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
5 study endpoints found for Carmine. 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 | Carcinogenicity | COSMOS_DB |
| NOAEL | 500 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| dose_tested | 500 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
| dose_tested | 1000 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
Expert Verdict
Carmine (CI 75470) is a permitted colorant in the EU (Annex IV, EC 1223/2009) and US (21 CFR 73.2087) for use in all cosmetics including eye area. Despite regulatory approval, it carries a high sensitization risk due to IgE-mediated hypersensitivity and documented occupational asthma cases, primarily from cochineal protein contaminants; mandatory labeling declaration required.
Regulatory Flags
Frequently Asked Questions
Is Carmine safe in cosmetics?
Carmine (CI 75470) is a permitted colorant in the EU (Annex IV, EC 1223/2009) and US (21 CFR 73.2087) for use in all cosmetics including eye area. Despite regulatory approval, it carries a high sensitization risk due to IgE-mediated hypersensitivity and documented occupational asthma cases, primarily from cochineal protein contaminants; mandatory labeling declaration required. The EU classifies Carmine as "permitted". Safety rating: MODERATE. 5 toxicological study endpoint(s) are available in our database.
Is Carmine allowed in the EU?
Carmine EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Carmine do in cosmetics?
Carmine functions as: colorant. It is classified as a Colorant in our database. CAS number: 1390-65-4.
What is the Margin of Safety for Carmine?
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 Carmine?
The NOAEL (No Observed Adverse Effect Level) for Carmine is 500 mg/kg bw/day based on a Carcinogenicity study via oral route in rat. A total of 5 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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