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

Home > Regulations > Listing of color additives exempt from certification > 73.1 Diluents in color additive mixtures for food use exempt from certification.






[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.



[[Page 339]]





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:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 73, Section 1


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