Global Compliance Perspective on HMOs: Approvals and Applications in Australia and New Zealand

Human Milk Oligosaccharides (HMOs) are a unique class of carbohydrates found exclusively in human milk. They are the third most abundant solid component in breast milk after lactose and fat. HMOs have multiple functions, including modulating gut microbiota, supporting cognitive development, and alleviating symptoms of irritable bowel syndrome. To date, more than 200 types of HMOs have been identified, each with specific structures, functions, and applications. Several HMOs have already undergone regulatory approval processes in multiple countries.

This article summarizes the approval status and usage of HMOs in the Australia–New Zealand for industry reference.

According to publicly available information from the Food Standards Australia New Zealand (FSANZ) website, as of December 24, 2025, a total of 11 HMOs have been approved for market use in Australia and New Zealand. The approved HMO types include:

2’-fucosyllactose (2’-FL)
Lacto-N-neotetraose (LNnT)
Lacto-N-tetraose (LNT)
3’-sialyllactose sodium salt (3’-SL)
6’-sialyllactose sodium salt (6’-SL)
A combination of 2’-fucosyllactose and difucosyllactose (DFL)

Detailed approval status and usage are provided in Table 1 below.

Table 1.The approval status and usage of HMOs in the Australia–New Zealand

Substance Name	Scope of Use	Maximum Use Level	Production Strain	Donor	Application Number – Applicant
2’-fucosyllactose (2’-FL)	Only permitted for use in infant formula products*	96 mg/100 kJ	Escherichia coli K-12	Helicobacter pylori	A1155 - Glycom A/S
			Escherichia coli BL21	Escherichia coli O126	A1190 - Chr. Hansen A/S
			Escherichia coli K-12	Bacteroides vulgatus	A1233 - Friesland Campina B.V.
			Escherichia coli K-12	enhydrae Helicobacter enhydrae	A1277 - Inbiose B.V.
			Corynebacterium glutamicum	Pseudopedobacter saltans	A1283 - Advanced Protein Technologies Corp
			Escherichia coli W	Helicobacter mustelae	A1308 - Kyowa Hakko Bio Co., Ltd
Lacto-N-neotetraose (LNnT)	Only permitted for use in combination with 2’-FL in infant formula products	When used in combination with 2’-FL, the total use level must not exceed 96 mg/100 kJ (of which LNnT must not exceed 24 mg/100 kJ)	Escherichia coli K-12	Neisseria meningitides； Helicobacter pylori	A1155 - Glycom A/S
Lacto-N-tetraose (LNT)	Only permitted for use in infant formula products	32 mg/100 kJ	Escherichia coli K-12	Neisseria meningitides； Helicobacter pylori	A1265 - Glycom A/S
3’-sialyllactose sodium salt (3’-SL)	Only permitted for use in infant formula products	8 mg/100 kJ	Escherichia coli K-12	Neisseria meningitides； Campylobacter jejuni	A1265 - Glycom A/S
6’-sialyllactose sodium salt (6’-SL)	Only permitted for use in infant formula products	16 mg/100 kJ	Escherichia coli K-12	Photobacterium damsela； Campylobacter jejuni	A1265 - Glycom A/S
A combination of 2’-fucosyllactose and difucosyllactose (DFL)	Only permitted for use in infant formula products	96 mg/100 kJ	Escherichia coli K-12	Helicobacter pylori	A1265 - Glycom A/S

*Infant formula products refer to products formulated based on milk or other animal- or plant-derived edible ingredients, designed according to the age stages of infants and young children. These products must be labeled as nutritionally adequate and suitable to serve as the sole or primary liquid source of nutrition for infants of specific age groups. Infant formula products include infant formula (0–6 months), follow-on formula (over 6 months), and foods for special medical purposes intended for infants.

If companies plan to place food products on the Australia–New Zealand market in compliance, they must fully adhere to relevant local regulations, including requirements on food ingredients, specifications, labeling, and conditions of use. Where necessary, applications should be submitted to FSANZ.

Note: The data presented in this article are current as of December 24, 2025, and are based on publicly available information from the FSANZ official website. For reference only.

About CIRS Food Division

Established in 2012, the Food Business Division of CIRS Group has helped over 1,000 food companies globally in achieving one-stop compliance solutions. CIRS offers a full range of regulatory services, including but not limited to China novel food applications, synthetic biology-derived foods, US GRAS notice, EU novel food application, health food registration, and food for special medical purposes (FSMP).

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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