Food Standards Australia New Zealand (FSANZ) has approved amendments to the Australia New Zealand Food Standards Code to permit the use of additional human-identical milk oligosaccharides (HiMO) produced through microbial fermentation using genetically modified strains of Escherichia coli BL21 in infant formula products. The approval follows an application submitted by Chr. Hansen A/S seeking permission for five HiMO ingredients to be used as nutritive substances in infant nutrition products.
The application covered 2′-fucosyllactose (2′-FL), 3-fucosyllactose (3-FL), lacto-N-tetraose (LNT), 3′-sialyllactose (3′-SL) sodium salt, and 6′-sialyllactose (6′-SL) sodium salt. FSANZ's scientific assessment concluded that the substances are chemically, structurally, and functionally identical to oligosaccharides naturally present in human milk. The authority found no public health or safety concerns associated with the use of 2′-FL, 3-FL, 3′-SL sodium salt, and 6′-SL sodium salt at the proposed use levels, which fall within concentrations observed in human milk.
FSANZ determined that the originally requested maximum level for LNT exceeded naturally occurring levels found in human milk and that sufficient evidence was not available to establish effects on infant growth at the proposed concentration. As a result, the authority approved a lower maximum amount of 60 mg/100 kJ for LNT rather than the higher level requested by the applicant.
The approved variation amends Schedule 29 of the Code to establish new maximum amounts for several HiMO ingredients in infant formula products, including 2′-FL at 120 mg/100 kJ, LNT at 60 mg/100 kJ, 3′-SL sodium salt at 11 mg/100 kJ, and 6′-SL sodium salt at 28 mg/100 kJ. The amendment also updates Schedule 26 to permit Chr. Hansen's 3-FL, LNT, 3′-SL sodium salt, and 6′-SL sodium salt as genetically modified foods for use in infant formula products, subject to specified conditions and a 15-month exclusive-use permission linked to the applicant's products. In addition, new ingredient specifications have been incorporated into Schedule 3.