Public Law 86-618 (74 Stat. 404; 21 U.S.C. 376, note) shall be submitted in quintuplicate to the Hearing Clerk of the Department and shall be accompanied by a filing fee as specified in § 8.50. Each objection to a provision of the regulation shall be separately numbered.

(b) A statement of objections shall not be accepted for filing if:

(1) It is received for filing more than 30 days after the date of publication of the order in the FEDERAL REGISTER; or

(2) It fails to establish that the objector is adversely affected by the regulation; or

(3) It does not specify with particularity the provisions of the regulation to which objection is taken; or

(4) It does not state reasonable grounds for each objection raised. Grounds which it is reasonable to conclude are capable of being established by reliable evidence at the hearing and which if proved would call for changing the provisions specified in the objections will be deemed reasonable grounds.

(5) The fee is not submitted. (c) If the statement of objections may not be filed, the Commissioner shall inform the objector of the reasons. § 8.20 Notice of public hearing.

If the objections and statement filed by any person, when they are considered with the record in the proceeding (including any reply to the objections that the petitioner may have filed), show that the person filing the objections will be adversely affected and that the grounds stated in support of the objections are reasonable, the Commissioner shall cause to be published in the FEDERAL REGISTER a notice reciting the objections and announcing a public hearing to receive evidence on them. The notice shall designate the place where the hearing will be held, specify the time within which appearances must be filed, and specify the time (not earlier than 30 days after the date of the notice) when the hearing will start. The hearing shall convene at the place and time announced in the notice, but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without other notice than announcement thereof by the presiding officer at the hearing,

§ 8.21 Hearing procedure.

Public hearings will be conducted in accordance with the rules provided in Subpart F of Part 2 of this chapter. [31 F.R. 3008, Feb. 22, 1966]

§ 8.22 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 § 8.51 unless the person has established with the Food and Drug Administration an advance 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 § 8.51 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 § 8.23 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 Subpart C, E, or G of this part.

(2) The name of a lake shall be the name derived in the manner described in Subpart B of this part.

(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 subparagraph (1), (2), or (3) of this paragraph, 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 § 8.27 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.

Batch manufactured by

at

pounds

(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 8.23 and is accurately representative thereof.

(Signed) By

(Title)

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

(3) Request for certification of a repack of a batch of certified color additive. Date

Commissioner of Food and Drugs,
Food and Drug Administration,
Department of Health, Education, and
Welfare.

Washington 25, D.O.

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.

(Title)

Name of color

(As listed in regulations and as certified; or repacker's name, if a mixture)

Original lot number Certified color content

(Title)

(4) Request for certification of a batch of color additive mixture.

Date

Commissioner of Food and Drugs,
Food and Drug Administration,
Department of Health, Education, and
Welfare,

Washington 25, D.C.

§ 8.23 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 person requesting certification until certified.

(c) Be labeled to show:

(1) The name of the color additive. (2) The manufacturer's batch number.

(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.

§ 8.24 Treatment of batch pending certification.

Immediately after the sample that is to accompany a request for certification 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 person requesting certification certified.

until

(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 be used until the requested certificate has been issued.

[28 F.R. 6439, June 22, 1963, as amended at 29 F.R. 14983, Nov. 5, 1964]

§ 8.25 Treatment of batch after certification.

(a) Immediately upon notification that a batch of color additive has been

certified, the person requesting certification thereof shall identify such batch, by labeling, with the certified lot number.

(b) The person requesting certification shall maintain storage in such manner as to prevent change in composition until such batch has been packaged and labeled as required by §§ 8.31 and 8.32, except that the person requesting certification may use such color additive for the purpose of coloring a food, drug, or cosmetic.

[29 F.R. 14983, Nov. 5, 1964]

§ 8.26 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 behalf of the Secretary of Health, Education, and Welfare, 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, § 8.27 Certification.

(a) If the Commissioner determines, after such investigations as he considers to be necessary, that:

(1) A request submitted in accordance with § 8.22 appears to contain no untrue statement of a material fact;

(2) Such color additive conforms to the specifications and any other conditions set forth therefor in Subpart C, E, or G of this part.

(3) The batch covered by such request otherwise appears to comply with the regulations in this part, the Commissioner 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 restrictions prescribed by Subpart C, E, or G of this part, is a certified batch.

(b) If the Commissioner determines, after such investigation as he considers to be necessary, that a request submitted in accordance with § 8.22, or the batch of color additive covered by 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.

§ 8.28 Authority to refuse certification

service.

(a) When it appears to the Commissioner that a person has:

(1) Obtained, or attempted to obtain, a certificate through fraud or misrepresentation of a material fact.

(2) Falsified the records required to be kept by § 8.26; 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 required by § 8.26; or

(4) Refused to permit duly authorized employees of the Food and Drug Administration free access to all manufacturing facilities, processes, and formulae involved in the manufacture of color additives and intermediates from which such color additives are derived;

he may immediately suspend certification service to such person and may continue such suspension until adequate corrective action has been taken.

(b) Upon receipt of the notice of suspension of service, the person so notified may request à hearing upon the factual basis for the suspension. The procedure at the hearing shall conform as nearly as possible to the procedure described in §§ 130.14-130.26 of this chapter.

§ 8.29 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 certificate was issued shall be considered to be from a batch that has not been certified in accordance with the regulations in this part. Whenever, the Commissioner learns that any certificate has been obtained through fraud or material misrepresentation, he shall notify 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 additive becomes changed in composition, such certificates shall not be effective 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 becomes 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 additive shall not be so considered when used for coloring a food, drug, or cosmetic, or for the purpose of certifying a batch of a mixture in which such color additive was used as an ingredient, 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 respect to any color additive covered thereby if the package in which such color additive was closed for shipment or delivery is opened. After such expiration such color additive shall be considered 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 cosmetic; (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 mix

ture 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 additive 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, statements, and other information required by § 8.32 to appear thereon.

(f) A certificate shall not be effective with respect to a package of color additive, 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 § 8.31;

(2) Such package has been sealed in accordance with § 8.31 and the seal has been broken, intentionally or accidentally, unless such seal has been broken for the purpose of using color additive in accordance with § 8.25, or, such package has been opened by a duly authorized representative of the Administration or Department in the performance of his official duties, and he has immediately resealed the package in conformance with § 8.31.

(g) A certificate shall not be effective with respect to a package of color additive 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 specifications 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 theretofore 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 unless a new certificate can be and is obtained in conformance with the new regulations. When a certificate thus ceases to be effective for a color additive, any certificates previously issued for a color additive mixture containing that color additive shall cease to be effective on the same date. Use of such color additive or color additive mixture after