Color additive certification (21 CFR 80.10-80.39)

491 Food and Drug Administration, HHS § 80.10 requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the medical devices in which the color ad ditive is used. (c) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (d) Certification. All batches of D&C Violet No. 2 shall be certified in ac cordance with regulations in part 80 of this chapter. [52 FR 19722, May 27, 1987, as amended at 55 FR 18868, May 7, 1990; 58 FR 60109, Nov. 15, 1993; 59 FR 11720, Mar. 14, 1994; 63 FR 20098, Apr. 23, 1998; 64 FR 32805, June 18, 1999; 65 FR 46344, July 28, 2000] § 74.3710 D&C Yellow No. 10. (a) Identity. The color additive D&C Yellow No. 10 shall conform to the identity requirements of § 74.1710(a). (b) Specifications. The color additive D&C Yellow No. 10 for use in contact lenses shall conform to the specifica tions of § 74.1710(b). (c) Uses and restrictions. (1) The color additive D&C Yellow No. 10 may be used for coloring contact lenses in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. (2) Authorization for this use shall not be construed as waiving any of the requirements of sections 510(k), 515, and 520(g) of the Federal Food, Drug, and Cosmetic Act with respect to the contact lens in which the color addi tive is used. (d) Labeling. The label of the color ad ditive shall conform to the require ments of § 70.25 of this chapter. (e) Certification. All batches of D&C Yellow No. 10 shall be certified in ac cordance with regulations in part 80 of this chapter. [52 FR 28690, Aug. 3, 1987] PART 80—COLOR ADDITIVE CERTIFICATION Subpart A—General Provisions Sec. 80.10 Fees for certification services. Subpart B—Certification Procedures 80.21 Request for certification. 80.22 Samples to accompany requests for certification. 80.31 Certification. 80.32 Limitations of certificates. 80.34 Authority to refuse certification serv ice. 80.35 Color additive mixtures; certification and exemption from certification. 80.37 Treatment of batch pending certifi cation. 80.38 Treatment of batch after certification. 80.39 Records of distribution. AUTHORITY: 21 U.S.C. 371, 379e. SOURCE: 42 FR 15662, Mar. 22, 1977, unless otherwise noted. Subpart A—General Provisions § 80.10 Fees for certification services. (a) Fees for straight colors including lakes. The fee for the services provided by the regulations in this part in the case of each request for certification submitted in accordance with § 80.21(j)(1) and (j)(2) shall be $0.35 per pound of the batch covered by such re quests, but no such fee shall be less than $224. (b) Fees for repacks of certified color additives and color additive mixtures. The fees for the services provided under the regulations in this part in the case of each request for certification sub mitted in accordance with § 80.21(j)(3) and (j)(4) shall be: (1) 100 pounds or less—$35. (2) Over 100 pounds but not over 1,000 pounds—$35 plus $0.06 for each pound over 100 pounds. (3) Over 1,000 pounds—$89 plus $0.02 for each pound over 1,000 pounds. (c) Advance deposits. Any person regu larly requesting certification services may deposit funds in advance of re quests as prepayment of fees required by this section. (d) Method of payment. All deposits and fees required by 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 such deposits and fees shall be for warded to the Center for Food Safety and Applied Nutrition (HFS–100), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, whereupon after making appropriate records thereof, they will be trans mitted to the Treasurer of the United VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00501 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 492 21 CFR Ch. I (4–1–16 Edition) § 80.21 States for deposit to the special ac count ‘‘Salaries and Expenses, Certifi cation, Inspection, and Other Services, Food and Drug Administration.’’ (e) Refunds from advance deposits. Whenever in the judgment of the Com missioner the ratio between fees col lected (which are based upon experi ence and the best estimate of costs and the best estimate of earnings) and the costs of providing the service during an elapsed period of time, in the light of all circumstances and contingencies, warrants a refund from the fund col lected during such period, he shall make ratable refunds to those persons to whom the services were rendered and charged, except that no refund shall be made where the computed rat able amount for the elapsed period is less than $5.00. [42 FR 15662, Mar. 22, 1977, as amended at 47 FR 24692, June 8, 1982; 54 FR 24890, June 12, 1989; 59 FR 60899, Nov. 29, 1994; 61 FR 3572, Feb. 1, 1996; 61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001; 70 FR 15756, Mar. 29, 2005; 71 FR 70875, Dec. 7, 2006] Subpart B—Certification Procedures § 80.21 Request for certification. A request for certification of a batch of color additive shall: (a) Be addressed to the Commissioner of Food and Drugs. (b) Be prepared in the manner set forth in paragraph (j) of this section. (c) Be submitted in duplicate. (d) Be signed by a responsible officer of the person requesting certification of the batch. In the case of a foreign manufacturer, the request for certifi cation must be signed by a responsible officer of such firm, and, by his agent who resides in the United States. (e) Show the name and post office ad dress of the actual manufacturer in case such manufacturer is not the per son requesting certification of the batch. (f) Be accompanied by the fee pre scribed in § 80.10 unless the person has established with the Food and Drug Administration an advanced deposit to be used for prepayment of such fees. In no case shall the Commissioner con sider a request for certification of a batch of color additive if the fee ac companying such request is less than that required by § 80.10 or if such fee ex ceeds the amount held in the advance deposit account of the manufacturer submitting such request for certifi cation. (g) Be accompanied by the sample prescribed in § 80.22 consisting of: (1) Four ounces in the case of straight colors and lakes. (2) Two ounces in the case of repacks and mixtures. A sample accompanying a request for certification must be submitted under separate cover and should be addressed to the Color Certification Branch. (h) The name of a color additive shall be given in the following manner: (1) The name of a straight color shall be the name of the color as listed in parts 74 and 81 of this chapter. (2) The name of a lake shall be the name derived in the manner described in part 82 of this chapter. (3) The name of a mixture shall be the name given to such mixture by the person requesting certification. (4) The name of a repack shall be the name described in paragraph (h)(1), (2), or (3) of this section, whichever is ap plicable. (i) The information and samples enu merated in paragraphs (a) to (h), inclu sive, of this section are the minimum required. Additional information and samples shall be submitted at the re quest of the Food and Drug Adminis tration when such additional informa tion and samples are necessary to de termine compliance with the require ments of § 80.31 for the issuance of a certificate. (j) The form for submission of the ap plication shall be one of the following, depending upon whether the color addi tive is a straight color, a lake, a repack of a previously certified color additive, or a color additive mixture. (1) Request for certification of a batch of straight color additive. Date llll Office of Cosmetics and Colors (HFS–100), Center for Food Safety and Applied Nutri tion, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 In accordance with the regulations promul gated under the Federal Food, Drug, and Cosmetic Act, we hereby make application VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00502 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 493 Food and Drug Administration, HHS § 80.21 for the certification of a batch of straight color additive. Name of color llllllllllllllll (As listed in 21 CFR part 74) Batch number llllllllllllllll (Manufacturer’s number) Batch weighs ll pounds Batch manufactured by llllll at lllllllll (Name and address of ac tual manufacturer) How stored pending certification llllll llllllllllllllllllllllll (State conditions of storage, with kind and size of containers, location, etc.) Certification requested of this color for use in lllllllllllllllllllll llllllllllllllllllllllll llllllllllllllllllllllll (State proposed uses) Required fee, $ll (drawn to the order of Food and Drug Administration). The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof. (Signed) llllllllll By llllllllll llllllllll (Title) (2) Request for certification of a batch of color additive lake. Date llll Office of Cosmetics and Colors (HFS–100), Center for Food Safety and Applied Nutri tion, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 In accordance with the regulations promul gated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color addi tive lake. Name of color llllllllllllllll Batch number llllllllllllllll (Manufacturer’s number) Batch weighs ll pounds Name of color used lllllllllllll Quantity ll pounds Lot number lllllllllllllllll (When certification of the lake for use in foods is requested) Precipitant used llllllllllllll Substratum used llllllllllllll Quantity ll pounds Batch manufactured by lllll at lllllll (Name and address of actual manufacturer) How stored pending certification llllll llllllllllllllllllllllll (State conditions of storage, with kind and size of containers, location, etc.) Certification requested of this color for use in lllllllllllllllllllll llllllllllllllllllllllll llllllllllllllllllllllll (State proposed uses) Required fee, $ll (drawn to the order of Food and Drug Administration). The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof. (Signed) llllllllll By llllllllll llllllllll (Title) (3) Request for certification of a repack of a batch of certified color additive. Date lllll Office of Cosmetics and Colors (HFS–100), Center for Food Safety and Applied Nutri tion, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 In accordance with the regulations promul gated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color addi tive repack. Name of color llllllllllllllll (As listed in regulations and as certified; or repacker’s name, if a mixture) Original lot number lllllllllllll Certified color content lllllllllll This color obtained from llllllllll Batch number llllllllllllllll Batch weighs ll pounds How stored pending certification llllll llllllllllllllllllllllll (State conditions of storage, with kind and size of containers, location, etc.) Certification requested for use in llllll llllllllllllllllllllllll llllllllllllllllllllllll (State proposed uses) Required fee, $ll (drawn to the order of Food and Drug Administration). The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof. (Signed) lllllllll By llllllllll llllllllll (Title) VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00503 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 494 21 CFR Ch. I (4–1–16 Edition) § 80.22 (4) Request for certification of a batch of color additive mixture. Date lllll Office of Cosmetics and Colors (HFS–100), Center for Food Safety and Applied Nutri tion, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740 In accordance with the regulations promul gated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color addi tive mixture. Name of mixture llllllllllllll (Manufacturer’s trade name) Batch number llllllllllllllll (Manufacturer’s number) Weight of batch ll pounds Volume of batch ll (If liquid) gallons Batch manufactured by lllllllllll Constituents of the mixture: 1. Color(s). (List separately each color and each lot number.) Name of color as certified Lot number llllllllllllllllllllllll llllllllllllllllllllllll Quantity used (in pounds) Obtained from llllllllllllllllllllllll llllllllllllllllllllllll 2. List of diluents. (List separately each dil uent.) Name of diluent llllllllllllllllllllllll llllllllllllllllllllllll Quantity used By volume By weight (if liquid) llllllllllllllllllllllll llllllllllllllllllllllll Batch mixed as follows lllllllllll (Describe in detail) How stored pending certification llllll llllllllllllllllllllllll (State conditions of storage, with kind and size of containers, location, etc.) Certification requested for use in llllll llllllllllllllllllllllll llllllllllllllllllllllll (State proposed uses) Required fee, $ll (drawn to the order of Food and Drug Administration). The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof. (Signed) llllllllll By lllllllll llllllllll (Title) [42 FR 15662, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979; 44 FR 22053, Apr. 13, 1979, as amended at 54 FR 24890, June 12, 1989; 61 FR 14479, Apr. 2, 1996; 66 FR 56035, Nov. 6, 2001] § 80.22 Samples to accompany requests for certification. A sample of a batch of color additive which is to accompany a request for certification shall: (a) Be taken only after such batch has been so thoroughly mixed as to be of uniform composition throughout. (b) Held under the control of the per son requesting certification until cer tified. (c) Be labeled to show: (1) The name of the color additive. (2) The manufacturer’s batch num ber. (3) The quantity of such batch. (4) The name and post-office address of the person requesting certification of such batch. (5) Be accompanied by any label or labeling intended to be used. § 80.31 Certification. (a) If the Commissioner determines, after such investigations as he con siders to be necessary, that: (1) A request submitted in accordance with § 80.21 appears to contain no un true statement of a material fact; (2) Such color additive conforms to the specifications and any other condi tions set forth therefor in parts 81 and 82 of this chapter. (3) The batch covered by such request otherwise appears to comply with the regulations in this chapter, the Com missioner shall issue to the person who submitted such request a certificate showing the lot number assigned to such batch and that such batch, subject to the terms, conditions, and restric tions prescribed by part 74, 81, and 82 of this chapter, is a certified batch. (b) If the Commissioner determines, after such investigation as he considers to be necessary, that a request sub mitted in accordance with § 80.21, or the batch of color additive covered by VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00504 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 495 Food and Drug Administration, HHS § 80.32 such request, does not comply with the requirements prescribed by paragraph (a) of this section for the issuance of a certificate, the Commissioner shall refuse to certify such batch and shall give notice thereof to the person who submitted such request, stating his reasons for refusal. Any person who contests such refusal shall have an op portunity for a regulatory hearing be fore the Food and Drug Administration pursuant to part 16 of this chapter. § 80.32 Limitations of certificates. (a) If a certificate is obtained through fraud or misrepresentation of a material fact, such certificate shall not be effective, and a color additive from the batch on which such certifi cate was issued shall be considered to be from a batch that has not been cer tified in accordance with the regula tions in this part. Whenever, the Com missioner learns that any certificate has been obtained through fraud or ma terial misrepresentation, he shall no tify the holder of the certificate that it is of no effect. (b) If between the time a sample of color additive accompanying a request for certification is taken and the time a certificate covering the batch of such color additive is received by the person to whom it is issued, any such color ad ditive becomes changed in composi tion, such certificates shall not be ef fective with respect to such changed color additive and such changed color additive shall be considered to be from a batch that has not been certified in accordance with the regulations in this part. (c) If at any time after a certificate is received by the person to whom it is issued any color additive from the batch covered by such certificate be comes changed in composition, such certificate shall expire with respect to such changed color additive. After such expiration, such color additive shall be considered to be from a batch that has not been certified in accordance with this part; except that such color addi tive shall not be so considered when used for coloring a food, drug, or cos metic, or for the purpose of certifying a batch of a mixture in which such color additive was used as an ingre dient, or for use in preparing a batch of a mixture for which exemption from certification has been authorized, if such change resulted solely from such use. (d) A certificate shall expire with re spect to any color additive covered thereby if the package in which such color additive was closed for shipment or delivery is opened. After such expi ration such color additive shall be con sidered to be from a batch that has not been certified, except that such color additive shall not be so considered when the package is opened; (1) and such color additive is used, subject to the restrictions prescribed by paragraphs (f), (g), and (h) of this section, in coloring a food, drug, or cos metic; (2) for the purpose of certifying a batch made by repacking such color; (3) for the purpose of certifying a batch of a mixture in which such color is used as an ingredient; or (4) for the purpose of preparing a batch of a mixture for which exemption from certification has been authorized; or (5) when the package is reopened solely for repackaging by the person to whom such certificate was issued. (e) A certificate shall not be effective with respect to a package of color addi tive and such color additive shall be considered to be from a batch that has not been certified if such package is shipped or delivered under a label which does not bear all words, state ments, and other information required by § 70.25 of this chapter to appear thereon. (f) A certificate shall not be effective with respect to a package of color addi tive, and such color additive shall be considered to be from a batch that has not been certified if: (1) Such package has not been sealed in accordance with § 70.20 of this chap ter. (2) Such package has been sealed in accordance with § 70.20 of this chapter and the seal has been broken, inten tionally or accidentally, unless such seal has been broken for the purpose of using color additive in accordance with § 80.38, or, such package has been opened by a duly authorized represent ative of the Administration or Depart ment in the performance of his official VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00505 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 496 21 CFR Ch. I (4–1–16 Edition) § 80.34 duties, and he has immediately re sealed the package in conformance with § 70.20 of this chapter. (g) A certificate shall not be effective with respect to a package of color addi tive and such color additive shall be considered to be from a batch that has not been certified if such color additive is used in any manner other than that for which it was certified. (h) When the listing or the specifica tions for a color additive are revoked or amended, the final order effecting the revocation or amendment may specify, in addition to its own effective date, a date on which all certificates for existing batches and portions of batches of such a color additive there tofore issued under such revoked or amended regulations shall cease to be effective; and any such lots of the color additive shall be regarded as uncertified after the date specified un less a new certificate can be and is ob tained in conformance with the new regulations. When a certificate thus ceases to be effective for a color addi tive, any certificates previously issued for a color additive mixture containing that color additive shall cease to be ef fective on the same date. Use of such color additive or color additive mix ture after such specified date without the new certificate in preparing foods, drugs, or cosmetics will result in such food, drugs, or cosmetics being adulter ated. When a certified color additive has been used in food, drugs, or cos metics and the status of the color addi tive is thereafter changed by amend ment or revocation of its listing or specification regulations, such food, drugs, and cosmetics will not be re garded as adulterated by reason of the use of such color additive, unless the hazard to health is such that existing stocks of the foods, drugs, or cosmetics cannot be safely used, in which cases findings to that effect will be made and regulations appropriate for such spe cial cases will be issued. § 80.34 Authority to refuse certifi cation service. (a) When it appears to the Commis sioner that a person has: (1) Obtained, or attempted to obtain, a certificate through fraud or misrepre sentation of a material fact. (2) Falsified the records required to be kept by § 80.39; or (3) Failed to keep such records, or to make them available, or to accord full opportunity to make inventory of stocks on hand or otherwise to check the correctness of such records, as re quired by § 80.39; or (4) Refused to permit duly authorized employees of the Food and Drug Ad ministration free access to all manu facturing facilities, processes, and for mulae involved in the manufacture of color additives and intermediates from which such color additives are derived; he may immediately suspend certifi cation service to such person and may continue such suspension until ade quate corrective action has been taken. (b) Any person who contests suspen sion of service shall have an oppor tunity for a regulatory hearing before the Food and Drug Administration pur suant to part 16 of this chapter. § 80.35 Color additive mixtures; certifi cation and exemption from certifi cation. (a) Color additive mixtures to be cer tified. Any color additive mixture that contains one or more straight colors listed in part 74 of this chapter, to gether with any diluents listed in such subparts for use with such straight col ors, shall be certified if intended for use in foods, drugs, or cosmetics, or in coloring the human body, as the case may be, subject to any restriction pre scribed in parts 70 and 71 of this chap ter. (b) Color additive mixtures exempted from certification. A color additive mix ture prepared from a previously cer tified batch of one or more straight colors, with or without any diluent that has been listed in part 73 of this chapter for use in mixtures, shall be exempt from batch certification if the straight color used has not changed in composition in any manner whatsoever since its certification and if it is sim ply mixed with the approved diluents for exempt mixtures. The label of such color additive mixtures shall not bear the lot number assigned by the Food and Drug Administration to the cer tified straight color components, but shall bear the manufacturer’s control VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00506 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 497 Food and Drug Administration, HHS § 81.1 number through which the history of the straight color can be determined. (c) Additions to the list of diluents. A person requesting additions to the list of diluents authorized for the purposes described in paragraphs (a) and (b) of this section shall submit a petition in accordance with the provisions of § 71.1 of this chapter. Each such petition shall be accompanied by the fee pre scribed in § 70.19 of this chapter, unless there is an advance deposit to be used for prepayment of such fees. NOTE: The provisions of § 80.35 with respect only to diluents for use in cosmetic color ad ditive mixtures were stayed, until a regula tion is effected listing safe diluents for cos metic use, including cosmetics which color the human body, 29 FR 18495, Dec. 29, 1964. § 80.37 Treatment of batch pending certification. Immediately after the sample that is to accompany a request for certifi cation of a batch of color additive is taken, the batch shall be: (a) Stored in containers of such kind as to prevent change in composition. (b) Held under the control of the per son requesting certification until cer tified. (c) Marked, by labeling or otherwise, in a manner such that there can be no question as to the identity of the batch and no question that it is not to be used until the requested certificate has been issued. § 80.38 Treatment of batch after cer tification. (a) Immediately upon notification that a batch of color additive has been certified, the person requesting certifi cation thereof shall identify such batch, by labeling, with the certified lot number. (b) The person requesting certifi cation shall maintain storage in such manner as to prevent change in com position until such batch has been packaged and labeled as required by §§ 70.20 and 70.25 of this chapter, except that the person requesting certifi cation may use such color additive for the purpose of coloring a food, drug, or cosmetic. § 80.39 Records of distribution. (a) The person to whom a certificate is issued shall keep complete records showing the disposal of all the color additive from the batch covered by such certificate. Upon the request of any officer or employee of the Food and Drug Administration or of any other officer or employee acting on be half of the Secretary of Health and Human Services, such person, at all reasonable hours until at least 2 years after disposal of all such color additive, shall make such records available to any such officer or employee, and shall accord to such officer or employee full opportunity to make inventory of stocks of such color additive on hand and otherwise to check the correctness of such records. (b) The records required to be kept by paragraph (a) of this section shall show: (1) Each quantity used by such person from such batch and the date and kind of such use. (2) The date and quantity of each shipment or delivery from such batch, and the name and post-office address of the person to whom such shipment or delivery was made. (c) The records required to be kept by paragraph (a) of this section shall be kept separately from all other records. PART 81—GENERAL SPECIFICA TIONS AND GENERAL RESTRIC TIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS Sec. 81.1 Provisional lists of color additives. 81.10 Termination of provisional listings of color additives. 81.30 Cancellation of certificates. 81.32 Limitation of certificates. AUTHORITY: 21 U.S.C. 371, 379e, 379e note. § 81.1 Provisional lists of color addi tives. The Commissioner of Food and Drugs finds that the following lists of color additives are provisionally listed under section 203(b) of the Color Additive Amendments of 1960 (sec. 203(b), 74 Stat. 405 (21 U.S.C. 379e note)). Except for color additives for which petitions VerDate Sep<11>2014 14:18 Apr 18, 2016 Jkt 238070 PO 00000 Frm 00507 Fmt 8010 Sfmt 8010 Q:\21\21V1.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B