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HHS/FDA RIN: 0910-AI15 Publication ID: Fall 2018 
Title: ●Rule to Revoke Uses of Partially Hydrogenated Oils in Foods  

In the Federal Register of June 17, 2015 (80 FR 34650), we published a declaratory order announcing our final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs) are generally recognized as safe (GRAS) for any use in human food. In the Federal Register of May 21, 2018 (83 FR 23382), we denied a food additive petition requesting that the food additive regulations be amended to provide for the safe use of PHOs in certain food applications. We are now proposing to update our regulations to remove all mention of partially hydrogenated oils and to revoke all prior sanctioned uses. This rulemaking implements FDA’s findings that the available data demonstrate that PHOs used in food may cause the food to be unsafe.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 101.4    21 CFR 161.190    21 CFR 164.150    21 CFR 184.1472    21 CFR 184.1555    ...     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 321, 341, 343, 348, 371, 379(e)   
Legal Deadline:  None
Action Date FR Cite
NPRM  06/00/2019 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Ellen Anderson
Consumer Safety Officer
Department of Health and Human Services
Food and Drug Administration
HFS-265, 4300 River Road,
College Park, MD 20740
Phone:240 402-1309