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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

Approval report - 25 September 2023(pdf 1.02 mb)​ ​(word 190 kb)​

Supporting document (at approval) - risk, technical and benefit assessment (pdf 1.06 mb)​ (word 424 kb)

Call for submissions ​​​

Call for submissions - 8 June 2023(pdf 657 kb)(word 262 kb)

Supporting document 1 - Risk assessment (pdf 831 kb)​(word 421 kb)

Submissions​​​(zip 2.09 mb)​​​


Administrative Assessment - 19 January 2022(pdf 212 kb)​(word 71 kb) 

Executive summary ​(pdf 205 kb)​

Application (pdf 6.40 mb)​​​

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