Red 4

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 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

FDA: Link to Code of Federal Regulations for Red 4
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

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 Cosmetics Directive: http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...

You can learn more about the regulation and labeling of colors at: http://www.personalcarecouncil.org/Content/NavigationMenu/Co...