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[42 FR 15643, Mar. 22, 1977, as amended at 57 FR 32175, July 21, 1992; 69 FR 24511, May 4, 2004] § 73.30 Annatto extract.
(a) Identity. (1) 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 paragraph (a)(1) (i) and (ii) of this section:
(i) 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 paragraph (a)(1)(ii) of this section. Food-grade alkalis or carbonates may be added to adjust alkalinity.
(ii) Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, trichloroethylene.
(2) Color additive mixtures for food use made with annatto extract may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
(b) Specifications. Annatto extract, including pigments precipitated therefrom, shall conform to the following specifications:
(1) Arsenic (as As), not more than 3 parts per million; lead as Pb, not more than 10 parts per million.
(2) When solvents listed under paragraph (a)(1)(ii) of this section 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 parts 170 through 189 of this chapter.
(c) Uses and restrictions. Annatto extract may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
(d) 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 §70.25 of this chapter. Labels shall bear information showing that the color is derived from annatto seed. The requirements of §70.25(a) of this chapter that all ingredients shall be listed by name shall not be construed as requiring the declaration of residues of solvents listed in paragraph (a)(1)(ii) of this section.
(e) 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 section 721(c) of the act. § 73.35 Astaxanthin.
(a) Identity. (1) The color additive astaxanthin is 3, 3′-dihydroxy-β, β-carotene-4, 4′-dione.
(2) 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 this subpart as safe for use in color additive mixtures for coloring foods.
(b) 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 practice:
Physical state, solid.
0.05 percent solution in chloroform, complete and clear.
Absorption maximum wavelength 484–493 nanometers (in chloroform).
Residue on ignition, not more than 0.1 percent.
Total carotenoids other than astaxanthin, not more than 4 percent.
Lead, not more than 5 parts per million.
Arsenic, not more than 2 parts per million.
Mercury, not more than 1 part per million.
Heavy metals, not more than 10 parts per million.
Assay, minimum 96 percent.
(c) Uses and restrictions. Astaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:
(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.
(2) 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.
(d) Labeling requirements. (1) 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 §70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section.
(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with §501.4 of this chapter.
(3) The presence of the color additive in salmonid fish that have been fed feeds containing astaxanthin shall be declared in accordance with §§101.22(k)(2) and 101.100(a)(2) of this chapter.
(e) 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 section 721(c) of the act.
[60 FR 18738, Apr. 13, 1995] § 73.40 Dehydrated beets (beet powder).
(a) Identity. (1) The color additive dehydrated beets is a dark red powder prepared by dehydrating sound, mature, good quality, edible beets.
(2) Color additive mixtures made with dehydrated beets may contain as diluents only those substances listed in this subpart as safe and suitable for use in color additive mixtures for coloring foods.
(b) Specifications. The color additive shall conform to the following specifications:
Volatile matter, not more than 4 percent.
Acid insoluble ash, not more than 0.5 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Mercury (as Hg), not more than 1 part per million.
(c) Uses and restrictions. Dehydrated beets may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.
(d) 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 §70.25 of this chapter.
(e) 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 section 721(c) of the act. § 73.50 Ultramarine blue.
(a) 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 °C. 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 Na7Ai6Si6O24 S3.
(b) Specifications. Ultramarine blue shall conform to the following specifications:
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Mercury (as Hg), not more than 1 part per million.
(c) 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.
(d) Labeling requirements. The color additive shall be labeled in accordance with the requirements of §70.25 of this chapter.
(e) 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 section 721(c) of the act. § 73.75 Canthaxanthin.
(a) Identity. (1) The color additive canthaxanthin is β-carotene-4,4′-dione.
(2) Color additive mixtures for food use made with canthaxanthin may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods.
(b) 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 practice:
Physical state, solid.
1 percent solution in chloroform, complete and clear.
Melting range (decomposition), 207 °C. to 212 °C. (corrected).
Loss on drying, not more than 0.2 percent.
Residue on ignition, not more than 0.2 percent.
Total carotenoids other than trans-canthaxanthin, not more than 5 percent.
Lead, not more than 10 parts per million.
Arsenic, not more than 3 parts per million.
Mercury, not more than 1 part per million.
Assay, 96 to 101 percent.
(c) Use and restrictions. (1) The color additive canthaxanthin may be safely used for coloring foods generally subject to the following restrictions:
(i) The quantity of canthaxanthin does not exceed 30 milligrams per pound of solid or semisolid food or per pint of liquid food; and
(ii) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
(2) 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 kilogam (4 grams per ton) of complete feed to supplement other known sources of xanthophyll and associated carotenoids to accomplish the intended effect.
(3) Canthaxanthin may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:
(i) Canthaxanthin may be added to the fish feed only in the form of a stabilized color additive mixture;
(ii) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish; and
(iii) The quantity of color additive in feed shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.
(d) Labeling requirements. (1) 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 §70.25 of this chapter.
(2) 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 §70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c)(3) of this section.
(3) The presence of the color additive in finished fish feed prepared according to paragraph (c)(3) of this section shall be declared in accordance with §501.4 of this chapter.
(4) The presence of the color additive in salmonid fish that have been fed feeds containing canthaxanthin shall be declared in accordance with §§101.22(b), (c), and (k)(2), and 101.100(a)(2) of this chapter.
(e) 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 section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 50 FR 47534, Nov. 19, 1985; 63 FR 14817, Mar. 27, 1998] § 73.85 Caramel.
(a) Identity. (1) 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 sirup.
Molasses.
Starch hydrolysates and fractions thereof.
Sucrose.
(2) The food-grade acids, alkalis, and salts listed in this subparagraph may be employed to assist caramelization, in amounts consistent with good manufacturing practice.
(i) Acids:
Acetic acid.
Citric acid.
Phosphoric acid.
Sulfuric acid.
Sulfurous acid.
(ii) Alkalis:
Ammonium hydroxide.
Calcium hydroxide U.S.P.
Potassium hydroxide.
Sodium hydroxide.
(iii) Salts: Ammonium, sodium, or potassium carbonate, bicarbonate, phosphate (including dibasic phosphate and monobasic phosphate), sulfate, and sulfite.
(3) Polyglycerol esters of fatty acids, identified in §172.854 of this chapter, may be used as antifoaming agents in amounts not greater than that required to produce the intended effect.
(4) Color additive mixtures for food use made with caramel may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
(b) Specifications. Caramel shall conform to the following specifications:
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 0.1 part per million.
(c) Uses and restrictions. Caramel may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
(d) 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 §70.25 of this chapter.
(e) 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 section 721(c) of the act. § 73.90 β-Apo-8′-carotenal.
(a) Identity. (1) The color additive is β-apo-8′-carotenal.
(2) Color additive mixtures for food use made with β-apo-8′-carotenal may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
(b) Specifications. β-Apo-8′-carotenal shall conform to the following specifications:
Physical state, solid.
1 percent solution in chloroform, clear.
Melting point (decomposition), 136 °C.–140 °C. (corrected).
Loss of weight on drying, not more than 0.2 percent.
Residue on ignition, not more than 0.2 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Assay (spectrophotometric), 96–101 percent.
(c) Uses and restrictions. The color additive β-apo-8′-carotenal may be safely used for coloring foods generally, subject to the following restrictions:
(1) The quantity of β-apo-8′-carotenal does not exceed 15 milligrams per pound of solid or semisolid food or 15 milligrams per pint of liquid food.
(2) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
(d) 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 §70.25 of this chapter.
(e) 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 section 721(c) of the act. § 73.95 β-Carotene.
(a) Identity. (1) The color additive is β-carotene prepared synthetically or obtained from natural sources.
(2) Color additive mixtures for food use made with β-carotene may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
(b) Specifications. β-carotene shall conform to the following specifications:
Physical state, solid.
1 percent solution in chloroform, clear.
Loss of weight on drying, not more than 0.2 percent.
Residue on ignition, not more than 0.2 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Assay (spectrophotometric), 96–101 percent.
(c) Uses and restrictions. The color additive β-carotene may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color those foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
(d) 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 §70.25 of this chapter.
(e) 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 section 721(c) of the act. § 73.100 Cochineal extract; carmine.
(a) Identity. (1) 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.
(2) 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.)).
(3) Color additive mixtures for food use made with cochineal extract or carmine may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.
(b) Specifications. (1) Cochineal extract shall conform to the following specifications:
pH, not less than 5.0 and not more than 5.5 at 25 °C.
Protein (N × 6.25), not more than 2.2 percent.
Total solids, not less than 5.7 and not more than 6.3 percent.
Methyl alcohol, not more than 150 parts per million.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Carminic acid, not less than 1.8 percent.
(2) Carmine shall conform to the following specifications:
Volatile matter (at 135 °C. for 3 hours), not more than 20.0 percent.
Ash, not more than 12.0 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
Carminic acid, not less than 50.0 percent.
Carmine and 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 paragraph, safe and suitable substances are those substances that perform a useful function in the pasteurization or other treatment to render the carmine and cochineal extract free of viable Salmonella microorganisms, which substances are not food additives as defined in section 201(s) of the act or, if they are food additives as so defined, are used in conformity with regulations established pursuant to section 409 of the act.
(c) Uses and restrictions. Carmine and cochineal extract may be safely used for coloring foods generally in amounts consistent with good manufacturing practice, except that they may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.
(d) 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 §70.25 of this chapter.
(e) Exemption from certification. Certification of these color additives is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 721(c) of the act. § 73.125 Sodium copper chlorophyllin.
(a) Identity. (1) The color additive sodium copper chlorophyllin is a green to black powder prepared from chlorophyll by saponification and replacement of magnesium by copper. Chlorophyll is extracted from alfalfa (Medicago sativa) using any one or a combination of the solvents acetone, ethanol, and hexane.
(2) Color additive mixtures made with sodium copper chlorophyllin may contain only those diluents that are suitable and are listed in this subpart as safe for use in color additive mixtures for coloring foods.
(b) Specifications. Sodium copper chlorophyllin 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 practice:
(1) Moisture, not more than 5.0 percent.
(2) Solvent residues (acetone, ethanol, and hexane), not more than 50 parts per million, singly or, in combination.
(3) Total copper, not less than 4 percent and not more than 6 percent.
(4) Free copper, not more than 200 parts per million.
(5) Lead (as Pb), not more than 10 parts per million.
(6) Arsenic (as As), not more than 3 parts per million.
(7) Mercury (as Hg), not more than 0.5 part per million.
(8) Ratio of absorbance at 405 nanometers (nm) to absorbance at 630 nm, not less than 3.4 and not more than 3.9.
(9) Total copper chlorophyllins, not less than 95 percent of the sample dried at 100 °C for 1 hour.
(c) Uses and restrictions. Sodium copper chlorophyllin may be safely used to color citrus-based dry beverage mixes in an amount not exceeding 0.2 percent in the dry mix.
(d) Labeling requirements. The label of the color additive and any mixtures prepared therefrom shall conform to the requirements of §70.25 of this chapter.
(e) 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 section 721(c) of the act.
[67 FR 35431, May 20, 2002] § 73.140 Toasted partially defatted cooked cottonseed flour.
(a) Identity. (1) 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.
(2) 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 this subpart as safe in color additive mixtures for coloring foods.
(b) Specifications. Toasted partially defatted cooked cottonseed flour shall conform to the following specifications:
Arsenic: 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.
Lead (as Pb), not more than 10 parts per million.
Free gossypol content, not more than 450 parts per million.
(c) 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 practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless added color is authorized by such standards.
(d) 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 §70.25 of this chapter.
(e) 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 section 721(c) of the act. § 73.160 Ferrous gluconate.
(a) Identity. The color additive ferrous gluconate is the ferrous gluconate defined in the Food Chemicals Codex, 3d Ed. (1981), pp. 122–123, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php.
(b) Specifications. Ferrous gluconate shall meet the specifications given in the Food Chemicals Codex, 3d Ed. (1981), which is incorporated by reference. The availability of this incorporation by reference is given in paragraph (a) of this section.
(c) Uses and restrictions. Ferrous gluconate may be safely used in amounts consistent with good manufacturing practice for the coloring of ripe olives.
(d) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(e) 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 section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 49 FR 10089, Mar. 19, 1984] § 73.165 Ferrous lactate.
(a) Identity. The color additive ferrous lactate is the ferrous lactate defined in §184.1311 of this chapter.
(b) Specifications. Ferrous lactate shall meet the specifications given in the Food Chemicals Codex, 4th ed. (1996), pp. 154 to 155, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the Center for Food Safety and Applied Nutrition's Library, 5100 Paint Branch Pkwy., College Park, MD, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php.
(c) Uses and restrictions. Ferrous lactate may be safely used in amounts consistent with good manufacturing practice for the coloring of ripe olives.
(d) Labeling. The label of the color additive shall conform to the requirements of §70.25 of this chapter.
(e) 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 section 721(c) of the Federal Food, Drug, and Cosmetic Act (the act).
[61 FR 40319, Aug. 2, 1996, as amended at 66 FR 66742, Dec. 27, 2001] § 73.169 Grape color extract.
(a) Identity. (1) The color additive grape color extract is an aqueous solution of anthocyanin grape pigments made from Concord grapes or a dehydrated water soluble powder prepared from the aqueous solution. The aqueous solution is prepared by extracting the pigments from precipitated lees produced during the storage of Concord grape juice. It contains the common components of grape juice, namely anthocyanins, tartrates, malates, sugars, and minerals, etc., but not in the same proportion as found in grape juice. The dehydrated water soluble powder is prepared by spray drying the aqueous solution containing added malto-dextrin.
(2) Color additive mixtures for food use made with grape color extract may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b) Specifications. Grape color extract shall conform to the following specifications: Pesticide residues, not more than permitted in or on grapes by regulations promulgated under section 408 of the Federal Food, Drug, and Cosmetic Act. Lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 1 part per million.
(c) Uses and restrictions. Grape color extract may be safely used for the coloring of nonbeverage food, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.
(d) Labeling. The color additive and any mixtures prepared therefrom intended solely or in part for coloring purposes shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of §70.25 of this chapter.
(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches are exempt from the certification requirements of section 721(c) of the Act.
[46 FR 47532, Sept. 29, 1981] § 73.170 Grape skin extract (enocianina).
(a) Identity. (1) The color additive grape skin extract (enocianina) is a purplish-red liquid prepared by the aqueous extraction (steeping) of the fresh deseeded marc remaining after grapes have been pressed to produce grape juice or wine. It contains the common components of grape juice; namely, anthocyanins, tartaric acid, tannins, sugars, minerals, etc., but not in the same proportions as found in grape juice. During the steeping process, sulphur dioxide is added and most of the extracted sugars are fermented to alcohol. The extract is concentrated by vacuum evaporation, during which practically all of the alcohol is removed. A small amount of sulphur dioxide may be present.
(2) Color additive mixtures for food use made with grape skin extract (enocianina) may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b) Specifications. Grape skin extract (enocianina) shall conform to the following specifications:
Pesticide residues, not more than permitted in or on grapes by regulations promulgated under section 408 of the Federal Food, Drug, and Cosmetic Act.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 1 part per million.
(c) Uses and restrictions. Grape skin extract (enocianina) may be safely used for the coloring of still and carbonated drinks and ades, beverage bases, and alcoholic beverages subject to the following restrictions:
(1) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless artificial color is authorized by such standards.
(2) Its use in alcoholic beverages shall be in accordance with the provisions of parts 4 and 5, title 27 CFR.
(d) 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 §70.25 of this chapter. The common or usual name of the color additive is “grape skin extract” followed, if desired, by “(enocianina)”.
(e) 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 section 721(c) of the act. § 73.185 Haematococcus algae meal.
(a) Identity. (1) The color additive haematococcus algae meal consists of the comminuted and dried cells of the alga Haematococcus pluvialis.
(2) 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 this subpart as safe for use in color additive mixtures for coloring foods.
(b) 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 practice:
Physical state, solid.
Lead, not more than 5 parts per million.
Arsenic, not more than 2 parts per million.
Mercury, not more than 1 part per million.
Heavy metals (as Pb), not more than 10 parts per million.
Astaxanthin, not less than 1.5 percent.
(c) Uses and restrictions. Haematococcus algae meal may be safely used in the feed of salmonid fish in accordance with the following prescribed conditions:
(1) The color additive is used to enhance the pink to orange-red color of the flesh of salmonid fish.
(2) 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 this part 73, shall not exceed 80 milligrams per kilogram (72 grams per ton) of finished feed.
(d) Labeling requirements. (1) 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 §70.25 of this chapter, and adequate directions to prepare a final product complying with the limitations prescribed in paragraph (c) of this section.
(2) The presence of the color additive in finished fish feed prepared according to paragraph (c) of this section shall be declared in accordance with §501.4 of this chapter.
(3) The presence of the color additive in salmonid fish that have been fed feeds containing haematococcus algae meal shall be declared in accordance with §§101.22(b), (c), and (k)(2), and 101.100(a)(2) of this chapter.
(e) 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 section 721(c) of the act.
[65 FR 41584, July 6, 2000] § 73.200 Synthetic iron oxide.
(a) Identity. (1) The color additive synthetic iron oxide consists of any one or any combination of synthetically prepared iron oxides, including the hydrated forms. It is free from admixture with other substances.
(2) Color additive mixtures for food use made with synthetic iron oxide may contain only those diluents that are suitable and that are listed in this subpart as safe for use in color additive mixtures for coloring foods.
(b) Specifications. (1) Synthetic iron oxide for human food use shall conform to the following specifications:
Arsenic (as As), not more than 3 parts per million.
Lead (as Pb), not more than 10 parts per million.
Mercury (as Hg) , not more than 1 part per million.
(2) Synthetic iron oxide for dog and cat food use shall conform to the following specifications:
Arsenic (as As), not more than 5 parts per million.
Lead (as Pb), not more than 20 parts per million.
Mercury (as Hg), not more than 3 parts per million.
(c) Uses and restrictions. (1) Synthetic iron oxide may be safely used for the coloring of sausage casings intended for human consumption in an amount not exceeding 0.10 percent by weight of the finished food.
(2) Synthetic iron oxide may be safely used for the coloring of dog and cat foods in an amount not exceeding 0.25 percent by weight of the finished food.
(d) Labeling requirements. The label of the color additive and any mixture prepared therefrom intended solely or in part for coloring purposes shall conform to the requirements of §70.25 of this chapter.
(e) 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 section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 59 FR 10578, Mar. 7, 1994] § 73.250 Fruit juice.
(a) Identity. (1) 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 section 401 of the act. However, where a standard of identity for a particular fruit juice has been promulgated under section 401 of the act, it shall conform to such standard.
(2) Color additive mixtures made with fruit juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b) Uses and restrictions. Fruit juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.
(c) 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 act, labeling in accordance with the provisions of §70.25 of this chapter.
(d) 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 section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995] § 73.260 Vegetable juice.
(a) Identity. (1) 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 section 401 of the act. However, where a standard of identity for a particular vegetable juice has been promulgated under section 401 of the act, it shall conform to such standard.
(2) Color additive mixtures made with vegetable juice may contain as diluents only those substances listed in this subpart as safe and suitable in color additive mixtures for coloring foods.
(b) Uses and restrictions. Vegetable juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.
(c) 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 act, labeling in accordance with the provisions of §70.25 of this chapter.
(d) 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 section 721(c) of the act.
[42 FR 15643, Mar. 22, 1977, as amended at 60 FR 52629, Oct. 10, 1995] § 73.275 Dried algae meal.
(a) 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.
(b) Uses and restrictions. The color additive dried algae meal may be safely used in chicken feed in accordance with the following prescribed conditions:
(1) The color additive is used to enhance the yellow color of chicken skin and eggs.
(2) The quantity of the color additive incorporated in the feed is such that the finished feed:
(i) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in paragraph (b)(1) of this section; and
(ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in §573.380 of this chapter.
(c) Labeling. The label of the color additives and any premixes prepared therefrom shall bear in addition to the information required by §70.25 of this chapter.
(1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein.
(2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (b) of this section.
(d) 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 section 721(c) of the act. § 73.295 Tagetes (Aztec marigold) meal and extract.
(a) Identity. (1) 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) 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.
(b) Specifications. (1) Tagetes (Aztec marigold) meal is free from admixture with other plant material from Tageteserecta L. or from plant material or flowers of any other species of plants.
(2) Tagetes (Aztec marigold) extract shall be prepared from tagetes (Aztec marigold) petals meeting the specifications set forth in paragraph (b)(1) of this section and shall conform to the following additional specifications:
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