Is Lactose safe in cosmetics?
Lactose has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.
Excellent
Cosmetic Ingredient
Lactose
Also known as: D-(+)-Lactose, Galactinum, Lactose anhydrous, Tablettose, 4-O-beta-D-Galactopyranosyl-beta-D-glucopyranose (+10 more)
INCI: LACTOSE
Lactose (CAS 63-42-3) is a cosmetic cosmetic ingredient functioning as Skin conditioning agent; humectant; bulking agent; filler. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
View industrial chemical safety profile for CAS 63-42-3 →
Auto-generated CPSR Part A draft with source citations
Function
Skin conditioning agent; humectant; bulking agent; filler
Safety Rating
EXCELLENT
Chemistry & Identifiers
IUPAC Name
(2R,3R,4S,5R,6S)-2-(hydroxymethyl)-6-[(2R,3S,4R,5R)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol
InChIKey
GUBGYTABKSRVRQ-QKKXKWKRSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted — GRAS food substance (21 CFR 184.1(b)(2)); widely used pharmaceutical excipient; no cosmetic restrictions under 21 CFR 700
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Lactose.
Calculate MoS for your specific formulation with the MoS Calculator.
EPA ToxValDB — Toxicity Values
1 toxicity value from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >10000 mg/kg | Rat | oral | - | ChemIDplus |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
humectant
{"cas_number": "63-42-3", "ingredient_class": "humectant/sugar_derivative", "molecular_weight_Da": "342.30", "chemical_type": "polysaccharide", "water_binding_mechanism": "hydrogen_bonding/hygroscopic", "water_holding_capacity_g_per_g": "0.3-0.5", "hygroscopicity_at_50_RH": "moderate", "hygroscopicity_at_80_RH": "good", "NMF_component": "no", "NMF_percentage_natural": "0", "TEWL_reduction_pct": "1…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Flavouring and nutrient
Fragrance
Humectant
Lubricating agent
Oxidizing agent
Processing aids not otherwise specified
Softener and conditioner
Solvent
Surfactant (surface active agent)
Thickening agent
Regulatory List Membership (2)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Lactose.
Regulatory Flags
ifra_fragrance
fda_food_additive
Known Synonyms
D-(+)-Lactose
Galactinum
Lactose anhydrous
Tablettose
4-O-beta-D-Galactopyranosyl-beta-D-glucopyranose
beta-D-Glucopyranose, 4-O-beta-D-galactopyranosyl-
β-D-Glucopyranose, 4-O-β-D-galactopyranosyl-
4-O-β-D-Galactopyranosyl-β-D-glucopyranose
4-17-00-03066
BRN 0093796
EINECS 200-559-2
4-(beta-D-Galactosido)-D-glucose
Lactose, anhydrous
Pharmatose 450M
UNII-3SY5LH9PMK
Chemical Function
Humectant
Softener and conditioner
Fragrance
Flavouring and nutrient
Processing aids not otherwise specified
Solvent
Thickening agent
Surfactant (surface active agent)
Lubricating agent
Regulatory Lists
inert_ingredient; Pesticides
IFRA Transparency
Canada; consumer_product; Substances in Products - Canada (4/2014)
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Australia
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
consumer_product; Europe
supplements
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
lactose
ChEMBL ID
CHEMBL2106323
Adverse Event Associations
182
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Lactose
Food Category
sweetener
Frequently Asked Questions
Is Lactose allowed in the EU?
Lactose EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Lactose do in cosmetics?
Lactose functions as: Skin conditioning agent; humectant; bulking agent; filler. It is classified as a cosmetic ingredient in our database. CAS number: 63-42-3.
Is Lactose used outside cosmetics?
Lactose also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Lactose compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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