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 ; fish oil, partially hydrogenated ; menhaden oil, partially hydrogenated ; vegetable oil, partially hydrogenated
• 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 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 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)