In July 2008, the Department of Health proposed the Regulations Amending the Food and Drug Regulations (1220-Enhanced Labelling for Food Allergen and Gluten Sources and Added Sulphites) (the Regulation). Under the current Food and Drug Regulations (the FDRs), labelling requirements for prepackaged products do not provide consumers with sufficient information about food ingredients. Certain components are exempt from the requirement to list ingredients and the use of some common names, such as casein (a milk protein), does not provide adequate information to consumers who are unfamiliar with such terminology. This lack of disclosure has put consumers with food allergies, Celiac Disease or sulphite sensitivity at risk.

Mandatory Declaration

The proposed regulatory amendment aims to enhance disclosure on prepackaged products to help consumer’s choose safe foods and thus avoid allergen-induced adverse reactions. It applies to all prepackaged foods that have a list of ingredients. The Regulation is similar to labelling requirements implemented in the United States, the European Union and Australia/New Zealand.

The Regulation requires the presence of prescribed food allergen (i.e., nut varieties, milk, eggs, soybeans, fish, shellfish and crustaceans) and gluten sources (i.e., wheat, spelt, kamut, oats, barley, rye and triticale) to be declared either in the list of ingredients or immediately after the list in a prescribed “Allergy and Intolerance Information - Contains:” statement. The Regulation provides specific names which must be used when listing the source of a food allergen or gluten. For example, “milk” must be listed if casein is present in the product. The Regulation also directs that the specific sources of hydrolysed proteins, starches, modified starches and lecithins be identified in the list of ingredients.

Additionally, the presence of added sulphites (food additives composed of sulphurous acid and its salts) totalling 10 parts per million or more must be disclosed in the prescribed “Allergy and Intolerance Information – Contains:” statement. When added sulphites are declared in the statement, the source of each food allergen and gluten in the food must also be declared in the statement, even if these sources are already disclosed in the ingredients list.

The Regulation also requires standardized alcoholic beverages (i.e., beer and wine) and vinegar products, which are currently not required to list ingredients, to declare the presence of food allergens, gluten or added sulphites.


The inadvertent presence of a food allergen or gluten in a product due to cross-contamination is not required to be declared under the Regulation. Health Canada and the Canadian Food Inspection Agency (the CFIA) encourage manufacturers to include precautionary allergen statements like “may contain” on prepackaged food labels to alert consumers to the potential presence of allergens. For further information on precautionary labelling, see the November 2007 issue of the Osler Advertising and Marketing Review.

Furthermore, the mandatory declaration requirements do not apply to certain products that currently are not required to have a list of ingredients. For example, individual portions of food that are served by a restaurant or other commercial enterprise with meals or snacks are exempt from the mandatory allergen labelling requirements unless a list of ingredients has been voluntarily included on the packaging.

Allergen-related Food Recall

The CFIA enforces the FDRs to ensure that manufacturers and importers label prepackaged products correctly. Under the Regulation, the CFIA can request a recall of food products containing undeclared food allergens, gluten or added sulphites. The CFIA will issue an allergy alert to the media if an allergen-related food recall has been initiated.

Looking Ahead

Once the Regulation is issued as a final regulation and published in the Canada Gazette Part II, manufacturers and importers will have one year to implement the new allergen labelling requirements. If a manufacturer or importer chooses to adopt the “Allergy and Intolerance Information” statement as part of its labelling practices before the deadline, the manufacturer or importer must comply with all new labelling requirements set out in the Regulation.

Until the Regulation takes effect, Health Canada and the CFIA strongly encourage manufacturers and importers to adopt the proactive practice of labelling priority food allergens, gluten sources and added sulphites in accordance with Health Canada’s directions for the labelling of prepackaged foods.