[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR81.30]
[Page 436-440]
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
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 437]]
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 438]]
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 439]]
(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 440]]
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.
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