P1028 – Infant Formula  

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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)​

• ​Supporting Document 1 – Food technology (pdf 770 kb) ​(word 212 kb)​​​
• Supporting Document 2 – Nutrient composition (pdf 1.11 mb) ​(word 346 kb)​
• Supporting Document 3 –  Labelling (pdf 893 kb)​(word 346 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)(word 239 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]​​

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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)​

• Supporting Document 1 – Safety and Food Technology (pdf 541 kb)​ (word 319 kb)
• ​           -  Attachment to SD1 – Microbiological safety of PIF (pdf 15​0 kb) (word 75.6 kb)
• Supporting Document 2 – Nutrient composition (pdf 513 kb) (word 278 kb)
• Supporting Document 3 –  Labelling for provision of information(pdf 281 kb) (word 164 kb)
•             - Attachment to SD3 – Consumer research on infant formula labelling ​(pdf 320 kb) (word 227 kb)
• Supporting Document 4 – Special Medical Purpose Formula for infants (composition and labelling)​(pdf 240 kb)   (word 131 kb)
• Supporting Document 5 – Costs and benefits​(pdf 153 kb) (word 84.6 kb)
• Supporting Document 6 – Assessment against the Ministerial Policy Guidelines (pdf 137 kb) (word 84.1 kb

Submissions

FSANZ has summarised stakeholder feedback to the 1^st 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 standards.management@foodstandards.gov.au

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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.

Background

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 standards.management@foodstandards.gov.au.
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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

• Consultation paper 1 – ​Safety and Food Technology(pdf 715 kb) (word 454 kb)
• ​Supporting Document 1 - Food Additives  (pdf 694 kb)   (word 270 kb)
• Supporting Document 2 - L-lactic acid producing microorganisms (pdf 369 kb)   (word 478 kb)
• Supporting Document 3 - Review of powdered infant formula effect of storage temperature (pdf 185 kb)   (word 90kb) 
• Supporting Document 4 - Consumer research (pdf 437 kb)  (word 911 kb)

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)

• Supporting Document  1 – Definitions & nutrient composition ​(pdf 1199 kb) |   (word 480 kb)
• Appendix 1 – Labelled composition available on the retail market in Australia & New Zealand ​(pdf 664 kb) | (word 117 kb)
  
• Attachment A1.1 – Nutrition assessment (pdf 1253 kb)​ |(word 397 kb)
• Supporting Document 1 – A1.1 Appendices 1–4 ​(pdf 721 kb) |  (word 229 kb) 
• Supporting Document 2 – Safety & food technology ​(pdf 1509 kb) |  (word 561 kb)
  
• Supporting Document 3 – Provision of information ​(pdf 569 kb) |  (word 147 kb)
  

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

• Infant formula review Consultation Paper (word 166 kb)​
  
• Infant formula review Consultation Paper - Supporting Document 1​ (word 93.5 kb)​

​​​Additional background