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GOVERNMENT NOTICES - DEPARTMENT OF HEALTH
FOOD AND DRUGS ACT
Food and Drug Regulations - Amendments
Interim Marketing Authorization
Appendix G - Interim Marketing Authorization for Amendments
to vegetable-based or vegetable and milk based products
There is no provision in the Food and Drug
Regulations to permit the addition of vitamins or
mineral nutrients to vegetable based or vegetable and milk
protein based products, which resemble cheese, so that these
products may contain the important nutrients provided by
cheese. Health Canada has received a request to permit the
addition of vitamins and mineral nutrients to vegetable based
or vegetable and milk protein based products, which resemble
cheese, so that these products may contain the important
nutrients provided by cheese for those individuals who do not
consume cheese for health or other reasons.
Health Canada has completed a safety assessment of the
proposal to permit the addition of vitamins and mineral
nutrients to vegetable based or vegetable and milk protein
based products. Addition of vitamins and mineral nutrients to
these products is consistent with the General Principles
for the Addition of Essential Nutrients to Food
published in the Codex Alimentarius, under the Joint FAO/WHO
Food Standards Programme. In the 1970's, similar principles
were used as the basis for the development of regulations
under the Food and Drugs Act governing the
nutritional quality of simulated meat and poultry products,
simulated whole egg products and substitutes for fruit
juices. In November of 1997, a Notice of Interim Marketing
Authorization was published to allow for the sale of
plant-based beverages as nutritionally adequate alternatives
to milk.
The proposed amendment is in the interest of public health
because it increases the choice and availability of products
with the key ingredients provided by cheese for those
individuals who choose not to consume cheese for health or
other reasons.
Over the years, some stakeholders have expressed concerns
regarding the labelling and representation of this type of
products. The Canadian Food Inspection Agency has determined
that the advertising and labelling of these fortified
products are adequately addressed by the related provisions
of the Food and Drugs Act and the Consumer
Packaging and Labelling Act and the respective
regulations. These provisions prohibit a person from
labelling, packaging, treating, processing, selling or
advertising a food in a manner that is false, misleading or
deceptive or is likely to create an erroneous impression.
Furthermore, where a standard for a food has been prescribed,
these Acts and Regulations prohibit a person from labelling,
packaging, selling or advertising a food in such a manner
that it is likely to be mistaken for that standardized food
unless it complies with the prescribed standard. These Act
and Regulations also prohibit the use of a common name of a
standardized food to describe any food unless that food meets
the provisions set out in the standard.
The Food and Drug Regulations require that a
complete list of ingredients and components be declared on
the label of almost all prepackaged foods. Accurate and
complete ingredient labelling of such foods containing milk
protein will assist consumers with sensitivities to milk
protein to make safe choices from a wide variety of foods in
the marketplace.
Health Canada intends to recommend that the Food and Drug
Regulations be amended to provide that:
(1) Notwithstanding Sections D.01.009, D.01.011 and D.02.009,
no person shall sell a vegetable based or vegetable and milk
protein based product which is similar to a cheese in
appearance, texture, flavour, or odour, to which a vitamin or
mineral nutrient has been added, unless the product, when
ready-to-serve,
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contains not less than 25 g of protein per 100 g in the
case of products intended to have a nutritional value
comparable to ripened (mature) cheese, or not less than 15
g of protein per 100 g in the case of products intended to
have a nutritional value comparable to fresh cheese,
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has not more than 50% of its fat as saturated fat, not
more than 10% of its fat as trans-fatty acids and not less
than 2.5% of its fat as linoleic acid and not less than
1.5% of its fat as linolenic acid,
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contains not more than 600 mg of sodium per 100 g, and
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has a protein rating of not less than 62 in the case of
products intended to have a nutritional value comparable
to ripened (mature) cheese or not less than 37 in the case
of products intended to have a nutritional value
comparable to fresh cheese, as determined by official
method FO-1, Determination of Protein Rating, October 15,
1981.
(2) Subject to subsections (3) and (4), the vitamins and
mineral nutrients listed in column I of the Table to this
section may be added to a product meeting the requirements of
subsection (1) provided that the product contains the added
vitamins or mineral nutrients in the amounts set out in
column II of the Table.
(3) The amount of a vitamin or mineral nutrient that is not
an added ingredient in the product may exceed the amount
listed in column II of the Table to this Section.
(4) The amount of a vitamin or mineral nutrient listed in
column II of the Table to this Section does not include
overages.
(5) The common name of products that meet the requirements in
subsection (1) will be "fortified (naming the proteins/naming
the oil) (naming the form)" (e.g., fortified casein/soy oil
loaf, fortified soy protein/casein/soy oil slices).
(6) The label shall carry the following information,
expressed in the following units per serving of stated
quantity:
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The energy value of the product, expressed in calories
(Calories or Cal) and kilojoules (kilojoules or kJ),
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the protein, fat, linoleic acid and carbohydrate contents
expressed in grams,
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the polyunsaturated, monounsaturated, saturated, and
trans-fatty acid totals expressed in grams,
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the contents of the vitamins and mineral nutrients listed
in the Table to this section, expressed as a percentage of
the recommended daily intakes specified in column II of
Table I to Division 1 and in column II of Table I to
Division 2 of Part D of these Regulations for those
vitamin and mineral nutrients, and
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TABLE
the content of sodium and potassium expressed in
milligrams.
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Item
|
Column I
Vitamin or
Mineral Nutrient
|
Column II
Amount
per g. protein
|
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1.
|
Vitamin A
|
10 RE
|
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2.
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Vitamin B 12
|
0.06 μg
|
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3.
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Riboflavin
|
20 μg
|
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4.
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Niacin
|
0.22 NE
|
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5.
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Calcium
|
30 mg
|
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6.
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Phosphorus
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20 mg
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7.
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Magnesium
|
1 mg
|
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8.
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Zinc
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0.15 mg
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Therefore, it is the intention of Health Canada to recommend
that the Food and Drug Regulations be amended to
permit the addition of vitamins and mineral nutrients to
vegetable based or vegetable and milk protein based products,
which resemble cheese, at levels which are consistent with
Codex General Principles for the Addition of Essential
Nutrients to Foods as indicated above.
As a means to improve the responsiveness of the regulatory
system while enhancing the nutritional well-being of
consumers, an Interim Marketing Authorization (IMA) is being
issued to permit the immediate sale of fortified vegetable
based or vegetable and milk protein based products, which
resemble cheese, so that these products may contain the
important nutrients provided by cheese, while the regulatory
process is undertaken to formally amend the Regulations.
DATE: March 29, 2001
Diane C. Gorman
Assistant Deputy Minister
Health Products and Food Branch
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