P1028 - Infant Formula

Through Proposal P1028, FSANZ is reviewing regulatory requirements for infant formula.

Our review aims to ensure regulation of infant formula is clear and reflects the latest scientific evidence. 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.

Second Call for Submissions - submission period closed

Second Call for Submissions (pdf 1.75 mb)

Submissions (ZIP 21MB)

  • Supporting Document 1 - Food technology (pdf 770 kb)
  • Supporting Document 2 - Nutrient composition (pdf 1.11 mb)
  • Supporting Document 3 -  Labelling (pdf 893 kb) 
    • Attachment 1 to SD3 - Consumer Evidence Stage Labelling and Proxy advertising (pdf 467 kb)
    • Attachment 2 to SD3 - Analysis of Current Stage Labelling and Proxy advertising (pdf 520 kb) 
  • Supporting Document 4 - Costs and benefits (pdf 638 kb) 

Living document

Due to the breadth and complexity of the regulatory requirements for infant formula products, FSANZ has also created a 'living document' that provides clarification to questions from stakeholders about the second call for submissions. This document will be updated throughout the course of the consultation to note any clarifications to the second call for submissions documents. 

P1028 Second Call for Submissions - Living Document (PDF 62KB)

First Call for Submissions - submission period closed

FSANZ invited written submissions on the assessment of Proposal P1028 - Infant formula. Submissions closed 17 June 2022. The assessment summarised our considerations to date and presented preferred options for potential amendments to Standard 2.9.1, Schedule 29, and other standards relevant to infant formula product requirements.

1st Call for submissions (pdf 717 kb) 

  • Supporting Document 1 Safety and Food Technology (pdf 541 kb) 
  • Supporting Document 2 Nutrient composition (pdf 513 kb) 
  • Supporting Document 3  Labelling for provision of information (pdf 281 kb) 
    • Attachment to SD3 - Consumer research on infant formula labelling (pdf 320 kb) 
  • Supporting Document 4 Special Medical Purpose Formula for infants (composition and labelling) (pdf 240 kb)
  • Supporting Document 5 Costs and benefits (pdf 153 kb) 
  • Supporting Document 6 Assessment against the Ministerial Policy Guidelines (pdf 137 kb)


FSANZ has summarised stakeholder feedback to the 1st CFS in the following report:

Please note:

The Stakeholder Feedback Summary Report was amended on 9 September 2022 to include one additional submission. Due to a technical issue with FSANZ's submissions portal, we are aware that one submission had been excluded from consideration despite being submitted on time. If you have any concerns about this, please contact standards.management@foodstandards.gov.au

Previous consultation

Given the broad scope of this proposal, FSANZ released several consultation papers in 2021, each focused on key aspects of infant formula regulation:

  1. Safety and technology
  2. Nutrient composition
  3. Regulatory framework and definitions.

These consultations have now closed. See the consultation and submission documents available below.


Infant formula is currently regulated under Standard 2.9.1 - Infant Formula Products and Schedule 29 - Special Purpose Foods in the Australia New Zealand Food Standards Code (the Code). Other standards in the Code also contain provisions related to safety and food technology for infant formula, such as Standards 1.3.1 - Food Additives and 1.4.1 - Contaminants and Natural Toxicants.

Through Proposal P1028, FSANZ aims to revise and clarify standards relating to infant formula (for use from birth to Ministerial policy guidance and alignment with international regulations.

This review considers all infant formula products regulated by Standard 2.9.1 of the Code, including infant formula (for use from newborn), follow-on formula (for use from 6 months

2021 Consultation Paper 3 

Open for comment 8 September 2021 - 20 October 2021

2021 Consultation Paper 2 

Open for comment 8 July 2021 - 2 September 2021

2021 Consultation Paper 1 

Open for comment 21 May 2021 - 7 July 2021

2017 Consultation - IFPSDU

2016 Consultation - Infant formula

Submissions (zip file 27369 kb) | Late comments (pdf 925 kb)

Consultation paper - 23 February 2016 (pdf 749 kb) (includes Attachment 1 - Summary of questions for submitters) (as at 4 May 2016)

2012 Preliminary review - Regulation of Infant Formula Products in the Australia New Zealand Food Standards Code

Additional background

The current  Standard 2.9.1​ was developed based on Proposal P93​, gazetted in 2002. This proposal can be viewed at Proposal P93.