§ 5.7 Wrapped fish fillets. (a) Wrapped fish fillets of nonuniform weight intended to be unpacked and marked with the correct weight at the point of retail sale in an establishment other than that where originally packed shall be exempt from the requirement of section 403 (e) (2) of the act during introduction and movement in interstate commerce and while held for sale prior to weighing and marking: Provided, That: (1) The outside container bears a label declaration of the total net weight; and (2) The individual packages bear a conspicuous statement "To be weighed at time of sale" and a correct statement setting forth the weight of the wrapper; and Provided further, That it is the practice of the retail establishment to weigh and mark the individual packages with a correct net-weight statement prior to or at the point of retail sale. A statement of the weight of the wrapper shall be set forth so as to be readily read and understood, using such term as "wrapper tare ounce," the blank being filled in with the correct average weight of the wrapper used. (b) The act of delivering the wrapped fish fillets during the retail sale without the correct net-weight statement shall be deemed an act which results in the product's being misbranded while held for sale. Nothing in this section shall be construed as requiring net-weight statements for wrapped fish fillets delivered into institutional trade provided the outside container bears the required information. § 5.8 Bananas, wrapped clusters (consumer units). (a) Wrapped clusters (consumer units) of bananas of nonuniform weight intended to be unpacked from a master carton or container and weighed at the point of retail sale in an establishment other than that where originally packed shall be exempt from the requirements of section 403 (e) (2) of the act during introduction and movement in interstate commerce and while held for sale prior to weighing: Provided, That: (1) The master carton or container bears a label declaration of the total net weight; and (2) The individual packages bear a conspicuous statement "To be weighed at the time of sale" and a correct state ment setting forth the weight of the wrapper; and Provided, further, That it is the practice of the retail establishment to weigh the individual packages either prior to or at the time of retail sale. (b) The act of delivering the wrapped clusters (consumer units) during the retail sale without an accurate net weight statement or alternatively without weighing at the time of sale shall be deemed an act which results in the product's being misbranded while held for sale. Nothing in this paragraph shall be construed as requiring net-weight statements for clusters (consumer units) delivered into institutional trade, provided that the master container or carton bears the required information. § 5.9 Labeling of foods in which salt containing anticaking agents or other substances is an ingredient. Anticaking agents and other substances added to salt for the purpose of improving the physical properties of such salt are deemed to be incidental additives and are exempt from label declaration as ingredients of foods fabricated from such salt and other ingredients when: (a) The salt anticaking agents or substances added for otherwise improving the physical properties of salt are not food additives within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act, are present at a level not greater than necessary to accomplish their intended physical effect, or if food additives, are used in salt in accordance with section 409 of the act and regulations thereunder. (b) The classes of substances named in paragraph (a) of this section are present at nonfunctional and insignificant levels and do not exert any effect on the fabricated food containing such salt. [30 F.R. 15292, Dec. 10, 1965] § 5.10 Labeling foods in the production of which dimethylpolysiloxane defoaming agents containing silica aerogel were used. Silica aerogel added to dimethylpolysiloxane (defoaming agent complying with the provisions of § 121.1099 of this chapter) is deemed to be an incidental additive and is exempt from label declaration as an ingredient of fabricated foods in which such defoaming agent is used provided the silica aerogel complies with the provisions of § 121.101(d) (8) of this chapter and is present at a level not greater than necessary and at such level as to be quantitatively insignificant and nonfunctional in the finished fabricated foods. [35 F.R. 2584, Feb. 5, 1970] PART 8-COLOR ADDITIVES Subpart A-Definitions and Procedural and Interpretative Regulations Sec. 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 8.10 Definitions and interpretations. Color additives in standardized foods, Notification of filing of petition. Extension of time for studying petitions; 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. 8.11 8.12 8.16 Revocation of exemption from certification. com 8.8004 Potassium sodium copper chlorophyllin (chlorophyllin-copper plex). 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 examina tion 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 another substance) of imparting a color thereto. 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 transmittal of the color 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. 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 coal tar hair dyes intended for use in altering the color of the hair and which are, or which bear or contain, color additives derived from coal tar 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. The exemption does not apply to coloring ingredients in hair dyes not derived from coal tar, and it does not 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 cosmetic 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; 36 F.R. 16902, Aug. 26, 1971] § 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 of 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 |