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

(February 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  (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)









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