peeka
← All posts

What are HiMOs? FSANZ just approved five for Australian infant formula

3 August 2026 · Peeka

There’s a new ingredient name turning up on infant formula tins, and it’s worth understanding before it does: a sugar built in a lab to match one that occurs naturally in human breast milk. The acronym is HiMO — human-identical milk oligosaccharide — and Australia just got five more of them permitted for use in formula.

What FSANZ actually approved

On 2–3 June 2026, the FSANZ Board approved Application A1339, permitting the voluntary use of five HiMOs — 2′-FL, 3-FL, LNT, 3′-SL and 6′-SL — alone or in combination, in infant formula (FSANZ Board Communiqué, 2–3 June 2026). The application was lodged by Chr. Hansen A/S, and the five compounds are produced using a genetically modified E. coli strain, BL21 (FSANZ, A1339 Call for Submissions).

Voluntary is the operative word: the approval sets a permitted maximum for each compound. No formula maker is required to add any of them, and a tin without HiMOs listed on it is exactly as compliant as one that does.

What an approval means — and doesn’t

FSANZ’s own assessment describes the five HiMOs as “chemically, structurally and functionally identical” to the oligosaccharides that occur naturally in human milk (FSANZ, A1339 Call for Submissions). That’s a safety finding, not a performance claim. FSANZ’s job is to decide whether an ingredient meets the bar to be permitted in food sold in Australia — not whether a particular formula containing it does more for a particular baby. Permitted and proven beneficial are two different questions, and this approval only answers the first one.

One part of the assessment shows that distinction clearly. The applicant asked for a maximum of 73 mg/100 kJ (1.82 g/L) for LNT — higher than what’s typically found in human milk. FSANZ’s assessment notes that at that higher level, the effect on infant growth “could not be determined,” so the Board set a lower limit instead: 60 mg/100 kJ (1.50 g/L) — below the highest natural concentrations of LNT recorded in human milk, and in line with the level already permitted in the US and Canada (FSANZ, A1339 Call for Submissions). That’s the regulator applying caution to an amount it couldn’t establish an effect for, not confirming a benefit at any amount.

Researchers’ interest in this group of sugars centres on an argued anti-pathogenic effect, similar to what’s described in breast milk (FSANZ, A1339 Call for Submissions). This approval doesn’t test or confirm that effect for any specific formula product — it establishes that the ingredient can be present, up to a set maximum, without an identified safety concern at that level.

What this changes on a tin, and when

Nothing changes automatically. Being permitted means a formula maker can choose to add one or more of these five HiMOs, up to the levels FSANZ set:

HiMOPermitted maximumNotes
2′-FL120 mg/100 kJ (3.0 g/L)Set by A1339
3-FL80 mg/100 kJ (2.0 g/L)Unchanged by A1339 — already set by an earlier application
LNT60 mg/100 kJ (1.50 g/L)Lowered from the applicant’s request — see above
3′-SL (sodium salt)11 mg/100 kJ (0.28 g/L)Set by A1339
6′-SL (sodium salt)28 mg/100 kJ (0.7 g/L)Set by A1339

It’s up to each manufacturer whether, and when, to reformulate a specific product, and Peeka isn’t aware of an AU-sold brand that has announced doing so under this approval yet. If a tin later lists one of these five ingredients, this approval is the reason it’s allowed to be there — not a claim about what it does for your baby specifically.

What this means for you

A new set of ingredients is now permitted, one of them got a genuinely more cautious number than the applicant asked for, and the label decision from here sits with each formula maker, not with this approval. If a HiMO shows up on the tin in your cupboard one day, you’ll know what it is and what the approval behind it actually says — and what it doesn’t.

General information, not medical advice. Chat with your GP or child health nurse.

Peeka’s coming — join the launch list