A1265 - 2'-FL DFL, LNT, 6'-SL sodium salt and 3'-SL sodium salt for use as nutritive substances in infant formula products

This application seeks to permit the voluntary use of four human-identical milk oligosaccharide (HiMO) ingredients produced by microbial fermentation, alone or in combinations, as nutritive substances in infant formula products (IFP) namely:

  • Mixture of 2'-fucosyllactose (2'-FL) and difucosyllactose (DFL) (“2' FL/DFL');
  • Lacto-N-tetraose (LNT);
  • 6'-Sialyllactose (6'-SL) sodium salt; and
  • 3'-Sialyllactose (3'-SL) sodium salt.

The four HiMO ingredients are produced from the same genetically engineered Escherichia coli (E. coli) K-12-derived platform strain as Glycom's 2'-FL and LNnT which is already authorised for use in Australia and New Zealand.


​Approval report - 25 September 2023 (pdf 1.02 mb)​ ​

Supporting document (at approval) - risk, technical and benefit assessment (pdf 1.06 mb)​ ​

Call for submissions

Call for submissions - 8 June 2023 (pdf 657 kb)

Supporting document 1 - Risk assessment (pdf 831 kb)

A1265 Submissions (ZIP 2.09MB)

Administrative assessment

Administrative Assessment - 19 January 2022 (pdf 212 kb)

Executive summary (pdf 205 kb)

Application (pdf 6.40 mb)