Good Active Ingredient NOAEL Data GHS Classified Dermal Penetration

Caffeine

INCI: CAFFEINE

CAS Number
58-08-2
Function
active / lipolytic / antioxidant
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
EU Max Conc. 6% leave-on body, 1.5% eye lotions, 2% face powder
🇺🇸 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
none

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 100 mg/kg bw/day oral cat Short Term Toxicity COSMOS_DB
NOAEL 75 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 75 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 136 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 177 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 86.6 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 800 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 120 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 135 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 55 mg/kg bw/day oral mouse Chronic 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.

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

Expert Verdict

CIR Expert Panel (2024, Int J Toxicol) concluded safe in present practices of use and concentration. EU: not listed in Annexes II, III, V, or VI — permitted without restriction (EU Reg 1223/2009). MOIE 27-fold confirmed adequate (Bury et al. 2021). Genotoxicity: Ames positive in vitro without S9 but negative with metabolic activation; NTP 2-year bioassays negative; IARC inadequate evidence — not classifiable as carcinogen.

⚠️
Concern Level: Low

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

Frequently Asked Questions

Is Caffeine safe in cosmetics?

CIR Expert Panel (2024, Int J Toxicol) concluded safe in present practices of use and concentration. EU: not listed in Annexes II, III, V, or VI — permitted without restriction (EU Reg 1223/2009). MOIE 27-fold confirmed adequate (Bury et al. 2021). Genotoxicity: Ames positive in vitro without S9 but negative with metabolic activation; NTP 2-year bioassays negative; IARC inadequate evidence — not classifiable as carcinogen. The EU classifies Caffeine as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

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 Margin of Safety for Caffeine?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Caffeine?

The NOAEL (No Observed Adverse Effect Level) for Caffeine is 100 mg/kg bw/day based on a Short Term Toxicity study via oral route in cat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Caffeine 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 55 jurisdictions
 🧮
MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

Related Ingredients

Baicapil
Good
Exosomes
Good
Hexylresorcinol
Excellent
Calcium Pantothenate
Excellent
L-Proline
Excellent
Browse all 30,000+ ingredients →
📱

Is Caffeine in Your Products?

Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free →

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Caffeine in your formulation.

Ingredient Decoder MoS Calculator