Infant Formula Products

The regulation of infant formula products has recently been reviewed and gazettal of the new Standards is pending, following the Food Ministers’ Meeting on 25 July 2024. The new regulation is subject to a transition period of 5 years (inclusive of stock-in-trade). During the 5 year period, infant formula products may be sold if they comply with either the Code as in force (as if the variation had not taken effect) or the Code as amended by the draft variations.

Infant formula products are breast milk substitutes that are formulated to provide infants with optimal nutrition for growth and development. 

Although breastfeeding is the recommended way to feed infants, a safe and nutritious substitute for breast milk is needed for infants who are not breastfed. Infant formula products are the only safe and suitable alternative to breast milk.

Infant formula products include infant formula (for use from birth), follow-on formula (for use from 6 – 12 months) and special medical purpose products for infants (for use under medical supervision).

Infant and follow-on formula and special medical purpose product for infants

Use

Infant formula is formulated for healthy infants for use as the sole source of nutrition from birth.

Follow-on formula is formulated for healthy infants aged 6 - 12 months for use as a part of a diversified diet.

Special medical purpose products for infants is formulated for infants with a medically diagnosed disease, disorder or condition and must be used under medical supervision. They are intended for infants from birth. However, some products may be used as a supplementary feed for other age groups based on medical advice.


Regulation

The regulation for infant formula products has recently been updated and revised under Proposal P1028 – Infant Formula

Standard 2.9.1 and Schedule 29 of the Food Standards Code regulates composition, labelling and sale of infant formula products. 

Infant formula products do not include supplementary or modular medical products for infants, toddler milks or commercial foods for infants and young children. 

As special medical purpose products for infants are predominately manufactured overseas and imported into Australia and New Zealand, the standard aligns with the relevant regulations of the European Union as much as possible.


Other information

For further information relating to infant feeding:

For details of dietitians in Australia and New Zealand:

National feeding guidelines for infants:

Caregiver support: