Cellular agriculture

On this page

• About cellular agriculture
• Safety assessments of cellular agriculture products
• Statutory and regulatory requirements beyond novel food safety assessment
• Labelling of products containing ingredients produced by cellular agriculture methods

About cellular agriculture

Cellular agriculture is an emerging technology in the production of food usually derived from animals (meat, seafood, eggs, milk products) using cell culture methods instead of live animals. This can also be referred to as:

• lab-grown foods
• cell-based foods
• cell-cultured foods
• cell-cultivated foods

Various technologies, including molecular biology, synthetic biology, and tissue culture, are driving advancements in this field of food innovation. Some of these technologies are well-established in food production, while others are still in development.

Ingredients produced by cellular agriculture methods commonly include cultivated animal cells, such as muscle fibre, which is a recent area of innovation in food production. Their production generally involves selecting cells (for example, muscle cells) from a desired animal (for example, chicken) and growing them in controlled culture conditions to produce the desired tissue type. The resulting tissues are intended to be used (for example, baked, grilled, etc.) like any other food ingredient.

Some product developers have used cellular agriculture to describe:

• whole non-animal cells (for example, bacteria or fungi such as yeast) used in a similar way to animal-derived foods
• novel proteins, fats, sugars and other nutrients made from both animal or non-animal cells
• precision fermentation, which uses microorganisms to produce nutrients and other metabolites

We expect that some consumer food products will likely contain a combination of ingredients produced by conventional methods and cellular agriculture technology.

You can find an overview of scientific, safety and other considerations related to cellular agriculture in the Food and Agriculture Organization of the United Nations' document Food safety aspects of cell-based food.

Safety assessments of cellular agriculture products

In Canada, foods and food ingredients that are considered novel under the Food and Drug Regulations require a pre-market safety assessment to show that they are safe before being sold. The majority of cellular agriculture products are likely to be novel in Canada, even if they are already approved somewhere else. Health Canada has already assessed some food ingredients produced from cellular agriculture methods. These food ingredients can be found in our list of completed safety assessments of novel foods. As Health Canada receives submissions for cell-cultivated meat products and completes the safety reviews, these will be presented on that list.

We will:

• conduct the safety assessment of cell-cultivated foods on a case-by-case basis
• consider all the specific aspects of a product, including its development and manufacturing processes
• consider the potential for harmful chemical and microbial contaminants, allergens, toxins, and nutritional quality
• aim to complete safety assessments within 410 calendar days of receiving a novel food pre-market notification

For more information, please consult the:

• guidelines for the safety assessment of novel foods
• pre-market submission management process for food additives, infant formulas and novel foods

To submit a novel food notification, please use the online application form for pre-market submissions.

Health Canada encourages developers of cell-cultivated foods to request a pre-submission consultation with the Food Directorate during the early stages of their product development. These consultations are an opportunity to:

• seek clarity on data requirements
• improve the overall quality of the submission package and thus the predictability of the assessment process

You may send requests for a pre-submission consultation to the Submission Management Information Unit at smiu-ugdi@hc-sc.gc.ca.

Products of cellular agriculture will follow generic rules on food hygiene and safety including:

• good manufacturing practices (GMP)
• hazard analysis and critical control points (HACCP) rules
• the general prohibitions in Sections 4 and 7 of the Food and Drugs Act, which includes the prohibition from selling a food:
  • manufactured under unsanitary conditions
  • containing a poisonous or harmful substance

Statutory and regulatory requirements beyond novel food safety assessment

We expect that consumer-ready products made using cellular agriculture ingredients may also include other ingredients that have specific regulatory requirements. Before manufacturers submit a pre-market notification to Health Canada, all ingredients must comply with the:

• Food and Drugs Act
• Safe Food for Canadians Act
• the regulations associated with these acts

Depending on the intended end use of the ingredients used in making consumer-ready products, additional regulations may apply beyond pre-market food safety considerations. Health Canada, the Canadian Food Inspection Agency (CFIA) and Environment and Climate Change Canada (ECCC) conduct comprehensive pre-market safety assessments before cell-cultivated foods can be sold in Canada.

ECCC conducts ecological assessments to ensure these products don't pose risks to the environment. All new substances are subject to the Canadian Environmental Protection Act, 1999 (CEPA), specifically the:

• New Substances Notification Regulations (Organisms)
• New Substances Notification Regulations (Chemicals and Polymers)

Please refer to the New Substances program for more information and potential obligations under these regulations.

The CFIA has several roles in food safety, for example:

• issuing licences to domestic manufacturers prior to commercial distribution, if the cell-cultivated food is intended for interprovincial trade or export
• verifying that manufacturers comply with the Safe Food for Canadians Regulations, including preventive control plan and traceability requirements and any other mandatory requirements
• conducting pre-market assessment for approval or registration by the Animal Feed Program of cellular agriculture products to be sold in, manufactured in, or imported into Canada for livestock feeds

Learn more about CFIA's role in ensuring food safety in Canada:

• Ask CFIA
• Food Safety for Industry
• Find permits, licences, and approvals

Labelling of products containing ingredients produced by cellular agriculture methods

Like for all foods, certain mandatory food labelling rules apply to products of cellular agriculture. This includes the general prohibitions against label information that is false and misleading as stated in Section 5 of the Food and Drugs Act (FDA) and Section 6 of the Safe Food for Canadians Act (SFCA). Other requirements may also apply for cell-cultured foods, such as composition and common names that are set out in standards of identity. Regulated parties are responsible to comply with these requirements, and CFIA verifies compliance.

For general information on food labelling in Canada, please refer to:

• Food labelling
• Food labelling for consumers
• General principles for labelling and advertising

For an overview of the Canadian legislative framework for labelling, please refer to:

• Labelling legislative framework

For more information for industry, please refer to:

• Food labelling for industry
• Labelling, standards of identity and grades