FSANZ approved A1155 in December 2019.
Application A1155 sought permission for two new substances in infant formula products and formulated supplementary foods for young children. The permission is for the voluntary use of 2'-O-fucosyllactose (2'-FL) alone or in combination with Lacto-N-neotetraose (LNnT). These are oligosaccharides, produced by microbial fermentation using genetically modified bacteria.
On 17 February 2020 the Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) 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.
Further information on the Forum's decision can be found on the Food Regulation website.
Relevant documents, including the Review Report, Approval Report, consultation documents and the original application are below.
Review Report
- Review Report - 27 November 2020PDF (1.54 mb) | Word (251 kb)
- Supporting Document 1 - Safety and growth assessment PDF (1.16 mb) | Word (257 kb)
- Supporting Document 2 - Beneficial effects assessment PDF (1.06 mb) | Word (146 kb)
- Supporting Document 3 - Peer review of the safety assessment PDF (309 kb) | Word (297 kb)
- Supporting Document 4 - IEAG Summary of conclusions PDF (110 kb) | Word (40 kb)
- Supporting Document 5 - Innovation in the manufactured food and infant formula sectors PDF (1.1 mb)
Approval Report
- 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)
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)
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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