In the past, colorants had been used in cosmetics without any consideration being given to their possible toxicity. Today, all countries have regulations that control the type and purity of colors that may be used in cosmetics.
United States: U.S. Food and Drug Administration (FDA)
21 CFR 73, 74; Positive List : Colors listed for general cosmetic use, including eye area only if stated specifically, or external only, meaning no contact with mucous membranes. Hair dyes and true soaps are exempt.
European Union (EU): European Commission (EC)
Directive 76/786, Annex IV ; Positive List: Colors listed for ingested use, general, including eye area, external, or rinse-off. Annex II: Negative List
Japan: Ministry of Health and Welfare (MHW) °
MHW Ordinance No. 30 ; Positive List, Coal-Tar Colors: Premarket approval by MHW for all other cosmetic ingredients, including inorganic and natural colorants.
Primary/Straight Color: A color that is pure, containing no extenders or dilutents. Dye: A color that is soluble in the medium in which it is dispersed. (e.g., FD&C Blue #1).
Pigment: A color that is insoluble in the medium in which it is dispersed. (e.g.,
FD&C Blue #1 Al lake, Black iron oxide). Lake: A water-insoluble pigment composed of a water-soluble straight color strongly absorbed onto an insoluble substratum through the use of a precipitant (e.g., FD&C Blue #1 Al Lake). Generally, 10 to 40% color.* Toner: A pigment that is produced by precipitating a water-soluble dye as an insoluble metal salt (e.g., D&C Red #6 barium salt, D&C Red #7 calcium salt). True Pigment: A pigment that, based on its chemistry, precipitates as it is formed
(e.g., D&C Red #36). Extender: A pigment diluted on substrate
1. during manufacture by precipitation, or
2. postmanufacture by intimate milling or mixing.
21 CFR Part 73 : Listing of Color Additives Exempt from Certification
Inorganic pigments, powdered metals, and naturally derived colorants approved for food, drug, and/or cosmetic use. Listed permitted uses are as follows:
• Ingested/externally applied drugs
• General cosmetic
• Eye area only if mentioned
• External (no mucous membrane), i.e., ultramarines, ferric ammonium ferrocya-nide not permitted in lip or bath products
21 CFR Part 74 : Listing of Color Additives Subject to Certification
Synthetic organic dyes and pigments. Each batch must be submitted by the manufacturer to the FDA for certification that specifications are met. Permitted uses as in Part 73. Four certified organic dyes and their lakes are now permitted for eye-area use:
21 CFR Part 82 : Listing of Certified Provisionally Listed Colors
FD&C: Aluminum or calcium salt on alumina.
* FDA has considered any certified colorant mixed with a diluent to be a lake; e.g., D&C Red 30 Plus talc, and D&C Red #7 CA lake on calcium carbonate.
D&C: Sodium, potassium, barium, calcium, strontium, or zirconium salt on alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium carbonate.
A salt prepared from straight color, i.e., D&C Red #6, by combining the color with a basic radical.
Proposed Permanent Listing of Color Additive Lakes (FR Vol. 61 #43), March 4, 1996 
• List substrate, e.g., D&C Red #27 aluminum lake on alumina
• Extenders of insoluble straight colors will no longer be called lakes, e.g., D&C Red #30
• Permit blends of previously certified straight colors in a lake, e.g., FD&C Blue #1 and Yellow #5 aluminum lake
• All lakes to be prepared from previously certified batches of straight color would necessitate process changes for D&C Reds #6, #7, and #34
• Abbreviations permitted for cosmetic ingredient labeling, omitting FD&C, precipitate and substrate designation e.g., Blue 1
Directive 76/786, as amended . Annex IV
This is a list of coloring agents allowed in cosmetic products. List by color index number:
Part 1: Permanently listed Part 2: Provisionally listed
Four fields of application:
1. All cosmetic products
2. All cosmetic products, except those intended to be applied in the vicinity of the eyes, in particular eye makeup and makeup remover
3. Allowed exclusively in cosmetic products intended not to come into contact with mucous membranes (including the eye area)
4. Allowed exclusively in cosmetic products intended to come into contact only briefly with skin (not permitted in nail preparations)
If a color index number is listed in Annex IV, then the pure color plus its salts and lakes are allowed, unless prohibited under Annex II (the list substances that cosmetics may not contain). Exceptions include barium, strontium, and zirconium.
Prohibited under Annex II, but where Footnote 3 appears in Annex IV, ''the insoluble barium, strontium, and zirconium lakes, salts, and pigments . . . shall also be permitted.'' They must pass the test for insolubility which will be determined by the procedure in Article 8. (Insoluble in 0.1 N HCl).
Only colors designated by an ''E,'' those also permitted for food use, must meet the general specification for food colors.
<100 ppm Sb, Cu, Cr, Zn, BaSO4 separately
<200 ppm Of those together
None detectable Cd, Hg, Se, Te, Th, U Cr+6, or soluble Ba
Sixth Amendment to the directive is currently adopted. Update of purity criteria is being considered, test methods may be stipulated.
MHW ordinance No. 30 (1966) as amended by MHW ordinance No. 55 (1972) . Positive List 83 Coal-tar colors:
• Must be declared on cosmetic product label
• Fields of application: oral, lip, eye area, external, rinse-off
Listing, specifications, test methods:
• Japan standards of cosmetic ingredients (JSCI)
• Comprehensive licensing standards of cosmetics by category (CLS)
• Japan cosmetic ingredient dictionary (CLS)
U.S. Colorants Not Permitted/Restricted in Japan
D&C RED #6
D&C RED #21
D&C RED #27
D&C RED #33
D&C ORANGE #5
0.5% maximum :
7.0% maximum :
In general, inorganic colors are more opaque, more light fast, more solvent resistant, but not as bright as organic colors. They may be affected by alkali and acid. Inorganic colorants are formed from compounds of the transition elements. Color is produced as a result of the ease with which the outer ''d'' electrons can absorb visible light and be promoted to the next higher energy level.
Good stability, opacity
Good stability, opacity Chromium Hydroxide
Good stability, lower tinting strength Ultramarines Good light stability, lower tinting strength, unstable to acid
Good light stability, lower tinting strength, unstable to water Ferric Ammonium, Ferrocyanide
Lower light stability, high tinting strength, unstable to alkali and salts, difficult dispersion Ferric Ferrocyanide
Physical/chemical stability as above, precipitated on a substrate (i.e., mica) Titanium Dioxide
Medium light stability, good chemical stability, high opacity
Fe2O3 Fe3O4 FeOOH
Deep Blue FeNH4Fe(CN)6
Organic pigments are characterized by:
• Variable chemical and physical stability
Color is produced by chromophoric groups, generally electron acceptors.
Shade is modified or intensified by auxochromes, generally electron donors.
Categories of Organic Colorants
Insoluble (unsulfonated): D&C Red #36; light stable
Soluble (sulfonated): D&C Red #33, FD&C Red #40, FD&C Yellow #5, FD&C Yellow
#6; stable to acid, alkali, light, bleed in water Slightly soluble (sulfonated/insoluble salt): D&C Red #6; D&C Red #7, D&C Red #34;
color shift in acid and alkali; light fast; resistant to oil bleed Oil soluble (unsulfonated): D&C Red #17
D&C Orange #5; D&C Red; D&C Red #21; D&C Red #27. ''Staining dyes'': structure changes with pH, poor light stability, bleed in solvent
FD&C Blue #1, FD&C Green #3 water soluble; poor light stability Anthraquinone
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