ART 8-COLOR ADDITIVES art A-Definitions and Procedural and Interpretative Regulations Definitions and interpretations. Color additives in standardized foods, Notification of filing of petition. Samples; additional information. tions; substantive amendments; withdrawal of petitions without prejudice. Confidentiality of petition. Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued. Allocation of color additives. Advisory committee on the application of the cancer clause. Appointment of advisory committee. Procedure for advisory committee. Condition for certification. 8.305 Annatto extract. 8.306 Tagetes (Aztec marigold) meal and extract. Revocation of exemption from certification. 50-041-71- -9 FD&C Red No. 3. D & C Red No. 39. FD&C Yellow No. 5. AUTHORITY: The provisions of this Part 8 issued under secs. 701, 706, 52 Stat. 1055 as amended; 74 Stat. 399; 21 U.S.C. 371, 376, unless otherwise noted. Subpart A-Definitions and Procedural and Interpretative Regulations SOURCE: The provisions of this Subpart A appear at 28 F.R. 6439, June 22, 1963, unless otherwise noted. § 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 i termediate or final change of identi from a vegetable, animal, mineral, <| other source and that, when added c applied to a food, drug, or cosmetic c to the human body or any part thereo is capable (alone or through reaction with other substance) of imparting color thereto. This includes all diluent Substances capable of imparting a colc to a container for foods, drugs, or cosmetics are not color additives unless the customary or reasonably foreseeable hardling or use of the container may reasonably be expected to result in the colc: being transmitted to the contents of the package or any part thereof. Food in gredients such as cherries, green or red peppers, chocolate, and orange juice which contribute their own natural colc: when mixed with other foods are not regarded as "color additives"; but where & food substance such as beet juice is de liberately 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 asis that it is used (or intended to be sed) solely for a purpose or purposes her than coloring, the material must be sed in a way that any color imparted is early unimportant insofar as the apearance, value, marketability, or conmer acceptability is concerned. (It is ot enough to warrant exemption if contions are such that the primary purose of the material is other than to part color.) (h) The exemption that applies to a esticide chemical, soil or plant nutrient, · other agricultural chemical, where its ploring effect results solely from its ding, retarding, or otherwise affecting rectly or indirectly, the growth or ther natural physiological processes of roduce of the soil, applies only to color eveloped in such product through natral physiological processes such as enymatic action. If the pesticide chemial, soil or plant nutrient, or other agriultural chemical itself acts as a color r carries as an ingredient a color, and ecause of this property colors the prodce of the soil, it is a "color additive" nd is not exempt. (i) "Safe" means that there is conincing evidence that establishes with easonable certainty that no harm will esult from the intended use of the color dditive. (j) The term "straight color" means color additive listed in Subparts C, D, , F, G, and H of this part, and includes akes and such substances as are peritted by the specifications for such olor. (k) The term "mixture" means a color dditive made by mixing two or more traight colors, or one or more straight olors and one or more diluents. (1) The term "lake" means a straight olor extended on a substratum by adorption, coprecipitation, or chemical ombination that does not include any ombination of ingredients made by simle mixing process. (m) The term "diluent" means any omponent of a color additive mixture hat is not of itself a color additive and as been intentionally mixed therein to acilitate the use of the mixture in colorng foods, drugs, or cosmetics or in colorng the human body. The diluent may erve another functional purpose in the oods, drugs, or cosmetics, as for example weetening, flavoring, emulsifying, or tabilizing, or may be a functional com>onent of an article intended for colorng 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 F.R. 14983, Nov. 5, 1964, 30 F.R. 7484, June 8, 1965; 31 F.R. 12019, Sept. 14, 1966] § 8.2 Related substances. may (a) Different color additives 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 the must be submitted with respect to thi safety of the color additive (if such formation has not previously been su mitted and safety of the color additiv for the intended use has not been alread established), and the petition must show also that the use of the color additives the standardized food would be in con formance with section 401 of the act with the terms of a temporary perm issued under § 10.5 of this chapter. (2) If a petition for a definition an standard of identity contains a proposa for a color additive regulation, and th petitioner fails to designate it as suc the Commissioner, upon determinin that the petition includes a proposal f a color additive regulation, shall so m tify the petitioner and shall thereaf proceed in accordance with the regul tions in this part. (3) A regulation will not be issue allowing the use of a color additive a food for which a definition and stand ard or identity is established, unless issuance is in conformance with section 401 of the act or with the terms of temporary permit issued under § 10.5 this chapter. When the contemplate use of such additive complies with th terms of a temporary permit, the cor additive regulation will be conditioned such compliance and will expire wit the expiration of the temporary perm (b) New drugs and antibiotics. Where an application for a new drug for certification of an antibiotic drug received and this application propos for coloring purposes only, the inci sion of a color additive, the provisions the regulations in this part shall app with respect to the information that m be submitted about the safety of color additive, if such information not previously been submitted and safe of the color additive for the intended has not already been established. (2) If an application for a new de or certification of an antibiotic drugi ferentially contains a proposal for color additive regulation, and the app cant fails to designate it as such, Commissioner, upon determining t the application includes a proposal a color additive regulation, shall so not fy the applicant and shall thereafte proceed in accordance with the regu tions in this part. (3) Where a petition for a color add tive must be filed in accordance wi ubparagraph (2) of this paragraph, the ate of filing of the color additive petion shall be considered as the date of ling of the new-drug application or the quest for certification of the antibiotic rug. 8.4 Petitions proposing regulations for color additives. (a) Any interested person may proose the listing of a color additive for se in or on any food, drug, or cosmetic for coloring the human body. uch proposal shall be made in a petition the form prescribed in paragraph (c) this section. The petition shall be bmitted in triplicate. If any part of he material submitted is in a foreign nguage, it shall be accompanied by an ccurate and complete English translaon. The petitioner shall state the postfice address in the United States to hich published notices or orders issued objections filed pursuant to section 06 of the act may be sent. (b) Pertinent information may be inorporated in, and will be considered as art of, a petition on the basis of specific eference to such information submitted › and retained in the files of the Food nd Drug Administration. However, any eference to unpublished information Furnished by a person other than the aplicant will not be considered unless se of such information is authorized a written statement signed by the peron who submitted the information. ny reference to published information ffered in support of a color additive etition should be accompanied by rerints or photostatic copies of such eferences. (c) Petitions shall include the followng data and be submitted in the folowing 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 |