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U.S. Department of Health and Human Services

For Industry

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Color Additive Petitions

As prescribed by law, a color additive must be shown to be safe and be listed in the CFR before it may be used to color foods, drugs, cosmetics or certain medical devices. An interested person may petition the Food and Drug Administration (FDA) for the use of a proposed color additive and submit data demonstrating its safety and suitability as described in 21 CFR Part 71. The FDA will, upon written request, advise on the adequacy of experiments planned to yield these data (21 CFR 70.42(c)). If, upon evaluation of the data in the petition, additional data, and public comments, the Agency finds that the proposed color additive is safe and suitable for the intended use, then a regulation may be issued or an existing regulation altered, thereby listing the color additive for such use. The color additive will be listed in 21 CFR Part 73 if it is exempt from batch certification, or in 21 CFR Part 74 if it is subject to batch certification.

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