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81.10 Termination of provisional listings of color additives.

Home > Regulations > General specifications and general restrictions for provisional color additives for use in foods, drugs, and cosmetics > 81.10 Termination of provisional listings of color additives.






[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR81.10]



[Page 432-434]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 81_GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL 

COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS--Table of Contents

 

Sec.  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 [beta]-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. [beta]-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 concluded 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 ingestion:

    (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 5\1/2\ 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 

Sec. Sec.  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.



[[Page 433]]



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 [beta]-naphthyl-amine. The Commissioner 

concludes that these colors cannot be produced with any reasonable 

assurance that they will not contain [beta]-naphthylamine as an impurity 

or not yield [beta]-naphthylamine from the metabolism of subsidiary 

colors present in them. [beta]-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 4-aminobiphenyl. The 

Commissioner concludes that this color cannot be produced with any 

reasonable assurance that it will not contain 4-aminobiphenyl as an 

impurity or not yield benzidine from the decomposition of a subsidiary 

reaction product that might be present in the color. 4-Aminobiphenyl 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.

    (l) [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



[[Page 434]]



listing of D&C Orange No. 10 and D&C Orange No. 11 for use in ingested 

drugs and cosmetics, effective April 28, 1981.

    (n) D&C Blue No. 6. The Commissioner of Food and Drugs, having 

concluded that unresolved questions remain concerning the chemistry of 

unidentified minor components, hereby terminates the provisional listing 

of D&C Blue No. 6 for use in drugs and cosmetics.

    (o) D&C Green No. 6. In the absence of a petition to list D&C Green 

No. 6 for use in ingested drugs and cosmetics, there no longer exists a 

basis for provisional listing for such uses. Accordingly, the 

Commissioner of Food and Drugs hereby terminates the provisional listing 

of D&C Green No. 6 for use in ingested drugs and cosmetics, effective 

March 27, 1981.

    (p) [Reserved]

    (q)(1) D&C Red No. 19 and D&C Red No. 37. Having concluded that, 

when ingested, D&C Red No. 19 causes cancer in rats and mice, the agency 

hereby terminates the provisional listings of D&C Red No. 19 and 

chemically related D&C Red No. 37 for use in ingested drugs and ingested 

cosmetics, effective February 4, 1983.

    (2) D&C Red No. 37. In the absence of a petition to list D&C Red No. 

37 for external uses, there no longer exists a basis for provisional 

listing for such uses. Accordingly, the Commissioner of Food and Drugs 

hereby terminates the provisional listings of D&C Red No. 37 for use in 

externally applied drugs and cosmetics, effective June 6, 1986.

    (r) [Reserved]

    (s) D&C Orange No. 17. Having concluded that, when ingested, D&C 

Orange No. 17 causes cancer in rats and mice, the agency has terminated 

the provisional listing of D&C Orange No. 17 for use in ingested drugs 

and ingested cosmetics, effective March 31, 1983.

    (t) D&C Red No. 8 and D&C Red No. 9. In the absence of a petition to 

list D&C Red No. 8 and D&C Red No. 9 for mouthwash, dentifrices, and 

ingested drugs, except ingested drug lip products, there no longer 

exists a basis for provisional listing for such uses. Accordingly, the 

Commissioner of Food and Drugs hereby terminates the provisional 

listings of D&C Red No. 8 and D&C Red No. 9 for use in mouthwash, 

dentifrices, and ingested drugs, except ingested drug lip products, 

effective January 6, 1987.

    (u) FD&C Red No. 3. Having concluded that FD&C Red No. 3 causes 

cancer in rats, the agency hereby terminates the provisional listing of 

FD&C Red No. 3 for use in cosmetics and externally applied drugs and the 

provisional listing of the lakes of FD&C Red No. 3 for use in food, 

drug, and cosmetic products, effective January 29, 1990.



[42 FR 15665, Mar. 22, 1977]



    Editorial Note: For Federal Register citations affecting Sec.  

81.10, see the List of CFR Sections Affected, which appears in the 

Finding Aids section of the printed volume and on GPO Access.










Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 81, Section 10


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