Moderate Cosmetic Ingredient NOAEL Data

Caramel

INCI: CARAMEL

CAS Number
8028-89-5
Function
Colorant (brownish-orange to dark brown), burnt sugar coloring
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Permanently listed, exempt from certification - Foods, Drugs, Cosmetics generally, including eye area use

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Caramel. 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 10000 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 10000 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 15000 mg/kg bw/day oral mouse Special Toxicology Study COSMOS_DB
NOAEL 1150 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 2250 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 1150 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 500 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB
NOAEL 1600 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 1600 mg/kg bw/day oral mouse Developmental COSMOS_DB

Expert Verdict

Permitted in EU and US with strict limits on 4-methylimidazole and 2-methylimidazole per EU Regulation 231/2012; comprises family of distinct products (E150a-d).

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Concern Level: Moderate

Regulatory Flags

colorant natural-origin epa_safer_alternative ifra_fragrance fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is Caramel safe in cosmetics?

Permitted in EU and US with strict limits on 4-methylimidazole and 2-methylimidazole per EU Regulation 231/2012; comprises family of distinct products (E150a-d). The EU classifies Caramel as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Caramel allowed in the EU?

Caramel EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Caramel do in cosmetics?

Caramel functions as: Colorant (brownish-orange to dark brown), burnt sugar coloring. It is classified as a cosmetic ingredient in our database. CAS number: 8028-89-5.

What is the Margin of Safety for Caramel?

not established 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 Caramel?

The NOAEL (No Observed Adverse Effect Level) for Caramel is 10000 mg/kg bw/day based on a Carcinogenicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Caramel compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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