Is FD&C Blue No. 1 safe in cosmetics?
FD&C Blue No. 1 has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
FD&C Blue No. 1
Also known as: FD & C Blue No. 1 (Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, disodium salt), Aizen Food Blue No. 2, Brilliant Blue FCF Supra, Canacert Brilliant Blue FCF, Cosmetic Blue Lake (+15 more)
INCI: FD&C BLUE NO. 1
FD&C Blue No. 1 (CAS 3844-45-9) is a cosmetic colorant functioning as colorant. NOAEL 631 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 0.5% (hair dye); permitted for lip products per EU Cosmetics Regulation Annex IV. 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 3844-45-9 →
Auto-generated CPSR Part A draft with source citations
Regulatory Status
EU EU Status
permitted
EU Max Conc.
0.5% (hair dye); permitted for lip products per EU Cosmetics Regulation Annex IV
US US Status
permitted
US Notes
Batch certification mandatory under 21 CFR 74.2101 and Part 80. Approved for all cosmetics at GMP levels. Also listed under 21 CFR 74.101 (food) and 74.1101 (drugs). Permanently listed since 1969.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for FD&C Blue No. 1.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for FD&C Blue No. 1. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 200 mg/kg bw/day | oral | rabbit | Developmental | COSMOS_DB |
| NOAEL | 250 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Multigeneration Reproductive | COSMOS_DB |
| NOAEL | 1319 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 1500 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | =50 mg/kg bw/day | oral | Human; Rat | Reproductive toxicity | INCHEM_WHO_jecfa_jecmono_v75je01 |
| NOAEL | =50 mg/kg bw/day | oral | Human; Rat | Reproductive toxicity | INCHEM_WHO_jecfa_jecmono_v75je01 |
| NOAEL | =50 mg/kg bw/day | oral | Human; Rat | Reproductive toxicity | INCHEM_WHO_jecfa_jecmono_v75je01 |
| NOAEL | =200 mg/kg bw/day | - | - | Toxicology study | INCHEM_WHO_jecfa_jecmono_v75je01 |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for FD&C Blue No. 1 across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| ADI | <=6 mg/kg | Human | oral | - | WHO JECFA ADI |
| NOAEL | =631 mg/kg-day | Rat | oral | - | EFSA |
| NOAEL | =631 mg/kg-day | Rat | oral | chronic | EFSA |
| NOEL | =2000 mg/kg-day | Mouse | oral | acute | ECOTOX |
| NOEL | =2 % diet | Mouse | oral | chronic | ECOTOX |
| NOEL | =2 % diet | Mouse | oral | chronic | ECOTOX |
| NOEL | =1 % diet | Rat | oral | chronic | ECOTOX |
| NOEL | =2 % diet | Rat | oral | chronic | ECOTOX |
| LOEL | =5 % | Rat | oral | short-term | ECOTOX |
| NOEL | =5 % | Rat | oral | short-term | ECOTOX |
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
16, Sup 7
Evaluation Year
1987
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
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.
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| BR | permitted_colorant | - | Column 2: All products except eye area |
| ASEAN | restricted | 0.5% | Non-oxidative hair dye products only |
| ASEAN | permitted_colorant | - | All products (0.5% limit in non-oxidative hair dye — Annex III) |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
pregnancy_detail
{"pregnancy_safe": "insufficient-data", "breastfeeding_safe": "insufficient-data", "risk_category": "not-rated", "reason": "Synthetic dye; limited pregnancy data", "alternative_ingredient": "Mineral colorants", "source": "FDA"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Flavouring and nutrient
Fragrance
Regulatory List Membership (5)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
EPA Safer Chemical Ingredients List (SCIL)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for FD&C Blue No. 1.
Regulatory Flags
batch-certification-required
annex-iv-permitted
low-dermal-absorption
triphenylmethane-dye
hair-dye-max-0.5-pct
sccnfp-assessed
e133-food-approved
color-additive
eu_children_restricted
epa_safer_alternative
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to FD&C Blue No. 1 by CAS number or substance name.
Studies
91
Lowest NOAEL
0.414
Highest NOAEL
9000
Units vary across source rows: mg/kg bw/day, mg/kg bw/d, mg/kg
COSMOS_DB
INCHEM_WHO_jecfa_jecmono_v75je01
SCCNFP_vision_codex
Known Synonyms
FD & C Blue No. 1 (Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo-, inner salt, disodium salt)
Aizen Food Blue No. 2
Brilliant Blue FCF Supra
Canacert Brilliant Blue FCF
Cosmetic Blue Lake
EINECS 223-339-8
FD & C Blue No. 1
FDC Blue No. 1
Fenazo Blue XI
Food Blue Dye No. 1
Hexacol Brilliant Blue A
Intracid Pure Blue L
Japan Blue 1
Japan Blue No. 1
Merantine Blue EG
Usacert Blue No. 1
Usacert FD and C Blue No. 1
Modr Brilantni FCF
Modr Kysela 9
Modr Potravinarska 2
Chemical Function
Dye
Regulatory Lists
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
IFRA Transparency
inert_ingredient; non_food_use; Pesticides
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bath salts
children; Europe; Personal care - body hygiene - body wash
children; Europe; Personal care - hair styling and care - shampoo
children; Europe; Personal care - specialized bath products - bubble bath
children; Europe; Personal care - dental care - toothpaste
children; Europe; Personal care
children; Europe; Personal care
Europe; Personal care
Europe; Personal care
Arts and crafts/Office supplies - body paint - tattoo ink; Europe
general_foods
pharmaceutical
Personal care
Australian Status
AICIS status: listed
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.
ChEMBL ID
CHEMBL3184128
Frequently Asked Questions
Is FD&C Blue No. 1 allowed in the EU?
FD&C Blue No. 1 EU regulatory status: permitted. Maximum allowed concentration: 0.5% (hair dye); permitted for lip products per EU Cosmetics Regulation Annex IV. This is based on EU Regulation 1223/2009 and its amendments.
What does FD&C Blue No. 1 do in cosmetics?
FD&C Blue No. 1 functions as: colorant. It is classified as a Colorant in our database. CAS number: 3844-45-9.
What is the NOAEL for FD&C Blue No. 1?
The NOAEL (No Observed Adverse Effect Level) for FD&C Blue No. 1 is 200 mg/kg bw/day based on a Developmental study via oral route in rabbit. A total of 10 study endpoints are available. Source: COSMOS_DB.
Is FD&C Blue No. 1 used outside cosmetics?
FD&C Blue No. 1 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 FD&C Blue No. 1 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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