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A1155 – 2’-FL and LNnT in infant formula and other products

Last updated: 28 October 2020

The purpose of the application is to permit the voluntary use of 2’-O-fucosyllactose (2’-FL) alone or in combination with Lacto-N-neotetraose (LNnT), produced by microbial fermentation using genetically modified Escherichia coli(E.coli) strains, in infant formula products and formulated supplementary foods for young children (FSFYC).

Approval Report - 20 December 2019  (PDF1.68 mb) | (Word 298 kb)

Supporting Document 1 - Health effects assessment (at Approval) (PDF 647 kb) | (Word 101 kb)

Supporting Document 2 - Policy guidelines (at Approval) (PDF 290 kb) | (Word 88 kb)

Request for​​ review

​On 17 February 2020 the Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) requested a review of FSANZ's decision in relation to this application.

We have completed our review and after careful consideration of the best available evidence have notified the Forum of our decision to re-affirm the approval of the voluntary addition of 2′-O-fucosyllactose (2′-FL) alone or in combination with Lacto-N-neotetraose (LNnT), produced by microbial fermentation, in infant formula products and formulated supplementary foods for young children.

This decision was notified to the Forum on 30 September 2020 and will be considered at their next face to face meeting.

A full summary of the review and the reasons for the decision are outlined in our review report below:​

Read the Review Report PDF (1.54 mb)​​​ | Word (251 kb)

  • Supporting Document 5 - Innovation in the manufactured food and infant formula sectors ​PDF (1.1 mb)​

Further information on the review process is available on the Food Regulation website.


Second call for submissions 

Submissions: (Zip 7.2 mb)

2nd Call for submissions – 22 July 2019 (PDF 1.34 mb) | (Word 286 kb)

Supporting document 1 - Risk assessment (PDF 2.76 mb) | (Word 2.1 mb)

Supporting document 2 - Policy guidelines (PDF 275 kb) | (Word 86 kb)

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 (Zip 6.2 mb)

Call for Submissions – 22 November 2018 (PDF 1.03 mb) | (Word 175 kb)

Supporting Document 1 - Risk assessment (PDF 2.75 mb) | (Word 2.09 mb)

Supporting Document 2 - Policy guidelines (PDF 269 kb) | (Word 91 kb)


Administrative Assessment Report – 12 January 2018 ​(PDF 178 kb) | (Word 75 kb)


Application (PDF 6.89 mb) | Appendices (Zip 11.5 mb)

Executive Summary (PDF 124 kb)

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