[Code of Federal Regulations] [Title 21, Volume 1] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR80.21] [Page 424-427] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 80--COLOR ADDITIVE CERTIFICATION--Table of Contents Subpart B--Certification Procedures Sec. 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 certification 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 address of the actual manufacturer in case such manufacturer is not the person requesting certification of the batch. [[Page 425]] (f) Be accompanied by the fee prescribed in Sec. 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 consider a request for certification of a batch of color additive if the fee accompanying such request is less than that required by Sec. 80.10 or if such fee exceeds the amount held in the advance deposit account of the manufacturer submitting such request for certification. (g) Be accompanied by the sample prescribed in Sec. 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 applicable. (i) The information and samples enumerated in paragraphs (a) to (h), inclusive, of this section are the minimum required. Additional information and samples shall be submitted at the request of the Food and Drug Administration when such additional information and samples are necessary to determine compliance with the requirements of Sec. 80.31 for the issuance of a certificate. (j) The form for submission of the application shall be one of the following, depending upon whether the color additive 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 ________ Office of Cosmetics and Colors (HFS-100), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St., SW., Washington, DC 20204 In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of straight color additive. Name of color___________________________________________________________ (As listed in 21 CFR part 74) Batch number____________________________________________________________ (Manufacturer's number) Batch weighs ____ pounds Batch manufactured by ____________ at __________________(Name and address of actual manufacturer) How stored pending certification________________________________________ _______________________________________________________________________ (State conditions of storage, with kind and size of containers, location, etc.) Certification requested of this color for use in________________________ _______________________________________________________________________ _______________________________________________________________________ (State proposed uses) Required fee, $__ __ (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) ____________________ By ____________________ ____________________ (Title) (2) Request for certification of a batch of color additive lake. Date ________ Office of Cosmetics and Colors (HFS-100), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204 In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color additive lake. Name of color___________________________________________________________ Batch number____________________________________________________________ (Manufacturer's number) Batch weighs ____ pounds Name of color used______________________________________________________ Quantity ____ pounds [[Page 426]] Lot number______________________________________________________________ (When certification of the lake for use in foods is requested) Precipitant used________________________________________________________ Substratum used_________________________________________________________ Quantity ____ pounds Batch manufactured by __________ at ______________ (Name and address of actual manufacturer) How stored pending certification________________________________________ _______________________________________________________________________ (State conditions of storage, with kind and size of containers, location, etc.) Certification requested of this color for use in________________________ _______________________________________________________________________ _______________________________________________________________________ (State proposed uses) Required fee, $____ (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) ____________________ By ____________________ ____________________ (Title) (3) Request for certification of a repack of a batch of certified color additive. Date __________ Office of Cosmetics and Colors (HFS-100), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204 In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color additive repack. Name of color___________________________________________________________ (As listed in regulations and as certified; or repacker's name, if a mixture) Original lot number_____________________________________________________ Certified color content_________________________________________________ This color obtained from________________________________________________ Batch number____________________________________________________________ Batch weighs ____ pounds How stored pending certification________________________________________ _______________________________________________________________________ (State conditions of storage, with kind and size of containers, location, etc.) Certification requested for use in______________________________________ _______________________________________________________________________ _______________________________________________________________________ (State proposed uses) Required fee, $____ (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) __________________ By ____________________ ____________________ (Title) (4) Request for certification of a batch of color additive mixture. Date __________ Office of Cosmetics and Colors (HFS-100), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 20204 In accordance with the regulations promulgated under the Federal Food, Drug, and Cosmetic Act, we hereby make application for the certification of a batch of color additive mixture. Name of mixture_________________________________________________________ (Manufacturer's trade name) Batch number____________________________________________________________ (Manufacturer's number) Weight of batch ____ pounds Volume of batch ____ (If liquid) gallons Batch manufactured by___________________________________________________ Constituents of the mixture: 1. Color(s). (List separately each color and each lot number.) Name of color as certified Lot number _______________________________________________________________________ _______________________________________________________________________ Quantity used (in pounds) Obtained from _______________________________________________________________________ _______________________________________________________________________ 2. List of diluents. (List separately each diluent.) Name of diluent _______________________________________________________________________ _______________________________________________________________________ Quantity used By volume By weight (if liquid) _______________________________________________________________________ _______________________________________________________________________ Batch mixed as follows__________________________________________________ (Describe in detail) How stored pending certification________________________________________ _______________________________________________________________________ (State conditions of storage, with kind and size of containers, location, etc.) Certification requested for use in______________________________________ _______________________________________________________________________ _______________________________________________________________________ [[Page 427]] (State proposed uses) Required fee, $____ (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) ____________________ By __________________ ____________________ (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]