High Oleic Soybean

In 2020, Health Canada received a submission to allow the sale of high oleic soybean, which was gene-edited using transcription activator-like effector nucleases (TALENs) in order to introduce small nucleotide deletions and disrupt the genes coding for two enzymes involved in the conversion of oleic acid to linoleic acid. In order to determine whether the soybean could be sold in Canada as food, the scientists at Health Canada conducted a scientific assessment that ensured the soybean is safe for consumption, still has all its nutritional value, and therefore does not differ from other soybean available on the market. Our scientists also needed to assess how the soybean was developed and whether it can be toxic or cause allergic reactions.

Health Canada has approved high oleic soybean for sale in Canada. This high oleic soybean is missing working enzymes because of the deletion in these two genes, FAD2-1A and FAD2-1B, that cause the accumulation of oleic acid and the desired high oleic soybean oil profile.

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 changes made to this soybean did not pose a greater risk to human health than soybean currently available on the Canadian market. In addition, Health Canada also concluded that high oleic soybean would have no impact on allergies, and that there are no differences in the nutritional value of high oleic soybean compared to other soybean available for consumption.

Health Canada's assessment of high oleic soybean was conducted according to the Guidelines for the Safety Assessment of Novel Foods. The approach taken by Health Canada in the safety assessment of GM 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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