Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Papain. 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 | 5000 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 1080 mg/kg bw/day | oral | mouse | Developmental | COSMOS_DB |
| NOAEL | 820 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 750 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 750 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 375 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 488 mg/kg bw/day | oral | rat | Special Toxicology Study | COSMOS_DB |
| NOAEL | 800 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 800 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| dose_tested | 1080 mg/kg bw/day | oral | mouse | Developmental | COSMOS_DB |
Expert Verdict
Papain is an effective enzymatic exfoliant with a milder profile than chemical acids, but carries genuine sensitization and IgE-allergy risk. The less than 0.8% sensitization rate is manageable in well-formulated rinse-off products but not acceptable for leave-on formats or compromised/reactive skin. Enzyme activity stability throughout shelf life is non-negotiable for both safety and efficacy.
Regulatory Flags
Frequently Asked Questions
Is Papain safe in cosmetics?
Papain is an effective enzymatic exfoliant with a milder profile than chemical acids, but carries genuine sensitization and IgE-allergy risk. The less than 0.8% sensitization rate is manageable in well-formulated rinse-off products but not acceptable for leave-on formats or compromised/reactive skin. Enzyme activity stability throughout shelf life is non-negotiable for both safety and efficacy. The EU classifies Papain as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.
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.
What is the Margin of Safety for Papain?
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 Papain?
The NOAEL (No Observed Adverse Effect Level) for Papain is 5000 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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