Canada Grants its First Approval for Animal-Free Milk Protein
On January 31, 2024, Health Canada published[1] its regulatory approval of the first animal-free protein produced by microbial fermentation.[2] Specifically, following a comprehensive review under the Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms (“Guidelines”),[3] Health Canada announced[4] its issuance of a no objection letter, approving the use of β-lactoglobulin protein (“r-βLG”) from yeast strain Komagataella phaffii yRMK-66 in nutritional products (e.g., bars and meal replacers), plant-based beverages, dairy-based products (e.g., cheese), desserts and confections, baked goods, etc.
In Canada, alternative proteins may be evaluated and approved by Health Canada under the regulatory framework for novel foods.[5] Per the announcement, the authority performed a thorough safety assessment of the animal-free protein, covering the development and characterization of the r-βLG production strain, characterization, composition and nutritional quality of the r-βLG compared to whey protein from cow’s milk, toxicology and allergenicity considerations, as well as estimation of its level of consumption. It is worth noting that safety assessment criteria for novel foods derived from animals are still under development in Canada and, thus, Health Canada advises[6] manufacturers or importers of such products to consult with the authority first to understand the applicable data requirements for evaluating the safety of their particular products.
With Canada’s recent approval paving the way, we can see food authorities worldwide are advancing their efforts to create a regulatory framework for alternative proteins. Singapore, the U.S., and Israel have already granted approvals for cultivated meat (more details regarding Israel’s approval can be found in our newsletter - Israel Grants the World’s First Regulatory Approval for Cultivated Beef), while countries such as South Korea are actively formulating new rules[7] to allow industry to commence the regulatory process to obtain approvals for new proteins, including raw materials intended for use in food obtained through new technologies such as cell and microbial cultivation. These regulatory developments offer unique opportunities for companies that are ready to commercialize their products to contemplate market-entry strategies across the globe.
If you need any assistance submitting novel food applications for alternative protein approvals around the world, or have any questions regarding alternative proteins, please do not hesitate to contact David Ettinger (ettinger@khlaw.com), Jenny Xin Li (li@khlaw.com), or your existing contact at Keller and Heckman LLP.
[1] https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/approved-products/b-lactoglobulin-protein-komagataella-phaffii-yrmk-66/document.html
[2] https://www.remilk.com/newsroom/remilk-makes-history-as-first-animal-free-milk-protein-greenlit-for-use-in-canada
[3] https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/guidelines-safety-assessment-novel-foods-derived-plants-microorganisms.html
[4] https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/approved-products/b-lactoglobulin-protein-komagataella-phaffii-yrmk-66.html
[5] https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods.html. Canada maintains a database of approved novel foods deemed safe for human consumption after evaluation, available at: https://www.canada.ca/en/health-canada/services/food-nutrition/genetically-modified-foods-other-novel-foods/approved-products.html.
[6] https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/guidance-documents/guidelines-safety-assessment-novel-foods-derived-plants-microorganisms.html
[7] https://www.mfds.go.kr/brd/m_207/view.do?seq=14965&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1