{"data":{"id":"us/21-cfr-74.101","jurisdiction":"us","citation":"21 CFR 74.101","heading":"FD\u0026C Blue No. 1.","body":"(a) Identity. (1) The color additive FD\u0026C Blue No. 1 is principally the disodium salt of ethyl [4-[p-[ethyl (m-sulfobenzyl) amino]-α-(o-sulfophenyl) benzylidene] - 2,5 -cyclohexadien - 1 - ylidene] (m-sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the isomeric disodium salts of ethyl [4-[p-[ethyl(p-sulfobenzyl) amino]-α-(o-sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (p-sulfobenzyl) ammonium hydroxide inner salt and ethyl [4-[p-[ethyl (o-sulfobenzyl) amino] - α - (o -sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (o-sulfobenzyl) ammonium hydroxide inner salt.\n(2) Color additive mixtures for food use (including dietary supplements) made with FD\u0026C Blue No. 1 may contain only those diluents that are suitable and that are listed in part 73 of this chapter as safe for use in color additive mixtures for coloring foods.\n(b) Specifications. FD\u0026C Blue No. 1 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 current good manufacturing practice:\nSum of volatile matter (at 135 °C) and chlorides and sulfates (calculated as sodium salts), not more than 15.0 percent.\nWater-insoluble matter, not more than 0.2 percent.\nLeuco base, not more than 5 percent.\nSum of o-, m-, and p-sulfobenzaldehydes, not more than 1.5 percent.\nN-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not more than 0.3 percent.\nSubsidiary colors, not more than 6.0 percent.\nChromium (as Cr), not more than 50 parts per million.\nManganese (as Mn), not more than 100 parts per million.\nArsenic (as As), not more than 3 parts per million.\nLead (as Pb), not more than 10 parts per million.\nTotal color, not less than 85.0 percent.\n(c) Uses and restrictions. FD\u0026C Blue No. 1 may be safely used for coloring foods (including dietary supplements) generally in amounts consistent with good manufacturing practice except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.\n(d) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of § 70.25 of this chapter.\n(e) Certification. All batches of FD\u0026C Blue No. 1 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 A—Foods"],"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":"3d9b954b53277add9be80864e3f0e4d5e7285e736f8cfdb7d5cf8bcd86b48876","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-73.3129","next":"us/21-cfr-74.102"},"notice":"GroundRules: Original legal text. Not legal advice."}
