Latest Approval Status of HMOs in Australia and New Zealand

Human Milk Oligosaccharides (HMOs) stand as a unique carbohydrate present exclusively in breast milk, ranking as the third-largest solid component, following lactose and fat. With diverse functions, HMOs play a crucial role in enhancing gut microbiota, boosting cognitive function, and alleviating irritable bowel syndrome, among other benefits. Currently, there are over 200 known types of HMOs, each with distinct structures, functions, and applications. Notably, the compliance efforts of several types of HMOs have been initiated globally.

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CIRS Group has summarized the detailed approval information of HMOs in Australia and New Zealand as follows:

Australia-New Zealand food security regulations

Food standards legislation- The Australia New Zealand Food Standards Code

In 1995, the governments of Australia and New Zealand signed an agreement to establish a common food standard system. On December 20, 2002, The Australia New Zealand Food Standards Code (hereinafter referred to as the Code) was formally enacted.

The Code serves as the legal framework for food standards in both Australia and New Zealand, with the exceptions of certain provisions that do not apply in New Zealand. It covers quality specifications and usage requirements for various foods, food additives, nutrient enhancers, novel foods, processing aids, among others. Additionally, it encompasses production standards, food packaging, and labeling requirements.

Food regulatory body - Food Standards Australia New Zealand (FSANZ)

FSANZ is an independent statutory agency established by the Food Standards Australia New Zealand Act 1991 (FSANZ Act). It develops and administers the Australia New Zealand Food Standards Code.

* Any individual or enterprise can apply to establish or change the existing standards in the Code.

Management of HMOs in Australia and New Zealand

While both the EU and Australia-- New Zealand have the regulatory category for Novel Foods, unlike in the EU, HMOs are not managed as Novel Foods in Australia and New Zealand. Instead, corresponding standards in the Code are revised based on the primary functional role of HMOs (i.e., as infant food nutrition enhancers) to ensure compliant use in the Australian and New Zealand markets. These standards include:

Standard 1.5.2 Food produced using gene technology;
Standard 2.9.1 Infant formula products;
Schedule 26 – Food produced using gene technology; and
Schedule 29 – Special purpose foods.

According to the official website of FSANZ, HMOs approved in Australia and New Zealand as of February 4, 2024, mainly include the following:

2’-Fucosyllactose (2’-FL);
Lacto-N-tetraose (LNT);
Lacto-N-neotetraose (LNnT);
3’-Sialyllactose (3’-SL);
6’-Sialyllactose (6’-SL); and
Mixture of 2’-fucosyllactose (2’-FL) and difucosyllactose (DFL) (2’-FL/DFL)

Latest Compliance Advances of Human Milk Oligosaccharides (HMOs) in China

Details are shown in the Table below:

Table 1 HMOs approved in Australia and New Zealand

Application code	Substance	Date of approval	Production stain	Donor	Applicant
A1155	2’-FL	2019.12.20	Escherichia coli K-12	Helicobacter enhydrae	Glycom A/S
A1155	LNnT	2019.12.20	Escherichia coli K-12	Neisseria meningitidis; Helicobacter enhydrae	Glycom A/S
A1190	2’-FL	2021.11.08	Escherichia coli BL21	Escherichia coli O126	Chr. Hansen A/S
A1233	2’-FL	2022.05.06	Escherichia coli K-12	Bacteroides vulgatus	Friesland Campina B.V.
A1251	2’-FL combined with galacto-oligosaccharides and/or inulin-type fructans	2022.12.14	Escherichia coli BL21	Escherichia coli O126	Nutricia Australia Pty Ltd; Chr. Hansen A/S
A1265	LNT	2023.09.25	Escherichia coli K-12	Neisseria meningitidis	Glycom A/S
	3’-SL			Neisseria meningitidis; Campylobacter jejuni
	6’-SL			Photobacterium damselae; Campylobacter jejuni
	2’-FL/DFL			Helicobacter enhydrae

In addition to the above-mentioned approved HMOs, there are currently two types of 2’-FL in the application process. Details are as follows:

Table 2 HMOs in the application process in Australia and New Zealand

Application code	Substance	Application status	Production stain	Donor	Applicant
A1277	2’-FL	Call for submissions on 2023.10.10	Escherichia coli K-12	Helicobacter enhydrae	Inbiose N.V.
A1283	2’-FL	Application accepted on 2023.09.22	Corynebacterium glutamicum	/	Advanced Protein Technologies Corp

If a company intends to launch food products into the Australian and New Zealand markets, it is imperative to comply with all relevant laws and regulations, including those related to food composition, quality specifications, and product labeling. When necessary, the company shall submit the applications to FSANZ for approval.

The Food Business Division at CIRS Group boasts a highly professional team specializing in the application of “Three New Foods” in China, namely new food raw materials, new food additives, and food contact materials, as well as FDA GRAS in the United States and Novel Food in the EU. With extensive experience in these fields, our team has numerous successful cases. As of now, CIRS Group has acted as an agent for dozens of applications for genetically modified microorganism new food raw materials and additives both domestically and internationally, positioning our project experience at the forefront of the industry. We welcome inquiries or visits for a deeper understanding of our technical capabilities.

Note: The data presented is accurate as of February 4, 2024. The information is sourced from publicly available platforms and is for reference only.

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

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