Exempt colours

Certifiable and certification-exempt colour additives must undergo the FDA pre-market approval process in order to be listed. A proposal to list a new colottr additive or new uses of a colour additive is made by petition to the FDA as desoibed in 21 CFR Part 71. Descriptions of the approval process can be found on the FDA website (see references). The listing regulations desoibe the identity of each colottr additive, specifications, uses and restrictions, labeling requirmnents, and the requirement for or exanption lirom batch certification. In addition, a regttlation must specifically authorize use of the colottr additive in the area of the eye (21 CFR Section 70.5(a)), in injections (21 CFR Section 70.5(b), currently, no colour additive is listed for use in injections), and in surgical sutures (21 CFR Section 70.5(c)). 

In U.S., for example, the colouring agents that are part of a cosmetic product must be declared by name on the product s label (21 CFR Section 701.3). Analysis of the cosmetic may find undeclared certified or certification-exempt colour additives. If the information is not complete or not correct, the product is misbranded and may also be adulterated depending on what is found. 

The addition of additives to food, including colour additives, is strictly regulated in the developed world, for example by the Food and Drug Administration in the USA." Colonr additives are classified by the FDA as either certifiable or exempt from certification . 

Food colours are broadly divided into two classes natural and artificial. In the United States, these are listed as either exempt from certification or certified . The natural colours are botanical extracts, with the exception of carmine (a red colour), which should perhaps be termed an entomological extract as it is obtained from the insect Dactilopius coccus, sometimes termed the cochineal beetle, which breeds and feeds on particular cacti indigenous to Central and South America. Table 5.6 lists artificial colours permitted in soft drinks under EU legislation. 

Apart from the derivatives of p-carotene, other pigments are the anthocyanins, the chlorophylls, cochineal, the betalaines, turmeric, caramel and riboflavin. In this account the historical background in brief, the chemistry of these pigments, their extraction from natural sources and their synthesis will be discussed. The present permitted natural substances and nature-identical synthetic materials (also described by the Food and Drugs Administration, the FDA, as colorants exempt from certification ) is quite small in number. Reference is also made to colourants no longer listed but which have an historical organic chemical significance such as for example brazilin and its relative haematoxylin. 

Hallagan, J.B.,D.C.AUen, and J.F Borzelleca. 1995. TTie safety and regulatory status of food, drug and cosmetics colour additives exempt from certification. Food Chem. Toxicol. 33(6) 515-528. 

Reguiatay FDA 21 CFR 73.3107, exempt from certification, permanently listed for use in medical devices ManufJDistrib. Albion Colours Ltd Sinochem Jiangsu Wuxi Trade Names Ponolith Supra Violet EB Liq. 

Uses Colorant in paints/coatings, industrial finishes, plastics, printing inks, lacquers, leather and book cloth, paper surfacing, chalks, colored pencils, food-contact polymers, hair dyes, contact lenses Regulatory FDA 21CFR 73.3124, 178.3297 exempt from certification, permanently listed for use in medical devices OSHA nonhazardous Manuf./Distrib. Aceto http //www.aceto.com, Albion Colours Ltd... 

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

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