2'-Fucosyllactose (HMO)
2'-Fucosyllactose is a trisaccharide of fucose, galactose and glucose, the most abundant of the human milk oligosaccharides. Commercial 2'-FL is not taken from milk; it is made by fermentation with engineered strains, usually of Escherichia coli, that build it from lactose and a carbon source, then purified by filtration, ion exchange and crystallization or spray drying. It is sold as a white powder, mainly for infant formula, with growing use in supplements and foods.
Suppliers sell different products under the same name. Specify the one you need.
Amorphous 2'-FL powder, usually 90% or more purity on a dry basis.
Crystallized grade with high purity and lower moisture.
Produced and documented to the specifications infant formula makers require.
2'-FL combined with other HMOs such as lacto-N-neotetraose or 3-fucosyllactose.
Compare each result with your own specification when the lot arrives.
Keep 2'-FL in sealed, moisture-barrier packaging in a cool, dry place; the amorphous powder is hygroscopic. Shelf life is set by the supplier, and infant formula grades usually come with a defined retest date.
Purity, by-product profile and the production strain differ between manufacturers, and each GRAS notice covers one notifier's product, so record the manufacturer and strain with each lot. Keep endotoxin and residual DNA results on file.
Facts from regulators and standards bodies, each linked to its source.
GRN 546, for 2'-O-fucosyllactose notified by Glycom for term infant formula at up to 2,400 mg per liter and listed foods, closed on Sep 16, 2015 with FDA having no questions.
Source: hfpappexternal.fda.gov (opens in a new tab)GRN 852, for 2'-fucosyllactose notified by BASF for listed foods, formulas and baby foods, closed on Nov 15, 2019 with FDA having no questions; FDA's inventory lists many other 2'-FL notices, each for its own notifier's product.
Source: hfpappexternal.fda.gov (opens in a new tab)Health Canada's prebiotics natural health product monograph lists 2'-fucosyllactose with Escherichia coli whole cell for biosynthesis as its source.
Source: webprod.hc-sc.gc.ca (opens in a new tab)This is general information, not regulatory advice. Status differs by country and by how the ingredient is used, so check the rules for your product and market.
Manufacturers and distributors whose own websites say they sell it.
Manufacturer · Lyngby, Denmark
Sells it as MyOli
Danish biosolutions company formed from Novozymes and Chr. Hansen that supplies probiotic strains, HMOs, dairy cultures and enzymes to supplement, infant formula and food makers.
Suppliers are in alphabetical order and none pays to appear. Each claim is checked against the supplier’s own website on the date shown. Ask for the specification sheet and a recent COA before you order, and confirm details with the supplier.
Common forms include spray-dried powder, crystalline 2'-FL, infant formula grades and hMO blends. Ask each supplier for the specification sheet of the exact grade they quote.
Expect 2'-FL assay, related carbohydrates, residual protein and endotoxin, absence of production strain DNA, moisture and microbiology, each with its method, specification and result for that lot.
Keep 2'-FL in sealed, moisture-barrier packaging in a cool, dry place; the amorphous powder is hygroscopic. Shelf life is set by the supplier, and infant formula grades usually come with a defined retest date.
GRN 546, for 2'-O-fucosyllactose notified by Glycom for term infant formula at up to 2,400 mg per liter and listed foods, closed on Sep 16, 2015 with FDA having no questions. GRN 852, for 2'-fucosyllactose notified by BASF for listed foods, formulas and baby foods, closed on Nov 15, 2019 with FDA having no questions; FDA's inventory lists many other 2'-FL notices, each for its own notifier's product. Health Canada's prebiotics natural health product monograph lists 2'-fucosyllactose with Escherichia coli whole cell for biosynthesis as its source.
Request a free listing for the ingredients you make or distribute. No paid placement.