§ 8.1 Definitions and interpretations. (a) "Secretary" means the Secretary of Health, Education, and Welfare. (b) "Department" means the Department of Health, Education, and Welfare. (c) "Commissioner" means the Commissioner of Food and Drugs. (d) "Act" means the Federal Food, Drug, and Cosmetic Act as amended. (e) "Color Certification Branch" means the unit established within the Food and Drug Administration located in the Bureau of Foods, charged with the responsibility for the mechanics of the certification procedure hereinafter described, and including the examination of samples of color additives subject to certification. (f) A "color additive" is any material, not exempted under section 201(t) of the act, that is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source and that, when added or applied to a food, drug, or cosmetic or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting a color thereto. This includes all diluents. Substances capable of imparting a color to a container for foods, drugs, or cosmetics are not color additives unless the customary or reasonably foreseeable handling or use of the container may reasonably be expected to result in the color being transmitted to the contents of the package or any part thereof. Food ingredients such as cherries, green or red peppers, chocolate, and orange juice which contribute their own natural color when mixed with other foods are not regarded as "color additives"; but where a food substance such as beet juice is deliberately used as a color, as in pink lemonade, it is a "color additive." Food ingredients as authorized by a definition and standard of identity prescribed by regulations pursuant to section 401 of the act are "color additives," where the ingredients are specifically designated in the definitions and standards of identity as permitted for use for coloring purposes. An ingredient of an animal feed whose intended function is to impart, through the biological processes of the animal, a color to the meat, milk, or eggs of the animal is a color additive and is not exempt from the requirements of the statute. This definition shall apply whether or not such ingredient has nutritive or other functions in addition to the property of imparting color. A substance that, when applied to the human body results in coloring, is a "color additive," unless the function of coloring is purely incidental to its intended use, such as in the case of deodorants. Lipstick, rouge, eye makeup colors, and related cosmetics intended for coloring the human body are "color additives." An ingested drug the intended function of which is to impart color to the human body is a "color additive." For the purposes of this part, the term "color" includes black, white, and intermediate grays, but substances including migrants from packaging materials which do not contribute any color apparent to the naked eye are not "color additives." (g) For a material otherwise meeting the definition of "color additive" to be exempt from section 706 of the act, on the basis that it is used (or intended to be used) solely for a purpose or purposes other than coloring, the material must be used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned. (It is not enough to warrant exemption if conditions are such that the primary purpose of the material is other than to impart color.) (h) The exemption that applies to a pesticide chemical, soil or plant nutrient, or other agricultural chemical, where its coloring effect results solely from its aiding, retarding, or otherwise affecting directly or indirectly, the growth or other natural physiological processes of produce of the soil, applies only to color developed in such product through natural physiological processes such as enzymatic action. If the pesticide chemical, soil or plant nutrient, or other agricultural chemical itself acts as a color or carries as an ingredient a color, and because of this property colors the produce of the soil, it is a "color additive" and is not exempt. (i) "Safe" means that there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive. (j) The term "straight color" means a color additive listed in Subparts C, D, E, F, G, and H of this part, and includes lakes and such substances as are permitted by the specifications for such color. (k) The term "mixture" means a color additive made by mixing two or more straight colors, or one or more straight colors and one or more diluents. (1) The term "lake" means a straight color extended on a substratum by adsorption, coprecipitation, or chemical combination that does not include any combination of ingredients made by simple mixing process. (m) The term "diluent" means any component of a color additive mixture that is not of itself a color additive and has been intentionally mixed therein to facilitate the use of the mixture in coloring foods, drugs, or cosmetics or in coloring the human body. The diluent may serve another functional purpose in the foods, drugs, or cosmetics, as for example sweetening, flavoring, emulsifying, or stabilizing, or may be a functional component of an article intended for coloring the human body. (n) The term "substratum" means the substance on which the pure color in a lake is extended. (0) The term "pure color" means the color contained in a color additive, exclusive of any intermediate or other component, or of any diluent or substratum contained therein. (p) The term "batch" means a homogeneous lot of color additive or color additive mixture produced by an identified production operation, which is set apart and held as a unit for the purpose of obtaining certification of such quantity. (q) The term "batch number" means the number assigned to a batch by the person who requests certification thereof. (r) The term "lot number" means an identifying number or symbol assigned to a batch by the Food and Drug Administration. (s) The term "area of the eye" means the area enclosed within the circumference of the supra-orbital ridge and the infra-orbital_ridge, including the eyebrown, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge. (t) The term "package" means the immediate container in which a color additive or color additive mixture has been packed for shipment or delivery. If the package is then packed in a shipping carton or other protective container, such container shall not be considered to be the immediate container. In the case of color additive mixtures for household use containing less than 15 percent pure color, when two or more containers of 3 ounces each or less, each containing a different color, are distributed as a unit, the immediate container for such unit shall be considered to be the package as defined in this section. (u) The "hair dye" exemption in section 601(a) of the act applies to those articles intended for use in altering the color of the hair and which are, or which bear or contain, color additives with the sensitization potential of causing skin irritation in certain individuals and possible blindness when used for dyeing the eyelashes or eyebrows. The exemption is permitted with the condition that the label of any such article bear conspicuously the statutory caution and adequate directions for preliminary patch-testing. If the poisonous or del eterious substance in the "hair dye" is one to which the caution is inapplicable and for which patch-testing provides no safeguard, the exemption does not apply; nor does the exemption extend to poisonous or deleterious diluents that may be introduced as wetting agents, hair conditioners, emulsifiers, or other components in a color shampoo, rinse, tint, or similar dual-purpose cosmetics that alter the color of the hair. (v) The terms "externally applied drugs" and "externally applied cosmetics" mean drugs or cosmetics applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane. [28 F.R. 6439, June 22, 1963, as amended at 29 FR. 14983, Nov. 5, 1964, 30 FR. 7484, June 8, 1965; 31 F.R. 12019, Sept. 14, 1966] § 8.2 Related substances. (a) Different color additives may cause similar or related pharmacological or biological effects, and, in the absence of evidence to the contrary, those that do so will be considered to have additive toxic effects. (b) Food additives may also cause pharmacological or biological effects similar or related to such effects caused by color additives, and, in the absence of evidence to the contrary, those that do so will be considered as having additive toxic effects. (c) Pesticide chemicals may also cause pharmacological or biological effects similar or related to such effects caused by color additives, and, in the absence of evidence to the contrary, those that do so will be considered to have additive toxic effects. (d) In establishing tolerances for color additives, the Commissioner will take into consideration, among other things, the amount of any common component permitted in other color additives, in food additives, and in pesticide chemical residues as well as the similar biological activity (such as cholinesterase inhibition) produced by such substance. § 8.3 Color additives in standardized foods, new drugs, and antibiotics. (a) Standardized foods. (1) Where a petition is received for issuance or amendment of a regulation establishing a definition and standard of identity for a food under section 401 of the act, which proposes the inclusion of a color additive in the standardized food, the provisions of the regulations in this part shall apply with respect to the information that must be submitted with respect to the safety of the color additive (if such information has not previously been submitted and safety of the color additive for the intended use has not been already established), and the petition must show also that the use of the color additive in the standardized food would be in conformance with section 401 of the act or with the terms of a temporary permit issued under § 10.5 of this chapter. (2) If a petition for a definition and standard of identity contains a proposal for a color additive regulation, and the petitioner fails to designate it as such, the Commissioner, upon determining that the petition includes a proposal for a color additive regulation, shall so notify the petitioner and shall thereafter proceed in accordance with the regulations in this part. (3) A regulation will not be issued allowing the use of a color additive in a food for which a definition and standard or identity is established, unless its issuance is in conformance with section 401 of the act or with the terms of a temporary permit issued under § 10.5 of this chapter. When the contemplated use of such additive complies with the terms of a temporary permit, the color additive regulation will be conditioned on such compliance and will expire with the expiration of the temporary permit. (b) New drugs and antibiotics. (1) Where an application for a new drug or for certification of an antibiotic drug is received and this application proposes, for coloring purposes only, the inclusion of a color additive, the provisions of the regulations in this part shall apply with respect to the information that must be submitted about the safety of the color additive, if such information has not previously been submitted and safety of the color additive for the intended use has not already been established. (2) If an application for a new drug or certification of an antibiotic drug inferentially contains a proposal for a color additive regulation, and the applicant fails to designate it as such, the Commissioner, upon determining that the application includes a proposal for a color additive regulation, shall so notify the applicant and shall thereafter proceed in accordance with the regulations in this part. (3) Where a petition for a color additive must be filed in accordance with subparagraph (2) of this paragraph, the date of filing of the color additive petition shall be considered as the date of filing of the new-drug application or the request for certification of the antibiotic drug. § 8.4 Petitions proposing regulations for color additives. (a) Any interested person may propose the listing of a color additive for use in or on any food, drug, or cosmetic or for coloring the human body. Such proposal shall be made in a petition in the form prescribed in paragraph (c) of this section. The petition shall be submitted in triplicate. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petitioner shall state the postoffice address in the United States to which published notices or orders issued or objections filed pursuant to section 706 of the act may be sent. (b) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of the Food and Drug Administration. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized in a written statement signed by the person who submitted the information. Any reference to published information offered in support of a color additive petition should be accompanied by reprints or photostatic copies of such references. (c) Petitions shall include the following data and be submitted in the following form: [Petitioner may propose a listing for general use in food, drugs, or cosmetics or, if such general listing is not believed suitable and safe, the petitioner shall describe the conditions under which he believes the additive can be safely used and for which it will be suitable. These conditions may include tolerance limitations, specifications as to the manner in which the additive may be added or used, and directions and other labeling or packaging safeguards that should be applied. The level of use proposed should not be higher than reasonably required to accomplish the intended color effect.] Attached hereto in triplicate and constituting a part of this petition are the following: A. The name and all pertinent information concerning the color additive, including chemical identity and composition of the color additive, its physical, chemical, and biological properties, and specifications prescribing its component(s) and identifying and limiting the reaction byproducts and other impurities. The petition shall contain a description of the chemical and physical tests relied upon to identify the color additive and shall contain a full description of the methods used in, and the facilities and controls used for, the production of the color additive. These shall establish that it is a substance of reproducible composition. Alternative methods and controls and variations in methods and controls, within reasonable limits, that do not affect the characteristics of the substance or the reliability of the controls may be specified. The petition shall supply a list of all substances used in the synthesis, extraction, or other method of preparation of any straight color, regardless of whether they undergo chemical change in the process. Each substance should be identified by its common or usual name and its complete chemical name, using structural formulas when necessary for specific identification. If any proprietary preparation is used as a component, the proprietary name should be followed by a complete quantitive statement of composition. Reasonable alternatives for any listed substance may be specified. If the petitioner does not himself perform all the manufacturing, processing, and packing operations for a color additive, the petitioner shall identify each person who will perform a part of such operations and designate the part. The petition shall include stability data, and, if the data indicate that it is needed to insure the identity, strength, quality, or purity of the color additive, the expiration period that will be employed as well as any packaging and labeling precautions needed to preserve stability. B. The amount of the color additive proposed for use and the color effect intended to be achieved, together with all directions, recommendations, and suggestions regarding the proposed use, as well as specimens of |