FD&C Yellow No. 5
FD&C Yellow No. 5. (a) Identity. The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the additive, 4-aminobenzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. (b) Specifications. (1) FD&C Yellow No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 4,4′-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent. 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, tetrasodium salt, not more than 1 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazole-3-carboxylate, disodium salt, not more than 1 percent. Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent. 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent. 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent. 4-Aminoazobenzene, not more than 75 parts per billion. 4-Aminobiphenyl, not more than 5 parts per billion. Aniline, not more than 100 parts per billion. Azobenzene, not more than 40 parts per billion. Benzidine, not more than 1 part per billion. 1,3-Diphenyltriazene, not more than 40 parts per billion. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (1) FD&C Yellow No. 5 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, subject to the restrictions on use of color additives in § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [50 FR 35782, Sept. 4, 1985, as amended at 51 FR 24524, July 7, 1986; 59 FR 60898, Nov. 29, 1994]
Regulatory decision and full conditions
- Status
- Permitted list with conditions
- Legal role
- Binding rule
- Regulatory summary
- FD&C Yellow No. 5. (a) Identity. The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the additive, 4-aminobenzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. (b) Specifications. (1) FD&C Yellow No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 4,4′-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent. 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, tetrasodium salt, not more than 1 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazole-3-carboxylate, disodium salt, not more than 1 percent. Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent. 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent. 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent. 4-Aminoazobenzene, not more than 75 parts per billion. 4-Aminobiphenyl, not more than 5 parts per billion. Aniline, not more than 100 parts per billion. Azobenzene, not more than 40 parts per billion. Benzidine, not more than 1 part per billion. 1,3-Diphenyltriazene, not more than 40 parts per billion. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (1) FD&C Yellow No. 5 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, subject to the restrictions on use of color additives in § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [50 FR 35782, Sept. 4, 1985, as amended at 51 FR 24524, July 7, 1986; 59 FR 60898, Nov. 29, 1994]
- Conditions and restrictions
- FD&C Yellow No. 5. (a) Identity. The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the additive, 4-aminobenzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. (b) Specifications. (1) FD&C Yellow No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practice: Sum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent. Water-insoluble matter, not more than 0.2 percent. 4,4′-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent. 4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, tetrasodium salt, not more than 1 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1 H -pyrazole-3-carboxylate, disodium salt, not more than 1 percent. Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1 H -pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent. 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent. 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent. Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1 H -pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent. 4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent. 4-Aminoazobenzene, not more than 75 parts per billion. 4-Aminobiphenyl, not more than 5 parts per billion. Aniline, not more than 100 parts per billion. Azobenzene, not more than 40 parts per billion. Benzidine, not more than 1 part per billion. 1,3-Diphenyltriazene, not more than 40 parts per billion. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. Total color, not less than 87 percent. (2) FD&C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter. (c) Uses and restrictions. (1) FD&C Yellow No. 5 may be safely used for coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in amounts consistent with current good manufacturing practice. (2) FD&C Yellow No. 5 Aluminum Lake may be safely used for coloring cosmetics intended for use in the area of the eye, subject to the restrictions on use of color additives in § 70.5(b) and (c) of this chapter, in amounts consistent with current good manufacturing practice. (d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter. (e) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter. [50 FR 35782, Sept. 4, 1985, as amended at 51 FR 24524, July 7, 1986; 59 FR 60898, Nov. 29, 1994]
Substance identity
- Official source name
- FD&C Yellow No. 5
- CAS
- 1934-21-0
- EC
- Not supplied in this source row
- Identity mapping
- standalone:official_cfr_section
Cross-market snapshot for this identity
Exact linked records currently present in this site. An absent market means no imported exact match, not permission to use the substance.
European Union
2 linked records · 2 with specific conditions
Open supporting recordGreat Britain
1 linked record · 1 with specific conditions
Open supporting recordNew Zealand
2 linked records · 2 with specific conditions
Open supporting recordASEAN
1 linked record · 1 with specific conditions
Open supporting recordUnited States
Current record1 linked record · 1 with specific conditions
Open supporting recordIndia
1 linked record · 1 with specific conditions
Open supporting recordSaudi Arabia
1 linked record
Open supporting recordVerified chemistry for CAS 1934-21-0
Tartrazine
Tartrazine is an organic sodium salt which is the trisodium salt of tartrazine acid. A synthetic lemon yellow azo dye used as a food colouring. It has a role as a histological dye and a food colouring. It contains a tartrazine(3-). — ChEBI
- IUPAC name
- trisodium;5-oxo-1-(4-sulfonatophenyl)-4-[(4-sulfonatophenyl)diazenyl]-4H-pyrazole-3-carboxylate
- Molecular formula
- C16H9N4Na3O9S2
- Molecular weight
- 534.4 g/mol
- Exact mass
- 533.95040307 Da
- Monoisotopic mass
- 533.95040307 Da
- Topological polar surface area
- 229.0 Ų
- Molecular complexity
- 949.0
- Formal charge
- 0
- Hydrogen-bond donors
- 0
- Hydrogen-bond acceptors
- 12
- Rotatable bonds
- 3
- Heavy atoms
- 34
- Covalent units
- 4
Names and synonyms reported to PubChem
16 more reported names
External database identifiers
- ChEBI:CHEBI:9405
Advanced structure statistics
- Defined atom stereocentres
- 0
- Undefined atom stereocentres
- 1
- Defined bond stereocentres
- 0
- Undefined bond stereocentres
- 0
- 3D conformers
- 0
Machine-readable structure identifiers
- SMILES
C1=CC(=CC=C1N=NC2C(=NN(C2=O)C3=CC=C(C=C3)S(=O)(=O)[O-])C(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+].[Na+]- InChI
InChI=1S/C16H12N4O9S2.3Na/c21-15-13(18-17-9-1-5-11(6-2-9)30(24,25)26)14(16(22)23)19-20(15)10-3-7-12(8-4-10)31(27,28)29;;;/h1-8,13H,(H,22,23)(H,24,25,26)(H,27,28,29);;;/q;3*+1/p-3- InChIKey
UJMBCXLDXJUMFB-UHFFFAOYSA-K
Retrieved from NIH PubChem on 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.
Official source and provenance
- Registered source
- US FDA cosmetic ingredient framework
- Source reference
- 21 CFR 74.2705
- Source record ID
74.2705- Source version
- 2026-08-27
- Source language
- English
- Translation status
- Original is English
- Source updated
- 2026-08-27
- Snapshot checked
- 2026-08-30 04:30 UTC
- Validation method
- eCFR XML subpart/section parse; 99 records
- SHA-256
25a55a997379f510077dfb234fe3f366e8a1429cec3d0b20fe4b60e2baf3c36d
Registered dataset notes
- Dataset coverage
- Federal ingredient framework, prohibited/restricted examples and color-additive rules
- Authority note
- The US has no EU-style general approved-ingredient catalogue; MoCRA listing is not approval
How this record fits the market dataset
Status distribution
Condition text is present on 90 of 99 current records. An empty condition field is interpreted according to the record type above; it is never converted into an unrestricted-use claim.
United States market context
Complete enumerated federal ingredient rules
Coverage version: eCFR Title 21 issue date 27 August 2026
All cosmetic prohibitions/restrictions in Part 700 Subpart B and cosmetic-use colour additive listings in Parts 73, 74 and 82.
Verification checklist
- Search Part 700 and all relevant colour-additive parts.
- Confirm colour additive identity, permitted uses, limits and certification status.
- Assess safety and adulteration under the FD&C Act.
- Complete MoCRA facility/product, adverse-event and label obligations where applicable.
Official market sources
- US FDA cosmetic ingredient frameworkThe US has no EU-style general approved-ingredient catalogue; MoCRA listing is not approval
Verification workflow and record completeness
Before using this result in a compliance decision
- Confirm that “FD&C Yellow No. 5” and every CAS/EC identifier refer to the material in your supplier specification.
- Search Part 700 and all relevant colour-additive parts.
- Confirm colour additive identity, permitted uses, limits and certification status.
- Assess safety and adulteration under the FD&C Act.
- Complete MoCRA facility/product, adverse-event and label obligations where applicable.
- Document the source version and recheck the regulator before manufacture, notification or market placement.
Fields available in this record
- Official substance nameAvailable
- CASAvailable
- ECNot supplied
- Separate condition textAvailable
- Effective dateNot supplied
- Snapshot hash and methodAvailable
Questions this page answers
Stable citation
FD&C Yellow No. 5. 21 CFR 74.2705. United States. Source version 2026-08-27. CosIng Checker regulatory record: https://cosingchecker.com/regulations/us/records/781/
Cite the regulator as the legal authority. This page is a structured evidence index and verification aid, not a substitute for the official text or professional legal assessment.
Interpretation and limits for United States
This identity appears on a market positive list for the list function represented by the source record.
Confirm that the intended function and product use fall within the list scope and every stated condition.
How to interpret the legal role
The cited row forms part of a binding rule or legally incorporated list for this market.
Evidence on this page
- Recorded outcome: Permitted list with conditions
- Legal role: Binding rule
- Source version: 2026-08-27
What it does not prove
FDA has no general approved-cosmetic-ingredient catalogue; absence from these sections is not approval or proof of safety.
Further authoritative substance research
These sources can add identity, safety, exposure or hazard context. A link is not evidence that the database contains this exact substance, and none of these sources overrides the market decision above.
Cosmetic Ingredient Review safety assessments
Expert Panel conclusions, assessed ingredient groups, use conditions, dates and report documents
Independent expert review considered by FDA; not a government approval or binding market rule
Research this identity at the sourceFDA Global Substance Registration System
UNII identifiers, preferred names, substance types, codes and public substance relationships
Identity registry only; UNII availability does not imply FDA review or approval
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Hazards, symptoms, first aid, storage, incompatibilities and physical properties for covered chemicals
International occupational chemical-safety reference; not cosmetic-use approval
Research this identity at the sourceJapan NITE-CHRIP
Chemical identity, Japanese and foreign legal lists, GHS hazards and exposure-related information
Chemical-management evidence; cosmetic status remains governed by the applicable MHLW standard and market rules
Research this identity at the sourceNIOSH Pocket Guide to Chemical Hazards
REL, PEL, IDLH, properties, exposure routes, symptoms, target organs, first aid and measurement methods for covered workplace chemicals
US occupational-health guidance and limits; not a cosmetic ingredient decision
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Gateway to authority-owned physical-property, fate, ecotoxicity, toxicity, exposure and GHS records
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API key required for importDTXSID identity, experimental and predicted properties, toxicity, bioactivity, exposure and environmental data
Scientific and computational evidence; predictions must remain labelled and do not determine cosmetic legality
Research this identity at the source