Color additives certified

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. 

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. 

FDA-certifiable color additives are batch certified by the United States Food and Drug Administration using analytical chemistry methods developed for this purpose by the FDA. The color additive regulations are described in Title 21, Parts 70 to 82, of the United States Code of Federal Regulations (21 CFR Parts 70 to 82). The batch certification process is described in 21 CFR Part 80. Current certification analytical methods are available from the Office of Cosmetics and Colors, Colors Certification Branch (HFS-107), U.S. Food and Drug Administration, 5100 Paint Branch Parkway, College Park, Maryland 20740. 

Public hearings and regulations that occured after the 1938 law gave colors the numbers that separate their hues. These letter and number combinations— FD C blue 1 or D C red 17, for example—make it easy to distinguish colors used in foods, drugs, or cosmetics from dyes made for textiles and other uses. Only FDA certified color additives can carry these special designations. 

Certified color additives are synthetic organic dyes that are described in an approved color additive petition. Each manufactured lot of a certified dye must be analyzed and certified by the FDA prior to usage. 

Color lakes are pigments that generally consist of an insoluble metallic salt of a certified color additive deposited on an inert substrate. These lakes are subject to the color additive regulations of the FDA and must be certified by the agency prior to use. 

Color additives that are not classified as certified color or color lakes are identified as non-certified color additives. Each of these substances is the subject of an approved color additive petition, but individual batches do not require certification by the FDA prior to use. 

A soap to which an OTC Category I antimicrobial agent has been added is converted into a drug. This raises an interesting secondary issue. Soaps may be tinted with non-certified color additives. This inclusion of the antimicrobial requires not only drug labeling but also reformulation with approved colorants. 

T lot used in the United States for the names of certified color additives. 

Beverages—One of the largest users of the certified colors (FD C) is the beverage industry. Most of the fruit-type beverages contain single or combinations of certified color additives while colas and root beers are colored with caramel. 

FDA—Food and Dmg Administration, 1995. FDA—Food and Drug Administration, 1999, FDA Response to CTFA Request Regarding the Use of Abbreviated Labeling for Declaring Certified Color Additives in Cosmetics. ... 

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