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Selling infant formula and baby food in Australia

In Australia, infant formula and follow-on formula are regulated by Standard 2.9.1 and Schedule 29 of the Food Standards Code, revised under Proposal P1028 with a transition to 13 September 2029. Labels carry prescribed names, the protein source and set warnings, and must not show a picture of an infant. Food for infants follows Standard 2.9.2.

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

Formula
Standard 2.9.1 and Schedule 29
Food for infants
Standard 2.9.2
Prescribed names
'Infant formula' and 'Follow-on formula'
Follow-on formula
For infants aged 6 to 12 months
Transition
P1028 changes, to 13 September 2029
Toddler milks
Not infant formula products

Before a product goes on sale

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

  1. 1Is the product infant formula, follow-on formula, a special medical purpose product, or food for infants? Read more
  2. 2Does the composition meet the protein, fat and nutritive substance requirements? Read more
  3. 3Does the front of pack carry the prescribed name, protein source and age statement? Read more
  4. 4Are the warning statements and preparation directions present, in the right print size? Read more
  5. 5Is anything on the label a prohibited picture or representation? Read more
  6. 6For food for infants, are sodium, sugars, honey and the minimum age statement in order? Read more

The rules, by area

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

Which products are infant formula products

The categories Standard 2.9.1 covers, and what it leaves out.

  • Infant formula products include infant formula (from birth), follow-on formula (from 6 to 12 months) and special medical purpose products for infants (under medical supervision).
  • They do not include supplementary or modular medical products for infants, toddler milks, or commercial foods for infants and young children.
  • A food may only be represented as infant formula or follow-on formula if it complies with Standard 2.9.1 (section 2.9.1—14).
  • Special medical purpose products for infants may be sold to consumers only by or from a medical practitioner or dietitian, a medical practice, pharmacy or responsible institution, or a majority seller to those.

How we help: Compliant Always records which category each product sits in, with the definition it rests on, so the rules that follow are the right ones. Ask about this

Formula composition

What goes into infant formula and follow-on formula.

  • Standard 2.9.1 and Schedule 29 regulate the composition, labelling and sale of infant formula products, including protein and fat requirements and required and optional nutritive substances.
  • Powdered formula comes with a measuring scoop, except in single-serve sachets.
  • The revised requirements under Proposal P1028 have a transition period from 13 September 2024 to 13 September 2029.

How we help: Compliant Always reads your formulation and certificates of analysis against the Schedule 29 values, and keeps them with each batch. Ask about this

Formula labelling

The names, statements and directions a formula label carries, and what it must not show.

  • The name of the food is on the front, using the prescribed name, with the protein source, such as 'Infant formula based on cow milk'; 'milk' alone is not a protein source.
  • Warnings read 'Warning – follow instructions exactly. Prepare bottles and teats as directed. Incorrect preparation can make your baby very ill.' and, under 'Important Notice', 'Breast milk is best for babies. Before you decide to use this product, consult your doctor or health worker for advice.'
  • The warnings are at least 3 mm high, or 1.5 mm on packs of 500 g or less.
  • Directions in words and pictures cover preparing each bottle individually, refrigerating and using within 24 hours, boiled and cooled water, the enclosed scoop, and discarding leftovers within 2 hours.
  • The label must not show a picture of an infant, idealise formula use, say 'humanised' or 'maternalised', use 'HMO', or claim the formula is suitable for all infants.
  • Stage numbers '1' and '2' may be used, on the front, next to the age statement.

How we help: Compliant Always reads your formula label artwork against each statement and prohibition in Standard 2.9.1, and shows which are missing or present when they should not be. Ask about this

Food for infants

Commercial foods for infants other than formula.

  • Food for infants must not contain honey unless treated to inactivate Clostridium botulinum spores, and has sodium limits, such as 350 mg/100 g for rusks and 100 mg/100 g for ready-to-eat foods (section 2.9.2—3).
  • Food for infants under 6 months is made to a consistency that minimises the risk of choking.
  • The label states the consistency and the minimum age in numbers, and must not recommend the food for infants under 4 months.
  • Food recommended for infants under 6 months carries the warning 'Not recommended for infants under the age of 4 months'; food with more than 4 g/100 g of sugars from added sugars or honey is labelled 'sweetened', and honey as an ingredient is described as 'sterilised'.

How we help: Compliant Always reads your recipe and label against the limits and statements in Standard 2.9.2, with the section beside each. Ask about this

Imported formula and baby food

Border controls for formula and baby food made overseas.

  • Food imported for sale must comply with the Food Standards Code, and importers are responsible for that.
  • FSANZ has assessed infant formula products as medium to high risk in its advice to the Department of Agriculture, Fisheries and Forestry on imported food.
  • Imported food carries an English trade description stating its country of origin.

How we help: Compliant Always keeps the manufacturer's certificates and test reports with each consignment, and shows what expires before the next one ships. Ask about this

Who answers for what

WhoWhat they answer forHow we help
BrandThe formula or food label: names, statements, warnings and what it leaves out.The label checked against Standards 2.9.1 and 2.9.2, with each gap shown.
ManufacturerComposition within Schedule 29 or Standard 2.9.2, and a written recall plan.Formulations and certificates of analysis kept with each batch.
ImporterFormula that meets the Code, import records and a recall plan.Overseas manufacturers' documents read and dated before the goods arrive.
Retailer of special medical purpose productsSelling only through the channels section 2.9.1—31 allows.Product category and channel records kept together.

States and territories

Food standards are developed by FSANZ and adopted without variation by the states and territories, whose agencies and local councils enforce the Food Standards Code. The Department of Agriculture, Fisheries and Forestry enforces it at the border.

The Australian Consumer Law is enforced by the ACCC for widespread issues and by state and territory consumer protection agencies, which handle individual complaints.

Questions businesses ask

Which rules apply to infant formula in Australia?
Standard 2.9.1 and Schedule 29 of the Food Standards Code, which regulate composition, labelling and sale. They were revised under Proposal P1028, with a transition period ending on 13 September 2029.
What is the difference between infant formula and follow-on formula?
Infant formula is for healthy infants as the sole source of nutrition from birth. Follow-on formula is for healthy infants aged 6 to 12 months as part of a diversified diet.
Are toddler milks regulated as infant formula?
No. FSANZ says infant formula products do not include toddler milks, supplementary or modular medical products, or commercial foods for infants and young children.
Can an infant formula label show a picture of a baby?
No. The label must not contain a picture of an infant, or a picture that idealises the use of infant formula or follow-on formula (section 2.9.1—28).
What warnings go on infant formula in Australia?
'Warning – follow instructions exactly. Prepare bottles and teats as directed. Incorrect preparation can make your baby very ill.' and, under 'Important Notice', 'Breast milk is best for babies. Before you decide to use this product, consult your doctor or health worker for advice.'
Can infant formula mention HMOs on the label?
No. The label must not include 'human milk oligosaccharide', 'human identical milk oligosaccharide', 'HMO', 'HiMO' or words with a similar effect (section 2.9.1—28).
Can I use stage numbers on formula?
Yes. '1' for infant formula and '2' for follow-on formula, on the front of the package next to the age statement (section 2.9.1—27).
Can baby food contain honey?
Only if the honey has been treated to inactivate Clostridium botulinum spores. Where honey is an ingredient, the label includes the word 'sterilised' in association with the word 'honey' (Standard 2.9.2).
From what age can baby food be recommended?
Not under 4 months. The label states the minimum age in numbers; food recommended for under 6 months also carries 'Not recommended for infants under the age of 4 months'.
Where can special medical purpose infant formula be sold?
Only by or from a medical practitioner, dietitian, medical practice, pharmacy or responsible institution, or by a majority seller of the product to those (section 2.9.1—31).
How does Compliant Always help with selling in Australia?
Our team reads the rules for the markets you sell in, including the Commonwealth, state and territory layers in Australia. Compliant Always shows which apply to your product and keeps the documents behind each one ready. 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.

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