Is CI 42051 (Patent Blue V / Acid Blue 3) safe in cosmetics?
CI 42051 (Patent Blue V / Acid Blue 3) has a safety rating of "MODERATE" in our database. EU status: restricted. US status: prohibited.
Moderate
Cosmetic Ingredient
CI 42051 (Patent Blue V / Acid Blue 3)
INCI: CI 42051
CI 42051 (Patent Blue V / Acid Blue 3) (CAS 3536-49-0) is a cosmetic cosmetic ingredient functioning as Colorant. Synthetic triphenylmethane blue dye (Patent Blue V, also known as. EU Regulation 1223/2009 status: restricted, max Permitted in non-hair-dye cosmetics under Annex IV (Entry IV/60); prohibited in hair dye formulations (Annex II Entry 1356). Applies to free acid, calcium salt, and insoluble lakes/pigments thereof.. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 3536-49-0 →
Auto-generated CPSR Part A draft with source citations
Function
Colorant. Synthetic triphenylmethane blue dye (Patent Blue V, also known as Acid Blue 3, Food Blue 5, E131). Imparts blue coloration to cosmetic products. Water-soluble anionic sulfonated triphenylmethane dye used as a colorant in cosmetics, food (E131 in EU), and as a medical sentinel lymph node mapping agent. Available as calcium salt and insoluble barium, strontium, and zirconium lakes and pigments.
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
calcium bis(4-[[4-(diethylamino)phenyl]-(4-diethylazaniumylidenecyclohexa-2,5-dien-1-ylidene)methyl]-6-hydroxybenzene-1,3-disulfonate)
InChIKey
RTMBGDBBDQKNNZ-UHFFFAOYSA-L
Regulatory Status
EU EU Status
restricted
EU Max Conc.
Permitted in non-hair-dye cosmetics under Annex IV (Entry IV/60); prohibited in hair dye formulations (Annex II Entry 1356). Applies to free acid, calcium salt, and insoluble lakes/pigments thereof.
US US Status
prohibited
US Notes
CI 42051 (Patent Blue V) is not listed on the FDA Color Additives Permitted for Use in Cosmetics (21 CFR Parts 73, 74, or 82). Patent Blue V has not been certified by FDA as a color additive for food, drugs, or cosmetics in the United States. Use in US cosmetics is not authorized. EWG VERIFIED program lists this ingredient as unacceptable for use in certified products.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for CI 42051 (Patent Blue V / Acid Blue 3).
Calculate MoS for your specific formulation with the MoS Calculator.
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1 - 10 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1356
(EC) 2013/344
Annex IV — Permitted Colorants
Product type: Blue
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: 1356
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
India: Permitted Colorant
Additional Jurisdictional Restrictions (1)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| ASEAN | permitted_colorant | - | All products |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
colorant
{"Common_Name": "D&C Blue No. 9", "Chemical_Name": "Indigotine disulphonic acid", "CAS_Number": "2650-18-2", "Colorant_Type": "Synthetic Dye", "Approved_Uses": "External use only", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved 21 CFR 74.109", "Notes": "Not for mucous membranes"}
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (2)
JECFA Evaluation
CI FOOD BLUE 5 | 1982 | NO ADI ALLOCATED | TRS 683-JECFA 26/23 | FAS 6/NMRS 54A-JECFA 18/106 (1974)
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Regulatory List Membership (3)
EU Banned in Cosmetics
EU Restricted for Children (Cosmetics)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for CI 42051 (Patent Blue V / Acid Blue 3).
Regulatory Flags
eu-annex-iv
eu-hair-dye-prohibited-annex-ii
not-fda-listed
not-fda-approved-us
ewg-unacceptable
triphenylmethane-dye
food-colorant-e131-eu
medical-use-anaphylaxis-risk
water-soluble
calcium-salt-lakes-permitted
eu_banned_cosmetics
eu_children_restricted
eu_cosing_listed
jecfa_concern
Chemical Function
Dye
Regulatory Lists
children; Europe; Personal care
children; Europe; Personal care - hair styling and care - shampoo
children; Europe; Personal care
children; Europe; Personal care
Cleaning products and household care - laundry and fabric treatment - laundry detergent; Europe
Cleaning products and household care - dishwasher and dishes - automatic dishwashing detergent; Europe
Cleaning products and household care; Europe
banned; Europe; Personal care
Europe; Personal care - hair styling and care - shampoo-dandruff
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA count match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Adverse Event Associations
1
Frequently Asked Questions
Is CI 42051 (Patent Blue V / Acid Blue 3) allowed in the EU?
CI 42051 (Patent Blue V / Acid Blue 3) EU regulatory status: restricted. Maximum allowed concentration: Permitted in non-hair-dye cosmetics under Annex IV (Entry IV/60); prohibited in hair dye formulations (Annex II Entry 1356). Applies to free acid, calcium salt, and insoluble lakes/pigments thereof.. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 42051 (Patent Blue V / Acid Blue 3) do in cosmetics?
CI 42051 (Patent Blue V / Acid Blue 3) functions as: Colorant. Synthetic triphenylmethane blue dye (Patent Blue V, also known as Acid Blue 3, Food Blue 5, E131). Imparts blue coloration to cosmetic products. Water-soluble anionic sulfonated triphenylmethane dye used as a colorant in cosmetics, food (E131 in EU), and as a medical sentinel lymph node mapping agent. Available as calcium salt and insoluble barium, strontium, and zirconium lakes and pigments.. It is classified as a cosmetic ingredient in our database. CAS number: 3536-49-0.
Is CI 42051 (Patent Blue V / Acid Blue 3) used outside cosmetics?
CI 42051 (Patent Blue V / Acid Blue 3) also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check CI 42051 (Patent Blue V / Acid Blue 3) compliance across multiple jurisdictions:
Ingredient Decoder
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Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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