Moderate Cosmetic Ingredient

CI 12490 (Pigment Red 5 / Permanent Carmine FB)

INCI: CI 12490

CAS Number
6410-41-9
Function
Colorant
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status restricted
🇺🇸 US Status prohibited
US Notes Not listed on FDA-approved color additives list (21 CFR Parts 73/74/82). Identified in FDA Import Alert 53-06 as no certifiable equivalent — non-permitted. Use in US cosmetics constitutes adulteration under the FD&C Act.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

CI 12490 is restricted in the EU for colorant use (excluding hair dyes per Annex II restriction 1347) but prohibited in the US as non-FDA-approved. Azo bond cleavage produces potentially carcinogenic aromatic amines; absorption through mucous membranes and repeated dermal exposure present elevated carcinogenicity risk. High concern warranted due to metabolic activation hazard and lack of US regulatory approval.

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Concern Level: High

Regulatory Flags

eu-annex-iv eu-annex-ii-hair-dye-prohibited not-fda-approved fda-import-alert-53-06 azo-dye aromatic-amine-precursor hair-dye-prohibited-eu mucous-membrane-concern eu_banned_cosmetics ifra_fragrance eu_cosing_listed

Frequently Asked Questions

Is CI 12490 (Pigment Red 5 / Permanent Carmine FB) safe in cosmetics?

CI 12490 is restricted in the EU for colorant use (excluding hair dyes per Annex II restriction 1347) but prohibited in the US as non-FDA-approved. Azo bond cleavage produces potentially carcinogenic aromatic amines; absorption through mucous membranes and repeated dermal exposure present elevated carcinogenicity risk. High concern warranted due to metabolic activation hazard and lack of US regulatory approval. The EU classifies CI 12490 (Pigment Red 5 / Permanent Carmine FB) as "restricted". Safety rating: MODERATE.

Is CI 12490 (Pigment Red 5 / Permanent Carmine FB) allowed in the EU?

CI 12490 (Pigment Red 5 / Permanent Carmine FB) EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 12490 (Pigment Red 5 / Permanent Carmine FB) do in cosmetics?

CI 12490 (Pigment Red 5 / Permanent Carmine FB) functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 6410-41-9.

What is the Margin of Safety for CI 12490 (Pigment Red 5 / Permanent Carmine FB)?

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.

Compliance Tools

Check CI 12490 (Pigment Red 5 / Permanent Carmine FB) compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
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