In December 2024, we hosted our last webinar of 2024 featuring Jennifer Holtzman from Health Canada. As a reminder, this is a collaboration among New Harvest, District 3 Innovation Centre and Agriculture and Agri-Food Canada (AAFC).
We had a great response, 40+ participants highly engaged in the discussion. If you missed out, no worries at all! We’ve put together a handy blog post summarizing all the key highlights.
Novel Food Definition and Regulations
The Canadian regulations were designed in the late 1990s for oversight of a range of novel food types, including genetically modified foods and unanticipated future innovations more broadly. Novel foods are defined under three categories in Canada’s Food and Drug Regulations, Part B Division 28:
- a substance that does not have a history of safe use as food
- a food that has been manufactured, prepared, preserved, or packaged by a process that has not been previously applied to that food AND causes the food to undergo a major change
- a food that is derived from a plant, animal, or microorganism that has been genetically modified to alter its characteristics (new, removed, no longer within the anticipated range).
Most if not all cellular agriculture products are expected to fall under one or more of these definitions. Novelty is product-based, meaning that the characteristics of a product and the potential for new, unique, or unknown food safety risks inform its regulatory status, rather than the specific technologies used to develop and produce the product.
Pre-Market Notification Process
Products that meet the regulatory definition of a novel food must undergo a pre-market notification process, including submitting a detailed dossier consisting of a collection of product information as listed in the regulation. Health Canada conducts a safety assessment based on a set of broadly defined endpoints that are effectively the same for all types of novel foods. Health Canada is not prescriptive in terms of specific data and methods to meet these endpoints, so developers have the flexibility to present any combination of scientifically valid evidence (e.g., data, bridging to relevant published articles, and scientifically valid rationale) that pertains to their product. Health Canada assesses the safety of novel foods case-by-case in accordance with the Guidelines that were developed from Codex principles and are aligned with approaches used internationally by peer regulators.
Safety Assessment Components
Information and considerations to address in a novel food notification (i.e., submission dossier) include:
- A description of the novel product and its development
- Molecular characterization showing how changes were made, and what was changed intentionally and unintentionally (if genetically modified)
- A description of the manufacturing process, highlighting critical control points
- Contaminant analysis (both microbial and chemical), including hazard identification, mitigation steps, and validation that the product meets the specifications required to produce food that is safe.
- Dietary exposure
- Toxicology
- Allergenicity
- Nutritional quality
Preparing a well-organized and high-quality submission contributes to a smooth assessment process. This includes providing a clear and easy-to-follow narrative linking each piece of evidence to the relevant safety endpoints, with a level of scientific rigour comparable to what would be presented in a scientific journal article, i.e., including a list of materials and discussion of their purpose and safety, methodologies (high level, not detailed lab protocols), and explanation of study design including proper controls, etc.
Regulatory Support and Transparency
Health Canada offers voluntary pre-submission consultations to provide feedback on the approach companies are planning to take in preparing their submissions, as well as answer questions about the submission review and authorization process. These consultations can support companies in preparing high-quality submissions and identifying and addressing gaps early on. Companies can request multiple meetings with regulators, who maintain the confidentiality of information shared. The decision regarding the level of readiness to submit at a given production scale is up to the company and can be a topic of discussion with regulators.
In addition to pre-submission consultations, Health Canada provides voluntary novelty determinations. This could be useful in cases where a company seeks assistance in determining the regulatory status for specific product components, such as scaffolds or ingredients.
Companies are encouraged to “come early and come often” to discuss with Canadian regulators. The meetings are organized with a view to ensuring the right program experts are included in the discussions.
Transparency in the outcome of regulatory decisions is maintained through the lists of completed novel food safety assessments and non-novel determinations publicly posted on the Health Canada website. For assessed novel foods, a technical summary of the information considered in reaching final decisions is also published. Before publication, petitioners can review this information to ensure no confidential details are disclosed.
Companies can consult the Food and Nutrition Directorate’s (FND) Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods for detailed information on the administrative steps for pre-market assessments relating to novel foods, as well as food additives, and infant formulas. Note that food additives generally require separate pre-market notification from the novel food notification process. Any questions can be discussed with FND.
Timeline and Process
The standard timeline for processing notifications is 410 calendar days from notification receipt to decision, with no clock stoppage for the time with the petitioner to address questions and clarifications. Having pre-submission consultations does not shorten this timeline, but can help submission quality to support a smooth review process. Steps in the review timeline include:
- Administrative verification to ensure all components of the data package are provided.
- Scientific screening to determine if information is provided to address all product characterization and safety endpoints.
- A thorough review of the evidence for safety presented in the submission conducted by Health Canada experts. This step includes any requests to answer questions or provide clarifications within specified timeframes.
- Presentation of the safety assessment conclusions to the Food Rulings Committee of the FND, which makes the final decision.
Following a positive decision, the company is issued a letter of no objection (LONO) granting authorization to sell the product in Canada, subject to all other applicable laws and regulations.
In cases where questions are not adequately addressed during the process, the submission may be closed without prejudice to refiling. Companies can resubmit after gathering additional information, and the submission review will resume. However, the 410-day timeline restarts.
Health Canada’s assessment considerations are based on Codex principles that were originally developed for the assessment of genetically modified organisms (microbes, plants and animals) and also consider the unique aspects of any notified product. Countries that conduct novel food safety assessments generally use a similar approach. However, specific regulatory requirements and administrative processes are particular to each jurisdiction. As such, approval of novel foods in other countries does not directly influence Health Canada’s process. However, publicly available information from other regulators may be considered as additional reference material.
Health Canada’s FND collaborates closely with other Canadian regulatory programs responsible for different areas of oversight relating to cellular agriculture (i.e., environmental safety and animal feed). Regulators share expertise and knowledge to stay informed of developments in this emerging sector.
Current Status and Engagement
Health Canada has launched a website on cellular agriculture, providing information to the industry and the public about regulatory considerations and oversight. Safety assessments have been completed for a number of precision fermentation ingredients (soy leghemoglobin protein expressed in Pichia pastoris, a cow’s milk beta lactoglobulin, human milk oligosaccharides), with summaries posted on the list of completed safety assessments of novel foods. No submission has been made to date for products made using cultivated animal cells.
Health Canada’s FND continues to engage with industry stakeholders, partners, and regulator peers across the world to learn about developments in the cellular agriculture sector and share practical knowledge about Canadian regulations.
FND is currently analyzing the existing novel food guidelines to understand gaps that may exist for cellular agriculture products. Any potential future guidance would be subject to consultation to seek feedback. Industry and academic researchers are encouraged to be proactive in advancing dialogue and knowledge exchange with Canadian regulators on new technologies, new scientific insights, and industry practices.
Open and ongoing collaboration will be important in supporting innovation while maintaining Canada’s high food safety standards and uphold consumer and public trust.
If you want to further your knowledge of the Canadian regulatory approach to cell cultured food products, you can check this paper, Understanding Cell-Cultured Seafood and Its “Food Safety Challenges.” In addition, if you want to support expanding the regulators’ knowledge base through scientific research, you can reach out to yadira@new-harvest.org to discuss your idea or directly to Jennifer Holtzman.
