Insect-resistant and herbicide-tolerant maize - DP-51291-2

In 2023, Health Canada received a submission to allow the sale of food derived from a novel maize variety referred to as insect resistant and herbicide tolerant maize – DP-51291-2.

The safety of DP-51291-2 for food use was assessed as part of the second pilot of Health Canada and Food Standards Australia New Zealand (FSANZ)'s Safety Assessment Sharing Initiative. For this pilot, FSANZ was the primary assessor and conducted the safety assessment of this maize line. Health Canada acted as the secondary assessor, peer-reviewing FSANZ's initial assessment report for DP-51291-2, providing feedback regarding the report, and used the finalized report to inform the Department's own regulatory decision regarding this product.

In order to determine whether this maize variety developed through recombinant DNA technology could be sold in Canada as food, the scientists at FSANZ conducted a scientific assessment that ensured that it is safe for consumption. FSANZ scientists also assessed how this maize variety was developed, 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 changes made to this novel maize variety do not pose a greater risk to human health than maize varieties currently available on the Canadian market. In addition, it was also concluded that this novel maize variety would have no impact on allergies, and that there are no differences in the nutritional value of this maize variety compared to other traditional maize varieties available for consumption.

The safety assessment conducted by FSANZ and peer-reviewed by Food and Nutrition Directorate evaluators was conducted according to FSANZ's Application Handbook, specifically its guidelines for applications for new foods produced using gene technology. These guidelines are based on internationally established scientific principles and guidelines developed through work in international fora 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), and align with Health Canada's Guidelines for the Safety Assessment of Novel Foods. The approach taken by Health Canada and FSANZ in the safety assessment of novel foods and new foods produced using gene technology, respectively, is currently applied by regulatory agencies around the world in other countries such as the European Union, Japan, and the United States.

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