Regulation of colorants

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). 

H. Hopkkis, FDA Consumer, 24—27 (Mar. 1980). Some kisight kito the use and regulation of color additives. 

A great deal of frustration has arisen over the way hazardous chemicals are defined by OSHA. Most people feel more comfortable if there is a specific list of chemicals to which they can refer, but there is no such list provided under the Hazard Communication Standard. In addition, chemicals that were not previously considered hazardous because they are virtually inert or are not harmful to humans by contact with skin are now considered a dust hazard (particularly inorganic, nontoxic, noncombustible dusts that can enter the body via the respiratory system). This is where the regulation of colorants under OSHA occurs via the Hazard Communication Standard. 

Coloring agents can be assigned without being specified individually, unless this is required in a separate section for regulation of coloring agents, and inoffensive substances added exclusively for individual identification of each product need not be mentioned. 

This paper summarizes current knowledge of the chemistry of neurohormones involved in the regulation of color changes in insects, as well as the nature of other insect neuropeptides with chromatophorotropic actions in Crustacea--with emphasis on pigment-dispersing peptides. 

Adapted from Francis, F. J., 1999. Chap. 4, Regulation of Colorants in Colorants, Eagan Press. St. Paul, MN. pp. 223-32. 

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. 

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. 

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. 

C. Cal2olari, L. Coassini, and L. ToUat, QuademiMerceol 1, 89—131 (1962). Synthetic Food Colors. Reviews the regulation of food colors in various countries, the toxicity of the intermediates used to prepare them, and the toxicity of the degradation products of colorants. 

A. Weissler, Food Technol, 38, 46 (May 1975). FDA Regulation of Food Colors. Outdated but interesting. 

N. Dkiesen, FoodTechnol, 40 (May 1975). Toxicology and Regulation of Natural Colors. Some thoughts on international regulation. 

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. 

Limits on emissions are both subjective and objective. Subjective limits are based on the visual appearance or smell of an emission. Objective limits are based on physical or chemical measurement of the emission. The most common form of subjective limit is that which regulates the optical density of a stack plume, measured by comparison with a Ringelmann chart (Fig. 25-1). This form of chart has been in use for over 90 years and is widely accepted for grading the blackness of black or gray smoke emissions. Within the past four decades, it has been used as the basis for "equivalent opacity" regulations for grading the optical density of emissions of colors other than black or gray. 

Consider, as an example, the logic of a policy decision to build and locate an electric generating plant or oil refinery. Economic considerations such as the availability of ample and inexpensive land, and social considerations such as zoning regulations and political influence, would play a major role m such a decision. In practice, this makes it more likely that plants and refineries, as well as waste sites and other locally undesirable land uses, will be located in poorer communities whose population is often largely people of color. 

In the preceding section, we presented principles of spectroscopy over the entire electromagnetic spectrum. The most important spectroscopic methods are those in the visible spectral region where food colorants can be perceived by the human eye. Human perception and the physical analysis of food colorants operate differently. The human perception with which we shall deal in Section 1.5 is difficult to normalize. However, the intention to standardize human color perception based on the abilities of most individuals led to a variety of protocols that regulate in detail how, with physical methods, human color perception can be simulated. In any case, a sophisticated instrumental set up is required. We present certain details related to optical spectroscopy here. For practical purposes, one must discriminate between measurements in the absorbance mode and those in the reflection mode. The latter mode is more important for direct measurement of colorants in food samples. To characterize pure or extracted food colorants the absorption mode should be used. 

The use of food colors is governed by the Code of Federal Regulations (CFR), a compilation divided into 50 titles. The FDA established regulations for color additives in Title 21 of the CFR, in parts 70 through 82. The parts cover different issues concerning color additives. - ... 

The approved color additives appear on positive lists issued by the Food and Drug Administration in the US, the EU, and Japan, but the colorants permitted in each market vary considerably. US and EU regulatory organizations provide provisional and permanent lists of approved color additives. The permanently listed additives are considered safe for use in cosmetic and toiletry products by the regulatory bodies. Provisionally listed color additives are those on which some safety studies are still to be undertaken or their test results are under review. The Japanese regulations include only a permanent list of color additives. 

Code of Federal Regulations, 21 Color Additive Regulations, US Pood and Drug Administration, http //www.cfsan.fda.gov, 2001, retrieved 2006. 

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