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
2 study endpoints found for Shellac. 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 | 500 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| dose_tested | 500 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
Sensitization Profile
Contact sensitization data for Shellac based on clinical patch test studies and IFRA standards.
Source: IVDK; ESSCA; NACDG
Expert Verdict
Shellac is a natural resin permitted without restriction under EU Cosmetics Regulation (EC) No 1223/2009. CIR Expert Panel concluded safe as used in cosmetics at concentrations up to 6%; genotoxicity studies are negative and systemic absorption is minimal due to its polymeric structure. Notable sensitization concern exists with patch test studies showing 2-12% reactivity rates, particularly linked to mascara and eye products, though clinical relevance is confirmed in only a minority of positive cases.
Regulatory Flags
Frequently Asked Questions
Is Shellac safe in cosmetics?
Shellac is a natural resin permitted without restriction under EU Cosmetics Regulation (EC) No 1223/2009. CIR Expert Panel concluded safe as used in cosmetics at concentrations up to 6%; genotoxicity studies are negative and systemic absorption is minimal due to its polymeric structure. Notable sensitization concern exists with patch test studies showing 2-12% reactivity rates, particularly linked to mascara and eye products, though clinical relevance is confirmed in only a minority of positive cases. The EU classifies Shellac as "permitted". Safety rating: GOOD. 2 toxicological study endpoint(s) are available in our database.
Is Shellac allowed in the EU?
Shellac EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Shellac do in cosmetics?
Shellac functions as: Film-forming agent; binding agent; coating agent. It is classified as a Active Ingredient in our database. CAS number: 9000-59-3.
What is the Margin of Safety for Shellac?
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 Shellac?
The NOAEL (No Observed Adverse Effect Level) for Shellac is 500 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 2 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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