Petition(s): CAP 8C0257

Listing of Color Additives Exempt from Certification; Mica-Based Pearlescent Pigments

• Petitioner: EM Industries, Inc.
• Docket number (legacy and/or former docket number(s)): FDA-1998-C-0080 (1998C-0431) (98C-0431)
• Subject additive and intended use: amending the color additive regulations to provide for the safe use of mica-based pearlescent pigments as color additives in ingested drugs.
• 21 CFR* affected: 73.1350 Mica-based pearlescent pigments.
• Substance(s)*, (CAS Registry® No.): mica-based pearlescent pigments
• Federal Register publication history: Jun 22, 1998 63 FR 33934 Notice ; Jun 29, 1999 64 FR 34816 Notice (Amendment) ; Jul 22, 2005 70 FR 42271 Final Rule Aug 23, 2005 ; Jul 20, 2006 71 FR 41125 Final rule; response to objections; removal of stay Aug 23, 2005 ; Mar 8, 2007 72 FR 10356 Final rule, technical amendment; Section 73.1128 of 21 CFR redesignated as §73.1350 Mar 8, 2007

 

*Definitions

• 21 CFR: Title 21 of the Code of Federal Regulations.
• Substance: The name of the substance listed in the CFR.
• CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
• Petitions (see also Questions and Answers About the Petition Process)
  • FAP: Food Additive Petition
  • CAP: Color Additive Petition
  • GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 1998)