Ingredient Record

2'-fucosyllactose and difucosyllactose

Carbohydrate used in infant formula to support immunity.

HigherBar policy

No policy

No HigherBar policy on this ingredient.

Regulatory status

Approved in 1 of 7 tracked registries, no published record in 6.

See the status of each registry, with sources

What It Is

Naturally derived carbohydrates found in human breast milk, used to fortify infant formulas. Support immune development and promote beneficial gut microbiota colonization in infants. Approved by the US FDA specifically for use in non-exempt infant formulas at up to 1.6 grams per liter.

Regulatory Record

What each registry publishes about 2'-fucosyllactose and difucosyllactose.

Every row comes from a published regulator source, linked so you can read it yourself. "Prohibited" means a regulator has affirmatively banned it; "not authorized" means it has never been cleared for that use there. The two are not the same thing, so we never collapse them.

Approved in 1 of 7 tracked registries, no published record in 6. Last verified Oct 1, 2026.

Published regulatory status for 2'-fucosyllactose and difucosyllactose, one row per registry.
RegistryStatusPublished record
United States (FDA)ApprovedgrasFor use as an ingredient in non-exempt infant formulas for term infants at a maximum level of 1.6 grams per liter (g/L); in toddler formula and in other drinks for young children (between 1 and 3 years of age) at 1.2 g/L; in other foods for infants and young children at 10 grams per kilogram (g/kg); and, in beverages and beverage bases, grain products and pastas, milk (whole and skim), and milk products that are conventional food products used by the general population, at levels ranging from 2 to 40 g/kg.No effective date published · Last verified Oct 1, 2026View the source document
European Union (EFSA)No published dataOur sources hold no evidenced record here. That is not a clearance and not a ban.
United Kingdom (FSA)No published dataOur sources hold no evidenced record here. That is not a clearance and not a ban.
Codex Alimentarius (JECFA)No published dataOur sources hold no evidenced record here. That is not a clearance and not a ban.
Japan (CAA)No published dataOur sources hold no evidenced record here. That is not a clearance and not a ban.
Australia & New Zealand (FSANZ)No published dataOur sources hold no evidenced record here. That is not a clearance and not a ban.
Canada (Health Canada)No published dataOur sources hold no evidenced record here. That is not a clearance and not a ban.

We publish only evidenced regulatory rows, each with its source. Coverage is uneven across registries, and a missing row is reported as missing.

Keep Digging

Check a whole label, not just one ingredient.

Paste a product's full ingredient list and get this same record for every ingredient we can identify, plus an honest "not recognized" for the rest.