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Human Milk Oligosaccharides (HMOs) have become the core focus for next-generation infant formula and functional nutritional products. This article reviews the official approval status of HMOs that have been approved or are under public consultation in China, and analyzes the market development and policy orientation of HMOs, providing a reference for the next steps of enterprises.
1. Definition and Production Routes of HMOs
Human milk oligosaccharides are the third largest solid component in breast milk. Currently, over 200 types of HMOs have been identified. Based on their chemical structure and functions, they are mainly divided into three categories:
Fucosylated HMOs: 2'-fucosyllactose, 3-fucosyllactose
Neutral non-fucosylated HMOs: Lacto-N-tetraose, Lacto-N-neotetraose
Sialylated HMOs: 3'-sialyllactose, 6'-sialyllactose
The proportions of these types in breast milk vary due to individual differences (e.g., influenced by maternal genes) and are often used as nutrition enhancers in infant formula to mimic the benefits of breast milk.
The industrial production of HMOs is primarily based on synthetic biology using genetically modified microbial fermentation. Through genetic engineering, key enzyme genes responsible for synthesizing HMOs (such as fucosyltransferase, sialyltransferase) are introduced into microorganisms (such as E. coli, yeast), enabling the microorganisms to autonomously synthesize target HMOs using cheap substrates like glucose and lactose during the fermentation process.
2. HMOs Approved as New Food Additives in China
From August 10, 2016, when the National Health Commission (NHC) issued the Acceptance Announcement for New Varieties of Food Additives (2016) No. 0040 for the first application of 2′-fucosyllactose, to October 18, 2021, when Announcement (2021) No. 0048 and No. 0049 accepted 2'-fucosyllactose and Lacto-N-neotetraose respectively, official approval was finally granted on October 7, 2023, via Announcement No. 8 of 2023.
Currently, China has officially approved two types of HMOs. The detailed production strain categories are as follows:
2′-Fucosyllactose (2'-FL)
HMOs | Source | Donor | NHC announcement |
|---|---|---|---|
2′-Fucosyllactose (2'-FL) | E. coli K-12 DH1 MDO | Helicobacter spp.a | |
E. coli K-12 MG1655 | Helicobacter spp.a | ||
E. coli BL21(DE3) | Neisseria spp.a | ||
E. coli BL21(DE3) | Helicobacter pylori spp.a | ||
E. coli BL21star (DE3) | E. coli O126 spp.a | ||
Corynebacterium glutamicum ATCC 13032 | Pseudopedobacter saltans a | ||
E. coli K-12 GI724 | Bacteroides vulgatus a | ||
E. coli BL21(DE3) | Bacteroides fragilis a | ||
E. coli BL21(DE3) | Escherichia spp. a | ||
E. coli BL21(DE3) | Helicobacter spp. a | ||
E. coli W | Helicobacter spp. a | ||
Bacillus subtilis 168 | Bacillus subtilis a E. coli b Helicobacter pylori c | ||
E. coli BL21(DE3) | Helicobacter pylori c E. coli O126 c | ||
E. coli K- 12 MG1655 | Helicobacter pylori c | ||
Notes: a refers to the donor for α-1,2-fucosyltransferase. b refers to the donors for phosphomannomutase, mannose-1-phosphate guanylyltransferase, GDP-mannose 4,6-dehydratase, GDP-fucose synthase, lactose permease, and sugar efflux transporter. c refers to the donor for mannose-6-phosphate isomerase. | |||
Usage Level and Scope of Application
Food category | Usage amount | NHC announcement | Notes | |
|---|---|---|---|---|
01.03.02 | Modified milk powder (only for the milk powder for children) | 0.7–2.4 g/L (calculated as pure substance, based on ready-to-eat form; for powdered products, the amount should be adjusted according to the dilution ratio) | When used in combination with LNnT, GOS, FOS, polyfructose, or raffinose, the total amount of such substances must not exceed 64.5 g/kg. | |
13.01.01 | Infant formula | |||
13.01.02 | Formula for follow-up infants and young children | |||
13.01.03 | Infant formula for special medical purposes | |||
13.02.01 | Cereal-based complementary foods for infants and young children | |||
13.02.02 | Canned complementary foods for infants and young children | / | ||
Lacto-N-neotetraose (LNnT)
HMOs | Source | Donor | NHC announcement |
|---|---|---|---|
Lacto-N-neotetraose (LNnT) | E. coli K-12 DH1 MDO | Neisseria spp.a Helicobacter spp.b | |
E. coli BL21 star (DE3) | Neisseria spp.a Helicobacter spp.b | ||
E. coli BL21 (DE3) | Neisseria spp.a Helicobacter spp.b | ||
Notes: a refers to the donor for β-1,3-N-acetylglucosaminyltransferase. b refers to the donor forβ-1,4-galactosyltransferase. | |||
Usage Level and Scope of Application
Food category | Usage amount | NHC announcement | Notes | |
|---|---|---|---|---|
01.03.02 | Modified milk powder (only for the milk powder for children) | 0.2–0.6 g/L (calculated as pure substance, based on ready-to-eat form; for powdered products, the amount should be adjusted according to the dilution ratio) | When used in combination with 2'FL, GOS, FOS, polyfructose, or raffinose, the total amount of such substances must not exceed 64.5 g/kg. | |
13.01.01 | Infant formula | |||
13.01.02 | Formula for follow-up infants and young children | |||
13.01.03 | Infant formula for special medical purposes | |||
3. Proposed HMOs Under Public Consultation
In addition to the approved HMOs mentioned above, there are currently new varieties of HMOs and HMOs from new production strain sources under application. Their safety and technical necessity have passed the technical review by the expert review committee, and some have progressed to the public consultation stage.
Furthermore, the application categories and usage levels of HMOs in food are also expected to increase.
HMOs | Source | Donor | Proposal announcement |
|---|---|---|---|
2′-fucosyllactose (2'-FL) | Chemical synthesis method | ||
Corynebacterium glutamate ATCC 13032 | Pseudopedobacter saltans a | ||
Corynebacterium glutamicum ATCC13032 | Corynebacterium spp.a | ||
E. coli BL21(DE3) | E. coli a | ||
Kluyveromyces lactis DSM70799 | Bacillus spp. a | ||
E. coli K-12 MG1655 | Helicobacter spp. a | ||
E. coli C43(DE3) | Bacillus cereus a | ||
E. coli K-12 BW25113 | Mycobacterium spp. a | ||
3-fucosyllactos, 3-FL | E. coli K-12 MG1655 | Helicobacter spp. b | |
E. coli BL21(DE3) | Bacteroides fragilis b | ||
E. coli K-12 MG1655 | Bacteroides gallinaceum b | ||
E. coli BL21 (DE3) | Azospirillum lipoferum B510 b | ||
Kluyveromyces lactis DSM70799 | Bacillus smithii b | ||
Lacto-N-tetraose (LNT) | E. coli BL21 star (DE3) | Neisseria spp. c Salmonella spp. e | |
E. coli K-12 GI724 | Neisseria spp. c Helicobacter spp. e | ||
E. coli BL21 star (DE3) | Salmonella enterica e | ||
E. coli BL21 star (DE3) | Neisseria spp. d E. coli e | ||
E. coli BL21 star (DE3) | Neisseria meningitidis d Citrobacter meridianamericanus e | ||
Lacto-N-neotetraose (LNnT) | E. coli K-12 MG1655 | Neisseria spp. d Helicobacter spp. f | |
E. coli BL21 (DE3) | Neisseria meningitidis d Citrobacter meridianamericanus f | ||
3'-Sialyllactose sodium salt, 3'-SL | E. coli W NEO3 | Saccharomyces cerevisiae a' Synechocystis sp.b' Rhodobacter capsulatus c' Pasteurella multocida d' Neisseria lactamica e' | |
E. coli BL21 (DE3) | Campylobacter spp. c' g' Neisseria spp. d' Bibersteinia spp. e' | ||
E. coli W (ATCC 9637) | Saccharomyces spp.a' Synechocystis spp.b' Rhodobacter spp.c' Pasteurella spp.d' Neisseria spp.e' | ||
E. coli K-12 DH1 MDO | Neisseria spp.e' Campylobacter spp. d' c' g | ||
6'-Sialyllactose sodium salt, 6'-SL | E. coli W NEO6 | Saccharomyces cerevisiae a' Synechocystis sp.b' Pasteurella multocida c' Photobacterium damselae d' Rhodobacter capsulatus f' | |
Notes: a refers to the donor for α-1,2-fucosyltransferase. b refers to the donor for α-1,3-fucosyltransferase. c refers to the donor for β-1,3-N-acetylglucosaminyl aminotransferase. d refers to the donor for β-1,3-N-acetylglucosamine transferase. e refers to the donor for β-1,3-galactosyltransferase f refers to the donor for β-1,4-galactosyltransferase. g refers to the donor for UDP-N-acetylglucosamine epimerase. a' refers to the donor for Glucosamine-6-phosphate N-acetyltransferase. b' refers to the donor for N-acetylglucosamine-2-epimerase. c' refers to the donor for N-acetylneuraminic acid synthase. d' refers to the donor for Cytidine 5'-monophosphate-N-acetylneuraminic acid synthetase. e' refers to the donor for α-2,3-sialyltransferase. f' refers to the donor for α-2,6-sialyltransferase. | |||
Application for Expanded Scope of Use
HMOs | Food category | Usage amount | Notes | NHC announcement | |
|---|---|---|---|---|---|
2′-fucosyllactose (2'-FL) | 01.01.03 | Modified milk | 0.3-1.2 g/kg | 1. When used in combination with LNnT, GOS, FOS, polyfructose, or raffinose, the total amount of such substances must not exceed 64.5 g/kg. 2. For beverages, based on ready-to-eat form; for powdered products, the amount should be adjusted according to the dilution ratio) | |
01.02.02 | Flavored fermented milk | ||||
01.03.02 | Modified milk powder and modified cream powder | ||||
01.06 | Cheese, processed cheese, cheese products, and cheese analogues | 2.5-8.4 g/kg | |||
03.0 | Frozen beverages | ||||
05.02 | Candy | ||||
07.0 | Bakery foods | ||||
14.0 | Beverages (excluding 14.01 packaged drinking water) | 0.3-1.2 g/kg | |||
Application for Scope of Use
HMOs | Food category | Usage amount | Notes | NHC announcement | |
|---|---|---|---|---|---|
3-fucosyllactos,3-FL | 01.03.02 | Modified milk powder (only for the milk powder for children) | 0.25-1.75 g/L (calculated as pure substance, based on ready-to-eat form; for powdered products, the amount should be adjusted according to the dilution ratio) | When used in combination with 2'FL, LNnT, GOS, FOS, polyfructose, or raffinose, the total amount of such substances must not exceed 64.5 g/kg. | |
13.01.01 | Infant formula | ||||
13.01.02 | Formula for follow-up infants and young children | ||||
13.01.03 | Infant formula for special medical purposes | ||||
Lacto-N-tetraose (LNT) | 01.03.02 | Modified milk powder (only for the milk powder for children) | 0.25-1.82 g/L (calculated as pure substance, based on ready-to-eat form; for powdered products, the amount should be adjusted according to the dilution ratio) | When used in combination with 2'FL, LNnT, GOS, FOS, polyfructose, or raffinose, the total amount of such substances must not exceed 64.5 g/kg. | |
13.01.01 | Infant formula | ||||
13.01.02 | Formula for follow-up infants and young children | ||||
13.01.03 | Infant formula for special medical purposes | ||||
3'-Sialyllactose sodium salt,3'-SL | 01.03.02 | Modified milk powder (only for the milk powder for children) | 0.06-0.28 g/L (calculated as pure substance, based on ready-to-eat form; for powdered products, the amount should be adjusted according to the dilution ratio) | When used in combination with 2'FL, LNnT, GOS, FOS, polyfructose, or raffinose, the total amount of such substances must not exceed 64.5 g/kg. | |
13.01.01 | Infant formula | ||||
13.01.02 | Formula for follow-up infants and young children | ||||
13.01.03 | Infant formula for special medical purposes | ||||
6'-Sialyllactose sodium salt, 6'-SL | 13.01.01 | Infant formula | 0.14-0.40 g/L (calculated as pure substance, based on ready-to-eat form; for powdered products, the amount should be adjusted according to the dilution ratio) | When used in combination with 2'FL, LNnT, 3'-SL, GOS, FOS, polyfructose, or raffinose, the total amount of such substances must not exceed 64.5 g/kg. | |
13.01.02 | Formula for follow-up infants and young children | ||||
13.01.03 | Infant formula for special medical purposes | ||||
4. Analysis of Future Development Directions for HMOs
Judging from official announcements and industry information summaries, the future development of HMOs presents the following trends in terms of production technology and the market:
Production Technology: Led by Synthetic Biology
The industrial production route of HMOs is dominated by synthetic biology—microbial fermentation, using genetically engineered E. coli strains as production strains. The maturity of this technical path has been fully verified by the industry. In the future, strain modification will rely on the precise regulation of gene editing technology to gradually cross from "function realization" to "performance optimization".
Market Application Areas: Multi-dimensional Expansion
HMOs were initially applied primarily in the field of infant formula, with over 90% of global high-end infant formula brands having added 2'-FL. With in-depth research and the global aging population, as well as increasing demand for functional foods, the application of HMOs in adult health foods, foods for special medical purposes (FSMP), and animal feed additives is also gradually increasing. For example, HMOs can be used to alleviate symptoms of Irritable Bowel Syndrome (IBS) and metabolic syndrome, and can also serve as animal feed additives to improve animal gut health. In the cosmetics field, HMOs have also become a hotspot for new raw material declarations; they can be used to regulate the skin microbiome or for anti-acne product development. In oral care, HMOs can inhibit cariogenic bacteria and may be integrated into anti-cavity toothpaste formulas in the future, opening paths for various functional cosmetics.
Rapid Market Growth: According to QYResearch, HMOs market sales have climbed rapidly from $250 million in 2023 to $700 million in 2024, and are expected to exceed $3.2 billion by 2031, with a compound annual growth rate (CAGR) of 24.6%. According to reports and predictions, the market size of HMOs in milk powder is expected to reach 5 billion RMB in 2025 and exceed 20 billion RMB by 2030, demonstrating the huge development potential of HMOs in the Chinese market.
Market Competition: Diversified Landscape
Currently, the core production technology and market share of the HMOs industry are highly concentrated among multinational corporations and biotechnology companies, such as Glycom (now part of DSM-Firmenich) and Chr. Hansen (now merged into Novonesis), which account for more than half of the global HMOs market share. In comparison, China's HMOs industry started late. However, with the gradual opening of approval policies for HMOs in 2023, Hongmo Biology became the first domestic enterprise to be approved for 2'-FL, and Lankun Technology became the first domestic enterprise approved for Lacto-N-neotetraose (LNnT), creating critical development opportunities to take the lead in seizing core application scenarios such as domestic infant formula products.
Following closely, other domestic enterprises are also breaking through technical bottlenecks and expanding production capacity through independent R&D, gradually breaking the supply monopoly of multinational enterprises. Shandong Henglu Biotechnology achieved crystalline mass production of Lacto-N-triose II through an independently developed yeast fermentation method; this product has successfully obtained GRAS certification from the US FDA, making it the first enterprise globally to obtain GRAS certification via a yeast synthesis pathway. Baolingbao's planned 2,500-ton HMO construction project is expected to commence production in the second half of 2025, with its core production technology certified by the iSEE Global Innovation Award. Huangshan Tongxi Biology has taken the lead in building the first domestic HMO production line; upon completion of phase II expansion, the annual capacity will reach 3,000 tons, becoming the world's largest HMO monomer factory, with products already stably supplied to leading dairy enterprises such as Yili, Feihe, and Junlebao.
In addition, Chinese enterprises are also shortening their growth cycles and quickly laying out the high-end nutrition field through acquisitions, integration, and ecological cooperation. For instance, Meihua Biological rapidly entered the HMO production field by acquiring the food amino acid, pharmaceutical amino acid, and HMO-related businesses and assets of Kyowa Hakko (under Japan's Kirin Holdings), penetrating the high-end nutrition markets such as infant formula and FSMP through the HMO business.
Policies and Regulations: Fast-Evolving Environment
The National Health Commission (NHC) conducts approvals across all dimensions, including product quality specifications, product safety, and strain safety. Combining the development characteristics of synthetic biology technology with international review experience, systematic optimization is being carried out across four dimensions:
Review mechanism stratification: strain maturity grading, product risk level classification;
Technical standard synergy: standardized templates of data declaration, clarifying core elements of toxicology tests and clinical verification;
Data interoperability and sharing: led by the NHC to integrate enterprise declaration data, third-party testing agency reports, and international certification information to build a unified national HMO compliance database;
International rule mutual recognition: mutual recognition of OECD standard data.
Although new HMOs such as LNT, 3-FL, 3'-SL, and 6'-SL have not yet been officially approved, the China National Center for Food Safety Risk Assessment (CFSA) has publicly solicited opinions. Most manufacturers have also laid out plans in advance; for example, Novonesis's genetically modified production strains used to produce 5 types of HMOs passed the biosafety review by the Ministry of Agriculture and Rural Affairs (MARA) in September 2023, providing guarantees for subsequent industrialization. Enterprises such as Cabio and Quantum Hi-Tech are also conducting simultaneous R&D and approval advancement for multiple categories of HMOs, attempting to enhance competitiveness through "multi-category coverage".
5. Summary
HMOs have huge development potential in China. The industry overall presents a trend where overseas enterprises lead in technology and certification, while domestic enterprises are accelerating to catch up in approvals and localization. Expanding on three key elements, enterprises must focus on:
Approval Qualifications (NHC "New Food Additive" approval, MARA biosafety review);
Technical Barriers (e.g., fermentation efficiency of genetically modified microorganisms, screening and modification of key enzyme preparations);
Market Binding Ability (Global market certification layout, cooperation with dairy leaders).
Furthermore, the advance layout of new categories such as LNT, 3-FL, 3'-SL, and 6'-SL, which have not yet been approved in China, along with the high-efficiency production of innovative strains, has become the key focus for the next step of "technical reserve before approval, and rapid volume expansion after approval".
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