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Selling infant formula and baby food in Canada

In Canada, infant formula (a "human milk substitute" in the Food and Drug Regulations) and baby food are covered by Division 25 of the Food and Drug Regulations and by the Safe Food for Canadians Regulations. A new formula is notified to Health Canada at least 90 days before sale. Labels follow Division 25, and the CFIA enforces.

Updated · Each section links to the official source it comes from

Main rules
Division 25, Food and Drug Regulations
New formula
Notified to Health Canada at least 90 days before sale
Formula label
Common name "infant formula", expiration date, directions
Baby food age claims
Not represented for infants under 6 months
Label language
English and French

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it infant formula, a human milk fortifier or another infant food? Read more
  2. 2Has a new or majorly changed formula been notified to Health Canada? Read more
  3. 3Does the formula label carry the Division 25 particulars? Read more
  4. 4Does the baby food meet the sodium limits and age-claim rules? Read more
  5. 5Is the container a standard size, and is the packaging safe? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Infant formula: composition and pre-market notification

What a formula must contain, and what Health Canada is told before it goes on sale.

  • A human milk substitute is any food labelled or advertised for use as a partial or total replacement for human milk and intended for consumption by infants (B.25.001, FDR).
  • No person shall sell or advertise a new human milk substitute unless the manufacturer notifies the Minister in writing at least 90 days before (B.25.046, FDR).
  • The notification includes the ingredients stated quantitatively, specifications, quality control and manufacturing details, expiration date testing, evidence of nutritional adequacy, packaging type and directions for use.
  • Formula that has undergone a major change in composition, manufacturing or packaging is also subject to pre-market notification.
  • Formula must meet the compositional requirements in the FDR, and may not need any nutritive substance other than water, a source of carbohydrates, or both, added when prepared.

How we help: Compliant Always keeps the notification file, specifications and stability data with each formula, and shows when a change may need a new notification. Ask about this

Infant formula labelling

What a formula's label shows.

  • The common name must be "infant formula" (B.25.045, FDR).
  • An expiration date is required, and formula past it must not be sold (B.25.057, FDR; section 216.1, SFCR).
  • The label gives adequate directions for preparation, use and storage after opening.
  • Nutrients are declared per 100 g or 100 mL as sold and per stated quantity when ready to serve; the label must not use the Nutrition Facts table heading and must not carry the front-of-package nutrition symbol.
  • Mandatory information is in English and French.

How we help: Compliant Always reads the formula label against the Division 25 particulars and keeps the nutrient analysis behind each declared value. Ask about this

Baby food

Food for infants other than formula and human milk fortifiers.

  • Infant foods listed in Table I to Division 25 may not exceed the sodium amounts set for them (B.25.002, FDR).
  • Salt may not be added to infant food containing strained fruit, fruit juice, fruit drink or cereal, other than strained desserts (B.25.003, FDR).
  • Infant foods may state a suitable age group but may not be represented as suitable for infants under 6 months.
  • Foods intended solely for infants aged 6 to 12 months use a specific Nutrition Facts format and must not display the front-of-package symbol.
  • Infant and junior foods that are processed fruit or vegetable products in hermetically sealed packages, traded between provinces or imported, come in 128 mL or 213 mL, or any size from 500 mL to 20 L in 500 mL steps.

How we help: Compliant Always reads recipes and lab reports against the sodium limits and the label against the age-claim rules, with the provision beside each. Ask about this

Packaging

Packaging safety for formula.

  • No person shall sell any food in a package that may yield to its contents any substance that may be injurious to health (B.23.001, FDR).
  • Specific information on packaging materials is provided to Health Canada for infant formula, as packaging forms part of its evaluation.

How we help: Compliant Always keeps packaging suppliers' declarations with each formula, dated, and shows which ones are out of date. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Formula manufacturerComposition, pre-market notification, expiration dating and the label.Notification file, specifications and label kept together and dated.
BrandLabel claims, age statements and directions.Label checked against Division 25, with the evidence in one place.
ImporterA Safe Food for Canadians licence to import, and the recall and traceability duties.Suppliers' documents read and dated before the goods arrive.

Provinces and territories

The federal Acts and regulations in these guides apply across Canada. Provincial regulations may add labelling requirements for products sold within a province, and Quebec has additional requirements on the use of French on products marketed there.

Alcohol is largely provincial: provincial and territorial liquor boards set their own requirements, and liquor imported into a province is consigned to the provincial body authorised to sell it.

Questions businesses ask

Does infant formula need approval before sale in Canada?
A new human milk substitute, or one with a major change, is notified to Health Canada in writing at least 90 days before it is sold or advertised (B.25.046, FDR). Submissions go to the Food Directorate through its online form.
What does the Food and Drug Regulations call infant formula?
A human milk substitute: any food labelled or advertised for use as a partial or total replacement for human milk and intended for consumption by infants, or for use as an ingredient in such a food.
What must an infant formula label show in Canada?
The common name "infant formula", an expiration date, adequate directions for preparation, use and storage after opening, and the nutrient declarations set by Division 25, in English and French.
Can infant formula carry a Nutrition Facts table?
It must not use the Nutrition Facts heading. It declares nutrients per 100 g or 100 mL under Division 25, and may borrow the table's format. It must not carry the front-of-package nutrition symbol.
Can expired infant formula be sold?
No. Infant formula that has passed the expiration date on its label must not be sold, sold unpackaged or used as an ingredient in another food (section 216.1, SFCR).
Can baby food be labelled for babies under six months?
No. Infant foods other than formula and human milk fortifiers may state a suitable age group, but may not be represented as suitable for infants under 6 months.
Can salt be added to baby food in Canada?
Some infant foods may contain added sodium up to set maximums. Salt may not be added to infant food containing strained fruit, fruit juice, fruit drink or cereal, other than strained desserts.
Are there standard container sizes for baby food?
Yes, for infant and junior foods that are processed fruit or vegetable products in hermetically sealed packages traded between provinces or imported: 128 mL, 213 mL, or 500 mL to 20 L in 500 mL increments.
Does baby food carry the front-of-package nutrition symbol?
No. Foods intended solely for infants aged 6 months to under 1 year, and infant formula, are prohibited from displaying it.
How does Compliant Always help with selling in Canada?
Our team reads the rules for the markets you sell in, including Canada's federal rules and the bilingual labelling they share. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Canada and what your paperwork needs to show.

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