Color Add Status List (2023)

Food Additives Status List

foreword

Formerly called Appendix A of the Investigations Operations Manual (IOM), this status list provides up-to-date information on color additives and allows you to identify the status and limitations of most color additives that may be found in a food, drug, appliance, or cosmetic establishment.

For the sake of brevity, this list is limited in a number of ways in terms of certifications, regulations, labeling, etc. and 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 with respect to sections 201(s)(3) and (t), 402(c), 403(m), 501(a) and 502(m) [ 21 USC 321(s)(3) and (t), 342(c), 343(m), 351(a) and 352(m)].

LIST 1

Color additives that require certification and are permanently listed (unless otherwise noted) for use inESSEN. Most are also listed for use inDRUGS AND COSMETICSas observed. (None of these colors may be used in products intended for the eye area unless otherwise noted).

FD&C Azul Nr. 1- Food, medicines and cosmetics, including medicines and cosmetics for the eye area - GMP - 74.101, 74.1101, 74.2101, 82.101
FD&C Blau Nr. 1 Aluminiumlagune- Medicines and cosmetics for the eye area - GMP - 74.1101, 74.2101, 82.101
FD&C Azul Nr. 2- Ingested food and medicines - GMP - 74.102, 74.1102; Suture material - see medical devices - 74.3102.
FD&C Blue #2 Aluminium Lake aus Aluminiumoxid- Bone cement - see medical devices - 74.3102, 82.102
FD&C Green #3- Food, medicine and cosmetics - GMP - 74.203, 74.1203, 74.2203, 82.203
FD&C Rot Nr. 3- Ingested food and medicines - GMP - 74.303, 74.1303. Can no longer be used in cosmetics, external medicines, and varnishes
FD&C Red #40 and its aluminum lagoon- Food, medicines and cosmetics, including medicines and cosmetics for the eye area - GMP. Other lakes for food, medicine and cosmetics are also permanently listed - 74.340, 74.1340, 74.2340
FD&C-Gelb Nr. 5- Food, medicines and cosmetics, including medicines and cosmetics for the eye area - GMP - 74.705, 74.1705, 74.2705, 82.705
FD&C Gelb Nr. 5 Aluminiumlack- Medicines and cosmetics for the eye area - GMP - 74.1705, 74.2705, 82.705
FD&C-Gelb Nr. 6- Food, medicine and cosmetics - GMP - 74.706, 74.1706, 74.2706, 82.706
FD&C Lagos(See preface to this exhibition) - Provisionally listed. Can be made from any of the above certified FD&C colors except FD&C Red #3 - GMP - 81.1, 82.51
Citrus Red #2- peel of ripe oranges - ≤ 2 wppm. of whole fruits - 74,302 Orange B - Surfaces and casings of sausages or sausages - ≤ 150 wppm. of the finished product - 74,250

The use of the following color additives is no longer permitted or has been restricted:

FD&C Green Nr. 1 - Removido da lista - 81.30(d)
FD&C Green Nr. 2 - Removido da lista - 81.30(d)
FD&C Red #1 – Delisted – 81.10(c), 81.30(b)(1)
FD&C Red #2 - Delisted - 81.10(f), 13 February 1976 - 81.30(j)
FD&C Red #3 - All varnishes, all cosmetics and external drugs delisted - 81.10(u), February 1, 1990 - 81.30(u). The use of FD&C Red #3, but not its varnishes, in ingested foods and pharmaceuticals is permitted.
FD&C Red #4 – Ingested foods, drugs and ingested cosmetics have been removed from the list. Use in medicines and cosmetics for external use is permitted - 81.10(d), September 23, 1976 - 81.30(c).
FD&C Violet #1 - Delisted - 81.10(e), 10 Apr 1973 - 81.30(h)

LIST 2

Color additives are subject to certification and are permanently listed (unless otherwise noted).PHARMACEUTICALS AND COSMETICSuse. (None of these colors may be used in products for use around the eye area unless otherwise noted)

D&C Therefore #2- Only for the following cosmetics: eyeliner, eyebrow brush, eyeshadow, mascara, lipstick, blush and blush, make-up and foundation and nail polish - GMP - 74.2052
D&C Verde Nr. 5- For medicines and cosmetics, including medicines and cosmetics for the eye area - GMP - 74.1205, 74.2205, 82.1205
D&C Laranja No. 5- Medication: mouthwash and dentifrices that are ingested medication (GMP) and external medication (maximum 5 mg per day). Cosmetics: lipsticks (maximum 5% by weight of the final product), mouthwashes and dentifrices which are ingestible cosmetics and external cosmetics (GMP) 74.1255, 74.2255, 82.1255
D&C Root No. 6- For pharmaceuticals (combined D&C Red #6 and D&C Red #7 <5 mg per day); for cosmetics (gmp) -74.1306 ,= "" 74.2306,="">
D&C Root No. 7- For pharmaceuticals (combined D&C Red #6 and D&C Red #7 <5 mg per day); for cosmetics (gmp) -74.1307 ,="" 74.2307,="">
D&C Root No. 21- For pharmaceuticals in general and cosmetics - GMP -74.1321, 74.2321, 82.1321
D&C Root No. 22- For pharmaceuticals in general and cosmetics - GMP -74.1322, 74.2322, 82.1322
D&C Root No. 27- For pharmaceuticals in general and cosmetics - GMP -74.1327, 74.2327, 82.1327
D&C Root No. 28- For pharmaceuticals in general and cosmetics - GMP -74.1328, 74.2328, 82.1328
D&C Root No. 30- For pharmaceuticals in general and cosmetics - GMP -74.1330, 74.2330, 82.1330
D&C Root No. 33- Drugs: ingested drugs other than mouthwash and dentifrices (maximum 0.75 mg per day); and mouthwashes, dentifrices and external medicines (GMP). Cosmetics: lipsticks (maximum 3% by weight of the final product); and Mouthwash, Dentifrices and External Cosmetics (GMP) 74.1333, 74.2333, 82.1333
D&C Root No. 36- Medications: Ingested medications, excluding mouthwashes and toothpastes, if taken continuously < 1 year (at most 1.7 mg per day). ;= " "taken="" drug="" if="" taken="" continuously="" for=""> 1 year (maximum 1.0 mg per day); and external medicinal products (GMP). Cosmetics: lipsticks (maximum 3% by weight of the final product) and external cosmetics (GMP) 74.1336, 74.2336, 82.1336
D&C-Gelb Nr. 10- For pharmaceuticals in general and cosmetics - GMP -74.1710, 74.2710, 82.1710
D&C Lakes (see preamble to this appendix)- Provisionally listed. Can be made from any of the FD&C or D&C color additives listed in Part 82

The use of the following color additives is no longer permitted or has been restricted:

D&C Black No. 1 - 4 September 1966 - 81.30 hours (d)
D&C Blue #6 - Use in pharmaceuticals and cosmetics is no longer approved. 81.10(n); Use in seams is permitted (December 13, 1977) - 81.30 (o)
D&C Blue No. 7 - 4 September 1966 - 81.30 hours (d)
D&C Green #6 – Use in ingested medicines and ingested cosmetics is no longer approved. Mar. 27, 1981 – 81.10(o). Use in external medicines, external cosmetics and sutures is allowed
D&C Green No. 7 - 4 September 1966 - 81.30 hours (d)
D&C Orange #3 - 4. September 1966 - 81h30 (d)
D&C Orange Nr. 8 - 4 September 1966 - 81h30 (d)
D&C Orange No. 10 - Discontinued Use in Ingested Drugs and Ingested Cosmetics - 81.10(m), 28 April 1981 - 81.30(n). Use in external medicines and external cosmetics is allowed
D&C Orange No. 11 - Discontinued Use in Ingested Drugs and Ingested Cosmetics - 81.10(m), 28 April 1981 - 81.30(n). Use in external medicines and external cosmetics is allowed
D&C Orange #14 - 4. September 1966 - 81.30 (d)
D&C Orange #15 - 4. September 1966 - 81.30 (d)
D&C Orange #16 - Sep 4, 1966 - 81:30 (d)
D&C Orange #17 - Delisted March 31, 1983 - 81.10(s)
D&C Red #5 - Sep 4, 1966 - 81:30 (d)
D&C Red #8 - Delisted January 6, 1987 - 81.10(t), 81.30(s)(1); July 15, 1988 - 81.30 (s) (3)
D&C Red #9 - Delisted January 6, 1987 - 81.10(t), 81.30(s)(1); July 15, 1988 - 81.30 (s) (3)
D&C Red #10 - Delisted December 13, 1977 - 81.10(h), 81.30(k)
D&C Red #11 - Delisted 13 December 1977 - 81.10(h), 81.30(k)
D&C Red #12 - Delisted 13 December 1977 - 81.10(h), 81.30(k)
D&C Red #13 - Delisted 13 December 1977 - 81.10(h), 81.30(k)
D&C Rot Nr. 14 - 4. September 1966 - 81.30 (d)
D&C Red #18 - Sep 4, 1966 - 81:30 (d)
D&C Red #19 - Delisted Feb. 4, 1983 - 81.10(q)(1)
D&C Rot Nr. 24 - 4. September 1966 - 81.30 (d)
D&C Rot Nr. 29 - 4. September 1966 - 81.30 (d)
D&C Rot Nr. 35 - 4. September 1966 - 81.30 (d)
D&C Red #37 - Delisted 4 February 1983 and 6 June 1986 - 81.10(q)
D&C Rot Nr. 38 - 4. September 1966 - 81.30 (d)

LIST 3

Color additives that require certification and are permanently listed (unless otherwise noted) for use inEXTERNAL PHARMACEUTICALS AND COSMETICS. (None of these colors may be used in products intended for the eye area)

D&C Braun Nr. 1Only external cosmetics - GMP - 74.2151
FD&C Rot Nr. 4- Only for use in medicines and cosmetics for external use - GMP - 74.1304, 74.2304, 82.304
D&C Root No. 17- GMP-74.1317, 74.2317, 82.1317
D&C Root No. 31- GMP-74.1331, 74.2331, 82.1331
D&C Root No. 34- GMP-74.1334, 74.2334, 82.1334
D&C Root No. 39- Only as a topical drug in germicidal quaternary ammonium solutions (maximum 0.1% by weight of the finished product) 74.1339
D&C Violet #2- Medicines and external cosmetics (GMP) as well as contact lenses, sutures, haptics and pins (see medical devices) 74.1602, 74.2602, 82.1602
Ext. D&C Violeta Nr. 2- Only for external cosmetics - GMP -74.2602a
D&C Azul Nr. 4- GMP-74.1104, 74.2104, 82.1104
D&C Verde Nr. 6- GMP-74.1206, 74.2206, 82.1206
D&C Verde Nr. 8- Limit value ≤ 0.01% by weight of the finished drug or cosmetic - 74.1208, 74.2208
D&C Gelb Nr. 7 -GMP - 74.1707, 74.2707, 82.1707
Ext. D&C Amarelo Nr. 7- GMP - 74.1707a, 74.2707a, 82.2707a
D&C-Gelb Nr. 8- GMP-74.1708, 74.2708, 82.1708
D&C-Gelb Nr. 11- GMP-74.1711, 74.2711
D&C Laranja No. 4- GMP-74.1254, 74.2254, 82.1254
D&C Laranja No. 10- GMP-74.1260, 74.2260, 82.1260
D&C Laranja No. 11- GMP-74.1261, 74.2261, 82.1261
Ext. D&C Lakes (see foreword to this appendix)- The only allowed extension. Lake D&C is ext. Lake D&C Yellow #7 prepared from Ext. D&C Yellow #7 (GMP) 81.1, 82.2051, 82.2707a

The use of the following color additives is no longer permitted:

Ext. D&C Blue Nr. 1 - 4. September 1966 - 81:30 (d)
Ext. D&C Red Nr. 11 - 4. September 1966 - 81:30 (d)
Ext. D&C Blue No. 4 - 4 September 1966 - 81.30 hours (d)
Ext. D&C Red Nr. 13 - 4. September 1966 - 81.30 (d)
Ext. D&C Green #1 - 29. November 1977 - 81.10(k)
Ext. D&C Red Nr. 14 - 4. September 1966 - 81.30 (d)
Ext. D&C Orange Nr. 1 - 4 September 1966 - 81:30 (d)
Ext. D&C Red Nr. 15 - 4. September 1966 - 81.30 (d)
Ext. D&C Orange Nr. 3 – 1. Juli 1968 – 81:30 (e)
Ext. D&C Yellow #1 - 13 December 1977 - 81.10(i)
Ext. D&C Orange #4 - Sep 4, 1966 - 81:30 (d)
Ext. D&C Red #1 - 4. September 1966 - 81:30 (d)
Ext. D&C Gelb Nr. 3 - 1. Juli 1968 - 81.30(e)
Ext. D&C Red #2 - 4. September 1966 - 81:30 (d)
Ext. D&C Gelb #5 - 4. September 1966 - 81:30 (d)
Ext. D&C Red #3 - 4. September 1966 - 81:30 (d)
Ext. D&C Gelb Nr. 6 – 4. September 1966 – 81:30 (d)
Ext. D&C Red #8 - 1. Juli 1968 - 81.30(e)
Ext. D&C Amarelo Nr. 9 - 81.10(a)
Ext. D&C Red Nr. 10 - 4. September 1966 - 81.30 (d)
Ext. D&C Amarelo Nr. 10 – 81.10(a)

LIST 4

Color additives are exempt from certification and permanently listed forESSENuse.

Algae meal, dried- Chicken feed only: ≤ 0.3% ethoxyquin in feed ≤ 150 ppm ethoxyquin in final feed - 73.275
Annatto Extract- GMP-73,30
Astaxanthin- Salmon feed only: Total astaxanthin from all astaxanthin color sources listed in Part 73 ≤ 80 mg per kg of finished feed - 73.35
Astaxanthin Dimethyldisuccinat- Salmon fish feed only: Total astaxanthin from all astaxanthin color sources listed in Part 73 ≤ 80 mg per kg of finished feed - 73.37
Beet juice (as vegetable juice)- GMP-73.260
Beet powder (dried beetroot)- GMP-73,40
Beta-Apo-8'-Carotinal- General Use: ≤ 15 mg/lb of solid or semi-solid food or per liter of liquid food - 73.90
Beta carotene, natural and synthetic- GMP - 73,95
Butterfly Pea Flower Extract- (water extract only; ultrafiltered) - alcoholic beverages, sports and energy drinks, flavored or carbonated water, fruit drinks (including smoothies and grain drinks), carbonated soft drinks (fruit or juice flavored, ginger ale and root beer), fruit and vegetable juices, Nutritional drinks, chewing gum, teas, coated nuts, liquid creamers (with and without milk), ice cream and frozen dairy desserts, hard candy, dairy and non-dairy beverages, fruit preparations in yoghurts and soft candies: GMP - 73.69
calcium carbonate- soft and hard mints and mints and in colors used on the surface of chewing gum (except chocolate): GMP- 73.70
Canthaxanthin- General use: ≤ 30 mg/kg of solid or semi-solid food or per liter of liquid food; Broiler feed: ≤ 4.41 mg per kg (4 g/ton) of complete feed; Feed for salmonids: ≤ 80 mg per kg (72 g/ton) finished feed - 73.75
Caramel- GMP-73,85
Karminrot- GMP-73.100
carrot oil- GMP-73.300
Cochineal-Extrakt- GMP-73.100
More Endospermol- Feed only for chickens - 73,315
Cottonseed Meal, Cooked Partially Defatted Toast- GMP-73.140
Iron gluconate-Only ripe olives - GMP -73.160
Eisenlactat- Ripe olives only - GMP - 73.165
fruit juice- GMP-73.250
Grape Color Extract- Only food without drinks - 73,169
Grape Skin Extract (Enocyanin)- Still and Aerated Beverages and Beverages, Beverage Bases and Alcoholic Beverages (according to Parts 4 and 5 of 27 CFR) - 73.170
Haematococcus Algenmehl- Only feed salmon fish. Total astaxanthin from all astaxanthin color additive sources listed in Part 73 ≤ 80 mg per kg of finished feed – 73.185
synthetic iron oxide- Human sausage casings: ≤ 0.10% by weight. of ready-to-eat meals; Hard and soft candies, mints and chewing gum: GMP; Specification Pb ≤ 5ppm; Cat and dog food: ≤ 0.25% by weight of the ready-to-eat food; Dietary supplements, pills and capsules, including coatings and inks: The total amount of elemental iron per day for labeled dosages does not exceed 5 mg - 73,200
Lycopene, tomato paste or concentrate- GMP-73.585
Mica based pearlescent pigment- Cereals, confectionery and toppings, gelatin desserts, hard and soft candies (including lozenges), dietary supplements in gelatin tablets and capsules and chewing gum: ≤ 1.25% w/w; Distilled beverages with not less than 18% and not more than 25% alcohol, liqueurs, liqueurs, malt flavored alcoholic beverages, wine coolers, cocktails and non-alcoholic cocktail mixes and mixes: ≤0.07% by weight; Kits for decorating eggs for dyeing eggshells: GMP - 73.350
Paprika & Paprika-Oleoresin- GMP - 73.340
Paracoccus-Pigment- Salmon fish feed only: Total astaxanthin from all astaxanthin color sources listed in Part 73 ≤ 80 mg per kg of finished feed - 73.352
Phafla yeast- Only feed salmon fish. Total astaxanthin from all astaxanthin color additive sources listed in Part 73 ≤ 80 mg per kg of finished feed – 73.355
Riboflavin- GMP - 73.450
Safran- GMP - 73.500
Chlorophyllin Natriumkupfer- Only citrus-based dry drink mixes: ≤ 0.2% by weight. of dry mix - 73.125
I am leghemoglobin- Similar minced meat products: ≤0.8% by weight of raw product - 73,520
Spirulina-Extract- Confectionery (including candies and chewing gum), icing, ice cream and frozen desserts, dessert toppings and toppings, drink mixes and powders, yogurts, creams, puddings, cottage cheese, gelatin, breadcrumbs and ready-to-eat cereals (except extruded cereals), coating formulations Dietary Supplement Tablets and Capsules, Hard Boiled Egg Shells (Seasonal): GMP – 73,530
Marigold (Aztec Marigold) Flour and Extract- Chicken feed only: ethoxyquin content ≤ 0.3% by weight. Additive and ≤ 150 wppm. final supply - 73,295
titanium dioxide- ≤ 1.0% by weight food - 73,575
Turmeric and Turmeric Oleoresin- GMP - 73.600 and 73.615
ultramarine blue- Salt for animal feed only: ≤ 0.5% by weight. Salt - 73.50
vegetable juice- GMP-73.260

The use of the following color additives is no longer permitted:

Alkane (Alkane)
Calcium Carbonate - Allowed in medicines
carbon black
Coal - Invoice XI
Red color
ferric chloride
Iron sulfate
Firewood, Shavings & Extract - Firewood extract is still allowed in sutures
Safflower (American Saffron)

LIST 5

Color additives are exempt from certification and permanently listed forDRUGuse. (None of these color additives may be used in eye care products unless otherwise noted.)

clay- Medicines in general - GMP - 73.1010
Aluminiumpulver- Medicines for external use, including use around the eyes - GMP - 73.1645
Annatto Extract- Medicines in general, including those used in the eye area - GMP - 73.1030
Beta carotene, natural and synthetic- Drugs in general, also for the eye area - GMP - 73.1095
bismuth oxychloride- Only medicines for external use, also for the eye area - GMP - 73.1162
Bronzepulver- Only medicines for external use, also for the eye area - GMP - 73.1646
calcium carbonate- Medicines in general - GMP - 73.1070
Canthaxanthin- GMP - Medication ingested only - 73.1075
Caramel- Medicines in general - GMP - 73.1085
Karminrot- Medicines in general - GMP - 73.1100
Chlorophyllin, Kupferkomplex- Dentifrices that are medicinal - ≤ 0.1% by weight. - 73.1125
Chromium hydroxide, green- Medicines for external use, including for the area around the eyes - GMP - 73.1326
Chrome Oxide Green- Medicines for external use, including for the area around the eyes - GMP - 73.1327
Cochineal-Extrakt- Medicines in general - GMP - 73.1100
copper, metallic powder- Medicines for external use, including for the area around the eyes - GMP - 73.1647
Potassium Sodium Copper Chlorophyllin (Chlorophyllin Copper Complex)- Dentifrices that are medicinal - ≤ 0.1% by weight. - 73.1125
Dihydroxyaceton- Externally applied medicines intended to impart color to the human body - GMP - 73.1150
Ferric ammonium ferrocyanide (iron blue)- Medicines for external use, including for the area around the eyes - GMP - 73.1298
Iron(III) ferrocyanide (iron blue)- Medicines for external use, including for the area around the eyes - GMP - 73.1299
Guanine (Pearl Essence)- Medicines for external use, including for the area around the eyes - GMP - 73.1329
Glimmer- Dentifrices and medicines for external use, including for the area around the eyes - GMP - 73.1496
Mica based pearlescent pigment- 3% by weight drug; Iron pigment 55% - 73.1128
Pyrophilit- Medicines for external use - GMP - 73.1400
synthetic iron oxide- Drugs in general. Limit for ingested medications ≤ 5 mg elemental iron per day - 73.1200
Baby pillows- Medicines in general - GMP - 73.1550
titanium dioxide- Medicines in general, also for the eye area - GMP - 73.1575
Zinc oxide- Medicines for external use, including for the area around the eyes - GMP - 73.1991

The use of the following color additives is no longer permitted:

black bone
Coal NF XI
copper chlorophyll complex
Tatajuba
Ultramarine blue - use in cosmetics is allowed

LIST 6

Color additives are exempt from certification and permanently listed forCOSMETICSuse. (None of these colors may be used in products for use around the eye area unless otherwise noted)

Aluminiumpulver- Cosmetics for external use, including for the area around the eyes - GMP - 73.2645
Annatto- Cosmetics in general, including the eye area - GMP - 73.2030
bismuth citrate- For cosmetics intended only for coloring hair on the scalp (Not for coloring eyelashes or eyebrows or other body hair) - ≤ 2.0% (wt/v) - 73.2110
bismuth oxychloride- Cosmetics in general, including eye area - GMP - 73.2162
Bronzepulver- Cosmetics in general, including eye area - GMP - 73.2646
Caramel- Cosmetics in general, including the eye area - GMP - 73.2085
Karminrot- Cosmetics in general, including the eye area - GMP - 73.2087
beta-carotene- Cosmetics in general, including the eye area - GMP - 73.2095
green chromium hydroxide- Cosmetics for external use, including for the area around the eyes - GMP - 73.2326
Chrome Oxide Green- Cosmetics for external use, including for the area around the eyes - GMP - 73.2327
copper, metallic powder- Cosmetics in general, including eye area - GMP - 73.2647
Dihydroxyaceton- Cosmetics for external use - GMP - 73.2150
Disodium EDTA Copper- Cosmetic shampoos - GMP - 73.2120
iron ammonium ferrocyanide- Cosmetics for external use, including for the area around the eyes - GMP - 73.2298
Ferric ferrocyanate- Cosmetics for external use, including for the area around the eyes - GMP - 73.2299
Guaiazule (Azule)- Cosmetics for external use - GMP - 73.2180
Guanine (Pearl Essence)- Cosmetics in general, also for the eye area - GMP - 73.2329
Meat- For coloring hair only, not for coloring eyelashes or eyebrows - 73.2190
iron oxides- Cosmetics in general, including eye area - GMP - 73.2250
Luminescent zinc sulfide- Cosmetics for external use (enamel and facial) - 73.2995
Manganviolett- Cosmetics in general, including eye area - GMP - 73.2775
Glimmer- Cosmetics in general, including eye area - GMP - 73.2496
Potassium Sodium Copper Chlorophyllin (Chlorophyllin Copper Complex)- Cosmetic dentifrices - ≤ 0.1% by weight. May only be used in combination with substances listed in 21 CFR 73.2125(b)(2) - 73.2125
Pyrophilit- External cosmetics - GMP -73.2400
Speak- nail polish - ≤ 1% by weight. - 73.2500
Silbernitrat- Cosmetics for external use only for professional use for coloring eyebrows and eyelashes: ≤4% by weight; viscosity 120-180 Pas; Use for persons over 16 years of age; apply for ≤1 min-73.2550
titanium dioxide- Cosmetics in general, including the eye area - GMP - 73.2575
Ultramarine (Blue, Green, Pink, Red and Purple)- Cosmetics for external use, including for the area around the eyes - GMP - 73.2725
Zinc oxide- Cosmetics in general, also for the eye area - GMP - 73.2991

The use of the following color additives is no longer permitted:

houses
black bone
Soot (duct process)
carminic acid
copper chlorophyll complex
Cobalt aluminas (Kobaltblau)
cochineal
Fullers Land
bright white
graphite
kieselguhr (diatomita)
Bleiacetat
Pictures
logs (glued wood, campeche wood)
4-Methyl-7-diethylaminocumarin (MDAC)
B-Methylumbelliferon
Potassium ferrocyanide
Siena
Umber
Vermiculit
zirconia
Zirconium silicate

LIST 7

Color additives are exempt from certification (unless otherwise noted) and are permanently listed for use inMEDICAL EQUIPMENT

1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracendion-bis(2-propensäure)ester-Copolymere- Contact lenses - GMP - 73.3100
1,4-Bis[4-(2-methacryloxyethyl)phenylamino]-9,10-anthrachinon-Copolymere- GMP contact lenses - 73.3106
1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenodion- Contact lenses - GMP - 73.3105
Carbazol Violeta- Contact lenses - GMP - 73.3107
Chlorophyllin copper complex- Polymethylmethacrylate bone cement - ≤ 0.003% by weight. - 73.3110
Chromium Cobalt Alumina- Linear surgical sutures made of polyethylene - ≤ 2% by weight - 73.1015 and contact lenses - GMP -.73.3110a
Chrome Oxide Green- Contact lenses - GMP - 73.3111
CI Kuba Laranja 1- Contact lenses - GMP - 73.3112
7,16-Dichlor-6,15-dihydro-5,9,14,18-anthrazinetetron- Contact lenses - GMP - 73.3119
2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzoltriol- To mark soft contact lenses with the letter R or L - < 0.11="" microgram="" in="" a="" contact="" lens="" -="">
16,23-Dihidrodinapto[2,3-a:2',3'-i]napth[2',3':6,7]indolo[2,3-c]carbazol-5,10,15,17, 22,24-Hexona- Contact lenses - GMP - 73.3117
N,N'-(9,10-Dihydro-9,10-dioxo-1,5-anthracenodiyl)bis-benzamid- Contact lenses - GMP - 73.3118
16,17-Dimethoxydinapto[1,2,3-cd:3',2',1'-lm]perylen-5,10-dion- Contact lenses - GMP - 73.3120
4-[(2,4-Dimethylfenil)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-Pyrazol-3-on- Contact lenses - GMP - 73.3122
1-Amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-di-hydro-9,10-dioxoanthracene-2-sulfonate-dissodium-Contact lenses - GMP - 73.3129
D&C Therefore #4- Subject to certification. Suture: ≤1% w/w - 74.3054
D&C Azul Nr. 6- Subject to certification. Surgical Stitches. The limits are in the regulation - 74.3106
D&C Azul Nr. 9- Subject to certification. Surgical suture material - ≤ 2.5% by weight - 74.1109
D&C Verde Nr. 5- Subject to certification. Seams - ≤ 0.6% Seam Weight - 74.1205
D&C Verde Nr. 6- Subject to certification. Surgical sutures, haptics and contact lenses. The limits are in the regulation - 74.3206
D&C Root No. 17- Subject to certification. Contact lenses - GMP - 74.3230
D&C Violet #2- Subject to certification. Contact lenses - GMP. Absorbable sutures. The limits are in the regulation. Polymethyl methacrylate intraocular lenses - ≤ 0.2% by weight Absorbable meniscus pins made of poly(L-lactic acid) - ≤ 0.15% by weight - 74.3602
D&C-Gelb Nr. 8– Subject to certification. Contact lens solutions: Rx only, ≤0.044% in solution - 74.3708
D&C-Gelb Nr. 10- Subject to certification. Contact lenses - GMP - 74.3710
6-Ethoxy-2-(6-ethoxy-3-oxobenzo[B]thien-2-(3H)-ylideno)benzo[B]Tiofen-3-(2H)-like- Contact lenses - GMP - 73.3123
FD&C Azul Nr. 2- Subject to certification. Nylon surgical suture - ≤ 1% by weight. the seam - 74.3102
FD&C Blue #2 aluminum on aluminum oxide paint- Subject to certification. Bone cement - ≤ 0.1% by weight. made of cement - 74.3102
Iron oxides, synthetic- Contact lenses - GMP - 73.3125
ferric ammonium citrate- In combination with Pyrogallol for coloring smooth or chrome catgut seams. Limit of FAC pyrogallol complex ≤ 3% of thread weight - 73.1025
Logwood-Extrakt- Surgical suture material - ≤ 1% by weight - 73.1410
Mica-based pearlescent pigments- Contact lenses - GMP - 73.3128
[phthalocyanine(2-)] copper- Subject to certification. Sutures, intraocular lenses - ≤ 0.5 wt%, contact lenses - GMP - 74.3045
Phthalocyaningrün- Contact lenses - GMP -73.3124
Poly(hydroxyethyl methacrylate) dye copolymers- Contact lenses - GMP - 73.3121. Color additives are formed by reacting one or more of the following colorants with poly(hydroxyethyl methacrylate):
- IC Black Reactive 5
- IC blue reactive 4
- IC blue reactive 19
- IC blue reactive 21
- IC blue reactive 163
- IC Reactive Orange 78
- IC Rot Reaktiv 11
- IC Rot Reaktiv 180
- Yellow reactive IC 15
- IC Reactive Yellow 86
Pyrogallol- In combination with ferric ammonium citrate for coloring smooth or chrome catgut seams. Limit of FAC pyrogallol complex ≤ 3% of thread weight - 73.1025
titanium dioxide- Leading brands of contact lenses and intraocular lenses: GMP - 73.3126
Vinyl alcohol/methyl methacrylate - dye reaction products- Contact lenses - GMP - 73.3127. Color additives are formed by reacting one or more of the following colorants with vinyl alcohol/methyl methacrylate copolymers:
- IC Black Reactive 5
- IC blue reactive 19
- IC blue reactive 21
- IC Reactive Orange 78
- IC Rot Reaktiv 180
- Yellow reactive IC 15