Red 33

The Food and Drug Administration (FDA) has reviewed the safety of Red 33 and approved its use in cosmetics and personal care products, with the exception of products intended for use in the area of the eye. It is allowed for use in lipsticks at a maximum concentration of 3%. It may also be safely used for coloring mouthwashes (including breath fresheners), dentifrices and externally applied cosmetics and personal care products when it conforms to FDA specifications. According to U.S. regulations, all Red 33 and Red 33 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

Link to FDA Code of Federal Regulations for Red 33
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

Red 33 is sometimes converted to an insoluble pigment for use in those situations where migration of the color to surrounding ingredients needs to be controlled. These insoluble pigments are referred to as “lakes” and the ingredient declaration on the product may be labeled as “Red 33 Lake”. FDA has also considered the safety of these lakes and has issued regulations that address their use in products.

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

Red 33 is listed as CI 17200 in the Cosmetics Directive of the European Union (Annex IV, Part I) and may be used in all cosmetics and personal care products. The insoluble barium, strontium and zirconium lakes, salts and pigments of Red 33 are also permitted and must pass the test for insolubility. When used in cosmetic products in the European Union, these ingredients must be called CI 17200.
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...