   
  
G/SPS/N/USA/2766/Add.2  
23 August 2023  
(23-5668)  Page: 1/3 
Committee on Sanitary and Phytosanitary Measures  Original: English  
 
  
NOTIFICATION  
Addendum  
The following communication, received on 22 August 2023, is being circulated at the request of the 
Delegation of  the United States of America . 
 
_______________  
 
 
Revocation of Uses of Partially Hydrogenated Oils in Foods; Direct Final Rule  
The Food and Drug Administration (FDA or we) is 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). The rule removes PHOs  as an optional ingredient in the 
standards of identity for peanut butter and canned tuna. It revises FDA's regulations affirming food 
substances as GRAS pertaining to menhaden oil and rapeseed oil to no longer include partially 
hydrogenated forms of these  oils, and deletes the regulation affirming hydrogenated fish oil as GRAS 
as an indirect food substance. We are also revoking prior sanctions ( i.e., pre-1958 authorization of 
certain uses) for the use of PHOs in margarine, shortening, and bread, rolls, an d buns based on our 
conclusion that these uses of PHOs may be injurious to health. We are issuing these amendments 
directly as a final rule because they are noncontroversial given the public health risks associated with 
PHOs and the increasing use of PHO a lternatives, and we anticipate no significant adverse comments 
because PHOs were declared no longer GRAS for any use in human food in 2015.  
This rule is effective 22 December 2023. Either electronic or written comments on the direct final rule 
or its compa nion proposed rule must be submitted by 23 October 2023. If FDA receives no significant 
adverse comments within the specified comment period, we intend to publish a document confirming 
the effective date of the final rule in the Federal Register  within 30 days after the comment period 
on this direct final rule ends. If timely significant adverse comments are received, FDA will publish a 
document in the Federal Register  withdrawing this direct final rule within 30 days after the comment 
period on this direct  final rule ends and we will then proceed to respond to comments under the 
companion proposed rule using the usual notice and comment procedures.  
Direct Final Rule: https://www.govinfo.gov/content/pkg/FR -2023-08-09/pdf/2023 -16725.pdf  
Companion  Proposed  Rule:  https://www.govinfo.gov/content/pkg/FR -2023-08-09/pdf/2023 -
16724.pdf  
https://members.wto.org/crnattachments/2023/SPS/USA/23_1 1951_00_e.pdf  
https://members.wto.org/crnattachments/2023/SPS/USA/23_11951_01_e.pdf  
This addendum c oncerns a:  
[ ] Modification of final date for comments  
[X] Notification of adoption, publication or entry into force of regulation  
[ ] Modification of content and/or scope of previously notified draft regulation  
[ ] Withdrawal of proposed regulation  
[ ] Change in proposed date of adoption, publication or date of entry into force  
[ ] Other:  G/SPS/N/USA/2766/Add.2  
 
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  Comment period: (If the addendum extends the scope of the previously notified measure 
in terms of products and/or potentially affected Members, a new  deadline for receipt of 
comments should be provided, normally of at least 60 calendar days. Under other 
circumstances, such as extension of originally announced final date for comments, the 
comment period provided in the addendum may vary.)  
[ ] Sixty days from the date of circulation of the addendum to the notification and/or 
(dd/mm/yy) : 23 October 2023  
Agency or authority designated to handle comments: [  ] National Notification Authority, 
[ ] National Enquiry Point. Address, fax number and e -mail address (if available) of other 
body:  
You may submit comments as follows. Please note that late, untimely filed comments will not be 
considered. The https://www.regulations.gov  electronic filing system will accept com ments until 
11:59 p.m. Eastern Time at the end of 23 October 2023. Comments received by mail/hand 
delivery/courier (for written/paper submissions) will be considered timely if they are received on or 
before that date.  
Electronic Submissions  
Submit electron ic comments in the following way:  
• Federal eRulemaking Portal: https://www.regulations.gov . Follow the instructions for submitting 
comments. Comments submitted electronically, inc luding attachments, to 
https://www.regulations.gov  will be posted to the docket unchanged. Because your comment will 
be made public, you are solely responsible for ensuring that y our comment does not include any 
confidential information that you or a third party may not wish to be posted, such as medical 
information, your or anyone else's Social Security number, or confidential business information, 
such as a manufacturing process.  Please note that if you include your name, contact information, 
or other information that identifies you in the body of your comments, that information will be 
posted on https://www.regulations.gov . 
• If you want to submit a comment with confidential information that you do not wish to be made 
available to the public, submit the comment as a written/paper submission and in the manner 
detailed (see "Written/Paper Submissions" and "In structions").  
Written/Paper Submissions  
Submit written/paper submissions as follows:  
• Mail/Hand Delivery/Courier (for written/paper submissions):  Dockets Management Staff (HFA –
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20 852. 
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your 
comment, as well as any attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in "Instructions ". 
Instructions:  All submissions received must include the Docket No. FDA –2019–N–4750 for 
"Revocation of Uses of Partially Hydrogenated Oils in Foods ". Received comments, those filed in a 
timely manner (see ADDRESSES  ) will be placed in the docket and, except  for those submitted as 
"Confidential Submissions ", publicly viewable at https://www.regulations.gov  or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through F riday, +(240) 402 7500.  
• Confidential Submissions —To submit a comment with confidential information that you do not 
wish to be made publicly available, submit your comments only as a written/paper submission. 
You should submit two copies total. One copy wil l include the information you claim to be 
confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL 
INFORMATION ". We will review this copy, including the claimed confidential information, in our 
consideration of comments. T he second copy, which will have the claimed confidential information 
redacted/blacked out, will be available for public viewing and posted on 
https://www.regulations.gov . Submit both copies to the Dockets Management Staff. If you do 
not wish your name and contact information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your comments and you must identify this 
information  as "confidential ". Any information marked as "confidential" will not be disclosed 
except in accordance with 21 CFR 10.20  and other applicable disclosure law. For  more information 
about FDA's posting of comments to public dockets, see 80 FR 56469 , September 18, 2015, or G/SPS/N/USA/2766/Add.2  
 
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  access the information at: https://www.govinfo.gov/content/pkg/FR -2015-09-18/pdf/2015 -
23389.pdf . 
Docket:  For access to the docket to read background documents or the electron ic and written/paper 
comments received, go to https://www.regulations.gov  and insert the docket number, found in 
brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, +(240) 402 
7500.  
FOR FURTHER INFORMA TION CONTACT:  
Ellen Anderson, Center  for Food Safety and Applied Nutrition, Office of Food Additive Safety (HFS –
255), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, +(240) 402 1309; 
or Carrol Bascus, 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.  
Text(s) available from: [  ] National Notification Authority, [  ] National Enquiry Point. 
Address, fax number and e -mail address (if available) of  other body:  
Text can be found in the Federal Register, Vol. 88, No. 152, page 53764 or on the internet at: 
https://www.govinfo.gov/content/pkg/FR -2023-08-09/pdf/2023 -16725 .pdf 
 
__________  