Red 4
What Is It?
Red 4 (FD&C Red No. 4) and Red 4 Lake are synthetic colorants. Red 4 and Red 4 Lake are used in the formulation of a wide variety of product types, including makeup products, nail polish and skin care products.
Why Is It Used?
Red 4 and Red 4 Lake may be used alone or in combination with other colors to color cosmetics and personal care products.
Scientific Facts
Red 4 is a synthetic pigment sometimes referred to as a monoazo color. Color additives are classified as straight colors, lakes, and mixtures. Straight colors are color additives that have not been mixed or chemically reacted with any other substance. Red 4 is a straight color.
Safety Information
The Food and Drug Administration (FDA) reviewed the safety of Red 4 and Red 4 Lake and approved the use of these ingredients for coloring externally applied cosmetics (this does not include products intended for use on the lips or the eye area) and personal care products if they conform to FDA specifications. FDA determined that these colors may also be used in coloring externally applied drugs. According to U.S. regulations, all Red 4 and Red 4 Lake that is manufactured for use in products are 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 ReviewThe 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
FDA: Link to Code of Federal Regulations for Red 4
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
- http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
Red 4 and Red 4 Lake are listed as CI 14700 in the Cosmetics Directive of the European Union (Annex IV, Part I) and may be used in cosmetics and personal care products without restriction. When used in cosmetic products in the European Union, Red 4 and Red 4 Lake must be called CI 14700.
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 4 is identified chemically as the disodium salt of 3-[(2,4-dimethyl-5-sulfophenyl)azo]-4-hydroxy-1-naphthalenesulfonic acid. Red 4 is soluble in water, while Red 4 Lake is insoluble in water. Red 4 and Red 4 Lake are the abbreviated names given by FDA for the certified color, FD&C Red No. 4. Certifiable color additive such as Red 4 are used widely because their coloring ability is more intense than most colors derived from natural products; thus, they are often added in smaller quantities. In addition, certifiable color additives are more stable, provide better color uniformity and blend together easily to provide a wide range of hues. Certifiable color additives typically are available for use as either “dyes” or “lakes.” Dyes dissolve in water and are manufactured as powders, granules, liquids or other special purpose forms. Lakes are the water insoluble form of the dye. Lakes are typically more stable than dyes and are ideal for coloring products lacking sufficient moisture to dissolve dyes.
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/