Labelling Requirements for Infant Foods, Infant Formula and Human Milk

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Table of Contents

Overview

This section provides information on the labelling requirements for infant foods, infant formula and human milk subject to the Food and Drugs Act (FDA), the Food and Drug Regulations (FDR) and the Consumer Packaging and Labelling Act (CPLA) and Consumer Packaging and Labelling Regulations (CPLR). In addition, provincial regulations may also have labelling requirements for infant foods and infant formula that apply to products sold in that province.

The requirements detailed in the following sections are specific to infant foods (definition) and infant formula (definition). They are in addition to the core labelling and claims and statements pages of the Industry Labelling Tool that apply to all prepackaged foods.

Infant Foods

The information below applies to infant foods other than infant formula. Infant formula is covered in the following section. It is prohibited to sell or advertise for sale an infant food that does not comply with the compositional requirements set out in the Food and Drug Regulations [B.25.002, B.25.003, FDR].

Nutrition Labelling for Infant Foods

There are specific nutrition labelling requirements, including format and required nutrients within the Nutrition Facts table for foods solely for children under two years of age. These are outlined in Foods Intended Solely for Children Under Two Years of Age.

Sodium Restrictions on Infant Foods

Infant foods are subject to maximum sodium levels. It is an offence to sell or advertise for sale an infant food that contains more sodium than that provided for in the Food and Drug Regulations [B.25.002 & B.25.003, FDR].

Voluntary Claims and Statements for Infant Foods

There are specific requirements applicable to foods intended solely for children under two years of age. Refer to Nutrient Content Claims on Foods Intended Solely for Children Under Two Years of Age and Children Under Two Years of Age in Health Claims for more information.

Age Claims on Infant Foods

It is acceptable, on the label of infant foods, to indicate an age group for which the product is suitable. However it is not permitted to represent infant foods as being suitable for infants under the age of 6 months, with the exception of infant formula [B.25.061 of the FDR]. The claim should not be presented in the form of a "recommendation". An acceptable statement would be "Suitable for infants between 6 and 12 months of age".

Infant Formula

It is prohibited to sell or advertise for sale an infant formula that does not comply with the compositional requirements set out in the Food and Drug Regulations [B.25.054 & B.25.062, FDR]. It is also not permitted to sell or advertise for sale an infant formula that, when prepared according to directions, requires the addition of a nutritive substance other than water, a source of carbohydrates, or both [B.25.053, FDR].

Common Name for Infant Formula

The common name for all human milk substitutes (definition) must be "infant formula" [B.25.045, FDR].

Expiration Date for Infant Formula

The expiration date must be present on infant formula and foods that are represented as containing infant formula. For information, refer to Date Markings [B.25.057, FDR].

List of Ingredients for Infant Formula

When infant formula is in a food represented as containing infant formula, the common name of the human milk substitute in the list of ingredients must be followed by a statement of all the components contained in the infant formula [B.25.057, FDR]. For more information, refer to List of Ingredients.

Infant Formula Pre-market Notification

All new infant formula (definition) and infant formula that has undergone major changes in composition, manufacturing or packaging is subject to pre-market notification [B.25.046 & B.25.048, FDR]. Labels must be submitted to Health Canada for review as part of the pre-market notification, at the following address:

Assistant Deputy Minister
Health Products and Food Branch
Health Canada
1st Floor, Health Protection Building
Tunney's Pasture, A.L. 0701A1
Ottawa, Ontario
K1A 0L2

Directions for Preparation, Use and Storage

The label of an infant formula and foods that are represented as containing infant formula must have adequate directions for the preparation, use and storage after the container has been opened [B.25.057, FDR].

Statement for Foods Represented as Containing Infant Formula

The label of foods represented as containing infant formula must have a statement on the principal display panel indicating the proportion of infant formula present in the food as offered for sale, in close proximity and in equal prominence to any claim regarding the presence of the infant formula in the food [B.25.057, FDR].

Nutrition Labelling for Infant Formula

Infant formula and foods that are represented as containing infant formula have detailed and explicit labelling requirements, including nutrition labelling requirements, set out in Division 25 of the Food and Drug Regulations.

The labels for these products are prohibited from using the Nutrition Facts table heading (i.e. "Nutrition Facts", "valeur nutritive" or "valeurs nutritives"). An appropriate heading in this case could be anything reasonable, including "Nutrition Information". However, these products may voluntarily use the Nutrition Facts table format with respect to order of presentation, naming of nutrients, fonts, layout, etc. provided the applicable requirements of Divisions 25 are met [B.01.401(4) & (5), FDR].

Nutrient Content Declaration

The label of infant formula and foods that are represented as containing infant formula must declare per 100 grams or 100 millilitres as sold and per stated quantity when ready to serve:

  • the content of protein, fat, available carbohydrate, ash, and when present, crude fibre, in grams;
  • the energy value in Calories;
  • the amount of vitamins and mineral nutrients listed in table II to Division 25 in International Units or milligrams; and
  • the content of choline and any added nutritive substance normally contained in human milk (e.g., nucleotides, docosahexaenoic acid [DHA] and arachidonic acid [ARA]) in grams or milligrams [B.25.057, FDR].

The label of foods that are represented as containing infant formula must also declare per 100 grams or 100 millilitres of the infant formula portion of the food as offered for sale:

  • the content of protein, fat, available carbohydrate, ash, and when present, crude fibre, in grams;
  • the energy value in Calories;
  • the amount of vitamins and mineral nutrients listed in table II to Division 25 in International Units or milligrams; and
  • the content of choline and any added nutritive substance normally contained in human milk (e.g., nucleotides, DHA and ARA) in grams or milligrams [B.25.057, FDR].

Compliance of Nutrient Content Declarations

Refer to Compliance of Nutrient Content Declarations of the Food for Special Dietary Use page for more information on rounding rules and tolerance for these products.

Voluntary Claims and Statements for Infant Formula

Nutrient Content Claims

Some Nutrient Content Claims are not permitted on infant formula or a food represented as containing infant formula [B.01.503(2), FDR]:

Refer to Nutrient Content Claims on Foods Intended Solely for Children Under Two Years of Age for information on permitted claims.

In addition, it is prohibited, on the label of or in any advertisement of an infant formula to make any statement or claim relating to the percent (%) daily value content in the food from:

  • fat,
  • saturated fatty acids and trans fatty acids,
  • sodium,
  • potassium,
  • carbohydrate,
  • fibre, or
  • cholesterol;

or the number of Calories from:

  • fat, or
  • saturated fatty acids and trans fatty acids.

[B.25.059, FDR].

Iron Content Claims and Infant Formula

Other than identifying the quantity of iron on the label, it is prohibited to make a claim with respect to the iron content of an infant formula unless it contains at least 1 mg of iron per 100 available Calories [B.25.058, FDR].

Representations Pertaining to the Presence of Specific Fatty Acids

A statement regarding the presence of specific fatty acids in infant formula is permitted. For instance, these may be used to differentiate infant formula with and without added sources of the long chain fatty acids, docosahexaenoic acid (DHA) and arachidonic acid (ARA), the addition of which is not mandatory.

Example: the statement "with added DHA (an omega-3 fatty acid) and ARA (an omega-6 fatty acid)" would be acceptable. However, since all infant formulas are required to contain linoleic acid, an omega-6 fatty acid, and alpha-linolenic acid, an omega-3 fatty acid, it is important that statements regarding the content of "omega-3" and " omega-6" fatty acids do not imply that DHA and ARA are the only omega-3 and omega-6 fatty acids in an infant formula.

Health Claims

For information on the use of Health Claims, refer to Children Under Two Years of Age.

Easy to Digest Claims on Infant Formula

All infant formula (definition) in Canada must be demonstrated to be digestible, tolerable and provide adequate nutrition for growth and development. All "easy to digest" claims are equally applicable to all infant formula. Therefore, if used, these claims need to be qualified by a statement to the effect that "as all infant formula, this product is easy to digest". Digestion is a complex process, with multiples components and therefore, it is not a single measurable physiologic event or function. The substantiation for an "easy digest" claim should be based on all or multiple aspects of the digestive process.

Such claims, on food labels or in advertising, whether explicit or implied, are subject to pre-market assessment by the Food Directorate of Health Canada. See Science Research in Conditions for Use for Function Claims for more information.

References to Breast-milk

The International Code of Marketing of Breast-milk Substitutes - (PDF 128 kb), to which Canada is a signatory, outlines labelling principles that promote clear labelling regarding the appropriate use of an infant formula while promoting breastfeeding. Comparing infant formula to breast-milk, including comparisons of the levels of a nutrient in infant formula to the levels of the same nutrient in breast-milk, is contrary to the message embodied in the Code.

The Canadian Food Inspection Agency (CFIA) and Health Canada (HC) strongly urge the infant formula industry to support and implement the principles of the International Code of Marketing of Breast-milk Substitutes. In addition, HC and CFIA guidance with respect to subsection 5(1) of the FDA aligns with certain principles set out in the Code. For example, highlighting an ingredient in infant formula as a key component of breast-milk is considered misleading as many components in breast-milk are equally important.

Human Milk

Human milk is considered to be an unstandardized food, subject to the same safety, compositional and labelling requirements as other unstandardized foods. If sold or distributed in prepackaged form, human milk is subject to the same labelling requirements as for all prepackaged foods. This includes nutrition labelling, net quantity, common name, identity and principal place of business of the responsible party, storage instructions and durable life date (if applicable).

Common Name for Human Milk

The terms "Human Milk / Lait maternel" are acceptable common names for the product in each official language. "Donor Human Milk / Lait maternel de donneuse" may also be used to further clarify its description in the common name.

Nutrition Labelling for Human Milk

Nutrition labelling information for human milk must be provided in accordance with the requirements related to foods for children under two years of age set out in section B.01.403 of the Food and Drug Regulations (FDR). Note that the information must be provided for all 13 core nutrients and declared per serving size. As described in section B.01.405 of the FDR, for prepackaged multi-serving human milk intended solely to be portioned and served by an institution (such as a milk bank), there is flexibility to provide this information on an accompanying document.

Additional information

Related Links

Definitions

Human Milk Substitute (Infant Formula)

A food that is represented for use as a partial or total replacement for human milk and intended for consumption by infants, or for use as an ingredient in a food that is represented for use as a partial or total replacement for human milk and intended for consumption by infants [B.25.001, FDR].

Infant

A person who is under the age of one year [B.25.001, FDR].

Infant Food

A food that is represented for consumption by infants [B.25.001, FDR].

New Human Milk Substitute (New Infant Formula)

A human milk substitute that is manufactured for the first time, sold in Canada for the first time, or manufactured by a person who manufactures it for the first time [B.25.001, FDR].

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