Ingredient Record

3-fucosyllactose

Oligosaccharide prebiotic derived from human milk.

CAS 41312-47-4

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

3-Fucosyllactose is an oligosaccharide naturally present in human breast milk with prebiotic properties. Used in infant formula and functional foods, it supports gut microbiota development and digestive health without caloric sweetness.

Regulatory Record

What each registry publishes about 3-fucosyllactose.

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 3-fucosyllactose, one row per registry.
RegistryStatusPublished record
United States (FDA)ApprovedgrasIntended for use as an ingredient in cow milk-, soy-, and partially hydrolyzed protein-based, non-exempt infant formulas for term infants up to 0.9 g/L of formula (as consumed); formula intended for young children aged 1 to 3 years up to 1.2 g/L of formula (as consumed); other drinks and foods for infants and young children under 3 years of age that include 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; cereal, granola, energy, protein, and meal replacement bars; enhanced and fortified waters; sports, isotonic and energy drinks; breakfast cereals; fermented milk, flavored milk and mixes; smoothies, yogurts, meal replacement beverages (milk- and non-milk based), and milk substitutes; fruit juices and nectars; fruit-flavored beverages and vegetable juices; and gummy candies at maximum levels ranging from 0.26 to 8.8 g/kg; and in oral and enteral tube feeding formulas (11 years and older) up to 6.6 g/L (as consumed).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.