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Food & Nutrition

Tunney's Pasture
A.L. 0701A5
Ottawa, Ontario
K1A 0L2


Dear


You will find enclosed information on Health Canada's regulatory proposal to enhance labelling requirements for specific priority allergens, gluten sources and sulphites in prepackaged foods sold in Canada.

The joint Health Canada/Canadian Food Inspection Agency policy team has now completed the review of the information received during the Business Impact Test and the meetings with interested parties. This information has been very useful for the policy team in reaching conclusions about the proposed scope and application of the regulatory proposals. The scope of the proposed regulatory amendments is described in enclosed Appendix.

Health Canada intends to recommend that the proposed regulatory amendments be published in the Canada Gazette, Part I, by mid-2004. If you have any questions about the proposals, please contact Mr. Ronald Burke, Director, Bureau of Food Regulatory, International and Interagency Affairs, by telephone: (613) 957-1828; fax: (613) 941-3537; or e-mail: Ronald_Burke@hc-sc.gc.ca

Thank you again for your cooperation on this important initiative.

Yours truly,


Paul Mayers
A/Director General
Food Directorate

c.c. John Salminen, SC
Ronald Burke, SC
Greg Orriss, ACIA


Appendix

Proposed Regulatory Amendments to Enhance the Labelling of Priority Allergens in Foods

The proposed regulatory amendments to the Food and Drug Regulations would include:

1) (a) the label declaration of the following foods, or any protein-containing derivatives of these, in the list of ingredients by their common name if added directly as an ingredient in prepackaged foods:

  • peanuts;
  • naming the tree nuts;
  • sesame;
  • milk;
  • eggs;
  • naming the fish; naming the crustaceans; naming the shellfish;
  • soy; and
  • wheat, including spelt and kamut, or oats, barley, rye or triticale, or any protein-containing part thereof and hybridized strains of these grains;

(b) if the name of the allergenic food is not already identified in the common name of the derivative, then the name of the allergenic food would have to appear in brackets following the ingredient;

2) (a) amendments to section B.01.009, which exempts certain ingredients or classes of ingredients from label declaration, to require the declaration of the foods mentioned above or any protein-containing derivative, when they are added as a component of an ingredient listed in the Table to subsection B.01.009(1);

(b) the declaration would be made in the list of ingredients by common name, as if they were an ingredient of that food, followed, in brackets, by the name of the specific allergenic food specified above (e.g. casein (milk)), if it is not already identified in the common name of the derivative;

(c) if more than one component of an ingredient or of a class of ingredient contains the same priority allergen or gluten source, the name of the specific allergen or gluten source may be declared only once in the list of ingredients;

3) identification of the plant or animal source in the common name of all hydrolysed proteins;

4) identification of the specific source of the plant in the common name of all forms of starch (including maltodextrin) or modified starch;

5) identification of the source of lecithin in the common name of lecithin;

6) amendments to subsection B.01.009(1) to require the declaration of sulphites when they have been added to a component of an ingredient listed in the Table to this subsection and are present at a level of 10 ppm or more in the final food product;. the declaration would be a statement that the food contains sulphites or a sulphiting agent, or the word "sulphites", or the words "sulphiting agent", or the name of the sulphiting agent would be shown in the list of ingredients;

Note: The proposed amendments would not change the current requirement for the declaration of sulphites directly added to a food product at any level, as is the case for any food additive or ingredient not exempted from component declaration in the Table to subsection B.01.009(1). The only change would be in the manner of declaration as the proposed regulatory amendments would allow the optional use of a statement to indicate that the food contains sulphites in addition to the current options of declaring "sulphites", "sulphiting agents" or the name of the sulphiting agent in the list of ingredients;

7) a requirement for a statement on the principal display panel of standardized vinegars and alcoholic beverages that the product contains one or more priority allergens, protein-containing derivatives of these allergens and sulphites (if the sulphites are present at a level of 10 ppm or more) should they have been added directly or indirectly to the product;

8) consequential amendments to paragraph B.01.010(3)(b), which lists common names for groups of specific ingredients or components, to reflect the requirements for the declaration of priority allergens and gluten sources.

Exemptions from the Proposed Regulatory Amendments

The following products would be exempted from the proposed requirements:

  • foods exempted from the requirement for a label under subparagraphs B.01.003(a)(i) and (ii) of the Regulations (FDR); the foods included in these subparagraphs are:
    • prepackaged confections, commonly known as one bite confections, that are sold individually, and
    • prepackaged products consisting of fresh fruits or fresh vegetables that are packaged in a wrapper or confining band of less than ½ inch in width;
  • food products sold in bulk;
  • foods exempted from labelling requirements under paragraphs B.01.008(2)(a), (b), (c), (d) and (e) of the FDR; the foods included in these paragraphs are:
    • prepackaged products packaged from bulk on retail premises, except prepackaged products that are a mixture of nuts;
    • prepackaged individual portions of food that are served by a restaurant or other commercial enterprise with meals or snacks;
    • prepackaged individual servings of food that are prepared by a commissary and sold by automatic vending machines or mobile canteens;
    • prepackaged meat, meat by-products, poultry, poultry meat or poultry meat by-products that are barbecued, roasted or broiled on the retail premises;
  • foods exempted from labelling requirements under subsections B.01.008(7)and (10) of the FDR; the foods included in these subsections are:
    • components of wax coating products for fruits and vegetables;
    • components of ingredients of a sandwich made with bread.

Food Directorate
Health Products and Food Branch
Health Canada
February 2004

Date Modified: 2004-03-31 Top