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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 9C0314

Listing of Color Additives Exempt From Certification; Soy Leghemoglobin

Petitioner: Impossible Foods, Inc.
Docket number (legacy and/or former docket number(s)): FDA-2018-C-4464
Subject additive and intended use: amending the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products.
21 CFR* affected: 73.520; Soy leghemoglobin.
Substance(s)*, (CAS Registry® No.):
  • soy leghemoglobin
  • Federal Register publication history: Dec 13, 2018; 83 FR 64045; Notification of petition
    Aug 1, 2019; 84 FR 37573; Final Rule; Effective date: Sep 4, 2019
    Dec 19, 2019; 84 FR 69620; Final rule; response to objections and denial of public hearing requests; removal of administrative stay

     

    *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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