Caramel is a colorant derived from heating edible sugar. In cosmetics and personal care products, Caramel is used in the formulation of a wide variety of product types.
FDA also lists Caramel as a color additive exempt from certification. Caramel is determined to be safe for use in coloring cosmetics and personal care products, including products applied to the lips and area of the eye.
The 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: Links to Code of Federal Regulations for Caramel
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...
Caramel is listed in Annex IV, Part I (coloring agent allowed for use in cosmetic products) of the Cosmetics Directive of the European Union and may be used without restriction when purity requirements included in food regulations are fulfilled.
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...
The World Health Organization Food Additives Committee has evaluated the intake of Caramel colour II, which differs from Caramel colour I, or plain Caramel. Caramel 1 has not been evaluated.
http://www.inchem.org/documents/jecfa/jecmono/v46je13.htm#_4...
You can learn more about the regulation and labeling of colors at: http://www.personalcarecouncil.org/Content/NavigationMenu/Co...