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 and the grounds for review will be published to this website on 5 March 2020.
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)
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