Proposed Rule2025-18023
Proposal To Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages
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Published
September 17, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is proposing to issue an order that would remove the color additive regulation that allows for the use of Orange B for coloring the casings or surfaces of frankfurters and sausages. Based on certification data, it appears that Orange B is no longer used for coloring the casings or surfaces of frankfurters and sausages and has not been certified for use as a color additive in food marketed in the United States since 1978. Because the authorized use of Orange B appears to have been abandoned, we have tentatively concluded that this color additive regulation is outdated and unnecessary.
Full Text
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<title>Federal Register, Volume 90 Issue 178 (Wednesday, September 17, 2025)</title>
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[Federal Register Volume 90, Number 178 (Wednesday, September 17, 2025)]
[Proposed Rules]
[Pages 44786-44788]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18023]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 90, No. 178 / Wednesday, September 17, 2025 /
Proposed Rules
[[Page 44786]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 74
[Docket No. FDA-2025-C-3543]
Proposal To Remove the Color Additive Listing for Use of Orange B
on Casings or Surfaces of Frankfurters and Sausages
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed amendment; proposed order.
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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
issue an order that would remove the color additive regulation that
allows for the use of Orange B for coloring the casings or surfaces of
frankfurters and sausages. Based on certification data, it appears that
Orange B is no longer used for coloring the casings or surfaces of
frankfurters and sausages and has not been certified for use as a color
additive in food marketed in the United States since 1978. Because the
authorized use of Orange B appears to have been abandoned, we have
tentatively concluded that this color additive regulation is outdated
and unnecessary.
DATES: Submit electronic or written comments on the proposed order by
October 17, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 17, 2025. 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 electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your 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 comment, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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 ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> 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-2025-C-3543 for ``Proposal to Remove the Color Additive Listing for
Use of Orange B on Casings or Surfaces of Frankfurters and Sausages.''
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 will 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. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 access the information at:
<a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 INFORMATION CONTACT: Shayla West-Barnette, Office of Pre-
market Additive Safety, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1262;
or Meridith L. Kelsch, Office of Policy, Regulations, and Information,
Human Foods Program, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
[[Page 44787]]
II. Description of the Proposed Order
III. Proposed Effective Date of a Final Order
IV. Analysis of Environmental Impact
V. Paperwork Reduction Act of 1995
VI. References
I. Background
President Trump has directed the heads of executive departments and
agencies to eliminate unnecessary and burdensome regulations (Executive
Order 14192, ``Unleashing Prosperity Through Deregulation'' (90 FR
9065, Feb. 6, 2025)). Independently, Secretary Kennedy has expressed
support for deregulatory initiatives across all HHS components to focus
on the core mission to Make America Healthy Again (see ``Request for
Information (RFI): Ensuring Lawful Regulation and Unleashing Innovation
to Make America Healthy Again'' (90 FR 20478, May 14, 2025)). Removing
the color additive regulation for Orange B, which we tentatively
conclude is no longer used for its authorized use in food in the United
States, is consistent with these directives. It is also consistent with
Executive Order 13563, ``Improving Regulation and Regulatory Review''
(76 FR 3821, Jan. 21, 2011), which requires agencies to periodically
conduct retrospective analyses of existing regulations to identify
those ``that may be outmoded, ineffective, insufficient, or excessively
burdensome, and to modify, streamline, expand, or repeal them,''
accordingly.
The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes us
to regulate ``color additives'' (see section 721(b) of the FD&C Act (21
U.S.C. 379e(b))). The FD&C Act defines ``color additive,'' in relevant
part, as a material which is a dye, pigment, or other substance made by
a process of synthesis or similar artifice, or extracted, isolated, or
otherwise derived, with or without intermediate or final change of
identity, from a vegetable, animal, mineral, or other source, and that
when added or applied to a food, drug, or cosmetic, or to the human
body or any part thereof, is capable (alone or through reaction with
another substance) of imparting color (see section 201(t) of the FD&C
Act (21 U.S.C. 321(t))). Color additives used in or on a food, drug,
cosmetic, or certain medical devices are deemed unsafe and prohibited
except to the extent that we approve their use through issuance of a
regulation and, when subject to certification, are batch certified (see
section 721(a) of the FD&C Act).
Sections 701(e), (f), and (g) of the FD&C Act (21 U.S.C. 371(e),
(f), and (g)) apply to the issuance, amendment, or repeal of color
additive regulations (see section 721(d) of the FD&C Act). Section
701(e) of the FD&C Act provides that any action for the issuance,
amendment, or repeal of a color additive regulation may be initiated by
a proposal made by the Secretary or by a petition of any interested
persons. It further requires that FDA publish such a proposal, provide
an opportunity for interested parties to present their views, and then
by order act upon such proposal.
FDA may issue a regulation listing a color additive for use in or
on food, drugs, devices, or cosmetics only if it determines that the
additive is suitable and safe for such use (see section 721(b)(2)(A) of
the FD&C Act). The regulation that permits the use of a color additive
includes appropriate limitations and requirements for its safe use and
specifies whether certification is required (see section 721(a)(1), (c)
of the FD&C Act; 21 CFR 71.20). (For additional information on
certification of color additives, see Color Certification FAQs,
available at: <a href="https://www.fda.gov/industry/color-certification/color-certification-faqs">https://www.fda.gov/industry/color-certification/color-certification-faqs</a>.)
FDA determines the need for batch certification based on whether
the color additive composition needs to be controlled to protect the
public health (see 21 CFR 71.20(b)). Some color additives, in their
uncertified forms, might contain impurities at levels that pose a
health concern. When batch certification is required for a color
additive, the color additive must be batch certified by FDA. If it is
not batch certified, it is deemed unsafe under the relevant
adulteration provision, for example, under section 402(c) of the FD&C
Act for food (see section 721(a)(1) of the FD&C Act). To receive
certification for a color additive, a request must be filed with FDA,
along with a batch sample. FDA assesses the information in the request
and analyzes whether the batch sample conforms to the applicable
identity and specifications stated in the listing regulation for the
color additive. If FDA finds that the batch sample meets the applicable
requirements for composition and purity stated in the listing
regulation, FDA will issue a certificate indicating the lot number for
the batch and stating that the batch is certified (see 21 CFR 80.21,
80.31).
II. Description of the Proposed Order
On January 4, 1966 (31 FR 8), we issued a regulation allowing for
the use of Orange B as a color additive in casings for frankfurters and
sausages, subject to certain specifications, restrictions, labeling
requirements, and certification. Under Sec. 74.250 (21 CFR 74.250),
Orange B is authorized for coloring the casings or surfaces of
frankfurters and sausages subject to the restriction that the quantity
of the color additive does not exceed 150 parts per million by weight
of the finished food. It is not authorized for other uses as a color
additive. The regulation also specifies that all batches of Orange B
must be certified in accordance with our regulations under 21 CFR part
80.
Our records indicate that Orange B was last batch certified in 1978
and that FDA has not received any requests to batch certify Orange B
since that time (Ref. 1). We tentatively conclude that the absence of
requests to certify a batch of Orange B since 1978 indicates that the
color additive is no longer manufactured for uses established in Sec.
74.250. Without a certification, Orange B may not be used as a color
additive in food in the United States. Considering this information, we
tentatively conclude that the authorized use of Orange B has been
abandoned. Therefore, we tentatively conclude that the color additive
listing for Orange B at Sec. 74.250 is outdated and unnecessary and we
propose to repeal this color additive regulation. We would consider
this action to also partially respond to the Center for Science in the
Public Interest's (CSPI) 2008 citizen petition (Docket No. FDA-2008-P-
0349), which requests, in part, that FDA revoke the color additive
approval of Orange B.
If this proposed order is finalized, in accordance with 21 CFR
80.32(h), all certificates for any existing batches and portions of
batches of Orange B would cease to be effective for use in food on the
effective date for the removal of Sec. 74.250, and any lots of Orange
B would be regarded as uncertified after that date. The use of Orange B
in any food after its certificate ceases to be effective would result
in such food being adulterated.
III. Proposed Effective Date of a Final Order
We propose that any final order based on this proposed order be
effective 45 days following its publication in the Federal Register.
IV. Analysis of Environmental Impact
We have determined under 21 CFR 25.32(m) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Paperwork Reduction Act of 1995
FDA tentatively concludes that this proposed order contains no
collection of
[[Page 44788]]
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520)
is not required.
VI. References
The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it also is
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Although FDA
verified the website addresses in this document, please note that
websites are subject to change over time.
1. Memorandum from S. West-Barnette, Division of Food Ingredients,
Regulatory Review Branch, Human Foods Program, FDA, to M. Honigfort,
Division of Food Ingredients, Regulatory Review Branch, Human Foods
Program, FDA, August 19, 2025.
List of Subjects in 21 CFR Part 74
Color additives, Cosmetics, Drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, we propose
to amend 21 CFR part 74 as follows:
PART 74--LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
0
1. The authority citation for part 74 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.
Sec. 74.250 [Removed]
0
2. Remove Sec. 74.250.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18023 Filed 9-16-25; 8:45 am]
BILLING CODE 4164-01-P
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