Coloring Agents

Coloring Agents for Cosmetic Products in the USA, Japan and EU

The coloring of cosmetic products is regulated by law in the USA, Japan and the European Union. Other countriesoften use the regulations of these countries as a model. The following references can be used for further information.

Blue List: Cosmetic Ingredients, ECV Editio Cantor Verlag, Aulendorf (2000); G. Otterstätter, Die Färbung von Lebensmitteln, Arzneimittel, Kosmetika, Behr's Verlag, Hamburg (1995); C. Fox, Color in Cosmetics, Cosmetics & Toiletries 111 (3), 35 (1996); G. Otterstätter, Die Färbung von Kosmetika, SÖFW-Journal 123, 328 (1997); G. Otterstätter, Kosmetische Färbemittel im internationalen Vergleich, Parfümerie und Kosmetik 78 (10), 8 (1997); R. Romanowski and R. Schüeller, Creating Colorful Cosmetics, Cosmetics & Toiletries 112 (9), 73 (1997); D. C. Steinberg, Regulatory Review, Cosmetics & Toiletries 111 (10), 29 (1996); CTFA Color Handbook 1992, Cosmetic, Toiletry and Fragrance Association, Inc., 1101 17th Street, NW, Suite 300, Washington, D.C. 20036-4702, USA; Principles of cosmetic licensing in Japan, 2nd Edition; Yakuji Nippo Ltd. 1, Kanda Izumicho, Chiyoda-Ku, Tokyo, 101, Japan.

The coloring agents authorized in the USA for coloring cosmetic products are listed in the Code of Federal Regulations 21 (CFR 21), which can be ordered from the U.S. Government Printing Office, Superintendent of Documents, Mail Stop: SSOP. Washington, DC 20402-9328.

Furthermore a summary of color additives listed for use in the United States in foods, drugs, cosmetics, and medical devices is given by the following address: Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Parkway, College Park, MD 20740-3835, USA.

Further information: ec.europa.eu/consumers/cosmetics/cosing/index.cfm

Coloring Agents for Cosmetic Products in Germany

www.gesetze-im-internet.de/bundesrecht/kosmetikv/gesamt.pdf

Coloring Substances in Drugs

The use of coloring substances in medicaments is regulated by the Council Directive 94/36/EEC, June 30, 1994, originally designed for colors in food. It is completed by the Council Directive 95/45/EEC, July 26, 1995 on purity of food colors. The list (Appendix I) contains the following substances:

Appendix I

Colour shade EEC No.

Name

Chemical name or description

Yellow

E 100

Curcumin

1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadien-3,5-dione

E 101

Riboflavin (Lactoflavin)

7,8-dimethyl-10-(1'-D-ribityl)isoalloxazin

E 102

Tartrazine

5-hydroxy-1-(4-sulfophenyl)-4-(4-sulfophenylazo)-3-pyrazol-carboxylic acid, trisodium salt

E 104

Quinoline yellow

2-(1,3-dioxo-2-indanyl)quinoline disulfonic acid, disodiumsalt (also containing monosulfonic acid derivatives, also partly methylated)

Orange

E 110

Yellow orange S (Sunset yellow FCF)

6-hydroxy-5-(4-sulfophenylazo)-2-naphthalene-sulfonic acid, disodium salt

Red

E 120

Carmine (Cochineal carminic acid)

extract from Dactylopius coccus [syn. Coccus cacti] including the ammonium salts

E 122

Azorubin (Carmoisine)

1'-hydroxy-1,2'-azonaphthalene-4,4'-disulfonic acid, disodium salt

E 123

Amaranth

2-hydroxy-1,1'-azonaphthalene-3,4',6-trisulfonic acid, trisodium salt

E 124

Ponceau 4R (Cochineal Red A)

2-hydroxy-1,1'-azonaphthalene-4',6,8-trisulfonic acid, trisodium salt

E 127

Erythrosine

2',4',5',7'-tetraiodofluorescein, disodium salt or 2-(6-hydroxy-2,4,5,7-tetraiodo-3-oxo-3H-xanthene-9-yl)benzoic acid, disodium salt

E 128

Red 2G

disodium-8-acetamido-1-hydroxy-2-phenylazo-naphthalene-3,6-disulfonate

E 129

Allulared AC

disodium-2-hydroxy-1(2-methoxy-5-methyl-4-sulfo-phenyl- azo)-naphthalene-6-sulfonate

Blue

E 131

Patent Blue V

α-(4-diethylaminophenyl)-α-(4-diethylimino-2,5-cyclohexadiene-1-ylidene)-5-hydroxy-4-sulfo-o-toluenesulfonate, calcium salt

E 132

Indigo carmine (Indigotin)

3,3'-dioxo[∆2,2'-biindoline]-5,5'-disulfonic acid, disodium salt

E 133

Brilliant Blue FCF

disodium-α-(4-(N-ethyl-3-sulfobenzylamino)phenyl)-α-(4(N-ethyl-3-sulfobenzylamino)cyclohexa-2.5-diethylidene) toluene-2-sulfonate

Green

E 140

Chlorophyll

Chlorophyll a and Chlorophyll b

E 141

Chlorophyll- and Chlorophyllin- copper-complexes

Chlorophyll a(b)-copper-complexes and Chlorophyllin a(b)-copper-complexes

E 142

Acid brilliant green BS (Wool GreenBS, Lissamine green)

1-(α-(4-dimethylimino-2,5-cyclohexadiene-1-ylidene)-4-dimethylaminobenzyl)-2-hydroxy-6-sulfo-3-naphthalenesulfonate, sodium salt

Brown

E 150

Caramel

Product manufactured from sucrose (or other kinds of sugar suitable for consumption) solely by heating, or amorphous, brown, water-soluble products manufactured by controlled heating of edible sugars in the presence of acetic, citric, phosphoric or sulfuric acid, sulfur dioxide, ammonium-, sodium- and potassium hydroxide, -carbonate, -phosphate, -sulfate or -sulfite.

 

a) Simple caramel

Prepared by controlled heating of carbohydrates.

 

b) Sulfite caramel

Prepared by controlled heating of carbohydrates under the addition of sodium or potassium sulfite or bisulfite.

 

c) Ammonia caramel

Prepared by controlled heating of carbohydrates under the addition of ammonia compounds like ammonium hydroxide, ammonium hydrogen carbonate or ammonium carbonate.

 

d) Ammonium sulfite caramel

Prepared by controlled heating of carbohydrates under the addition of sulfite and ammonia compounds.

E 154

Brown FK

A mixture of the following main components:

I. sodium-4-(2,4-diaminophenylazo)benzene sulfonate

II. sodium-4-(4,6-diamino-m-tolylazo)benzene sulfonate

III. disodium-4,4'-(4,6-diamino-1,3-phenylenebisazo)-di-benzenesulfonate

IV. disodium-4,4'-(2,4-diamino-1,3-phenylenebisazo)-di-benzenesulfonate

V. disodium-4,4'-(2,4-diamino-5-methyl-1,3-phenylenebisazo)-di-benzenesulfonate

VI. trisodium-4,4',4''-(2,4-diaminobenzene-1,3,5-trisazo) tribenzenesulfonate

 

Brown HT

disodium-4,4'-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylenebisazo)-di-naphthalene-1 sulfonate

Black

E 151

Brilliant Black BN

4-sulfophenylazo-4-(7-sulfonaphthalene)-1-azo-2-(8-acet- amido-1-hydroxy-3,5-naphthalenedisulfonic acid), tetrasodium salt

E 153

Carbon Black (Carbo medicinalis vegetabilis)

Vegetable charcoal having the properties of medicinal char coal

Various colours

E 160

Carotinoids:

 

 

a) β,ε-Carotene (α''-Carotene) Betacarotene (β,β-Carotene) β,ψ -Carotene (γ-Carotene)

all-trans forms as main components

 

b) Bixin, Norbixin (Annatto, Orlean)

Annatto is an extract of the seeds of Bixa orellana; the extract in oil is the carotinoid Bixin, the mono methyl ester of 6,6'-diapo-6,6'-carotene-dioic acid. Norbixin is the free dicarboxylic acid; the main colouring substance of the aqueous Annatto extracts is the alkali salt of Norbixin.

 

c) Capsanthin, Capsorubin

Extract from paprika (Capsicum annuum fruits)

 

d) Lycopene

ψ,ψ-Carotene (all-trans-form as main constituent)

 

e) 8'-Apo-β,ψ-carotenal

8'-apo-β,ψ-carotenal (all-trans-form as main constituent)

 

f) Ethyl-8'-apo-β,ψ-carotenoate

ethyl-8'-apo-β,ψ-carotenoate (all-trans-form as main constituent)

E 161

Xanthophylls:

Xanthophylls are keto- and/or hydroxy-derivatives of carotenes

 

a) Flavoxanthin

5,8-epoxy-5,8-dihydro-β,β-carotene-3,3'-diol

 

b) Lutein

β,ε-carotene-3,3'-diol

 

c) Cryptoxanthin

β,β-carotene-3-ol

 

d) Rubixanthin

β,ψ-carotene-3-ol

 

e) Violaxanthin

5,6,5',6'-diepoxy-5,5',6,6'-tetrahydro-β,β-carotene-3,3'-diol

 

f) Rhodoxanthin

4',5'-didehydro-4,5-retro-β,β-carotene-3,3'-dione

 

g) Canthaxanthin

β,β-carotene-4,4'-dione

E 162

Beetroot Red, Betanin

aqueous extract from the root of the red beet (Beta vulgaris var. conditiva)

E 163

Anthocyanins

Anthocyanins are glycosides of hydroxylated derivatives of2-phenylbenzopyrylium salts; they contain the following anthocyanidins as aglycones: Pelargonidin, Cyanidin, Paeonidin (Peonidin), Delphinidin (Oenantidin), Petunidin, Malvidin. Anthocyanins must only be obtained from edible fruit or vegetables such as strawberries, mulberries, cherries, plums, raspberries, blackberries, black and red currants, red cabbage, red onions, cranberries, huckleberries, aubergines, grapes and elderberries.

E 170

Calcium carbonate

CaCO3

E 171

Titanium(IV)-oxide (Titanium dioxide)

TiO2

E 172

Iron oxides and -hydroxides

xFe2O3 · yFeO · nH2O

E 173

Aluminum

Al

E 174

Silver

Ag

E 175

Gold

Au


For the substances with the EEC numbers E 102, E 104, E 110, E 122 to E 124, E 127, E 131, E 132, E 142 and E 151 the acid on which the compound is based and any sodium, calcium, potassium and aluminum salt of this substance islicensed in addition to the sodium or calcium salt of the substance which is given in the column “Chemical name orDescription”.

Synthetic colouring substances which are identical to the natural colouring substances mentioned are also authorized.