Ferric Ferrocyanide

The Food and Drug Administration (FDA) lists Ferric Ferrocyanide and Ferric Ammonium Ferrocyanide as color additives exempt from certification. Ferric Ferrocyanide and Ferric Ammonium Ferrocyanide are safe for use in coloring externally applied cosmetics and personal care products, including products applied to the area of the eye, when these ingredients conform to FDA specifications. Ferric Ferrocyanide and Ferric Ammonium Ferrocyanide are also allowed to be used in externally applied drugs. These ingredients are not allowed to be used in products intended for use on the lips. The 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. Certification exempt colors are specifically allowed for use in cosmetics in the United States, however, they do not require individual batch analysis and certification by the FDA. Based on the relatively simple composition or derivation of these colors, the FDA has determined that individual batches of these colors do not require certification for purity. FDA has set strict limits on the levels of soluble cyanide in Ferric Ferrocyanide and Ferric Ammonium Ferrocyanide to no more than 10 parts per million (ppm).

You can find out more about FDA regulation of colors at: http://www.cfsan.fda.gov/~dms/cos-col.html

FDA: Link to Code of Federal Regulations for Ferric Ferrocyanide

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

Link to FDA Code of Federal Regulations for Ferric Ammonium Ferrocyanide

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

Ferric Ferrocyanide and Ferric Ammonium Ferrocyanide are listed as CI 77510 the Cosmetics Directive of the European Union (Annex IV, Part I) and may be used in all cosmetics and personal care products and must be free from cyanide ions. When used in cosmetic products in the European Union, these ingredients must be called CI 77510.

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…