Scientific Publications by FDA Staff

J AOAC Int 2014 Jul-Aug;97(4):1039-47

Qualitative identification of permitted and non-permitted color additives in cosmetics.

Miranda-Bermudez E, Harp BP, Barrows JN

Color additives are dyes, pigments, or other substances that can impart color when added or applied to foods, drugs, cosmetics, medical devices, or the human body. These substances must be pre-approved by the U.S. Food and Drug Administration (FDA) and listed in the Code of Federal Regulations before they may be used in FDA-regulated products. Both domestic and imported cosmetic products sold in interstate commerce fall under FDA jurisdiction, and FDA's district laboratories use a combination of analytical methods for identifying or confirming the presence of potentially violative color additives. We have developed a qualitative method for identifying 29 water- and methanol-soluble color additives in various types of cosmetic products. The color additives are extracted with combinations of methylene chloride, methanol, acetic acid, and water and are identified by LC with photodiode array detection. Estimated LOD values ranged from 0.1 to 1.5 mg/L. A survey of lip products, nail polishes, eye products, blushes, body glitter, face paints, bath products, creams, and toothpastes identified permitted and non-permitted color additives. Our new LC method is intended to supplement the visible spectrophotometry and TLC methods currently used by FDA's district laboratories and will help optimize the use of time, labor, and solvents.