Portfolio Extension after 2'-FL
3-FL works best when the nutrition company already understands 2'-FL and now wants a wider HMO story. It lets the product line show more than one fucosylated structure.
Fucosylated HMO
3-Fucosyllactose (3-FL)
3-Fucosyllactose helps nutrition companies build a more diverse fucosylated HMO range. It shares the same molecular formula and molecular mass class as 2'-FL, while giving formulators another structure to review for portfolio differentiation.
Nutrition companies can compare 3-FL with 2'-FL or use it as part of a wider HMO blend strategy.
- High-yield strain and low-cost inorganic-salt medium platform
- Water-phase purification with no organic-solvent residue
- Batch residue testing and release inspection before shipment
Fermentation-Based HMO- Molecular Formula
- C18H32O15
- Relative Molecular Mass
- 488.44
- HMO Family
- Fucosylated HMO
- Appearance
- White to off-white powder
CAS No.41312-47-4
MOQ10 kg
Shipping PortShanghai or Qingdao
Purity3-FL water free, >=90.0%
Application and Regulatory Review
3-FL Application, Use-Level, and Regulatory Review
Review 3-FL application direction, use-level references, permitted categories, labelling points, and destination-market requirements before sampling, quotation, or commercial formulation.
Supplement and Functional Drink Concepts
3-FL fits gut-health supplement powders, sachets, beverages, capsules, and stick-pack concepts where HMO diversity is part of the product story.
Multi-HMO Formula Planning
3-FL can sit beside 2'-FL, LNnT, LNT, 3'-SL, and 6'-SL in 5-HMO or 6-HMO development. We use it to explain fucosylated coverage inside a blend.
R&D Screening Difference
The six-HMO comparison material supports the idea that each HMO structure deserves separate screening. We present 3-FL as a structure-specific R&D option, not as a generic copy of 2'-FL.
EU Novel Food Review
EU 2021/2029 authorises 3-FL as a novel food, and EU 2025/1537 updates conditions of use for a source-specific 3-FL entry. Some entries are source-specific and data-protected, so nutrition companies must check which authorised source applies.
U.S. GRAS Review
The FDA GRAS Notice Inventory includes 3-FL entries with 'no questions' response letters, including GRN 925, GRN 951, GRN 1037, and GRN 1099. GRN 1099 gives a clear current reference for infant formula, young-child formula, foods, drinks, and oral or enteral formulas.
Use-Level Review Notes
- FDA GRN 1099 lists use in cow milk-, soy-, and partially hydrolyzed protein-based non-exempt infant formulas for term infants up to 0.9 g/L as consumed.
- FDA GRN 1099 lists formula for young children aged 1 to 3 years up to 1.2 g/L as consumed.
- FDA GRN 1099 also covers infant and young-child foods such as yogurt and juice beverages up to 0.44 g/kg, and hot cereals, crackers, pretzels, cookies, and snack items up to 4.4 g/kg.
- For broader foods and supplements, FDA GRN 1099 includes bars, drinks, milk products, milk substitutes, juices, vegetable juices, gummy candies, and oral or enteral tube feeding formulas at category-specific levels.
- EU 3-FL entries vary by authorised source. Public entries show infant formula levels from about 0.85 g/L to 1.75 g/L.
- EU follow-on formula entries show source-dependent levels, including 0.85 g/L, 1.2 g/L, and 1.75 g/L in final product ready for use.
- EU food supplement entries include 3 g/day to 5 g/day depending on the authorised entry and population restrictions.
Technical Data
Specification Snapshot
3-FL Specification
| Color | White to off-white |
|---|---|
| Appearance | Powder |
| 3-Fucosyllactose (Water-Free) | >=90.0% |
| D-Lactose | <=3.0% |
| L-Fucose | <=3.0% |
| D-Galactose and D-Glucose | <=2.0% |
| Moisture | <=9.0% |
| Ash | <=0.5% |
| Residual Protein | <=100 mg/kg |
| Endotoxins | <=10 EU/mg |
| Total Arsenic | <=0.2 mg/kg |
| Lead | <=0.05 mg/kg |
| Total Plate Count | <=500 CFU/g |
| Enterobacteriaceae | <10 CFU/g |
| Salmonella | Absent in 25 g |
Specification Notes
- Product Description
- 3-Fucosyllactose (3-FL) is a fucosylated HMO ingredient for nutrition formulations that need portfolio depth beyond 2'-FL. The specification describes a fermentation-based ingredient with downstream purification and drying.
- Storage Condition
- Store at room temperature in sealed packaging. Keep dry and away from light.
- Pack Size and Shelf Life
- 20 kg per carton or drum, packed as 10 kg x 2 bags. Shelf life: 24 months.
- Packaging Material
- Inner packaging uses food-grade PE bags and food-grade aluminum foil bags. Outer packaging uses a cardboard drum or carton.
- Anticipated Use
- For formulation review in children's milk powder, infant formula, older-infant and young-child formula, and infant formula for special medical purposes, subject to the destination market's authorization.
Project Support
Planning a 3-FL or Multi-HMO Project?
Share your specification target, annual forecast, and market requirements. We will help check supply options, sample route, and application direction.