Source: http://www.foodsafetymagazine.com/magazine-archive1/octobernovember-2003/color-additives-fdas-regulatory-process-and-historical-perspectives/
Timestamp: 2013-12-06 09:32:50
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Matched Legal Cases: ['arts 70', 'arts 73', 'art 71', 'art 80', 'art 74', 'art 82', 'art 73', 'arts 70']

Color Additives: FDA's Regulatory Process and Historical Perspectives - Food Safety Magazine
ASK THE REGULATORS | October/November 2003
By Julie N. Barrows, Ph.D., Arthur L. Lipman, Ph.D., and Catherine J. Bailey, M.Ed. Series Editor: Sebastian Cianci
Federal oversight of color additives began in the 1880s. The assessment of color-imparting ingredients in foods was among the first public initiatives undertaken by the U.S. when, in 1881, the U.S. Department of Agriculture's (USDA) Bureau of Chemistry began research on the use of colors in food. Butter and cheese were the first foods for which the federal government authorized the use of artificial coloring.
By 1900, many foods, drugs and cosmetics available in the U.S. were artificially colored. However, not all of the coloring agents were harmless and some were being used to hide inferior or defective foods. A careful assessment of the chemicals used for coloring foods at the time found many blatantly poisonous materials such as lead, arsenic, and mercury being added. In many cases, the toxicities of the starting materials for synthesizing coloring agents were well known and could be toxins, irritants, sensitizers, or carcinogens.
Food and Drugs Act. In 1906, Congress passed the Food and Drugs Act, which prohibited the use of poisonous or deleterious colors in confectionery and the coloring or staining of food to conceal damage or inferiority. The USDA had initial enforcement authority for this act. In 1907, the USDA issued Food Inspection Decision (F.I.D.) 76, which contained a list of seven straight colors approved for use in food. Subsequent F.I.D's in the early part of the century established a voluntary certification program and listed new colors.
FDA has regulatory oversight for color additives used in foods, drugs, cosmetics, and medical devices. FDA lists new color additives or new uses for listed color additives that have been shown to be safe for their intended uses in the Code of Federal Regulations (CFR), conducts a certification program for batches of color additives that are required to be certified before sale, and monitors the use of color additives in products in the U.S., including product labeling. These activities stem from FDA's role in enforcing the color additive provisions of the FD&C Act, the Fair Packaging and Labeling Act, and other applicable laws, including the recently enacted Public Health Security and Bioterrorism Preparedness and Response Act of 2002 that requires domestic and foreign manufacturers of color additives used as ingredients in foods to register with FDA by Dec. 12, 2003.
FDA has established regulations for color additives in Title 21 of the CFR, parts 70-82. The regulations in 21 CFR parts 73, 74 and 82 identify each listed color additive, provide chemical specifications for the color additives, and identify uses and restrictions, labeling requirements and the requirement for certification. The regulations in 21 CFR part 71 describe the premarket approval process for new color additives or new uses for listed color additives. 21 CFR part 80 pertains to color additive certification.
Additional regulations that provide specific requirements for color additives in foods, drugs, cosmetics, and medical devices are found in other parts of the CFR. For example, the labeling of food products is found at 21 CFR 101.22(k) and cosmetic products at 21 CFR 701.3. Color additives are sometimes called "artificial color" or "artificial coloring" (21 CFR 101.22(a)(4)). From the regulatory standpoint, the term "colorant" refers to a dye or pigment used in a food contact material such as a polymer and doesn't migrate to food. These materials are regulated not as color additives but as food additives (21 CFR 178.3297(a)).
Straight colors subject to batch certification are listed in 21 CFR part 74 and lakes subject to batch certification are listed in 21 CFR part 82. Color additives exempt from certification are listed in 21 CFR part 73. Table 1 gives the complete list of straight colors permitted for use in foods. More information on listed color additives is given on FDA's website.
Color Additives and GRAS The FD&C Act provides for an exemption of some substances from the definition of "food additive" if they are generally recognized as safe for their intended uses. Such an exemption does not apply to color additives. However, a substance that is listed as GRAS also may be listed as a color additive. An example is ferrous lactate (21 CFR 184.1311 and 21 CFR 73.165).
A mixture of carotenoid xanthophyll esters ("lutein esters") is the subject of a recent GRAS notice submitted to FDA in support of its use as a food ingredient. The compound is dark orange-brown and may be capable of imparting color to a food. FDA's response letter to the notice reminds the manufacturer that use of the substance as a color additive, in addition to use as a GRAS substance, would require premarket approval by FDA.
Color additive certification is the process by which FDA assures that newly manufactured batches of color additives meet the identity and specification requirements of their listing regulations. During fiscal year 2002, FDA certified batches representing a total of 16.5 million pounds of color additives, much of it for food uses.
• Identity of the proposed color additive
• Physical, chemical, and biological properties
• Chemical specifications
• Manufacturing process description
• Intended uses and restrictions
• Tolerances and limitations
• Analytical methods for enforcing chemical specifications
• Analytical methods for determination of the color additive in products
• Identification and determination of any substance formed in or on products because of the use of the color additive
• Estimate of probable exposure
• Proposed exemption from batch certification
• An environmental assessment or claim for categorical exclusion
Upon approval of the petition, FDA will issue a new listing regulation or alter an existing regulation for the new color additive or new use. The process for submitting petitions is described in detail in 21 CFR parts 70 and 71, which describe the format, the administrative requirements, and the information and data required. The data that are appropriate for support of a color additive petition will vary depending on whether the petition is for a new color additive or for a new use for a listed color additive, the level and type of use of the proposed color additive, and the amount of color additive and its impurities that may enter body tissues. The petition process also is described on the agency's website.
Some of FDA's color additive enforcement actions may be found at www.cfsan.fda.gov/~dms/col-enf.html. FDA has recently sent warning letters for undeclared FD&C Yellow No. 6 in dehydrated papaya, for undeclared FD&C Red No. 40 and FD&C Yellow No. 6 in bakery products, and for undeclared FD&C Blue No. 1 and FD&C Yellow No. 5 in noodle products. FDA also recently reported recalls for undeclared FD&C Red No. 40 and incorrectly declared FD&C Yellow No. 6 in bottled food color and for presence of the unapproved color additive Ponceau 4R in strawberry filling.
FDA frequently offers guidance on the appropriate use of color additives. One example of a long-standing policy since the early 1900s concerns the use of small, silver balls or "silver dragees" sold for decorating cookies, cakes, etc. As expressed in a Compliance Policy Guide (CPG), "When small silver balls known as 'silver dragees' are sold exclusively for decorating cakes and are used under conditions which preclude their consumption as confectionery, they are not considered to be in the category of a food or confectionery." For specifics, visit www.fda.gov/ora/compliance_ref/cpg/ cpgfod/cpg545-200.html.
Julie N. Barrows, Ph.D.,is a consumer safety officer in the Office of Cosmetics and Colors, FDA CFSAN. She has worked at FDA since 1988, first in research on color additive certification and currently in the regulation of color additives and cosmetics.
Arthur L. Lipman, Ph.D.,is supervisory Consumer Safety Officer in CFSAN's Office of Food Additive Safety. Dr. Lipman has worked at FDA in the regulation of food ingredients, with a specialty in color additives, since 1977.
The authors thank Ray Decker and Naomi Richfield-Fratz for their contributions to this article. Categories: Food Types: Ingredients; Regulatory: FDA, Guidelines