Food Safety
search
cart
facebook twitter linkedin
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Food Safety
  • NEWS
    • Latest News
    • White Papers
  • PRODUCTS
  • TOPICS
    • Contamination Control
    • Food Types
    • Management
    • Process Control
    • Regulatory
    • Sanitation
    • Supply Chain
    • Testing and Analysis
  • PODCAST
  • EXCLUSIVES
    • Food Safety Five Newsreel
    • eBooks
    • FSM Distinguished Service Award
    • Interactive Product Spotlights
    • Videos
  • BUYER'S GUIDE
  • MORE
    • ENEWSLETTER >
      • Archive Issues
      • Subscribe to eNews
    • Store
    • Sponsor Insights
  • WEBINARS
  • FOOD SAFETY SUMMIT
  • EMAG
    • eMagazine
    • Archive Issues
    • Editorial Advisory Board
    • Contact
    • Advertise
  • SIGN UP!
NewsFood TypeRegulatoryIngredientsFDA

FDA Finalizes 2015 Determination Revoking GRAS Status for Partially Hydrogenated Oils in Food

knife cutting through margarine fda logo overlay

Image credit: ds_30 via Pixabay

August 8, 2023

The U.S. Food and Drug Administration (FDA) has issued a direct final rule finalizing the agency’s prior determination that the use of partially hydrogenated oils (PHOs) in foods is no longer Generally Recognized as Safe (GRAS).

The direct final rule completes administrative actions that reflect the agency’s June 2015 final determination on the GRAS status of PHOs. In the 2015 final determination, FDA indicated that there were outdated references to PHOs in regulations that the agency would address separately. With respect to removing PHOs from the food supply, FDA established January 1, 2021, as the final compliance date to allow manufacturers time to reformulate foods and ensure an orderly transition in the marketplace.   

FDA’s actions regarding PHOs address artificial sources of trans fats, but trans fats will not be completely removed from the food supply because of their natural occurrence in meat and dairy products and presence at very low levels in other edible oils.

The direct final rule:

  • Revises regulations to no longer include PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna.
  • Revises FDA GRAS affirmation regulations to no longer include partially hydrogenated forms of menhaden and rapeseed oils.   
  • Revokes the regulation for partially hydrogenated fish oil as an indirect food substance.  
  • Revokes pre-1958 authorization for using PHOs in margarine, shortening, bread, rolls, and buns. This authorization occurred before the enactment of the Food Additives Amendment of 1958 so such uses of PHOs could not be regulated as food additives.

FDA is issuing the present amendments directly as a final rule because the agency anticipates no significant adverse comments due to the original declaration of PHOs no longer being GRAS for any human food in 2015. However, the agency is issuing a companion proposed rule on the same issue in the Federal Register in case the direct final rule is withdrawn in the case of significant adverse comments, and because the agency needs to move forward with a proposed rule to enact changes.

FDA is accepting comments on both the direct final and proposed rules. Comments must be submitted no later than 75 days after publication in the Federal Register. Electronic comments can be submitted at regulations.gov. Written comments can be sent to: Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, room 1061, Rockville, MD 20852

The direct final rule would be effective 135 days after the date of publication in the Federal Register.  

KEYWORDS: FDA generally recognized as safe

Share This Story

Looking for a reprint of this article?
From high-res PDFs to custom plaques, order your copy today!

Recommended Content

JOIN TODAY
to unlock your recommendations.

Already have an account? Sign In

  • people holding baby chicks

    Serovar Differences Matter: Utility of Deep Serotyping in Broiler Production and Processing

    This article discusses the significance of Salmonella in...
    Testing & Analysis
    By: Nikki Shariat Ph.D.
  • woman washing hands

    Building a Culture of Hygiene in the Food Processing Plant

    Everyone entering a food processing facility needs to...
    Training
    By: Richard F. Stier, M.S.
  • graphical representation of earth over dirt

    Climate Change and Emerging Risks to Food Safety: Building Climate Resilience

    This article examines the multifaceted threats to food...
    Risk Assessment
    By: Maria Cristina Tirado Ph.D., D.V.M. and Shamini Albert Raj M.A.
Subscribe For Free!
  • eMagazine Subscription
  • Subscribe to eNewsletter
  • Manage My Preferences
  • Website Registration
  • Subscription Customer Service

More Videos

Sponsored Content

Sponsored Content is a special paid section where industry companies provide high quality, objective, non-commercial content around topics of interest to the Food Safety Magazine audience. All Sponsored Content is supplied by the advertising company and any opinions expressed in this article are those of the author and not necessarily reflect the views of Food Safety Magazine or its parent company, BNP Media. Interested in participating in our Sponsored Content section? Contact your local rep!

close
  • Two men standing in a produce storage facility having a discussion.
    Sponsored byOrkin Commercial

    Staying Compliant With FSMA

  • Deli Salads
    Sponsored byCorbion

    How Food Safety is Becoming the Ultimate Differentiator in Refrigerated and Prepared Foods

Popular Stories

Image of produce being washed on a conveyor belt in a facility

Science in Action: How Nanobubbles Are Advancing Food Safety Standards

FoodSafetyMattersFinal-900x550-(002).jpg

Ep. 195. Dr. Christopher Daubert: The Value of a Food Science Education

Students returning their lunch trays in a cafeteria

California Bill Would Remove Ultra-Processed Foods from School Lunches

Events

June 26, 2025

How to Design and Conduct Challenge Studies for Safer Products and Longer Shelf Life

Live: June 26, 2025 at 2:00 pm EDT: During this webinar, attendees will learn how to conduct challenge studies for microbial spoilage and pathogen growth, including the common challenges encountered, laboratory selection, and use of predictive models.

May 11, 2026

The Food Safety Summit

Stay informed on the latest food safety trends, innovations, emerging challenges, and expert analysis. Leave the Summit with actionable insights ready to drive measurable improvements in your organization. Do not miss this opportunity to learn from experts about contamination control, food safety culture, regulations, sanitation, supply chain traceability, and so much more.

View All

Products

Global Food Safety Microbial Interventions and Molecular Advancements

Global Food Safety Microbial Interventions and Molecular Advancements

See More Products
Environmental Monitoring Excellence eBook

Related Articles

  • FDA Seeks to Revoke GRAS Status for Trans Fats

    See More
  • United States Department of Agriculture (USDA) Building

    FSIS moves on label claim sampling program, partially hydrogenated oils

    See More
  • knife buttering bread with FDA logo overlay

    FDA Issues Final Rule to Complete 2015 Decision that PHOs are No Longer GRAS

    See More

Related Directories

  • BD Food Safety Consultants LLC

    We are a Food Safety Training and Consulting firm located in Naperville, IL. Our primary goal is to provide with effective training and consulting solutions for Food Manufacturing and Distributing companies. Our training services include the following: FSPCA PCQI classes, IAVA Courses, IHA Accredited HACCP classes, FSVP Courses and Internal Auditor Training classes. We also offer Learning Management System for food manufacturing industry. Our LMS provides effective training solutions and easy training reporting system. Consulting service we offer includes complex assistance with preparations for SQF, BRC & FSSC audits, other 3rd party audits, FSMA (PC, FSVP, IA), HACCP, Dietary Supplements compliance & more. We serve our clients worldwide.
  • Food Safety and Quality Consultants LLC

    Food Safety and Quality Consultants, LLC (FSQC) is a professional full-service food safety and quality consulting firm offering a complete line of training, consulting, and auditing services to meet your needs. We will help you turn the complicated into compliance by making your food safety systems simple and effective!
×

Never miss the latest news and trends driving the food safety industry

eNewsletter | Website | eMagazine

JOIN TODAY!
  • RESOURCES
    • Advertise
    • Contact Us
    • Directories
    • Store
    • Want More
  • SIGN UP TODAY
    • Create Account
    • eMagazine
    • eNewsletter
    • Customer Service
    • Manage Preferences
  • SERVICES
    • Marketing Services
    • Reprints
    • Market Research
    • List Rental
    • Survey/Respondent Access
  • STAY CONNECTED
    • LinkedIn
    • Facebook
    • Instagram
    • X (Twitter)
  • PRIVACY
    • PRIVACY POLICY
    • TERMS & CONDITIONS
    • DO NOT SELL MY PERSONAL INFORMATION
    • PRIVACY REQUEST
    • ACCESSIBILITY

Copyright ©2025. All Rights Reserved BNP Media.

Design, CMS, Hosting & Web Development :: ePublishing