Food Safety Substance
2'-Fucosyllactose
2'-Fucosyllactose is a food additive with Approved novel food (infant formula, supplements) in the EU, FDA has no questions in the US, and data from 4 regulatory sources.
CAS 41263-94-9
Indexable evidence set
FDA
FDA has no questions
ADI / TDI
No ADI/TDI row found
Codex
0 row(s)
SOURCE
D1 identity resolution
e number aliases | Food Additives | dsstox identifiers | 4 matched regulatory source group(s)
Substance Identity
Resolved identifiers used to render this food-safety record.
Substance name
2'-Fucosyllactose
CAS
41263-94-9
DTXSID
DTXSID40194179
PubChem CID
170484
Evidence tier
Indexable evidence set (6)
SOURCE
EU Commission
FDA | Health Canada | Codex Alimentarius
Multi-Jurisdiction Comparison
Side-by-side status rows for the same resolved substance across public food regulators.
| Jurisdiction | Authority | Status | Evidence |
|---|---|---|---|
| European Union | EU Commission | Approved novel food (infant formula, supplements) | - |
| United States | FDA | FDA has no questions | GRAS notice |
SOURCE
FDA
FDA GRAS
FDA GRAS Status
US FDA GRAS notice evidence from enriched and notice tables.
| Jurisdiction | GRN | Substance | FDA response | Intended use | Basis | Notifier |
|---|---|---|---|---|---|---|
| United States | 546 | 2'-O-fucosyllactose | FDA has no questions | Intended for use in term infant formula at a maximum level of 2,400 milligrams (mg)/Liter. Also intended for use in baked goods and baking mixes, beverages and beverages bases... | Scientific Procedures | Glycom A/S |
| United States | 571 | 2'-Fucosyllactose | FDA has no questions | For use as an ingredient in infant and toddler formula at a level of not more than 2 grams 2-fucosyllactose per liter of formula. | Scientific procedures | Jennewein Biotechnologie, GmgH |
| United States | 650 | 2'-O-fucosyllactose | FDA has no questions | For use in term infant formula at a maximum level of 2,400 milligrams (mg)/Liter. Also intended for use in baby foods and drinks for young children, beverages and beverages bases... | Scientific procedures | Glycom A/S |
| United States | 735 | 2'-Fucosyllactose | FDA has no questions | Ingredient in milk-and soy-based, non-exempt infant formulas for term infants and in toddler formulas at a maximum level of 2.4 g/L of formula as consumed; infant and toddler... | Scientific procedures | Glycosyn, LLC and Friesland Campina Domo B.V. |
| United States | 749 | 2'-O-fucosyllactose | FDA has no questions | Ingredient in nonexempt infant formulas for term infants and in toddler formulas up to 2.4 g/L, in infant and toddler foods up to 12 g/kg, and in toddler drinks up to 1.2 g/L. | Scientific procedures | DuPont Nutrition & Health |
| United States | 815 | 2'-fucosyllactose and difucosyllactose | FDA has no questions | For 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... | Scientific procedures | Glycom A/S |
| United States | 852 | 2'-fucosyllactose | FDA has no questions | For use as an ingredient in beverages and beverage bases; breakfast cereals; dairy product analogues; frozen dairy desserts and mixes; gelatins, puddings, and fillings; grain... | Scientific procedures | BASF SE |
| United States | 859 | 2'-fucosyllactose | At the notifier's request, FDA ceased to evaluate this notice | For use an ingredient in whey, milk, and soy-based, non-exempt infant formulas at a level of 2.4 g/L of formula as consumed; infant and toddler foods at levels ranging from... | Scientific procedures | Advanced Protein Technologies, Corp. |
| United States | 897 | 2'-O-fucosyllactose | FDA has no questions | Intended for use as an ingredient in term infant formula, toddler formulas, baby foods and beverages for young children at levels ranging from 0.24 to 2.04 grams per serving, and... | Scientific procedures | DuPont Nutrition and Health |
| United States | 924 | 2'-fucosyllactose | At the notifier's request, FDA ceased to evaluate this notice | Intended for use as an ingredient in cows milk-based, non-exempt term infant formula at a level of 3.64 g/L. | Scientific procedures | Jennewein Biotechnologie GmbH |
| United States | 929 | 2'-fucosyllactose | FDA has no questions | Intended for use as an ingredient in exempt hypoallergenic infant formula for term infants and hypoallergenic toddler formula at a level of 2 g/L of formula, as consumed. The... | Scientific procedures | Jennewein Biotechnologie GmbH |
| United States | 932 | 2'-fucosyllactose | FDA has no questions | Intended for use as an ingredient at a level of 2.4 g/L of formula as consumed in milk- and soy-based, non-exempt infant formula for term infants; at a level of 2.4 g/L in drinks... | Scientific procedures | Advanced Protein Technologies Corp. |
| United States | 987 | 2'-fucosyllactose | At the notifier's request, FDA ceased to evaluate this notice | Intended for use as an ingredient in nonexempt infant formula for term infants at a maximum level of 2.4 g/L of formula, as consumed; in toddler formulas and meal replacement... | Scientific procedures | Amyris, Inc. |
| United States | 1014 | 2'-fucosyllactose | FDA has no questions | Intended for use as an ingredient at a level of 2.4 g/L in formula for young children (> 12 months); at a level of 12 g/kg (or g/L) in milk- and soy-based meal replacement... | Scientific procedures | Chr. Hansen A/S |
| United States | 1034 | 2'-fucosyllactose | FDA has no questions | Intended for use as an ingredient in exempt hypoallergenic extensively hydrolyzed cow milk or goat milk protein- and amino acid-based infant formula for term infants with cow milk... | Scientific procedures | Glycom A/S |
| United States | 1035 | Lacto-N-fucopentaose I with 2'-fucosyllactose | FDA has no questions | Intended for use as an ingredient in non-exempt infant formula for term infants at use levels providing up to 0.8 g LNFP-I/L infant formula as consumed. LNFP-I/2'-FL is also... | Scientific procedures | Glycom A/S |
| United States | 1040 | 2'-fucosyllactose | At the notifier's request, FDA ceased to evaluate this notice | Intended for use as an ingredient in cow milk-based, exempt infant formula for post-discharge preterm infants at a level up to 2.0 g/L, as consumed. | Scientific procedures | Chr. Hansen A/S |
| United States | 1051 | 2'-fucosyllactose | FDA has no questions | Intended for use as an ingredient in non-exempt infant formula for term infants at a level of 2.4 g/L of formula as consumed; in toddler formulas intended for children ages 1-3... | Scientific procedures | Kyowa Hakko Bio Co., Ltd. |
| United States | 1060 | 2'-fucosyllactose | FDA has no questions | Intended for use as an ingredient in non-exempt infant formula for term infants at a maximum level of 2.4 g/L as consumed, and in other food categories at the maximum levels... | Scientific procedures | Glycom A/S |
| United States | 1091 | 2'-fucosyllactose | FDA has no questions | Intended for use as an ingredient in non-exempt infant formula for term infants and formula intended for young children (>12 months) at up to 2.4 g/L; foods intended for infants... | Scientific procedures | Inbiose N.V. |
| United States | 1157 | 2'-fucosyllactose | FDA has no questions | Intended for use as an ingredient in milk- and soy-based, non-exempt infant formula for term infants at up to 2.4 g/L of formula as consumed; in formula intended for young... | Scientific procedures | Synaura Biotechnology (Shanghai) Co., Ltd. |
| United States | 1238 | 2'-fucosyllactose | FDA has no questions | Intended for use as an ingredient in non-exempt infant formula for term infants at a maximum use level of 2.4 g/L as consumed, and in other food categories at the maximum levels... | Scientific procedures | Cataya Bio (Shanghai) Co., Ltd. |
| United States | 1257 | 2'-Fucosyllactose | Pending | Intended for use as an ingredient in non-exempt infant formula for term infants at a use level of 3 g/L and in other food categories at levels up to 600 g/L. | Scientific procedures | Chr. Hansen A/S |
| United States | 1261 | 2'-Fucosyllactose | FDA has no questions | Intended for use as an ingredient in non-exempt infant formula for term infants, formula for young children (>12 months) at a maximum use level of 2.4 g/L and in other food... | Scientific procedures | Suzhou Yixi Biotech Co., Ltd. |
| United States | 1262 | 2'-Fucosyllactose | Pending | Intended for use as an ingredient in non-exempt infant formula for term infants and formula for young children (>12 months) at a maximum use level of 2.4 g/L and in other food... | Scientific procedures | Zhuhai Long Health Biotechnology Co., Ltd. |
| United States | 815 | 2'-fucosyllactose and difucosyllactose | FDA has no questions (in PDF) | For 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... | Scientific procedures | Glycom A/S |
| United States | 852 | 2'-fucosyllactose | FDA has no questions (in PDF) | For use as an ingredient in beverages and beverage bases; breakfast cereals; dairy product analogues; frozen dairy desserts and mixes; gelatins, puddings, and fillings; grain... | Scientific procedures | BASF SE |
| United States | 924 | 2'-fucosyllactose | At the notifier's request, FDA ceased to evaluate this notice (in PDF) | Intended for use as an ingredient in cows milk-based, non-exempt term infant formula at a level of 3.64 g/L. | Scientific procedures | Jennewein Biotechnologie GmbH |
| United States | 929 | 2'-fucosyllactose | FDA has no questions (in PDF) | Intended for use as an ingredient in exempt hypoallergenic infant formula for term infants and hypoallergenic toddler formula at a level of 2 g/L of formula, as consumed. The... | Scientific procedures | Jennewein Biotechnologie GmbH |
| United States | 987 | 2'-fucosyllactose | At the notifier's request, FDA ceased to evaluate this notice (in PDF) | Intended for use as an ingredient in nonexempt infant formula for term infants at a maximum level of 2.4 g/L of formula, as consumed; in toddler formulas and meal replacement... | Scientific procedures | Amyris, Inc. |
| United States | 1014 | 2'-fucosyllactose | FDA has no questions (in PDF) | Intended for use as an ingredient at a level of 2.4 g/L in formula for young children (> 12 months); at a level of 12 g/kg (or g/L) in milk- and soy-based meal replacement... | Scientific procedures | Chr. Hansen A/S |
| United States | 1034 | 2'-fucosyllactose | FDA has no questions (in PDF) | Intended for use as an ingredient in exempt hypoallergenic extensively hydrolyzed cow milk or goat milk protein- and amino acid-based infant formula for term infants with cow milk... | Scientific procedures | Glycom A/S |
| United States | 1035 | Lacto-<i>N</i>-fucopentaose I with 2'-fucosyllactose | FDA has no questions (in PDF) | Intended for use as an ingredient in non-exempt infant formula for term infants at use levels providing up to 0.8 g LNFP-I/L infant formula as consumed. LNFP-I/2'-FL is also... | Scientific procedures | Glycom A/S |
| United States | 1040 | 2'-fucosyllactose | At the notifier's request, FDA ceased to evaluate this notice (in PDF) | Intended for use as an ingredient in cow milk-based, exempt infant formula for post-discharge preterm infants at a level up to 2.0 g/L, as consumed. | Scientific procedures | Chr. Hansen A/S |
| United States | 1060 | 2'-fucosyllactose | FDA has no questions (in PDF) | Intended for use as an ingredient in non-exempt infant formula for term infants at a maximum level of 2.4 g/L as consumed, and in other food categories at the maximum levels... | Scientific procedures | Glycom A/S |
| United States | 1051 | 2'-fucosyllactose | FDA has no questions (in PDF) | Intended for use as an ingredient in non-exempt infant formula for term infants at a level of 2.4 g/L of formula as consumed; in toddler formulas intended for children ages 1-3... | Scientific procedures | Kyowa Hakko Bio Co., Ltd. |
| United States | 571 | 2'-Fucosyllactose | FDA has no questions | For use as an ingredient in infant and toddler formula at a level of not more than 2 grams 2-fucosyllactose per liter of formula. | Scientific procedures | Jennewein Biotechnologie, GmgH |
| United States | 1091 | 2'-fucosyllactose | FDA has no questions (in PDF) | Intended for use as an ingredient in non-exempt infant formula for term infants and formula intended for young children (>12 months) at up to 2.4 g/L; foods intended for infants... | Scientific procedures | Inbiose N.V. |
| United States | 1157 | 2'-fucosyllactose | FDA has no questions (in PDF) | Intended for use as an ingredient in milk- and soy-based, non-exempt infant formula for term infants at up to 2.4 g/L of formula as consumed; in formula intended for young... | Scientific procedures | Synaura Biotechnology (Shanghai) Co., Ltd. |
| United States | 932 | 2'-fucosyllactose | FDA has no questions (in PDF) | Intended for use as an ingredient at a level of 2.4 g/L of formula as consumed in milk- and soy-based, non-exempt infant formula for term infants; at a level of 2.4 g/L in drinks... | Scientific procedures | Advanced Protein Technologies Corp. |
| United States | 859 | 2'-fucosyllactose | At the notifier's request, FDA ceased to evaluate this notice (in PDF) | For use an ingredient in whey, milk, and soy-based, non-exempt infant formulas at a level of 2.4 g/L of formula as consumed; infant and toddler foods at levels ranging from... | Scientific procedures | Advanced Protein Technologies, Corp. |
| United States | 735 | 2'-Fucosyllactose | FDA has no questions (in PDF) | Ingredient in milk-and soy-based, non-exempt infant formulas for term infants and in toddler formulas at a maximum level of 2.4 g/L of formula as consumed; infant and toddler... | Scientific procedures | Glycosyn, LLC and Friesland Campina Domo B.V. |
| United States | 1257 | 2'-Fucosyllactose | Pending | Intended for use as an ingredient in non-exempt infant formula for term infants at a use level of 3 g/L and in other food categories at levels up to 600 g/L. | Scientific procedures | Chr. Hansen A/S |
| United States | 1262 | 2'-Fucosyllactose | Pending | Intended for use as an ingredient in non-exempt infant formula for term infants and formula for young children (>12 months) at a maximum use level of 2.4 g/L and in other food... | Scientific procedures | Zhuhai Long Health Biotechnology Co., Ltd. |
| United States | 1238 | 2'-fucosyllactose | FDA has no questions (in PDF) | Intended for use as an ingredient in non-exempt infant formula for term infants at a maximum use level of 2.4 g/L as consumed, and in other food categories at the maximum levels... | Scientific procedures | Cataya Bio (Shanghai) Co., Ltd. |
| United States | 1274 | 2'-Fucosyllactose | FDA has no questions (in PDF) | As an ingredient in non-exempt infant formula for term infants and formula for young children (>12 months) at a maximum use level of 2.4 g/L as consumed, and in other food... | Scientific procedures | Tianjin Hesheng Biotechnology Co., Ltd. |
| United States | 1281 | 2'-Fucosyllactose | - | Intended for use as an ingredient in cow milk- and soy-based, non-exempt infant formula for term infants and formula for young children (>12 months) at a maximum level of 2.4... | Scientific procedures | CABIO Biotech (Wuhan) Co., Ltd. |
| United States | 1261 | 2'-Fucosyllactose | FDA has no questions (in PDF) | Intended for use as an ingredient in non-exempt infant formula for term infants, formula for young children (>12 months) at a maximum use level of 2.4 g/L and in other food... | Scientific procedures | Suzhou Yixi Biotech Co., Ltd. |
SOURCE
ingredients
ghs classifications
Cross-Reference to Cosmetics / Chemicals / Pharma
Same-CAS public rows from adjacent Roots verticals where available.
SOURCE
FAQPage JSON-LD
public food renderer rows
Frequently Asked Questions
Food-use, safety, ADI, and cross-vertical answers mirrored into FAQPage JSON-LD.
What is 2'-Fucosyllactose used for in food?
2'-Fucosyllactose appears in food-use rows as: Sweetener.
Is 2'-Fucosyllactose safe?
This page does not assign a standalone safety verdict; it renders public regulatory evidence. EU status evidence: Approved novel food (infant formula, supplements). US/FDA evidence: FDA has no questions.
What is the ADI for 2'-Fucosyllactose?
No ADI row was found for 2'-Fucosyllactose in the rendered EFSA, food_substances, food_additives, or JECFA tables.
Is 2'-Fucosyllactose also used in cosmetics?
No same-CAS cosmetics row was found for 2'-Fucosyllactose in the rendered cross-reference data.