Application A1190 - 2′-FL in infant formula and other products - Administrative Assessment Report

Genetically modified (GM) Escherichia coli BL21 strains have been developed for the production of the oligosaccharide 2′-fucosyllactose (2′-FL) by fermentation. 2′-FL is one of the oligosaccharides that can be found in human milk, for the majority of women. Limited evidence suggests 2′-FL may be a bioactive compound with functional benefits in infants. The applicant has requested this oligosaccharide be added to infant formula products (IFP), which include: infant formula, follow-on formula, and infant formula products for special dietary use; and formulated supplementary foods for young children (FSFYC), with the aim of better reflecting the oligosaccharide composition of human milk. The maximum amount of 2′-FL requested to be used in these products is 2 g/L. The maximum permitted level in the Australia New Zealand Food Standards Code (the Code) is 96 mg/100 kJ, which equates to 2.4 g/L. As 2′-FL is already permitted in the Code, the purpose of this assessment is to determine the risk and safety of 2′-FL, produced by a new production strain, with its own specifications.