Tunney's Pasture
A.L. 0701A5
Ottawa, Ontario
K1A 0L2
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Dear
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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.
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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.
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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
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Thank you again for your cooperation on this
important initiative.
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Yours truly,
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Paul Mayers
A/Director General
Food Directorate
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c.c. John Salminen, SC
Ronald Burke, SC
Greg Orriss, ACIA
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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:
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peanuts;
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naming the tree nuts;
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sesame;
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milk;
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eggs;
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naming the fish; naming the crustaceans; naming the
shellfish;
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soy; and
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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:
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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:
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prepackaged confections, commonly known as one bite
confections, that are sold individually, and
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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;
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food products sold in bulk;
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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:
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prepackaged products packaged from bulk on retail
premises, except prepackaged products that are a
mixture of nuts;
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prepackaged individual portions of food that are
served by a restaurant or other commercial
enterprise with meals or snacks;
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prepackaged individual servings of food that are
prepared by a commissary and sold by automatic
vending machines or mobile canteens;
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prepackaged meat, meat by-products, poultry, poultry
meat or poultry meat by-products that are barbecued,
roasted or broiled on the retail premises;
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foods exempted from labelling requirements under
subsections B.01.008(7)and (10) of the FDR; the foods
included in these subsections are:
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components of wax coating products for fruits and
vegetables;
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components of ingredients of a sandwich made with
bread.
Food Directorate
Health Products and Food Branch
Health Canada
February 2004
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