United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2013_register executive 2013-06-12 article Rules and Regulations D09002ee1c7fb5f39 D09002ee1c7fb6023 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume but not including distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis. This action is in response to a petition filed by E. & J. Gallo Winery. 78 FR 35115 https://www.govinfo.gov/app/details/FR-2013-06-12/2013-13857 2013-13857 fr12jn13-4 4160-01-P Docket No. FDA-2012-C-0224 https://www.govinfo.gov/app/details/FR-2013-06-12/2013-13857 https://www.govinfo.gov/content/pkg/FR-2013-06-12/html/2013-13857.htm https://www.govinfo.gov/content/pkg/FR-2013-06-12/pdf/2013-13857.pdf Color Additives Cosmetics Drugs Medical Devices 3 p. 35115 35117 78 FR 35115 Title 21 Part 73 21 CFR Part 73 Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments; Federal Register Vol. 78, Issue RULE 2013-13857 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2013-07-15 2013-07-12 Docket No. FDA-2012-C-0224 4160-01-P 2013-13857 Final rule.

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments prepared from titanium dioxide and mica as color additives in distilled spirits containing not less than 18 percent and not more than 23 percent alcohol by volume but not including distilled spirits mixtures containing more than 5 percent wine on a proof gallon basis. This action is in response to a petition filed by E. & J. Gallo Winery.

This rule is effective July 15, 2013. See section VIII for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing by July 12, 2013. Raphael A. Davy, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1272. Color Additives Cosmetics Drugs Medical Devices Color Additives Exempt from Certification: Mica-Based Pearlescent Pigments , http://www.regulations.gov Vol. 78, no. 113 Office of the Federal Register, National Archives and Records Administration 2013-06-12 continuing daily deposited born digital 449 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2013-06-12 P0b002ee184fba617 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr12jn13 https://www.govinfo.gov/app/details/FR-2013-06-12 https://www.govinfo.gov/content/pkg/FR-2013-06-12/pdf/FR-2013-06-12.pdf https://www.govinfo.gov/content/pkg/FR-2013-06-12/xml/FR-2013-06-12.xml fdlp 35101 35543 DGPO 2013-06-12 2024-06-03 FR-2013-06-12 machine generated eng FR FR-2013-06-12 78 113