Color additive

Copies of regulations governing the listing, certification, and use of colors in foods, drags, devices, and cosmetics shipped in interstate commerce or offered for entry into the United States, or answers to questions concerning them, are available from the Food and Drag Administration. Recommendations on submission of chemical and technological data are provided in the FDA s online publication (http //vm.cfsan.fda.gov/ -dms/opa-coll.html). 

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Color Additives. Color additives, for the benefit of dog and cat owners, help simulate food richness, which is evaluated ia many differeat ways. The additioa of color helps minimi2e variatioas ia appearance associated with batch difference ia food iagredieats and fineness of gtind. Cats and dogs are practically color blind colors have Utfle influence on them. 

Hair Coloring Regulation Issues. In the United States the classification of color additives is complex. Under the Federal Food, Dmg and Cosmetic Act, all cosmetic colors must be the subject of an approved color additive petition to the Food and Dmg Administration there is an exception for coal-tar colorants used to color hair. Based on the composition of these colorants, FDA can require a certification on each manufactured batch of colorant to assure conformance with the approved specifications. In the early 1990s FDA has required certification only for synthetically derived coal-tar type colors. Many of the approved color additives, both certified and noncertified, are restricted ia their potential use. These restrictions can be found ia the color additive regulations ia the Code of Federal Regulations at 21 CFR 73 and 74. 

Alkali or alkaline-earth salts of both complexes are soluble in water (except for Ba2[Fe(CN)g]) but are insoluble in alcohol. The salts of hexakiscyanoferrate(4—) are yellow and those of hexakiscyanoferrate(3—) are mby red. A large variety of complexes arise when one or more cations of the alkah or alkaline-earth salts is replaced by a complex cation, a representative metal, or a transition metal. Many salts have commercial appHcations, although the majority of industrial production of iron cyanide complexes is of iron blues such as Pmssian Blue, used as pigments (see Pigments, inorganic). Many transition-metal salts of [Fe(CN)g] have characteristic colors. Addition of [Fe(CN)g] to an unknown metal salt solution has been used as a quaUtative test for those transition metals. 

Center for Eood Safety and AppHed Nutrition (CESAN). This center is responsible for the regulation and approval of food for human consumption, food additives, color additives, and cosmetics. Although CESAN does not regulate meat and poultry, it does set safety and sanitation standards for supermarkets, restaurants, and other retail food estabUshments. 

To further improve the general safety standards, the Delaney Clause was included in the Pood Additives Amendment of 1958. The Delaney Clause states that no food additive or color additive can be deemed safe if it has been found to induce cancer when ingested by humans or animals (23). The Clause acts as an absolute prohibition on the use of any additive found to cause cancer without any regard for whether, or to what extent, the substance is hazardous to human health. As scientific advances continue, both in the realm of food technology and analysis of previously undetected contaminants, the... 

This proliferation in the use of color additives was soon recognized as a threat to the pubHc s health. Of particular concern were the practices of a dding poisonous colorants to food, and of using dyes to hide poor quaUty or to add weight or bulk to certain items. References 5—14 provide additional information on the history of food colorants and thek regulation. Reference 15 provides more information regarding the appHcations, properties, specifications, and analysis of color additives, as well as methods for the determination of colorants in products. 

During the next three decades there was a continual growth in the use and number of color additives, and using Hesse s rules, the Hst of colors certifiable for use in foods was expanded. 

The disputes that followed these events centered around interpretation of the 1938 act, which states that "The Secretary shall promulgate regulations providing for the listing of coal-tar colors which are harmless and suitable for use in food..." The FDA felt that harmless meant that a colorant must be safe regardless of the amount used, that is, harmless per se and on this basis deHsted the colorants in question. The food-color manufacturers argued that the FDA interpretation of the law was too strict, that a color additive need only be harmless when properly used, and that the FDA should estabHsh safe limits. They also contended that the conditions used for the new animal feeding tests were too severe. 

Through the efforts of the Certified Color Industry and the FDA, a new law was formulated, the Color Additives Amendments of 1960 (PubHc Law 86-618) (21). The amendments provided a breathing speU by allowing the continued use of existing color additives pending the completion of... 

With the passage of the Medical Device Amendments of 1976 (PubHc Law 94-295) Congress created a new category of color additive by mandating the separate listing of colorants for use in medical devices if the color additive in them comes in dkect contact with the body for a significant period of time. 

Colorants currentiy in use and thek status are shown in Tables 1—4. These Hsts are accurate as of January 1993 but are subject to change. Such changes as well as any changes in the regulation of color additives are routinely pubHshed in the Federal Register The FDA, Division of Colors and Cosmetics also provides additional regulatory information (14). 

No color additive or product containing one can be used iu the area of the eye, iu surgical sutures, or iujections unless so stated. Colorants without restrictions can be used for coloring cosmetics generally, iu amounts consistent with good manufacturiag practice. 

Colorless Foods. The principal use of color additives in food is in products containing Htde or no color of their own. These include many hquid and powdered beverages, gelatin desserts, candies, ice creams, sherbets, icings, jams, jeUies, and snack foods. Without the addition of color to some of these, eg, gelatin desserts and soft drinks, all flavors of the particular product would be colorless, unidentifiable, and probably unappealing to the consumer. 

Color additives are routinely added to medical devices such as surgical sutures, surgical cements, and contact lenses (32). Sutures are usually colored to make them more visible during survery and, depending on the appHcation, during removal of the suture after the sutured area has healed. Surgical cements, too, are colored to make them more visible during use (Table 4). 

Certification of Colorants. A further distinction between color additives is made relative to whether there is requirement for FDA certification. In general, only synthetic organic colorants are now subject to certification, whereas natural organic and inorganic colorants, such as turmeric and titanium dioxide, are not. The exemption from certification for a particular colorant holds whether the colorant is obtained from natural sources or is synthetically produced, as in the case of natural and synthetic -carotene. 

Use Restrictions. There are numerous restrictions on the use of color additives. They caimot, for example, be employed to deceive the pubHc by adding weight or bulk to a product or by hiding quaUty. In addition, special permission is needed to use colorants or products containing them in the area of the eyes, in injections, in surgical sutures, and in foods for which standards of identity have been promulgated under Section 401 of the Eederal Eood, Dmg, and Cosmetic Act. 

Included in this grouping are D C Green No. 5 (13), a water-soluble sulfonate, D C Green No. 6 (14), an unsulfonated water-insoluble compound, and D C Violet No. 2 (29), a water-insoluble hydroxyanthraquinone. Anthraquinone color additives, in general, are light stable and have good physical and chemical properties for use in cosmetics (see Dyes, ANTHRAQUINONE). 

There are three color additives of the indigoid type, including D C Blue No. 6 (35) (an insoluble pigment), FD C Blue No. 2 (2) (the water-soluble disodium sulfonate derivative of indigo), and D C Red No. 30 (23) (an insoluble thioindigoid). AH are related to indigo [482-89-3] which has stmcture (35) (Fig. 3). 

The second largest group of color additives are the xanthenes, which are characterized by the foHowing stmcture ... 

Lakes. Lakes are a special kind of color additive prepared by precipitating a soluble dye onto an approved iasoluble base or substratum. In the case of D C and Ext. D C lakes, this substratum may be alumina, blanc fixe, gloss white, clay, titanium dioxide, 2iac oxide, talc, rosia, aluminum ben2oate, calcium carbonate, or any combination of two or more of these materials. Currentiy, alumina is the only substratum approved for manufactuting FD C lakes. 

Properties of lakes that enhance their usefiilness iaclude their opacity, their abiUty to be iacorporated iato products ia the dry state, their relative iasolubihty, and their superior stabiUty toward heat and light. Such properties have made possible the more effective and more efficient preparation of candy and tablet coatings, and often eliminate the need to remove moisture from dry products before coloring them. Lakes have also made possible the coloring of certain products that, because of their nature, method of preparation, or method of storage, caimot be colored with ordinary color additives. 

Properties of Colorants. Properties of a number of colorants are shown ia Tables 5—9. Eor other properties see Refereace 15. Most values are from the Hterature and, ia geaeral, refer to commercial colorants and not pure compounds. The composition of certified colorants can vary substantially with regard to the amounts of pure dye, salt, moisture, subsidiary dyes, trace metals, etc. that they contain, and of course the properties of color additives are affected by their composition. 

Table 10. Color Additives Certified by FDA during Fiscal Year, t...

With the passage of the 1960 amendments, all exempt coloiants then in use weie piovisionaHy Hsted pending completion of the studies needed to obtain thek permanent listing. Since that time, most of them as well as several completely new colors have achieved this status. Exempt color additives now in use and thek status are shown in Tables 1—4. 

Exempt colorants are inherently neither more nor less safe than certified colorants. However, they are viewed as having been obtained from nature (natural) (43—45) and thus imagined as less of a health ha2ard than certified colorants. In fact, like all color additives, they are fabricated products. 

The colorant is prepared by leaching the annatto seeds with an extractant prepared from one or more approved, food-grade materials taken from a hst that includes various solvents, edible vegetable oils and fats, and alkaline aqueous and alcohoHc solutions (46,47). Depending on the use intended, the alkaline extracts are often treated with food-grade acids to precipitate the annatto pigments, which ia turn may or may not be further purified by recrystallization from an approved solvent. Annatto extract is one of the oldest known dyes, used siace antiquity for the coloring of food, textiles, and cosmetics. It has been used ia the United States and Europe for over 100 years as a color additive for butter and cheese (48—50). 

Canthaxanthin. The newest of the synthetically produced carotenoid color additives, canthaxanthin [514-78-3] (39) (P-carotene-4-4 -dione), became commercially available about 1969 (60). Its Cl designation is Food Orange 8, Cl No. 40850. Its EEC designation is E 160g. 

Caramel. Officially, the color additive caramel is the dark brown Hquid or soHd material resulting from the carefully controlled heat treatment of the following food-grade carbohydrates dextrose, invert sugar, lactose, malt symp, molasses, starch hydrolysates and fractions thereof, or sucrose. Practically speaking, caramel is burned sugar. 

Dehydrated Beets. This color additive is defined as a dark ted powder prepared by dehydrating sound, mature, good quality, edible beets. 

Paprika and its oleoresin are approved for use in foods in general where its appHcation as a color additive frequendy ovedaps its use as a spice. Both products have good tinctorial strength and are used at 0.2—100 ppm to produce orange to bright red shades. 

Chromium Hydroxide Green. This color additive is principally hydrated chromic sesquioxide [12182-82-0], -xHpD (Cl Pigment... 

Synthetic Iron Oxide. This colorant is one or a combination of various synthetically prepared iron oxides, including the hydrated forms. The naturally occurring oxides are unacceptable as color additives because of the difficulties frequendy encountered ia purifyiag them. 

Only synthetically prepared Ti02 can be used as a color additive. It is permitted ia foods to 1% and is used to color such products as confectionary paimed goods, cheeses, and icings. It is also widely used ia tableted dmg products and ia numerous cosmetics such as Upsticks, nail enamels, face powder, eye makeup, and rouges, ia amounts consistent with good manufactuting practice (42). 

Ferric ferrocyanide—Cl Pigment Blue 27, Cl No. 77510. The color additive ferric ferrocyanide is a ferric hexacyanoferrate is a pigment characterized by the stmctural formula Fe4[Fe(CN)g]2ArH20, which may contain small amounts of ferric sodium ferrocyanide and ferric potassium ferrocyanide. ... 

Poly(hydroxyethyl methacrylate)-dye copolymers —The color additives formed by reaction of one or more of the foUowiag reactive dyes with poly(hydroxyethyl methacrylate), so that the sulfate group (or groups) or chlorine substituent of the dye is replaced by an ether linkage to poly(hydroxyethyl methacrylate) (see Dyes, reactive). The dyes that may be used alone or ia combination are... 

H. J. White, Jr., ed.. Proceedings of the Perkin Centennial, Sept. 10, 1956, New York, sponsored by the American Association of Textile Chemists and Colorists. Includes chapters on the use, properties, and reasons for using color additives in various foods, dmgs, and cosmetics. 

U.S. Supreme Court. 358 U.S. 153, Dec. 15, 1958. The court ruling that established the harmless per se principle that a color additive had to be harmless regardless of the quantity used. 

J. Noonan, "Color Additives in Foods" in Handbook of Food Additives, The Chemical Rubber Co., Cleveland, Ohio, 1968, pp. 25—49. Food colors— their description, properties, regulation, and use. 

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