Regulatory update: Proposed regulations for mandatory allergen, gluten and sulphites labelling

On July 26, 2008, Health Canada published proposed amendments to Canada’s Food and Drug Regulations (FDR) regarding the declaration of food allergens, gluten and sulphites. Generally, manufacturers and importers will have one (1) year to comply once the final regulations are published.

The proposed amendments would require the labels of certain prepackaged foods to declare the following ingredients in a prescribed format when present.

  1. Food allergens, defined as any protein, modified protein or protein fraction derived from the following foods: specific nuts (almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios, walnuts, peanuts); sesame seeds; wheat; kamut; spelt; triticale; eggs; milk; soybeans; crustaceans; shellfish; and fish. The food allergen source must be identified on the label.
  2. Gluten, defined as any gluten protein from one of the following cereals, the grain of a hydridized strain created from at least one of the following cereals, or any modified gluten protein or gluten protein fraction derived from the following: barley; oats; rye; triticale; wheat, including kamut or spelt. The gluten source must be identified on the label.
  3. Sulphites when added directly to the food or when the total amount of added sulphites contained within the prepackaged food is 10 parts per million or more.

While the FDR require that a complete and accurate list of food ingredients appears on the labels of most prepackaged foods, presently the composition of certain ingredients, such as flavours and seasonings, do not have to be declared on the label. It appears the proposed allergy regulations attempt to address this gap.

Certain prepackaged foods, such as prepackaged foods made and sold at the same retail store and prepackaged fruits and vegetables whose packaging meets specific requirements, are exempt from mandatory ingredient labelling and thus also exempt from the allergy regulations. However, if a manufacturer chooses to include an ingredient list on an exempt food, then the allergy regulations’ requirements must be met.

Interested persons can comment on the proposed regulations by October 24, 2008. All comments must cite the Canada Gazette, Part I and the date the proposed regulations were published (July 26, 2008). Comments are to be sent to: William Ross, Director, Bureau of Food Regulatory, International and Interagency Affairs, Department of Health, 200 Tunney’s Pasture Driveway, Address Locator 0702C1, Ottawa, Ontario, K1A 0K9, telephone 613-946-4591, fax 613-941-3537, e-mail


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