2. Product Categories

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Infant, Follow-up, and Young Child Formula
Canada

This section provides the regulatory definition of the food category in scope, or the appropriate food category for the product in scope. Additionally, it provides the food products that belong to this food category along with the definition and specific information on each of these types of food products.

2.1 Category Name & Definition

Category 1

Category Name

Food for infants

Division 25 of the Food and Drugs Regulations is untitled. However, this division has been designated for regulations pertaining to food for infants [1].

Definition

Infant: an individual under the age of one (1) year.

Canadian regulations do not distinguish infant formula based on age. There is no legal category for the follow-on formula. However, pre-market notifications may reference stage feeding based on age (i.e. follow-on formula) since Canadian health professionals recognize this practice.

Category 2

Young child formulas are not specifically regulated in Canadian legislation. They fall under the product category Nutritional supplement, under Food for Special Dietary Use category (Division 24).

Food for Special Dietary Use [2]

A food that has been specially processed or formulated to meet the particular requirements of a person:

in whom a physical or physiological condition exists as a result of a disease, disorder or injury, or
for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods [B.24.001, FDR].

2.2 Product & Definition

1) Human Milk Substitute

Definition

Any food labeled or advertised for use as a partial or total replacement for human milk and as intended for infant consumption, or for use as an ingredient in a food intended for infant consumption. [3]

Specifications/Target Age

Under 1 year of age.

Additional Information

“Infant formula” is the legal common name that can be used for Human Milk substitutes. [3]

2) Nutritional Supplement (under the category Food for Special Dietary Use)

Definition

Nutritional supplement means a food sold or represented as a supplement to a diet that may be inadequate in energy and essential nutrients. It does not include a human milk fortifier; in [B.01.001(1), FDR] [4,5].

Specifications/Target Age

N/A (as defined by manufacturer).

Additional Information

Nutritional supplements must meet nutrient composition requirements as prescribed in B.24.201 [5] of the Food and Drugs Regulations on a per-serving basis when prepared according to directions on the package. Products must also comply with labeling requirements pertaining to nutritional supplements in B.24.202 [5] of the Food and Drugs Regulations.