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

Human Milk Oligosaccharides (HMOs) stand as a vital category of naturally occurring nutrients found in breast milk. Currently, there are over 200 known structures of HMOs, with six types being extensively researched, of which the nutritional necessity and safety have gained broad international recognition.

Notably, in China, there’s widespread attention on four compliant HMOs:

• 2’-fucosyllactose (2’-FL);
• lacto-N-neotetraose (LNnT);
• 6’-sialyllactose sodium salt (6’-SL); and
• 3’-sialyllactose sodium salt (3’-SL).

To clarify the compliance advances of HMOs in China, CIRS Group has summarized detailed application and approval status as follows.

Approved HMOs: one type of LNnT and three types of 2’-FL

As of now, one type of lacto-N-neotetraose (LNnT) and three types of 2'-fucosyllactose (2’-FL) have obtained approval. Specifically, the approved 2’-FL are all prepared through fermentation sources, with the same standard requirements but differing production strains. Details are shown in the table below:

Two types of 2’-FL issued for public comments but not yet approved

It can be seen from the table below that the synthetically derived 2’-FL has faced another extension since January 2022, with no further public review progress after supplementing dossiers. On a different note, a fermentation-based 2’-FL was just open for public comments on August 23, this year. If all progresses smoothly, it’s highly likely to be one of the next batch of approved HMOs.

8 HMOs that have been accepted and are in the process of technical review

According to the information released on the Administrative Service Platform of the National Health Commission (NHC), in addition to the HMOs already approved and issued for public comments, there are eight HMOs currently undergoing technical review, which include four types of 2’-FL, two types of 6’-SL, and two types of 3’-SL. Details are shown in the table below:

Warm Reminder

Since the inception of HMO compliance in China, major dairy enterprises have been gearing up for action. With the recent introduction of 2’-FL and LNnT, numerous leading brands have promptly launched new products. It’s worth mentioning that the current offerings are HMOs-enriched children's milk powder. The introduction of infant formula with added HMOs will require formula adjustments or registration, requiring a certain time period. With the anticipated approval of more HMO substances, the infant formula industry is likely to witness a significant upgrade in formulas.

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