CI 14815 (Scarlet GN / FD&C Red No. 4)

INCI: CI 14815

CAS Number
3257-28-1
Function
Colorant. Synthetic monoazo red dye (Disodium 6-[(2,4-dimethyl-6-sulphonatophenyl)azo]-5-hydroxynaphthalene-1-sulphonate), also known as Scarlet GN, Food Red 2, and FD&C Red No. 4. Water-soluble anionic dye producing a red hue. Previously used as a food dye (FD&C Red No. 4) but delisted from food use by FDA in 1976 due to potential carcinogenic effects when ingested. Now limited to externally applied cosmetics and drugs in the US.
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes FDA permanently listed as FD&C Red No. 4 under 21 CFR 74.2304 for externally applied cosmetics. Subject to mandatory FDA batch certification before market distribution. NOT permitted for use in eye area products, lip products, food, ingested drugs, or injections. Delisted from food use in 1976. All batches must be certified per 21 CFR Part 80.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

CI 14815 (Scarlet GN / FD&C Red No. 4) is EU Annex IV listed and permitted in all cosmetic product types with no maximum concentration restriction. In the US, it is permanently listed under 21 CFR 74.2304 for externally applied cosmetics only, with mandatory FDA batch certification required. It is explicitly prohibited in eye area products, lip products, food, and ingested drugs. Within its defined regulatory scope, CI 14815 has a well-established safety record for external cosmetics with low concern for compliant, non-eye, non-lip external applications.

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Concern Level: Low

Regulatory Flags

azo-dye eu-annex-iv fda-certified-color fda-batch-certification-required no-eye-area-us no-lip-use-us no-food-use externally-applied-only synthetic-colorant eu_cosing_listed

Frequently Asked Questions

Is CI 14815 (Scarlet GN / FD&C Red No. 4) safe in cosmetics?

CI 14815 (Scarlet GN / FD&C Red No. 4) is EU Annex IV listed and permitted in all cosmetic product types with no maximum concentration restriction. In the US, it is permanently listed under 21 CFR 74.2304 for externally applied cosmetics only, with mandatory FDA batch certification required. It is explicitly prohibited in eye area products, lip products, food, and ingested drugs. Within its defined regulatory scope, CI 14815 has a well-established safety record for external cosmetics with low concern for compliant, non-eye, non-lip external applications. The EU classifies CI 14815 (Scarlet GN / FD&C Red No. 4) as "permitted". Safety rating: GOOD.

Is CI 14815 (Scarlet GN / FD&C Red No. 4) allowed in the EU?

CI 14815 (Scarlet GN / FD&C Red No. 4) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 14815 (Scarlet GN / FD&C Red No. 4) do in cosmetics?

CI 14815 (Scarlet GN / FD&C Red No. 4) functions as: Colorant. Synthetic monoazo red dye (Disodium 6-[(2,4-dimethyl-6-sulphonatophenyl)azo]-5-hydroxynaphthalene-1-sulphonate), also known as Scarlet GN, Food Red 2, and FD&C Red No. 4. Water-soluble anionic dye producing a red hue. Previously used as a food dye (FD&C Red No. 4) but delisted from food use by FDA in 1976 due to potential carcinogenic effects when ingested. Now limited to externally applied cosmetics and drugs in the US.. It is classified as a cosmetic ingredient in our database. CAS number: 3257-28-1.

What is the Margin of Safety for CI 14815 (Scarlet GN / FD&C Red No. 4)?

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.

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