The Food and Drug Administration has issued a final rule that, effective Nov. 2, will amend the color additive regulations regarding the use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives. Specifically, this rule increases from 23 percent to 25 percent alcohol by volume the maximum permitted alcohol content of distilled spirits to which mica-based pearlescent pigments may be added as a color additive at a level of up to 0.07 percent by weight. This rule also removes the current limitation for distilled spirits mixtures containing more than five percent wine on a proof gallon basis.

Mica-based pearlescent pigments may currently be used as color additives in amounts up to 1.25 percent by weight in cereals, confections and frostings, gelatin desserts, hard and soft candies (including lozenges), nutritional supplement tablets and gelatin capsules, and chewing gum. They are also approved in egg decorating kits used for coloring the shells of eggs in amounts consistent with good manufacturing practice. In addition, certain mica-based pearlescent pigments are permitted for use as color additives in ingested drugs and for use in contact lenses.

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