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81.30 Cancellation of certificates.

Home > Regulations > General specifications and general restrictions for provisional color additives for use in foods, drugs, and cosmetics > 81.30 Cancellation of certificates.






[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: 21CFR81.30]



[Page 434-438]

 

                        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.  81.30  Cancellation of certificates.



    (a) Certificates issued heretofore for colors being removed from the 

provisional list (Sec.  81.10(a)) are cancelled and of no effect after 

December 1, 1960, and use of such color additives in drugs or cosmetics 

after that date will result in adulteration.

    (b)(1) Certificates issued heretofore for the color additive 

designated FD&C Red No. 1 are cancelled as of the date of the 

publication of this Order, and use of this color additive in the 

manufacture of foods, drugs, or cosmetics after that date will result in 

adulteration.

    (2) The Commissioner finds that no action needs to be taken to 

remove foods, drugs, and cosmetics containing this color additive from 

the market on the basis of the scientific evidence before him, taking 

into account that the additive is not an acute toxic substance and that 

it is only used in small amounts in foods, drugs, and cosmetics.

    (c) Certificates issued for FD&C Red No. 4 and all mixtures 

containing this color additive are cancelled and have no effect after 

September 23, 1976 insofar as food, ingested drugs, and ingested 

cosmetics are concerned, and use of this color additive in the 

manufacture of food, ingested drugs, and ingested cosmetics after this 

date will result in adulteration. The certificates shall continue in 

effect for the use of FD&C Red No. 4 in externally applied



[[Page 435]]



drugs and cosmetics. The Commissioner finds, on the basis of the 

scientific evidence before him that no action has to be taken to remove 

from the market food, ingested drugs and ingested cosmetics containing 

the color additive.

    (d) Certificates issued for the following color additives and all 

mixtures containing these color additives are canceled and have no 

effect after October 4, 1966, and use of such color additives in the 

manufacture of foods, drugs, or cosmetics after that date will result in 

adulteration:



FD&C Green No. 1.

FD&C Green No. 2.

D&C Green No. 7.

D&C Red No. 5.

D&C Red No. 14.

D&C Red No. 18.

D&C Red No. 24.

D&C Red No. 29.

D&C Red No. 35.

D&C Red No. 38.

D&C Orange No. 3.

D&C Orange No. 8.

D&C Orange No. 14.

D&C Orange No. 15.

D&C Orange No. 16.

D&C Blue No. 7.

D&C Black No. 1.

Ext. D&C Yellow No. 5.

Ext. D&C Yellow No. 6.

Ext. D&C Red No. 1.

Ext. D&C Red No. 2.

Ext. D&C Red No. 3.

Ext. D&C Red No. 10.

Ext. D&C Red No. 11.

Ext. D&C Red No. 13.

Ext. D&C Red No. 14.

Ext. D&C Red No. 15.

Ext. D&C Blue No. 1.

Ext. D&C Blue No. 4.

Ext. D&C Orange No. 1.

Ext. D&C Orange No. 4.



    (e) Certificates issued for the following color additives and all 

mixtures containing these color additives are canceled and have no 

effect after July 1, 1968, and use of such color additives in the 

manufacture of drugs or cosmetics after that date will result in 

adulteration:



Ext. D&C Yellow No. 3.

Ext. D&C Red No. 8

Ext. D&C Orange No. 3.



    (f) Certificates issued for D&C Yellow No. 11 and all mixtures 

containing this color additive are canceled and have no effect after 

April 30, 1968, insofar as ingested use is concerned. Use of this color 

additive in the manufacture of ingested drugs or cosmetics subject to 

ingestion after that date will result in adulteration.

    (g) Certificates issued for D&C Red No. 17, D&C Red No. 31, D&C Red 

No. 34, D&C Orange No. 4, and D&C Violet No. 2, and all mixtures 

containing these color additives, are canceled and have no effect after 

December 31, 1968, insofar as ingested use is concerned. Use of these 

color additives in the manufacture of ingested drugs or cosmetics 

subject to ingestion after that date will result in adulteration.

    (h)(1) Certificates issued for FD&C Violet No. 1 and all mixtures 

containing this color additive are canceled and have no effect after 

April 10, 1973, and use of such color additive in the manufacture of 

foods, drugs, or cosmetics after that date will result in adulteration.

    (2) The Commissioner finds that no action needs to be taken to 

remove foods, drugs, and cosmetics containing this color additive from 

the market on the basis of the scientific evidence before him.

    (i) Certificates issued prior to July 1, 1968, for D&C Brown No. 1 

and Ext. D&C Violet No. 2 and all mixtures containing these colors are 

canceled and have no effect. This cancellation does not apply to 

certificates issued after March 15, 1973, for D&C Brown No. 1 and Ext. 

D&C Violet No. 2, which are provisionally listed in Sec.  81.1(b) and 

(c) respectively for coloring externally applied cosmetics.

    (j)(1) Certificates issued for FD&C Red No. 2 and all mixtures 

containing this color additive are canceled and have no effect after 

January 28, 1976, and use of this color additive in the manufacture of 

food, drugs, or cosmetics after this date will result in adulteration.

    (2) The Commissioner finds, on the basis of the scientific evidence 

before him, that no action has to be taken to remove from the market 

food, drugs, and cosmetics containing the color additive.

    (k)(1) Certificates issued for D&C Red No. 10, D&C Red No. 11, D&C 

Red No. 12, and D&C Red No. 13, their lakes and



[[Page 436]]



all mixtures containing these color additives or their lakes are 

cancelled and have no effect after December 13, 1977, and use of these 

color additivies in the manufacture of drugs or cosmetics after this 

date will result in adulteration.

    (2) The Commissioner finds, on the basis of the scientific evidence 

before him, that no action has to be taken to remove from the market, 

drug and cosmetic products containing the color additives.

    (l)(1) Certificates issued for Ext. D&C Yellow No. 1 and all 

mixtures containing this color additive are cancelled and have no effect 

after December 13, 1977, and use of this color additive in the 

manufacture of drugs or cosmetics after this date will result in 

adulteration.

    (2) The Commissioner finds, on the basis of the scientific evidence 

before him, that no action has to be taken to remove from the market 

drugs and cosmetics containing the color additive.

    (m)(1) Certificates issued for Ext. D&C Green No. 1 and all mixtures 

containing this color additive are cancelled and have no effect after 

November 29, 1977, and use of the color additive in the manufacture of 

drugs or cosmetics after this date will result in adulteration.

    (2) The Commissioner finds, on the basis of the scientific evidence 

before him, that no action has to be taken to remove from the market 

drugs and cosmetics containing the color additive.

    (n)(1) Certificates issued for D&C Orange No. 10, D&C Orange No. 11, 

their lakes, and all mixtures containing these color additives are 

cancelled and have no effect as pertains to their use in ingested drugs 

and cosmetics after April 28, 1981 and use of these color additives in 

the manufacture of ingested drugs or cosmetics after this date will 

result in adulteration.

    (2) The agency finds, on the basis of the scientific evidence before 

it, that no action has to be taken to remove from the market drugs and 

cosmetics to which the color additives were added on or before April 28, 

1981.

    (o)(1) Certificates issued for D&C Blue No. 6 and all mixtures 

containing this color additive are cancelled insofar as its use in drugs 

and cosmetics is concerned and have no effect after December 13, 1977, 

and use of the color additive in the manufacture of drugs or cosmetics 

after this date will result in adulteration. The color will continue to 

be certified for use in the coloring of surgical sutures.

    (2) The Commissioner finds, on the basis of the scientific evidence 

before him, that no action has to be taken to remove from the market 

drugs and cosmetics containing the color additive.

    (p)(1) Certificates issued for D&C Green No. 6, its lakes and all 

mixtures containing this color additive are cancelled and have no effect 

as pertains to their use in ingested drugs and cosmetics after May 4, 

1982 and use of the color additive in the manufacture of ingested drugs 

or cosmetics after this date will result in adulteration.

    (2) The agency finds, on the basis of the scientific evidence before 

it, that no action has to be taken to remove from the market ingested 

drugs and cosmetics containing the color additive.

    (q) [Reserved]

    (r)(1) Certificates issued for D&C Red No. 19 and D&C Red No. 37, 

their lakes, and all mixtures containing these color additives are 

cancelled and have no effect as pertains to their use in ingested drugs 

and cosmetics after February 4, 1983, and use of these color additives 

in the manufacture of ingested drugs or cosmetics after this date will 

result in adulteration.

    (2) The agency finds, on the scientific evidence before it, that no 

action has to be taken to remove from the market ingested drugs and 

cosmetics to which D&C Red No. 19 and D&C Red No. 37 were added on or 

before February 4, 1983, or externally applied drugs and cosmetics to 

which D&C Red No. 37 was added on or before June 6, 1986.

    (3) Certificates issued for D&C Red No. 37, its lakes, and all 

mixtures containing this color additive are cancelled and have no effect 

as pertains to its use in externally applied drugs and cosmetics after 

June 6, 1986, and use of this color additive in the manufacture of 

externally applied drugs or cosmetics after this date will result in 

adulteration.



[[Page 437]]



    (4) Certificates issued for D&C Red No. 19, its lakes, and all 

mixtures containing this color additive are cancelled and have no effect 

as pertains to its use in externally applied drugs and cosmetics after 

July 15, 1988, and use of this color in the manufacture of externally 

applied drugs or cosmetics after this date will result in adulteration.

    (5) The agency finds, on the scientific evidence before it, that no 

action has to be taken to remove from the market externally applied 

drugs and cosmetics to which D&C Red No. 19 was added on or before July 

15, 1988.

    (s)(1) Certificates issued for D&C Red No. 8 and D&C Red No. 9, 

their lakes, and all mixtures containing these color additives are 

canceled and have no effect as pertains to their use in mouthwash, 

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

after January 6, 1987, and use of these color additives in the 

manufacture of mouthwash, dentifrices, and ingested drugs, except 

ingested drug lip products, after this date will result in adulteration.

    (2) The agency finds, on the basis of the scientific evidence before 

it, that no action has to be taken to remove from the market mouthwash, 

dentifrices, and ingested drugs to which the color additives were added 

on or before January 6, 1987. Ingested drug lip products, however, are 

regulated for use in Sec. Sec.  74.1308 and 74.1309.

    (3) Certificates issued for D&C Red No. 8, and D&C Red No. 9, their 

lakes, and all mixtures containing these color additives are cancelled 

and have no effect as pertains to their use in ingested drug and 

cosmetic lip products and in externally applied drugs and cosmetics 

after July 15, 1988, and use of these color additives in the manufacture 

of ingested drugs and cosmetic lip products and in externally applied 

drugs and cosmetics after this date will result in adulteration.

    (4) The agency finds, on the basis of the scientific evidence before 

it, that no action has to be taken to remove from the market ingested 

drug and cosmetic lip products and externally applied drugs and 

cosmetics to which the color additives were added on or before July 15, 

1988.

    (t)(1) Certificates issued for D&C Orange No. 17, its lakes, and all 

mixtures containing this color additive are cancelled and have no effect 

as pertains to its use in ingested drugs and ingested cosmetics after 

March 31, 1983 and use of this color additive in the manufacture of 

ingested drugs or ingested cosmetics after this date will result in 

adulteration.

    (2) The agency finds, on the scientific evidence before it, that no 

action has to be taken to remove from the market drugs and cosmetics to 

which the color additive was added on or before March 31, 1983.

    (3) Certificates issued for D&C Orange No. 17, its lakes and all 

mixtures containing this color additive are cancelled and have no effect 

as pertains to its use in externally applied drugs and cosmetics after 

July 15, 1988, and use of this color in the manufacture of externally 

applied drugs or cosmetics after this date will result in adulteration.

    (4) The agency finds, on the scientific evidence before it, that no 

action has to be taken to remove from the market externally applied 

drugs and cosmetics to which D&C Orange No. 17 was added on or before 

July 15, 1988.

    (u)(1) Certificates issued for FD&C Red No. 3 and all mixtures 

containing this color additive are cancelled and have no effect as 

pertains to their use in cosmetics and externally applied drugs after 

January 29, 1990. Certificates issued for FD&C Red No. 3 lakes and all 

mixtures containing these lakes are cancelled and have no effect as 

pertains to their use in food, drugs, and cosmetics after January 29, 

1990. Certificates issued for D&C Red No. 3 lakes and all mixtures 

containing those lakes are cancelled and have no effect as pertains to 

their use in drugs and cosmetics after January 29, 1990. Use of this 

color additve in the manufacture of cosmetics and of externally applied 

drugs and any use of the lakes of FD&C Red No. 3 (including the lakes of 

D&C Red No. 3) after this date will result in adulteration.

    (2) The agency finds, on the scientific evidence before it, that no 

action must be taken to remove from the market food, drugs, and 

cosmetics to which the provisionally listed color additive or its lakes 

were added on or before January 29, 1990.



[42 FR 15665, Mar. 22, 1977]



[[Page 438]]





    Editorial Note: For Federal Register citations affecting Sec.  

81.30, 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 30


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