Regulatory Status
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Safety Data
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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.
Regulatory Flags
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.
Compliance Tools
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Related Ingredients
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