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[47 FR 57688, Dec. 28, 1982; 48 FR 3946, Jan. 28, 1983; 48 FR 7438, Feb. 22, 1983; 48 FR 10811, Mar. 15, 1983]

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.

the Food and Drug Administration, collectable at par at Washington, DC. All such deposits and fees shall be forwarded 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 transmitted to the Treasurer of the United States for deposit to the special account "Salaries and Expenses, Certification, Inspection, and Other Services, Food and Drug Administration."

(e) Refunds from advance deposits. Whenever in the judgment of the Commissioner the ratio between fees collected (which are based upon experience 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 collected 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 ratable 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)

Subpart B-Certification

Procedures

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 (i)(2) shall be 30 cents per pound of the batch covered by such requests, but no such fee shall be less than $192.

(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 submitted in accordance with $ 80.21(j)(3) and (j)(4) shall be:

(1) 100 pounds or less $30.

(2) Over 100 pounds but not over 1,000 pounds—$30 plus 6 cents for each pound over 100 pounds.

(3) Over 1,000 pounds—$84 plus 2 cents for each pound over 1,000 pounds.

(c) Advance deposits. Any person regularly requesting certification services may deposit funds in advance of requests 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

$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

(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

(Name and address of actual manufacturer) How stored pending certification

at

(State conditions of storage, with kind and

size of containers, location, etc.) Certification requested of this color for use

in

case such manufacturer is not the person requesting certification of the batch.

(f) Be accompanied by the fee prescribed in 880.10 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.

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Quantity pounds
Lot number

(When certification of the lake

for use in foods is requested)
Precipitant used
Substratum used
Quantity pounds
Batch manufactured by

(Name and address of actual manufacturer) How stored pending certification

The accompanying sample was taken after the batch was mixed in accordance with 21 CFR 80.22 and is accurately representative thereof.

(Signed)

By

at

(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 S (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.

(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.)
Name of color
as certified

Lot number

(Signed)

By

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(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

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(State conditions of storage, with kind and

size of containers, location, etc.) Certification requested for use in

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).

(State proposed uses)

(b) If the Commissioner determines, Required fee, $ (drawn to the order of after such investigation as he considers Food and Drug Administration).

to be necessary, that a request sube accompanying sample was taken aftermitted in accordance with $80.21, or the batch was mixed in accordance with 21 the batch of color additive covered by CFR 80.22 and is accurately representative such request, does not comply with the thereof.

requirements prescribed by paragraph (Signed)

(a) of this section for the issuance of a By

certificate, the Commissioner shall

refuse to certify such batch and shall (Title)

give notice thereof to the person who [42 FR 15662, Mar. 22, 1977; 44 FR 17658, Mar

submitted such request, stating his 23, 1979; 44 FR 22053, Apr. 13, 1979, as amended

reasons for refusal. Any person who at 54 FR 24890, June 12, 1989; 61 FR 14479, Apr.

contests such refusal shall have an op2, 1996; 66 FR 56035, Nov. 6, 2001)

portunity for a regulatory hearing be

fore the Food and Drug Administration 8 80.22 Samples to accompany requests pursuant to part 16 of this chapter.

for certification. A sample of a batch of color additive

$ 80.32 Limitations of certificates. which is to accompany a request for (a) If a certificate is obtained certification shall:

through fraud or misrepresentation of (a) Be taken only after such batch a material fact, such certificate shall has been so thoroughly mixed as to be not be effective, and a color additive of uniform composition throughout. from the batch on which such certifi

(b) Held under the control of the per cate was issued shall be considered to son requesting certification until cer be from a batch that has not been certified.

tified in accordance with the regula(c) Be labeled to show:

tions in this part. Whenever, the Com(1) The name of the color additive. missioner learns that any certificate

(2) The manufacturer's batch num has been obtained through fraud or maber.

terial misrepresentation, he shall no(3) The quantity of such batch.

tify the holder of the certificate that it (4) The name and post-office address is of no effect. of the person requesting certification (b) If between the time a sample of of such batch.

color additive accompanying a request (5) Be accompanied by any label or for certification is taken and the time labeling intended to be used.

a certificate covering the batch of such

color additive is received by the person $ 80.31 Certification.

to whom it is issued, any such color ad(a) If the Commissioner determines, ditive becomes changed in composiafter such investigations as he con tion, such certificates shall not be efsiders to be necessary, that:

fective with respect to such changed (1) A request submitted in accordance color additive and such changed color with $ 80.21 appears to contain no un additive shall be considered to be from true statement of a material fact;

a batch that has not been certified in (2) Such color additive conforms to accordance with the regulations in this the specifications and any other conditions set forth therefor in parts 81 and (c) If at any time after a certificate 82 of this chapter.

is received by the person to whom it is (3) The batch covered by such request issued any color additive from the otherwise appears to comply with the batch covered by such certificate beregulations in this chapter, the Com- comes changed in composition, such missioner shall issue to the person who certificate shall expire with respect to submitted such request a certificate such changed color additive. After such showing the lot number assigned to expiration, such color additive shall be such batch and that such batch, subject considered to be from a batch that has to the terms, conditions, and restric- not been certified in accordance with tions prescribed by part 74, 81, and 82 of this part; except that such color addithis chapter, is a certified batch.

tive shall not be so considered when

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