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  • FDA-Approved Microspheres

    Posted on January 19th, 2011 Microsphere Expert

    What makes a microsphere FDA-approved?

    In order to tell whether the microsphere can be used in cosmetics, food, or medical devices it is important to look at the raw materials that are incorporated into the microsphere during manufacturing process.  For example, unpigmented or clear polyethylene microspheres supplied by Cospheric in sizes from 10 micron to 1000 micron meet the quality requirements of the US FDA as specified in 21 CFR 172.888 and 21 CFR 178.3720.  Specific grade of polyethylene used in manufacturing of these microspheres is  FDA-approved for food applications in chewing gum base, on cheese and raw fruits and vegetables, and as a defoamer in food.

    Color additives are subject to a strict system of approval under U.S. law (FD&C Act), sec. 721; 21 U.S.C. 379e. Color additive violations are a common reason for detaining imported cosmetic products offered for entry into this country. If a product contains a color additive, by law [FD&C Act, Sec. 721; 21 U.S.C. 379e; 21 CFR Parts 70 and 80] you must adhere to requirements for:

    • Approval. All color additives used in cosmetics (or any other FDA-regulated product) must be approved by FDA. There must be a regulation specifically addressing a substance’s use as a color additive, specifications, and restrictions.
    • Certification. In addition to approval, a number of color additives must be batch certified by FDA if they are to be used in cosmetics (or any other FDA-regulated product) marketed in the U.S.
    • Identity and specifications. All color additives must meet the requirements for identity and specifications stated in the Code of Federal Regulations (CFR).
    • Use and restrictions. Color additives may be used only for the intended uses stated in the regulations that pertain to them. The regulations also specify other restrictions for certain colors, such as the maximum permissible concentration in the finished product.

    How are color additives categorized?

    The FD&C Act Section 721(c) [21 U.S. C. 379e(c)] and color additive regulations [21 CFR Parts 70 and 80] separate approved color additives into two main categories: those subject to certification (sometimes called “certifiable”) and those exempt from certification. In addition, the regulations refer to other classifications, such as straight colors and lakes.

    • Colors subject to certification. These color additives are derived primarily from petroleum and are sometimes known as “coal-tar dyes” or “synthetic-organic” colors. (NOTE: Coal-tar colors are materials consisting of one or more substances that either are made from coal-tar or can be derived from intermediates of the same identity as coal-tar intermediates. They may also include diluents or substrata. (See Federal Register, May 9, 1939, page 1922.) Today, most are made from petroleum.)
      • Except in the case of coal-tar hair dyes, these colors must not be used unless FDA has certified that the batch in question has passed analysis of its composition and purity in FDA’s own labs. If the batch is not FDA-certified, don’t use it.
      • These certified colors generally have three-part names. The names include a prefix FD&C, D&C, or External D&C; a color; and a number. An example is “FD&C Yellow No. 5.” Certified colors also may be identified in cosmetic ingredient declarations by color and number alone, without a prefix (such as “Yellow 5″).
    • Colors exempt from certification. These color additives are obtained primarily from mineral, plant, or animal sources. They are not subject to batch certification requirements. However, they still are considered artificial colors, and when used in cosmetics or other FDA-regulated products, they must comply with the identity, specifications, uses, restrictions, and labeling requirements stated in the regulations [21 CFR 73].
    • Straight color. “Straight color” refers to any color additive listed in 21 CFR 73, 74, and 81 [21 CFR 70.3(j)].
    • Lake. A lake is a straight color extended on a substratum by adsorption, coprecipitation, or chemical combination that does not include any combination of ingredients made by a simple mixing process [21 CFR 70.3(l)]. Because lakes are not soluble in water, they often are used when it is important to keep a color from “bleeding,” as in lipstick. In some cases, special restrictions apply to their use. As with any color additive, it is important to check the Summary of Color Additives Listed for Use in the United States in Foods, Drugs, Cosmetics and Medical Devices and the regulations themselves [21 CFR 82, Subparts B and C] to be sure you are using lakes only for their approved uses.

    Titanium dioxide is on the list of the approved colorants that do not require certification.  White polyethylene microsheres made with titanium dioxide also meet FDA requirements for cosmetics and  other FDA-regulated products.

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