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 Retinol. 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 | 30 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 9 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 137 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 51 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 39 mg/kg bw/day | oral | guinea pig | Short Term Toxicity | COSMOS_DB |
| NOAEL | 0.48 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 75 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 54 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 21 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 300 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Retinol, relevant to systemic exposure and MoS calculations.
Source: SCCS/1516/13, CIR
Expert Verdict
Retinol (CAS 68-26-8) is EU-restricted under Regulation 2024/996 with maximum concentrations of 0.05% RE in body lotions and 0.3% RE in other leave-on and rinse-off products. SCCS opinion SCCS/1639/21 found worst-case modeling reaches approximately 97% of the EFSA UL from cosmetics alone, creating meaningful concern for high consumers already at UL from diet or supplements. Products must carry mandatory label warnings for children under 12 years and pregnancy considerations.
Regulatory Flags
Frequently Asked Questions
Is Retinol safe in cosmetics?
Retinol (CAS 68-26-8) is EU-restricted under Regulation 2024/996 with maximum concentrations of 0.05% RE in body lotions and 0.3% RE in other leave-on and rinse-off products. SCCS opinion SCCS/1639/21 found worst-case modeling reaches approximately 97% of the EFSA UL from cosmetics alone, creating meaningful concern for high consumers already at UL from diet or supplements. Products must carry mandatory label warnings for children under 12 years and pregnancy considerations. The EU classifies Retinol as "restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.
Is Retinol allowed in the EU?
Retinol EU regulatory status: restricted. Maximum allowed concentration: 0.05% RE in body lotions; 0.3% RE in other leave-on and rinse-off products. This is based on EU Regulation 1223/2009 and its amendments.
What does Retinol do in cosmetics?
Retinol functions as: retinoid / skin-renewing / active. It is classified as a Active Ingredient in our database. CAS number: 68-26-8.
What is the Margin of Safety for Retinol?
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 Retinol?
The NOAEL (No Observed Adverse Effect Level) for Retinol is 30 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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