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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 3C0298

Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide

Petitioner: Wm. Wrigley Jr. Company
Docket number (legacy and/or former docket number(s)): FDA-2013-C-1008
Subject additive and intended use: amending the color additive regulations to provide for the expanded safe use of synthetic iron oxide as a color additive to include use in soft and hard candy, mints, and chewing gum.
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: Sep 17, 2013; 78 FR 57105; Notice of petition
    Mar 20, 2015; 80 FR 14839; Final Rule; Effective date: Apr 21, 2015
    Jun 3, 2015; 80 FR 31466; Final Rule; Confirmation of Effective Date; Effective date: Apr 21, 2015

     

    *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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