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Appendix A - COLOR ADDITIVE STATUS LISTPrefaceThis 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:
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 1Color 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)
LIST 2Color additives subject to certification and permanently listed (unless otherwise indicated) for DRUG AND COSMETIC use.
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
LIST 3Color 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
LIST 4Color 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 5Color 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
LIST 6Color 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)
LIST 7Color 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,
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
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