P1028 - Infant Formula

Proposal P1028 – Infant Formula reviewed the regulatory requirements for infant formula products in the Australia New Zealand Food Standards Code (the Code). The FSANZ Board approved variations to the regulatory requirements on 4 June 2024. These are being considered by Australian and New Zealand food ministers, with a final decision anticipated by late August 2024.

The variations will be gazetted if food ministers do not request a review. At gazettal, the Code will be amended to incorporate revision of 5 standards and 8 schedules. The amendments include changes to the regulatory framework, definitions for product categories, nutrient composition, food additives, contaminants and labelling of infant formula products.

The approved variation is subject to a transition period of 5 years (inclusive of stock-in-trade), commencing on the day of gazettal. 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.

Why we did this work

The proposal has ensured the regulation of infant formula products continues to be safe and suitable, while taking account of the latest scientific evidence, market developments, changes in the international regulatory context and revised Australian and New Zealand policy guidance. 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).

Key amendments include prohibiting the cross-promotion of other similar products on infant formula product labels, mandating the nutrition information panel to better assist caregivers in making informed choices and a restriction on sale for special medical purpose product for infants to ensure appropriate access and use of these specialised products.

Approval documents

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.

Second call for submissions

FSANZ released the second call for submissions on the assessment of Proposal P1028 from 26 April to 7 July 2023. At this time, FSANZ sought comment on the proposed draft variation to the Code. This included amendments to Standard 2.9.1 and consequential amendments to Schedule 29 and other standards and schedules relevant to infant formula products. The second call for submissions, associated supporting documents and the submissions received are available below.

  • Second call for submissions (pdf 1.75 mb)
  • 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) 

Submissions

Due to the breadth and complexity of the regulatory requirements for infant formula products, FSANZ responded to questions from stakeholders in order to provide clarification about matters relating to the second call for submissions. This clarification is provided in the document below.  

First call for submissions

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.

  • First 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)

Submissions

2021 Consultation Paper 3 

FSANZ consulted on the regulatory framework and definitions from 8 September to 20 October 2021.  

2021 Consultation Paper 2 

FSANZ consulted on the nutrient composition requirements from 8 July to 2 September 2021.   

2021 Consultation Paper 1 

FSANZ consulted on safety and food technology requirements from 21 May to 7 July 2021.  

2017 Consultation - IFPSDU

FSANZ consulted on the requirements for infant formula products for special dietary use from 3 August to 28 September 2017. 

2016 Consultation - Infant formula

FSANZ consulted on the preliminary consideration of issues related to infant formula regulation from 23 February to 31 May 2016. 

2013 Administrative Assessment Report 

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.