P1028 - Infant Formula

The approval report is available below.

The review considered the latest scientific evidence, market developments, changes in international regulations and revised Australian and New Zealand policy guidance, through seven rounds of public consultation, resulting in amendments to five standards and eight schedules in the Code. At gazettal, the amended standard will include:

• clarifications to product categories including renaming of specialised formula to Special Medical Purpose Products for infants (SMPPi) with an accompanying definition, restriction on sale and standalone labelling and composition requirements
• aligning compositional requirements with the latest scientific evidence, breast milk concentrations, Australian and New Zealand nutrient requirements and recently updated international regulations. This included explicitly stating permitted protein and carbohydrate sources, clarifying novel food permissions and updating food additive and contaminant permissions 
• tightening of labelling provisions including:
  • mandating the nutrition information statement
  • clarifying the prohibition on claims
  • prohibiting proxy advertising
  • requiring products to be differentiated using text, imagery and/or colour
  • prescribing voluntary requirements for stage numbers 
  • aligning SMPPi labelling requirements with all other food for special medical purposes.

FSANZ has developed educational resources to assist consumers, healthcare professionals, infant formula manufactures and jurisdictions with the revised regulations. These can be viewed on the infant formula products page.

The approved variation is subject to a transition period of 5 years (inclusive of stock-in-trade), commencing on 13 September 2024. During that 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. By 13 September 2029 all products sold will meet the new standard.

Why we did this work

The proposal aimed to ensure the regulation of infant formula products continues to be safe and suitable. The protection of public health and safety is a primary objective for FSANZ in developing or reviewing food standards. Infant formula must be safe for formula-fed infants to consume, and caregivers need to know how to prepare, use and store the product safely.

The review considered all infant formula products regulated by Standard 2.9.1 of the Code, including infant formula (for use from birth), follow-on formula (for use from 6 to 12 months) and special medical purpose product for infants (for use under medical supervision).

Approval documents

• P1028 Approval report (PDF 3.52MB)
• Supporting Document 1 – Regulatory intent (PDF 1.14MB)
• Supporting Document 2 – Decision regulation impact statement (913KB)

Public consultations

Proposal P1028 commenced in 2013 and was assessed under FSANZ’s major procedure, requiring two statutory calls for submissions. In addition, given the broad scope of the proposal, a further 6 rounds of non-statutory public consultation occurred, each focusing on key aspects of infant formula product regulation. More than 40 stakeholder workshops and targeted consultations were also held. All consultations are now closed.