Orange 4

The Food and Drug Administration (FDA) reviewed the safety of Orange 4 and approved the use of this ingredient for coloring externally applied cosmetics (this does not include products intended for use on the lips or the eye area) and personal care products if it conforms to FDA specifications. FDA determined that this color may also be used in coloring externally applied drugs. According to U.S. regulations, all Orange 4 that is 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 ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (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 Orange 4

• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…
• http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr…

Orange 4 is listed as CI 15510 in the Cosmetics Directive of the European Union and is a coloring agent allowed for use in all cosmetics and personal care products except those intended to be applied in the vicinity of the eyes, in particular eye makeup and eye makeup remover. The insoluble lakes, salts and pigments of Orange 4 are also permitted and must pass the test for insolubility. When used in cosmetic products in the European Union, this ingredient must be called CI 15510.

Link to the EU Cosmetic Regulation: 
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

You can learn more about the regulation and labeling of colors at: 
http://www.personalcarecouncil.org/colors-cosmetics-regulation-and-nomen…