Exempt colorants

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 made up of a wide variety of organic and inorganic compounds representing the animal, vegetable, and mineral kingdoms. Some, like -carotene and 2inc oxide, are essentially pure factory-produced chemicals of definite and known composition. Others, including annatto extract, cochineal extract, caramel, and beet powder are mixtures obtained from natural sources and have somewhat indefinite compositions. 

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. 

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. 

The food industry, following scientific and technological developments and market demands, takes into account consumer wishes to have more naturally colored foods and adapts its methodologies to safer ways of producing food. In recent decades, we experienced a shift from exclusive use of certifiable synthetic colorants to exempt colorants and to natural complex extracts. 

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. 

Exempt colors do not have to undergo formal FDA certification requirements, hut are monitored for purity. The colorants exempt from FD C certification are annatto extract, /i-carolene, beet powder, 0-apo—8 -carntenol. canlhaxanthin. caramel, carmine, carrot oil. cochineal extract, cottonseed Hour, ferrous gluconate, fruit juices, grape skin extract, paprika, paprika oleoresin. riboflavin, saffron, titanium dioxide, turmeric, turmeric oleoresin. ultramarine blue, and vegetable juices. See also Colorants (Foods). 

The Commissioner of Food and Drug has the authority to exempt particular color additives, from the batch-certification procedure when it is believed that, because of their nature, certification is not needed to protect the public health. Although exempt colorants need not be certified prior to their sale, they are subject to surveillance by FDA to ensure that they meet current government specifications and that they are used in accordance with the law. 

In the United States, colorants used in food, drugs, and cosmetics are regulated by the Food and Drug Administration (FDA). Colorants are classified either as certified colors or those exempt from certification. Certified colors are divided into FD C, approved for use in food, drugs, and cosmetics D C, for drugs and cosmetics and Ext. D C, for use in external use drugs and cosmetics only. Each batch of certified color is analyzed and approved by the FDA. Exempt colors are mainly derived from mineral, plant, or animal sources [38-40]. Additional information can be found on the FDA web site [41]. Approved colors constitute a relatively short list. Two examples are included here, FD C Blue 1 (1) (Fig. 3) and D C Yellow 10 (10) (Fig. 6). 

Colour Index (Cl) number. Not used in the U.S. for certification-exempt color additives. Chemical Abstracts Service (CAS) number. 

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