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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): Direct Final Rule

Revocation of Uses of Partially Hydrogenated Oils in Foods

Docket number (legacy and/or former docket number(s)): FDA-2019-N-4750
Subject additive and intended use: amending our regulations that provide for the use of partially hydrogenated oils (PHOs) in food in light of our determination that PHOs are no longer generally recognized as safe (GRAS); revoking prior sanctions for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on our conclusion that these uses of PHOs may be injurious to health.
21 CFR* affected: 161.190; Canned tuna
164.150; Peanut butter
184.1472; Menhaden oil
184.1555; Rapeseed oil
186.1551; Hydrogenated fish oil (regulation removed)
Substance(s)*, (CAS Registry® No.):
  • canola oil, partially hydrogenated
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  • fish oil, partially hydrogenated
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  • menhaden oil, partially hydrogenated
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  • vegetable oil, partially hydrogenated
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    Federal Register publication history: Nov 8, 2013; 78 FR 67169; Notice; request for comments and for scientific data and information
    Jun 17, 2015; 80 FR 34650; Notice; declaratory order
    Aug 9, 2023; 88 FR 53764; Direct final rule; Effective date: Dec 22, 2023
    Aug 9, 2023; 88 FR 53827; Proposed rule; companion document to the direct final rule
    Dec 14, 2023; 88 FR 86580; Direct final rule; confirmation of effective date; Effective date: Dec 22, 2023

     

    *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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