U. S. Food
and Drug Administration Center
for Food Safety
& Applied Nutrition Office of Premarket Approval November
2000
|
Summary of Color Additives Listed for Use in
the United States in Foods, Drugs, Cosmetics, and Medical Devices
Notice: This document is not intended to be used as a substitute for the
regulations that list color additives for use in the United States and the
conditions imposed on their use in foods, drugs, cosmetics, and medical devices.
These regulations may be found in Title 21 of the Code of Federal Regulations
Parts 73 and 74. This summary groups the color additives according to their
categories of use and identifies the listing citation in Title 21 for each color
additive. The reader should refer to the regulation for the specific color
additive of interest. Any questions about the use of color additives may be
referred to the following address:
Office of Premarket Approval, HFS-200 Food and Drug
Administration 200 C Street, SW Washington, DC
20204 202-418-3066
Table of Contents
-
Color Additives Approved for Use in Human
Food
-
Color Additives Approved for Use in
Drugs
-
Color Additives Approved for Use in
Cosmetics
-
Color Additives Approved for Use in Medical
Devices
Notes
-
The color additives Astaxanthin, Ultramarine blue, Canthaxanthin, Synthetic
iron oxide, Dried algae meal, Tagetes (Aztec marigold) meal and extract, and
Corn endosperm oil are approved for specific uses in animal foods (see 21 CFR
73.35, 73.50, 73.75, 73.200, 73.275, 73.295, 73.315, respectively).
Haematococcus algae meal (21 CFR 73.185) and Phaffia yeast (21 CFR 73.355) for
use in fish feed to color salmoids were added in 7/6/2000.
-
The year approved is based on the date listed in the "Confirmation of
Effective Date" notice for the action as published in the Federal
Register.
-
Petitioned for use after the 1960 amendments; not provisionally
listed.
-
Lakes of certified straight color additives are provisionally listed under
21 CFR 81.1 for use as listed in 21 CFR 82.51 (food, drugs, and cosmetics), 21
CFR 82.1051 (drugs and cosmetics), or 21 CFR 2051 (external drugs and
cosmetics).
Color
Additives Approved for Use in Human Food Part
73, Subpart A: Color additives exempt from batch certification(1)
|
| 21 CFR Section |
Straight Color |
EEC# |
Year(2)
Approved |
Uses and
Restrictions |
| 73.30 |
Annatto extract |
E160b |
1963 |
Foods generally. |
| 73.40 |
Dehydrated beets (beet powder) |
E162 |
1967 |
Foods generally. |
| 73.75 |
Canthaxanthin(3) |
E161g |
1969 |
Foods generally, NTE 30 mg/lb of solid or semisolid food or per pint
of liquid food; May also be used in broiler chicken feed. |
| 73.85 |
Caramel |
E150a-d |
1963 |
Foods generally. |
| 73.90 |
-Apo-8'-carotenal |
E160e |
1963 |
Foods generally, NTE: 15 mg/lb solid, 15 mg/pt liquid. |
| 73.95 |
-Carotene |
E160a |
1964 |
Foods generally. |
| 73.100 |
Cochineal extract
| E120 |
1969 |
Foods generally. |
| Carmine |
1967 |
| 73.140 |
Toasted partially defatted cooked cottonseed flour |
---- |
1964 |
Foods generally. |
| 73.160 |
Ferrous gluconate |
---- |
1967 |
Ripe olives. |
| 73.165 |
Ferrous lactate |
---- |
1996 |
Ripe olives. |
| 73.169 |
Grape color extract(3) |
E163? |
1981 |
Nonbeverage food. |
| 73.170 |
Grape skin extract (enocianina) |
E163? |
1966 |
Still & carbonated drinks & ades; beverage bases; alcoholic
beverages (restrict. 27 CFR Parts 4 & 5). |
| 73.200 |
Synthetic iron oxide(3) |
E172 |
1994 |
Sausage casings NTE 0.1 percent (by wt). |
| 73.250 |
Fruit juice(3) |
---- |
1966 |
Foods generally. |
| 1995 |
Dried color additive. |
| 73.260 |
Vegetable juice(3) |
---- |
1966 |
Foods generally. |
| 1995 |
Dried color additive, water infusion. |
| 73.300 |
Carrot oil |
---- |
1967 |
Foods generally. |
| 73.340 |
Paprika |
E160c |
1966 |
Foods generally. |
| 73.345 |
Paprika oleoresin |
E160c |
1966 |
Foods generally. |
| 73.450 |
Riboflavin |
E101 |
1967 |
Foods generally. |
| 73.500 |
Saffron |
E164 |
1966 |
Foods generally. |
| 73.575 |
Titanium dioxide |
E171 |
1966 |
Foods generally; NTE 1 percent (by wt). |
| 73.600 |
Turmeric |
E100 |
1966 |
Foods generally. |
| 73.615 |
Turmeric oleoresin |
E100 |
1966 |
Foods generally. |
Color
Additives Approved for Use in Human Food Part
74, Subpart A: Color additives subject to batch certification(4) |
| 21 CFR Section |
Straight Color |
EEC# |
Year(2)Approved |
Uses and
Restrictions |
| 74.101 |
FD&C Blue No. 1 |
E133 |
1969 |
Foods generally. |
| 1993 |
Added Mn spec. |
| 74.102 |
FD&C Blue No. 2 |
E132 |
1987 |
Foods generally. |
| 74.203 |
FD&C Green No. 3 |
---- |
1982 |
Foods generally. |
| 74.250 |
Orange B(3) |
---- |
1966 |
Casings or surfaces of frankfurters and sausages; NTE 150 ppm (by
wt). |
| 74.302 |
Citrus Red No. 2 |
---- |
1963 |
Skins of oranges not intended or used for processing; NTE 2.0 ppm (by
wt). |
| 74.303 |
FD&C Red No. 3 |
E127 |
1969 |
Foods generally. |
| 74.340 |
FD&C Red No 40(3) |
E129 |
1971 |
Foods generally. |
| 74.705 |
FD&C Yellow No. 5 |
E102 |
1969 |
Foods generally. |
| 74.706 |
FD&C Yellow No. 6 |
E110 |
1986 |
Foods generally. |
Color
Additives Approved for Use in Drugs Part 73,
Subpart B: Color additives exempt from batch
certification |
| 21 CFR Section |
Straight Color |
Year(2)Approved |
Uses and Restrictions |
| 73.1010 |
Alumina (dried aluminum hydroxide) |
1967 |
Drugs generally. |
| 73.1030 |
Annatto extract |
1963 |
Ingested drugs generally; external drugs including eye area use. |
| 73.1070 |
Calcium Carbonate |
1967 |
Drugs generally. |
| 73.1075 |
Canthaxanthin(3) |
1969 |
Ingested drugs generally. |
| 73.1085 |
Caramel |
1963 |
Ingested and topically applied drugs generally. |
| 73.1095 |
-Carotene |
1964 |
Ingested drugs generally. |
| 1977 |
Externally applied drugs including eye area use. |
| 73.1100 |
Cochineal Extract |
1969 |
Ingested and externally applied drugs. |
| Carmine |
1967 |
| 73.1125 |
Potassium sodium copper chlorophyllin (chlorophyllin-copper
complex) |
1969 |
Dentrifices that are drugs; NTE 0.1% |
| 73.1150 |
Dihydroxyacetone |
1973 |
Externally applied drugs intended solely or in part to impart a color
to the human body |
| 73.1162 |
Bismuth oxychloride |
1977 |
Externally applied drugs including eye area use. |
| 73.1200 |
Synthetic iron oxide |
1966 |
Ingested or topically applied drugs ingested dosage by man NTE 5 mg/d
(as Fe). |
| 73.1298 |
Ferric ammonium ferrocyanide |
1977 |
Externally applied drugs including eye area use. |
| 73.1299 |
Ferric ferrocyanide |
1977 |
Externally applied drugs including eye area use. |
| 73.1326 |
Chromium hydroxide green |
1977 |
Externally applied drugs including eye area use. |
| 73.1327 |
Chromium oxide greens |
1977 |
Externally applied drugs including eye area use. |
| 73.1329 |
Guanine |
1977 |
Externally applied drugs including eye area use. |
| 73.1400 |
Pyrophillite |
1966 |
Externally applied drugs. |
| 73.1496 |
Mica |
1977 |
Externally applied drugs including eye area use. |
| 1987 |
Dentifrices. |
| 73.1550 |
Talc |
1967 |
Drugs generally. |
| 73.1575 |
Titanium dioxide |
1966 |
Drugs generally including eye area use; |
| 73.1645 |
Aluminum powder |
1977 |
Externally applied drugs including eye area use. |
| 73.1646 |
Bronze powder |
1977 |
Externally applied drugs including eye area use. |
| 73.1647 |
Copper Powder |
1977 |
Externally applied drugs including eye area use. |
| 73.1991 |
Zinc oxide |
1977 |
Externally applied drugs including eye area use. |
Color
Additives Approved for Use in Drugs(4)
Part 74, Subpart B: Color additives subject to batch
certification |
| 21 CFR Section |
Straight Color |
Year(2)Approved |
Uses and Restrictions |
| 74.1101 |
FD&C Blue No. 1 |
1969 |
Ingested drugs generally. |
| 1982 |
Externally applied drugs. |
| 1994 |
Eye area use (includes lake). |
| 74.1102 |
FD&C Blue No. 2 |
1987 |
Ingested drugs. |
| 74.1104 |
D&C Blue No. 4 |
1977 |
Externally applied drugs. |
| 74.1203 |
FD&C Green No. 3 |
1982 |
Drugs generally. |
| 74.1205 |
D&C Green No. 5 |
1982 |
Drugs generally. |
| 1994 |
Eye area use. |
| 74.1206 |
D&C Green No. 6 |
1982 |
Externally applied drugs. |
| 74.1208 |
D&C Green No. 8 |
1976 |
Externally applied drugs (NTE 0.01% (by weight). |
| 74.1254 |
D&C Orange No. 4 |
1977 |
Externally applied drugs. |
| 74.1255 |
D&C Orange No. 5 |
1984 |
Externally applied drugs (NTE 5 mg/daily dose of drug). |
| 1982 |
Mouthwashes and dentifrices. |
| 74.1260 |
D&C Orange No. 10 |
1981 |
Externally applied drugs. |
| 74.1261 |
D&C Orange No. 11 |
1981 |
Externally applied drugs. |
| 74.1303 |
FD&C Red No. 3 |
1969 |
Ingested drugs. |
| 74.1304 |
FD&C Red No. 4 |
1976 |
Externally applied drugs. |
| 74.1306 |
D&C Red No. 6 |
1983 |
Drugs such that total with D&C Red No. 7 NTE 5 mg/daily dose of
drug. |
| 74.1307 |
D&C Red No. 7 |
1983 |
Drugs such that total with D&C Red No. 6 NTE 5 mg/daily dose of
drug. |
| 74.1317 |
D&C Red No. 17 |
1976 |
Externally applied drugs. |
| 74.1321 |
D&C Red No. 21 |
1983 |
Drugs generally. |
| 74.1322 |
D&C Red No. 22 |
1983 |
Drugs generally. |
| 74.1327 |
D&C Red No. 27 |
1982 |
Drugs generally. |
| 74.1328 |
D&C Red No. 28 |
1982 |
Drugs generally. |
| 74.1330 |
D&C Red No. 30 |
1982 |
Drugs generally. |
| 74.1331 |
D&C Red No. 31 |
1976 |
Externally applied drugs. |
| 74.1333 |
D&C Red No. 33 |
1988 |
Ingested drugs, other than mouthwashes and dentifrices (NTE 0.75
mg/daily dose of drug); externally applied drugs, mouthwashes and
dentifrices. |
| 74.1334 |
D&C Red No. 34 |
1976 |
Externally applied drugs. |
| 74.1336 |
D&C Red No. 36 |
1989 |
Certain ingested drugs. (Limitations described in reg.) |
| 1988 |
Cosmetics, and externally applied drugs. |
| 74.1339 |
D&C Red No. 39 |
1966 |
Quaternary ammonium type germicidal solutions for external application
(NTE 0.1% (by wt) of finished drug product). |
| 74.1340 |
FD&C Red No. 40(3) |
1971 |
Drugs generally. |
| 1994 |
Eye area use (includes lake). |
| 74.1602 |
D&C Violet No. 2 |
1976 |
Externally applied drugs. |
| 74.1705 |
FD&C Yellow No. 5 |
1969 |
Ingested drugs generally. |
| 1985 |
Externally applied drugs. |
| 1994 |
Eye area use (includes lake). |
| 74.1706 |
FD&C Yellow No. 6 |
1986 |
Drugs generally. |
| 74.1707 |
D&C Yellow No. 7 |
1976 |
Externally applied drugs. |
| 74.1707a |
Ext. D&C Yellow No. 7 |
1976 |
Externally applied drugs. |
| 74.1708 |
D&C Yellow No. 8 |
1976 |
Externally applied drugs. |
| 74.1710 |
D&C Yellow No. 10 |
1983 |
Drugs generally. |
| 1984 |
Modification of uses and restrictions. |
| 74.1711 |
D&C Yellow No. 11 |
1976 |
Externally applied drugs. |
Color
Additives Approved for Use in Cosmetics Part
73, Subpart C: Color additives exempt from batch
certification |
| 21 CFR Section |
Straight Color |
Year(2)Approved |
Uses and Restrictions |
| 73.2030 |
Annatto |
1977 |
Cosmetics generally including eye area use. |
| 73.2085 |
Caramel |
1981 |
Cosmetics generally including eye area use. |
| 73.2087 |
Carmine |
1977 |
Cosmetics generally including eye area use. |
| 73.2095 |
-Carotene |
1977 |
Cosmetics generally including eye area use. |
| 73.2110 |
Bismuth citrate(3) |
1978 |
Cosmetics intended for coloring hair on the scalp (w/
restrictions). |
| 73.2120 |
Disodium EDTA-copper |
1974 |
Coloring of shampoos that are cosmetics. |
| 73.2125 |
Potassium sodium copper chlorophyllin (Chlorophyllin copper
complex) |
1969 |
Coloring dentifrices that are cosmetics (w/restrictions). |
| 73.2150 |
Dihydroxyacetone |
1973 |
Externally applied cosmetics intended solely or in part to impart
color to the human body. |
| 73.2162 |
Bismuth oxychloride |
1977 |
Cosmetics generally including eye area use. |
| 73.2180 |
Guaiazulene |
1977 |
Externally applied cosmetics. |
| 73.2190 |
Henna(3) |
1965 |
Coloring hair (w/restrictions). |
| 73.2250 |
Iron oxides |
1977 |
Cosmetics generally including eye area use. |
| 73.2298 |
Ferric ammonium ferrocyanide |
1977 |
Externally applied cosmetics including eye area use. |
| 73.2299 |
Ferric ferrocyanide |
1978 |
Externally applied cosmetics including eye area use. |
| 73.2326 |
Chromium hydroxide green |
1977 |
Externally applied cosmetics including eye area use. |
| 73.2327 |
Chromium oxide greens |
1977 |
Externally applied cosmetics including eye area use. |
| 73.2329 |
Guanine |
1977 |
Cosmetics generally including eye area use. |
| 73.2396 |
Lead acetate(3) |
1981 |
Cosmetics intended for coloring hair on the scalp (w/
restrictions). |
| 73.2400 |
Pyrophyllite |
1973 |
Externally applied cosmetics. |
| 73.2496 |
Mica |
1977 |
Cosmetics generally including eye area use. |
| 73.2500 |
Silver (3) |
1979 |
Coloring fingernail polish (NTE 1% of final product). |
| 73.2575 |
Titanium dioxide |
1973 |
Cosmetics generally including eye area use. |
| 73.2645 |
Aluminum powder |
1977 |
Externally applied cosmetics including eye area use. |
| 73.2646 |
Bronze powder |
1977 |
Cosmetics generally including eye area use. |
| 73.2647 |
Copper powder |
1977 |
Cosmetics generally including eye area use. |
| 73.2725 |
Ultramarines |
1976 |
Externally applied cosmetics including eye area use. |
| 73.2775 |
Manganese violet |
1976 |
Cosmetics generally including eye area use. |
| 73.2991 |
Zinc oxide |
1977 |
Cosmetics generally including eye area use. |
| 73.2995 |
Luminescent zinc sulfide (3) |
2000 |
Nail polish and externally applied facial makeup NTE 10% of final
product for limited, occasional use. |
Color
Additives Approved for Use in Cosmetics(4) Part 74, Subpart C: Color additives subject to batch
certification |
| 21 CFR Section |
Straight Color |
Year(2)Approved |
Uses and Restrictions |
| 74.2101 |
FD&C Blue No. 1 |
1982 |
Cosmetics generally. |
| 1993 |
Allows MnO2 in manufacture. |
| 1994 |
Eye area use (includes lake). |
| 74.2104 |
D&C Blue No. 4 |
1977 |
Externally applied cosmetics. |
| 74.2151 |
D&C Brown No. 1 |
1976 |
Externally applied cosmetics. |
| 74.2203 |
FD&C Green No. 3 |
1982 |
Cosmetics generally. |
| 74.2205 |
D&C Green No. 5 |
1982 |
Cosmetics generally. |
| 1994 |
Eye area use. |
| 74.2206 |
D&C Green No. 6 |
1982 |
Externally applied cosmetics. |
| 74.2208 |
D&C Green No. 8 |
1976 |
Externally applied cosmetics (NTE 0.01% (by wt) of finished cosmetic
product). |
| 74.2254 |
D&C Orange No. 4 |
1977 |
Externally applied cosmetics. |
| 74.2255 |
D&C Orange No. 5 |
1984 |
Externally applied cosmetics. |
| 1982 |
Restricted ingested uses. |
| 74.2260 |
D&C Orange No. 10 |
1981 |
Externally applied cosmetics. |
| 74.2261 |
D&C Orange No. 11 |
1981 |
Externally applied cosmetics. |
| 74.2304 |
FD&C Red No. 4 |
1976 |
Externally applied cosmetics. |
| 74.2306 |
D&C Red No. 6 |
1983 |
Cosmetics generally. |
| 74.2307 |
D&C Red No. 7 |
1983 |
Cosmetics generally. |
| 74.2317 |
D&C Red No. 17 |
1976 |
Externally applied cosmetics. |
| 74.2321 |
D&C Red No. 21 |
1982 |
Cosmetics generally. |
| 74.2322 |
D&C Red No. 22 |
1982 |
Cosmetics generally. |
| 74.2327 |
D&C Red No. 27 |
1982 |
Cosmetics generally. |
| 74.2328 |
D&C Red No. 28 |
1982 |
Cosmetics generally. |
| 74.2330 |
D&C Red No. 30 |
1982 |
Cosmetics generally. |
| 74.2331 |
D&C Red No. 31 |
1976 |
Externally applied cosmetics. |
| 74.2333 |
D&C Red No. 33 |
1988 |
Externally applied cosmetics; mouthwashes, dentifrices; cosmetic lip
products (NTE 3% (by wt) of finished cosmetic product). |
| 74.2334 |
D&C Red No. 34 |
1976 |
Externally applied cosmetics. |
| 74.2336 |
D&C Red No. 36 |
1988 |
Externally applied cosmetics; cosmetic lip products (NTE 3% (by wt) of
finished cosmetic product). |
| 74.2340 |
FD&C Red No. 40(3) |
1975 |
Cosmetics generally. |
| 1994 |
Eye area use (includes Al lake). No oxidizing or reducing agents that
may affect integrity. |
| 74.2602 |
D&C Violet No. 2 |
1976 |
Externally applied cosmetics. |
| 74.2602a |
Ext. D&C Violet No. 2 |
1976 |
Externally applied cosmetics. |
| 74.2705 |
FD&C Yellow No. 5 |
1985 |
Cosmetics generally. |
| 1994 |
Eye area use (includes lake). |
| 74.2706 |
FD&C Yellow No. 6 |
1986 |
Cosmetics generally. |
| 74.2707 |
D&C Yellow No. 7 |
1976 |
Externally applied cosmetics. |
| 74.2707a |
Ext. D&C Yellow No. 7 |
1976 |
Externally applied cosmetics. |
| 74.2708 |
D&C Yellow No. 8 |
1976 |
Externally applied cosmetics. |
| 74.2710 |
D&C Yellow No. 10 |
1983 |
Cosmetics generally. |
| 1984 |
Modification of uses and restrictions. |
| 74.2711 |
D&C Yellow No. 11 |
1976 |
Externally applied cosmetics. |
Color
Additives Approved for Use in Medical Devices Part 73, Subpart D: Color additives exempt from batch
certification |
| 21 CFR Section |
Straight Color |
Year(2)Approved |
Uses and Restrictions |
| 73.1015 |
Chromium-cobalt-aluminum oxide |
1974 |
Linear polyethylene surgical sutures NTE 2% general surgery. |
| 73.1025 |
Ferric ammonium citrate |
1973 |
With pyrogallol for coloring plain or chromic catgut sutures; NTE 3%
general and ophthalmic surgery. |
| 73.1375 |
Pyrogallol: C.I. Oxidation base 32 |
1973 |
With ferric ammonium citrate for coloring plain or chromic catgut
sutures; NTE 3% general and ophthalmic surgery. |
| 73.1410 |
Logwood extract; C.I. Natural black 1 |
1977 |
For coloring nylon 66, nylon 6, or silk non-absorbable sutures; NTE 1%
general and ophthalmic surgery. |
| 73.3100 |
1,4-Bis((2-hydroxy-ethyl)amino)-9,10-anthracenedione
bis(2-pric)ester copolymers |
1996 |
Contact lenses |
| 73.3105 |
1,4-Bis ((2-methylphenyl)amino) -9,10-anthracenedione(3) |
1984 |
Contact lenses. |
| 73.3106 |
1,4-Bis(4- (2-methacryloxyethyl) phenylamino) anthraquinone
copolymers(3) |
1990 |
Contact lenses. |
| 1993 |
Added copolymer, renamed. |
| 1995 |
Additional copolymer. |
| 73.3107 |
Carbazole violet(3) |
1988 |
Contact lenses. |
| 73.3110 |
Chlorophyllin-copper complex, oil soluble(3) |
1984 |
Bone cement only NTE 0.003%. |
| 73.3110a |
Chromium-cobalt-aluminum oxide(3) |
1988 |
Contact lenses. |
| 73.3111 |
Chromium oxide greens(3) |
1986 |
Contact lenses. |
| 73.3112 |
C.I. Vat Orange 1(3) |
1985 |
Contact lenses. |
| 73.3115 |
2-((2,5-Diethoxy- 4-((4-methylphenyl)thiol) phenyl)azo)
-1,3,5-benzenetriol(3) |
1983 |
Formed in situ in soft contact lenses to mark L and R NTE
1.1x10-7 g/lens. |
| 73.3117 |
C.I. Vat brown 1: 16,23-Dihydrodinaphtho (2,3-a:2',3'-i) naphth
(2',3':6,7) indolo (2,3-c) carbazole- 5,10,15,17,22,24-hexone(3) |
1983 |
Contact lenses. |
| 73.3118 |
C.I. Vat yellow 3: N,N'-(9,10-Dihydro- 9,10-dioxo- 1,5-anthracenediyl)
bisbenzamide(3) |
1983 |
Contact lenses. |
| 73.3119 |
C.I. Vat blue 6: 7,16-Dichloro- 6,15-dihydro-
5,9,14,18-anthrazinetetrone(3)
| 1983
| Contact lenses. |
| 73.3120 |
C.I. Vat green 1: 16,17-Dimethoxydinaphtho (1,2,3-cd:3',2',1'-lm)
perylene-5,10-dione(3)
| 1983 |
Contact lenses. |
| 73.3121 |
Poly(hydroxyethyl methacrylate) -dye copolymers(3):
one or more of (1) C.I. Reactive black 5 |
1984 |
Contact lenses. |
| (2) C.I. Reactive blue 21 |
1984 |
| (3) C.I. Reactive orange 78 |
1984 |
| (4) C.I. Reactive yellow 15 |
1984 |
| (5) C.I. Reactive blue 19 |
1985 |
| (6) C.I. Reactive blue 4 |
1985 |
| (7) C.I. Reactive red 11 |
1985 |
| (8) C.I. Reactive yellow 86 |
1985 |
| (9) C.I. Reactive blue 163 |
1985 |
| (10) C.I. Reactive red 180 |
1993 |
| 73.3122 |
C.I. Solvent Yellow 18: 4-((2,4-dimethylphenyl)azo)- 2,4-dihydro-
5-methyl-2-phenyl- 3H-pyrazol-3-one(3) |
1986 |
Contact lenses. |
| 73.3123 |
C.I. Vat orange 5: 6-Ethoxy-2- (6-ethoxy-3-oxobenzo(b) thien-2(3H)-
ylidene) benzo(b)thiophen- 3(2H)-one(3)
| 1986 |
Contact lenses. |
| 73.3124 |
Phthalocyanine green(3) |
1986 |
Contact lenses. |
| 73.3125 |
Iron oxides(3) |
1986 |
Contact lenses. |
| 73.3126 |
Titanium dioxide(3) |
1986 |
Contact lenses. |
| 73.3127 |
Vinyl alcohol/methyl methacrylate-dye reaction products(3);
one or more of: (1) C.I. Reactive red 180 |
1993 |
Contact lenses. |
| (2) C.I. Reactive black 5 |
| (3) C.I. Reactive orange 78 |
| (4) C.I. Reactive yellow 15 |
| (5) C.I. Reactive blue 19 |
| (6) C.I. Reactive blue 21 |
Color
Additives Approved for Use in Medical Devices Part 74, Subpart D: Color additives subject to batch
certification |
| 21 CFR Section |
Straight Color |
Year(2)Approved |
Uses and Restrictions |
| 74.1109 |
D&C Blue No. 9 |
1974 |
Cotton and silk surgical sutures; NTE 2.5% general and ophthalmic
use. |
| 74.1205 |
D&C Green No. 5 |
1973 |
Nylon 66 nonabsorbable sutures; NTE 0.6% general surgery. |
| 1977 |
Nylon 6 same conditions. |
| 74.3045 |
(Phthalocyaninato(2-)) copper |
1969 |
Polypropylene sutures NTE 0.5%. |
| 1983, 1986 |
Contact lenses.(3)
|
| 1985 |
Polybutester sutures NTE 0.5%.(3) |
| 1986 |
Increased chlorine spec.(3) |
| 1987 |
Haptics for intraocular lens NTE 0.5%.(3) |
| 1990 |
Polybutylene terephthalate sutures NTE 0.5%.(3) |
| 74.3102 |
FD&C Blue No. 2 |
1971 1999 |
Nylon surgical sutures; NTE 1% general surgery. Suture listing
moved from 74.1102 to 74.3102 |
| 1999(3) |
Bone cement |
| 74.3106 |
D&C Blue No. 6 |
1978, 1985(3) |
Various sutures NTE specified levels. |
| 74.3206 |
D&C Green No. 6 |
1963, 1975 |
Various sutures NTE specified levels. |
| 1983 |
Contact lenses NTE 0.03%.(3) |
| 1986 |
Uniform specifications.(3) |
| 1993 |
Haptics of intraocular lenses NTE 0.1%.(3) |
| 74.3230 |
D&C Red No. 17 |
1990 |
Contact lenses.(3) |
| 74.3602 |
D&C Violet No. 2 |
1974 1980 (3)
1993 (3)
1994 (3)
1998 (3)
2000 (3)
|
Various sutures, NTE specified levels. |
| 1987 |
Contact lenses.(3) |
1990 1999 (3)
|
Intraocular lens haptics.(3) Meniscal
tacks. |
| 74.3710 |
D&C Yellow No. 10 |
1987 |
Contact lenses.(3) |
|