Is Basic Blue 9 (Methylene Blue) safe in cosmetics?
Basic Blue 9 (Methylene Blue) has a safety rating of "MODERATE" in our database. EU status: permitted. US status: restricted.
MODERATE
Cosmetic Ingredient
Basic Blue 9 (Methylene Blue)
Also known as: D and C Blue No. 1, D And C Blue Number 1, C.I. Basic Blue 9, M-B Tabs, Aizen Methylene Blue BH (+15 more)
INCI: BASIC BLUE 9
Basic Blue 9 (Methylene Blue) (CAS 61-73-4) is a cosmetic cosmetic ingredient functioning as Hair colorant (phenothiazinium dye); biological stain and pharmaceutical agent. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
Function
Hair colorant (phenothiazinium dye); biological stain and pharmaceutical agent
Editorial assessment
MODERATE
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
US US Status
restricted
US Notes
Approved as a pharmaceutical (prescription drug) but not approved as a cosmetic color additive. Coal tar hair dye exemption may apply.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Basic Blue 9 (Methylene Blue).
Calculate MoS for your specific formulation with the MoS Calculator.
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1306
(EC) 2009/1223
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: 1306
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (1)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| KR | prohibited | - | - |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (3)
EU Banned in Cosmetics
FDA Indirect Food Contact Additives
EU CosIng Cosmetics Ingredient Database
Editorial summary
Preliminary editorial summary for Basic Blue 9 (Methylene Blue) — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
potential-allergen
colorant
eu_banned_cosmetics
eu_cosing_listed
Known Synonyms
D and C Blue No. 1
D And C Blue Number 1
C.I. Basic Blue 9
M-B Tabs
Aizen Methylene Blue BH
Aizen Methylene Blue FZ
Calcozine Blue ZF
Caswell No. 567
Ceruleum methylenum
CI Basic Blue 9
EINECS 200-515-2
EPA Pesticide Chemical Code 039505
Ext D and C Blue No. 1
External Blue 1
Hidaco Methylene Blue Salt Free
Leather Pure Blue HB
Methylene Blue A
Methylene Blue B
Methylene Blue D
Methylene Blue G
Chemical Function
Dye
Regulatory Lists
inert_ingredient; non_food_use; Pesticides
CEDI
Indirect additives food contact (10/2018)
Canada; pharmaceutical
Canada; pharmaceutical
pharmaceutical
active_ingredient; Europe; Pesticides
banned; Europe; Personal care
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
METHYLENE BLUE ANHYDROUS
ChEMBL ID
CHEMBL405110
Max Phase
4
Adverse Event Associations
23
Frequently Asked Questions
Is Basic Blue 9 (Methylene Blue) allowed in the EU?
Basic Blue 9 (Methylene Blue) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Basic Blue 9 (Methylene Blue) do in cosmetics?
Basic Blue 9 (Methylene Blue) functions as: Hair colorant (phenothiazinium dye); biological stain and pharmaceutical agent. It is classified as a cosmetic ingredient in our database. CAS number: 61-73-4.
Is Basic Blue 9 (Methylene Blue) used outside cosmetics?
Basic Blue 9 (Methylene Blue) also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Basic Blue 9 (Methylene Blue) compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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