Colors used in cosmetics

COLOURS USED IN COSMETICS

1. COLOURS USED IN COSMETICS BY : MEET PATEL SUBJECT: HERBAL DRUG TECHNOLOGY

2. Content Introduction Regulatory bodies Classification of color Table (Color Additives That Are Subject to Certification and Permitted for Use in Cosmetics and Color Additives That Are Exempt from Certification and Permitted for Use in Cosmetics ) Natural colors Annatto beta-Carotene Caramel Carmine Chlorphyllin Cu complex Henna Summary

3. Introduction A color additive is any dye, pigment or substance which when added or applied to a food, drug or cosmetic, or to the human body, is capable (alone or through reactions with other substances) of imparting color.

4. Ideal properties of a colorant Nontoxic and have no physiological activity.  Free from harmful  impurities  Is a definite chemical compound because then only its coloring  power will be reliable, its assay will be practicable and easier.  Its  Tinctorial   (coloring)  power  should  be  high  so  that  only  small quantities are required.  Unaffected  by  light,  tropical  temperatures,  hydrolysis  and  micro‐organisms and, therefore, be stable on storage.  

5. Classification of cosmetic colorants Cosmetic colorants are classified as organic inorganic. organic colors would be the safest, they were actually originally called “coal tar” because they were derived from coal sources. However, nowadays almost all organic colorants are synthetic and are available as either water soluble, oil soluble or insoluble (Lakes) agents in all kinds of shades. Organic colors (lakes and dyes) are synthetic, chemically very complex molecules and are divided into various groups including indigoids, xanthenes, azos , nitros and others.

6. Compared to inorganic colors, organic colors are available in a larger variety of shades. Since most organic pigments are soluble (either water or oil soluble), they can be utilized not only in solid makeup products (e.g. lipsticks), but also in aqueous products (e.g. nail lacquer, liquid makeups ). Water soluble dyes are used for coloring soaps, lotions, creams, powders, salts, etc.

7. inorganic colorants are composed of insoluble metallic compounds derived from natural sources (e.g. china clay, carbon deposits), or are synthesized. Inorganic colors aren’t thought to pose the same kinds of health risks as organic colors, so don’t require certification. In addition to inorganic colors, natural materials used to color cosmetics, like carrot oil, beet extract and henna, are also considered ‘safe’ and are exempt from classification. In the category of decorative cosmetics, the majority of colors used are pigments. It is the inorganic pigments that are popular with cosmetics but are subject to purity levels of heavy metals and have to be approved by the EU (Directive 76/768/EEC) and the FDA for use in cosmetics. The following are inorganic pigments commonly used in makeup.

8. Some Basic Requirements If your product (except coal-tar hair dyes) contains a color additive, by law [FD&C Act, Sec. 721; 21 U.S.C. 379e; 21 CFR Parts 70 and 80] you must adhere to requirements for: Approval.  All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance's use as a color additive, specifications, and restrictions. Certification.  In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S. Identity and specifications.  All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR). Use and restrictions.  Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.

9. REGULATORY BODIES Regulation of Colors in the US The US FDA has established regulations for color additives in  Title 21 of the CFR, parts 70-82 . These color additive regulations identify each listed color additive, provide chemical specifications and identify uses and restrictions, labeling requirements and the requirement for certification. The regulations in  21 CFR part 71  describe the premarket approval process for new color additives or new uses for listed color additives. Color manufacturers routinely carry out quality assurance testing on the products they sell to ensure that they meet the specifications laid out in the Code of Federal Regulations.

10. FDA's permitted colors are classified as subject to certification or  exempt from certification , both of which are subject to rigorous safety standards prior to their approval and listing for use in foods. Certified colors  are synthetically produced (or human made) and used widely because they impart an intense, uniform color, are less expensive, and blend more easily to create a variety of hues. There are nine certified color additives approved for use in the United States. Colors that are  exempt from certification  include pigments derived from natural sources such as vegetables, minerals or animals. Nature derived color additives are typically more expensive than certified colors .

11. Color Additives That Are Subject to Certification and Permitted for Use in Cosmetics Color Additive Eye Area ** Generally (Includes Lipsticks) External Use Specific Limitations and Comments 21 CFR Section D&C Black No. 2 Subject to Limitations Subject to Limitations Subject to Limitations Eyeliner, brush-on-brow, eye shadow, mascara, lipstick, blushers & rouge, makeup & foundation, nail enamel 74.2052 D&C Black No. 3 Subject to Limitations No Subject to Limitations Eyeliner, eye shadow, mascara, face powder 74.2053 FD&C Blue No. 1 Yes, also Al lake Yes Yes   74.2101 D&C Blue No. 4 No No Yes   74.2104 D&C Brown No. 1 No No Yes   74.2151 FD&C Green No. 3 No Yes Yes   74.2203 D&C Green No. 5 Yes Yes Yes   74.2205 D&C Green No. 6 No No Yes   74.2206 D&C Green No. 8 No No Subject to Limitations ≤0.01% 74.2208 D&C Orange No. 4 No No Yes   74.2254 D&C Orange No. 5 No Subject to Limitations Yes Mouthwashes, dentifrices; ≤5% for lipsticks 74.2255 D&C Orange No. 10 No No Yes   74.2260 D&C Orange No. 11 No No Yes   74.2261 FD&C Red No. 4 No No Yes   74.2304 D&C Red No. 6 No Yes Yes   74.2306 D&C Red No. 7 No Yes Yes   74.2307 D&C Red No. 17 No No Yes   74.2317 D&C Red No. 21 No Yes Yes   74.2321 D&C Red No. 22 No Yes Yes   74.2322 D&C Red No. 27 No Yes Yes   74.2327 D&C Red No. 28 No Yes Yes   74.2328 D&C Red No. 30 No Yes Yes   74.2330 D&C Red No. 31 No No Yes   74.2331 D&C Red No. 33 No Subject to Limitations Yes Lipstick products ≤3%; mouthwash, dentrifices 74.2333 D&C Yellow No. 11 No No Yes   74.2711

12. D&C Red No. 34 No No Yes   74.2334 D&C Red No. 36 No Subject to Limitations Yes Lipstick products ≤3% 74.2336 FD&C Red No. 40 Yes, also Al lake Yes Yes   74.2340 D&C Violet No. 2 No No Yes   74.2602 Ext. D&C Violet No. 2 No No Yes   74.2602a FD&C Yellow No. 5 Yes, also Al lake Yes Yes   74.2705 FD&C Yellow No. 6 No Yes Yes   74.2706 D&C Yellow No. 7 No No Yes   74.2707 Ext. D&C Yellow No. 7 No No Yes   74.2707a D&C Yellow No. 8 No No Yes   74.2708 D&C Yellow No. 10 No Yes Yes   74.2710

13. Color Additives That Are Exempt from Certification and Permitted for Use in Cosmetics   Color Additive Eye Area Generally (Includes Lipsticks) External Use Specific Limitations and Comments 21 CFR Section Aluminum powder Yes No Yes   73.2645 Annatto Yes Yes Yes   73.2030 Bismuth citrate No No Subject to limitations Hair on the scalp 73.2110 Bismuth oxychloride Yes Yes Yes   73.2162 Bronze powder Yes Yes Yes   73.2646 Caramel Yes Yes Yes   73.2085 Carmine Yes Yes Yes   73.2087 β- Carotene Yes Yes Yes   73.2095 Chromium hydroxide green Yes No Yes   73.2326 Chromium oxide greens Yes No Yes   73.2327 Copper powder Yes Yes Yes   73.2647 Dihydroxyacetone No No Subject to limitations For use in tanning preparations 73.2150 Disodium EDTA-copper No No Subject to limitations Shampoos 73.2120 Ferric ammonium ferrocyanide Yes No Yes   73.2298

14. Ferric ferrocyanide Yes No Yes   73.2299 Guaiazulene No No Yes   73.2180 Guanine Yes Yes Yes   73.2329 Henna No No Subject to limitations Hair on the scalp 73.2190 Iron oxides Yes Yes Yes   73.2250 Lead acetate No No Subject to limitations Hair on the scalp; ≤0.6% lead 73.2396 Luminescent zinc sulfide No No Subject to limitations Externally applied facial makeup and nail polish; <10%; for="" infrequent="" use="" (e.g.,=""> 73.2995 Manganese violet Yes Yes Yes   73.2775 Mica Yes Yes Yes   73.2496 Potassium sodium copper chlorophyllin ( chlorophyllin -copper complex) No No Subject to limitations Dentifrices; ≤0.1% 73.2125 Pyrophyllite No No Yes   73.2400 Silver No No Subject to limitations Fingernail polish; ≤1% 73.2500 Titanium dioxide Yes Yes Yes   73.2575 Ultramarines Yes No Yes   73.2725 Zinc oxide Yes Yes Yes   73.2991

15. NATURAL COLOUR Annatto beta-Carotene Caramel Carmine Chlorphyllin Cu complex Guaiazulene Henna Guanine

16. Inorganic colors used in cosmetics Mica Titanium dioxides Iron oxides Manganese violet Zinc oxide

17. Lycopene – reddish / orange color derived from tomatoes Vegetable Carbon – Black color derived from burnt vegetable matter. Curcumin – Yellow color derived from the spice turmeric. Capsanthin / Capsorubin – Orange color derived from sweet red peppers. Commonly known as paprika. Canthaxanthin – yellow – red color derived from mushrooms or shrimp .

18. Henna SOURCE Henna is the natural material derived from the dried powdered leaves of the plant  Lawsonia inermis . Henna is used in the formulation of hair coloring products. Henna imparts color to the hair. The exact color obtained will depend on the other ingredients that are used in the preparation and the starting color of the hair.

19. BENEFITS OF HENNA: Henna Hair Dye: Naturally, Gently Colors Hair. Strengthens the Hair Shaft. Detoxes the follicles. Conditions the Scalp. Fights Dandruff. Henna’s pigment, lawsone , gradually migrates into the hair shaft while setting and will naturally & gently bind to the keratin(protein) in your hair. It will actually maintain your current natural highlights and undertones. Henna fuses into, does not artificially cover, your existing hair color variations. The color appears completely natural—never “cakey” and artificial like traditional chemical-based hair dyes. Henna will condition and repair the hair while it colors during the treatment (1-2 hours+). Unlike artificial slick-coating leave-in conditioners, henna works from the scalp up. The conditioning effects are the  total process of the application : the henna paste detoxes the scalp and roots(anti-bacterial & fungal); the lawsone pigment positively restructures the hair proteins; the cuticle layer of the hair smoothes and lies flat adding shine; and the rinsing of the dry paste naturally extracts hair residue (pollution, styling products, etc.) as it washes out—like a facial mud mask…just a natural, time-proven, super combo.

20. Hair dyeing formulations belong to three categories – Temporary semi-permanent and permanent coloring of hair. Temporary coloring preparations, often called color rinses, provide color which lasts until the first shampooing. Ingredients which impart temporary color may have a fairly high molecular weight and are unable to penetrate the hair shaft. These materials are simply deposited onto the hair  fiber  and are removed by subsequent shampooing. Semi-permanent coloring preparations generally provide color through several shampooings . These materials are often low molecular weight pre-formed dyes which can penetrate the hair shaft to some extent. Henna function as a  hair colorant

21. Safety Information The Food and Drug Administration (FDA) lists Henna as a color additive exempt from certification and it may be safely used for coloring hair only. It may not be used on the skin or for coloring the eyelashes or eyebrows. The  Cosmetic Ingredient Review (CIR) Expert Panel has deferred evaluation of Henna because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.

22. Beta - carotene Beta-Carotene is a precursor of vitamin A. It is the pigment responsible for the orange color of carrots and it is found in many other fruits and vegetables. Beta-Carotene used in cosmetics and personal care products is prepared synthetically or obtained from natural sources. Beta-Carotene is listed as CI 40800 and CI 75130 in the Cosmetics Directive of the European Union and may be used as a coloring agent in all cosmetics and personal care products. When used in cosmetics and personal care products in the European Union Beta-Carotene must be called CI 40800 or CI 75130. The color additive β-carotene may be safely used in coloring cosmetics generally, including cosmetics intended for use in the area of the eye, in lipstick, in amounts consistent with good manufacturing practices .

23. Annatto SOURCE Annatto is the coloring matter made from from the seeds of the tree,  Bixa orellana , commonly called the lipstick tree.  In cosmetics and personal care products, Annatto is used in the formulation of face and neck products, lipsticks, shampoos, and skin care products. Why is it used in cosmetics and personal care products? Annatto imparts a red or orange color to cosmetics and personal care products .

24. Methods for preparations The color additive  annatto  extract is an extract prepared from  annatto  seed,  Bixa orellana  L. The alkaline alcohol or aqueous extracts may be treated with food-grade acids to precipitate  annatto  pigments, which are separated from the liquid and dried, with or without intermediate recrystallization , by using any of them from Acetone, ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, trichloroethylene. Food-grade alkalis or carbonates may be added to adjust alkalinity.

25. Safety Information The Food and Drug Administration (FDA) lists Annatto as a color additive exempt from certification and it may be safely used in coloring foods, as well as cosmetics and drugs including products intended for use in the area of the eye.

26. Mica(inorganic colour ) Mica is a naturally occurring group of silicate minerals. In cosmetics and personal care products, Mica, from muscovite mica is used in the formulation of a wide variety of product types, including makeup, nail products and skin care products. Why is it used in cosmetics and personal care products? Mica imparts a sparkly white appearance to cosmetics and personal care products

27. Safety Information The Food and Drug Administration (FDA) lists Mica as a color additive exempt from certification. Mica, is safe for use in coloring products, including cosmetics and personal care products applied to the lips, and the area of the eye.

28. Caramel Caramel is a  colorant  derived from heating edible sugar. In cosmetics and personal care products, Caramel is used in the formulation of a wide variety of product types. Why is it used in cosmetics and personal care products? Caramel imparts a brown color to cosmetics and personal care products .

29. The Food and Drug Administration (FDA) includes Caramel on its list of substances considered Generally Recognized As Safe ( GRAS ) as a multipurpose food substances. FDA also lists Caramel as a color additive exempt from certification. Caramel is determined to be safe for use in coloring cosmetics and personal care products, including products applied to the lips and area of the eye. The  Cosmetic Ingredient Review  (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.

30. Chlorophyllin -Copper Complex Chlorophyllin -Copper Complex is obtained by extracting chlorophyllin from fescue and rye grasses. Chlorophyllin -Copper Complex is made from chlorophyll. Chlorophyll is the green pigment in plants that is essential for photosnythesis . In cosmetics and personal care products, Chlorophyllin -Copper Complex is used in the formulation of bath products, cleansing products, dentifrices, deodorants, hair conditioners, shampoos, skin care products and other hair products. Chlorophyllin -Copper Complex also imparts a green color to dentifrice products .

31. Carmine Carmine is the aluminum lake of the coloring agent, cochineal, a natural pigment derived from the dried female insect  Coccus cacti  (cochineal). In cosmetics and personal care products, Carmine is used in the formulation of a wide variety of product types, including make up and nail polish. Why is it used in cosmetics and personal care products? Carmine imparts a red color to cosmetics and personal care products.

32. Safety Information: Carmine may be safely used in cosmetics and personal care products, including products intended for use on the lips and in products intended for use in the area of the eye.  

33. Titanium Dioxide( inorganic colour ) Titanium dioxide is a naturally occurring mineral that is mined from the earth then further processed and purified for use in consumer products.  Titanium dioxide is used as a  colorant  to make cosmetics and personal care products that are applied to the skin (including the eye area), nails, and lips white in color.

34. SUMMARY Colors which are permitted for hair products Bismuth citrate : it imparts yellow color to the hair. Disodium EDTA-copper: it imparts color on hair. Henna: Turning hair red, or in the case of white or blonde hair, orange, when used alone. Henna can be mixed with other plants like indigo to make a variety of shades including dark brown and black. Lead acetate: In low concentrations, Lead Acetate is used as a color additive in "progressive" hair dye products. These products are applied over a period of time to achieve a gradual coloring effect.

35. Colors which are permitted for lipstick Annatto Bismuth oxychloride Bronze powder Caramel Carmine β- Carotene Copper powder Manganese violet Mica Titanium dioxide

36. Colors which are permitted for eye area Bismuth oxychloride Bronze powder Caramel Carmine β- Carotene Chromium hydroxide green Chromium oxide greens Copper powder

37. Colors which are permitted for external use Bismuth oxychloride Bronze powder Caramel Carmine β- Carotene Chromium hydroxide green Chromium oxide greens Copper powder Ferric ferrocyanide Guaiazulene Guanine

38. REFERENCE https://iacmcolor.org/how-colors-are-regulated/ https://www.fda.gov/cosmetics/cosmetic-ingredient-names/color-additives-permitted-use-cosmetics https://www.hennacolorlab.com/shop/natural-black-henna-hair-dye/ https://cosmeticsinfo.org/ https://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=d1e893bdb7eb4f21dc0d6979702c7372&rgn=div6&view=text&node=21:1.0.1.1.27.3&idno=21#se21.1.73_12496 https://medium.com/@cosmethics/the-world-of-colors-in-cosmetics-964dc165d43