Is Petrolatum safe in cosmetics?
Petrolatum has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted.
Petrolatum
Also known as: Caswell No. 645A, EINECS 232-373-2, EPA Pesticide Chemical Code 598400, Extra amber, Mineral fat (+15 more)
INCI: PETROLATUM
Petrolatum (CAS 8009-03-8) is a cosmetic cosmetic ingredient functioning as Emollient, occlusive, skin protectant, hair conditioning. NOAEL 125 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); 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 and pharmaceutical data.
View industrial chemical safety profile for CAS 8009-03-8 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Petrolatum is classified GHS Danger (H350) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Emollient, occlusive, skin protectant, hair conditioning
Safety Rating
EXCELLENT
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA GRAS for OTC skin protectant (21 CFR 347). Widely permitted in cosmetics.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Petrolatum.
Calculate MoS for your specific formulation with the MoS Calculator.
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Routes of Exposure
The substance can be absorbed into the body by ingestion.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Petrolatum across SCCS product categories, with measured dermal absorption where available.
Dermal Penetration Profile
Skin absorption and penetration characteristics of Petrolatum, relevant to systemic exposure and MoS calculations.
Absorption %
0%
Penetration Level
surface
Penetration Depth
surface only
Molecular Weight
Variable Da
Log P
n/a
Systemic Absorption
no
Topical Bioavailability
0%
Safety Margin Factor
none
Source: CIR
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Health Hazard
Hazard Class and Category
Carc. 1B
Hazard Statements
- H350 May cause cancer
Inserted via ATP: ATP02
HRIPT Human Patch Test Studies
1 human repeat insult patch test aggregated from dermatological literature.
| Test Type | N | Sensitized | Dose µg/cm² | NESIL µg/cm² | Potency |
|---|---|---|---|---|---|
| HMT | - | 0 | 15517.24 | - | - |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100,000 - 1,000,000 tonnes
Substance Type
SUBSTANCE; GROUP
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 904
(EC) 2009/1223
CMR: Carcinogenic Cat. 1B()
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (II - Prohibited)
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Lip Balm | 5–40 | 100 | CIR/VCRP |
| Body Lotion | 2–10 | 25 | CIR/VCRP |
Additional Ingredient Properties
10 property records from structured ingredient metadata.
baby_pediatric
{"cas_number": "8009-03-8", "ingredient_class": "moisturizer_baby", "pediatric_safety_rating": "excellent", "minimum_age_months": "0", "neonatal_safe": "yes", "premature_infant_safe": "yes", "skin_barrier_maturity_consideration": "GOLD STANDARD: Occlusive, barrier repair, extensively tested", "transepidermal_absorption_risk_pediatric": "very_low", "dose_per_kg_body_weight_concern": "Non-absorbed",…
concentration
{"min_concentration_pct": "5.0", "max_concentration_pct": "40.0", "typical_concentration_pct": "20.0", "product_type": "Body Butter", "function_at_concentration": "Occlusive", "source": "FDA OTC Monograph"}
dermal_absorption
{"molecular_weight_da": "Variable", "skin_penetration_level": "surface", "penetration_depth": "surface only", "absorption_pct": "0", "systemic_absorption": "no", "penetration_enhancer": "no", "occlusion_effect": "yes", "vehicle_dependent": "no", "skin_barrier_effect": "neutral", "bioavailability_topical_pct": "0", "source": "CIR"}
emulsion_hlb
{"hlb_required_as_emulsifier": "no", "hlb_required_of_oil_phase": "7-9", "co_emulsifier_pairs": "sorbitan_oleate,polysorbate_60", "optimal_oil_phase_pct": "20-50", "optimal_water_phase_pct": "50-80", "droplet_size_range_um": "10-80", "creaming_resistance": "moderate", "coalescence_resistance": "excellent", "ostwald_ripening_resistance": "excellent", "freeze_thaw_stability": "excellent", "rheology_…
hair_care
{"hair_function": "moisturizing", "hair_type_suitability": "coarse", "curl_pattern_suitability": "all", "porosity_suitability": "low", "protein_sensitivity": "neutral", "moisture_protein_balance": "no", "cg_method_approved": "not-a-silicone", "silicone_type": "not-a-sulfate", "sulfate_type": "no", "drying_alcohol": "no", "fatty_alcohol": "no", "heat_protectant": "no", "color_safe": "neutral", "ker…
pediatric_safety
{"safe_for_newborn_0_6m": "yes", "safe_for_infant_6_12m": "yes", "safe_for_toddler_1_3y": "yes", "safe_for_child_3_12y": "yes", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "100.0", "adult_max_concentration_pct": "100.0", "pediatric_dermal_absorption_factor": "minimal", "oral_ingestion_risk": "low", "diaper_area_safe": "yes", "pediatric_allergy_prevalence": "low", "banned_in_c…
pregnancy_detail
{"pregnancy_safe": "yes", "breastfeeding_safe": "yes", "risk_category": "not-rated", "reason": "Safe; occlusive; USP grade recommended", "source": "dermatology literature"}
sensory
{"silky": "waxy", "smooth, glides easily": "heavy, occlusive", "dry-touch, non-greasy": "greasy, protected", "instant": "very-slow", "low": "very-high", "w/o": "w/o", "no": "yes", "yes": "yes", "light-diffusing": "high-shine", "1.40": "1.47", "transparent": "translucent", "colorless": "white", "light": "very-rich", "synthetic": "petrochemical"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Binder
Corrosion inhibitor
Emulsifier
Flavouring and nutrient
Humectant
Lubricating agent
Softener and conditioner
Solubility enhancer
Solvent
Regulatory List Membership (4)
EU Banned in Cosmetics
EU Regulated in Personal Care
FDA Substances Added to Food (EAFUS)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Petrolatum.
Regulatory Flags
eu_banned_cosmetics
fda_food_additive
eu_cosing_listed
jecfa_concern
Known Synonyms
Caswell No. 645A
EINECS 232-373-2
EPA Pesticide Chemical Code 598400
Extra amber
Mineral fat
Mineral wax
Petrolatum, amber
Petrolatum USP
Petrolatum, yellow
Protopet, alba
Protopet, white 1S
Protopet, white 2L
Saxoline
Vasoliment
White petrolatum USP
White petroleum jelly
Yellow petrolatum
UNII-4T6H12BN9U
Petrolatum, white
Soft paraffin
Chemical Function
Softener and conditioner
Regulatory Lists
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
inert_ingredient; non_food_use; Pesticides
Europe; Personal care - liniment
Europe; Personal care
Europe; Personal care
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; pharmaceutical
Canada; pharmaceutical
Europe; Personal care - oral and dental care - teeth whitener
banned; Europe; Personal care
Cleaning products and household care - shoes; Europe
Cleaning products and household care - shoes; Europe
Europe; Personal care - make-up and related
Europe; Personal care - make-up and related
drinking_water; Europe; manufacturing; plastic_additive
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA count match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Adverse Event Associations
905
Frequently Asked Questions
Is Petrolatum allowed in the EU?
Petrolatum EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Petrolatum do in cosmetics?
Petrolatum functions as: Emollient, occlusive, skin protectant, hair conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 8009-03-8.
Is Petrolatum used outside cosmetics?
Petrolatum also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Petrolatum have different safety status in cosmetics vs industrial chemicals?
Petrolatum is classified GHS Danger (H350) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Petrolatum 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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