Food Safety Substance

Lactose

Lactose is a food additive with Permitted in the EU, FDA has no questions in the US, and data from 5 regulatory sources.

CAS 63-42-3 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 | 5 matched regulatory source group(s)

Substance Identity

Resolved identifiers used to render this food-safety record.

Substance name

Lactose

CAS

63-42-3

DTXSID

DTXSID2023193

PubChem CID

440995

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	Permitted	-
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	766	3'-sialyllactose sodium salt	FDA has no questions	For use as an ingredient in non-exempt term infant formula at a maximum level of 238 mg/L as consumed. Also for use as an ingredient in dairy product analogs, infant and toddler...	Scientific procedures	GeneChem, Inc.
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	880	3'-sialyllactose sodium salt	FDA has no questions	Ingredient at levels up to 0.2 g/L in cows milk-based, non-exempt infant formula for term infants; 0.15 g/L in beverages and formula for young children (>12 months of age); 1.25...	Scientific procedures	Glycom A/S
United States	881	6'-sialyllactose sodium salt	FDA has no questions	Ingredient at levels up to 0.4 g/L in non-exempt infant formula for term infants; 1 0.3 g/L in beverages and formula for young children (>12 months of age); 2.5 g/kg in foods for...	Scientific procedures	Glycom A/S
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	921	3'-sialyllactose sodium salt	FDA has no questions	Intended for use as an ingredient in cow milk-based, non-exempt infant formula for term infants at a level of 0.28 g/L.	Scientific procedures	Jennewein Biotechnologie GmgH
United States	922	6'-sialyllactose sodium salt	FDA has no questions	Intended for use as a substitute for other forms of 6-SL in cows milk-based, non-exempt infant formula for term infants at a level of 0.4 g/L.	Scientific procedures	Jennewein Biotechnologie GmgH
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	925	3-fucosyllactose	FDA has no questions	As an ingredient in cow milk-based, non-exempt infant formula for term infants at a level of 0.44 g/L infant formula as consumed.	Scientific procedures	Jennewein Biotechnologie GmgH
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	951	3-fucosyllactose	FDA has no questions	Intended for use as an ingredient in cow milk-based and soy-based non-exempt infant formula for term infants and formula intended for young children aged 1-3 years at a level of...	Scientific procedures	Danisco, USA
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	1015	3'-sialyllactose sodium salt	FDA has no questions	Intended for use as an ingredient at 0.28 g/L in formulas for young children (> 12 months); 0.9 g/L in milk- and soy-based meal replacement beverages for children and meal...	Scientific procedures	Chr. Hansen A/S
United States	1016	6'-sialyllactose sodium salt	FDA has no questions	Intended for use as an ingredient at 0.4 g/L in formulas for young children (> 12 months); 2.28 g/L in milk-based meal replacement beverages for children and meal replacements...	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	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	749	2'-O-fucosyllactose	FDA has no questions (in PDF)	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	766	3'-sialyllactose sodium salt	FDA has no questions (in PDF)	For use as an ingredient in non-exempt term infant formula at a maximum level of 238 mg/L as consumed. Also for use as an ingredient in dairy product analogs, infant and toddler...	Scientific procedures	GeneChem, Inc.
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	880	3'-sialyllactose sodium salt	FDA has no questions (in PDF)	Ingredient at levels up to 0.2 g/L in cows milk-based, non-exempt infant formula for term infants; 0.15 g/L in beverages and formula for young children (>12 months of age); 1.25...	Scientific procedures	Glycom A/S
United States	881	6'-sialyllactose sodium salt	FDA has no questions (in PDF)	Ingredient at levels up to 0.4 g/L in non-exempt infant formula for term infants; 1 0.3 g/L in beverages and formula for young children (>12 months of age); 2.5 g/kg in foods for...	Scientific procedures	Glycom A/S
United States	897	2'-<i>O</i>-fucosyllactose	FDA has no questions (in PDF)	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	921	3'-sialyllactose sodium salt	FDA has no questions (in PDF)	Intended for use as an ingredient in cow milk-based, non-exempt infant formula for term infants at a level of 0.28 g/L.	Scientific procedures	Jennewein Biotechnologie GmgH
United States	922	6'-sialyllactose sodium salt	FDA has no questions (in PDF)	Intended for use as a substitute for other forms of 6-SL in cows milk-based, non-exempt infant formula for term infants at a level of 0.4 g/L.	Scientific procedures	Jennewein Biotechnologie GmgH
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	925	3-fucosyllactose	FDA has no questions (in PDF)	As an ingredient in cow milk-based, non-exempt infant formula for term infants at a level of 0.44 g/L infant formula as consumed.	Scientific procedures	Jennewein Biotechnologie GmgH
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	951	3-fucosyllactose	FDA has no questions (in PDF)	Intended for use as an ingredient in cow milk-based and soy-based non-exempt infant formula for term infants and formula intended for young children aged 1-3 years at a level of...	Scientific procedures	Danisco, USA
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	1015	3'-sialyllactose sodium salt	FDA has no questions (in PDF)	Intended for use as an ingredient at 0.28 g/L in formulas for young children (> 12 months); 0.9 g/L in milk- and soy-based meal replacement beverages for children and meal...	Scientific procedures	Chr. Hansen A/S
United States	1016	6'-sialyllactose sodium salt	FDA has no questions (in PDF)	Intended for use as an ingredient at 0.4 g/L in formulas for young children (> 12 months); 2.28 g/L in milk-based meal replacement beverages for children and meal replacements...	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	1037	3-fucosyllactose	FDA has no questions (in PDF)	Intended for use as an ingredient in non-exempt infant formula for term infants at a level up to 0.75 g/L as consumed; formula and drinks for young children (>12 months) at...	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	1052	3'-sialyllactose sodium salt	FDA has no questions (in PDF)	Intended for use as an ingredient in non-exempt infant formula for term infants and formulas for young children (>12 months) at a level of 0.24 g/L, as consumed; in drinks for...	Scientific procedures	Kyowa Hakko Bio Co., Ltd.
United States	1053	6'-sialyllactose sodium salt	FDA Has No Questions (in PDF)	Intended for use as an ingredient in non-exempt infant formula for term infants at a level of 0.40 g/L of formula as consumed; in toddler formulas at a level of 0.50 g/L, as...	Scientific procedures	Kyowa Hakko Bio Co., Ltd.
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

SOURCE ingredients ghs classifications

Cross-Reference to Cosmetics / Chemicals / Pharma

Same-CAS public rows from adjacent Roots verticals where available.

SOURCE Cross-vertical comparison ingredients | ghs classifications

Cross-Vertical Regulatory Divergence

This substance has different regulatory treatment across food, cosmetics, and industrial use.

CosmeticsLactoseEU status: permitted Industrial / GHSGHS row foundEuropean Chemicals Agency (ECHA)

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 Lactose used for in food?

Lactose appears in food-use rows as: Sweetener.

Is Lactose safe?

This page does not assign a standalone safety verdict; it renders public regulatory evidence. EU status evidence: Permitted. US/FDA evidence: FDA has no questions.

What is the ADI for Lactose?

No ADI row was found for Lactose in the rendered EFSA, food_substances, food_additives, or JECFA tables.

Is Lactose also used in cosmetics?

Lactose has a same-CAS cosmetics cross-reference: Lactose, EU status permitted.