Is FD&C Yellow No. 5 (CI 19140) safe in cosmetics?
FD&C Yellow No. 5 (CI 19140) 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 Yellow No. 5 (CI 19140)
Also known as: 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, trisodium salt, C.I. 19140, Tartrazine, Tartrazine yellow 19140, D&C Yellow 5 (+15 more)
INCI: FD&C YELLOW NO. 5
FD&C Yellow No. 5 (CI 19140) (CAS 1934-21-0) is a cosmetic cosmetic ingredient functioning as Colorant. NOAEL 1 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 0.11%. 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 1934-21-0 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
FD&C Yellow No. 5 (CI 19140) is classified GHS Danger (H317, H334) in the chemicals database but is allowed in EU cosmetics at max 0.11%.
Source: Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Regulatory Status
EU EU Status
permitted
EU Max Conc.
0.11%
US US Status
permitted
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 Yellow No. 5 (CI 19140).
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for FD&C Yellow No. 5 (CI 19140). 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 | 500 mg/kg bw/day | oral | rat | Neurotoxicity | COSMOS_DB |
| NOAEL | 750 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 773 mg/kg bw/day | oral | mouse | Reproductive | COSMOS_DB |
| NOAEL | 1064 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 1105 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 1500 mg/kg bw/day | oral | dog | Chronic | COSMOS_DB |
| NOAEL | 2190 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 2418 mg/kg bw/day | oral | mouse | Chronic | COSMOS_DB |
| NOAEL | 2500 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 2995 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for FD&C Yellow No. 5 (CI 19140) 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 |
|---|---|---|---|---|---|
| NOAEL | =1064.3 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =642.8 mg/kg-day | Mouse | oral | - | ECHA IUCLID |
| NOAEL | =1064.3 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1250 mg/kg-day | Rat | oral | subchronic | ECHA IUCLID |
| NOAEL | =1250 mg/kg-day | Rat | oral | subchronic | ECHA IUCLID |
| NOAEL | =1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1000 mg/kg-day | Rat | oral | - | ECHA IUCLID |
| NOAEL | =1064.3 mg/kg-day | Rat | oral | - | ECHA IUCLID |
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 (5)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_hair_dye | 0.5 | Non-oxidative hair dye |
| CN | permitted_colorant | - | All cosmetics (Class 1) |
| 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; tartrazine allergen; limited pregnancy data", "alternative_ingredient": "Mineral colorants", "source": "FDA"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Dye
Flavouring and nutrient
Fragrance
No specific technical function
Regulatory List Membership (4)
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 Yellow No. 5 (CI 19140).
Regulatory Flags
eu_children_restricted
epa_safer_alternative
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to FD&C Yellow No. 5 (CI 19140) by CAS number or substance name.
Studies
19
Lowest NOAEL
500
Highest NOAEL
5000
Units vary across source rows: mg/kg bw/day, mg/kg
COSMOS_DB
ToxValDB_ECHA_IUCLID
SCCNFP_vision_codex
Known Synonyms
1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, trisodium salt
C.I. 19140
Tartrazine
Tartrazine yellow 19140
D&C Yellow 5
A.F. Yellow No. 4
Acid Leather Yellow T
Dye FD and C Yellow No. 5
EINECS 217-699-5
FD & C Yellow No. 5
FD & C Yellow No. 5 tartrazine
FD and C Yellow 5
FD&G Yellow No. 5
Schultz No. 737
1-(4-Sulfophenyl)-4-((4-sulfophenyl)azo)-1H-pyrazole-3-carboxylic
Tartrazine A expo T
Tartrazine C Extra
Tartrazine Extra Pure A
Tartrazine FD & C Yellow #5
Tartrazine FD&C Yellow #5
Chemical Function
Dye
Regulatory Lists
Europe; Personal care - hair coloring
Europe; Personal care - hair coloring
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bath salts
children; Europe; Personal care - general moisturizing - hand/body lotion
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
children; Europe; Personal care
children; Europe; Personal care
Cleaning products and household care; Europe
general_foods
pharmaceutical
Personal care
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
SCIL (9/2019)
active_ingredient; Pesticides
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
CHEMBL4792247
Frequently Asked Questions
Is FD&C Yellow No. 5 (CI 19140) allowed in the EU?
FD&C Yellow No. 5 (CI 19140) EU regulatory status: permitted. Maximum allowed concentration: 0.11%. This is based on EU Regulation 1223/2009 and its amendments.
What does FD&C Yellow No. 5 (CI 19140) do in cosmetics?
FD&C Yellow No. 5 (CI 19140) functions as: Colorant. It is classified as a cosmetic ingredient in our database. CAS number: 1934-21-0.
What is the NOAEL for FD&C Yellow No. 5 (CI 19140)?
The NOAEL (No Observed Adverse Effect Level) for FD&C Yellow No. 5 (CI 19140) is 500 mg/kg bw/day based on a Neurotoxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.
Is FD&C Yellow No. 5 (CI 19140) used outside cosmetics?
FD&C Yellow No. 5 (CI 19140) 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.
Does FD&C Yellow No. 5 (CI 19140) have different safety status in cosmetics vs industrial chemicals?
FD&C Yellow No. 5 (CI 19140) is classified GHS Danger (H317, H334) in the chemicals database but is allowed in EU cosmetics at max 0.11%.
Compliance Tools
Check FD&C Yellow No. 5 (CI 19140) 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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Chemical family
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