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Hello Isha,
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.
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Short on time? No problem! Here's a quick rundown:
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Health Canada has a website on cellular agriculture providing information to industry and the public about regulatory considerations and oversight.
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Most if not all cellular agriculture products are expected to be novel and require notification to Health Canada and pre-market safety assessment to obtain authorization for sale in Canada
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Health Canada’s considerations for the pre-market safety assessment of novel foods are based on Codex principles, with assessment conducted on a case-by-case basis and taking into account unique aspects of the notified product
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A novel food notification should include a well-organized and clear presentation of product characterization and evidence supporting food safety endpoints, including:
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A description of the novel product and its development
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Molecular characterization (if genetically modified)
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A description of the manufacturing process
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Contaminant analysis (both microbial and chemical)
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Dietary exposure assessment
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Evaluation of toxicology, allergenicity, and nutritional quality
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Health Canada is not prescriptive about the methodology and approaches companies can use to demonstrate product safety as long as these are scientifically valid.
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The time standard for assessing notifications is 410 calendar days. With a positive outcome, the company is issued a letter of no objection (LONO) authorizing the sale of the novel product in Canada. For transparency, a summary of the information assessed is published on the Health Canada website, and companies can review the summary before web posting to confirm the absence of confidential business information.
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Health Canada has completed assessments for a number of precision fermentation ingredients but has not yet received notifications for products made from cultivated animal cells.
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Companies can engage with Canadian regulators at any point during product development, from concept to product notification. Taking part in voluntary pre-submission consultations may increase the quality of submissions. Industry is encouraged to “come early and come often” for dialogue.
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Knowledge exchange opportunities of all kinds (e.g., meetings, events, consultations) are valuable for regulators to stay informed about new science and emerging industry practices and developments in other jurisdictions and for industry to gain familiarity with the regulations for food, feed, and environmental safety.
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Analysis of the existing novel food guidelines is ongoing to identify any gaps to address for products of cellular agriculture. Any future guidance will be subject to consultation.
As regulators continue to learn about this emerging field, they encourage an open dialogue with other stakeholders. Researchers are also invited to share their findings to enhance the scientific understanding of these products. This information could provide regulators with crucial insights into the industry's practices.
If you are interested in presenting your research to regulators or have any other ideas on how we can support their scientific understanding, reach out and let me know!
Cheers,
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February 24, 2025View this email in your browser
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