[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR73.1]
[Page 336-339]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 73_LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION--Table
of Contents
Subpart A_Foods
Sec. 73.1 Diluents in color additive mixtures for food use exempt
from certification.
Subpart A_Foods
Sec.
73.1 Diluents in color additive mixtures for food use exempt from
certification.
73.30 Annatto extract.
73.35 Astaxanthin.
73.40 Dehydrated beets (beet powder).
73.50 Ultramarine blue.
73.75 Canthaxanthin.
73.85 Caramel.
73.90 [beta]-Apo-8'-carotenal.
73.95 [beta]-Carotene.
73.100 Cochineal extract; carmine.
73.125 Sodium copper chlorophyllin.
73.140 Toasted partially defatted cooked cottonseed flour.
73.160 Ferrous gluconate.
73.165 Ferrous lactate.
73.169 Grape color extract.
73.170 Grape skin extract (enocianina).
73.185 Haematococcus algae meal.
73.200 Synthetic iron oxide.
73.250 Fruit juice.
73.260 Vegetable juice.
73.275 Dried algae meal.
73.295 Tagetes (Aztec marigold) meal and extract.
73.300 Carrot oil.
[[Page 337]]
73.315 Corn endosperm oil.
73.340 Paprika.
73.345 Paprika oleoresin.
73.355 Phaffia yeast.
73.450 Riboflavin.
73.500 Saffron.
73.575 Titanium dioxide.
73.585 Tomato lycopene extract; tomato lycopene concentrate.
73.600 Turmeric.
73.615 Turmeric oleoresin.
Subpart B_Drugs
73.1001 Diluents in color additive mixtures for drug use exempt from
certification.
73.1010 Alumina (dried aluminum hydroxide).
73.1015 Chromium-cobalt-aluminum oxide.
73.1025 Ferric ammonium citrate.
73.1030 Annatto extract.
73.1070 Calcium carbonate.
73.1075 Canthaxanthin.
73.1085 Caramel.
73.1095 [beta]-Carotene.
73.1100 Cochineal extract; carmine.
73.1125 Potassium sodium copper chlorophyllin (chlorophyllin-copper
complex).
73.1128 Mica-based pearlescent pigments.
73.1150 Dihydroxyacetone.
73.1162 Bismuth oxychloride.
73.1200 Synthetic iron oxide.
73.1298 Ferric ammonium ferrocyanide.
73.1299 Ferric ferrocyanide.
73.1326 Chromium hydroxide green.
73.1327 Chromium oxide greens.
73.1329 Guanine.
73.1375 Pyrogallol.
73.1400 Pyrophyllite.
73.1410 Logwood extract.
73.1496 Mica.
73.1550 Talc.
73.1575 Titanium dioxide.
73.1645 Aluminum powder.
73.1646 Bronze powder.
73.1647 Copper powder.
73.1991 Zinc oxide.
Subpart C_Cosmetics
73.2030 Annatto.
73.2085 Caramel.
73.2087 Carmine.
73.2095 [beta]-Carotene.
73.2110 Bismuth citrate.
73.2120 Disodium EDTA-copper.
73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper
complex).
73.2150 Dihydroxyacetone.
73.2162 Bismuth oxychloride.
73.2180 Guaiazulene.
73.2190 Henna.
73.2250 Iron oxides.
73.2298 Ferric ammonium ferrocyanide.
73.2299 Ferric ferrocyanide.
73.2326 Chromium hydroxide green.
73.2327 Chromium oxide greens.
73.2329 Guanine.
73.2396 Lead acetate.
73.2400 Pyrophyllite.
73.2496 Mica.
73.2500 Silver.
73.2575 Titanium dioxide.
73.2645 Aluminum powder.
73.2646 Bronze powder.
73.2647 Copper powder.
73.2725 Ultramarines.
73.2775 Manganese violet.
73.2991 Zinc oxide.
73.2995 Luminescent zinc sulfide.
Subpart D_Medical Devices
73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-
propenoic)ester copolymers.
73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.
73.3106 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone
copolymers.
73.3107 Carbazole violet.
73.3110 Chlorophyllin-copper complex, oil soluble.
73.3110a Chromium-cobalt-aluminum oxide.
73.3111 Chromium oxide greens.
73.3112 C.I. Vat Orange 1.
73.3115 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-
benzenetriol.
73.3117 16,23-Dihydrodinaphtho[2,3-a:2',3'-i] naphth [2',3':6,7] indolo
[2,3-c] carbazole-5,10,15,17,22,24-hexone.
73.3118 N,N'-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.
73.3119 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.
73.3120 16,17-Dimethoxydinaphtho [1,2,3-cd:3',2',1'-lm] perylene-5,10-
dione.
73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers.
73.3122 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-
pyrazol-3-one.
73.3123 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene)
benzo[b]thiophen-3 (2H)-one.
73.3124 Phthalocyanine green.
73.3125 Iron oxides.
73.3126 Titanium dioxide.
73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products.
73.3128 Mica-based pearlescent pigments.
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361,
362, 371, 379e.
Source: 42 FR 15643, Mar. 22, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 73 appear at 66 FR
66742, Dec. 27, 2001.
[[Page 338]]
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).
------------------------------------------------------------------------
(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:
------------------------------------------------------------------------
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.
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Shellac, purified............ Food grade.........
------------------------------------------------------------------------
(ii) Inks for marking fruit and vegetables. Items listed in
paragraph (a) of this section and the following:
------------------------------------------------------------------------
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 [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 Sec. 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 Sec. 172.820 of this
chapter).
Polyvinyl alcohol.
Rosin and rosin derivatives (as identified in Sec. 172.615 of this
chapter).
(3) Miscellaneous special uses. Items listed in paragraph (a) of
this section and the following:
------------------------------------------------------------------------
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.
------------------------------------------------------------------------
[42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992;
69 FR 24511, May 4, 2004]
Additives that reference this regulation: - ACETONE
- ALCOHOL SDA-3A
- ALCOHOL, DENATURED FORMULA 23A
- BENZOIN
- BUTYL ALCOHOL
- CASTOR OIL (RICINUS COMMUNIS L.)
- CETYL ALCOHOL
- COPALS, MANILA
- CYCLOHEXANE
- DAMAR GUM (SHOREA DIPTEROCARPACEAE)
- DIETHYLENE GLYCOL DISTEARATE
- DIOCTYL SODIUM SULFOSUCCINATE
- EDTA, CALCIUM DISODIUM
- EDTA, DISODIUM
- ETHYL ACETATE
- ETHYL CELLULOSE
- ETHYLENE GLYCOL DISTEARATE
- ETHYLENE GLYCOL MONOETHYL ETHER
- ISOBUTYL ALCOHOL
- ISOPROPYL ALCOHOL
- JAPAN WAX
- METHYLENE CHLORIDE
- NAPHTHA
- POLYETHYLENE GLYCOL (M W 200-9,500)
- POLYSORBATE 80
- POLYVINYL ACETATE
- POLYVINYL ALCOHOL
- POLYVINYLPYRROLIDONE
- ROSIN (PINUS SPP.) AND ROSIN DERIVATIVES
- ROSIN, ADDUCT WITH FUMARIC ACID, PENTAERYTHRITOL ESTER
- ROSIN, LIMED
- SHELLAC, PURIFIED
- SILICON DIOXIDE
- TERPENE RESINS, NATURAL
- TERPENE RESINS, SYNTHETIC
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