Red 40

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.

Scientific Facts

Red 40 is a water-soluble colorant 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.
Safety Information

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. Cosmetic Ingredient Review (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: 
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

You can learn more about the regulation and labeling of colors at: 
http://www.personalcarecouncil.org/colors-cosmetics-regulation-and-nomen…

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.
Resources

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/