Is CI 15880 (D&C Red No. 34 / Pigment Red 63:1) safe in cosmetics?
CI 15880 (D&C Red No. 34 / Pigment Red 63:1) has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted.
Good
Cosmetic Ingredient
CI 15880 (D&C Red No. 34 / Pigment Red 63:1)
Also known as: EINECS 229-142-3, UNII-BAN556989E
INCI: CI 15880
CI 15880 (D&C Red No. 34 / Pigment Red 63:1) (CAS 6417-83-0) is a cosmetic cosmetic ingredient functioning as Colorant. Synthetic azo pigment (Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)a. EU Regulation 1223/2009 status: restricted, max Not permitted in hair dye products (EU Annex II/1349). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.
View industrial chemical safety profile for CAS 6417-83-0 →
Auto-generated CPSR Part A draft with source citations
Function
Colorant. Synthetic azo pigment (Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate), also known as D&C Red No. 34, Pigment Red 63, and Pigment Red 63:1. Insoluble calcium lake pigment providing a red hue. Used predominantly in nail polish, nail lacquers, and other externally applied cosmetics. Prohibited for use in hair dye products in the EU under Annex II.
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
calcium 2-[(3-carboxy-2-oxidonaphthalen-1-yl)diazenyl]naphthalene-1-sulfonate
InChIKey
OVHKKOQGPOYPLY-UHFFFAOYSA-L
Regulatory Status
EU EU Status
restricted
EU Max Conc.
Not permitted in hair dye products (EU Annex II/1349)
US US Status
permitted
US Notes
FDA permanently listed as D&C Red No. 34 under 21 CFR 74.2334 for externally applied cosmetics in amounts consistent with good manufacturing practice. Subject to mandatory FDA batch certification before market distribution. NOT permitted for use in products applied to the lips or in the vicinity of the eyes. Subject to batch certification per 21 CFR Part 80.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for CI 15880 (D&C Red No. 34 / Pigment Red 63:1).
Calculate MoS for your specific formulation with the MoS Calculator.
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1349
(EC) 2013/344
Annex IV — Permitted Colorants
Product type: Red
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 1349
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
India: Permitted Colorant
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Pigment
Regulatory List Membership (3)
EU Banned in Cosmetics
EU Regulated in Personal Care
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for CI 15880 (D&C Red No. 34 / Pigment Red 63:1).
Regulatory Flags
azo-dye
eu-annex-iv
eu-hair-dye-prohibited
fda-certified-color
fda-batch-certification-required
no-eye-area-us
no-lip-use-us
externally-applied-only
nail-polish-use
calcium-lake
pigment
insoluble-colorant
synthetic-colorant
annex-ii-restricted
eu_banned_cosmetics
eu_cosing_listed
Known Synonyms
EINECS 229-142-3
UNII-BAN556989E
Chemical Function
Dye
Pigment
Regulatory Lists
Arts and crafts/Office supplies - body paint; Europe
Europe; Personal care
banned; Europe; Personal care
Arts and crafts/Office supplies - body paint - tattoo ink; Europe
pharmaceutical
Personal care
Arts and crafts/Office supplies - body paint - tattoo ink; Europe
Australian Status
AICIS status: listed
Frequently Asked Questions
Is CI 15880 (D&C Red No. 34 / Pigment Red 63:1) allowed in the EU?
CI 15880 (D&C Red No. 34 / Pigment Red 63:1) EU regulatory status: restricted. Maximum allowed concentration: Not permitted in hair dye products (EU Annex II/1349). This is based on EU Regulation 1223/2009 and its amendments.
What does CI 15880 (D&C Red No. 34 / Pigment Red 63:1) do in cosmetics?
CI 15880 (D&C Red No. 34 / Pigment Red 63:1) functions as: Colorant. Synthetic azo pigment (Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate), also known as D&C Red No. 34, Pigment Red 63, and Pigment Red 63:1. Insoluble calcium lake pigment providing a red hue. Used predominantly in nail polish, nail lacquers, and other externally applied cosmetics. Prohibited for use in hair dye products in the EU under Annex II.. It is classified as a cosmetic ingredient in our database. CAS number: 6417-83-0.
Is CI 15880 (D&C Red No. 34 / Pigment Red 63:1) used outside cosmetics?
CI 15880 (D&C Red No. 34 / Pigment Red 63:1) also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check CI 15880 (D&C Red No. 34 / Pigment Red 63:1) compliance across multiple jurisdictions:
Ingredient Decoder
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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Chemical family
Colorant (calcium azo lake pigment)
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Moderate
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