Title 21: Food and Drugs
PART 73—LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
Subpart A—Foods
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§ 73.1 Diluents in color additive mixtures for food use exempt from certification.
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.
(a) General use. (1) Substances that are generally recognized as safe under the conditions set forth in section 201(s) of the act.
(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.
(3) The following:
------------------------------------------------------------------------ Definitions and Substances specifications Restrictions------------------------------------------------------------------------Calcium disodium EDTA Contains calcium May be used in (calcium disodium ethyl- disodium ethyl- aqueous solutions enediamine- tetraacetate). enediamine- and aqueous tetraacetate dispersions as a dihydrate (CAS preservative and Reg. No. 6766-87- sequestrant in 6) as set forth in color additive the Food Chemicals mixtures intended Codex, 3d ed., p. only for ingested 50, 1981. 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).Castor oil................... As set forth in Not more than 500 U.S.P. XVI. 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.Dioctylsodium sulfosuccinate. As set forth in Not more than 9 sec. 172.810 of p.p.m. in the this chapter. 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.Disodium EDTA (disodium ethyl- Contains disodium May be used in enediamine- tetraacetate). ethyl- enediamine- aqueous solutions tetraacetate and aqueous dihydrate (CAS dispersions as a Reg. No. 6381-92- preservative and 6) as set forth in sequestrant in the Food Chemicals color additive Codex, 3d ed., p. mixtures intended 104, 1981. 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).------------------------------------------------------------------------
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(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:
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------------------------------------------------------------------------ Definitions and Substances specifications Restrictions------------------------------------------------------------------------Alcohol, SDA-3A.............. As set forth in 26 No residue. CFR pt. 212.n-Butyl alcohol.............. ................... Do.Cetyl alcohol................ As set forth in Do. N.F. XI.Cyclohexane.................. ................... Do.Ethyl cellulose.............. As set forth in sec. 172.868 of this chapter.Ethylene glycol monoethyl ................... Do. ether.Isobutyl alcohol............. ................... Do.Isopropyl alcohol............ ................... Do.Polyoxyethylene sorbitan As set forth in monooleate (polysorbate 80). sec. 172.840 of this chapter.Polyvinyl acetate............ Molecular weight, minimum 2,000.Polyvinylpyrrolidone......... As set forth in sec. 173.55 of this chapter.Rosin and rosin derivatives.. As set forth in sec. 172.615 of this chapter.Shellac, purified............ Food grade.........------------------------------------------------------------------------
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(ii) Inks for marking fruit and vegetables. Items listed in paragraph (a) of this section and the following:
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------------------------------------------------------------------------ Definitions and Substances specifications Restrictions------------------------------------------------------------------------Acetone...................... As set forth in No residue. N.F. XI.Alcohol, SDA-3A.............. As set forth in 26 Do. CFR pt. 212.Benzoin...................... As set forth in U.S.P. XVI.Copal, Manila................ ...................Ethyl acetate................ As set forth in Do. N.F. XI.Ethyl cellulose.............. As set forth in sec. 172.868 of this chapter.Methylene chloride........... ................... Do.Polyvinylpyrrolidone......... As set forth in sec. 173.55 of this chapter.Rosin and rosin derivatives.. As set forth in sec. 172.615 of this chapter.Silicon dioxide.............. As set forth in Not more than 2 pct sec. 172.480 of of the ink solids. this chapter.Terpene resins, natural...... As set forth in sec. 172.615 of this chapter.Terpene resins, synthetic.... Polymers of α- and β-pinene.------------------------------------------------------------------------
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(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:
Alcohol, denatured, formula 23A (26 CFR part 212), Internal Revenue Service.
Damar gum (resin).
Diethylene glycol distearate.
Dioctyl sodium sulfosuccinate.
Ethyl cellulose (as identified in §172.868 of this chapter).
Ethylene glycol distearate.
Japan wax.
Limed rosin.
Naphtha.
Pentaerythritol ester of fumaric acid-rosin adduct.
Polyethylene glycol 6000 (as identified in §172.820 of this chapter).
Polyvinyl alcohol.
Rosin and rosin derivatives (as identified in §172.615 of this chapter).
(3) Miscellaneous special uses. Items listed in paragraph (a) of this section and the following:
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------------------------------------------------------------------------ Definitions and Substances specifications Restrictions------------------------------------------------------------------------Polyvinylpyrrolidone......... As set forth in In or as food-tablet sec. 173.55 of coatings; limit, this chapter. not more than 0.1 pct in the finished food; labeling of color additive mixtures containing polyvinylpyrrolidon e shall bear adequate directions for use that will result in a food meeting this restriction.------------------------------------------------------------------------
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[42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992; 69 FR 24511, May 4, 2004]
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