Good Cosmetic Ingredient NOAEL Data

CI 75470 (Carmine)

INCI: CI 75470

CAS Number
1390-65-4
Function
Colorant. Natural red pigment derived from the dried bodies of female cochineal insects (Dactylopius coccus Costa); also known as Carmine, Cochineal, Crimson Lake, Carmine Lake, Natural Red 4, and food colorant E120. The active chromophore is carminic acid precipitated with aluminium or calcium salts. Imparts bright red-pink coloration to cosmetic products including lipsticks, eyeshadows, and blushes. The only organic red/pink colorant approved for eye area use in the US. Purity criteria per Commission Directive 95/45/EC.
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA permanently lists Carmine as a color additive exempt from certification under 21 CFR 73.2087 for cosmetics generally including eye area use, and under 21 CFR 73.1087 for ingested and externally applied drugs. Also approved for food use (21 CFR 73.100). As of 2011, all products containing carmine must declare it by name on the label. Carmine is the only organic pink/red colorant permitted for use around the eye area in the US.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

5 study endpoints found for CI 75470 (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

CI 75470 (Carmine/Natural Red 4) is a broadly permitted natural insect-derived colorant in both EU and US regulatory frameworks, listed in EU Annex IV as a permitted colorant for all cosmetics. FDA permanently lists it exempt from certification for cosmetics and drugs, including eye area use—the only organic pink/red colorant with US eye-area authorization. Moderate concern rating reflects documented IgE-mediated sensitization potential and mandatory label declaration requirements. Safety is good for non-sensitized individuals; formulators must declare by INCI name 'Carmine' on labels. Animal-derived (insect) origin is relevant for vegan-free formulations.

⚠️
Concern Level: Moderate

Regulatory Flags

natural-colorant insect-derived eu-annex-iv fda-exempt-certification eye-area-permitted allergen-risk ige-mediated mandatory-label-declaration vegan-concern e120 anaphylaxis-risk fda_food_additive

Frequently Asked Questions

Is CI 75470 (Carmine) safe in cosmetics?

CI 75470 (Carmine/Natural Red 4) is a broadly permitted natural insect-derived colorant in both EU and US regulatory frameworks, listed in EU Annex IV as a permitted colorant for all cosmetics. FDA permanently lists it exempt from certification for cosmetics and drugs, including eye area use—the only organic pink/red colorant with US eye-area authorization. Moderate concern rating reflects documented IgE-mediated sensitization potential and mandatory label declaration requirements. Safety is good for non-sensitized individuals; formulators must declare by INCI name 'Carmine' on labels. Animal-derived (insect) origin is relevant for vegan-free formulations. The EU classifies CI 75470 (Carmine) as "permitted". Safety rating: GOOD. 5 toxicological study endpoint(s) are available in our database.

Is CI 75470 (Carmine) allowed in the EU?

CI 75470 (Carmine) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 75470 (Carmine) do in cosmetics?

CI 75470 (Carmine) functions as: Colorant. Natural red pigment derived from the dried bodies of female cochineal insects (Dactylopius coccus Costa); also known as Carmine, Cochineal, Crimson Lake, Carmine Lake, Natural Red 4, and food colorant E120. The active chromophore is carminic acid precipitated with aluminium or calcium salts. Imparts bright red-pink coloration to cosmetic products including lipsticks, eyeshadows, and blushes. The only organic red/pink colorant approved for eye area use in the US. Purity criteria per Commission Directive 95/45/EC.. It is classified as a cosmetic ingredient in our database. CAS number: 1390-65-4.

What is the Margin of Safety for CI 75470 (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 CI 75470 (Carmine)?

The NOAEL (No Observed Adverse Effect Level) for CI 75470 (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.

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