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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2018]
[CITE: 21CFR73.1]



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

Sec. 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, 1981May 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 oilAs set forth in U.S.P. XVINot 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 sulfosuccinateAs set forth in sec. 172.810 of this chapterNot 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, 1981May 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-3AAs set forth in 26 CFR pt. 212No residue.
n-Butyl alcohol Do.
Cetyl alcoholAs set forth in N.F. XI Do.
Cyclohexane Do.
Ethyl celluloseAs 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 acetateMolecular weight, minimum 2,000
PolyvinylpyrrolidoneAs set forth in sec. 173.55 of this chapter
Rosin and rosin derivativesAs set forth in sec. 172.615 of this chapter
Shellac, purifiedFood grade

(ii) Inks for marking fruit and vegetables. Items listed in paragraph (a) of this section and the following:

Substances Definitions and specifications Restrictions
AcetoneAs set forth in N.F. XINo residue.
Alcohol, SDA-3AAs set forth in 26 CFR pt. 212 Do.
BenzoinAs set forth in U.S.P. XVI
Copal, Manila
Ethyl acetateAs set forth in N.F. XI Do.
Ethyl celluloseAs set forth in sec. 172.868 of this chapter
Methylene chloride Do.
PolyvinylpyrrolidoneAs set forth in sec. 173.55 of this chapter
Rosin and rosin derivativesAs set forth in sec. 172.615 of this chapter
Silicon dioxideAs set forth in sec. 172.480 of this chapterNot more than 2 pct of the ink solids.
Terpene resins, naturalAs set forth in sec. 172.615 of this chapter
Terpene resins, syntheticPolymers of [alpha]- and [beta]-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
PolyvinylpyrrolidoneAs set forth in sec. 173.55 of this chapterIn 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]

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