Pigments subject to FDA Batch Certification

FDA Batch Certification

Colors that are subject to batch certification must be purchased from the manufacturer if you are planning to use them formanufacturing or resale products. All our Lakes are purchased from FDA approved manufacturers with a batch certification. Once the package is opened and repacked this batch# is no longer valid and the color may not be used for manufactured products marketed in the US. For DIY purposes for yourself, friends and family they may be used for the purposes they are approved for.

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.

Colors subject to batch certification

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”).

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.

When purchasing colors subject to certification, confirm that the manufacturer has requested certification. For example, you can choose a manufacturer from FDA’s list of companies that have requested color certification within the past two years. If the company that appears on the color additive label is not on this list, you may contact FDA at to determine whether the company has in fact requested certification of its color additives.



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