Breastfeeding is the recommended way to feed infants. However, a safe and nutritious substitute for human milk is needed for infants when breastfeeding is not possible. As infants are a vulnerable population group, infant formula products are regulated by prescriptive provisions for composition and labelling. Any changes to the composition of these products must be established as safe prior to being permitted. As our knowledge of human milk expands, infant formula ingredients are developed to better replicate it. Food Standards Australia New Zealand (FSANZ) has assessed the addition of ingredients for the addition to infant formula products including human identical milk oligosaccharides (HiMOs) isolated using precision fermentation methodology. These ingredients are considered to be nutritive substances as their addition to food is intended to achieve specific nutritional purposes. In accordance with the Ministerial Policy Guidelines, FSANZ must assess both the safety and the health effect of nutritive substances for their use in infant formula. FSANZ risk assessments are undertaken by a multidisciplinary team covering toxicological and nutritional considerations using the best available scientific evidence. FSANZ assessments of the health effects concluded that the use of HiMOs in infant formula products would have a beneficial outcome for infants and align with the equivalent role of these substances in human milk(1,2). The weight of evidence supports health effects through an increase in the abundance of Bifidobacterium spp. in the infant gut microbiota, anti-pathogenic effects, inflammatory suppression and facilitation of appropriate immune responses and antigenic memory. FSANZ safety and technical assessments concluded that there are no public health and safety concerns associated with adding HiMOs to infant formula products(1, 2). The permitted levels are comparable to levels in human milk and are chemically and structurally identical to the naturally occurring forms. Food Standards Australia New Zealand, Canberra, 2606, Australia Based on the available evidence and intended purpose, a number of HiMOs have been permitted for use in infant formula products including 2′- fucosyllactose, lacto-N-neotetraose, difucosyllactose, lacto-N-tetraose, 3'-sialyllactose sodium salt, 6'-sialyllactose sodium salt. Evidence continues to emerge on the beneficial effects of HiMOs on infant health.