Is Caffeine safe in cosmetics?
Caffeine has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Caffeine
Also known as: 1H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-, 5-26-13-00558, Anhydrous caffeine, BRN 0017705, Cafamil (+14 more)
INCI: CAFFEINE
Caffeine (CAS 58-08-2) is a cosmetic active ingredient functioning as active / lipolytic / antioxidant. NOAEL 206.2 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 6% leave-on body, 1.5% eye lotions, 2% face powder. 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.
Function
active / lipolytic / antioxidant
Editorial assessment
GOOD
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
EU Max Conc.
6% leave-on body, 1.5% eye lotions, 2% face powder
US US Status
permitted
US Notes
FDA permits in cosmetics without restriction — no pre-approval required. GRAS as food additive in cola beverages ≤0.02% (21 CFR 182.1180). Approved OTC stimulant drug (100–200 mg oral). NOT a GRASE sunscreen active — not listed in FDA sunscreen monograph; only zinc oxide and titanium dioxide hold full GRASE status for UV protection. MoCRA: no specific caffeine designation.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Caffeine.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Caffeine. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 3 mg/kg bw/day | oral | rat | Neurotoxicity | COSMOS DB |
| NOAEL | 6 mg/kg bw/day | oral | rat | Developmental | COSMOS DB |
| NOAEL | 10 mg/kg bw/day | oral | rat | Special Toxicology Study | COSMOS DB |
| NOAEL | 12.5 mg/kg bw/day | oral | monkey | Multigeneration Reproductive | COSMOS DB |
| NOAEL | 13 mg/kg bw/day | oral | monkey | Reproductive | COSMOS DB |
| NOAEL | 15 mg/kg bw/day | oral | rat | Neurotoxicity | COSMOS DB |
| NOAEL | 20 mg/kg bw/day | oral | rat | Neurotoxicity | COSMOS DB |
| NOAEL | 22.5 mg/kg bw/day | oral | rat | Developmental | COSMOS DB |
| NOAEL | 24.7 mg/kg bw/day | oral | rat | Developmental | COSMOS DB |
| NOAEL | 25 mg/kg bw/day | oral | rat | Developmental | COSMOS DB |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Short-term Exposure Effects
The substance may cause effects on the central nervous system and cardiovascular system. This may result in insomnia, excitement, tachycardia and polyuria.
Routes of Exposure
The substance can be absorbed into the body by inhalation and by ingestion.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Caffeine across SCCS product categories, with measured dermal absorption where available.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Caffeine, relevant to systemic exposure and MoS calculations.
Absorption %
15-30%
Penetration Level
epidermis
Penetration Depth
epidermis/dermis
Molecular Weight
194.2 Da
Log P
-0.07
Systemic Absorption
yes
Topical Bioavailability
10-25%
Safety Margin Factor
high
Vehicle Dependent
Yes — absorption varies by formulation
Source: Skin Pharmacol Physiol 2007
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LC50 | ~4940 mg/m3 | Rat | inhalation | - | ECHA |
| LD50 | >2000 mg/kg | Rat | dermal | acute | ECHA |
| LD50 | =367.7 mg/kg | Rat | oral | - | ECHA |
| LD50 | =185 mg/kg | Mouse | oral | - | ECHA |
| LD50 | >=200 mg/kg | Rat | oral | - | ECHA |
| LD50 | <=400 mg/kg | Rat | oral | - | ECHA |
| LEL | =220 mg/kg-day | Rat | oral | - | ECHA |
| LEL | =240 mg/kg-day | Rat | oral | - | ECHA |
| LEL | ~35 mg/kg-day | Mouse | oral | - | ECHA |
| LOEL | =20 mg/kg-day | Rat | oral | short-term | ECOTOX |
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
51
Evaluation Year
1990
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Warning
Pictograms
Harmful / Irritant
Hazard Class and Category
Acute Tox. 4 *
Hazard Statements
- H302 Harmful if swallowed
Inserted via ATP: CLP00
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE; GROUP
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
EPA Dryad Skin Absorption (physics-based)
MW: 194.194
LogP: -0.0709947
Kp epidermis: 0.00248 cm/h
% dose epidermis: 0.97%
% dose stratum corneum: 0.96%
% dose dermis: 0.94%
Source: EPA Dryad Skin Absorption 2024
Roberts Skin Permeation (Mendeley 2022)
MW: 194.19
Log Kow: -0.63
Log Kp: -3.6556077263148894
Log Jmax: -7.418237303551122
Source: Roberts Cheruvu Mendeley 2022
Aggregated DA Values (1 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_in_vitro | 0.09-0.39 | In vitro; OECD TG 428 ring trial (GLP, 6 labs); Nitsche 2004 | Human split-thickness skin | Regul Toxicol Pharmacol 2022; Nitsche 2004 (2022) |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Eye Cream | 0.5–3 | 5 | CIR Safety Assessment |
| Serum | 1–5 | 5 | CIR Safety Assessment |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Deodorizer
Flavouring and nutrient
Fragrance
Pharmaceutical
Softener and conditioner
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)
Editorial summary
Preliminary editorial summary for Caffeine — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
cir-reviewed
oecd-assessed
no-sccs-opinion
follicular-penetration
phosphodiesterase-inhibitor
anti-cellulite
gras-food
not-grase-sunscreen
endocrine_disruptor
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Caffeine by CAS number or substance name.
Studies
40
Lowest NOAEL
3 mg/kg bw/day
Highest NOAEL
228 mg/kg bw/day
COSMOS DB
ECHA
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 0.09-0.39 | In vitro; OECD TG 428 ring trial (GLP, 6 labs); Nitsche 2004 | Standard |
Known Synonyms
1H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-
5-26-13-00558
Anhydrous caffeine
BRN 0017705
Cafamil
Cafecon
Caffeine, synthetic
Caffine
Coffeine
Coffeinum
Dexitac
EINECS 200-362-1
Eldiatric C
FEMA No. 2224
NCI-C02733
Nix Nap
Organex
Quick-Pep
Theobromine, 1-methyl-
Chemical Function
Deodorizer
Softener and conditioner
Pharmaceutical
Fragrance
Flavouring and nutrient
Biocide
Regulatory Lists
active_ingredient; Australia
pharmaceutical
active_ingredient; Europe; Pesticides
active_ingredient; animal_products; Europe; pharmaceutical; residue
Europe; pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
detected; drinking_water
detected; drinking_water
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
CAFFEINE
ChEMBL ID
CHEMBL113
Max Phase
4
Adverse Event Associations
3536
SOURCE
EFSA / FDA GRAS
food_additives + fda_gras_enriched
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Caffeine Anhydrous
FDA GRAS
At the notifier's request, FDA ceased to evaluate this notice
GRN
347
Food Category
sports_nutrition
Flavoring ingredient in alcoholic beverages at levels of up to 200 parts per million
View full food safety profile →Frequently Asked Questions
Is Caffeine allowed in the EU?
Caffeine EU regulatory status: permitted. Maximum allowed concentration: 6% leave-on body, 1.5% eye lotions, 2% face powder. This is based on EU Regulation 1223/2009 and its amendments.
What does Caffeine do in cosmetics?
Caffeine functions as: active / lipolytic / antioxidant. It is classified as a Active Ingredient in our database. CAS number: 58-08-2.
What is the NOAEL for Caffeine?
The NOAEL (No Observed Adverse Effect Level) for Caffeine is 3 mg/kg bw/day based on a Neurotoxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS DB.
Is Caffeine used outside cosmetics?
Caffeine 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 Caffeine compliance across multiple jurisdictions:
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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