Red 6 Lake

The Food and Drug Administration (FDA) reviewed the safety of Red 6, Red 6 Lake, Red 7 and Red 7 Lake and approved the use of these ingredients for coloring cosmetics and personal care product including products intended for use on the lips if these ingredients conform to FDA specifications. These colors are not permited for use in products intended for use on area around the eye. FDA also determined that these colors may also be used in coloring externally applied drugs.

According to U.S. regulations, all Red 6, Red 6 Lake, Red 7 and Red 7 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 only be used if it is certified by the agency to meet the established 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.

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 6
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
and Red 7
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

Red 6 and Red 7 are listed as Color Index No. 15850 (CI 15850) in the Cosmetics Directive of the European Union and may be used in all cosmetics and personal care products. The lakes, salts and pigments are also permitted in Europe. When used in cosmetic products in the European Union, these ingredients must be called CI 15850.
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...