β-Lactoglobulin protein from Komagataella phaffii yRMK-66

In 2022, Health Canada received a submission to allow the sale of β-lactoglobulin protein produced from a novel yeast strain, Komagataella phaffii yRMK-66. This protein is the same as β-lactoglobulin in whey protein from cow's milk.

In order to determine whether this β-lactoglobulin protein could be sold in Canada as food, the scientists at Health Canada conducted a scientific assessment that ensured that it is safe for consumption. Our scientists also assessed how the genetically modified yeast strain was developed, how the β-lactoglobulin protein was produced and whether it can be toxic or cause allergic reactions.

Scientists with expertise in molecular biology, microbiology, toxicology, chemistry, and nutrition conducted a thorough analysis of the data and the protocols provided by the applicant to ensure the validity of the results.

Following this assessment, it was determined that the β-lactoglobulin protein produced in this yeast strain does not pose a greater risk to human health than whey protein from cow's milk that is currently available on the Canadian market. In addition, Health Canada also concluded that this β-lactoglobulin protein is no different in nutritional value compared to whey protein from cow's milk. β-lactoglobulin produced in this novel yeast strain may produce the same allergic response as milk when it is consumed, so all products containing it will be labelled to indicate that it contains a milk allergen.

Health Canada's assessment of β-lactoglobulin produced from yeast strain K. phaffii yRMK-66 was conducted according to the Guidelines for the Safety Assessment of Novel Foods. The approach taken by Health Canada in the safety assessment of novel foods is based upon scientific principles developed through expert international consultation over the last 20 years with agencies such as the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), and the Organization for Economic Co-operation and Development (OECD). The approach taken by Canada is currently applied by regulatory agencies around the world in countries such as the European Union, Australia/New Zealand, Japan, and the United States.

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