We invite you to read an extensive material prepared by Piotr Włodawiec, in which our expert discusses the potential of cellular meat, the process and cost of its production, as well as the legal issues related to its introduction into the Polish market.

Cultivated meat (also known as lab-grown meat, in vitro meat, cultured meat, clean meat, cell-based meat) is a type of meat produced in laboratory conditions by cultivating animal cells instead of obtaining meat from traditional methods of raising and slaughtering animals. The process involves taking animal cells, such as stem cells, and then multiplying them under controlled conditions, such as in bioreactors, where the cells develop and differentiate into muscle.

No need to breed and slaughter animals – a key argument in favor of cultivated meat production, related to ethics and animal welfare.

Lesser environmental impact – Cultivated meat production potentially consumes fewer resources, such as water, feed, and land, and generates less greenhouse gas emissions.

Cultivated meat production does indeed have the potential to reduce negative environmental impacts compared to traditional animal husbandry. However, figures on the actual resources needed for industrial production are still in development, as most cultivated meat production is still at the pilot or research stage.

Studies estimate that cultivated meat production could use 82-96% less water compared to traditional animal husbandry. In traditional livestock farming, water consumption includes not only the water needed for the animals, but also the water needed for feed production.

Cultivated meat requires much less agricultural land, as it does not require large areas for pasture or for growing fodder.

Studies indicate that cultivated meat production can generate 78-96% less greenhouse gas emissions than traditional farming. Traditional cattle farming is responsible for significant methane emissions, mainly through the digestion process and manure production.

Despite these promising numbers, there are many variables that will affect the final environmental balance.

Plants for industrial-scale cultivated meat production are still in the design phase. Potential energy and water consumption will depend on many technological factors, such as the scale of production, efficiency of bioreactors, composition of culture media, etc.

It has been calculated that large-scale production may require about 15-50 kWh of energy per kilogram of meat, which is comparable to or slightly higher than intensive animal husbandry.

Water and energy consumption in factories will largely depend on bioreactor technology and treatment methods.

Resource consumption figures are still estimates and depend on future technological solutions. According to various analyses, a full-scale factory could produce thousands of tons of meat per year, but the resources required (water, energy) are difficult to predict in great detail before the technology becomes fully commercialized.

Cultivated meat production process

Control over meat composition – it is possible to fine-tune the nutritional values and characteristics of meat, such as fat content, which can have a positive impact on consumer health.

Cultivated meat provides the opportunity to precisely control its nutritional composition, which can lead to products that are more healthy than traditional meat. For example, unhealthy fats can be reduced or health-promoting ingredients can be added. However, more research is needed to better understand its full impact on health.

Cultivated meat production process:

1. Cell collection – small tissue samples are taken from animals from which cells are isolated, usually muscle stem cells.

The process begins with the collection of a small sample of muscle cells from a living animal. Stem cells or satellite cells, which have the ability to differentiate and regenerate, are often used. The sample is taken in a minimally invasive manner, such as by biopsy.

2. Cell culture – cells are grown in special media rich in nutrients (such as proteins, vitamins, minerals).

The collected cells are then isolated and placed in a bioreactor – a special device that allows them to be further cultured. The cells need the right environment to divide and differentiate. An important element is the so-called culture medium, rich in nutrients such as amino acids, glucose, minerals, vitamins and growth factors. Special proteins can be added to the culture media to stimulate cell growth.

Under favorable conditions, the cells begin to divide, and their number increases rapidly. The multiplication process can take from a few days to several weeks, depending on the type of cells and culture conditions. At this stage, it is important to maintain sterile conditions to prevent infection and to ensure adequate oxygen and nutrient levels.

3. Tissue formation – muscle cells are stimulated to differentiate and form muscle tissue, which is the basis of meat.

The cells begin to form a structure that resembles muscle fibers. As they grow, they form a compact tissue that is similar to natural meat. Sometimes mechanical or biophysical techniques are used to mimic the natural tension of the muscles, which helps create the appropriate texture.

When the tissue reaches the right size and structure, it is harvested from the bioreactor. The resulting meat can be molded into various food products, such as ground meat, burgers or nuggets. At this stage, the meat can also be processed, seasoned or further subjected to technological processes to achieve the desired texture and taste.

Cultivated meat is a cutting-edge solution that could reduce the negative environmental impact of animal husbandry and improve animal welfare in the future, but large-scale production is still under development and optimization.

Reiss J. et al. 2021: Cell Sources for Cultivated Meat: Applications and Considerations throughout the Production Workflow

The challenges of cultivated meat

The challenges of cultivated meat

1. Production costs
2. Public acceptance
3. Legislation

Production costs – although prices are falling, cultivated meat production is still more expensive than traditional methods

Cultivated meat production costs are higher than traditional methods mainly due to expensive technology, cell culture media, high energy consumption and as yet unscaled production.

• Cost of technology and infrastructure
• Culture media – nutrient solutions
• Production
• Energy and resources
• Research and development process
• Regulations and certifications

Public acceptance – many people are still skeptical about eating lab-grown meat

Cultivated meat is a relatively new technology, which raises fears of the unknown. Many consumers are unsure of the long-term health effects of eating lab-grown meat, especially in the absence of long-term studies. This raises questions about safety, purity and potential allergies.

The very idea of eating meat that does not come from animals, but is grown in a laboratory, creates psychological discomfort.

Some consumers mistakenly equate cultivated meat with genetically modified food (GMOs). Cultivated meat is not a GMO food, although its production process may evoke some associations with genetic engineering

New technologies in food production, especially those that deviate significantly from traditional methods, often provoke psychological resistance. Cultivated meat can be perceived as “artificial” or “unnatural”, which in itself raises concerns. In this context, there is a large role for educating and informing consumers about the production process and the results of safety and nutritional studies.

Legislation – there are no regulations governing the production and sale of this type of product (this type of product is regulated by Regulation 2015/2283 on novel foods)

Lab-grown meat is considered as one of the potential answers to the growing demand for protein that at the same time reduces the negative environmental impact of animal husbandry.

Cultivated meat is an innovative product that poses new challenges to legal systems both in Poland and throughout the European Union. Currently, cultivated meat regulations are not yet fully formed.

NOVEL FOOD GETS ITS FOOT IN THE DOOR

NOVEL FOOD GETS ITS FOOT IN THE DOOR

• Regulation in the EU
• Marketing authorization
• Labeling
• Standardization and quality standards

Novel Food Regulation

Products such as cultivated meat are classified as “novel foods” under Regulation (EU) No. 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods.

• “Novel foods” refers to products that were not used for human consumption to a significant degree before 15 May 1997.
• The marketing of cultivated meat in the EU requires notification and approval from the European Food Safety Authority (EFSA).

Marketing authorization

Only after EFSA has given a positive opinion can cultivated meat be approved by the European Commission for sale in the European Union.

The process can be time-consuming, and the lack of clear regulations on cultivated meat itself means that each application will be considered on a case-by-case basis.

EFSA assesses the safety of the new product, including possible health risks, nutritional properties, production method and labeling.

Labeling

The requirements for labeling and informing consumers about the product are strictly regulated.

Cultivated meat will have to be clearly labeled as a product that does not originate from traditional animal husbandry.

Standardization and quality standards

Over time, there may be more detailed regulations on the quality of cultivated meat, its production methods, control over the origin of animal cells and environmental standards

There are no laws that regulate cultivated meat production, its marketing and liability issues.

It is impossible to point to a single factor that absolutely determines the development of cultivated meat, since its development depends on a combination of several factors, including:

• Technology infrastructure and investment (capital).
• Limited availability of land and natural resources (environment).
• Social and environmental pressures (consumer preferences, environmental protection).
• Government policy and support.

In practice, capital and technological innovation may be the most important factors, as without them the development of this technology would not be possible, but it is also strongly driven by growing consumer demand as well as urbanization and environmental issues

Legislation – cultivated meat

Currently, there are no laws in Poland that regulate cultivated meat. These products, as is the case in the EU, will have to go through the approval process as a novel food, according to EU regulations.

If cultivated meat is approved for marketing in Poland, it will be subject to Polish food regulations, including food safety and labeling regulations (e.g. the Food and Nutrition Safety Act).

The future of regulation:

Given the growing interest in cultivated meat technology, there is a high probability that both the European Union and Poland will develop more detailed regulations in this area. The new regulations are likely to include safety, environmental and labeling aspects to protect consumers and promote sustainable food technologies.

Currently, the biggest challenge is to adapt the law to rapidly developing technology that does not fit into the traditional legal framework.

There are many cultivated meat companies in the world and in Poland. Here are some of them:

In Poland:

• LabFarm is the first Polish company to produce cultivated meat. They focus on growing chicken meat. They have received financial support in the amount of PLN 9 million from the National Center for Research and Development (NCBiR), which is expected to help them develop and scale production.

Worldwide:

• UPSIDE Foods (formerly Memphis Meats) – an American company from California, specializing in chicken meat. Investors include Bill Gates and Richard Branson.
• GOOD Meat – a U.S.-based chicken company, a pioneer in Singapore, where their products have been approved for sale.
• Aleph Farms – an Israeli company that produces cultured steaks and was one of the first to produce meat in space.
• MeaTech 3D – an Israel-based company specializing in 3D printing premium meats such as beef and poultry.

These companies are at the forefront of cultivated meat innovation, changing the food industry worldwide.

Cultivated meat – meat or meat product

According to Regulation (EC) No. 853/2004 of the European Parliament and of the Council of 29 April 2004, the term “meat” defines the edible parts of the animals specified below:

• Domestic ungulates – domestic bovine, porcine, ovine and caprine animals, and domestic solipeds;
• Poultry – farmed birds, including birds that are not considered as domestic but which are farmed as domestic animals, with the exception of ratites;
• Lagomorphs – rabbits, hares and rodents;
• Wild game – wild ungulates and lagomorphs, as well as other land mammals that are hunted for human consumption and are considered to be wild game under the applicable law in the Member State concerned, including mammals living in enclosed territory under conditions of freedom similar to those of wild game; and wild birds that are hunted for human consumption;
• Small wild game – wild land mammals living freely in the wild.
• Large wild game – means wild land mammals living freely in the wild that do not fall within the definition of small wild game;

In turn, according to Regulation (EC) No. 853/2004 of the European Parliament and of the Council of 29 April 2004, “meat products” are processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat.

Under EU law, meat is defined in Regulation (EC) No. 853/2004, which sets out specific hygiene regulations for food of animal origin. Meat is described here as: „Edible parts of animals” (such as mammals, birds, etc.) that have been slaughtered in accordance with relevant veterinary standards.

Since cultivated meat does not come from the traditional process of slaughtering animals, it does not fit directly into this definition. The technology involves growing muscle cells from animals under laboratory conditions.

Cultivated meat is likely to be classified as a Novel Food, according to Regulation (EU) 2015/2283. Novel food is food that has not been used for human consumption to a significant degree in the EU before 15 May 1997. Cultivated meat meets these criteria because it is the result of a new technology and was not previously available on the market.

According to the regulation, novel foods must go through an approval process before they can be sold on the EU market. This means that cultivated meat must be deemed safe for consumers by the European Food Safety Authority (EFSA) and be approved as compliant with food hygiene and safety regulations.

In the context of EU regulations, meat products are defined in Regulation (EC) No. 853/2004 as products derived from meat that may contain other ingredients. Cultivated meat, although technically produced from muscle cells, is not a traditional meat product, as it does not come from traditionally reared and slaughtered animals.

It can therefore be argued that cultivated meat does not fully comply with existing definitions of meat or meat products. That is why it will likely have to be classified as a novel food, with separate regulations for production, labeling and sale.

The question of whether cultivated meat can be called „meat” in the legal sense is being debated. EU countries will have to form a position on the issue.

Cultivated meat could be classified as “meat”, as it is made from animal cells, although the production process is different.

Some regulations may require that the term „meat” be reserved only for products derived from traditional animal husbandry, and cultivated meat would have to have a different name, such as “meat alternative”.

Novel Food Regulation

The current Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001, which entered into force in 2018, significantly reformed the previous authorization procedure established by the outdated Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients.

The current Regulation (EU) 2015/2283 has introduced major reforms in the regulation of novel foods in the European Union, replacing the outdated Regulation (EC) 258/97. The main changes are the centralization of the risk assessment and risk management process, with the aim of simplifying and facilitating the approval procedure for new food products.

The regulations also require that the novel food belongs to at least one of the ten categories listed in Article 3(2)(a).

Category No. VI, which refers to „food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae,” explicitly includes cultured meat, which therefore requires pre-market approval to be marketed in the EU.

The marketing of food products in the „novel food” category is subject to prior authorization based on a food safety risk assessment by the food agency.

This is a regulatory arrangement that exists in countries such as Canada, Australia, the EU, Israel and the UK, where lawmakers have developed regulations for the marketing of novel foods with the primary goal of ensuring a high standard of consumer health protection.

Due to its innovative (non-traditional) production process, cultivated meat is considered a novel food.

Novel food marketing regulations

European Union regulations play a key role in shaping innovation in the food industry, including the production of meat alternatives.

Decisions to bring innovative products to market must take into account consumer safety and high production standards.

In the current legislation, especially in the context of the regulation of novel foods, the safety assessment, carried out by the European Food Safety Authority (EFSA), plays a crucial role.

EFSA assesses the potential risks of new foods, taking into account nutritional, toxicological and allergic issues. However, this process is time-consuming, which can affect the pace of innovation.

One of the challenges is also the issue of how plant-based products and cultured meat should be labelled. Currently, there is no clear regulation in this area, leading to uncertainty among both producers and consumers. Decisions on the names that can be used for meat analogs and how they are to be labeled are important for the future of that market.

In the context of emerging technologies, such as lab-grown meat production, the European Commission is taking a reactive rather than proactive approach. The approval process for a novel food is initiated only after the manufacturer formally submits an application.

Novel food will be authorized and used only if it meets the criteria set forth in the regulation. Novel food must be safe and pose no risk to public health. Before the authorization is granted, novel foods must undergo scientific evaluation by EFSA to ensure that such products are safe.

The procedure for authorization to market a novel food in the EU is initiated by the Commission or the applicant on the basis of an application submitted to the Commission. The application for authorization must include:

• name and address of the applicant;
• name and description of the novel food;
• description of the production process or processes;
• detailed composition of the novel food;
• scientific evidence proving that the new food does not pose a risk to human health;
• where applicable, a description of the method or methods of analysis;
• a proposal for conditions of intended use and specific labeling requirements that do not mislead the consumer, or verifiable justification as to why these elements are unnecessary.

The procedure for authorizing novel foods to be placed on the EU market and updating the EU list ends with the adoption of an implementing act.

Conditions for inclusion of novel foods on the EU list:

The Commission authorizes a novel food and puts it on the EU list only if the food meets the following conditions:

• food does not, based on available scientific evidence, pose a risk to human health;
• intended use of the food is not misleading to the consumer, especially if the food is intended to replace another food and there has been a significant change in nutritional value;
• where the food is intended to replace another food, it does not differ from that food in such a way that its normal consumption is nutritionally disadvantageous to the consumer.

Once a novel food has been authorized for marketing, any manufacturer can market products that meet the same conditions and specifications. The exception is if the data on the novel food is proprietary, in which case data protection applies for five years (Article 26 of the regulation).

The current Regulation (EU) No. 2015/2283, which came into force in 2018, introduced major reforms in the regulation of novel foods in the European Union, replacing the outdated Regulation (EC) 258/97. The main changes are the centralization of the risk assessment and risk management process, with the aim of simplifying and facilitating the approval procedure for new food products.

Effects of approval

Approved novel foods are placed on the EU list of novel foods and can be marketed by others without the need for further applications. The exception is if the applicant obtains data protection and “proprietary” status under Article 26 of the Regulation for a period of 5 years.

Examples of novel foods covered by data protection:

• Partially defatted Acheta domesticus (house cricket) powder
• Alphitobius diaperinus (Thrush shiner) larvae in frozen, paste, dried and powdered form
• Frozen, dried and powdered forms of Acheta domesticus (house cricket)
• Frozen, dried and powdered form of migratory locust (Locusta migratoria)

Froggatt A., Wellesley L. 2019: Meat Analogues: Considerations for the EU

Cultivated meat – its current situation around the world

In the EU, cell-cultured foods, including cultivated meat, are subject to Regulation (EC) No 2015/2283 on Novel Foods.

This means that before a product such as cultivated meat can be marketed, it must undergo a detailed safety assessment conducted by the European Food Safety Authority (EFSA). The authorization process includes:

• A consumer health risk assessment.
• Demonstration that the product is safe for consumption.
• Evaluation of the production process and ingredients

The European Food Safety Authority (EFSA) plays a key role in food risk assessment in the EU. Any new ingredient, especially food additives, must be evaluated by EFSA before they are placed on the market. For example, EFSA carefully studied the risks associated with aspartame before allowing its use in the EU.

Under the aforementioned Regulation, all products placed on the market must be clearly labeled and comply with food safety standards. The EU has strict food labeling regulations to protect consumers. Food products must be clearly labeled with allergen, ingredient and nutritional information. These regulations are in line with the idea of protecting consumers’ health, ensuring that they have access to full information about the products they consume.

LabFarm is a Polish biotech startup focused on producing meat from cell cultures. The company was founded in 2021. Its main objective is to create alternatives to traditional animal husbandry. LabFarm has received significant financial support from the Polish government in the form of a PLN 9 million grant from the National Center for Research and Development (NCBiR). The funding is expected to help the company scale up production and further develop its own bioprocesses and growth media for livestock meat, and ultimately structure all processes for future food production.

The company unveiled its first prototype – cultured chicken meatballs – in June 2024. This product was presented as a sustainable and cruelty-free alternative to conventional meat, mimicking its taste, texture and nutritional profile. LabFarm emphasizes the environmental and animal welfare benefits of its products, aiming to reduce the negative impact of animal farming. While the company’s progress has been lauded, challenges remain. These include ensuring the long-term safety of cultured meat for consumers and addressing public concerns about the ethical and economic implications of the technology. Nevertheless, LabFarm is positioned as a pioneer in the fast-growing cultured meat industry in Poland, with ambitions to expand its reach into European markets in the coming years.

Cultivated B (TCB) began discussions with the European Food Safety Authority (EFSA) on September 14, 2023, and officially entered the preliminary process of applying for a novel food authorization for a new sausage meat or cultured meat product. With the official submission, TCB has become the first biotech company in the world to apply for EFSA certification for cultured meat. This is a key first step in the evolution of the cultured meat market and sets a viable path for large-scale commercial production.

Italy

On December 1, 2023, the Italian Chamber of Deputies passed Law 172 banning the production of cultivated meat. The ban applies to the production, use, sale, import, distribution and promotion of both food and feed made from isolated or cultivated cell cultures or tissues derived from vertebrates.

The law provides for a fine of between €10,000 and €150,000 for those who produce, or trade food and feed made from cell cultures or tissues derived from vertebrates. The law also bans the naming of meatless products with terms typically used for animal meat products, such as using the names soy meatballs, chickpea burger or vegetable fishburger.

The European regulatory framework is directly enforced in each member state, so any future authorization for cultured meat obtained at the EU level would also have binding effect in Italy.

BMT – Bene Meat Technologies

Czech company BMT is the first company to obtain EU certification for lab-grown meat in pet food. The product has been included in the European Register of Feed Materials. In the long term, the company aims to develop cultured meat suitable for human consumption as one of its goals.

Cultivated meat is a new technology whose regulation in the European Union (EU) is just beginning to take shape. Although the EU so far lacks full regulations for cultivated meat for humans, the technology is beginning to find its way into animal feed.

In November 2023, Bene Meat Technologies (BMT), a biotech startup from the Czech Republic, obtained registration of its product (cultured cells derived from mammals) in the European Register of Feed Materials.

This means that the company has been approved to sell cultured meat as a feed ingredient, mainly in the production of pet food. This is the first such case in the EU, although it does not yet apply to products intended for human consumption. The cultivation process takes place in bioreactors, without the need to slaughter the animals, which is in line with the growing need for sustainable and ethical solutions in the food and feed industry.

This registration is an important step toward the future commercialization of other forms of cultured meat in the EU that may also find applications in food intended for human consumption in the future. For now, however, these products are only available in the animal feed sector.

United States

In the U.S., regulation of cultivated meat is governed by two main bodies:

• FDA (Food and Drug Administration): responsible for overseeing the cell culture process, cell multiplication and the product development stage.
• USDA (United States Department of Agriculture): responsible for overseeing final meat products and their processing and packaging.

The two bodies are working together to ensure that cultivated meat is safe, healthy and properly labeled. In the U.S., there is a particular interest in clearly labeling this type of product so that consumers are aware that they are choosing lab-grown meat over traditional meat.

The Food and Drug Administration (FDA) regulates food safety in the U.S., enforcing strict regulations on food additives such as preservatives, colorings and flavorings. Each new additive must be approved by the FDA after toxicological studies that assess its impact on health. For example, the approval of new sweeteners, such as stevia, required detailed testing before they could be approved for use.

The FDA also strictly controls imported food, requiring food products to meet U.S. safety standards. Programs such as the Foreign Supplier Verification Program (FSVP) require importers to verify that their suppliers comply with relevant food safety regulations.

Singapore

Singapore is the first country to allow cultivated meat for sale, approving the product from Eat Just in 2020. Regulators in Singapore, the Singapore Food Agency (SFA), have adopted strict food safety standards, requiring full documentation of the production process and detailed toxicological and microbiological testing to ensure that the cultivated meat is safe for consumption.

The authority responsible for food regulation in Singapore is the Singapore Food Agency (SFA), which replaced the Agri-Food & Veterinary Authority of Singapore (AVA) in 2019. Although the AVA was replaced by the SFA, it left behind the principles of strict food regulation. In Singapore, every new food product, especially those containing new additives, must go through a risk assessment process. The SFA requires a detailed analysis to make sure the product is safe for consumers.

GOOD Meat 3″ is a hybrid product that uses only 3% farm-raised chicken and is said to provide the same culinary experience as traditional chicken in terms of taste and texture. Other ingredients include vegetable proteins, sunflower oil, coconut oil, natural flavors, modified starch, soy lecithin and spices. The product costs 7.20 Singapore dollars (about JPY 830; PLN 21.70) for 120g.

Israel

Israel is one of the leading countries in the development of cultivated meat technology. Although official regulations are still in development, Israeli authorities are working with technology companies and scientists to introduce regulations for cell culture and meat production. Israel is promoting innovation in this area, attracting many companies operating in the sector.

Australia and New Zealand

Australia and New Zealand, as part of their cooperation on food regulation, have similar rules for novel foods. Food Standards Australia New Zealand (FSANZ) is the body responsible for approving novel food products, including cultivated meat. As in the EU, a product must undergo a thorough safety assessment before it can be placed on the market.

Cultivated meat as great innovation, but also the subject of regulatory challenges

Cultured meat is becoming an increasingly debated topic in the EU, not only in scientific circles, but also among the general public and policy makers. The Italian example is a good illustration of the complexity of regulating this innovative food, where safety concerns and potential risks to traditional meat production systems meet the need for innovation. In this context, further communication and appropriate regulation are crucial to balance innovation with the protection of cultural heritage and farmers’ interests.

Meat consumption in the European Union is not only an environmental issue, but also a highly political and cultural one. The strength of the traditional livestock industry and the cultural importance of the sector make it difficult to carry out effective policies to support a shift away from conventional meat production and consumption. Despite the apparent negative environmental impacts associated with livestock production, EU efforts to create a more sustainable food system face political, economic and social resistance.

The Common Agricultural Policy, as a key mechanism for supporting agriculture, also contributes to the difficulty of implementing change. Spending on that policy in the period between 2014 and 2020 amounted to about 38% of the total EU budget, which shows how important this sector is for the European economy.

At the same time, the EU has committed to ambitious climate and health goals, including through initiatives such as “Food 2030”. Research suggests that reducing meat consumption can help achieve these goals, especially in the context of reducing greenhouse gas emissions. Alternative meat products, such as plant-based meat analogs and lab-grown meat, are seen as a potential solution that could not only reduce the negative environmental impact of animal production, but also meet the demand for meat. Initial analyses suggest that these alternatives could reduce emissions, resource consumption and free up land for other more sustainable activities, such as renewable energy production and carbon capture.

The European Food Safety Authority (EFSA) held a scientific symposium on cell-based foods and food ingredients in May 2023.

The European Commission and EFSA have differing approaches to entrepreneurs and messaging in the context of innovative products such as cell-based foods. During discussions on the development of this industry at EFSA, several key issues were highlighted:

Need for dialogue and consultation

Entrepreneurs from the cell culture industry pointed to the need for earlier consultations with EFSA and the European Commission, especially regarding the data requirements to be provided when submitting applications. Pre-application meetings can help optimize testing, which benefits both entrepreneurs and regulators by making applications more precise and relevant.

Transparency and data protection

The European Commission, under the Transparency Regulation (Regulation (EU) 2019/1381), requires EFSA to publish full applications, excluding only certain information that may be considered confidential. However, businesses are often reluctant to share data, resulting in numerous requests for access to documents submitted by competitors, which creates additional challenges for both companies and EFSA.

Information exchange and cooperation

There is a lack of consistency in information sharing in the cell culture sector. Some companies are more open to collaboration and data sharing, while others, fearing competition, are more cautious. Nevertheless, EFSA is promoting the development of data-sharing standards to foster innovation and improve risk assessment. Platforms for information sharing between universities, entrepreneurs and regulators are also recommended.

In the context of cultivated meat, EFSA has identified several potential toxicological and allergic risks.

Components of the culture medium, such as hormones (e.g. insulin) and growth factors, can remain in the final product despite purification processes. These substances are not typically present in traditional food products, so careful monitoring of their concentrations is necessary. Potential risks associated with proteins present in the product that may act as allergens are also considered in the risk assessment.

Approaches comparing cell culture foods with their traditional counterparts with respect to residues such as insulin, as well as with respect to nutritional composition, can be a valuable tool in assessing the safety of cell culture products.

The need for toxicological and allergy testing can be reduced through comprehensive characterization of the manufacturing process.

In conclusion, while cultivated meat has potential as an innovative alternative to traditional meat, EFSA stresses the need for detailed research into the substances used in the production process and possible allergic reactions to ensure its safety.

Cultivated meat is a future product with the potential to revolutionize the food industry, but its production requires further research and optimization. The use of cell culture technology can bring environmental and ethical benefits, but the development of safety standards and effective communication between all parties involved in the sector will be key.

If you have any questions or concerns regarding the above matter, please feel free to contact our expert, Piotr Wlodawiec: wlodawiec[at]prokurent.com.pl

Author:

Piotr Włodawiec – Attorney-at-law / Senior Partner

Learn more:

Ex‑ante life cycle assessment of commercial‑scale cultivated meat production in 2030