Ext. Violet 2

The FDA reviewed the safety of Ext. Violet 2 and determined that it may be safely used for coloring externally applied cosmetics and personal care products when it conforms to FDA specifications and is certified by FDA to meet the regulatory specifications. Ext. Violet 2 is not permitted for use in lip products or in products intended for use in the 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

Link to FDA Code of Federal Regulations for Ext. Violet 2
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

Ext. Violet 2 is listed as CI 60730 in the Cosmetics Directive of the European Union and may be used in all cosmetics and personal care products intended not to come into contact with the mucous membranes (see Annex IV). When used in cosmetic products in the European Union, this ingredient must be called CI 60730.
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...