Page images
PDF
EPUB

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 mixture 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 $70.25 of this chapter 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 §70.20 of this chapter.

(2) Such package has been sealed in accordance with §70.20 of this chapter 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 § 80.38, 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 §70.20 of this chapter.

(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.

as

(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 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 such specified date without the new certificate in preparing foods, drugs, or cosmetics will result in such food, drugs, or cosmetics being adulterated. When a certified color additive has been used in food, drugs, or cosmetics and the status of the color additive is thereafter changed by amendment or revocation of its listing or specification regulations, such food, drugs, and cosmetics will not be regarded as adulterated by reason of the use of such color additive, unless the hazard to health is such that existing stocks of the foods, drugs, or cosmetics cannot be safely used, in which cases findings to that effect will be made and regulations appropriate for such special cases will be issued.

§ 80.34 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 § 80.39; 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 § 80.39; 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) Any person who contests suspension of service shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.

§ 80.35 Color additive mixtures; certification and exemption from certification.

(a) Color additive mixtures to be certified. Any color additive mixture that contains one or more straight colors listed in part 74 of this chapter, together with any diluents listed in such subparts for use with such straight colors, shall be certified if intended for use in foods, drugs, or cosmetics, or in coloring the human body, as the case may be, subject to any restriction prescribed in parts 70 and 71 of this chapter.

(b) Color additive mixtures exempted from certification. A color additive mixture prepared from a previously certified batch of one or more straight colors, with or without any diluent that has been listed in part 73 of this chapter for use in mixtures, shall be exempt from batch certification if the straight color used has not changed in composition in any manner whatsoever since its certification and if it is simply mixed with the approved diluents

for exempt mixtures. The label of such color additive mixtures shall not bear the lot number assigned by the Food and Drug Administration to the certified straight color components, but shall bear the manufacturer's control number through which the history of the straight color can be determined.

(c) Additions to the list of diluents. A person requesting additions to the list of diluents authorized for the purposes described in paragraphs (a) and (b) of this section shall submit a petition in accordance with the provisions of §71.1 of this chapter. Each such petition shall be accompanied by the fee prescribed in §70.19 of this chapter, unless there is an advance deposit to be used for prepayment of such fees.

NOTE: The provisions of § 80.35 with respect only to diluents for use in cosmetic color additive mixtures were stayed, until a regulation is effected listing safe diluents for cosmetic use, including cosmetics which color the human body, 29 FR 18495, Dec. 29, 1964.

§ 80.37 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 until certified.

(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 to be used until the requested certificate has been issued.

§ 80.38 Treatment of batch after cer

tification.

(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 §§ 70.20 and 70.25 of this chapter, except

that the person requesting certification may use such color additive for the purpose of coloring a food, drug, or cosmetic.

§ 80.39 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 and Human Services, 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.

PART 81-GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS

[blocks in formation]

section 203(b) of the Color Additive Amendments of 1960 (sec. 203(b), 74 Stat. 405 (21 U.S.C. 379e note)). Except for color additives for which petitions have been filed, progress reports are required by January 1, 1968, and at 6month intervals thereafter. Specifications for color additives listed in paragraphs (a), (b), and (c) of this section appear in the respective designated sections. The listing of color additives in this section is not to be construed as a listing for surgical suture use unless color additive petitions have been submitted for such use or the Commissioner has been notified of studies underway to establish the safety of the color additive for such use. The color additives listed in paragraphs (a), (b), and (c) of this section may not be used in products which are intended to be used in the area of the eye. The color additives listed in paragraphs (a), (b), and (c) of this section are provisionally listed until the closing dates set forth therein.

(a) Color additives previously and presently subject to certification and provisionally listed for food, drug, and cosmetic

[blocks in formation]

Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

§ 81.10 Termination of provisional listings of color additives.

(a) Ext. D&C Yellow Nos. 9 and 10. These colors cannot be produced with any assurance that they do not contain B-naphthylamine as an impurity. While it has been asserted that the two colors can be produced without the impurity named, no method of analysis has been suggested to establish the fact. ẞ-Naphthylamine is a known carcinogen; therefore, there is no scientific evidence that will support a safe tolerance for these colors in products to be used in contact with the skin. The Commissioner of Food and Drugs, having conIcluded that such action is necessary to protect the public health, hereby terminated the provisional listing of Ext. D&C Yellow No. 9 and Ext. D&C Yellow No. 10.

(b) [Reserved]

(c) FD&C Red No. 1. Results of recent feeding tests of this color additive have demonstrated it to be toxic upon inges

tion:

(1) Groups of 50 rats are being fed diets containing FD&C Red No. 1 at levels of 5 percent, 2 percent, 1 percent, 0.5 percent, and 0 percent. At this stage of the tests, which have now been in progress for from 15 months to 18 months, 116 animals from the 250 being fed FD&C Red No. 1 at various levels and 27 of the 100 controls have died. Of these, 11 being fed at the 5 percent level, 16 being fed at the 2 percent level, 11 being fed at the 1 percent level, and 2 being fed at the 0.5 percent level, have shown liver damage. None of the controls that have died have shown liver damage.

(2) Groups of 100 mice are being fed diets containing 2 percent, 1 percent, 0.5 percent, and 0.1 percent FD&C Red No. 1, with 400 mice as controls. All mice on dosage levels of 2 percent and 1 percent died before the seventieth week. Gross liver damage has been observed in all groups fed at the 0.5 percent diet and above.

(3) Groups of 4 dogs are being fed diets containing 2 percent, 1 percent, 0.25 percent, and 0 percent FD&C Red No. 1. Three of the dogs on the 2 percent dosage level died before 32 weeks;

the other is living. Three of the dogs on the 1 percent dosage level died or were sacrificed within 13 months. All deceased or sacrificed dogs have shown liver damage grossly and/or microscopically. Deceased dogs on the 1 percent and 2 percent dosage level showed poor physical condition.

The Commissioner of Food and Drugs having concluded that ingestion of this color additive over a long period of time would be unsafe, and in order to protect the public health, hereby terminates the provisional listing of FD&C Red No. 1 for use in foods, drugs, and cosmetics.

(d) FD&C Red No. 4. Feeding tests of this color additive have been conducted with three species:

(1) Rats of the Osborne-Mendel and Sprague-Dawley strains were fed FD&C Red No. 4 for 2 years at levels of 5 percent, 2 percent, 1 percent, and 0.5 percent of the diet. No effect was found.

(2) Mice of the C3Hf and C57BL strains were fed FD&C Red No. 4 for 2 years at levels of 2 percent and 1 percent of the diet. No effect was found.

(3) Dogs were fed FD&C Red No. 4 at levels of 2 percent and 1 percent of the diet. Adverse effects were found at both levels in the urinary bladder and in the adrenals. Three dogs of five fed on the 2-percent level died after 6 months, 9 months, and 51⁄2 years on the test. Two of the dogs on the 2-percent level and all five of the dogs on the 1-percent level survived to the completion of the 7 year study.

The Commissioner of Food and Drugs has concluded that available data do not permit the establishment of a safe level of use of this color additive in food, ingested drugs and ingested cosmetics. In order to protect the public health, the Commissioner hereby terminates the provisional listing of FD&C Red No. 4 for use in food and ingested drugs. The Commissioner has previously terminated the provisional listing of FD&C Red No. 4 for use in ingested cosmetics. FD&C Red No. 4 is listed for use in externally applied drugs and cosmetics by §§74.1304 and 74.2304 of this chapter, respectively. Section 82.304 of this chapter is retained in part 82 of this chapter to permit the use of lakes of FD&C Red No.

4 in externally applied drugs and cosmetics.

(e) FD&C Violet No. 1. The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional listing of FD&C Violet No. 1 for use in foods, drugs, and cosmetics.

(f) FD&C Red No. 2. The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional listing of FD&C Red No. 2 for use in food, drugs, and cosmetics.

(g) Carbon black (prepared by the "impingement" or "channel" process). The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional listing of carbon black (prepared by the impingement or channel process) for use in food, drugs, and cosmetics.

(h) D&C Red Nos. 10, 11, 12, and 13. The petition for these color additives was withdrawn so that there no longer exists a basis for their continued provisional listing. In addition, the Commissioner has learned of the possible contamination of D&C Red No. 10, D&C Red No. 11, D&C Red No. 12, and D&C Red No. 13 with ẞ-naphthyl- amine. The Commissioner concludes that these colors cannot be produced with any reasonable assurance that they will not contain ẞ-naphthylamine as an impurity or not yield ẞ-naphthylamine from the metabolism of subsidiary colors present in them. ẞ-Naphthylamine is a known carcinogen; therefore, there is no scientific evidence that will support a safe tolerance for these colors in drugs or cosmetics. The Commissioner of Food and Drugs, upon withdrawal of the petition for their use and in order to protect the public health, hereby terminates the provisional listing of D&C Red No. 10, D&C Red No. 11, D&C Red No. 12, and D&C Red No. 13 for use in drugs and cosmetics, effective December 13, 1977.

(i) Ext. D&C Yellow No. 1. The Commissioner has learned of the contamination of Ext. D&C Yellow No. 1 with 4aminobiphenyl. The Commissioner concludes that this color cannot be produced with any reasonable assurance that it will not contain 4aminobiphenyl as an impurity or not yield benzidine from the decomposition

of a subsidiary reaction product that might be present in the color. 4Aminobiphenyl and benzidine are known carcinogens; therefore, there is no scientific evidence that will support a safe tolerance for these colors in drugs or cosmetics. In addition, insufficient data have been submitted to permit establishment of appropriate specifications for the batch certification of the color. The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional listing of Ext. D&C Yellow No. 1 for use in externally applied drugs and cosmetics, effective December 13, 1977.

(j) Graphite. Data have been developed that show the contamination of graphite with polynuclear aromatic hydrocarbons (PNA's). There is no reasonable assurance this color can be produced so that it will not contain PNA's as an impurity. The presence of certain PNA's in graphite would indicate that PNA's known to be carcinogenic to animals and humans may also be present. Therefore, there is no scientific evidence that will support a safe tolerance for this color in drugs or cosmetics. The Commissioner of Food and Drugs, in order to protect the public health, hereby terminates the provisional listing of graphite for use in externally applied cosmetics, effective November 29, 1977.

(k) Ext. D&C Green No. 1. The Commissioner concludes that there are inadequate analytical methods to permit certification of the color additive Ext. D&C Green No. 1. In addition, the Commissioner has found that there was a failure to comply with the conditions attached to the postponement of the closing date in accordance with section 203(a)(2) of the transitional provisions of the Color Additive Amendments of 1960. The Commissioner of Food and Drugs hereby terminates the provisional listing of Ext. D&C Green No. 1 for use in externally applied drugs and cosmetics, effective November 29, 1977. (1) [Reserved]

(m) D&C Orange Nos. 10 and 11. In the absense of a petition to list D&C Orange No. 10 and D&C Orange No. 11 for use in ingested drugs and cosmetics, there no longer exists a basis for provisional listing for such uses. Therefore, FDA is terminating the provisional

« PreviousContinue »