum. Achieving scalability and cost efficiency is crucial, with high-volume cell production in serum-free media being essential for safe manufacturing. Clear regulatory pathways are also necessary for safe commercialization. |
| 3 | The business of cultured meat | Choudhury et al. (2020) | Singapore | Growth media: Must contain necessary nutrients for cell proliferation. Challenges include optimizing media and ensuring it supports scalable production. | - Lack of framework: No established regulatory framework specifically for cultured meat.- Existing regulations: Safety is recognized but CM lacks clear regulatory guidelines.- Consumer perception: Concerns include taste, texture, and misleading labels. | - Commercialization challenges: These include optimizing growth media, improving taste and texture, and overcoming consumer biases.- Geographical spread: Culture meat companies are globally distributed, with significant investments and growing interest in North America, Asia, and Europe.- Funding: Significant investments from both public and private sectors are crucial for advancing culture meat production. |
| 4 | Food safety considerations and research priorities for the cultured meat and seafood industry | Ong et al. (2021) | USA | - Hazard identification: Focuses on identifying potential chemical and biological hazards in the manufacturing process of cell-cultured meat and seafood.- Assessment methods: Existing safety assessment methods from conventional foods, biotechnology, and pharmaceuticals are applicable, but additional evaluation of novel inputs may be necessary. | - Framework development: No existing regulatory framework specifically for cell-cultured meat and seafood; however, established principles from related fields can inform safety frameworks.- Harmonization: Existing global standards for quality management and safety testing may apply, but gaps in knowledge and novel contaminants require further attention.- Standardization: Development of standardized lists for residues, byproducts, and contaminants will enhance product testing efficiency. | - Modular manufacturing process: A generalized modular diagram was created to identify hazards across different manufacturing processes and enable tailored risk management.- Consumer acceptance: A data-driven, transparent approach to safety can support consumer acceptance and realization of cell-cultured products’ potential. |
| 5 | Safety of alternative proteins: Technological, environmental and regulatory aspects of cultured meat, plant-based meat, insect protein and single-cell protein | Hadi and Brightwell (2021) | New Zealand | - Cultured meat: Risks from viruses, prions, and genetic engineering. Serum-based media may pose hazards.- Plant-Based Meat: Risks include allergens, anti-nutrients, and potential carcinogens.- Insect protein: Concerns about microbiological safety and allergens.- Single-cell protein: Risks include toxins, allergens, and high RNA content. | - Cultured meat: Regulated as novel food; overseen by FDA and USDA-FSIS in the USA, and by European regulations in Europe.- Plant-based meat: Regulated similarly to non-animal foods; certain components may need novel food approval.- Insect protein: Governed by novel food regulations; recent approvals in Europe.- Single-cell protein: May need GRAS status in the USA; subject to novel food regulations in Europe. | - Cultured meat: Requires more research on contaminants and health effects.- Plant-based meat: Needs further study on health impacts and processing risks.- Insect protein: More research needed on allergens and microbiological safety.- Single-cell protein: Focus on toxin and allergen risks.- Global standards: Need for comprehensive global safety regulations. |
| 6 | Technological, regulatory, and ethical aspects of in vitro meat: A future slaughter‐free harvest | Bhat et al. (2019) | New Zealand | - Chemical and microbial safety: Cultured in a sterile bioreactor, reducing pathogens and chemical hazards.- Potential risks: Novel materials used may pose untested risks; genetic instability and contamination of cell lines or media are concerns.- Health risks: No living cells in final product; recombinant proteins should not pose novel risks. | - Current status: Limited to research; no established commercial regulations yet.- Oversight: Likely to involve food safety authorities; in the US, collaboration between USDA and FDA is anticipated.- Special considerations: Regulation will need to address unique aspects like culture media and scaffolds. | - Sustainability challenges: Environmental impacts and cost of large-scale production need addressing. Sustainability of cultured meat systems remains uncertain.- Technological barriers: Development of animal-free culture media and efficient bioreactors is crucial. Current reliance on fetal calf serum and animal-derived scaffolds is unsustainable.- Economic and social factors: Cost, social acceptance, and scalability are central challenges. Effective product-oriented publicity may drive consumer adoption. |
| 7 | US lawmakers float plan to regulate cultured meat | Servick (2018) | USA | - Safety assessment: Unclear processes for assessing safety; current regulations focus on traditional meat production, which differs significantly from cultured meat methods.- Concerns: Debate over whether USDA has the necessary expertise; potential for new risks related to the novel production process. | US regulation:- Proposed oversight: USDA would oversee cultured meat manufacturing and labeling as per recent House bill language.- Industry disputes: Some argue that the USDA’s approach may lead to unnecessary regulations; concerns about lack of expert input.- Possible alternatives: FDA may also play a role, given its expertise in cell and tissue-based products. | - Technological impact: Cultured meat technology promises reduced animal suffering, lower energy and land use, and fewer greenhouse gas emissions.- Regulatory debate: Ongoing discussions about appropriate regulatory bodies and standards. USDA’s ability to regulate cultured meat is questioned due to its traditional focus on livestock.- Global perspective: Different countries, including the EU, are developing their own regulations for cultured meat, reflecting varying approaches to safety and market introduction. |
| 8 | Cultured meat safety research priorities: Regulatory and governmental perspectives | Ong et al. (2023) | USA | - Need for new analytical methods or adaptation of existing ones for diverse cultured meat and seafood products.- Testing for residues of media ingredients, structural materials, cells, and bioactive molecules.- Common hazard prevention methods (e.g., HACCP, GMP) are deemed sufficient once contamination sources are understood.- Monitoring for pathogens and chemical compounds from both traditional and novel production environments. | - Safety and regulatory assessments should account for novel production processes and potential new hazards.- Existing approaches can be adapted for culture meat products, but specific criteria and methods need to be developed.- Emphasis on creating databases and sharing data from both private and public sectors to support safety evaluations and regulatory framework development.- Transparency in risk assessment is crucial for building consumer trust. | - Culture meat products may differ significantly from conventional products, requiring tailored safety evaluation criteria.- Compositional and process differences necessitate novel parameters for safety assessments. Unique production processes introduce potential new hazards, such as genetic and metabolic stability issues. No universal safety standards are currently available; products need to be assessed individually until standardized methods emerge. |
| 9 | Bringing cultured meat to market: Technical, socio-political, and regulatory challenges in cellular agriculture | Stephens et al. (2018) | UK | - Cell source and culture media: Challenges in replicating the in-vivo muscle growth environment and finding effective culture media.- Bioprocessing: Need for bioprocessing methods that can scale to commercial production while ensuring product affordability.- Contaminants: Lower purity of raw materials is acceptable compared to biomedical applications, but ongoing monitoring needed for contaminants and residues. | - Production: Regulatory frameworks need to address the novel technical aspects of cultured meat production, including scalability and cost-efficiency.- Public acceptance: While consumer acceptance is crucial, the broader political and institutional framework also affects regulation and industry development.- Regulatory frameworks: Need for comprehensive regulations that address both technical and socio- political aspects of cultured meat production. | - Technical challenges: Large-scale production and affordability are difficult; significant climate impacts may take decades.- Social and institutional issues: Beyond consumer acceptance, socio-political factors influence development; economic instability and start-up failures are risks.- Environmental benefits: Cultured meat may not inherently deliver all benefits; should be part of a broader strategy including meat reduction and policy reforms. |
| 10 | Risk assessment of cultured meat | Gu et al. (2023) | China | - Hazards and risks: Hazards and risks may be introduced at any stage during the production of cultured meat.- Risk assessment: Effective risk assessment strategies are necessary to ensure the safety of cultured meat.- Standardized practices: Implementation of good laboratory practices, good manufacturing practices, good cell culture practices, and codes of hygienic practices is essential for safe production. | - Novel food status: Cultured meat is considered a novel food, requiring evaluation by regulations or legislation of respective jurisdictions before market introduction.- Harmonized framework: The regulatory framework for cultured meat may differ across regions but should eventually be harmonized to promote safe and nutritious cultured meat products globally. | - Sustainability potential: Cultured meat has the potential to become a sustainable source of nutritional protein.- Technical challenges: There are significant technical challenges in producing cultured meat in large quantities.- Lack of transparency: Production processes remain largely undisclosed due to trade secrets, impacting transparency and safety assurance.- Ethical and health benefits: Cultured meat is perceived to have relative ethical and health advantages over conventional meat. |
| 11 | Cultured meat and challenges ahead: A review on nutritional, technofunctional and sensorial properties, safety and legislation | Broucke et al. (2023) | Belgium | - Food safety risks: Cultured meat production involves potential risks such as microbial contamination, prions, and genetically engineered starting materials.- Controlled production environment: The enclosed and controlled environment of in vitro meat production is believed to reduce the risk of animal diseases, foodborne illnesses, antibiotic-resistant pathogen strains, and exposure to chemical hazards. | - Cultured meat lies at the boundary between meat and non-meat, necessitating clear definitions and appropriate regulatory frameworks. Current discussions focus on EU and US regulations. | - Nutritional profile: Cultured meat consists of in vitro cultivated animal cells, producing proteins, fatty acids, growth factors, and cytokines.- Technofunctional and sensorial properties: There are significant differences between cultured meat and traditional meat in terms of texture, color, flavor, and overall sensory experience.- Processing impact: The impact of further processing on the quality of cultured meat, including protein quality and sensory properties, is still a subject of scientific research.- Production challenges: Cultured meat production faces challenges such as scaling up, optimizing bioreactors, and developing bioprinting techniques for producing complex multicellular tissues. |
| 12 | Cell-based meat labeling–Current worldwide legislation status: A review | Vlčko et al. (2023) | Poland | - Safety evaluation: In the EU and other regions, cell-based meat products are expected to undergo a safety evaluation under novel food legislation, though no applications have been registered yet.- Risk of stigmatization: Legal frameworks in some US states might impede market introduction or cause stigmatization of cell based meat products, impacting consumer perception. | - Global approval status: Singapore is the only country that has approved cell-based meat for market placement.- US regulatory framework: The US has established a regulatory framework where the USDA and FDA will control cell-based meat matters.- EU Novel Food Regulation: Cell-based meat products in the EU will be evaluated under the Novel Food Regulation, with additional guidelines for food business operators.- Other countries: Countries like Canada, Australia, New Zealand, Japan, and Israel are expected to evaluate cell-based meat under their novel food legislation.- Labeling regulations: There is a lack of clear legislation on the labeling of cell-based meat products in most countries. | - Increasing investment: There is growing investment in cell-based meat technology by major food industry corporations.- Anticipated market launch: Many companies are announcing plans to launch cell based meat production in several markets worldwide in the coming years.- Policymaker considerations: Policymakers should avoid implementing local laws that could negatively impact consumer perception of cell-based meat technology while ensuring clear labeling to distinguish product origin.- Implementation timeline: The introduction of cell-based meat to many markets is expected to take months or years, not weeks, due to the time required for regulatory approval and safety evaluations. |