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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2014]
[CITE: 21CFR80.21]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL

PART 80 -- COLOR ADDITIVE CERTIFICATION

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.

(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,

5100 Paint Branch Pkwy.,

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

______________________________________________________________

______________________________________________________________

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,

5100 Paint Branch Pkwy.,

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

______________________________________________________________

______________________________________________________________

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,

5100 Paint Branch Pkwy.,

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

______________________________________________________________

______________________________________________________________

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,

5100 Paint Branch Pkwy.,

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.)

______________________________________________________________

______________________________________________________________

______________________________________________________________

______________________________________________________________

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

______________________________________________________________

______________________________________________________________

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)

(State proposed uses)

Name of color

as certified Lot number

Quantity used

(in pounds ) Obtained from

[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]

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