FDA issues final rules on mica pearlescent pigments in distilled spirits-Lexology

2021-11-22 07:33:11 By : Ms. Villy Chen

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The U.S. Food and Drug Administration (FDA) has issued final rules that allow "safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives for certain distilled spirits." Pearlescent pigments based on mica are currently approved for use as color additives in many foods and beverages, including distilled spirits with "alcohol content of not less than 18% and not more than 23% by volume". Effective from November 5, 2015, the new regulations allow the use of up to 0.07% of pigments in distilled spirits with an alcohol content of not less than 18% and not more than 25%. At the same time, it was discovered that “mica-based pearlescent pigments prepared from titanium dioxide are effective in protecting Public health is not necessary."

"Regarding the cumulative exposure of the current and applications for the use of mica-based pearlescent pigments, we have noted that in our recent final rule, the safe use of mica-based pearlescent pigments as color additives in liqueurs, liqueurs, and flavored alcoholic malt beverages, wine In coolers, cocktails, non-alcoholic cocktail mixers and blends, and egg decoration kits used to color egg shells, we estimate the use of mica pearlescent pigments in food (§ 73.350) and ingested drugs (§ 73.1350) For the US population, the average value of CEDI is 0.25 g/p/d, and the 90th percentile is 0.50 g/p/d,” the FDA said. "Because the mica-based pearlescent pigments applied for will generally replace the mica-based pearlescent pigments currently allowed to be used in other alcoholic beverages, and the maximum usage amount is unchanged by 0.07% by weight, we have determined that the application for the use of mica-based pearlescent pigments Use will not lead to increased consumer exposure to these pigments." See Federal Register, September 30, 2015.

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