Title 21

SECTION 80.21

80.21 Request for certification.

§ 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.

(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.

(f) Be accompanied by the fee prescribed 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 consider a request for certification of a batch of color additive if the fee accompanying such request is less than that required by § 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 § 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 § 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, 5001 Campus Dr., College Park, MD 20740

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, 5001 Campus Dr., College Park, MD 20740

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 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, 5001 Campus Dr., College Park, MD 20740

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, 5001 Campus Dr., College Park, MD 20740

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 (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; 66 FR 56035, Nov. 6, 2001; 81 FR 49895, July 29, 2016]