Language selection

Search

Labelling requirements for infant foods, infant formula and human milk

On this page

Overview

Infant foods, infant formula, human milk fortifiers and human milk sold in Canada are subject to the provisions of the:

When sold intraprovincially, infant foods, infant formula, human milk fortifiers and human milk are subject to the labelling requirements under the FDA and FDR, as well as specific requirements of the SFCA and the SFCR that apply to prepackaged foods sold in Canada, regardless of the level of trade. Provincial regulations may also have labelling requirements that apply when these products are sold within that province.

The labelling requirements detailed in the following sections are specific to these foods. Refer to the Industry Labelling Tool for additional core labelling and voluntary claims and statements requirements that apply to all prepackaged foods.

Infant foods

The information below applies to infant foods, other than infant formula and human milk fortifiers, which are covered in subsequent sections. It is prohibited to sell or advertise for sale an infant food that does not comply with the compositional requirements set out in the FDR [B.25.002, B.25.003, B.25.062, FDR].

Nutrition labelling

There are specific requirements, including format and required nutrients within the Nutrition Facts table for foods solely for infants 6 months to less than 12 months of age. These are outlined in Foods intended solely for infants 6 months of age or older but less than 1 year of age.

It is prohibited to display a front-of-package (FOP) nutrition symbol on foods intended solely for infants 6 months of age or older but less than 1 year of age [B.01.350(15), FDR].

For more information, refer to Foods prohibited from displaying the FOP nutrition symbol in the Front-of-package nutrition symbol labelling guide for industry.

Sodium restrictions

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

It is also prohibited to sell an infant food, other than a strained dessert, that contains strained fruit, fruit juice, fruit drink or cereal if sodium chloride has been added to that food [B.25.003, FDR].

Voluntary claims and statements

There are specific requirements applicable to foods intended solely for children under 4 years of age. Refer to Nutrient content claims on foods intended for children under 4 years of age and Health claims for children under 4 years of age for more information.

Age claims

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 and human milk fortifiers [B.25.061, 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".

Standard container sizes for infant and junior foods

Infant and junior foods that are processed fruit or vegetable products and that are interprovincially traded or imported are subject to standard container sizes when packaged in hermetically sealed packages [187, SCFR].

The container size of these foods must correspond to a net quantity set out in Table 6 of the Standard Container Sizes document, which is incorporated by reference into the SFCR, shown below. If the container is metal, it must also have the dimensions set out for that net quantity [188(1), SFCR].

Standard container sizes for infant and junior foods
Prepackaged food Net quantity by volume Metal container dimensionsTable Note 1 (in millimetres) Metal container dimensionsTable Note 1 (in inches as expressed by industry)Table Note 2
Infant and junior foods that are processed fruit or vegetable products 128 mL 54 × 72 202 × 213.5
213 mL 68 × 76 211 × 300
Any size from 500 mL to 20 L, in increments of 500 mL Any dimensions Any dimensions

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 FDR [B.25.054, B.25.055, B.25.056, 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

The common name must be "infant formula" [B.25.045, FDR].

Expiration date

The expiration date must be present on infant formula and foods that are represented as containing infant formula. For more information on expiration dates, refer to Date markings [B.25.057(1)(f) and (2)(f), FDR].

Infant formula that has passed the expiration date shown on its label must not be sold. It must also not be sold as an unpackaged food or used as an ingredient in another food [216.1, SFCR].

List of ingredients for food represented as containing infant formula

When infant formula is in a food represented as containing infant formula, the common name of the infant formula in the list of ingredients must be followed by a statement of all the components contained in the infant formula [B.25.057(2)(b), FDR]. For more information, refer to List of ingredients.

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(1)(e) and (2)(e), 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(2)(a), FDR].

Nutrition labelling

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 FDR.

The labels for these products are prohibited from using the Nutrition Facts table heading ("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 Division 25 are met [B.01.401(4) and (5), FDR].

Infant formula and foods represented as containing infant formula are prohibited from carrying the front-of-package (FOP) nutrition symbol on their label [B.01.350(15), 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 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:

Compliance of nutrient content declarations

Refer to Compliance of nutrient content declarations of the Foods for special dietary use page for more information on rounding rules and tolerance for these products.

Voluntary claims and statements

Nutrient content claims

All infant formulas in Canada are subject to specific mandatory nutrient requirements set out under Division 25 of the FDR. It is therefore considered inappropriate and misleading to use nutrient content claims to suggest that an infant formula is superior to another based on its nutrient content. Consequently, only a very limited number of nutrient content claims are permitted on infant formulas, mainly to highlight differences in formulas rather than to suggest superiority.

Health Canada's policy is that nutrient content claims, other than iron claims, are only acceptable for formulas represented for infants 6 months of age or older (known as follow-up formulas) because follow-up formulas contain higher levels of some nutrients, such as calcium, to meet the needs of the older infant.

In addition, it is prohibited, on the label of or in any advertisement of an infant formula or a food represented as containing infant formula to make any statement or claim relating to the percent (%) daily value content in the food from [B.25.059, FDR]:

or the number of Calories from:

Iron content claims

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, including nutrient function claims, refer to Health claims for children under 4 years of age.

"Easy to digest" and "easier to digest" claims

All infant formula 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 "easier to 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 of use for function claims for more information.

References to breast-milk

The International Code of Marketing of Breast-milk Substitutes, 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 fortifiers

Human milk fortifiers (HMF) are infant foods which are intended to be added to human milk to increase its nutritional value and provide necessary nutrients for infants who are born prematurely or for other infants as medically required.

Sale of human milk fortifiers

The general public does not have access to HMFs due to the need for medical oversight. HMFs may be sold to individuals outside of hospitals if they have a written order from a physician or, where authorized to do so, from a nurse practitioner or dietitian.

Expiration date

The expiration date of a HMF must be present on both the outer label and inner label. If there is no outer label, the expiration date must appear on the inner label [B.25.020(1)(h), 2(a) and (3), FDR].

A HMF that has passed the expiration date shown on its label must not be sold. It must also not be sold as an unpackaged food or used as an ingredient in another food [216.1, SFCR].

For more information on expiration dates, refer to Date markings.

Lot number

For HMFs, a lot number must be displayed on both the outer and inner label. If there is no outer label, the lot number must appear on the inner label [B.25.020(1)(i) and (3), FDR].

Directions for preparation, use and storage

The outer label of a HMF must include:

If there is no outer label:

Nutrition labelling

HMFs have detailed and explicit labelling requirements, including nutrition labelling requirements, set out in Division 25 of the FDR.

The labels for these products are prohibited from using the Nutrition Facts table heading ("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, and so on, provided the applicable requirements of Division 25 are met [B.01.401(4) and (5), FDR].

HMFs are prohibited from carrying the front-of-package (FOP) nutrition symbol on their label [B.01.350(15), FDR].

Nutrient content declaration

For the quantity of HMF specified in the directions for use, the outer label of a HMF must declare:

If the HMF does not have an outer label, this information must be shown on the inner label [B.25.020(2)(a), FDR].

Voluntary claims and statements

Nutrient content claims

It is prohibited, on the label of or in any advertisement for a HMF, to make any statement or claim related to:

In addition, it is prohibited, on the label of or in any advertisement for a HMF, to make any statement or claim relating to the percent (%) daily value content in the HMF of:

or to the number of Calories from:

Infant formula and human milk fortifier pre-market notification

All new infant formula, and infant formula that has undergone major changes in composition, manufacturing or packaging, are subject to pre-market notification [B.25.046, B.25.048, FDR].

It is prohibited to sell or advertise for sale a HMF unless the Minister has notified the manufacturer that those activities are authorized. Therefore all new HMFs, as well as those that have undergone major changes in composition, manufacturing or packaging, are also subject to pre-market notification [B.25.010 to B.25.018, FDR].

Pre-market submissions for infant formula and HMFs must be submitted to Health Canada's Food Directorate through their online application form. For more information on the procedures related to pre-market submissions and to access the online application form, consult the Food Directorate's pre-market submission management process for food additives, infant formulas and novel foods.

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 consumer prepackaged foods. This includes net quantity, common name, name and principal place of business of the responsible party, storage instructions and durable life date (if applicable).

Consumer prepackaged foods that are distributed for no consideration, such as free samples distributed without exchange of money or other compensation (for example, breast milk samples given to premature babies in hospitals), are exempt from certain labelling requirements under the SFCR, such as net quantity declarations [299, SFCR]. For more information, refer to Exemptions from the Safe Food for Canadians Act and Regulations on the Food products that require a label page.

Common name

The terms "human milk" / "lait maternel" or "lait humain" are acceptable common names for the product in each official language. "Donor human milk" / "lait maternel de donneuse" or "lait humain de donneuse" may also be used to further clarify its description in the common name.

Nutrition labelling for prepackaged human milk

A Nutrition Facts table (NFt) is mandatory for most prepackaged foods sold in Canada. However, due to natural nutrient variation in human milk, it is challenging to establish accurate values to be declared in the NFt on prepackaged human milk. In addition, daily values (DV), the reference upon which the % DV in the NFt is based, have not been established for infants less than 6 months of age. Health Canada has published an interim policy exempting labels of prepackaged human milk from requiring an NFt. This exemption applies to prepackaged human milk and its prepackaged components (for example, human milk cream) distributed in Canada. The policy does not apply to the following foods:

Prepackaged human milk products are therefore exempt from the front-of-package nutrition symbol requirements.

Additional information

Related links

Definitions

Consumer prepackaged
In respect of a food, means packaged in a container in the manner in which the food is ordinarily sold to or used or purchased by an individual – or in which the food may reasonably be expected to be obtained by an individual – without being repackaged, to be used for non-commercial purposes [1, SFCR].
Human milk fortifier

Means a food that

  1. (a) includes at least 1 added vitamin, mineral nutrient or amino acid, and
  2. (b) is labelled or advertised as intended to be added to human milk to increase its nutritional value in order to meet the particular requirements of an infant in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state [B.01.001(3), B.25.001, D.01.001(1), FDR]
Infant
Means an individual who is under the age of 1 year [B.25.001, FDR].
Infant food
Means a food that is labelled or advertised for consumption by infants [B.25.001, FDR].
Infant formula

Means any food that is labelled or advertised

  1. (a) for use as a partial or total replacement for human milk and as intended for consumption by infants, or
  2. (b) for use as an ingredient in a food referred to in paragraph (a) [B.01.001(3), B.25.001, B.25.045, D.01.001(1), FDR]
Junior food
The term "junior food" is not specifically defined in the SFCA or in the SFCR. In general terms, "junior food" refers to a food that contains particles of a size to encourage chewing by infants, but may be readily swallowed by infants without chewing.
New infant formula

Means an infant formula that is

  1. (a) manufactured for the first time
  2. (b) sold in Canada for the first time, or
  3. (c) manufactured by a person who manufactures it for the first time [B.25.001, B.25.045, FDR]
Nutrition symbol

Nutrition symbol means a symbol that is carried on the principal display panel of a prepackaged product under subsection B.01.350(1) [B.01.001(1), FDR].

Date modified: