Annex 1

Health Risk Assessments in Support of Mitigating Food Allergy Incidents in Canada

The Bureau of Chemical Safety in Health Canada's Food Directorate will continue to conduct health risk assessments related to food allergens. These assessments usually relate to the mis-labelling of prepackaged foods discovered by the CFIA through periodic ingredient verification, or investigation of adverse response incidents or illness where an individual has consumed food containing an offending ingredient.

Risk assessments take into consideration several elements including:

• References from the scientific and medical literature related to threshold levels for reactions to food allergens (where available);
• Previous reports on adverse responses;
• Information on prevalence of food allergies and sensitivities;
• A consumption estimate for the amount of the undeclared/hidden ingredient that triggered or is likely to trigger the adverse response;
• The likelihood that a life-threatening reaction could occur.

From the health risk assessment the Bureau assigns a health risk classification to the particular incident.

• Health risk no. 1: The situation poses a risk that may cause severe adverse health consequences or death and/or there is the potential for further cases with severe consequences.
  
• Health risk no. 2: The situation may cause temporary, non life-threatening, adverse health consequences or may contribute to a long-term chronic illness. The probability of serious adverse consequences is low or remote.
  
• Health risk no. 3: The situation is an indication of a breakdown in good manufacturing practices and is not likely to result in an adverse health consequence.

If the risk assessment conducted by Health Canada identifies a significant health risk due to the inappropriate declaration of the presence of an allergen, the CFIA is prepared to take enforcement action. Enforcement and compliance actions that may be undertaken by the CFIA include education, product seizure, product detention, forfeiture of product and prosecution.