Petition(s): CAP 0C0318

Listing of Color Additives Exempt From Certification; Calcium Carbonate

• Petitioner: Colorcon, Inc.
• Docket number (legacy and/or former docket number(s)): FDA-2017-C-6238
• Subject additive and intended use: amending the color additive regulations in 21 CFR Part 73.70 “Calcium Carbonate,” by expanding the permitted uses of calcium carbonate to include use in dietary supplement tablets and capsules, including coatings and printing inks, in amounts consistent with good manufacturing practice.
• 21 CFR* affected: 73.50 Calcium carbonate
• Substance(s)*, (CAS Registry® No.): Calcium carbonate, (471-34-1)
• Federal Register publication history: Nov 20, 2020 85 FR 74304 Notification of Petition ; Sep 27, 2022 87 FR 58445 Final Rule Oct 28, 2022 ; Jan 24, 2023 88 FR 4085 Final rule; confirmation of effective date Oct 28, 2022

 

*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)