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U.S. Department of Health and Human Services

Final Rules: Food Additives and Color Additives
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Petition(s): CAP 7C0308

Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide

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 to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules.
21 CFR* affected: 73.200; Synthetic iron oxide.
Substance(s)*, (CAS Registry® No.):
  • synthetic iron oxide, including hydrated forms
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    Federal Register publication history: Nov 9, 2017; 82 FR 52037; Notification of petition
    Nov 1, 2018; 83 FR 54869; Final Rule; Effective date: Dec 4, 2018
    Apr 18, 2019; 84 FR 16205; Final Rule; Confirmation of Effective Date; Effective date: Dec 4, 2018

     

    *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)
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