Page last updated: May 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.
1st Call for Submissions
FSANZ invites written submissions on the assessment of the Proposal P1028 - Infant formula. The assessment summarises our considerations to date and presents preferred options for potential amendments to Standard 2.9.1, Schedule 29, and other standards relevant to infant formula product requirements.
FSANZ has extended the final deadline for the 1st call for submissions by one week and invites written comments by 6pm (Canberra time) 17 June 2022.
FSANZ will continue to engage with stakeholders throughout the proposal process, including undertaking workshops during the first consultation period and releasing a second public consultation later in 2022.
If you wish to attend the stakeholder workshops please express your interest via email to email@example.com by Friday 22 April 2022.
We will continue to update our website with further information as this work progresses.
Call for submissions (pdf 717 kb) (word 728 kb)
to SD1 – Microbiological safety of PIF (pdf 150 kb) (word 75.6 kb)
- Attachment to SD3 – Consumer research on infant formula labelling (pdf 320 kb) (word 227 kb)
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:
- Safety and technology
- Nutrient composition
- 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.
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 firstname.lastname@example.org.
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)
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)
– 3 August 2017(pdf 1034 kb) |(word 354 kb)
2016 Consultation – Infant formula
Submissions (zip file 27369 kb) | Late comments (pdf 925 kb)
– 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
The current Standard 2.9.1 was developed based on Proposal P93, gazetted in 2002. This proposal can be viewed at