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.

This study describes a new method for determining FD&C Blue No. 1, FD&C Blue No. 2, FD&C Green No. 3, FD&C Red No. 3, FD&C Red No. 40, FD&C Yellow No. 5, and FD&C Yellow No. 6 in food products. These seven color additives are water-soluble dyes that are required to be batch certified by the U.S. Food and Drug Administration (FDA) before they may be used in food and other FDA-regulated products. In the new method, the color additives are extracted from a product using one of two procedures developed for various product types, isolated from the noncolored components, and analyzed by liquid chromatography with photodiode array detection. The method was validated by determining linearity, range, precision, recovery from various matrices, limit of detection, limit of quantitation, and relative standard deviation for each color additive. A survey of 44 food products, including beverages, frozen treats, powder mixes, gelatin products, candies, icings, jellies, spices, dressings, sauces, baked goods, and dairy products, found total color additives ranging from 1.9 to 1221 mg/kg. FDA intends to use the new method for conducting a rigorous, comprehensive dietary exposure assessment of certified color additives in products likely to be consumed by children.

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Carbon black (C.I. 77266) is an insoluble pigment produced by the partial combustion of hydrocarbons. The pigment is known by several synonyms, including vegetable carbon, lamp black and carbon ash, that correspond to the raw materials and methods used for its production. Vegetable carbon (E153) is permitted for use in colouring food in the European Union. The US Food and Drug Administration (USFDA) has not approved the use of any type of carbon black for colouring food, although the agency batch certifies the pigment as D&C Black No. 2 for use in colouring certain cosmetics. Since carbon black (as vegetable carbon) may be present in food products offered for import into the United States, the USFDA's district laboratories need a qualitative analytical method for determining its presence. We have developed an extraction method for this purpose. A sample is broken down and dissolved with nitric acid. The resulting solution is filtered and treated with hydrochloric acid to dissolve any black iron oxide also present as a colour additive. A black residue remaining on the filter paper indicates the presence of carbon black in the food. We confirmed the presence of carbon black in residues from several standards and food products using Raman spectroscopy. The limit of detection for this method is 0.0001%.