Food Standards Australia New Zealand Logo
Food Standards Australia New Zealand Logo

Call for comment on an oligosaccharide in infant formula

Date: 22/07/2021

​Food Standards Australia New Zealand (FSANZ) is calling for comment on an application to allow a new production method for a permitted oligosaccharide added to infant formula products.

FSANZ Chief Executive Officer Mark Booth said the application is seeking to permit the voluntary addition of the oligosaccharide 2′fucosyllactose (2′-FL) produced by microbial fermentation using a new genetically modified (GM) production strain.
“2′-FL is a non-digestible carbohydrate, or oligosaccharide, found naturally in human milk that can be produced using microbial fermentation.
“Currently, the Australian New Zealand Food Standards Code (the Code) includes permissions for 2′-FL to be used as a nutritive substance in infant formula products at a maximum permitted level consistent with levels found in mature human milk.
“This permission does not apply to the applicant's 2′-FL which has a different source and specifications. As such, a pre-market assessment of that 2′-FL was required.
“In line with current Code permissions, FSANZ is proposing to permit the voluntary addition of the applicants 2′-FL to infant formula products at maximum levels of 2.4 g/L.
“FSANZ's safety and risk assessment found no safety concerns with the addition of this particular 2′-FL to infant formula products at the level requested, or at the higher level permitted in the Code," Mr Booth said.
Interested parties are invited to have their say on the draft variation by 6pm (Canberra Time) 19 August 2021.
FSANZ will consider all submissions before a final decision is made. All FSANZ decisions on applications are notified to ministers responsible for food regulation who can ask for a review or agree that the standard should become law.
FSANZ previously approved 2'-FL produced by microbial fermentation of a different GM production strain under application A1155 - 2′-FL and LNnT in infant formula and other products.

More information:

Media contact:



Return to top