21 CFR 73.1 - Diluents in color additive mixtures for food use exempt from certification.

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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:
Substances Definitions and specifications Restrictions
Calcium 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).
Castor 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.
Dioctylsodium 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.
Disodium 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).
(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:
Substances Definitions and specifications Restrictions
Alcohol, SDA-3A As set forth in 26 CFR pt. 212 No residue.
n-Butyl alcohol Do.
Cetyl alcohol As set forth in N.F. XI Do.
Cyclohexane Do.
Ethyl cellulose As set forth in sec. 172.868 of this chapter
Ethylene glycol monoethyl ether Do.
Isobutyl alcohol Do.
Isopropyl alcohol Do.
Polyoxyethylene sorbitan monooleate (polysorbate 80) As set forth in 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
(ii) Inks for marking fruit and vegetables. Items listed in paragraph (a) of this section and the following:
Substances Definitions and specifications Restrictions
Acetone As set forth in N.F. XI No residue.
Alcohol, SDA-3A As set forth in 26 CFR pt. 212 Do.
Benzoin As set forth in U.S.P. XVI
Copal, Manila
Ethyl acetate As set forth in N.F. XI Do.
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 sec. 172.480 of this chapter Not more than 2 pct of the ink solids.
Terpene resins, natural As set forth in sec. 172.615 of this chapter
Terpene resins, synthetic Polymers of α- and β-pinene
(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:
Substances Definitions and specifications Restrictions
Polyvinylpyrrolidone 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.
[42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992; 69 FR 24511, May 4, 2004]

Title 21 published on 2013-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-04-11; vol. 79 # 70 - Friday, April 11, 2014
    1. 79 FR 20095 - Listing of Color Additives Exempt From Certification; Spirulina Extract
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 13, 2014. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 12, 2014.
      21 CFR Part 73

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United States Code

Title 21 published on 2013-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 73 after this date.

  • 2014-04-11; vol. 79 # 70 - Friday, April 11, 2014
    1. 79 FR 20095 - Listing of Color Additives Exempt From Certification; Spirulina Extract
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective May 13, 2014. See section X for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by May 12, 2014.
      21 CFR Part 73