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P1028 – Infant Formula


Page last updated January 2022.​

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.


Given the broad scope of this proposal, FSANZ released a number of 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 documents available below.

All submissions received in response to the consultation papers will be considered in our ongoing assessment and will inform the first Call for Submission (CFS) report. This report, expected for release in the first quarter of 2022, will summarise our considerations to date and outline a proposed regulatory approach. Stakeholders will have another opportunity to comment through a second CFS expected for release in the third quarter of 2022.  


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–<4 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 complete the details on this form  (Word 101 kb) and send it to


2021 Consultation Paper 3 

Open for comment 8 September 2021 - 20 October 2021

Consultation paper 3 -  Regulatory framework and definition(pdf 631 kb) (word 599 kb) 

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)

2021 Consultation Paper 1 

Open for comment 21 May 2021 - 7 July 2021

Consultation paper 1 - Safety and Food Technology(pdf 715 kb) (word 454 kb)

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)


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