GOVERNMENT NOTICES - DEPARTMENT OF HEALTH
FOOD AND DRUGS ACT
Food and Drug Regulations - Amendments
Interim Marketing Authorization
Appendix F - Interim Marketing Authorization for Amendments
to Plant-based Beverages
There is no provision in the Food and Drug
Regulations to permit the addition of vitamins or
mineral nutrients to beverages made from plant bases such as
soy, rice, almond, etc. Health Canada has received a request
to permit the optional addition of vitamins and mineral
nutrients to plant-based beverages to enable them to be used
as nutritionally adequate alternatives for milk for those
individuals who are allergic to milk protein or are lactose
intolerant.
Health Canada has completed a safety assessment of the
proposal to fortify plant-based beverages as an alternative
for milk and considers this request to be in the public
interest. This fortification is consistent with the General
Principles for the Addition of Essential Nutrients to Food
published in the Codex Alimentarius, under the Joint Food and
Agriculture Organization of the United Nations/World Health
Organization Food Standards Programme. The General Principles
state:
5.1 “Where a substitute food is intended to
replace a food which has been identified as a significant
source of energy and/or essential nutrients in the food
supply, and particularly where there is demonstrated evidence
of public health need, nutritional equivalence in terms of
the essential nutrients of concern should be strongly
recommended.”
This rationale was used as a basis for the development of the
current 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.
Consultation with Canadian soy and dairy product producers,
manufacturers and importers, industry associations, health
professional associations, provincial governments and members
of the public was conducted in 1996. There was general
support for the fortification of plant-based beverages with
vitamins and mineral nutrients. In order to inform consumers
that not all of these products contain the levels of protein
found in milk, the statement "Not a source of protein" would
be required on the labels of products which do not have a
minimum level and quality of protein.
Some respondents had concerns regarding the labelling and
representation of these products. The Canadian Food
Inspection Agency has determined that advertising and
labelling should be covered by the general labelling
provisions of the Food and Drugs Act and Regulations
and the Guide to Food Labelling and Advertising.
Health Canada intends to recommend that the Regulations be
amended to provide that:
(1) Notwithstanding sections D.01.009, D.01.011 and D.02.009
and subject to subsection (5), no person shall sell a
beverage derived from legumes, nuts, cereal grains, or
potatoes to which a vitamin or a mineral nutrient has been
added unless the food, when ready-to-serve,
-
contains not less than 2.5 g of protein of a nutritional
quality equivalent to not less than 75% of casein per 100
mL;
-
contains not more than 3.3 g of fat per 100 ml of which
not more than 65% shall be saturated fatty acids, not more
than 5% trans fatty acids and not less than 2.5% linoleic
acid;
-
subject to subsection (3) and (4), contains the vitamins
and mineral nutrients listed in column I of Table I to
this Section in the amounts listed in column II.
(2) Subject to subsections (3) and (4), one or more of the
vitamins and mineral nutrients listed in column I of Table II
to this section may be added to a beverage meeting the
requirements of subsection (1) provided that the beverage
contains the added vitamin or mineral nutrient in the amount
set out in column II of Table II.
(3) The amount of a vitamin or mineral nutrient that is not
an added ingredient in the food may exceed the amount listed
in column II of Table I and Table II to this Section.
(4) The amount of a vitamin or mineral nutrient listed in
column II of Table I and Table II to this Section does not
include overages.
(5) The label of a beverage that does not meet the
requirements of paragraph (1)(a), but meets all other
requirements of subsection (1) shall carry the expression "
Not a source of protein" in close proximity to and in the
same size type used for the common name.
(6) The common name of a beverage meeting the requirements of
subsection (1) shall be " fortified (naming the plant)
beverage".
(7) Ingredients or components derived from milk, goat's milk
or milk products may not be used in the manufacture of a
fortified (naming the plant) beverage.
(8) The label shall carry the following information per
serving of stated quantity:
-
the energy value of the food, expressed in Calories
(Calories or Cal) and kilojoules (kilojoules or kJ),
-
the protein, fat, linoleic acid and carbohydrate contents
expressed in grams,
-
the contents of the vitamin and mineral nutrients listed
in Table I to this section and any of those vitamin and
mineral nutrients, except potassium, listed in Table II to
this section that have been added to the food, expressed
as a percentage of the recommended daily intake specified
in column II of the tables to Divisions 1 and 2 of Part D
for those vitamin and mineral nutrients,
-
the content of sodium and potassium expressed in
milligrams
TABLE I
Item
|
Column I
Vitamin or Mineral Nutrient
|
Column II
Amount per 100 mL ready-to-serve
|
1.
|
vitamin A
|
40 RE
|
2.
|
vitamin D
|
0.85 ug
|
3.
|
vitamin B12
|
0.4 ug
|
4.
|
riboflavin
|
0.15 mg
|
5.
|
calcium
|
125 mg
|
6.
|
zinc
|
0.4 mg
|
TABLE II
Item
|
Column I
Vitamin or Mineral Nutrient
|
Column II
Amount per 100 mL ready-to-serve
|
1.
|
vitamin B6
|
0.04 mg
|
2.
|
vitamin C
|
1.0 mg
|
3.
|
thiamine
|
0.04 mg
|
4.
|
niacin
|
0.85 NE
|
5.
|
folacin
|
5.0 ug
|
6.
|
pantothenic acid
|
0.35 mg
|
7.
|
phosphorus
|
100 mg
|
8.
|
potassium
|
150 mg
|
9.
|
magnesium
|
12 mg
|
This notice is, therefore, to advise the public of the
intention to promulgate an amendment to the Food and Drug
Regulations to permit the optional addition of vitamins
and mineral nutrients to plant-based beverages at levels
which are consistent with Codex General Principles for
the Addition of Essential Nutrients to Foods as
indicated in the Table 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 hereby
being issued to permit the immediate sale of fortified
plant-based beverages as nutritionally adequate alternatives
for milk while the legal process to amend the Regulations
formally is undertaken.
November 20, 1997
J.Z. LOSOS, M.D.
Deputy Minister
Health Protection Branch
|