FDA Issues Final Rule on Mica-Based Pearlescent Pigments in Distilled Spirits

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.

Issue 580