In March 2021, changes to the Australia New Zealand Food Standards Code (the Code) were gazetted to permit the voluntary use of two new substances in infant formula products.
The application sought approval to add 2′-fucosyllactose (2′-FL) alone or in combination with Lacto-N-neotetraose (LNnT). These are human-identical milk oligosaccharides (HiMO), produced using genetically modified bacteria.
Five Year Review
In approving the application, Food Ministers requested a review within 5 years to determine if there remains sufficient evidence of a ‘substantiated beneficial role (of the 2 HiMO) in the normal growth and development of infants, or a technological role’.
Further information on the Food Ministers decision can be found on the Food Regulation website.
FSANZ is committed to reviewing any new evidence on the beneficial role of HiMO in the normal growth and development of infants. As requested by Food Ministers, FSANZ is undertaking a 5-year review of the evidence of a substantiated beneficial role of 2′-FL and LNnT in the normal growth and development of infants.
The findings of this review were considered by Food Ministers in November 2025. It was noted that the addition of 2′-FL and LNnT to infant formula products have been shown to play a beneficial role in the normal growth and development of infants, contributing to a microbiota profile more similar to that of breastfed infants and demonstrating anti-pathogenic effects. Further information can be found on the Food Regulation Website.
Background to Application A1155
FSANZ approved Application A1155 in December 2019.
On 17 February 2020 the Australia and New Zealand Ministerial Forum on Food Regulation (the Forum, currently known as the Food Ministers’ Meeting) requested a review of FSANZ's approval decision. FSANZ's review report reaffirmed our original approval of A1155 without amendment. This decision was notified to the Forum on 30 September 2020.
On 27 November 2020 the Forum considered FSANZ's review report and decided to amend the FSANZ decision. The Forum agreed to allow voluntary addition of 2′-FL and LNnT to infant formula products but not allow voluntary addition of the oligosaccharides to formulated supplementary foods for young children.
Relevant documents, including the 2020 Review Report, Approval Report, consultation documents and the original application are below.
Review Report
- Review Report - 27 November 2020 (1.54MB)
- Supporting Document 1 - Safety and growth assessment (1.16MB)
- Supporting Document 2 - Beneficial effects assessment (1.06MB)
- Supporting Document 3 - Peer review of the safety assessment (390KB)
- Supporting Document 4 - IEAG Summary of conclusions (110KB)
- Supporting Document 5 - Innovation in the manufactured food and infant formula sectors (1.1MB)
Approval Report
- Approval Report (1.68MB)
- Supporting Document 1 - Health effects assessment (at Approval) (647KB)
- Supporting Document 2 - Policy guidelines (at Approval) (290KB)
Second call for submissions
- Submissions (Zipped 7.2MB)
- 2nd Call for submissions - 22 July 2019 (1.34MB)
- Supporting document 1 - Risk assessment (2.76MB)
- Supporting document 2 - Policy guidelines (275KB)
The 2nd CFS has been updated to amend a typographical error in Attachment A Draft Variation to the Australia New Zealand Food Standards Code. The amendment has removed reference to Standard 1.5.2 in Schedule 26.
First call for submissions
- Submissions (Zipped 6.2MB)
- Call for Submissions - 22 November 2018 (1.03KB)
- Supporting Document 1 - Risk assessment (2.75MB)
- Supporting Document 2 - Policy guidelines (269KB)
- Application (6.89MB)
- Appendices (11.5MB)
Administrative assessment
- Administrative Assessment Report (178KB)
- Executive Summary (124KB)