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.
Good
Colorant
FD&C Blue No. 1
INCI: FD&C BLUE NO. 1
FD&C Blue No. 1 (CAS 3844-45-9) is a cosmetic colorant functioning as colorant. 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 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.
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
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.
Is FD&C Blue No. 1 used outside cosmetics?
FD&C Blue No. 1 also appears in 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
Is FD&C Blue No. 1 in Your Products?
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