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 (pdf 1.68 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
The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) has requested a review of FSANZ's decision in relation to this application.
Further information on the review process is available on the Food Regulation website.
Submissions: (zip 7.2mb)
2nd Call for submissions – 22 July 2019 (pdf 1346 kb) | (word 286 kb)
Supporting document 1 - Risk assessment (pdf 2762 kb) | (word 2113 kb)
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.
Submissions (zip 6.2Mb)
1st Call for submissions – 22 November 2018 (pdf 1034 kb) | (word 175 kb)
Supporting document 1 - Risk assessment (pdf 2748 kb) | (word 2099 kb)
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 6892 kb) | Appendices (zip 11572 kb)
Executive Summary (pdf 124 kb)
Applications published on our website may contain material owned by a third party. If you wish to re-use third party material, you may need to seek permission from the copyright owner.