Red 21 Lake
What Is It?
In cosmetics and personal care products, Red 21 (D&C Red No. 21) and Red 21 Lake are colorants used in the formulation of foundations, lipsticks, rouges and other makeup products.
Why Is It Used?
Red 21 and Red 21 Lake impart color to cosmetics and personal care products.
Red 21 is a color belonging to the fluoran class. The fluoran colors are characterized by fluorescence when exposed to light and tend to brighten the appearance of the product, in addition to having a red hue.
The Food and Drug Administration (FDA) has reviewed the safety of Red 21 and determined that it may be safely used for coloring cosmetics and personal care products including products intended to be used on the lips. It is not permitted for use in products intended for use in the area of the eye. Red 21 is also permitted as to be used as a color extenally applied drugs. According to U.S. regulations, all Red 21 and Red 21 Lake that are manufactured for use in products is subject to certification by the FDA. This certification process ensures that the strict chemical and identity specifications set by FDA are met. The The Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (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.
All color additives used in foods, drugs and cosmetics in the United States must be approved by FDA and listed in the Code of Federal Regulations. In some cases, FDA requires that each batch of color produced for use in regulated products can be used only if it is certified by the agency to meet strict specifications. FDA maintains a laboratory especially for this purpose and color manufacturers must pay a fee to support this activity. FDA only approves colors after extensive review of all safety data and publication of the basis for its approval in the Federal Register.
You can find out more about FDA regulation of colors at: http://www.cfsan.fda.gov/~dms/cos-col.html
Link to FDA Code of Federal Regulations for Red 21
Red 21 is listed as CI 45380 in the Cosmetics Directive of the European Union and is a colouring agent allowed for use in all cosmetics and personal care products. 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid are limited to 1% and 2%, respectively. The insoluble barium, strontium and zirconium lakes, salts and pigments of Red 21 are also permitted and must pass the test for insolubility. When used in cosmetic products in the European Union, this ingredient must be called CI 45380.
Link to the EU Cosmetic Regulation:
You can learn more about the regulation and labeling of colors at:
More Scientific Information
Red 21 is chemically named as 2′,4′,5′,7′-tetrabromofluorescein. As a fluorescein color, it exhibits fluorescent properties, which means that the absorption of light triggers the emission of light with a longer wavelength. This can have the effect of making the product appear to glow. Fluorescence is named after the mineral fluorite, composed of calcium fluoride, which often exhibits this phenomenon. Red 21 is soluble in water. Red 21 Lake is an insoluble pigment used in applications where bleeding of the color is undesirable.
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/