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Annex II Entry 1306 15/10/2010

Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products

Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products 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: 1306

Chemical identity and properties

PubChem 2D chemical structure for CAS 61-73-4
CAS 61-73-4PubChem CID 6099

Methylene Blue

Methylene blue is an organic chloride salt having 3,7-bis(dimethylamino)phenothiazin-5-ium as the counterion. A commonly used dye that also exhibits antioxidant, antimalarial, antidepressant and cardioprotective properties. It has a role as an antioxidant, an antimicrobial agent, a physical tracer, an antidepressant, an EC 3.1.1.8 (cholinesterase) inhibitor, an antimalarial, an EC 1.4.3.4 (monoamine oxidase) inhibitor, an acid-base indicator, a fluorochrome, a neuroprotective agent, a histological dye, a cardioprotective agent and an EC 4.6.1.2 (guanylate cyclase) inhibitor. It contains a 3,7-bis(dimethylamino)phenothiazin-5-ium. — ChEBI

IUPAC name
[7-(dimethylamino)phenothiazin-3-ylidene]-dimethylazanium chloride
Molecular formula
C16H18ClN3S
Molecular weight
319.9 g/mol
Exact mass
319.0909965 Da
Topological polar surface area
43.9 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
4
Covalent units
2
Defined stereocentres
0

Also known as

Basic blue 9Methylthioninium chlorideSolvent blue 8Swiss BlueC.I. Basic Blue 9ChromosmonMethylene Blue anhydrousMethylene Blue N
16 more reported names
Methylene Blue BBUrolene blueMethylenium ceruleumMethylthionine chlorideMethylene Blue chlorideBleu de methyleneMethylene Blue AMethylene Blue BMethylene Blue DMethylene Blue GExternal Blue 1Tetramethylene BlueCalcozine Blue ZFMethylene Blue BDMethylene Blue BPMethylene Blue BX
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

Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products

Regulatory information

Regulation

(EC) 2009/1223

See every entry this act set

SCCS opinions

Identified ingredients

Key data

CAS
61-73-4
EC
200-515-2
Annex
II
Entry number
1306

Inventory links for Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products

Inventory Restriction reference
Ref 32068

BASIC BLUE 9

CAS: 61-73-4
EC: 200-515-2

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

What Annex II means for Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products

Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products 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. Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products 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 61-73-4 is the unique numerical identifier assigned to Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products 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 Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products

This page summarizes one Annex II record for Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products 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 Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye products, but confirm any final regulatory decision against the current official annex wording and source files.

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