PART 70—COLOR ADDITIVES Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 360b, 361, 371, 379e. Source: 42 FR 15636, Mar. 22, 1977, unless otherwise noted. Subpart A—General Provisions § 70.3 Definitions. (a) Secretary (b) Department (c) Commissioner (d) Act (e) Color Certification Branch (f) A color additive color additives color additive. color additives, color additive. color color additives. (g) For a material otherwise meeting the definition of color additive (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 (i) Safe (j) The term straight color (k) The term mixture (l) The term lake (m) The term diluent (n) The term substratum (o) The term pure color (p) The term batch (q) The term batch number (r) The term lot number (s) The term area of the eye (t) The term package (u) The hair dye (v) The terms externally applied drugs externally applied cosmetics [42 FR 15636, Mar. 22, 1977, as amended at 61 FR 14478, Apr. 2, 1996] § 70.5 General restrictions on use of color additives. (a) Color additives for use in the area of the eye. (b) Color additives for use in injections. (c) Color additives for use in surgical sutures. § 70.10 Color additives in standardized foods and new drugs. (a) Standardized foods. (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 part 71 of this chapter. (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 § 130.17 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. (2) If an application for a new 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 part 71 of this chapter. (3) Where a petition for a color additive must be filed in accordance with paragraph (b)(2) of this section, the date of filing of the color additive petition shall be considered as the date of filing of the new-drug application. [42 FR 15636, Mar. 22, 1977, as amended at 64 FR 400, Jan. 5, 1999] § 70.11 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. § 70.19 Fees for listing. (a) Each petition for the listing of a color additive shall be accompanied by a deposit of $3,000.00 if the proposal is for listing the color additive for use generally in or on foods, in or on drugs, and in or on cosmetics. (b) If the petition for the listing is for use in or on foods only, the deposit shall be $3,000.00. (c) If the petition for the listing is for use in or on drugs and/or cosmetics only, the deposit shall be $2,600.00. (d) The provisions of paragraphs (a), (b), and (c) of this section shall be applicable, whether or not the proposal contemplates any tolerances, limitations, or other restrictions placed upon the use of the color additive. (e) If a petition proposing the issuance of a regulation is withdrawn before it is finally accepted for filing, the deposit, less a $600.00 fee for clerical handling and administrative and technical review, shall be returned to the petitioner. (f) If a petition proposing the issuance of a regulation is withdrawn within 30 days after filing, the deposit, less $1,800.00 if the petition is covered by paragraph (a) or (b) of this section, and less $1,600.00, if the petition is covered by paragraph (c) of this section, shall be returned to the petitioner. (g) When a petition is withdrawn after filing and resubmitted within 6 months, it shall be accompanied by a deposit of $1,800.00 for a petition filed under paragraph (a) or (b) of this section, and $1,600.00 for a petition filed under paragraph (c) of this section. If a petition is resubmitted after 6 months, it shall be accompanied by the deposit that would be required if it were being submitted for the first time. (h) When the resubmission pertains to a petition that had been withdrawn before acceptance for filing, a new advance deposit shall be made in full as prescribed in paragraph (a), (b), or (c) of this section. (i) After a color additive has been listed, any request for an amendment or additional tolerance shall be accompanied by a deposit of $1,800.00 for use in the items specified in paragraphs (a) and (b) of this section, or $1,600.00 for use in items specified in paragraph (c) of this section. (j) The fee for services in listing a diluent under § 80.35 for use in color additive mixtures shall be $250.00. (k) Objections and request for public hearing under section 721(d) of the act or section 203(d)(2)(C) of Pub. L. 86-618 (74 Stat. 404; 21 U.S.C. 379e, note) shall be accompanied by a filing fee of $250.00. (l) In the event of a referral of a petition under this section to an advisory committee, all costs related thereto (including personal compensation of committee members, travel materials, and other costs) shall be borne by the person or organization requesting the referral, such costs to be assessed on the basis of actual cost to the Government: Provided, (m) In the case of requests of referrals to advisory committees, a special advance deposit shall be made in the amount of $2,500.00. Where required, further advance in increments of $2,500.00 each shall be made upon request of the Commissioner of Food and Drugs. All deposits for referrals to advisory committees in excess of actual expenses shall be refunded to the depositor. (n) All requests for pharmacological or other scientific studies shall be accompanied by an advance deposit of $5,000.00. Further advance deposits shall be made upon request of the Commissioner of Food and Drugs when necessary to prevent arrears in such cost. Any deposits in excess of actual expenses will be refunded to the depositor. If a request is denied the advance deposit will be refunded less such costs as are incurred for review of the request. (o) The person who files a petition for judicial review of an order under section 721(d) of the act shall pay the costs of preparing a transcript of the record on which the order is based. (p) All deposits and fees required by the regulations in this section shall be paid by money order, bank draft or certified check drawn to the order of the Food and Drug Administration, collectible at par at Washington, DC All deposits and fees shall be forwarded to the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, whereupon after making appropriate record thereof they will be transmitted to the Treasurer of the United States for deposit in the special account “Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration.” (q) The Commissioner of Food and Drugs may waive or refund such fees in whole or in part when in his judgment such action will promote the public interest. (r) Any person who believes that payment of these fees will work a hardship on him may petition the Commissioner of Food and Drugs to waive or refund the fees. [42 FR 15636, Mar. 22, 1977, as amended at 54 FR 24890, June 12, 1989; 61 FR 14478, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001; 81 FR 49895, July 29, 2016] Subpart B—Packaging and Labeling § 70.20 Packaging requirements for straight colors (other than hair dyes). Straight colors shall be packaged in containers which prevent changes in composition. Packages shall be sealed so that they cannot be opened without breaking the seal. An unavoidable change in moisture content caused by the ordinary and customary exposure that occurs in good storage, packing, and distribution practice is not considered a change in composition. If the packaging material is a food additive it shall be authorized by an appropriate regulation in parts 170 through 189 of this chapter. § 70.25 Labeling requirements for color additives (other than hair dyes). (a) General labeling requirements. (1) The name of the straight color or the name of each ingredient comprising the color additive, if it is a mixture. (2) A statement indicating general limitations for the use of the color additive, such as “for food use only”; “for food, drug, and cosmetic use”; “for use in drugs for external application only.” (3) Where regulations issued impose quantitative limitations for a general or specific use of a straight color, the amount of each such straight color in terms of weight per unit/volume or percent by weight. (4) An expiration date if stability data require it. (b) Special labeling for color additives with tolerances. (c) Special labeling for color additives with other limitations. (d) Special labeling for color additives not exempt from certification. Subpart C—Safety Evaluation § 70.40 Safety factors to be considered. In accordance with section 721(b)(5)(A)(iii) of the act, the following safety factor will be applied in determining whether the proposed use of a color additive will be safe: Except where evidence is submitted which justifies use of a different safety factor, a safety factor of 100 to 1 will be used in applying animal experimentation data to man; that is, a color additive for use by man will not be granted a tolerance that will exceed 1/100th of the maximum no-effect level for the most susceptible experimental animals tested. The various species of experimental animals used in the tests shall conform to good pharmacological practice. § 70.42 Criteria for evaluating the safety of color additives. (a) In deciding whether a petition is complete and suitable for filing and in reaching a decision on any petition filed, the Commissioner will apply the “safe-for-use” principle. This will require the presentation of all needed scientific data in support of a proposed listing to assure that each listed color additive will be safe for its intended use or uses in or on food, drugs, or cosmetics. The Commissioner may list a color additive for use generally in or on food, in or on drugs, or in or on cosmetics when he finds from the data presented that such additive is suitable and may safely be employed for such general use; he may list an additive only for more limited use or uses for which it is proven suitable and may safely be employed; and he is authorized to prescribe broadly the conditions under which the additive may be safely employed for such use or uses. This may allow the use of a particular dye, pigment, or other substance with certain diluents, but not with others, or at a higher concentration with some than with others. (b) The safety for external color additives will normally be determined by tests for acute oral toxicity, primary irritation, sensitization, subacute dermal toxicity on intact and abraded skin, and carcinogenicity by skin application. The Commissioner may waive any of such tests if data before him otherwise establish that such test is not required to determine safety for the use proposed. (c) Upon written request describing the proposed use of a color additive and the proposed experiments to determine its safety, the Commissioner will advise a person who wishes to establish the safety of a color additive whether he believes the experiments planned will yield data adequate for an evaluation of the safety of the additive. § 70.45 Allocation of color additives. Whenever, in the consideration of a petition or a proposal to list a color additive or to alter an existing listing, the data before the Commissioner fail to show that it would be safe to list the color additive for all the uses proposed or at the levels proposed, the Commissioner will notify the petitioner and other interested persons by publication in the Federal Register § 70.50 Application of the cancer clause of section 721 of the act. (a) Color additives that may be ingested. (b) Color additives that will not be ingested. (c) Color additives for use as an ingredient of feed for animals that are raised for food production. [42 FR 15636, Mar. 22, 1977, as amended at 43 FR 22675, May 26, 1978; 52 FR 49586, Dec. 31, 1987] § 70.51 Advisory committee on the applicability of the anticancer clause. All requests for and procedures governing any advisory committee on the anticancer clause shall be subject to the provisions of part 14 of this chapter, and particularly subpart H of that part. § 70.55 Request for scientific studies. The Commissioner will consider requests by any interested person who desires the Food and Drug Administration to conduct scientific studies to support a petition for a regulation for a color additive. If favorably acted upon, such studies will be limited to pharmacological investigations, studies of the chemical and physical structure of the color additive, and methods of analysis of the pure color additive (including impurities) and its identification and determination in foods, drugs, or cosmetics, as the case may be. All requests for such studies shall be accompanied by the fee prescribed in § 70.19.