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Call for comment on 2′-FL from a new GM source for infant formula

Food Standards Australia New Zealand (FSANZ) is calling for comment on an application to allow a new production method for a permitted oligosaccharide (2′fucosyllactose (2ʹ-FL)) added to infant formula products.

2ʹ-FL is a non-digestible carbohydrate, or oligosaccharide, found naturally in human milk. It can be used as a nutritive substance in infant formula products at levels consistent with those found in mature human milk.

FSANZ Interim Chief Executive Officer Dr Sandra Cuthbert said the application seeks to allow the voluntary addition of 2′-FL produced by microbial fermentation using a new genetically modified (GM) production strain.

“The Australian New Zealand Food Standards Code (the Code) already permits the addition of 2'FL to infant formula products," Dr Cuthbert said.

"However, this permission does not apply to the applicant's 2ʹ-FL, which has a different source and specifications. As such, we have completed a pre-market assessment of the applicant's 2′-FL.

"In line with current Code permissions, FSANZ proposes to permit the voluntary addition of the applicant's 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."

FSANZ invites interested parties to have their say on the draft variation by 6pm (Canberra Time) 31 January 2022.​

FSANZ will consider all submissions before developing a final decision to be considered by the FSANZ Board.

FSANZ previously approved 2ʹ-FL produced by microbial fermentation from a GM production strain under Application A1155 - 2′-FL and LNnT in infant formula and other products and is assessing an application to permit a second strain under Application A1190 – 2ʹ-FL in infant formula and other products.

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