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In cosmetics and personal care products, Yellow 5 (FD&C Yellow No. 5) and Yellow 5 Lake are used in the formulation of a wide variety of product types. These colors are subject to certification by the Food and Drug Administration (FDA).
Yellow 5 and Yellow 5 Lake are used to impart color to cosmetics and personal care products.
Yellow 5 is a synthetic pigment also known as tartrazine. In addition to its use in cosmetics and personal care products, Yellow 5 is commonly used as a food coloring and may often be found in colored soft drinks. In the United States, colorants are subject to a wide range of regulatory restrictions. A listing of approved colorants (except hair colors) that may be used in the United States may be found in U.S. FDA color additive regulations.
The FDA has reviewed the safety of Yellow 5 and determined that it may be safely used for coloring cosmetics and personal care products, including products intended for use on the lips, and in products intended for use in the area of the eye, when these ingredients conforms to FDA specifications. Yellow 5 is also permitted as to be used as a color in food and drugs. According to U.S. regulations, all Yellow 5 and Yellow 5 Lake that are manufactured for use in products is subject to certification by the FDA. This certification process ensures that the strict chemical and identity specifications set by FDA are met. The Cosmetic Ingredient Review (CIR) has deferred evaluation of these ingredients because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.
All color additives used in foods, drugs and cosmetics in the United States must be approved by FDA and listed in the Code of Federal Regulations. In some cases, FDA requires that each batch of color produced for use in regulated products can be used only if it is certified by the agency to meet strict specifications. FDA maintains a laboratory especially for this purpose and color manufacturers must pay a fee to support this activity. FDA only approves colors after extensive review of all safety data and publication of the basis for its approval in the Federal Register.
You can find out more about FDA regulation of colors at: http://www.cfsan.fda.gov/~dms/cos-col.html
FDA based their decision to approve Yellow 5 for use in food, drugs and cosmetics on extensive toxicology and chemistry information. In addition, FDA set specifications on the amount that can be used in certain products and, as a synthetic color additive, requires that each manufactured lot of color be submitted to the agency for analysis and certification.
FDA: Link to Code of Federal Regulations for Yellow 5
Yellow 5 is sometimes converted to an insoluble pigment for use in those situations where migration of the color to surrounding ingredients needs to be controlled. The same type of consideration applies for foods such as confectionaries where migration from the decorative frosting to the cake might spoil the intended effect. These insoluble pigments are referred to as "lakes" and the ingredient declaration on the product may be labeled as "Yellow 5 Lake". FDA has also considered the safety of these lakes and has issued regulations that address their use in products.
Link to FDA Code of Federal Regulations for color additive lakes:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CF...
Yellow 5 is listed as CI 19140 in Annex IV, Part I (colouring agent allowed for use in cosmetic products) of the Cosmetics Directive of the European Union and may be used in all cosmetics and personal care products provided it conforms to the specifications listed in the food regulations. The insoluble barium, strontium and zirconium lakes, salts and pigments of Yellow 5 are also permitted and must pass the test for insolubility. When used in cosmetic products in the European Union, Yellow 5 and Yellow 5 Lake must be called CI 19140.
Link to the EU Cosmetic Regulation: http://europa.eu/legislation_summaries/consumers/product_labelling_and_p...
You can learn more about the regulation and labeling of colors at: http://www.personalcarecouncil.org/colors-cosmetics-regulation-and-nomen...
Yellow 5 is principally the sodium salt of 4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid. Certifiable color additive such as Yellow 5 are used widely because their coloring ability is more intense than most colors derived from natural products; thus, they are often added in smaller quantities. In addition, certifiable color additives are more stable, provide better color uniformity and blend together easily to provide a wide range of hues. Certifiable color additives generally do not impart undesirable odors or flavors while color derived from foods such as beets and cranberries can produce such unintended effects. Certifiable color additives typically are available for use as either "dyes" or "lakes." Dyes dissolve in water and are manufactured as powders, granules, liquids or other special purpose forms. Lakes are the water insoluble form of the dye. Lakes are typically more stable than dyes and are ideal for coloring products lacking sufficient moisture to dissolve dyes. Lakes are often used to form the coating of drug tablets.
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/
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