To maintain concise form, this list is limited in many respects involving certification, regulations, labeling, etc. For specific details concerning these matters, please refer to the source documents, Code of Federal Regulations (CFR, Title 21, Parts 70 to 82) and to the Federal Food, Drug, and Cosmetic Act, as amended, Sections 601(e), 602(e), 706, and as it pertains to Sections 201(s)(3) and (t), 402(c), 403(m), 501(a), and 502(m).

Any color additives not included in this listing and found in the possession of manufacturers or processors where they may be used in foods, drugs, devices, or cosmetics should be referred to your district for consideration. Your Servicing Laboratory for color analysis is also a good reference source.

LAKES: Color additive lakes are provisionally listed under 21 CFR 81.1. Part 82 of 21 CFR explains how lakes may be manufactured and named and lists the color additives that may be used to manufacture lakes. All lakes are subject to certification.

Examples of nomenclature of lakes:

1. The name of a lake is formed from the name of the color additive combined with the name of the basic radical and the word "Lake". For example, the name of the lake prepared by extending the aluminum salt of FD&C Blue No. 1 upon alumina would be FD&C Blue No. 1 - Aluminum Lake.

2. If a lake is prepared by extending an FD&C color additive on a substratum other than alumina, the symbol "FD&C" will be replaced by "D&C". For example, the name of the lake prepared by extending the aluminum salt of FD&C Blue No. 1 upon a substratum other than alumina would be D&C Blue No. 1- Aluminum Lake.

NOTE: You are cautioned that this Exhibit is condensed and should be used for screening and guidance only. When you encounter situations involving possible violations of color additive regulations check the latest basic document as indicated in the second paragraph of this preface. Be certain of the complete status and report the facts. It is the district responsibility to instigate appropriate action, not yours. Do not advise firms to destroy stocks of possible suspect merchandise or institute recalls without district clearance.

Color Additives subject to certification and permanently listed (unless otherwise indicated) for FOOD DRUG and COSMETIC use.

(None of these colors may be used in products that are for use in the area of the eye, unless otherwise indicated).

FD&C Blue #1 - For food, drug and cosmetic use, including drugs and cosmetics for eye area - GMP - 74.101, 74.1101, 74.2101, 82.101 (Manganese dioxide now permitted in manufacturing process)

FD&C Blue #1 Aluminum Lake - For drug and cosmetic use in area of the eye - GMP

FD&C Blue #2 - For food and ingested drug use and for nylon surgical sutures (Limit £ 1% by wt of the suture) - GMP - 74.102, 74.1102, 82.102

FD&C Green #3 - For food, drug and cosmetic use - GMP -74.203, 74.1203, 74.2203, 82.203

FD&C Red #3 - For food and ingested drugs - GMP - 74.303, 74.1303. Lake use terminated 2-1-90; All cosmetic uses terminated 2-1-90.

FD&C Red #40 - For food, drug and cosmetic use, including drugs and cosmetics for eye area - GMP - 74.340, 74.1340, 74.2340

FD&C Red #40 Aluminum Lake - For drug and cosmetic eye area use - GMP

FD&C Yellow #5 - For food, drug and cosmetics, including drugs and cosmetics for eye area - GMP - 74.705, 74.1705, 74.2705, 82.705

FD&C Yellow #5 Aluminum Lake - For drug and cosmetic eye area use - GMP

FD&C Yellow #6 - For food, drug and cosmetics - GMP - 74.706, 74.1706, 74.2706, 82.706

FD&C Lakes (See Preface of this exhibit) - Provisionally listed. May be prepared from any of the above certified FD&C colors, except FD&C Red #3 - GMP - 81.1, 82.51

Citrus Red #2 - Permanently listed for use only in coloring of skins of mature oranges. Limit of 2 ppm calculated on basis of whole fruit weight - 74.302

Orange B - Permanently listed for use in coloring surfaces and casings of frankfurters or sausages. Limit £ 150 ppm by wt. of finished product - 74.250

FD&C Green #1

FD&C Green #2

FD&C Red #1

FD&C Red #2 (Removed from list on 2-13-76)

FD&C Red #3 (Lakes removed from list for all uses on 2/1/90. Straight color removed from list for cosmetic and external drug use 2/1/90.)

FD&C Red #4 (Removed from list for ingested uses on 9-23-76)

FD&C Violet #1 (Removed from list on 4-10-73)

Color additives subject to certification and permanently listed (unless otherwise indicated) for DRUG AND COSMETIC use.

(None of these colors may be used in products that are for use in the area of the eye)

D&C Green #5 - For drugs generally and sutures (Limit £ 0.6% by wt of suture) - GMP - 74.1205, 74.2205, 82.1205

D&C Orange #5 - For mouthwashes and dentifrices that are ingested drugs (GMP) and for externally applied drugs, limit £ 5 mg per day; For mouthwashes and dentifrices that are ingested cosmetics and for external cosmetics, GMP; for lipsticks, limit £ 5% by wt of finished product - 74.1255, 74.2255, 82.1255

D&C Red #6 - For drugs (combined total of D&C Red No.6 & D&C Red No. 7 £ 5 mg per day); For cosmetics (GMP) - 74.1306, 74.2306, 82.1306

D&C Red #7 - For drugs (combined total of D&C Red No.6 & D&C Red No. 7 £ 5 mg per day); For cosmetics (GMP) - 74.1307, 74.2307, 82.1307

D&C Red #21 - For drugs generally and cosmetics - GMP - 74.1321, 74.2321, 82.1321

D&C Red #22 - For drugs generally and cosmetics - GMP - 74.1322, 74.2322, 82.1322

D&C Red #27 - For drugs generally and cosmetics - GMP - 74.1327, 74.2322, 82.1327

D&C Red #28 - For drugs generally and cosmetics - GMP - 74.1328, 74.2328, 82.1328

D&C Red #30 - For drugs generally and cosmetics - GMP - 74.1330, 74.2330

D&C Red #33 - For ingested drugs other than mouthwashes and dentifrices, limit £ 0.75 mg per day; for externally applied drugs, mouthwashes and dentifrices, GMP; Cosmetics: lipsticks, limit £ 3% by wt of finished product; mouthwashes, dentifrices and externally applied cosmetics, GMP - 74.1333, 74.2333, 82.1333

D&C Red #36 - For ingested drugs other than mouthwashes and dentifrices, limit £ 1.7 mg per day (if taken continuously for < 1 year); £ 1.0 mg per day (if taken continuously for > 1 year); for externally applied drugs, GMP; Cosmetics: lipsticks, limit £ 3% by wt of finished product; externally applied cosmetics, GMP - 74.1336, 74.2336, 82.1336

D&C Yellow #10 - For drugs generally and cosmetics - GMP -74.1710, 74.2710, 82.1710

D&C Lakes (See Preface of this Exhibit) - Provisionally listed. May be prepared from any of the FD&C or D&C color additives listed in part 82

D&C Black #1 D&C Orange #15 D&C Red #13

D&C Blue #6 D&C Orange #16 D&C Red #14

D&C Blue #7 D&C Orange #17 D&C Red #18

D&C Green #7 D&C #5 D&C Red #19

D&C Orange #3 D&C Red #8 D&C Red #24

D&C Orange #8 D&C Red #9 D&C Red #29

D&C Orange #14 D&C Red #10 D&C Red #35

D&C Red #11 D&C Red #37 D&C Red #12

D&C Red #38

Color Additives subject to certification and permanently listed (unless otherwise indicated) for use in EXTERNALLY APPLIED DRUGS & COSMETICS.

(None of these colors may be used in products that are for use in the area of the eye)

D&C Brown #1 - GMP - 74.2151

FD&C Red #4 - For use only in externally applied drugs and cosmetics - GMP - 74.1304, 74.2304, 82.304

D&C Red #17 - GMP - 74.1317, 74.2317, 82.1317

D&C Red #31 - GMP - 74.1331, 74.2331, 82.1331

D&C Red #34 - GMP - 74.1334, 74.2334, 82.1334

D&C Red #39 - For use only in externally applied quaternary ammonium germicidal solutions (limit £ 0.1% by wt of the finished product) - 74.1339

D&C Violet #2 - GMP - 74.1602, 74.2602, 82.1602

Ext. D&C Violet #2 - For external cosmetics only - GMP - 74.2602a

D&C Blue #4 - GMP - 74.1104, 74.2104, 82.1104

D&C Green #6 - GMP - 74.1206, 74.2206, 82.1206

D&C Green #8 - Limit £ 0.01% by wt of finished drug or cosmetic - 74.1208, 74.2208

D&C Yellow #7 - GMP- 74.1707, 74.2707, 82.1707

Ext. D&C Yellow #7 - GMP - 74.1707a, 74.2707a, 82.2707a

D&C Yellow #8 - GMP - 74.1708, 74.2708, 82.1708

D&C Yellow #11 - GMP - 74.1711, 74.2711

D&C Orange #4 - GMP - 74.1254, 74.2254, 82.1254

D&C Orange #10 - GMP - 74.1260, 74.2260, 82.1260

D&C Orange #11 - GMP - 74.1261, 74.2261, 82.1261

Ext. D&C Lakes (See Preface of this Exhibit) - May be prepared from any of the above legal Ext. D&C colors - GMP -81.1, 82.2051

The following colors, previously commonly used, are no longer authorized for use:

Ext D&C Blue #1 Ext D&C Red #1

Ext D&C Red #11 Ext D&C Yellow #3

Ext D&C Blue #4 Ext D&C Red #2

Ext D&C Red #13 Ext D&C Yellow #5

Ext D&C Green #1 Ext D&C Red #3

Ext D&C Red #14 Ext D&C Yellow #6

Ext D&C Orange #1 Ext D&C Red #8

Ext D&C Red #15 Ext D&C Yellow #9

Ext D&C Orange #3 Ext D&C Red #10

Ext D&C Yellow #1 Ext D&C Yellow #10

Ext D&C Orange #4

Color additives exempt from certification and permanently listed for FOOD use.

Algae Meal, dried - For use in chicken feed only. Ethoxyquin content £ 0.3% (Ethoxyquin content in final feed £ 150 ppm). 73.275

Annatto extract - GMP - 73.30

Astaxanthin - For use in salmonid fish feed only. Limit < 8 mg per kg of finished feed - 73.35

Beet juice - (as vegetable juice) - GMP - 73.260

Beet Powder (Dehydrated beets) - GMP - 73.40

Beta carotene - GMP - 73.95

Canthaxanthin - Limit: £ 30 mg/lb of solid or semisolid food or per pint of liquid food; may also be used in broiler chicken feed at an amount £ 4.41 mg per kg (4 gm/ton) of complete feed - 73.75

Caramel - GMP - 73.85

Carmine - GMP - 73.100

Carrot oil - GMP - 73.300

Cochineal extract - GMP - 73.100

Corn Endosperm Oil - For use only in chicken feed - 73.315

Toasted partially defatted cooked cottonseed flour - GMP - 73.140

Ferrous Gluconate - To color ripe olives only - GMP - 73.160

Ferrous Lactate - To color ripe olives only - GMP - 73.165

Fruit juice - GMP - 73.250

Grape Color Extract - To color nonbeverage food - 73.169

Grape Skin Extract (enocianina) - To color still and carbonated drinks and ades, beverage bases and alcoholic beverages (in accordance with Parts 4 & 5 of 27 CFR) - 73.170 

Haematococcus Algae Meal – For use in salmonid fish feed only. The quantity of astaxanthin in finished feed from haematococcus algae meal when used alone or in combination with other astaxanthin color additive sources listed in part 73, shall not exceed 80 mg per kg of finished feed – 73.185

Synthetic Iron Oxide - For coloring sausage casings and for cat & dog food. Limit: £ 0.1% by wt of finished food (humans) and 0.25% by wt of finished food for dogs and cats - 73.200

Paprika & Paprika oleoresin - GMP - 73.340; 73.345

Riboflavin - GMP - 73.450

Saffron - GMP - 73.500

Tagetes Meal & Extract (Aztec Marigold) - For use in chicken feed only. Ethoxyquin content £ 0.3% (Ethoxyquin content in final feed £ 150 ppm) - 73.295

Titanium dioxide - Limit: £ 1.0% by wt of food - 73.575

Turmeric & Turmeric oleoresin - GMP - 73.600 & 73.615

Ultramarine Blue - To color salt for animal feed only; Limit: £ 0.5% by wt of salt - 73.50

Vegetable Juice - GMP - 73.260

Beta-Apo-8'-Caroteneal - Limit: £ 15 mg/lb of solid or semisolid food or per pint of liquid food - 73.90

Color additives exempt from certification and permanently listed for DRUG use.

Alumina - Drugs generally - GMP - 73.1010

Aluminum Powder - Externally applied drugs, including those for eye area use - GMP - 73.1645

Annatto Extract - Drugs generally, including those for eye area use - GMP - 73.1030

Bismuth oxychloride - Externally applied drugs only, including those for eye area - GMP - 73.1162

Bronze Powder - Externally applied drugs only, including those for eye area - GMP - 73.1646

Calcium carbonate - Drugs generally - GMP - 73.1070

Canthaxanthin - GMP - Ingested drugs only - 73.1075

Caramel - Drugs generally - GMP - 73.1085

Carmine - Drugs generally - GMP - 73.1100

Chlorophyllin, copper complex - To color dentrifices that are drugs only. Limit £ 0.1% - 73.1125

Cochineal extract - Drugs generally - GMP - 73.1100

Beta-carotene, natural and synthetic - Drugs generally, including those for eye area - GMP - 73.1095

Chromium hydroxide, green - Externally applied drugs, including those for eye area - GMP - 73.1326

Chromium oxides greens - Externally applied drugs, including those for eye area - GMP - 73.1327

Copper, metallic powder - Externally applied drugs, including those for eye area - GMP - 73.1647

Potassium sodium copper chlorophyllin (Chlorophyllin copper complex) - To color dentifrices that are drugs only. Limit £ 0.1% - 73.1125

Dihydroxyacetone - Externally applied drugs intended to impart a color to the human body - GMP - 73.1150

Ferric Ammonium ferrocyanide (Iron Blue) - Externally applied drugs, including those for eye area - GMP - 73.1298

Ferric Ferrocyanide (Iron Blue) - Externally applied drugs, including those eye area - GMP - 73.1299

Guanine (Pearl essence) - Externally applied drugs, including those eye area - GMP - 73.1329

Mica - To color dentifrices and externally applied drugs, including those for eye area - GMP - 73.1496

Pyrophyllite - Externally applied drugs - GMP - 73.1400

Synthetic iron oxide - Drugs generally. Limit for ingested drugs £ 5 mg elemental iron per day - 73.1200

Talc - Drugs generally - GMP - 73.1550

Titanium dioxide - Drugs generally, including those for eye area - GMP - 73.1575

Zinc oxide - Externally applied drugs, including those for eye area - GMP - 73.1991

The following colors, previously commonly used, are no longer authorized for use:

Bone Black Charcoal NF XI

Chlorophyll copper complex Ultramarine Blue

Fustic

Color additives exempt from certification and permanently listed for COSMETIC use.

Aluminum Powder - Externally applied cosmetics, including those for eye area - GMP -73.2645

Annatto - Cosmetics generally, including those for eye area - GMP - 73.2030

Bismuth Citrate - For cosmetics intended to color hair on scalp only (Not for coloring eyelashes or eyebrows or other body hair). Limit £ 0.5% - 73.2110

Bismuth oxychloride - Cosmetics generally, including those for eye area - GMP - 73.2162

Bronze powder - Cosmetics generally, including those for eye area - GMP - 73.2646

Caramel - Cosmetics generally, including those for eye area -GMP - 73.2085

Carmine - Cosmetics generally, including those for eye area -GMP - 73.2087

Beta-carotene - Cosmetics generally, including those for eye area - GMP - 73.2095

Chromium hydroxide green - Externally applied cosmetics, including those for eye area - GMP - 73.2326

Chromium oxide greens - Externally applied cosmetics, including those for eye area - GMP -73.2327

Copper, metallic powder - Cosmetics generally, including those for eye area - GMP - 73.2647

Dihydroxyacetone - Externally applied cosmetics - GMP - 73.2150

Disodium EDTA-Copper - Cosmetic shampoos - GMP - 73.2120

Ferric ammonium ferrocyanide - Externally applied cosmetics, including those for eye area - GMP - 73.2298

Ferric ferrocyanide - Externally applied cosmetics, including those for eye area - GMP - 73.2299

Guanine (Pearl essence) - Cosmetics generally, including those for eye area - GMP - 73.2329

Guaiazulene (Azulene) - ; Externally applied cosmetics - GMP -73.2180

Henna - For coloring hair only, not for coloring eyelashes or eyebrows - 73.2190

Iron oxides - Cosmetics generally, including those for eye area - GMP - 73.2250

Lead Acetate - For coloring hair only, not for coloring mustaches, eyelashes, eyebrows or other body hair. Limit £ 0.6% (wt/v) - 73.2396

Manganese Violet - Cosmetics generally, including those for eye area - GMP - 73.2775

Mica - Cosmetics generally, including those for eye area - GMP - 73.2496

Potassium sodium copper chlorophyllin (chlorophyllin copper complex) - For coloring cosmetic dentifrices. Limit £ 0.1%. May be used only in combination with the substances listed in 21 CFR 73.2125(b)

Pyrophyllite - Externally applied cosmetics - GMP - 73.2400

Silver - For coloring fingernail polish. Limit £ 1% - 73.2500

Titanium dioxide - Cosmetics generally, including those for eye area - GMP - 73.2575

Ultramarines (Blue, Green, Pink, Red & Violet) - Externally applied cosmetics, including those for eye area - GMP - 73.2725

Zinc oxide - Cosmetics generally, including those for eye area - GMP - 73.2991

The following colors, previously commonly used, are no longer authorized for use:

Color Additives exempt from certification (unless otherwise indicated) and permanently listed for use in MEDICAL DEVICES

1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-pric)ester copolymers - For use in contact lenses - GMP - 73.3100

Carbazole violet - For use in contact lenses - GMP- 73.3107

Chlorophyllin-copper complex - For coloring polymethylmeth-acrylate bone cement. Limit £ 0.003% by wt - 73.3110

Chromium-Cobalt-Aluminum oxide – For use in polyethylene surgical sutures. Limit £ 2% by wt - 73.1015

Chromium oxide greens - For use in contact lenses - GMP - 73.3111

16,23-Dihydrodinaptho[2,3-a:2',3'-i]napth[2',3':6,7]indolo [2,3-c]carbazole-5,10,15,17,22,24-hexone - For use in contact lenses - GMP - 73.3117

N,N'-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenz-amide - For use in contact lenses - GMP - 73.3118

7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone - For use in contact lenses - GMP - 73.3119

16,17-Dimethoxydinaptho[1,2,3-cd:3',2',1'-lm]perylene-5,10-dione - For use in contact lenses - GMP - 73.3120

4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl -3H-pyrazol-3-one - For use in contact lenses - GMP - 73.3122

D&C Blue #6 - For use in surgical sutures. Subject to certification. Limits are in regulation - 74.3106

D&C Blue #9 - For use in surgical sutures. Subject to certification. Limit £ 2.5% by wt - 74.1109

D&C Green #6 - For use in surgical sutures, haptics and contact lenses. Subject to certification. Limits are in regulation - 74.3206

D&C Red 17 - For use in contact lenses. Subject to certification - GMP - 74.3230

2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5- benzenetriol - For use in marking soft contact lenses with the letter R or L. Limit £ 0.11 microgram in a contact lens - 73.3115

6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2-(3H)-ylidene)benzo[b]thiophen-3-(2H)-one - For use in contact lenses - GMP -73.3123

[Phthalocyaninato(2-)] copper - For use in sutures (limit £ 0.5% by wt) and contact lenses (GMP). Subject to certification - 74.3045

Iron oxides - For use in contact lenses - GMP - 73.3125

Phthalocyanine green - For use in contact lenses - GMP - 73.3124

Poly(hydroxyethyl methacrylate)-dye copolymers - For use in contact lenses - GMP - 73.3121

The color additives are formed by reacting one or more of the following dyes with poly(hydroxyethyl methacrylate):

Reactive Blue 21,
Reactive Black 5,
Reactive Yellow 15
Reactive Orange 78
Reactive Blue 19
Reactive Blue 4
C.I. Reactive Red 11
C.I. Reactive Red 180
C.I. Reactive Yellow 86
C.I. Reactive Blue 163

Pyrogallol – For use in combination with ferric ammonium citrate for coloring plain or chromic catgut sutures. Limit FAC and pyrogallol £ 3% by wt - 73.1025

Vinyl alcohol/methyl methacrylate - dye reaction products - for use in contact lenses - GMP 73.3127

The color additives are formed by reacting one or more of the following dyes with vinyl alcohol/methyl methacrylate copolymers: