Appendix A - COLOR ADDITIVE STATUS LIST

Preface

This status list provides current information concerning color additives, and will enable you to determine the status and limitations of most color additives likely to be encountered in a food, drug, device, or cosmetic establishment.

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, [21 U.S.C. 361(e), 362(e), 376] and as it pertains to Sections 201(s)(3) and (t), 402(c), 403(m), 501(a), and 502(m) [21 U.S.C 321(s)(3), and (t), 342(c), 343(m), 351(a), and 352(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.

LIST 1

Color Additives subject to certification and permanently listed (unless otherwise indicated) for use in FOOD. Most are also listed for use in DRUGS AND COSMETICS as noted.

(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 - 74.1101, 74.2101, 82.101

FD&C Blue #2 - For food and ingested drug (GMP) and sutures (see medical devices). FD&C Blue #2 AluminumLakeon alumina (see medical devices). 74.102, 74.1102, 74.3102, 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. May no longer be used in cosmetics, external drugs, and lakes

FD&C Red #40 - and its Aluminum LakeFor food, drug and cosmetic use, including drugs and cosmetics for eye area - GMP - Other lakes for drugs and cosmetics are alsopermanently listed 74.340, 74.1340, 74.2340

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. at most 2 ppm by wt. of whole fruit - 74.302

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

The following colors, previously commonly used, are no longer authorized or have been restricted in their use:

FD&C Green #1 - Removed from list 81.30(d)
FD&C Green #2 - Removed from list 81.30(d)
FD&C Red #1 - Removed from list 81.30(d)
FD&C Red #2 - Removed from list (2-13-1976) 81.30(j)
FD&C Red #3 - All lakes, all cosmetics, and external drugs removed from list (2-1-1990) 81.30(u)
FD&C Red #4 - Food, ingested drugs, and ingested cosmetics removed from list (9-23-1976) 81.30(c)
FD&C Violet #1 (Removed from list on 4-10-73) 81.30(h)

LIST 2

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 unless otherwise indicated)

D&C Green #5 - For drugs and cosmetics including drugs and cosmetics for eye area - GMP - 74.1205, 74.2205, 82.1205

D&C Orange #5 - Drugs: mouthwashes and dentifrices that are ingested drugs (GMP), and external drugs (at most 5 mg per day). Cosmetics: lipsticks (at most 5% by wt. of finished product), mouthwashes and dentifrices that are ingested cosmetics, and external cosmetics (GMP) 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, 74.2327, 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, 82.1330

D&C Red #33 - Drugs: ingested drugs other than mouthwashes and dentifrices (at most 0.75 mg per day); and mouthwashes, dentifrices, and external drugs (GMP). Cosmetics: lipsticks (at most 3% by wt. of finished product); and mouthwashes, dentifrices and external cosmetics (GMP) 74.1333, 74.2333, 82.1333

D&C Red #36 - Drugs: ingested drugs, other than mouthwashes and dentifrices, if taken continuously for < 1 year (at most 1.7 mg per day ); ingested drugs if taken continuously for > 1 year (at most 1.0 mg per day); and external drugs (GMP). Cosmetics: lipsticks (at most 3% by wt. of finished product), and external 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

The following colors, previously commonly used, are no longer authorized for use or have been restricted in their use :

D&C Black #1 D&C Orange #15 D&C Red #13
D&C Blue #6 Drugs and cosmetics removed from list. Sutures allowed (12-13-1977) 81.30(o) 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 Red #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

LIST 3

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 Only external cosmetics - 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 -Only as an external drug in quaternary ammonium germicidal solutions (at most 0.1% by wt. of the finished product) 74.1339

D&C Violet #2 - External drugs and cosmetics (GMP) and contact lenses, sutures, haptics and tacks (see medical devices) 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) - The only permitted Ext. D&C lake is Ext. D&C Yellow No. 7 lake prepared from Ext. D&C Yellow No. 7 (GMP) 81.1, 82.2051, 82.2707a

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

LIST 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, natural and synthetic - 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

Phaffla yeast - For use in salmonid fish feed only. The quantity of astaxanthin in finished feed from phaffla yeast 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 - 73.355

Riboflavin - GMP - 73.450

Saffron - GMP - 73.500

Sodium copper chlorophyllin - For use in citrus-based dry beverage mixes in an amount not to exceed 0.2 percent in the dry mix- 73.125

Tagetes (Aztec marigold) meal and extract - Only chicken feed (ethoxyquin content at most 0.3% by wt. of additive and at most 150 ppm by wt. of final feed) 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

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

Alkanet (Alkane)

Calcium carbonate - Allowed in drugs

Carbon black

Charcoal - NF XI

Cudbear

Ferric chloride

Ferrous sulfate

Logwood, chips & extract - Logwood extract is still permitted in sutures

Safflower (American saffron)

LIST 5

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

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

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

LIST 6

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

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

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

Luminescent zinc sulfide - Externally applied cosmetics (nail polish and facial) - 73.2995

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)(2) - 73.2125

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:

4-Methyl-7-diethyl-aminocoumarin(MDAC)
Alloxan Cochineal
Bone Black Fuller's Earth
Carbon Black (Channel Process)
Carminic Acid Graphite
Chlorophyll Copper Complex
Cobaltous Aluminate (Cobalt Blue )
Gloss White Lithopone
Kieselguhr (Diatomite) Sienna
Logwood (Gluewood, Campeche wood)
Potassium Ferrocyanide B-Methyl umbelliferone
Vermiculite Umber
Zirconium oxide Zirconium Silicate

LIST 7

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-propenoic)ester copolymers - For use in contact lenses - GMP - 73.3100

1,4-Bis[(2-methylphenyl)amino]9,10-anthracenedione - For use in contact lenses - GMP - 73.3105

1,4-Bis[4(2-methacryloxyethyl) phenylamino] 9,10-anthraquinone copolymers - For use in contact lenses - GMP - 73.3106

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 Linear polyethylene surgical sutures and contact lenses (GMP). Limit £ 2% by wt - 73.1015, 73.3110a

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

C.I. Vat Orange 1 - For use in contact lenses - GMP - 73.3112

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 #5 For sutures (Limit = 0.6% by wt of suture); For drugs and cosmetics generally, including drugs and cosmetics for eye area - GMP - 74.1205, 74.2205, 82.1205.

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

D&C Violet No. 2 - Contact Lenses (GMP) For use in absorbable sutures. Limits are in regulation. For use in polymethylmethacrylate intraocular lens haptics at a level < 0.2% by wt. For use in absorbable meniscal tacks made from poly(L-lactic acid) at a level < 0.15% by wt - 74.3602

D&C Yellow #10 - Contact lenses (GMP).Subject to certification. 74.3710

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

FD&C Blue #2 - Nylon surgical sutures (at most 1% by wt. of the suture) 74.3102

FD&C Blue #2 Aluminum lake on alumina - Bone cement (at most 0.1% by wt. of the cement) 74.3102

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

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

Ferric Ammonium Citrate - For use in combination with pyrogallol for coloring plain or chromic catgut sutures. Limit FAC and pyrogallol £ 3% by wt - 73.1025

Logwood extract - for use in surgical sutures. Limit £ 1% by wt - 73.1410

Mica-based pearlescent pigments - For use in contact lenses- (GMP) 73.3128

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):

C.I. Reactive Blue 21,
C.I. Reactive Black 5,
C.I. Reactive Yellow 15
C.I. Reactive Orange 78
C.I. Reactive Blue 19
C.I. 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

Titanium dioxide - For use in contact lenses - GMP - 73.3126

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:

C.I. Reactive Black 5

C.I. Reactive Blue 19

C.I. Reactive Blue 21

C.I. Reactive Orange 78

C.I. Reactive Red 180

C.I. Reactive Yellow 15