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P1028 – Infant Formula

​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​Page last updated: 25 July 2023

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 Submissio​ns (pdf 1.75 mb)​(word 1.0​6 mb)​

               - 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) ​​

Living document

Due to the breadth and complexity of the regulatory requirements for infant formula products, FSANZ has created a ‘living document’ that provides clarification to questions from stakeholders about the second call for submissions. 

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 C​all ​for submissions (pdf 717 kb)​ (word 728 kb)​


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

Stakeholder Feedback Summary  pdf (pdf 287 kb) (word 125 kb)

 (zip 20.1 mb)

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

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 <12 months of age), comprising category definitions, composition, labelling and representation of products. Although the standards for infant formula are, on the whole, functioning adequately, there is scope to improve the clarity of some standards and to consider the application of 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 <12 months of age) and infant formula for special dietary use (IFPSDU). Toddler milks (designed for young children aged 1–3 years) are not infant formula products and will not be included in this review. These foods are regulated by Standard 2.9.3 as formulated supplementary foods for young children. ​

Stay informed

If you wish to receive updates and future advice about changes to Standard 2.9.1, please contact

 2021 Consultation Paper 3 

Open for comment 8 September 2021 - 20 October 2021

Consultation paper 3 -  Regulatory framework and definition(pdf 6​​31 kb) (word​​ 599 kb)​ ​

Submissions(zip 6.32 mb)

2021 Consultation Paper 2 

Open for comment 8 July 2021 - 2 September 2021

Consultation paper 2 - Nutrient Composition(pdf 1.05 mb)(word 770 kb)

Supporting Document 1 - Nutrition assessment(pdf 485 kb) (word 298 kb)

Submissions(zip 7.26 mb)​

2021 Consultation Paper 1 

Open for comment 21 May 2021 - 7 July 2021

Submissions​(zip 6.06 mb)​

2017 Consultation – IFPSDU

Submissions (zip file 13289 kb)  Late comments (zip file 1738 kb)

Consultation paper – 3 August 2017(pdf 1034 kb) |(word 354 kb)

2016 Consultation – Infant formula​

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

Consultation paper 23 February 2016(pdf 749 kb) |(word 198 kb)​(includes Attachment 1 Summary of questions for submitters) (as at 4 May 2016)

Administrative Assessment Report - 26 July 2013​(pdf 158 kb) |(word 63 kb)


​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​​.



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