Is Papain safe in cosmetics?
Papain has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted.
Moderate
Active Ingredient
Papain
Also known as: EINECS 232-627-2, Vegetable pepsin, Papaya Enzyme, EC 3.4.22.2, UNII-A236A06Y32
INCI: PAPAIN
Papain (CAS 9001-73-4) is a cosmetic active ingredient functioning as Proteolytic enzyme from Carica papaya. Hydrolyzes keratin protein bonds,. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in food safety data.
View industrial chemical safety profile for CAS 9001-73-4 →
Auto-generated CPSR Part A draft with source citations
Function
Proteolytic enzyme from Carica papaya. Hydrolyzes keratin protein bonds, facilitating removal of dead cells from the stratum corneum. Activity is milder than chemical acid exfoliation, with no pH manipulation required. Large molecular structure limits penetration to the stratum corneum only.
Safety Rating
MODERATE
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
CIR safety assessment available. Patch testing in over 2,000 subjects showed sensitization rates less than 0.8%. Contraindicated on compromised skin. Stability testing critical throughout shelf life. IgE-mediated allergy risk via dermal, oral, and respiratory routes documented.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Papain.
Calculate MoS for your specific formulation with the MoS Calculator.
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Harmful / IrritantHealth Hazard
Hazard Class and Category
STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Resp. Sens. 1
Hazard Statements
- H335 May cause respiratory irritation
- H315 Causes skin irritation
- H319 Causes serious eye irritation
- H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled
Inserted via ATP: CLP00
Additional Ingredient Properties
9 property records from structured ingredient metadata.
acne
{"cas_number": "9001-73-4", "anti_acne_mechanism": "keratolytic", "comedogenicity_rating_0_to_5": "0", "acne_type_efficacy": "non_inflammatory", "sebum_reduction_pct_clinical": "0-5", "keratolytic_strength": "mild", "exfoliation_mechanism": "enzymatic", "peel_depth": "superficial", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "No limit", "jap…
anti_aging
{"anti_aging_claim": "cell-turnover, brightening", "mechanism_of_action": "Enzymatic activity, targeted protein modification", "target_skin_layer": "epidermis, dermis", "collagen_stimulation": "Moderate", "elastin_protection": "Moderate", "wrinkle_reduction_pct": "8-15", "clinical_study_duration_weeks": "8", "sample_size": "25", "double_blind": "No", "placebo_controlled": "Yes", "published_journal…
anti_pollution
{"cas_number": "9001-73-4", "ingredient_class": "other", "primary_mechanism": "barrier_reinforcement", "pollution_types_targeted": "PM2_5", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation": "no", "NF_kB_inhibiti…
baby_pediatric
{"cas_number": "CAS-FUNC-36", "ingredient_class": "other", "pediatric_safety_rating": "good", "minimum_age_months": "3", "neonatal_safe": "no", "premature_infant_safe": "insufficient_data", "skin_barrier_maturity_consideration": "Functional ingredient - generally safe", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_weight_concern…
depigmentation
{"cas_number": "9001-73-4", "ingredient_class": "keratinocyte_turnover_enhancer", "primary_mechanism_of_action": "Proteolytic enzyme providing gentle exfoliation and melanin dispersal", "secondary_mechanisms": "Variable", "molecular_target": "other", "tyrosinase_inhibition_IC50_uM": "varies", "tyrosinase_inhibition_type": "competitive", "melanin_reduction_pct_in_vitro": "25-45", "melanin_reduction…
exfoliant
{"cas_number": "9001-73-4", "ingredient_class": "enzymatic_exfoliant", "chemical_subclass": "proteolytic_enzyme/fruit_enzyme", "molecular_weight_Da": "23000", "pKa_value": "N/A (protein)", "pH_dependent_activity": "yes", "optimal_pH_range": "5.0-7.0", "penetration_depth": "stratum_corneum", "mechanism_of_action": "proteolysis", "target_bonds": "keratin_crosslinks", "onset_of_action": "minutes", "p…
oral_care
{"cas_number": "9001-73-4", "ingredient_class": "whitening_agent", "function_primary": "Enzymatic whitening agent", "function_secondary": "Proteolytic enzyme", "fluoride_content_ppm_if_applicable": "0", "anti_plaque_mechanism": "Breaks down protein matrix of biofilm", "biofilm_disruption": "Moderate", "anti_gingivitis_mechanism": "Indirect (biofilm reduction)", "anti_inflammatory_oral": "Low", "wh…
self_tanning
{"cas_number": "9001-73-4", "ingredient_class": "tan_eraser", "tanning_mechanism": "other", "color_development_onset_hours": "0.0", "full_color_development_hours": "0", "color_duration_days": "0", "DHA_concentration_if_applicable_pct": "0", "erythrulose_concentration_pct": "0", "pH_dependent_color": "no", "formaldehyde_release_concern": "no", "formaldehyde_release_ppm": "0", "AGE_formation_concern…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-static agent
Chemical reaction regulator
Processing aids not otherwise specified
Softener and conditioner
Surface modifier
Thickening agent
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for Papain.
Regulatory Flags
sensitizer
ige-mediated-allergy-risk
enzyme
not-for-compromised-skin
stability-critical
contraindicated-eczema
rinse-off-preferred
eu-cpsr-enzyme-dossier-required
fda_food_additive
jecfa_safe
Known Synonyms
EINECS 232-627-2
Vegetable pepsin
Papaya Enzyme
EC 3.4.22.2
UNII-A236A06Y32
Chemical Function
Anti-static agent
Softener and conditioner
Chemical reaction regulator
Processing aids not otherwise specified
Regulatory Lists
inert_ingredient; non_food_use; Pesticides
active_ingredient; animal_products; Europe; pharmaceutical; residue
animal_products
animal_products
Canada; pharmaceutical
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
active_ingredient; Europe; Pesticides
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in food safety data.
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Papain
E Number
E1101ii
ADI
NOT LIMITED mg/kg bw
Food Category
emulsifier
Frequently Asked Questions
Is Papain allowed in the EU?
Papain EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Papain do in cosmetics?
Papain functions as: Proteolytic enzyme from Carica papaya. Hydrolyzes keratin protein bonds, facilitating removal of dead cells from the stratum corneum. Activity is milder than chemical acid exfoliation, with no pH manipulation required. Large molecular structure limits penetration to the stratum corneum only.. It is classified as a Active Ingredient in our database. CAS number: 9001-73-4.
Is Papain used outside cosmetics?
Papain also appears in food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Papain 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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