Cal. Code Regs. tit. 3 § 2804

Current through Register 2025 Notice Reg. No. 2, January 10, 2025

Section 2804 - Special Purpose Products

(a) Aloe vera gel concentrate. Classification Under Food Additives Amendment: Flavoring agent. Limitations or Restrictions: Not to exceed 125 parts per million (0.0125 percent) in finished feed.

(b) Ammoniated Cottonseed Meal (21 CFR 573.140) is obtained by the treatment of cottonseed meal with anhydrous ammonia until a pressure of 50 pounds per square inch gauge is reached. It is to be used in the feed of ruminants as a source of protein and/or as the sole source of non-protein nitrogen in an amount not to exceed 20 percent of the total ration. The label of the additive and of any feed additive supplement, feed additive concentrate, or feed additive premix prepared therefrom, must contain the following information in addition to any other required information:

(1) The name of the additive.

(2) The maximum percentage of equivalent crude protein from non-protein nitrogen.

(3) Directions for use to provide not more than 20 percent of the additive in the total ration and a prominent statement: "Warning -- This feed should be used only in accordance with the directions furnished on the label."

(c) Ammoniated Rice Hulls (21 CFR 573.160) is obtained by the treatment of ground rice hulls with monocalcium phosphate and anhydrous ammonia at a temperature of 350 degrees Fahrenheit and a pressure of 175 pounds per square inch. It is to be used in beef cattle feeds at a level not to exceed 20 percent of the total rations as a source of crude fiber and as the sole source of non-protein nitrogen. The label of the additive and of any feed additive supplement, feed additive concentrate, or feed additive premix prepared therefrom, must contain the following information in addition to any other required information:

(1) The name of the additive.

(2) The maximum percentage of equivalent crude protein from non-protein nitrogen.

(d) Anhydrous Ammonia (21 CFR 573.180) is applied to corn plant material prior to ensiling as a source of non-protein nitrogen in accordance with any one of the following methods:

(1) As a component of an aqueous premix containing 16 to 17 percent ammonia, with molasses, minerals, and not less than 83 percent crude protein. The labeling must bear the following statements: an expiration date of not less than 10 weeks after date of manufacture, additional protein should not be fed to lactating dairy cows producing less than 32 pounds of milk per day or beef cattle consuming less than one (1) percent of their body weight daily in shelled corn, and do not use additional trace mineral supplementation with treated silage;

(2) After being diluted to a 15 to 30 percent aqueous ammonia solution (by weight) and: does not exceed anhydrous ammonia equivalent to 0.3 percent of the corn plant material, the corn plant material contains 28 to 38 percent dry matter, and the treated silage is fed to dairy cattle only; and

(3) Directly, and does not exceed anhydrous ammonia equivalent to 0.35 percent of the corn plant material, the corn plant material contains 30 to 35 percent dry matter, 75 to 85 percent of the anhydrous ammonia is liquid at ambient pressure during the direct application, and the treated material is used in dairy or beef cattle rations.

(4) The labeling of the article must contain the following information in addition to any other required information: the name of the article, the concentration of ammonia, the maximum percentage of equivalent crude protein from non-protein nitrogen, directions for use consistent with the above, and a prominent: "Warning -- This feed should be used only in accordance with the directions furnished on the label."

(e) Anise seed (21 CFR 582.10). Classification Under Food Additives Amendment: Spices, seasonings, essential oils, oleo resins, and natural extractives. Limitations or Restrictions: In accordance with good manufacturing practices.

(f) Annatto Extract (21 CFR 73.30). The color additive, annatto extract, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive annatto extract is an extract prepared from annatto seed, Bixa orellana L., using any one or an appropriate combination of the food-grade extractants listed in this definition: Alkaline aqueous solution, alkaline propylene glycol, ethyl alcohol or alkaline solutions thereof, edible vegetable oils or fats, mono- and diglycerides from the glycerolysis of edible vegetable oils or fats. The alkaline alcohol or aqueous extracts may be treated with food-grade acids to precipitate annatto pigments, which are separated from the liquid and dried, with or without intermediate recrystallization, using the solvents listed under this definition. Food-grade alkalis or carbonates may be added to adjust alkalinity. Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, trichloroethylene. Color additive mixtures for food use made with annatto extract may contain only diluents that are suitable and that are listed in 21 CFR 73.1 as safe in color additive mixtures for coloring foods.

(2) Specifications. Annatto extract, including pigments precipitated therefrom, shall conform to the following specifications: Arsenic (as As), not more than three (3) parts per million; lead (as Pb), not more than 10 parts per million. When solvents listed under this definition are used, annatto extract shall contain no more solvent residue than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in 21 CFR 170 through 189.

(3) Uses and restrictions. Annatto extract may be safely used for coloring foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25. Labels shall bear information showing that the color is derived from annatto seed. The requirements of 21 CFR 70.25(a) that all ingredients shall be listed by name shall not be construed as requiring the declaration of residues of solvents listed in this definition.

(5) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of FD&C 721(c).

(g) Astaxanthin (21 CFR 73.35). The color additive, astaxanthin, may be safely used in the manufacture of salmonid fish feed in accordance with the following prescribed conditions:

(1) Identity. The color additive astaxanthin is 3, 3'-dihydroxy-B, B-carotene-4, 4'-dione. Astaxanthin may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with astaxanthin may contain only those diluents that are suitable and are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods.

(2) Specifications. Astaxanthin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practices:

(A) Physical state, solid.

(B) 0.05 percent Solution in chloroform, complete and clear.

(C) Absorption maximum wavelength 484 to 493 nanometers (in chloroform). Residue on ignition, not more than 0.1 percent.

(D) Total carotenoids other than astaxanthin, not more than four (4) percent.

(E) Lead, not more than five (5) parts per million.

(F) Arsenic, not more than two (2) parts per million.

(G) Mercury, not more than one (1) part per million.

(H) Heavy metals, not more than 10 parts per million.

(I) Assay, minimum 96 percent.

(3) Uses and restrictions. Astaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. The quantity of color additive in feed is such that the color additive shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.

(4) Labeling requirements. The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required 21 CFR 70.25, and adequate directions to prepare a final product complying with the limitations prescribed in this definition. The presence of the color additive in finished fish feed prepared according to this definition shall be declared in accordance with 21 CFR 501.4. The presence of the color additive in salmonid fish that have been fed feeds containing astaxanthin shall be declared in accordance with 21 CFR 101.22(k)(2) and 21 CFR 101.100(a)(2).

(h) Astaxanthin Dimethyldisuccinate. The color additive, astaxanthin dimethyldisuccinate, may be safely used in the manufacture of salmonid fish feed in accordance with the following prescribed conditions:

(1) Identity. The color additive astaxanthin dimethyldisuccinate is 3,3'-bis(4-methoxy-1,4-dioxobutoxy)-B,B-carotene-4,4'-dione. Astaxanthin dimethyldisuccinate may be added to the fish feed only as a component of a stabilized mixture. Color additive mixtures for fish feed use made with astaxanthin dimethyldisuccinate may contain only those diluents that are suitable and are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods.

(2) Specifications. Astaxanthin dimethyldisuccinate shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practices:

(A) Physical state, solid.

(B) 0.05 percent Solution in chloroform, complete and clear.

(C) Absorption maximum wavelength 484 to 493 nanometers (in chloroform).

(D) Residue on ignition, not more than 0.1 percent.

(E) Total carotenoids other than astaxanthin dimethyldisuccinate, not more than four (4) percent.

(F) Lead, not more than five (5) milligrams per kilogram (5 parts per million).

(G) Arsenic, not more than two (2) milligrams per kilogram (2 parts per million).

(H) Mercury, not more than one (1) milligrams per kilogram (1 part per million).

(I) Heavy metals, not more than 10 milligrams per kilogram (10 parts per million).

(J) Assay including astaxanthin dimethyldisuccinate, astaxanthin monomethylsuccinate, and astaxanthin, minimum 96 percent.

(3) Uses and restrictions. Astaxanthin dimethyldisuccinate may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. The quantity of astaxanthin dimethyldisuccinate in the finished feed, when used alone or in combination with other astaxanthin color additive sources listed in 21 CFR 73, shall not exceed 110 milligrams per kilogram, which is equivalent to 80 milligrams per kilogram astaxanthin (72 grams per ton).

(4) Labeling requirements. The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by 21 CFR 70.25, and adequate directions to prepare a final product complying with the limitations prescribed in this definition. The presence of the color additive in finished fish feed prepared according to this definition shall be declared in accordance with 21 CFR 501.4.

(i) Canthaxanthin (21 CFR 73.75). The color additive canthaxanthin may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive canthaxanthin is B-carotene-4,4'-dione. Color additive mixtures for food use made with canthaxanthin may contain only those diluents that are suitable and that are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods.

(2) Specifications. Canthaxanthin shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practices:

(A) Physical state, solid.

(B) One (1) percent solution in chloroform, complete and clear.

(C) Melting range (decomposition), 207 to 212 degrees Celsius (corrected).

(D) Loss on drying, not more than 0.2 percent.

(E) Residue on ignition, not more than 0.2 percent.

(F) Total carotenoids other than trans-canthaxanthin, not more than five (5) percent.

(G) Lead, not more than 10 parts per million.

(H) Arsenic, not more than three (3) parts per million.

(I) Mercury, not more than one (1) part per million.

(J) Assay, 96 to 101 percent.

(3) Use and restrictions. The color additive canthaxanthin may be safely used for coloring foods generally subject to the following restrictions: the quantity of canthaxanthin does not exceed 30 milligrams per pound of solid or semisolid food or per pint of liquid food; and it may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards. Canthaxanthin may be safely used in broiler chicken feed to enhance the yellow color of broiler chicken skin in accordance with the following conditions: The quantity of canthaxanthin incorporated in the feed shall not exceed 4.41 milligrams per kilogram (4 grams per ton) of complete feed to supplement other known sources of xanthophyll and associated carotenoids to accomplish the intended effect. Canthaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: Canthaxanthin may be added to the fish feed only in the form of a stabilized color additive mixture; the color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish; and the quantity of color additive in feed shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.

(4) Labeling requirements. The labeling of the color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25. For purposes of coloring fish, the labeling of the color additive and any premixes prepared therefrom shall bear expiration dates (established through generally accepted stability testing methods) for the sealed and open container, other information required by 21 CFR 70.25, and adequate directions to prepare a final product complying with the limitations prescribed in this definition. The presence of the color additive in feed prepared according to this definition shall be declared in accordance with 21 CFR 501.4. The presence of the color additive in salmonid fish that have been fed feeds containing canthaxanthin shall be declared in accordance with 21 CFR 101.22(b), (c), and (k)(2), and 101.100(a)(2).

(j) Capsicum; red pepper (21 CFR 582.10). Classification Under Food Additives Amendment: Spices, seasonings, etc. Limitations or Restrictions: In accordance with good manufacturing practices.

(k) Caramel (21 CFR 73.85). The color additive, caramel, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive caramel is the dark-brown liquid or solid material resulting from the carefully controlled heat treatment of the following food-grade carbohydrates: dextrose, invert sugar, lactose, malt syrup, molasses, starch hydrolysates and fractions thereof, and sucrose.

(A) The food-grade acids, alkalis, and salts listed in this subparagraph may be employed to assist caramelization, in amounts consistent with good manufacturing practices.

(i) Acids: acetic acid, citric acid, phosphoric acid, sulfuric acid, and sulfurous acid.

(ii) Alkalis: ammonium hydroxide, calcium hydroxide U.S.P., potassium hydroxide, and sodium hydroxide.

(iii) Salts: ammonium, sodium, or potassium carbonate, bicarbonate, phosphate (including dibasic phosphate and monobasic phosphate), sulfate, and sulfite.

(B) Polyglycerol esters of fatty acids, identified in 21 CFR 172.854, may be used as antifoaming agents in amounts not greater than that required to produce the intended effect.

(C) Color additive mixtures for food use made with caramel may contain only diluents that are suitable and that are listed in 21 CFR 73.1 as safe in color additive mixtures for coloring foods.

(2) Specifications. Caramel shall conform to the following specifications:

(A) Lead (as Pb), not more than 10 parts per million.

(B) Arsenic (as As), not more than three (3) parts per million.

(C) Mercury (as Hg), not more than 0.1 part per million.

(3) Uses and restrictions. Caramel may be safely used for coloring foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25.

(l) Carmine (21 CFR 73.100). The color additive, carmine, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive carmine is the aluminum or calcium-aluminum lake on an aluminum hydroxide substrate of the coloring principles, chiefly carminic acid, obtained by an aqueous extraction of cochineal [Dactylopius coccus costa (Coccus cacti L.)]. Color additive mixtures for food use made with carmine may contain only diluents that are suitable and that are listed in 21 CFR 73.1 as safe in color additive mixtures for coloring foods.

(2) Specifications. Carmine shall conform to the following specifications:

(A) Volatile matter (at 135 degrees Celsius for three (3) hours), not more than 20.0 percent.

(B) Ash, not more than 12.0 percent.

(C) Lead (as Pb), not more than 10 parts per million.

(D) Arsenic (as As), not more than one (1) part per million.

(E) Carminic acid, not less than 50.0 percent.

(F) Carmine shall be pasteurized or otherwise treated to destroy all viable Salmonella microorganisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances (other than chemical preservatives) that are essential to the method of pasteurization or other treatment used. For the purposes of this definition, safe and suitable substances are those substances that perform a useful function in the pasteurization or other treatment to render the carmine free of viable Salmonella microorganisms, which substances are not food additives as defined in FD&C 201(s) or, if they are food additives as so defined, are used in conformity with regulations established pursuant to FD&C 409.

(3) Uses and restrictions. Carmine may be safely used for coloring foods generally in amounts consistent with good manufacturing practices, except that they may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling requirements. The label of the color additives and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of 21 CFR 70.25.

(m) Carrot Oil (21 CFR 73.300). The color additive, carrot oil, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive carrot oil is the liquid or the solid portion of the mixture or the mixture itself obtained by the hexane extraction of edible carrots (Daucus carota L.) with subsequent removal of the hexane by vacuum distillation. The resultant mixture of solid and liquid extractives consists chiefly of oils, fats, waxes, and carrotenoids naturally occurring in carrots. The definition of "carrot oil" in this paragraph is for the purpose of identity as a color additive only and shall not be construed as setting forth an official standard for carrot oil or carrot oleoresin under FD&C 401. Color additive mixtures for food use made with carrot oil may contain only those diluents listed in 21 CFR 73.1 as safe and suitable in color additive mixtures for coloring foods.

(2) Specifications. Carrot oil shall contain no more than 25 parts per million of hexane.

(3) Uses and restrictions. Carrot oil may be safely used for coloring foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless the use of added color is authorized by such standards.

(4) Labeling requirements. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25.

(n) Cashew Nut Shell Extract is the mechanical cold-pressed liquid from cashew nut shells to be used as a flavor additive in cattle feeds in amounts not to exceed 500 parts per million in complete feed. The liquid ingredient must contain not less than 59 percent anacardic acid, not less than 18 percent cardol, and not more than three (3) percent moisture. Minimum percent anacardic acid must be guaranteed.

(o) Cochineal Extract (21 CFR 73.100). The color additive, cochineal extract, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive cochineal extract is the concentrated solution obtained after removing the alcohol from an aqueous-alcoholic extract of cochineal [Dactylopius coccus costa (Coccus cacti L.)]. The coloring principle is chiefly carminic acid. Color additive mixtures for food use made with cochineal extract may contain only diluents that are suitable and that are listed in 21 CFR 73.1 as safe in color additive mixtures for coloring foods.

(2) Specifications. Cochineal extract shall conform to the following specifications:

(A) pH, not less than 5.0 and not more than 5.5 at 25 degrees Celsius.

(B) Protein (N x 6.25), not more than 2.2 percent.

(C) Total solids, not less than 5.7 percent and not more than 6.3 percent.

(D) Methyl alcohol, not more than 150 parts per million.

(E) Lead (as Pb), not more than 10 parts per million.

(F) Arsenic (as As), not more than one (1) part per million.

(G) Carminic acid, not less than 1.8 percent.

(H) Cochineal extract shall be pasteurized or otherwise treated to destroy all viable Salmonella microorganisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances (other than chemical preservatives) that are essential to the method of pasteurization or other treatment used. For the purposes of this definition, safe and suitable substances are those substances that perform a useful function in the pasteurization or other treatment to render the cochineal extract free of viable Salmonella microorganisms, which substances are not food additives as defined in FD&C 201(s) or, if they are food additives as so defined, are used in conformity with regulations established pursuant to FD&C 409.

(3) Uses and restrictions. Cochineal extract may be safely used for coloring foods generally in amounts consistent with good manufacturing practices, except that they may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling requirements. The label of the color additives and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of 21 CFR 70.25.

(p) Corn Endosperm Oil (21 CFR 73.315). The color additive, corn endosperm oil, may be safely used in the manufacture of chicken feed in accordance with the following prescribed conditions:

(1) Identity. The color additive corn endosperm oil is a reddish-brown liquid composed chiefly of glycerides, fatty acids, sitosterols, and carotenoid pigments obtained by isopropyl alcohol and hexane extraction from the gluten fraction of yellow corn grain. The definition of corn endosperm oil in this paragraph is for the purpose of a color additive only and shall not be construed as a food standard of identity under FD&C 401. Color additive mixtures for food use made with corn endosperm oil may contain only those diluents listed in 21 CFR 73.1 as safe and suitable in color additive mixtures for coloring foods.

(2) Specifications. Corn endosperm oil shall conform to the following specifications:

(A) Total fatty acids, not less than 85 percent.

(B) Iodine value, 118 to 134.

(C) Saponification value, 165 to 185.

(D) Unsaponifiable matter, not more than 14 percent.

(E) Hexane, not more than 25 parts per million.

(F) Isopropyl alcohol, not more than 100 parts per million.

(3) Uses and restrictions. The color additive corn endosperm oil may be safely used in chicken feed in accordance with the following prescribed conditions: The color additive is used to enhance the yellow color of chicken skin and eggs. The quantity of the color additive incorporated in the feed is such that the finished feed is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in this definition.

(4) Labeling requirements. The label of the color additive and any premixes prepared therefrom shall bear, in addition to the information required by 21 CFR 70.25, a statement of the concentration of xanthophyll contained therein.

(q) Dehydrated Beets (21 CFR 73.40). The color additive, dehydrated beets, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive dehydrated beets is a dark red powder prepared by dehydrating sound, mature, good quality, edible beets. Color additive mixtures made with dehydrated beets may contain as diluents only those substances listed in 21 CFR 73.1 as safe and suitable for use in color additive mixtures for coloring foods.

(2) Specifications. The color additive shall conform to the following specifications:

(A) Volatile matter, not more than four (4) percent.

(B) Acid insoluble ash, not more than 0.5 percent.

(C) Lead (as Pb), not more than 10 parts per million.

(D) Arsenic (as As), not more than one (1) part per million.

(E) Mercury (as Hg), not more than one (1) part per million.

(3) Uses and restrictions. Dehydrated beets may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401, unless the use of added color is authorized by such standards.

(4) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25.

(r) Dried Algae Meal (21 CFR 73.275). The color additive, dried algae meal, may be safely used in the manufacture of chicken feed in accordance with the following prescribed conditions:

(1) Identity. The color additive dried algae meal is a dried mixture of algae cells (genus Spongiococcum, separated from its culture broth), molasses, cornsteep liquor, and a maximum of 0.3 percent ethoxyquin. The algae cells are produced by suitable fermentation, under controlled conditions, from a pure culture of the genus Spongiococcum.

(2) Uses and restrictions. The color additive dried algae meal may be safely used in chicken feed in accordance with the following prescribed conditions: The color additive is used to enhance the yellow color of chicken skin and eggs. The quantity of the color additive incorporated in the feed is such that the finished feed: is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in this definition; and meets the tolerance limitation for ethoxyquin in animal feed prescribed in 21 CFR 573.380.

(3) Labeling. The label of the color additives and any premixes prepared therefrom shall bear in addition to the information required by 21 CFR 70.25: a statement of the concentrations of xanthophyll and ethoxyquin contained therein; and adequate directions to provide a final product complying with the limitations prescribed in this definition.

(4) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of FD&C 721(c).

(s) FD&C Blue No. 1 (21 CFR 74.101). The color additive, FD&C Blue No. 1, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive FD&C Blue No. 1 is principally the disodium salt of ethyl [4-[p-[ethyl (m-sulfobenzyl) amino]-a-(o-sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (m-sulfobenzyl) ammonium hydroxide inner salt with smaller amounts of the isomeric disodium salts of ethyl [4-[p-[ethyl(p-sulfobenzyl) amino]-a-(o-sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (p-sulfobenzyl) ammonium hydroxide inner salt and ethyl [4-[p-[ethyl (o-sulfobenzyl) amino]-a-(o-sulfophenyl) benzylidene]-2,5-cyclohexadien-1-ylidene] (o-sulfobenzyl) ammonium hydroxide inner salt. Color additive mixtures for food use made with FD&C Blue No. 1 may contain only those diluents that are suitable and that are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods.

(2) Specifications. FD&C Blue No. 1 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practices:

(A) Sum of volatile matter (at 135 degrees Celcius) and chlorides and sulfates (calculated as sodium salts), not more than 15.0 percent.

(B) Water-insoluble matter, not more than 0.2 percent.

(C) Leuco base, not more than five (5) percent.

(D) Sum of o-, m-, and p-sulfobenzaldehydes, not more than 1.5 percent.

(E) N-Ethyl,N-(m-sulfobenzyl)sulfanilic acid, not more than 0.3 percent.

(F) Subsidiary colors, not more than six (6.0) percent.

(G) Chromium (as Cr), not more than 50 parts per million.

(H) Manganese (as Mn), not more than 100 parts per million.

(I) Arsenic (as As), not more than three (3) parts per million.

(J) Lead (as Pb), not more than 10 parts per million.

(K) Total color, not less than 85.0 percent.

(3) Uses and restrictions. FD&C Blue No. 1 may be safely used for coloring foods generally in amounts consistent with good manufacturing practices except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25.

(5) Certification. All batches of FD&C Blue No. 1 shall be certified in accordance with regulations in 21 CFR 80.

(t) FD&C Blue No. 2 (21 CFR 74.102). The color additive, FD&C Blue No. 2, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive FD&C Blue No. 2 is principally the disodium salt of 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 860-22-0) with smaller amounts of the disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 54947-75-0) and the sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid (CAS Reg. No. 605-18-5). Additionally, FD&C Blue No. 2 is obtained by heating indigo (or indigo paste) in the presence of sulfuric acid. The color additive is isolated and subjected to purification procedures. The indigo (or indigo paste) used above is manufactured by the fusion of N-phenylglycine (prepared from aniline and formaldehyde) in a molten mixture of sodamide and sodium and potassium hydroxides under ammonia pressure. The indigo is isolated and subjected to purification procedures prior to sulfonation. Color additive mixtures for food use made with FD&C Blue No. 2 may contain only those diluents that are suitable and that are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods.

(2) Specifications. The color additive FD&C Blue No. 2 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practices:

(A) Sum of volatile matter at 135 degrees Celsius (275 degrees Fahrenheit) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.

(B) Water-insoluble matter, not more than 0.4 percent.

(C) Isatin-5-sulfonic acid, not more than 0.4 percent.

(D) 5-Sulfoanthranilic acid, not more than 0.2 percent.

(E) Disodium salt of 2-(1,3-dihydro-3-oxo-7-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid, not more than 18 percent.

(F) Sodium salt of 2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid, not more than two (2) percent.

(G) Lead (as Pb), not more than 10 parts per million.

(H) Arsenic (as As), not more than three (3) parts per million.

(I) Mercury (as Hg), not more than one (1) part per million.

(J) Total color, not less than 85 percent.

(3) Uses and restrictions. The color additive FD&C Blue No. 2 may be safely used for coloring foods generally in amounts consistent with current good manufacturing practices except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25.

(5) Certification. All batches of FD&C Blue No. 2 shall be certified in accordance with regulations in 21 CFR 80.

(u) FD&C Green No. 3 (21 CFR 74.203). The color additive, FD&C Green No. 3, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive FD&C Green No. 3 is principally the inner salt disodium salt of N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino] phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfobenzenemethanaminium hydroxide (CAS Reg. No. 2353-45-9); with smaller amounts of the isomeric inner salt disodium salt of N-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl] (4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-sulfobenzenemethanaminium hydroxide; of N-ethyl-N-[4-[[4-[ethyl[(4-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl) methylene]-2,5-cyclohexadien-1-ylidene]-4-sulfobenzenemethanaminium hydroxide and of N-ethyl-N-[4-[[4-[ethyl[(2-sulfophenyl)methyl]amino] phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfobenzenemethanaminium hydroxide. Additionally, FD&C Green No. 3 is manufactured by the acid catalyzed condensation of one molecule of 2-formyl-5-hydroxybenzenesulfonic acid with two (2) molecules from a mixture consisting principally of 3-[(ethylphenylamino)methyl] benzensulfonic acid, and smaller amounts of 4-[(ethylphenylamino) methyl] benzenesulfonic acid and 2-[(ethylphenylamino)methyl] benzenesulfonic acid to form the leuco base. The leuco base is then oxidized with lead dioxide and acid or with dichromate and acid to form the dye. The intermediate 2-formyl-5-hydroxybenzenesulfonic acid is prepared by the potassium permanganate oxidation of 2,2'-(1,2-ethenediyl)-bis(5-aminobenzenesulfonic acid) to sodium amino-2-formylbenzenesulfonate. This amine is diazotized, and the resulting diazonium salt is hydrolyzed to the desired 2-formyl-5-hydroxybenzenesulfonic acid. Color additive mixtures for food use made with FD&C Green No. 3 may contain only those diluents that are suitable and that are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring food.

(2) Specifications. The color additive FD&C Green No. 3 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practices:

(A) Sum of volatile matter at 135 degrees Celsius (275 degrees Fahrenheit) and chlorides and sulfates (calculated as sodium salts), not more than 15 percent.

(B) Water-insoluble matter, not more than 0.2 percent.

(C) Leuco base, not more than five (5) percent.

(D) Sum of 2-, 3-, 4-formylbenzenesulfonic acids, sodium salts, not more than 0.5 percent.

(E) Sum of 3- and 4-[[ethyl(4-sulfophenyl)amino]methyl] benzenesulfonic acid, disodium salts, not more than 0.3 percent.

(F) 2-Formyl-5-hydroxybenzenesulfonic acid, sodium salt, not more than 0.5 percent.

(G) Subsidiary colors, not more than six (6) percent.

(H) Chromium (as Cr), not more than 50 parts per million.

(I) Arsenic (as As), not more than three (3) parts per million.

(J) Lead (as Pb), not more than 10 parts per million.

(K) Mercury (as Hg), not more than one (1) part per million.

(L) Total color, not less than 85 percent.

(3) Uses and restrictions. The color additive FD&C Green No. 3 may be safely used for coloring foods generally in amounts consistent with current good manufacturing practices except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25.

(5) Certification. All batches of FD&C Green No. 3 shall be certified in accordance with regulations in 21 CFR 80.

(v) FD&C Red No. 3 (21 CFR 74.303). The color additive, FD&C Red No. 3, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive FD&C Red No. 3 is principally the monohydrate of 9 (o-carboxyphenyl)-6-hydroxy-2,4,5,7-tetraiodo-3H-xanthen-3-one, disodium salt, with smaller amounts of lower imdinated fluoresceins. Color additive mixtures for food use made with FD&C Red No. 3 may contain only those diluents that are suitable and that are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods.

(2) Specifications. FD&C Red No. 3 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practices:

(A) Volatile matter (at 135 degrees Celcius) and chlorides and sulfates (calculated as the sodium salts), total not more than 13 percent.

(B) Water-insoluble matter, not more than 0.2 percent.

(C) Unhalogenated intermediates, total not more than 0.1 percent.

(D) Sodium iodide, not more than 0.4 percent.

(E) Triiodoresorcinol, not more than 0.2 percent.

(F) 2(2',4'-Dihydroxy-3', 5'-diiodobenzoyl) benzoic acid, not more than 0.2 percent.

(G) Monoiodofluoresceins not more than one (1.0) percent.

(H) Other lower iodinated fluoresceins, not more than nine (9.0) percent.

(I) Lead (as Pb), not more than 10 parts per million.

(J) Arsenic (as As), not more than three (3) parts per million.

(K) Total color, not less than 87.0 percent.

(3) Uses and restrictions. FD&C Red No. 3 may be safely used for coloring foods generally in amounts consistent with good manufacturing practices except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling. The label of the color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25.

(5) Certification. All batches of FD&C Red No. 3 shall be certified in accordance with regulations in 21 CFR 80.

(w) FD&C Red No. 40 (21 CFR 74.340). The color additive, FD&C Red No. 40, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive FD&C Red No. 40 is principally the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid. Color additive mixtures for food use (including dietary supplements) made with FD&C Red No. 40 may contain only those diluents that are suitable and that are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods. The listing of this color additive includes lakes prepared as described in 21 CFR 82.51, except that the color additive used is FD&C Red No. 40 and the resultant lakes meet the specification and labeling requirements prescribed by 21 CFR 82.51.

(2) Specifications. FD&C Red No. 40 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practices:

(A) Sum of volatile matter (at 135 degrees Celsius) and chlorides and sulfates (calculated as sodium salts), not more than 14.0 percent.

(B) Water-insoluble matter, not more than 0.2 percent.

(C) Higher sulfonated subsidiary colors (as sodium salts), not more than one (1.0) percent.

(D) Lower sulfonated subsidiary colors (as sodium salts), not more than one (1.0) percent.

(E) Disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl) azo]-8-(2-methoxy-5-methyl-4-sulfophenoxy)-2-naphthalenesulfonic acid, not more than one (1.0) percent.

(F) Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid (Schaeffer's salt), not more than 0.3 percent.

(G) 4-Amino-5-methoxy-o-toluenesulfonic acid, not more than 0.2 percent.

(H) Disodium salt of 6,6'-oxybis (2-naphthalene-sulfonic acid), not more than one (1.0) percent.

(I) Lead (as Pb), not more than 10 parts per million.

(J) Arsenic (as As), not more than three (3) parts per million.

(K) Total color, not less than 85.0 percent.

(3) Uses and restrictions. FD&C Red No. 40 may be safely used for coloring foods generally in amounts consistent with good manufacturing practices except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling. The label of the color additive and any lakes or mixtures prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25.

(5) Certification. All batches of FD&C Red No. 40 and lakes thereof shall be certified in accordance with regulations in 21 CFR 80.

(x) FD&C Yellow No. 6 (21 CFR 74.706). The color additive, FD&C Yellow No. 6, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive FD&C Yellow No. 6 is principally the disodium salt of 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid (CAS Reg. No. 2783-94-0). The trisodium salt of 3-hydroxy-4-[(4-sulfophenyl) azo]-2,7-naphthalenedisulfonic acid (CAS Reg. No. 50880-65-4) may be added in small amounts. The color additive is manufactured by diazotizing 4-aminobenzenesulfonic acid using hydrochloric acid and sodium nitrite or sulfuric acid and sodium nitrite. The diazo compound is coupled with 6-hydroxy-2-naphthalene-sulfonic acid. The dye is isolated as the sodium salt and dried. The trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid which may be blended with the principal color is prepared in the same manner except the diazo benzenesulfonic acid is coupled with 3-hydroxy-2,7-naphthalenedisulfonic acid. Color additive mixtures for food use made with FD&C Yellow No. 6 may contain only those diluents that are suitable and that are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods.

(2) Specifications. The color additive FD&C Yellow No. 6 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by current good manufacturing practices:

(A) Sum of volatile matter (at 135 degrees Celsius) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.

(B) Water-insoluble matter, not more than 0.2 percent.

(C) Sodium salt of 4-aminobenzenesulfonic acid, not more than 0.2 percent.

(D) Sodium salt of 6-hydroxy-2-naphthalenesulfonic acid, not more than 0.3 percent.

(E) Disodium salt of 6,6'-oxybis[2-naphthalenesulfonic acid], not more than one (1) percent.

(F) Disodium salt of 4,4'-(1-triazene-1,3-diyl)bis[benzenesulfonic acid], not more than 0.1 percent.

(G) Sum of the sodium salt of 6-hydroxy-5-(phenylazo)-2-naphthalenesulfonic acid and the sodium salt of 4-[(2-hydroxy-1-naphthalenyl)azo] benzenesulfonic acid, not more than one (1) percent.

(H) Sum of the trisodium salt of 3-hydroxy-4-[(4-sulfophenyl)azo]-2,7-naphthalenedisulfonic acid and other higher sulfonated subsidiaries, not more than five (5) percent.

(I) 4-Aminoazobenzene, not more than 50 parts per billion.

(J) 4-Aminobiphenyl, not more than 15 parts per billion.

(K) Aniline, not more than 250 parts per billion.

(L) Azobenzene, not more than 200 parts per billion.

(M) Benzidine, not more than one (1) part per billion.

(N) 1,3-Diphenyltriazene, not more than 40 parts per billion.

(O) 1-(Phenylazo)-2-naphthalenol, not more than 10 parts per million.

(P) Lead (as Pb), not more than 10 parts per million.

(Q) Arsenic (as As), not more than three (3) parts per million.

(R) Mercury (as Hg), not more than one (1) part per million.

(S) Total color, not less than 87 percent.

(3) Uses and restrictions. The color additive FD&C Yellow No. 6 may be safely used for coloring foods generally in amounts consistent with current good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling requirements. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of 21 CFR 70.25.

(5) Certification. All batches of FD&C Yellow No. 6 shall be certified in accordance with regulations in 21 CFR 80.

(y) FD&C Yellow No. 5 (21 CFR 74.705). The color additive, FD&C Yellow No. 5, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive FD&C Yellow No. 5 is principally the trisodium salt of 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[4-sulfophenyl-azo]-1H-pyrazole-3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the additive, 4-amino-benzenesulfonic acid is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is coupled with 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. Color additive mixtures for food use made with FD&C Yellow No. 5 may contain only those diluents that are suitable and that are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods.

(2) Specifications. FD&C Yellow No. 5 shall conform to the following specifications and shall be free from impurities other than those named to the extent that such other impurities may be avoided by good manufacturing practices:

(A) Sum of volatile matter at 135 degrees Celsius (275 degrees Fahrenheit) and chlorides and sulfates (calculated as sodium salts), not more than 13 percent.

(B) Water-insoluble matter, not more than 0.2 percent.

(C) 4,4'-[4,5-Dihydro-5-oxo-4-[(4-sulfophenyl)hydrazono]-1H-pyrazol-1,3-diyl]bis[benzenesulfonic acid], trisodium salt, not more than one (1) percent.

(D) 4-[(4',5-Disulfo[1,1'-biphenyl]-2-yl)hydrazono]-4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, tetrasodium salt, not more than one (1) percent.

(E) Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl) hydrazono]-1H-pyrazole-3-carboxylate, disodium salt, not more than one (1) percent.

(F) Sum of 4,5-dihydro-5-oxo-1-phenyl-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid, disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, disodium salt, not more than 0.5 percent.

(G) 4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent.

(H) 4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid, disodium salt, not more than 0.2 percent.

(I) Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylate, sodium salt, not more than 0.1 percent.

(J) 4,4'-(1-Triazene-1,3-diyl)bis[benzenesulfonic acid], disodium salt, not more than 0.05 percent.

(K) 4-Aminoazobenzene, not more than 75 parts per billion.

(L) 4-Aminobiphenyl, not more than five (5) parts per billion.

(M) Aniline, not more than 100 parts per billion.

(N) Azobenzene, not more than 40 parts per billion.

(O) Benzidine, not more than one (1) part per billion.

(P) 1,3-Diphenyltriazene, not more than 40 parts per billion.

(Q) Lead (as Pb), not more than 10 parts per million.

(R) Arsenic (as As), not more than three (3) parts per million.

(S) Mercury (as Hg), not more than one (1) part per million.

(T) Total color, not less than 87 percent.

(3) Uses and restrictions. FD&C Yellow No. 5 may be safely used for coloring foods generally in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling requirements. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of 21 CFR 70.25.

(5) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regulations in 21 CFR 80.

(z) Fennel (21 CFR 582.10). Classification Under Food Additives Amendment: Spices, seasonings, essential oils, etc. Limitations or Restrictions: In accordance with good manufacturing practices.

(aa) Fenugreek seed (21 CFR 582.10). Classification Under Food Additives Amendment: Spices, seasonings, essential oils, etc. Limitations or Restrictions: In accordance with good manufacturing practices.

(bb) Flavoring Agents. Flavoring substances and adjuvants may be safely used in animal food in accordance with the following conditions. They are used in the minimum quantity required to produce their intended technical effect and in accordance with all the principles of good manufacturing practices. In the appropriate forms (plant parts, fluid and solid extracts, concentrates, absolutes, oils, gums, balsams, resins, oleoresins, waxes, and distillates) consisting of one or more of the following:

(1) Aloe. Botanical Name of Plant Source: Aloe perryi Baker, Aloe barbadensis Mill., Aloe ferox Mill., and hybrids of this sp. with Aloe Africana Mill. and Aloe spicata Baker.

(2) Althea root and flowers. Botanical Name of Plant Source: Althea officinalis L.

(3) Amyris (West Indian sandalwood). Botanical Name of Plant Source: Amyris balsamifera L.

(4) Artemisia (wormwood). Botanical Name of Plant Source: Artemisia spp. Limitations: Finished food thujone free as determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in section 9.129 of the Official Methods of Analysis of the Association of Official Analytical Chemists, 13th edition (1980), which is incorporated by reference.

(5) Benzoin resin. Botanical Name of Plant Source: Styrax benzoin Dryander, Styrax paralleloneurus Perkins, Styrax tonkinensis (Pierre) Craib ex Hartwich, or other spp. of the Section Anthostyrax of the genus Styrax.

(6) Blackberry bark. Botanical Name of Plant Source: Rubus, Section Eubatus.

(7) Boronia flowers. Botanical Name of Plant Source: Boronia megastigma Nees.

(8) Buchu leaves. Botanical Name of Plant Source: Barosma betulina Bartl. et Wendl., Barosma crenulata (L.) Hook. or Barosma serratifolia Willd.

(9) Cajeput. Botanical Name of Plant Source: Melaleuca leucadendron L. and other Melaleuca spp.

(10) Camphor tree. Botanical Name of Plant Source: Cinnamomum camphora (L.) Nees et Eberm. Limitations: Safrole free.

(11) Cascara sagrada. Botanical Name of Plant Source: Rhamnus purshiana DC.

(12) Cassie flowers. Botanical Name of Plant Source: Acacia farnesiana (L.) Willd.

(13) Castor oil. Botanical Name of Plant Source: Ricinus communis L.

(14) Catechu, black. Botanical Name of Plant Source: Acacia catechu Willd.

(15) Cedar, white (aborvitae), leaves and twigs. Botanical Name of Plant Source: Thuja occidentalis L. Limitations: Finished food thujone free as determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in section 9.129 of the Official Methods of Analysis of the Association of Official Analytical Chemists, 13th edition (1980), which is incorporated by reference.

(16) Cherry pits. Botanical Name of Plant Source: Prunus avium L. or Prunus cerasus L. Limitations: Not to exceed 25 parts per million prussic acid.

(17) Cherry-laurel leaves. Botanical Name of Plant Source: Prunus laurocerasus L. Limitations: Not to exceed 25 parts per million prussic acid.

(18) Chestnut leaves. Botanical Name of Plant Source: Castanea dentate (Marsh.) Borkh.

(19) Copaiba. Botanical Name of Plant Source: South American spp. of Copaifera L.

(20) Costus root. Botanical Name of Plant Source: Saussurea lappa Clarke.

(21) Cubeb. Botanical Name of Plant Source: Piper cubeba L.

(22) Currant, black, buds and leaves. Botanical Name of Plant Source: Ribes nigrum L.

(23) Damiana leaves. Botanical Name of Plant Source: Turnera diffusa Willd.

(24) Davana. Botanical Name of Plant Source: Artemisia pallens Wall.

(25) Dill, Indian. Botanical Name of Plant Source: Anethum sowa Roxb. (Peucedanum graveolens Benth et Hook., Anethum graveolens L.

(26) Dittany of Crete. Botanical Name of Plant Source: Origanum dictamnus L.

(27) Dragon's blood (dracorubin). Botanical Name of Plant Source: Daemonorops spp.

(28) Elemi. Botanical Name of Plant Source: Canarium commune L. or Canarium Luzonicum Miq.

(29) Erigeron. Botanical Name of Plant Source: Erigeron canadensis L.

(30) Eucalyptus globulus leaves. Botanical Name of Plant Source: Eucalyptus globulus Labill.

(31) Fir ("pine") needles and twigs. Botanical Name of Plant Source: Abies sibirica Ledeb., Abies alba Mill., Abies sachalinesis Masters, or Abies mayriana Miyabe et Kudo.

(32) Fir, balsam, needles and twigs. Botanical Name of Plant Source: Abies balsamea (L.) Mill.

(33) Galbanum. Botanical Name of Plant Source: Ferula galbaniflua Boiss. et Buhse and other Ferula spp.

(34) Gambir (catechu, pale). Botanical Name of Plant Source: Uncaria gambir Roxb.

(35) Genet flowers. Botanical Name of Plant Source: Spartium junceum L.

(36) Gentian rhizome and roots. Botanical Name of Plant Source: Gentiana lutea L.

(37) Guaiac. Botanical Name of Plant Source: Guaiacum officinale L., Guaiacum sanctum L., Bulnesia sarmienti Lor.

(38) Guarana. Botanical Name of Plant Source: Paullinia cupana HBK.

(39) Haw, black, bark. Botanical Name of Plant Source: Viburnum prunifolium L.

(40) Hemlock needles and twigs. Botanical Name of Plant Source: Tsuga canadensis (L.) Carr. or Tsuga heterophylla (Raf.) Sarg.

(41) Hyacinth flowers. Botanical Name of Plant Source: Hyacinthus orientalis L.

(42) Imperatoria. Botanical Name of Plant Source: Peucedanum ostruthium (L.) Koch (Imperatoria ostruthium L.).

(43) Labdanum. Botanical Name of Plant Source: Cistus spp.

(44) Linaloe wood. Botanical Name of Plant Source: Bursera delpechiana Poiss. and other Bursera spp.

(45) Lovage. Botanical Name of Plant Source: Levisticum officinale Koch.

(46) Lungmoss (lungwort). Botanical Name of Plant Source: Sticta pulmonacea Ach.

(47) Maple, mountain. Botanical Name of Plant Source: Acer spicatum Lam.

(48) Mimosa (black wattle) flowers. Botanical Name of Plant Source: Acacia decurrens Willd. var. dealbata.

(49) Myrrh. Botanical Name of Plant Source: Commiphora molmol Engl., Commiphora abyssinica (Berg) Engl., or other Commiphora spp.

(50) Oak, white, chips. Botanical Name of Plant Source: Quercus alba L.

(51) Oak moss. Botanical Name of Plant Source: Evernia prunastri (L.) Ach., Evernia furfuracea (L.) Mann, and other lichens. Limitations: Finished food thujone free as determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in section 9.129 of the Official Methods of Analysis of the Association of Official Analytical Chemists, 13th edition (1980), which is incorporated by reference.

(52) Olibanum. Botanical Name of Plant Source: Boswellia carteri Birdw. and other Boswellia spp.

(53) Opopanax (bisabolmyrrh). Botanical Name of Plant Source: Opopanax chironium Koch (true opopanax) of Commiphora erythraea Engl. var. Llabrescens.

(54) Orris root. Botanical Name of Plant Source: Iris germanica L. (including its variety florentina Dykes) and Iris pallida Lam.

(55) Passion flower. Botanical Name of Plant Source: Passiflora incarnate L.

(56) Patchouli. Botanical Name of Plant Source: Pogostemon cablin Benth. And Pogostemon heyneanus Benth.

(57) Pine, dwarf, needles and twigs. Botanical Name of Plant Source: Pinus mugo Turra var. pumilio (Haenke) Zenari.

(58) Pine, Scotch, needles and twigs. Botanical Name of Plant Source: Pinus sylvestris L.

(59) Pine, white oil. Botanical Name of Plant Source: Pinus palustris Mill. and other Pinus spp.

(60) Quassia. Botanical Name of Plant Source: Picrasma excelsa (Sw.) Planch, or Quassia amara L.

(61) Quebracho bark. Botanical Name of Plant Source: Aspidosperma quebracho-blanco Schlecht, Schinopsis lorentzii (Griseb.) Engl., or Quebrachia lorentzii (Griseb.).

(62) Quillaia (soapbark). Botanical Name of Plant Source: Quillaja saponaria Mol.

(63) Rhatany root. Botanical Name of Plant Source: Krameria triandra Ruiz et Pav. Or Krameria argentea Mart.

(64) Rhubarb root. Botanical Name of Plant Source: Rheum officinale Baill., Rheum palmatum L., or other spp. (excepting Rheum rhaponticum L. or hybrids of Rheum grown in China).

(65) Sandalwood, white (yellow, or East Indian). Botanical Name of Plant Source: Santalum album L.

(66) Sarsaparilla. Botanical Name of Plant Source: Smilax aristolochiaefolia Mill., (Mexican sarsaparilla), Smilax regelii Killip et Morton (Honduras sarsaparilla), Smilax febrifuga Kunth (Ecuadorean sarsaparilla), or undetermined Smilax spp. (Ecuadorean or Central American sarsaparilla).

(67) Sassafras leaves. Botanical Name of Plant Source: Sassafras albidum (Nutt.) Nees. Limitations: Safrole free.

(68) Senna, Alexandria. Botanical Name of Plant Source: Cassia acutifolia Delile.

(69) Snakeroot, Canadian (wild ginger). Botanical Name of Plant Source: Asarum canadense L.

(70) Spruce needles and twigs. Botanical Name of Plant Source: Picea glauca (Moench) Voss or Picea mariana (Mill.) BSP.

(71) Storax (styrax). Botanical Name of Plant Source: Liquidambar orientalis Mill. or. Liquidambar styraciflua L.

(72) Tagetes (marigold). Botanical Name of Plant Source: Tagetes patula L., Tagetes erecta L., or Tagetes minuta L. (Tagetes glandulifera Schrank). Limitations: As oil only.

(73) Thymus capitatus (Spanish "origanum"). Botanical Name of Plant Source: Thymus capitatus Hoffmg. et Link.

(74) Tolu. Botanical Name of Plant Source: Myroxylon balsamum (L.) Harms.

(75) Turpentine. Botanical Name of Plant Source: Pinus palustris Mill. and other Pinus spp. that yield terpene oils exclusively.

(76) Valerian rhizome and roots. Botanical Name of Plant Source: Valeriana officinalis L.

(77) Violet, Swiss. Botanical Name of Plant Source: Viola calcarata L.

(78) Walnut husks (hulls), leaves, and green nuts. Botanical Name of Plant Source: Juglans nigra L. or Juglans regia L.

(79) Yerba santa. Botanical Name of Plant Source: Eriodictyon californicum (Hook et Arn.) Torr.

(80) Yucca, Joshua-tree. Botanical Name of Plant Source: Yucca brevifolia Engelm.

(81) Yucca, Mohave. Botanical Name of Plant Source: Yucca schidigera Roezl ex Ortgies (Yucca mohavensis Sarg.).

(cc) Fruit Juice (21 CFR 73.250). The color additive, fruit juice, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive fruit juice is prepared either by expressing the juice from mature varieties of fresh, edible fruits, or by the water infusion of the dried fruit. The color additive may be concentrated or dried. The definition of fruit juice in this paragraph is for the purpose of identity as a color additive only and shall not be construed as a standard of identity under FD&C 401. However, where a standard of identity for a particular fruit juice has been promulgated under FD&C 401, it shall conform to such standard. Color additive mixtures made with fruit juice may contain as diluents only those substances listed in 21 CFR 73.1 as safe and suitable in color additive mixtures for coloring foods.

(2) Uses and restrictions. Fruit juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401, unless the use of added color is authorized by such standards.

(3) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the FD&C, labeling in accordance with the provisions of 21 CFR 70.25.

(dd) Fumaric acid. Classification Under Food Additives Amendment: pH adjuster, preservative, or flavoring agent. Limitations or Restrictions: Not to exceed 0.5 percent of the diet.

(ee) Ginger (21 CFR 582.10). Classification Under Food Additives Amendment: Spices, seasonings, essential oils, etc. Limitations or Restrictions: In accordance with good manufacturing practices.

(ff) Glucose Syrup (21 CFR 168.120) is the purified, concentrated, aqueous solution of nutritive saccharides obtained from edible starch. It shall meet the following specifications: total solids content not less than 70.0 percent mass/mass and reducing sugar content (dextrose equivalent), expressed as D-glucose, not less than 20.0 percent mass/mass calculated on a dry basis. The sulfated ash content is not more than one (1.0) percent mass/mass (calculated on a dry basis), and the sulfur dioxide content is not more than 40 milligrams per kilogram. If the product bears a name descriptive of its kind or origin, e.g., "corn syrup," "grain sorghum syrup," it must correspond thereto.

(gg) Glutamic acid. Classification Under Food Additives Amendment: Flavoring agent. Limitations or Restrictions: Up to 400 parts per million in finished feed.

(hh) Glycyrrhizin ammoniated (21 CFR 582.20). Classification Under Food Additives Amendment: Spices, seasonings, essential oils, etc. Limitations or Restrictions: In accordance with good manufacturing practices.

(ii) Guanidinoacetic acid (21 CFR 573.496). The food additive guanidinoacetic acid may be safely used in poultry feeds in accordance with the following prescribed conditions:

(1) The additive is manufactured by reacting glycine with cyanamide in an aqueous solution.

(2) The additive is used or intended for use at levels not to exceed 0.12 percent of the complete feed: to spare arginine in broiler chicken and turkey feeds, or as a precursor of creatine in poultry feeds.

(3) The additive consists of not less than 97 percent guanidinoacetic acid [N-(aminoiminomethyl)-glycine] (CAS 352-97-6) by weight.

(4) The additive meets the following specifications: Dicyandiamide not to exceed 0.5 percent; Cyanamide not to exceed 0.01 percent; Melamine not to exceed 15 parts per million; sum of ammeline, ammelide, and cyanuric acid not to exceed 35 parts per million; and water not to exceed one (1) percent.

(5) To ensure safe use of the additive in addition to the other information required by the FD&C: The label and labeling of the additive, any feed premix, and complete feed shall contain the name of the additive. The label and labeling of the additive and any feed premix shall also contain: a statement to indicate that the maximum use level of guanidinoacetic acid must not exceed 0.12 percent of the complete feed for poultry; and adequate directions for use.

(jj) Haematococcus Algae Meal (21 CFR 73.185). The color additive, Haematococcus algae meal, may be safely used in the manufacture of salmonid fish feed in accordance with the following prescribed conditions:

(1) Identity. The color additive haematococcus algae meal consists of the comminuted and dried cells of the alga Haematococcus pluvialis. Haematococcus algae meal may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with haematococcus algae meal may contain only those diluents that are suitable and are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods.

(2) Specifications. Haematococcus algae meal shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practices:

(A) Physical state, solid.

(B) Lead (as Pb), not more than five (5) parts per million.

(C) Arsenic (as As), not more than two (2) parts per million.

(D) Mercury (as Hg), not more than one (1) part per million.

(E) Heavy metals, not more than 10 parts per million.

(F) Astaxanthin, not less than 1.5 percent.

(3) Uses and restrictions. Haematococcus algae meal may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. The quantity of astaxanthin in finished feed, from haematococcus algae meal when used alone or in combination with other astaxanthin color additive sources listed in 21 CFR 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.

(4) Labeling requirements. The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by 21 CFR 70.25, and adequate directions to prepare a final product complying with the limitations prescribed in this definition. The presence of the color additive in finished fish feed prepared according to this definition shall be declared in accordance with 21 CFR 501.4. The presence of the color additive in salmonid fish that have been fed feeds containing haematococcus algae meal shall be declared in accordance with 21 CFR 101.22(b), (c), and (k)(2), and 101.100(a)(2).

(kk) Microcrystalline Cellulose is purified, partially depolymerized cellulose prepared by processing alpha cellulose obtained as a pulp from fibrous plant material by treating with mineral acids.

(ll) Monosodium glutamate (21 CFR 582.1). Classification Under Food Additives Amendment: Spices, seasonings, etc. Limitations or Restrictions: In accordance with good manufacturing practices.

(mm) Neohesperidin Dihydrochalcone is the product resulting from hydrogenation of neohesperidin, a flavonoid extracted from bitter orange (Citrus aurantium), under alkaline conditions in the presence of a palladium-on-charcoal catalyst. It is to be used as a flavoring agent in weanling pig diets at levels not to exceed 15 parts per million of complete feed.

(nn) Paprika (21 CFR 73.340). The color additive, paprika, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive paprika is the ground dried pod of mild capsicum (Capsicum annuum L.). The definition of paprika in this paragraph is for the purpose of identity as a color additive only and shall not be construed as setting forth an official standard for paprika under FD&C 401. Color additive mixtures made with paprika may contain as diluents only those substances listed in 21 CFR 73.1 as safe and suitable in color additive mixtures for coloring foods.

(2) Uses and restrictions. Paprika may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401, unless the use of added color is authorized by such standards.

(oo) Paprika Oleoresin (21 CFR 73.345). The color additive, paprika oleoresin, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive paprika oleoresin is the combination of flavor and color principles obtained from paprika (Capsicum annuum L.) by extraction, using any one or a combination of the following solvents: acetone, isopropyl alcohol, ethyl alcohol, methyl alcohol, ethylene dichloride, methylene chloride, hexane, and trichloroethylene. The definition of paprika oleoresin in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for paprika oleoresin under FD&C 401. Color additive mixtures made with paprika oleoresin may contain as diluents only those substances listed in 21 CFR 73.1 as safe and suitable in color additive mixtures for coloring foods.

(2) Specifications. Paprika oleoresin shall contain no more residue of the solvents listed in this definition than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in 21 CFR 170 through 189.

(3) Uses and restrictions. Paprika oleoresin may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401, unless the use of added color is authorized by such standards.

(4) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the FD&C, labeling in accordance with the provisions of 21 CFR 70.25.

(pp) Paracoccus Pigment (21 CFR 73.352). The color additive, paracoccus pigment, may be safely used in the manufacture of salmonid fish feed in accordance with the following prescribed conditions:

(1) Identity. The color additive paracoccus pigment consists of the heat-killed, dried cells of a nonpathogenic and nontoxicogenic strain of the bacterium Paracoccus carotinifaciens and may contain added calcium carbonate to adjust the astaxanthin level. Color additive mixtures for fish feed use made with paracoccus pigment may contain only those diluents that are suitable and are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods.

(2) Specifications. Paracoccus pigment shall conform to the following specifications and shall be free from impurities, other than those named, to the extent that such impurities may be avoided by good manufacturing practices:

(A) Physical state, solid.

(B) Lead (as Pb), not more than five (5) milligrams per kilogram (5 parts per million).

(C) Arsenic (as As), not more than two (2) milligrams per kilogram (2 parts per million).

(D) Mercury (as Hg), not more than one (1) milligrams per kilogram (1 parts per million).

(E) Heavy metals, not more than 10 milligrams per kilogram (10 parts per million).

(F) Astaxanthin, not less than 1.75 percent.

(3) Uses and restrictions. Paracoccus pigment may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. The quantity of astaxanthin in finished feed, from paracoccus pigment when used alone or in combination with other astaxanthin color additive sources listed in 21 CFR 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.

(4) Labeling requirements. The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by 21 CFR 70.25, and adequate directions to prepare a final product complying with the limitations prescribed in this definition. The presence of the color additive in finished fish feed prepared according to this definition shall be declared in accordance with 21 CFR 501.4. The presence of the color additive in salmonid fish that have been fed feeds containing paracoccus pigment shall be declared in accordance with 21 CFR 101.22(b), (c), and (k)(2), and 101.100(a)(2).

(qq) Phaffia Yeast (21 CFR 73.355). The color additive, phaffia yeast, may be safely used in the manufacture of salmonid fish feed in accordance with the following prescribed conditions:

(1) Identity. The color additive phaffia yeast consists of the killed, dried cells of a nonpathogenic and nontoxicogenic strain of the yeast Phaffia rhodozyma. Phaffia yeast may be added to the fish feed only as a component of a stabilized color additive mixture. Color additive mixtures for fish feed use made with phaffia yeast may contain only those diluents that are suitable and are listed in 21 CFR 73.1 as safe for use in color additive mixtures for coloring foods.

(2) Specifications. Phaffia yeast shall conform to the following specifications and shall be free from impurities other than those named to the extent that such impurities may be avoided by good manufacturing practices:

(A) Physical state, solid.

(B) Lead (as Pb), not more than five (5) parts per million.

(C) Arsenic (as As), not more than two (2) parts per million.

(D) Mercury (as Hg), not more than one (1) part per million.

(E) Heavy metals, not more than 10 parts per million.

(F) Astaxanthin, not less than 0.4 percent.

(3) Uses and restrictions. Phaffia yeast may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions: The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish. The quantity of astaxanthin in finished feed, from phaffia yeast when used alone or in combination with other astaxanthin color additive sources listed in 21 CFR 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.

(4) Labeling requirements. The labeling of the color additive and any premixes prepared therefrom shall bear expiration dates for the sealed and open container (established through generally accepted stability testing methods), other information required by 21 CFR 70.25, and adequate directions to prepare a final product complying with the limitations prescribed in this definition. The presence of the color additive in finished fish feed prepared according to this definition shall be declared in accordance with 21 CFR 501.4. The presence of the color additive in salmonid fish that have been fed feeds containing phaffia yeast shall be declared in accordance with 21 CFR 101.22(b), (c), and (k)(2) and 21 CFR 101.100(a)(2).

(rr) Phosphoric acid (21 CFR 582.1073). Classification Under Food Additives Amendment: Misc. and/or general purpose. Limitations or Restrictions: In accordance with good manufacturing practices.

(ss) Polyethylene Roughage Replacement (21 CFR 573.780) consists of basic polymers manufactured by the catalytic polymerization of ethylene, is designed in a pellet form in a configuration presenting maximum angular surface having the following dimensions in centimeters. 0.9 + 0.1 x 0.8 + 0.1 x 1.2 + 0.1. It is used as a replacement for roughage in feedlot rations for finishing slaughter cattle. The labels and labeling shall bear the name of the additive "Polyethylene Roughage Replacement," and adequate directions for use which shall provide for the administration of one-half pound of polyethylene pellets per day for six (6) successive days. All natural roughage should be removed for a minimum of 12 hours prior to administration of polyethylene roughage replacement. Roughage replacement must be adequately mixed in the ration for uniform distribution.

(tt) Powdered Cellulose is purified, mechanically disintegrated cellulose prepared by processing alpha cellulose obtained as a pulp from fibrous plant materials.

(uu) Riboflavin (21 CFR 73.450). The color additive, riboflavin, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive riboflavin is the riboflavin defined in the Food Chemicals Codex, third edition (1981), pp. 262 to 263, which is incorporated by reference. Color additive mixtures made with riboflavin may contain as diluents only those substances listed in 21 CFR 73.1 as safe and suitable for use in color additive mixtures for coloring foods.

(2) Specifications. Riboflavin shall meet the specifications given in the Food Chemicals Codex, third edition (1981), which is incorporated by reference.

(3) Uses and restrictions. Riboflavin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401, unless the use of added color is authorized by such standards.

(4) Labeling. The label of the color additive shall conform to the requirements of 21 CFR 70.25.

(vv) Rice By-Products Fractions is obtained by screening and aspirating Ground Rice Hulls. It is used primarily as a pelleting aid and is composed of such fine particles of Ground Rice Hulls, Spongy Parenchyma, and minute amounts of Rice Flour, Rice Germ, Pericarp, and Rice Starch as will pass an 80 mesh screen and contain not less than five (5) percent crude protein, 1.5 percent crude fat, and not more than 25 percent crude fiber.

(ww) Saccharin sodium (GRAS). Classification Under Food Additives Amendment: Non-nutritive sweeteners. Limitations or Restrictions: In accordance with good manufacturing practices.

(xx) Saffron (21 CFR 73.500). The color additive, saffron, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive saffron is the dried stigma of Crocus sativus L. The definition of saffron in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for saffron under FD&C 401. Color additive mixtures made with saffron may contain as diluents only those substances listed in 21 CFR 73.1 as safe and suitable in color additive mixtures for coloring foods.

(2) Uses and restrictions. Saffron may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401, unless the use of added color is authorized by such standards.

(yy) Sodium bisulfate. Classification Under Food Additives Amendment: General purpose feed additive.

(zz) Tagetes (Aztec Marigold) Extract (21 CFR 73.295). The color additive, tagetes (Aztec marigold) extract, may be safely used in the manufacture of chicken feed in accordance with the following prescribed conditions:

(1) Identity. The color additive tagetes (Aztec marigold) extract is a hexane extract of the flower petals of the Aztec marigold (Tagetes erecta L.). It is mixed with an edible vegetable oil, or with an edible vegetable oil and a hydrogenated edible vegetable oil, and not more than 0.3 percent ethoxyquin. It may also be mixed with soy flour or corn meal as a carrier.

(2) Specifications. Tagetes (Aztec marigold) extract shall be prepared from tagetes (Aztec marigold) petals free from admixture with other plant material from Tagetes erecta L. or from plant material or flowers of any other species of plants and shall conform to the following additional specifications:

(A) Melting point, 53.5-55.0 degrees Celsius.

(B) Iodine value, 132-145.

(C) Saponification value, 175-200.

(D) Acid value, 0.60-1.20.

(E) Titer, 35.5-37.0 degrees Celsius.

(F) Unsaponifiable matter, 23-27 percent.

(G) Hexane residue, not more than 25 parts per million.

(H) All determinations, except the hexane residue, shall be made on the initial extract of the flower petals (after drying in a vacuum oven at 60 degrees Celsius for 24 hours) prior to the addition of the oils and ethoxyquin. The hexane determination shall be made on the color additive after the addition of the vegetable oils, hydrogenated vegetable oils, and ethoxyquin.

(3) Uses and restrictions. The color additive tagetes (Aztec marigold) extract may be safely used in chicken feed in accordance with the following prescribed conditions: The color additive is used to enhance the yellow color of chicken skin and eggs. The quantity of the color additive incorporated in the feed is such that the finished feed is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in this definition; and meets the tolerance limitation for ethoxyquin in animal feed prescribed in 21 CFR 573.380.

(4) Labeling requirements. The label of the color additive and any premixes prepared therefrom shall bear, in addition to the information required in 21 CFR 70.25: A statement of the concentrations of xanthophyll and ethoxyquin contained therein. Adequate directions to provide a final product complying with the limitations prescribed in this definition.

(aaa) Tagetes (Aztec Marigold) Meal (21 CFR 73.295). The color additive, tagetes (Aztec marigold) meal, may be safely used in the manufacture of chicken feed in accordance with the following prescribed conditions:

(1) Identity. The color additive tagetes (Aztec marigold) meal is the dried, ground flower petals of the Aztec marigold (Tagetes erecta L.) mixed with not more than 0.3 percent ethoxyquin.

(2) Specifications. Tagetes (Aztec marigold) meal is free from admixture with other plant material from Tagetes erecta L. or from plant material or flowers of any other species of plants.

(3) Uses and restrictions. The color additive tagetes (Aztec marigold) meal may be safely used in chicken feed in accordance with the following prescribed conditions: The color additive is used to enhance the yellow color of chicken skin and eggs. The quantity of the color additive incorporated in the feed is such that the finished feed is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in this definition; and meets the tolerance limitation for ethoxyquin in animal feed prescribed in 21 CFR 573.380.

(bbb) Titanium Dioxide (21 CFR 73.575). The color additive, titanium dioxide, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity.

(A) The color additive titanium dioxide is synthetically prepared TiO₂, free from admixture with other substances. Color additive mixtures for food use made with titanium dioxide may contain only those diluents that are suitable and that are listed in 21 CFR 73.1 as safe in color additive mixtures for coloring foods, and the following: silicon dioxide, SiO₂, and/or aluminum oxide, Al₂O₃, as dispersing aids -- not more than two (2) percent total.

(2) Specifications. Titanium dioxide shall conform to the following specifications:

(A) Lead (as Pb), not more than 10 parts per million.

(B) Arsenic (as As), not more than one (1) part per million.

(C) Antimony (as Sb), not more than two (2) parts per million.

(D) Mercury (as Hg), not more than one (1) part per million.

(E) Loss on ignition at 800 degrees Celsius (after drying for three (3) hours at 105 degrees Celsius), not more than 0.5 percent.

(F) Water-soluble substances, not more than 0.3 percent.

(G) Acid-soluble substances, not more than 0.5 percent.

(H) TiO₂, not less than 99.0 percent after drying for three (3) hours at 105 degrees Celsius.

(I) Lead, arsenic, and antimony shall be determined in the solution obtained by boiling 10 grams of the titanium dioxide for 15 minutes in 50 milliliters of 0.5N hydrochloric acid.

(3) Uses and restrictions. The color additive titanium dioxide may be safely used for coloring foods generally, subject to the following restrictions: The quantity of titanium dioxide does not exceed one (1) percent by weight of the food. It may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of 21 CFR 70.25.

(ccc) Toasted Partially Defatted Cooked Cottonseed Flour (21 CFR 73.140). The color additive, toasted partially defatted cooked cottonseed flour, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive toasted partially defatted cooked cottonseed flour is a product prepared as follows: Food quality cottonseed is delinted and decorticated; the meats are screened, aspirated, and rolled; moisture is adjusted, the meats heated, and the oil expressed; the cooked meats are cooled, ground, and reheated to obtain a product varying in shade from light to dark brown. Color additive mixtures for food use made with toasted partially defatted cooked cottonseed flour may contain only diluents that are suitable and that are listed in 21 CFR 73.1 as safe in color additive mixtures for coloring foods.

(2) Specifications. Toasted partially defatted cooked cottonseed flour shall conform to the following specifications:

(A) Arsenic (as As): It contains no added arsenic compound and therefore may not exceed a maximum natural background level of 0.2 part per million total arsenic, calculated as As.

(B) Lead (as Pb), not more than 10 parts per million.

(C) Free gossypol content, not more than 450 parts per million.

(3) Uses and restrictions. The color additive toasted partially defatted cooked cottonseed flour may be safely used for coloring foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401, unless added color is authorized by such standards.

(4) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25.

(ddd) Tomato Lycopene Concentrate (21 CFR 73.585). The color additive, tomato lycopene concentrate, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive tomato lycopene concentrate is a powder prepared from tomato lycopene extract by removing most of the tomato lipids with ethyl acetate and then evaporating off the solvent. Color additive mixtures made with tomato lycopene concentrate may contain only those diluents listed in 21 CFR 73.1 as safe and suitable for use in color additive mixtures for coloring food.

(2) Specifications. Tomato lycopene concentrate shall conform to the following specifications: Lycopene, not less than 60 percent of oleoresin.

(3) Uses and restrictions. Tomato lycopene concentrate may be safely used for coloring foods generally in amounts consistent with good manufacturing practices, except that they may not be used to color foods for which standards of identity have been issued under FD&C 401, unless the use of added color is authorized by such standards.

(4) Labeling. The label of the color additive shall conform to the requirements of 21 CFR 70.25.

(eee) Tomato Lycopene Extract (21 CFR 73.585). The color additive, tomato lycopene extract, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive tomato lycopene extract is a red to dark brown viscous oleoresin extracted with ethyl acetate from tomato pulp followed by removal of the solvent by evaporation. The pulp is produced from fresh, edible varieties of the tomato by removing the liquid. The main coloring component is lycopene. Color additive mixtures made with tomato lycopene extract may contain only those diluents listed in 21 CFR 73.1 as safe and suitable for use in color additive mixtures for coloring food.

(2) Specifications. Tomato lycopene extract shall conform to the following specification: Lycopene, not less than 5.5 percent of oleoresin.

(3) Uses and restrictions. Tomato lycopene extract may be safely used for coloring foods generally in amounts consistent with good manufacturing practices, except that they may not be used to color foods for which standards of identity have been issued under FD&C 401, unless the use of added color is authorized by such standards.

(4) Labeling. The label of the color additive shall conform to the requirements of 21 CFR 70.25.

(fff) Turmeric Oleoresin (21 CFR 73.615). The color additive, turmeric oleoresin, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive turmeric oleoresin is the combination of flavor and color principles obtained from turmeric (Curcuma longa L.) by extraction using any one or a combination of the following solvents: acetone, isopropyl alcohol, ethyl alcohol methyl alcohol, ethylene dichloride, methylene chloride, hexane, and trichloroethylene. The definition of turmeric oleoresin in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for turmeric oleoresin under FD&C 401. Color additive mixtures made with turmeric oleoresin may contain as diluents only those substances listed in 21 CFR 73.1 as safe and suitable in color additive mixtures for coloring foods.

(2) Specifications. Turmeric oleoresin shall contain no more residue of the solvents listed under this definition than is permitted for the corresponding solvents in spice oleoresins under applicable food additive regulation in 21 CFR 170 through 189.

(3) Uses and restrictions. Turmeric oleoresin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401, unless the use of added color is authorized by such standards.

(ggg) Turmeric (21 CFR 73.600). The color additive, turmeric, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive turmeric is the ground rhizome of Curcuma longa L. The definition of turmeric in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for turmeric under FD&C 401. Color additive mixtures made with turmeric may contain as diluents only those substances listed in 21 CFR 73.1 as safe and suitable in color additive mixtures for coloring foods.

(2) Uses and restrictions. Turmeric may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401, unless the use of added color is authorized by such standards.

(hhh) Ultramarine Blue (21 CFR 73.50). The color additive, ultramarine blue, may be safely used to color salt intended for animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive ultramarine blue is a blue pigment obtained by calcining a mixture of kaolin, sulfur, sodium carbonate, and carbon at temperatures above 700 degrees Celsius. Sodium sulfate and silica may also be incorporated in the mixture in order to vary the shade. The pigment is a complex sodium aluminum sulfo-silicate having the approximate formula Na₇Ai₆Si₆O₂₄S₃.

(2) Specifications. Ultramarine blue shall conform to the following specifications:

(A) Lead (as Pb), not more than 10 parts per million.

(B) Arsenic (as As), not more than one (1) part per million.

(C) Mercury (as Hg), not more than one (1) part per million.

(3) Uses and restrictions. The color additive ultramarine blue may be safely used for coloring salt intended for animal feed subject to the restriction that the quantity of ultramarine blue does not exceed 0.5 percent by weight of the salt.

(4) Labeling requirements. The color additive shall be labeled in accordance with the requirements of 21 CFR 70.25.

(iii) Vegetable Juice (21 CFR 73.260). The color additive, vegetable juice, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive vegetable juice is prepared either by expressing the juice from mature varieties of fresh, edible vegetables, or by the water infusion of the dried vegetable. The color additive may be concentrated or dried. The definition of vegetable juice in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as a standard of identity under FD&C 401. However, where a standard of identity for a particular vegetable juice has been promulgated under FD&C 401, it shall conform to such standard. Color additive mixtures made with vegetable juice may contain as diluents only those substances listed in 21 CFR 73.1 as safe and suitable in color additive mixtures for coloring foods.

(2) Uses and restrictions. Vegetable juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color foods for which standards of identity have been promulgated under FD&C 401, unless the use of added color is authorized by such standards.

(jjj) Yucca schidigera Extract (21 CFR 172.510) may be used as a flavoring agent in all animal foods. It is also an aid in the control of manure odor (post-excretion) when added to finished feeds of poultry and livestock. The inclusion rate shall be the minimum quantity necessary to produce the intended effect, but not exceeding 125 parts per million in the finished feed.

(kkk) [BETA]-Apo-8'-Carotenal (21 CFR 73.90). The color additive, B-apo-8'-carotenal, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive is B-apo-8'-carotenal. Color additive mixtures for food use made with B-apo-8'-carotenal may contain only diluents that are suitable and that are listed in 21 CFR 73.1 as safe in color additive mixtures for coloring foods.

(2) Specifications. B-Apo-8'-carotenal shall conform to the following specifications:

(A) Physical state, solid.

(B) one (1) percent solution in chloroform, clear.

(C) Melting point (decomposition), 136-140 degrees Celsius (corrected).

(D) Loss of weight on drying, not more than 0.2 percent.

(E) Residue on ignition, not more than 0.2 percent.

(F) Lead (as Pb), not more than 10 parts per million.

(G) Arsenic (as As), not more than one (1) part per million.

(H) Assay (spectrophotometric), 96-101 percent.

(3) Uses and restrictions. The color additive B-apo-8'-carotenal may be safely used for coloring foods generally, subject to the following restrictions: The quantity of B-apo-8'-carotenal does not exceed 15 milligrams per pound of solid or semisolid food or 15 milligrams per pint of liquid food. It may not be used to color foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25.

(lll) [BETA]-Carotene (21 CFR 73.95). The color additive, B-carotene, may be safely used in the manufacture of animal foods in accordance with the following prescribed conditions:

(1) Identity. The color additive is B-carotene prepared synthetically or obtained from natural sources. Color additive mixtures for food use made with B-carotene may contain only diluents that are suitable and that are listed in 21 CFR 73.1 as safe in color additive mixtures for coloring foods.

(2) Specifications. B-Carotene shall conform to the following specifications:

(A) Physical state, solid.

(B) One (1) percent solution in chloroform, clear.

(C) Loss of weight on drying, not more than 0.2 percent.

(D) Residue on ignition, not more than 0.2 percent.

(E) Lead (as Pb), not more than 10 parts per million.

(F) Arsenic (as As), not more than three (3) parts per million.

(G) Assay (spectrophotometric), 96-101 percent.

(3) Uses and restrictions. The color additive B-carotene may be safely used for coloring foods generally, in amounts consistent with good manufacturing practices, except that it may not be used to color those foods for which standards of identity have been promulgated under FD&C 401 unless added color is authorized by such standards.

(4) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of 21 CFR 70.25.

Cal. Code Regs. Tit. 3, § 2804

Note: Authority cited: Sections 407 and 14902, Food and Agricultural Code. Reference: Sections 14992 and 15011, Food and Agricultural Code.

1. New section filed 3-29-2022; operative 3/29/2022 pursuant to Government Code section 11343.4(b)(3) (Register 2022, No. 13). Filing deadline specified in Government Code section 11349.3(a)extended 60 calendar days pursuant to Executive Order N-40-20 and an additional 60 calendar days pursuant to Executive Order N-71-20.
2. Repealer and new section heading and section filed 11-12-2024 as an emergency; operative 11/12/2024 (Register 2024, No. 46). A Certificate of Compliance must be transmitted to OAL by 5-12-2025 or emergency language will be repealed by operation of law on the following day.