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Annex II Entry 378 15/10/2010

Colouring agent CI 12140

Colouring agent CI 12140 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: 378

Chemical identity and properties

PubChem 2D chemical structure for CAS 3118-97-6
CAS 3118-97-6PubChem CID 18386

Sudan II

Sudan II is a member of azobenzenes. — ChEBI

IUPAC name
1-[(2,4-dimethylphenyl)diazenyl]naphthalen-2-ol
Molecular formula
C18H16N2O
Molecular weight
276.3 g/mol
Exact mass
276.126263138 Da
XLogP3
5.3
Topological polar surface area
45.0 Ų
Hydrogen-bond donors
1
Hydrogen-bond acceptors
3
Covalent units
1
Defined stereocentres
0

Also known as

Solvent Orange 7Sudan redC.I. SOLVENT ORANGE 7Ceres Orange RRFat Scarlet 2GSudan Red IIFettorange BPyronalrot R
16 more reported names
Sudan OrangeSudan axMotirot GCerotinscharlach GSudan scarlet 6gSudan XCerisol Scarlet GResoform Orange RSudan Orange RPASudan Orange RRAGrasan Orange 3RLacquer Orange VRResin Scarlet 2RSomalia Orange 2RWaxakol vermilion LRed B
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Retrieved from NIH PubChem on 2026-09-02 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Chemical name

Colouring agent CI 12140

Chemical / IUPAC name

C.I. Solvent Orange 7; 1-(2,4-Dimethylphenylazo)-2-naphthol

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

Key data

CAS
3118-97-6
EC
221-490-4
Annex
II
Entry number
378

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

What Annex II means for Colouring agent CI 12140

Colouring agent CI 12140 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.

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 12140 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 3118-97-6 is the unique numerical identifier assigned to Colouring agent CI 12140 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 12140

This page summarizes one Annex II record for Colouring agent CI 12140 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 12140, but confirm any final regulatory decision against the current official annex wording and source files.

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