
[Federal Register Volume 88, Number 239 (Thursday, December 14, 2023)]
[Rules and Regulations]
[Page 86580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27506]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 161, 164, 184, and 186

[Docket No. FDA-2019-N-4750]
RIN 0910-AI15


Revocation of Uses of Partially Hydrogenated Oils in Foods; 
Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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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.

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.

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.

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

    Dated: December 11, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27506 Filed 12-13-23; 8:45 am]
BILLING CODE 4164-01-P


