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Annex II Entry 397 20/10/2010

Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts

Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts is listed in Annex II as a prohibited substance for cosmetic products placed on the EU market.

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Prohibited substance— Annex II, EU Regulation 1223/2009
Entry: 397

Chemical identity and properties

PubChem 2D chemical structure for CAS 3468-63-1
CAS 3468-63-1PubChem CID 18981

Fast Orange

D&C Orange No. 17 can cause cancer according to The Food and Drug Administration (FDA). — California Office of Environmental Health Hazard Assessment (OEHHA)

IUPAC name
1-[(2,4-dinitrophenyl)diazenyl]naphthalen-2-ol
Molecular formula
C16H10N4O5
Molecular weight
338.27 g/mol
Exact mass
338.06511943 Da
XLogP3
4.3
Topological polar surface area
137.0 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
7
Covalent units
1
Defined stereocentres
0

Also known as

Permatone OrangeHansa Orange RNLight Orange RSilopol Orange RCarnelio Red 2GChromatex Orange RGraphtol Red 2GLVersal Orange RNL
16 more reported names
Lake Red 2GLIsol Fast Red 2GCalcotone Orange 2RSyton Fast Red 2GHelio Fast Orange RNLutetia Fast Orange RBrilliant tangerine 13030Irgalite Fast Red 2GLNippon Orange X-881Segnale Light Orange RNGDainichi Permanent Red GGSignal Orange Orange Y-17Dinitroaniline Orange ND-204D&C Orange No. 17RefChem:1085302Permanent Orange
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Chemical name

Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts

Chemical / IUPAC name

1-[(2,4-dinitrophenyl)azo]-2-naphthol; C.I. Pigment Orange 5

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Identified ingredients

Key data

CAS
3468-63-1
EC
222-429-4
Annex
II
Entry number
397

Inventory links for Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts

Direct matches are limited for this record, so nearby entries from Annex II are shown as well.

Annex II 399
Nearby record in the same annex

Lidocaine (INN)

CAS: 137-58-6
EC: 205-302-8
Annex II 400
Nearby record in the same annex

1,2-Epoxybutane

CAS: 106-88-7
EC: 203-438-2
Annex II 393
Nearby record in the same annex

Acetonitrile

CAS: 75-05-8
EC: 200-835-2

What Annex II means for Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts

Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts is listed as a prohibited substance under Annex II of EU Cosmetics Regulation 1223/2009 and must not be intentionally added. Article 17 separately addresses unintended small quantities that are technically unavoidable under good manufacturing practice and compatible with the Article 3 safety requirement.

Formulators must screen their ingredients and raw materials to ensure none contain this substance. Suppliers should provide documentation confirming absence when requested.

This record is linked to 1 CosIng inventory ingredient for name and identifier cross-reference. The page also surfaces 12 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Verify this substance is absent from all raw materials and finished formulations.
  • Request absence confirmation or CoA from raw material suppliers.
  • Document the screening result in the Product Information File (PIF).

Frequently asked questions

Yes. Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts is listed in Annex II of EU Cosmetics Regulation 1223/2009 and is prohibited as an intentionally added cosmetic ingredient. Article 17 provides a narrow exception for unintended small quantities that are technically unavoidable under good manufacturing practice, provided the product remains safe under Article 3.

CAS 3468-63-1 is the unique numerical identifier assigned to Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts by the Chemical Abstracts Service. In cosmetic compliance work, the CAS number is used to cross-reference the substance across regulatory databases, raw material specifications and safety assessment reports. Multiple EU annex entries may share the same CAS number if the same substance appears under different conditions or in different annexes.

Use the INCI Checker tool on this site to paste your full ingredient list (INCI) and scan it against all Annex II–VI entries. The tool highlights any ingredients that match restricted, prohibited or allergen-flagged records. This is useful for rapid compliance screening of finished product formulas or raw material declarations.
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Source note for Annex II record Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts

This page summarizes one Annex II record for Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts from public European Commission cosmetic materials and adds linked inventory or identifier matches when available.

Use this record page to review Annex II conditions for Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts, but confirm any final regulatory decision against the current official annex wording and source files.

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