The Safety Assessment Process

Safety first: How a GM food makes it to the market

Suppose a seed company develops a corn that rootworm larvae can't devour in the field. This new kind of corn, created by genetically modifying its seeds, can increase yields and cut pesticide use. But the company needs to reassure farmers that the corn will be safe and marketable in Canada.

Before it can sell any genetically modified (GM) food in Canada, a company must file a pre-market notification with Health Canada, which triggers a comprehensive safety assessment to ensure the food is safe and nutritious.

This assessment is carried out by a team of molecular biologists, toxicologists, nutritionists, chemists and microbiologists who work with Health Canada's Food Directorate and use international standards set out by the Codex Alimentarius Commission as their guide.

A company filing a pre-market notification must provide detailed data on the novel GM food, including:

• A technical explanation of the process used to genetically modify the food, such as how the new DNA was introduced into the corn to express a new protein that repels rootworm larvae.
• Full documentation of the nutrient makeup of the GM food - including minerals, fatty acids, amino acids and vitamins - to gauge whether it is nutritionally comparable to the unmodified version.
• Evidence that the GM food does not contain toxins introduced through genetic modification and that the possibility of any toxicity being introduced is remote.
• Verification that the GM food does not contain allergens introduced through genetic modification and that the possibility of any allergens being introduced is remote.
• Detailed information about the safety and composition of the unmodified food, including any inherent undesirable substances associated with unmodified food for comparison with the GM version.
• Proof that levels of undesirable substances associated with the unmodified food have not increased in the GM version.

It typically takes seven to ten years of research before a company has compiled enough data to submit a pre-market notification for a novel food to Health Canada.

Only when there are no concerns about safety or health risks is a proposal to permit sale of the novel food drafted. The proposal is reviewed by a committee that is chaired by the Director General of the Food Directorate and includes senior managers of Food Directorate and representatives from the Canadian Food Inspection Agency, which enforces Health Canada's decision. If the proposal is accepted, the company is notified that Health Canada has no objection to the sale of the novel food.

To keep Canadians fully informed, Health Canada's decisions about all novel foods, including genetically modified ones, are published online at: Novel Food Decisions - Approved Products