Red 36 Lake

The Food and Drug Administration (FDA) has reviewed the safety of Red 36 and and Red 36 Lake and determined that they may be safely used for coloring externally applied cosmetics and personal care products and for coloring lip products at a maximum level of 3% The Food and Drug Administration (FDA) reviewed the safety of Red 36 and Red 36 Lake and approved the use of these ingredients for coloring cosmetics and personal care products and drugs when these colors conform with specifications established by FDA. These ingredients are permitted for use at a maximum concentration of 3% in lipstick, but may not be used in other oral products or in products intended for use in the area of the eye. According to U.S. regulations, all Red 36 and Red 36 Lake 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 these ingredients 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 Red 36

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

Red 36 is listed as Color Index No. 12085 in the Cosmetics Directive of the European Union and may be used in all cosmetics and personal care products subject to certain use levels. The insoluble lakes, salts and pigments of Red 36 are also permitted (see Annex IV). When used in cosmetic products in the European Union, this ingredient must be called CI 12085.

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…