Dihydroxyacetone

The Food and Drug Administration (FDA) lists Dihydroxyacetone as a color additive exempt from certification. It may be safely used in externally applied cosmetics "intended solely or in part to impart a color to the human body" provided that it conforms to FDA specifications. Dihydroxyacetone may also be used in externally applied drugs.

Cosmetic Ingredient Review (CIR) has deferred evaluation of this ingredient 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 comments regarding sunless tanner products
http://www.cfsan.fda.gov/~dms/cos-tan4.html

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

In Europe, Dihydroxyacetone is treated as a cosmetic ingredient rather than as a colorant. Dihydroxyacetone may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
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...