Early-Life Nutrition Starting Point
2'-FL should lead the early-life nutrition discussion. It fits infant formula, follow-on formula, young-child nutrition, baby food, and FSMP review where the customer's market allows HMO use.
Fucosylated HMO
2'-Fucosyllactose (2'-FL)
2'-Fucosyllactose is one of the best-known fucosylated HMOs in nutrition formulation. Nutrition companies commonly start with 2'-FL in their finished products because it has a clear product identity, a mature specification, and broad relevance in infant nutrition and digestive-health product development.
- Water-phase purification for clean taste and odorless finished product
- Batch residue testing for DNA, live bacteria, proteins, and endotoxin
- Heat-stability data for milk powder and complementary-food processing
Fermentation-Based HMO- Molecular Formula
- C18H32O15
- Relative Molecular Mass
- 488.44
- HMO Family
- Fucosylated HMO
- Appearance
- White to off-white powder
CAS No.41263-94-9
MOQ10 kg
Shipping PortShanghai or Qingdao
Purity2'-FL water free, >=94.0%
Application and Regulatory Review
2'-FL Application, Use-Level, and Regulatory Review
Review 2'-FL application direction, use-level references, permitted categories, labelling points, and destination-market requirements before sampling, quotation, or commercial formulation.
Gut Microbiota and Digestive-Health Concepts
We use 2'-FL for digestive-health positioning because it appears repeatedly in gut microbiota and bifidobacteria-oriented formulation discussions. For supplements and beverages, we keep claims general until the nutrition company completes local claim review.
2'-FL plus LNnT Combination
When nutrition companies want a stronger early-life HMO story, we usually suggest reviewing 2'-FL together with LNnT. The pair gives one fucosylated HMO and one neutral core HMO, which makes the formulation concept easier to explain.
Quality and Downstream Control
The 2'-FL crystallization material supports a clear quality story: purity, crystal form, particle consistency, lactose control, moisture, and downstream process stability matter before price comparison.
EU Novel Food Review
EU 2024/2036 gives a product-specific 2'-FL authorisation example, and EU 2024/2102 covers conditions of use and specification updates for 2'-FL. The nutrition company must still match the exact authorised source and food category before using any level.
U.S. GRAS Review
The FDA GRAS Notice Inventory includes many 2'-FL entries with 'no questions' response letters. Recent closed notices include GRN 1157, GRN 1238, GRN 1257, GRN 1261, GRN 1262, and GRN 1274. Pending or negative-basis notices are not used as launch support.
Use-Level Review Notes
- FDA recent 2'-FL notices commonly use 2.4 g/L as the maximum level for non-exempt infant formula for term infants, as consumed.
- FDA GRN 1157 also covers formula and meal-replacement drinks for young children up to 2.4 g/L, plus infant and young-child foods such as yogurt, juice drinks, cereals, desserts, and dry snacks at category-specific levels.
- FDA GRNs 1257, 1261, 1262, and 1274 expand 2'-FL review into other food categories. Those higher category levels are not default formula doses; confirm food matrix, serving size, and exposure before use.
- EU review anchors include 3.0 g/L for infant formula and 3.64 g/L for follow-on formula in final product ready for use.
- EU food supplement entries include 3.0 g/day for the general population and 1.2 g/day for young children, with same-day-use labelling checks.
- For trial work, start from the target market and product category, then select a level below the applicable authorised or GRAS-supported maximum.
Technical Data
Specification Snapshot
2'-FL Specification
| Color | White to off-white |
|---|---|
| Appearance | Powder |
| 2'-Fucosyllactose (Water-Free) | >=94.0% |
| D-Lactose | <=3.0% |
| Difucosyllactose (DFL) | <=2.0% |
| Water | <=5.0% |
| Ash | <=0.5% |
| Residual Protein | <=100 mg/kg |
| Endotoxins | <=10 EU/mg |
| Aflatoxin M1 | <=0.05 ug/kg |
| Total Arsenic | <=0.1 mg/kg |
| Cadmium | <=0.1 mg/kg |
| Lead | <=0.05 mg/kg |
| Mercury | <=0.01 mg/kg |
| Aerobic Plate Count | <=500 CFU/g |
| Moulds and Yeasts | <=100 CFU/g |
| Bacillus cereus | <=50 CFU/g |
| Enterobacteriaceae | <10 CFU/g |
| Salmonella | Absent in 25 g |
| Cronobacter spp. | Absent in 100 g |
| Staphylococcus aureus | Absent in 25 g |
| Listeria monocytogenes | Absent in 25 g |
Specification Notes
- Product Description
- 2'-Fucosyllactose (2'-FL) is a fermentation-derived HMO ingredient made from lactose-based raw material through fermentation, purification, and drying. It is the most abundant oligosaccharide in human milk and remains a key reference ingredient for early-life nutrition development.
- Storage Condition
- Keep sealed in a dry place at room temperature and away from light.
- Pack Size and Shelf Life
- 20 kg per carton or drum, packed as 10 kg x 2 bags. Best use before: 24 months.
- Packaging Material
- Inner packaging uses food-grade composite film bags and food-grade composite 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 2'-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.