How do you Apply for Approved HMOs in Foods for Special Medical Purposes in China?

Human milk oligosaccharides (HMOs) are the third most abundant solid component found in breast milk, playing a crucial role in establishing infant gut microbiota and immune functions. The discovery, production, and application of HMOs has been pivotal in promoting overall health, particularly in improving infant health and meeting nutritional needs.

Currently, HMOs have been approved or are about to be marketed in over 100 countries and regions. They are primarily used in infant formula and foods for special medical purposes (FSMP), significantly enhancing the nutritional value and diversity of these products.

You can click the links below to learn more about the application and approval status of HMOs in China and abroad.

• Latest Compliance Advances of Human Milk Oligosaccharides (HMOs) in China
• Latest Compliance Advances of Human Milk Oligosaccharides (HMOs) in the EU and U.S.
• Latest Approval Status of HMOs in Australia and New Zealand

The CIRS Group analyzes how to apply for approved HMOs in FSMP by combining the approval announcements and the raw materials requirements for FSMP.

Approved HMOs in China

The applicable scope of approved HMOs in China are as follows:

Approved substance	Applicable food category	Limit	Note
2’-fucosyllactose (2’-FL)	Modified milk (for children only) Infant formula Older infants and young children formula Infant formula for special medical purposes	0.7-2.4g/L	Calculated on a pure basis and ready-to-eat state, the use level of powdered products is increased by preparation times. When mixed with 2’-fucosyllactose (2’-FL), lacto-N-neotetraose (LNnT), galacto-oligosaccharide (GOS), fructooligosaccharides (FOS), polyfructose, and raffinose, the total amount must not exceed 64.5 g/kg.
Lacto-N-neotetraose (LNnT)		0.2-0.6g/L

Can HMOs be applied in FSMP?

Regulatory background

First, HMOs have been approved as a nutritional enhancer and fall under the category of dietary fiber.

Secondly, according to the provisions of GB 29922, dietary fiber can be optionally included in FSMP, and its sources should reference the permitted sources listed in Table C.2 of GB 14880. Although GB 14880 has not yet been updated to include HMOs, the usage limits for HMOs are consistent with that for dietary fiber specified in Table C.2 of GB 14880. Considering that approval announcements for HMOs as nutritional enhancers have been released, it can be inferred that HMOs will be included in future updates of GB 14880.

In which FSMP can HMOs be used? How should they be used?

Based on the above analysis, it can be inferred that approved HMOs can be added as dietary fiber in FSMP. Specific requirements are given in the table below:

Type of FSMP	Target population	Limit	Note
Infant formula for special medical purposes	Infants aged 0-12 months	2’-FL: 0.7-2.4g/L LNnT: 0.2-0.6g/L	Calculated on a pure basis and ready-to-eat state, the use level of powdered products is increased by preparation times. When mixed with 2’-fucosyllactose (2’-FL), lacto-N-neotetraose (LNnT), galacto-oligosaccharide (GOS), fructooligosaccharides (FOS), polyfructose, and raffinose, the total amount must not exceed 64.5 g/kg.
FSMP	Individuals over one year old	Refer to the regulations for infant formula: 2’-FL：0.7-2.4g/L LNnT: 0.2-0.6g/L

How to add HMOs to products with an FSMP registration certificate?

Adding HMOs can impact the formulation and nutritional profile of products, potentially affecting their safety, nutritional adequacy, or clinical effectiveness for special medical purposes. Therefore, approved products should apply for a change of registration to include HMOs. According to the Administrative Measures for Registration of Foods for Special Medical Purposes, companies should submit an application for formula change, providing comprehensive details on product safety, nutritional adequacy, and clinical effectiveness for special medical purposes. The review agency will then conduct an evaluation and provide a conclusion.

The above analysis is based on the approval announcements of HMOs and current FSMP regulations. The final requirements should be based on subsequent announcements or regulations.

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