What Is It?
In cosmetics and personal care products, Red 40 (FD&C Red No. 40) and Red 40 Lake are colorants used in the formulation of a wide variety of product types.
Why Is It Used?
Red 40 and Red 40 Lake are used to color to cosmetics and personal care products.
Red 40 is a water-soluble Ingredients that impart color to cosmetic products. In the United States, the FDA regulates which colorants may be used in cosmetics. referred to in general terms as a monoazo color. Red 40 Lake is formed from Red 40 by converting it to a water-insoluble pigment for use in situations where color bleeding is undesirable. In addition to its use in cosmetics and personal care products, Red 40 is approved by FDA for use in drugs and foods and may be found in products such as orange soda.
The Food and Drug Administration (FDA) has reviewed the safety of Red 40 and Red 40 Lake and determined that they may be safely used in food and in coloring cosmetics and personal care products (including products intended for use in the area of the eye and the lip and mouth), as well as drugs when conforming to specifications established by FDA. According to U.S. regulations, all Red 40 and Red 40 Lake 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 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 these ingredients 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 40
Red 40 is listed as CI 16035 in the Cosmetics Directive of the European Union and is a coloring agent allowed for use in all cosmetics and personal care products without restriction (see Annex IV). When used in cosmetic products in the European Union, this ingredient must be called CI 16035.
Link to the EU Cosmetic Regulation:
You can learn more about the regulation and labeling of colors at:
More Scientific Information
Red 40 is identified chemically as the disodium salt of 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid. Red 40 is freely soluble in water at all pHs and forms a deep yellowish-red color. It is stable to light and heat and can be used in a wide variety of products and formulations.
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/