2023-27506. Revocation of Uses of Partially Hydrogenated Oils in Foods; Confirmation of Effective Date  

  • Start Preamble

    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Direct final rule; confirmation of effective date.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is confirming the effective date of December 22, 2023, for the final rule that appeared in the Federal Register of August 9, 2023. The direct final rule amends our regulations to no longer provide for the use of partially hydrogenated oils (PHOs) in food given our determination that PHOs are no longer generally recognized as safe (GRAS). The rule also revokes prior sanctions ( i.e., pre-1958 authorization of certain uses) 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. This document confirms the effective date of the direct final rule.

    DATES:

    The effective date of December 22, 2023, for the direct final rule published in the Federal Register of August 9, 2023 (88 FR 53764) is confirmed.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    Ellen Anderson, Center for Food Safety and Applied Nutrition, Office of Food Additive Safety (HFS–225), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2378 or Keronica Richardson, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS–024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2378.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of August 9, 2023 (88 FR 53764), FDA issued a direct final rule amending its regulations that provide for the use of PHOs given our determination that PHOs are no longer GRAS and revoking prior sanctions ( i.e., pre-1958 authorization of certain uses) 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. The direct final rule provided a 75-day comment period ending October 23, 2023. We stated that the effective date of the direct final rule would be on December 22, 2023, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. We did not receive any significant adverse comments.

    Start Authority

    Authority: 21 U.S.C. 321, 341, 342, 343, 348, 371, 379e. Accordingly, the amendments issued thereby are effective on December 22, 2023.

    End Authority Start Signature

    Dated: December 11, 2023.

    Lauren K. Roth,

    Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2023–27506 Filed 12–13–23; 8:45 am]

    BILLING CODE 4164–01–P

Document Information

Effective Date:
12/22/2023
Published:
12/14/2023
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Direct final rule; confirmation of effective date.
Document Number:
2023-27506
Dates:
The effective date of December 22, 2023, for the direct final rule published in the Federal Register of August 9, 2023 (88 FR 53764) is confirmed.
Pages:
86580-86580 (1 pages)
Docket Numbers:
Docket No. FDA-2019-N-4750
RINs:
0910-AI15: Revocation of Uses of Partially Hydrogenated Oils in Foods
RIN Links:
https://www.federalregister.gov/regulations/0910-AI15/revocation-of-uses-of-partially-hydrogenated-oils-in-foods
PDF File:
2023-27506.pdf
Supporting Documents:
» Reference 11 RIA Direct Final Rule for Revocation of Uses of Partially Hydrogenated Oils in Foods re: Revocation of Uses of Partially Hydrogenated Oils in Foods
» Reference 10 FDA Memo Tox Memo 2Quantitative Risk AssessmentJune 112015 re: Revocation of Uses of Partially Hydrogenated Oils in Foods
» Reference 9 FDA Memo Tox Memo 3 Literature ReviewJune 112015 re: Revocation of Uses of Partially Hydrogenated Oils in Foods
» Reference 8 FDA Memo Tox Memo 1 Scientific Update TFA and CHD RiskJune 112015 re: Revocation of Uses of Partially Hydrogenated Oils in Foods
» Reference 7 FDA Memo Prior Sanctioned Uses of PHOs Literature Review Oct 22 2019 re: Revocation of Uses of Partially Hydrogenated Oils in Foods
» Reference 6 FDA Memo Prior Sanctioned Uses of PHOs Risk AssessmentOct 22 2019 re: Revocation of Uses of Partially Hydrogenated Oils in Foods
» Reference 5 FDA Memo Prior Sanctioned Uses of PHOs Trans Fat ExposureOct 232019 re: Revocation of Uses of Partially Hydrogenated Oils in Foods
» Reference 4 US Patent Office Record No 2909432 1959 re: Revocation of Uses of Partially Hydrogenated Oils in Foods
» Reference 3 US Patent Office Record No 1135351 1915 re: Revocation of Uses of Partially Hydrogenated Oils in Foods
» Reference 2 USDA Foods Enriched Restored Fortified 1945 re: Revocation of Uses of Partially Hydrogenated Oils in Foods
CFR: (4)
21 CFR 161
21 CFR 164
21 CFR 184
21 CFR 186