{"data":{"id":"us/21-cfr-74.2705","jurisdiction":"us","citation":"21 CFR 74.2705","heading":"FD\u0026C Yellow No. 5.","body":"(a) Identity. The color additive FD\u0026C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-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)-1H-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.\n(b) Specifications. (1) FD\u0026C 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:\nSum of volatile matter at 135 °C (275 °F) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.\nWater-insoluble matter, not more than 0.2 percent.\n4,4′-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1H-pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than 1 percent.\n4-[(4′,5-Disulfo[1,1′-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, tetrasodium salt, not more than 1 percent.\nEthyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)hydrazono]-1H-pyrazole-3-carboxylate, disodium salt, not more than 1 percent.\nSum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent.\n4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent.\n4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent.\nEthyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent.\n4,4′-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent.\n4-Aminoazobenzene, not more than 75 parts per billion.\n4-Aminobiphenyl, not more than 5 parts per billion.\nAniline, not more than 100 parts per billion.\nAzobenzene, not more than 40 parts per billion.\nBenzidine, not more than 1 part per billion.\n1,3-Diphenyltriazene, not more than 40 parts per billion.\nLead (as Pb), not more than 10 parts per million.\nArsenic (as As), not more than 3 parts per million.\nMercury (as Hg), not more than 1 part per million.\nTotal color, not less than 87 percent.\n(2) FD\u0026C Yellow No. 5 Aluminum Lake shall be prepared in accordance with the requirements of § 82.51 of this chapter.\n(c) Uses and restrictions. (1) FD\u0026C 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.\n(2) FD\u0026C 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.\n(d) Labeling. The label of the color additive shall conform to the requirements of § 70.25 of this chapter.\n(e) Certification. All batches of FD\u0026C Yellow No. 5 shall be certified in accordance with regulations in part 80 of this chapter.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 74—LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION","Subpart C—Cosmetics"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"fdbf5fb0852f42d0c624ef874dfbc6212cf927f305de118e041ef3b180275403","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-74.2602a","next":"us/21-cfr-74.2706"},"notice":"GroundRules: Original legal text. Not legal advice."}