Color certified

Colorants. According to U.S. regulations, colorants are divided into two classes certified and exempt (see Colorants for foods, drugs, COSMETICS, AND MEDICAL DEVICES). Batch samples of certified colors must be sent to the FDA for analysis and confirmation that the colorants comply with estabhshed specifications. Color manufacturers pay a small fee for each batch of color that is analy2ed. The number of certified colors available to food technologists has declined. Several of the historical colorants were found to have carcinogenic effects. Table 1 shows the certified colors that are permissible for food use in the United States as of 1993. 

Table 1. Certified Colors Permitted in the United States ...

The FD C certified colors are all water-soluble dyes, but can be transformed into insoluble pigments known as lakes by precipitating the dyes with alurninum, calcium, or magnesium salts on a substrate of aluminum hydroxide. The lakes are useful in appHcations that require color whereas in dry form, such as cake mixes, or where water may be present and bleeding is a problem, such as food packaging. FD C Red Lake No. 3 was deHsted in Febmary... 

In 1958 the Supreme Court ruled that under the 1938 law, the FDA did not have the authority to estabHsh limits of use for colorants and that they were obligated to decertify or deHst a color if any quantity of it caused harm even though lesser amounts were perfectiy safe (19). The FDA s hands were tied (20). A review of the remaining colors was started and soon several more were deHsted, including FD C YeUow Nos. 1—4. It became obvious that the existing law on certifiable colors was unworkable. 

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... 

Lead, arsenic, and antimony—determined in the solution obtained by boiling 10 g of the titanium dioxide for 15 min in 50 mL of 0.5 Nhydrochloric acid In addition to individual specifications, general specifications have been written for provisionally Hsted certifiable colors ... 

The limit of 1 ppm mercury placed on colors intended for use in foods was estabUshed by a letter from the Acting Director of the Division of Colors and Cosmetics to the certified color manufacturers in 1970. This action was the first step taken to replace the somewhat nebulous heavy metals specifications previously used with concrete limits for specific metals. 

Piesendy, all ceitified colois aie factory-piepaied materials belonging to one of several different chemical classes. Although a few such as D C Blue No. 6 (indigo) are known to exist in nature, certified colors owe their commercial importance to their synthetic production. Because of the starting materials used in their manufacture in the past, certified colors were once known as coal-tar dyes. Today, since most of the raw materials used in their preparation are obtained from petroleum, this term no longer appHes. 

FD C lakes were first approved for use ia 1959. Today, they are the most widely used type of lake. To make a lake, an alumina substrate is first prepared by adding sodium carbonate or sodium hydroxide to a solution of aluminum sulfate. Next, a solution of certified colorant is added to the resulting slurry, then aluminum chloride is added to convert the colorant to an aluminum salt, which then adsorbs onto the surface of the alumina. The slurry is then filtered, and the cake is washed, dried, and ground to an appropriate fineness, typically 0.1—4.0 p.m. 

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. 

In general, exempt colorants have less coloring power than certified colorants and thus have to be used at higher concentrations. Some, particularly those of plant origin, tend to be less stable, more variable in shade, and therefore more compHcated to use than certified colorants, and are more likely to introduce undeskable flavors and odors into the products in which they are incorporated. Also, depending on thek nature and origin, exempt colorants can vary substantially in composition from batch to batch, are more likely to be contaminated with undeskable trace metals, insecticides, herbicides, and bacteria such as Salmonella and can be more difficult to obtain in steady supply compared with certified colorants. 

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. 

Color Additives. The FDA has created a unique classification and strict limitations on color additives (see also CoLORANTS FOR FOOD, DRUGS, COSMETICS, AND MEDICAL DEVICES). Certified color additives are synthetic organic dyes that ate described in an approved color additive petition. Each manufactured lot of a certified dye must be analyzed and certified by the EDA prior to usage. Color lakes are pigments (qv) that consist of an insoluble metallic salt of a certified color additive deposited on an inert substrate. Lakes are subject to the color additive regulations of the EDA and must be certified by EDA prior to use. Noncertifted color additives requite an approved color additive petition, but individual batches need not be EDA certified prior to use. 

Certified color additives (FD C coiors) are synthetically produced organic molecules whose purities have been checked by the FDA. 

Food legislation in the US was implemented in 1938 and since then has been improved dynamically. The Food, Drug and Cosmetic Act classified specific colorants to be used in food and non-food products (FD C colorants). Each colorant has a color index (Cl) number and Cl name. Colorants are also identified by their Chemical Abstract Service (CAS) registry code numbers. The two groups are Certifiable Colorants and Exempt Colorants. 

Synthetic colorants are classified by the FDA as certified color additives and are defined as synthetically produced organic molecules that have their purities checked by the FDA. " A second category, colorants exempt from certification, includes naturally derived (animal, vegetal, mineral) compounds or their synthetic duplicates. Table 7.3.2 presents a summary of synthetic colorants and their utilization as food additives. 

Source Warner-Jenkinson Pamphlet of Certified Colors, September 1990. 

FDA Center for Food Safety and Applied Nutrition (CFSAN), 23 667 FDA certified colors, 12 35 FDA Fast Track Drug Approval programs, 18 697... 

Red No. 3 in 1998 (Fig. 8.1). Colorants in the three categories above were termed certified colorants but the Color Additive Amendment also set up a category of exempt colorants which were not subject to the rigorous requirements of the certified colorants. There are 26 colorants in this category (Table 8.1) and they comprise most of the preparations which would be called natural in other countries. The US does not officially recognize the term natural but it is often used in the popular press. 

One by one Kohnstamm succeeded with the colors. By November, it had four colors in large batches for which it had sent certificates to the Board. By the new year, it was sufficiently confident of success that on January 26, 1909 it announced to the trade that it was ready to accept orders for certified colors. Initially, orders would be accepted for the colors only as compounded into Kohnstamm s well established customary color mixtures which sold under names such as "auramine" and "chocolate brown," rather than as Hesse had hoped, as pure dyes (42,43). 

Much to everyone s surprise, there was little initial market response to Kohnstamm s January announcement that it would accept orders for certified colors. E. G. Kohnstamm wondered if he would be left with only glory and financial loss for his efforts but pressed on his company was publicly as well as financially committed and hoped that actual shipment of these colors and eventually the long promised Board announcement of a deadline mandating their use would spur sales (51). 

This backlog was not cleared up until early July, so Kohnstamm did not publish its first price list of certified colors until August. All colors on this list were trade-named mixtures. Shoelkopf followed in September, advertising the seven colors as certified under their technical names (55). 

Now that certified colors were in the marketplace, Hesse wrote Wiley in July, it seemed time for the Board to set a date after which the use of certified colors would be required. Wiley replied that he had already proposed to the Board that it set a date, perhaps October 1, after which it would proceed towards prosecution in all cases where other then certified colors were used. He had no idea, however, what action the Board, that is McCabe and Dunlap, would take. After consultation with both Kohnstamm and Schoelkopf, Hesse suggested January 1, 1910 as a more realistic date (56,57). 

In the meantime, Dunlap and McCabe worked out what they believed was as good a solution as the law allowed. They would strongly and officially recommend the use of certified colors. Wiley refused to sign his name to this, but Secretary Wilson approved the scheme on April 7, 1910, and issued it as FID 117. The cleverness with which the FID was worded bears repeating ... 

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