{"data":{"id":"us/21-cfr-73.1","jurisdiction":"us","citation":"21 CFR 73.1","heading":"Diluents in color additive mixtures for food use exempt from certification.","body":"The following substances may be safely used as diluents in color additive mixtures for food use exempt from certification, subject to the condition that each straight color in the mixture has been exempted from certification or, if not so exempted, is from a batch that has previously been certified and has not changed in composition since certification. If a specification for a particular diluent is not set forth in this part 73, the material shall be of a purity consistent with its intended use.\n(a) General use. (1) Substances that are generally recognized as safe under the conditions set forth in section 201(s) of the act.\n(2) Substances meeting the definitions and specifications set forth under subchapter B of this chapter, and which are used only as prescribed by such regulations.\n(3) The following:\nSubstances Definitions and specifications Restrictions\nCalcium disodium EDTA (calcium disodium ethyl- enediamine- tetraacetate) Contains calcium disodium ethyl- enediamine- tetraacetate dihydrate (CAS Reg. No. 6766-87-6) as set forth in the Food Chemicals Codex, 3d ed., p. 50, 1981 May be used in aqueous solutions and aqueous dispersions as a preservative and sequestrant in color additive mixtures intended only for ingested use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous calcium disodium ethyl-enediamine-tetraacetate).\nCastor oil As set forth in U.S.P. XVI Not more than 500 p.p.m. in the finished food. Labeling of color additive mixtures containing castor oil shall bear adequate directions for use that will result in a food meeting this restriction.\nDioctylsodium sulfosuccinate As set forth in sec. 172.810 of this chapter Not more than 9 p.p.m. in the finished food. Labeling of color additive mixtures containing dioctylsodium sulfosuccinate shall bear adequate directions for use that will result in a food meeting this restriction.\nDisodium EDTA (disodium ethyl- enediamine- tetraacetate) Contains disodium ethyl- enediamine- tetraacetate dihydrate (CAS Reg. No. 6381-92-6) as set forth in the Food Chemicals Codex, 3d ed., p. 104, 1981 May be used in aqueous solutions and aqueous dispersions as a preservative and sequestrant in color additive mixtures intended only for ingested use; the color additive mixture (solution or dispersion) may contain not more than 1 percent by weight of the diluent (calculated as anhydrous disodium ethyl- enediamine- tetraacetate).\n(b) Special use—(1) Diluents in color additive mixtures for marking food—(i) Inks for marking food supplements in tablet form, gum, and confectionery. Items listed in paragraph (a) of this section and the following:\nSubstances Definitions and specifications Restrictions\nAlcohol, SDA-3A As set forth in 26 CFR pt. 212 No residue.\nn-Butyl alcohol Do.\nCetyl alcohol As set forth in N.F. XI Do.\nCyclohexane Do.\nEthyl cellulose As set forth in sec. 172.868 of this chapter\nEthylene glycol monoethyl ether Do.\nIsobutyl alcohol Do.\nIsopropyl alcohol Do.\nPolyoxyethylene sorbitan monooleate (polysorbate 80) As set forth in sec. 172.840 of this chapter\nPolyvinyl acetate Molecular weight, minimum 2,000\nPolyvinylpyrrolidone As set forth in sec. 173.55 of this chapter\nRosin and rosin derivatives As set forth in sec. 172.615 of this chapter\nShellac, purified Food grade\n(ii) Inks for marking fruit and vegetables. Items listed in paragraph (a) of this section and the following:\nSubstances Definitions and specifications Restrictions\nAcetone As set forth in N.F. XI No residue.\nAlcohol, SDA-3A As set forth in 26 CFR pt. 212 Do.\nBenzoin As set forth in U.S.P. XVI\nCopal, Manila\nEthyl acetate As set forth in N.F. XI Do.\nEthyl cellulose As set forth in sec. 172.868 of this chapter\nMethylene chloride Do.\nPolyvinylpyrrolidone As set forth in sec. 173.55 of this chapter\nRosin and rosin derivatives As set forth in sec. 172.615 of this chapter\nSilicon dioxide As set forth in sec. 172.480 of this chapter Not more than 2 pct of the ink solids.\nTerpene resins, natural As set forth in sec. 172.615 of this chapter\nTerpene resins, synthetic Polymers of α- and β-pinene\n(2) Diluents in color additive mixtures for coloring shell eggs. Items listed in paragraph (a) of this section and the following, subject to the condition that there is no penetration of the color additive mixture or any of its components through the eggshell into the egg:\nAlcohol, denatured, formula 23A (26 CFR part 212), Internal Revenue Service.\nDamar gum (resin).\nDiethylene glycol distearate.\nDioctyl sodium sulfosuccinate.\nEthyl cellulose (as identified in § 172.868 of this chapter).\nEthylene glycol distearate.\nJapan wax.\nLimed rosin.\nNaphtha.\nPentaerythritol ester of fumaric acid-rosin adduct.\nPolyethylene glycol 6000 (as identified in § 172.820 of this chapter).\nPolyvinyl alcohol.\nRosin and rosin derivatives (as identified in § 172.615 of this chapter).\n(3) Miscellaneous special uses. Items listed in paragraph (a) of this section and the following:\nSubstances Definitions and specifications Restrictions\nPolyvinylpyrrolidone As set forth in sec. 173.55 of this chapter In or as food-tablet coatings; limit, not more than 0.1 pct in the finished food; labeling of color additive mixtures containing polyvinylpyrrolidone shall bear adequate directions for use that will result in a food meeting this restriction.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER A—GENERAL","PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM 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":"58deb1d282195f2e58ea614891106cf478d0d51e43247a912989c009647ca283","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-71.37","next":"us/21-cfr-73.30"},"notice":"GroundRules: Original legal text. Not legal advice."}
