(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 706(c) of the act. [31 F.R. 1065, Jan. 27, 1966] § 8.314 Vegetable juice. (a) Identity. (1) The color additive vegetable juice is the concentrated or unconcentrated liquid expressed from mature varieties of fresh, edible vegetables. 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 D as safe and suitable in color additive mixtures for coloring foods. Vegetable (b) Uses and restrictions. 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 or 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 § 8.32. (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 706 (c) of the act. [31 F.R. 1065, Jan. 27, 1966] § 8.315 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 ad 86-039-689 justed, 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 made with toasted partially defatted cooked cottonseed flour may contain as diluents only those substances that, if used in foods, are not food additives within the meaning of section 201(s) of the act; or if they are food additives, are used only as prescribed in regulations in Part 121 of this chapter. Toasted (b) Specifications. partially defatted cooked cottonseed flour conforms 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 (Pb), not more than 10 parts per million. Free gossypol content, not more than 450 parts per million (0.045 percent by weight). (c) Uses and restrictions. 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 section 401 of the act, unless the use of added color is authorized by such standards. (d) 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 § 8.32. (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 requirement of section 706(c) of the act. [29 F.R. 1801, Feb. 6, 1964, as amended at 29 F.R. 13319, Sept. 25, 1964] § 8.316 Titanium dioxide. (a) Identity. (1) The color additive titanium dioxide is synthetically prepared TiO2, free from admixture with other substances. (2) Color additive mixtures for food use made with titanium dioxide may contain only those diluents listed in this Subpart D as safe and suitable in color additive mixtures for coloring foods, and the following: Silicon dioxide, SiO2, and/or aluminum oxide, Al,O,, as dispersing aids-not more than 2 percent total. (b) Specifications. Titanium dioxide 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. Antimony (as Sb)—not more than 2 parts per million. Mercury (as Hg)-not more than 1 part per million. Loss on ignition at 800° C. (after drying for 3 hours at 105° C.)-not more than 0.5 percent. Water soluble substances-not more than 0.3 percent. Acid soluble substances-not more than 0.5 percent. Tio, not less than 99.0 percent after drying for 3 hours at 105° C. 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. (c) Uses and restrictions. The color additive titanium dioxide may be safely used for coloring foods generally, subject to the following restrictions: (1) The quantity of titanium dioxide does not exceed 1 percent by weight of the 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 its use is authorized by such standards. (d) Labeling requirements. 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 § 8.32. (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 706(c) of the act. [31 F.R. 1065, Jan. 27, 1966] § 8.317 Carmine. (a) Identity. (1) 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.)). (2) Color additive mixtures for food use made with carmine may contain only those diluents listed in this Subpart D as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. 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 shall be pasteurized or otherwise treated to destroy all viable Salmonella micro-organisms. 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 free of viable Salmonella micro-organisms, 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. Carmine (c) Uses and restrictions. 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 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 § 8.32. (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 706(c) of the act. [32 F.R. 6132, Apr. 19, 1967 as amended at 32 F.R. 10981, July 27, 1967] § 8.318 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 Subpart D of this part 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. Grape skin (c) Uses and restrictions. 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, Code of Federal Regulations. (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 § 8.32. 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 (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 § 8.32. (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 706(c) of the act. [31 F.R. 6104, Apr. 21, 1966] § 8.320 Ferrous gluconate. (a) Identity. The color additive ferrous gluconate is the ferrous gluconate defined in the Food Chemicals Codex, First Edition, Publication 1406 (1966), National Academy of Sciences-National Research Council, Washington, D.C. (b) Specifications. Ferrous gluconate shall meet the specifications given in the Food Chemicals Codex. (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 § 8.32. (e) Exemption from certification. Certification of this color additive is not (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 D 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 § 8.32. (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 706(c) of the act. [32 F.R. 6186, Apr. 20, 1967] § 8.322 Corn endosperm oil. (a) Identity. (1) 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 definition as a color additive only and shall not be construed as a food standard of identity under section 401 of the act. (2) Color additive mixtures for food use made with corn endosperm oil may contain only those diluents listed in this subpart as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Corn endosperm oil conforms to the following specifications: Total fatty acids, not less than 85 percent. Iodine value, 118 to 134. Saponification value, 165 to 185. Unsaponifiable matter, not more than 14 percent. Hexane, not more than 25 parts per million. Isopropyl alcohol, not more than 100 parts per million. (c) Uses and restrictions. The color additive corn endosperm oil 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 is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in subparagraph (1) of this paragraph. (d) Labeling requirements. The label of the color additive and any premixes prepared therefrom shall bear, in addition to the information required by § 8.32, a statement of the concentration of xanthophyll contained therein. (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 706 (c) of the act. [32 F.R. 5325, Mar. 30, 1967, as amended at 32 F.R. 10199, July 11, 1967] § 8.323 Riboflavin. (a) Identity. (1) The color additive riboflavin is the riboflavin defined in the Food Chemicals Codex, First Edition, Publication 1406 (1966), National Academy of Sciences-National Research Council, Washington, D.C. (2) Color additive mixtures made with riboflavin may contain as diluents only those substances listed in this Subpart D as safe and suitable for use in color additive mixtures for coloring foods. (b) Specifications. Riboflavin shall meet the specifications given in the Food Chemicals Codex. (c) Uses and restrictions. Riboflavin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice; except that it may not be used tc 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 shall conform to the requirements of § 8.32. (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 706(c) of the act. [32 F.R. 8853, June 22, 1967] § 8.324 Carrot oil. (a) Identity. (1) 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 carotenoids 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 section 401 of the act. (2) Color additive mixtures for food use made with carrot oil may contain only those diluents listed in this Subpart D as safe and suitable in color additive mixtures for coloring foods. (b) Specifications. Carrot oil shall contain no more than 25 parts per million of hexane. (c) Uses and restrictions. Carrot oil 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 the use of added color is authorized by such standards. (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 § 8.32. (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 706(c) of the act. [32 F.R. 10980, July 27, 1967] Subpart-Provisional Regulations AUTHORITY: The provisions of this Subpart issued under Title II of Public Law 86-618, sec. 203 (c), (d); 74 Stat. 405; 21 U.S.C. 376, note. NOTE 1: §§ 9.1 to 9.3 of this chapter shall continue in effect, insofar as they are not inconsistent with the following provisional regulations, until new regulations for the enforcement of section 706 of the Federal Food, Drug, and Cosmetics Act basic color additives amendments of 1960 can be proposed and made effective, 25 F.R. 9759, Oct. 12, 1960. § 8.501 Provisional lists of color additives. The Commissioner of Food and Drugs finds that the following lists of color additives are provisionally listed under section 203(b) of the Color Additives Amendments of 1960 (sec. 203(b), 74 Stat. 405; 21 U.S.C. 376, note). Except for color additives for which petitions have been filed, progress reports are required by January 1, 1968, and at 6month intervals thereafter. Specifications for color additives listed in paragraphs (a), (b), and (c) of this section appear in Part 9 of this chapter. (a) Color additives previously and presently subject to certification and provisionally listed for food, drug, and cosmetic use. Closing date FD&C Green No. 3 (§ 9.23 of this chapter) |