The U.S. Food and Drug Administration (FDA) has issued a final rule allowing “the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in certain distilled spirits.” Mica-based pearlescent pigments are currently approved as color additives in many foods and beverages, including distilled spirits containing “not less than 18 percent and not more than 23 percent alcohol by volume.” Effective November 5, 2015, the new rule permits the use of these pigments at a level of up to 0.07 percent by weight in distilled spirits containing not less than 18 percent and not more than 25 percent alcohol by volume, while finding that “certification of mica-based pearlescent pigments prepared from titanium dioxide is not necessary for the protection on the public health.”

“Regarding cumulative exposure from the current and petitioned uses of mica-based pearlescent pigments, we note that in our recent final rule that provided for the safe use of mica-based pearlescent pigments as color additives in cordials, liqueurs, flavored alcoholic malt beverages, wine coolers, cocktails, non-alcoholic cocktail mixers and mixes, and in egg decorating kits for coloring shell eggs, we estimated the CEDI for the use of mica-based pearlescent pigments in food (§ 73.350) and ingested drugs (§ 73.1350) to be 0.25 g/p/d at the mean and 0.50 g/p/d at the 90th percentile for the U.S. population,” states FDA. “Since the petitioned use of mica-based pearlescent pigments will generally substitute for currently-permitted uses of mica-based pearlescent pigments in other alcoholic beverages with no change in the maximum use level of 0.07 percent by weight, we have determined that the petitioned use of micabased pearlescent pigments will not result in an increase in consumer exposure to these pigments.” See Federal Register, September 30, 2015.