EU cosmetic ingredients, restrictions and safety

Annex II Entry 988 CMR15/10/2010

Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]

Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] 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: 988

CMR

Chemical identity and properties

PubChem 2D chemical structure for CAS 2602-46-2

CAS 2602-46-2PubChem CID 17449

C.I. Direct Blue 6

Direct Blue 6 (Technical Grade) can cause cancer according to an independent committee of scientific and health experts. — California Office of Environmental Health Hazard Assessment (OEHHA)

IUPAC name: tetrasodium;5-amino-3-[[4-[4-[(8-amino-1-hydroxy-3,6-disulfonatonaphthalen-2-yl)diazenyl]phenyl]phenyl]diazenyl]-4-hydroxynaphthalene-2,7-disulfonate

Molecular formula: C32H20N6Na4O14S4
Molecular weight: 932.8 g/mol
Exact mass: 931.9511112 Da
Topological polar surface area: 404.0 Å²
Hydrogen-bond donors: 4
Hydrogen-bond acceptors: 20
Covalent units: 5
Defined stereocentres: 0

Also known as

DIRECT BLUE 6Airedale Blue 2BDDirect Sky Blue KDirect Blue 2BIndigo Blue 2BKayaku directDiamine Blue BBDirect Blue 6 (technical grade)

16 more reported names

Chlorazol Blue BDirect Blue ADirect Blue BBDirect Blue GSDirect Blue KNippon Blue BBAzocard Blue 2BAzomine Blue 2BBenzo Blue GSDiamine Blue 2BDiazine Blue 2BDiphenyl Blue KFFenamin Blue 2BFixanol Blue 2BNiagara Blue 2BAmanil Blue 2BX

Open full PubChem record PubChem annotations 3D structure image

External database identifiers

EPA DTXSID:DTXSID2020185

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

Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]

Chemical / IUPAC name

CI Direct Blue 6

Regulatory information

Regulation

See every entry this act set

SCCS opinions

CMR

Category	Carcinogenic	Mutagenic	Reprotoxic
Cat. 1B	✓	—	—
Cat. 2	—	—	✓

Key data

CAS

EC

Annex

Entry number

988

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

Annex II 987

Nearby record in the same annex

Disodium 4-amino-3-[[4'-[(2,4-diaminophenyl)azo] [1,1'-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)n…

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EC: 217-710-3

Annex II 989

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Annex II 986

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Disodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)] bis(4-aminonaphthalene-1- sulphonate)

CAS: 573-58-0

EC: 209-358-4

Annex II 990

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Annex II 985

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Hydrocarbons, C26-55, arom.-rich

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EC: 307-753-7

Annex II 991

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EC: 240-221-1

Annex II 984

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Annex II 982

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Annex II 994

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What Annex II means for Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]

Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] 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).
This substance has CMR classification. Review the CMR table above and verify current Annex II/III status before use.

Frequently asked questions

Yes. Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] 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 2602-46-2 is the unique numerical identifier assigned to Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] 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.

Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] has a CMR (carcinogenic, mutagenic or reprotoxic) classification under EU CLP Regulation. Under Article 15 of EU Cosmetics Regulation 1223/2009, CMR substances of category 1A or 1B are prohibited in cosmetics unless specifically permitted. Category 2 CMR substances may be used only if assessed safe by the SCCS. Always verify current annex status and any applicable derogations before use.

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 Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]

This page summarizes one Annex II record for Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate] 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 Tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate], but confirm any final regulatory decision against the current official annex wording and source files.

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