Color Additive Petition From the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations To Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene Dichloride

Issuing agencies

Abstract

The Food and Drug Administration (FDA or we) is partially granting a color additive petition submitted by the International Association of Color Manufacturers (IACM or petitioner), by amending our color additive regulations, on the basis of abandonment, to remove the authorized uses of methylene chloride, trichloroethylene, and ethylene dichloride from the list of authorized extraction solvents for annatto extract, paprika oleoresin, and turmeric oleoresin. The petitioner provided data demonstrating that these uses have been permanently abandoned. FDA is denying as moot the portion of the petition proposing that the color additive regulations be amended, on the basis of abandonment, to no longer authorize the use of methylene chloride as a diluent in color additive mixtures in inks for marking fruit and vegetables. This request is moot because the authorization for this use has been removed, on the basis of the Delaney Clause, in response to a separate petition.

Full Text

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<title>Federal Register, Volume 91 Issue 216 (Tuesday, November 10, 2026)</title>
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[Federal Register Volume 91, Number 216 (Tuesday, November 10, 2026)]
[Rules and Regulations]
[Pages 72410-72413]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22866]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2026-C-3071]


Color Additive Petition From the International Association of 
Color Manufacturers; Request To Amend the Color Additive Regulations To 
Remove the Solvents Methylene Chloride, Trichloroethylene, and Ethylene 
Dichloride

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; order; notification of partial denial of 
petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is partially 
granting a color additive petition submitted by the International 
Association of Color Manufacturers (IACM or petitioner), by amending 
our color additive regulations, on the basis of abandonment, to remove 
the authorized uses of methylene chloride, trichloroethylene, and 
ethylene dichloride from the list of authorized extraction solvents for 
annatto extract, paprika oleoresin, and turmeric oleoresin. The 
petitioner provided data demonstrating that these uses have been 
permanently abandoned. FDA is denying as moot the portion of the 
petition proposing that the color additive regulations be amended, on 
the basis of abandonment, to no longer authorize the use of methylene 
chloride as a diluent in color additive mixtures in inks for marking 
fruit and vegetables. This request is moot because the authorization 
for this use has been removed, on the basis of the Delaney Clause, in 
response to a separate petition.

DATES: This order is effective January 11, 2027. If any provisions are 
delayed or stayed by the filing of proper objections, FDA will publish 
such notification in the Federal Register. Submit either electronic or 
written objections and requests for a hearing on the order by December 
10, 2026. See section IX for further information on the filing of 
objections.

ADDRESSES: You may submit objections and requests for a hearing as 
follows. Please note that late, untimely filed objections will not be 
considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system 
will accept objections until 11:59 p.m. Eastern Time at the end of 
December 10, 2026. Objections 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 objections 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. Objections 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 objection will be 
made public, you are solely responsible for ensuring that your 
objection 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 objection, that information will be 
posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
    <bullet> If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper instructions 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 objections submitted to the Dockets 
Management Staff, FDA will post your objection, 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-2026-C-3071 for ``Color Additive Petition from the International 
Association of Color Manufacturers; Request to Amend the Color Additive 
Regulations to Remove the Solvents Methylene Chloride, 
Trichloroethylene, and Ethylene Dichloride.'' Received objections, 
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 an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objection 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 objections. 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 objections 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

[[Page 72411]]

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: Daniel Hlavaty, Office of Food 
Chemical Safety, Dietary Supplements, and Innovation, Human Foods 
Program, Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 301-796-1481; or Alexandra Beliveau, Office of Regulations 
and International Programs, Human Foods Program, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
II. Background
III. Evaluation of Abandonment
IV. Comments Related to the Petition
V. Conclusion
VI. Public Disclosure
VII. Analysis of Environmental Impacts
VIII. Paperwork Reduction Act of 1995
IX. Objections

I. Introduction

    In the Federal Register of April 1, 2026 (91 FR 16169), we 
announced that we filed a color additive petition (CAP 5C0340) 
submitted by IACM, 1101 17th St. NW, Suite 700, Washington, DC 20036.
    The petition proposed that we amend Sec. Sec.  73.30 (21 CFR 73.30, 
``Annatto extract''), 73.345 (21 CFR 73.345, ``Paprika oleoresin''), 
and 73.615 (21 CFR 73.615, ``Turmeric oleoresin'') to remove methylene 
chloride, trichloroethylene, and ethylene dichloride as permitted 
extraction solvents for the manufacture of annatto extract, paprika 
oleoresin, and turmeric oleoresin for use as exempt color additives in 
food. The petition further proposed that we amend Sec.  73.1 (21 CFR 
73.1, ``Diluents in color additive mixtures for food use exempt from 
certification'') to remove methylene chloride as a permitted diluent in 
color additive mixtures in inks for marking fruit and vegetables. The 
petition identified Sec. Sec.  73.1030 (21 CFR 73.1030, ``Annatto 
extract'') and 73.2030 (21 CFR 73.2030, ``Annatto'') as also being 
impacted by this petition. Although the regulations in Sec. Sec.  
73.1030 and 73.2030 do not directly refer to methylene chloride, 
trichloroethylene, or ethylene dichloride, the regulations authorize 
their use by cross-referencing Sec.  73.30(a)(1). The petition 
requested that we make these amendments on the basis that these uses of 
the solvents have been permanently abandoned.
    The substances that were the subject of this petition and their 
corresponding Chemical Abstracts Service (CAS) numbers are:

1. Methylene chloride (CAS No. 75-09-2);
2. Trichloroethylene (CAS No. 79-01-6); and
3. Ethylene dichloride (CAS No. 107-06-2).

    The notification of petition gave interested parties until June 1, 
2026, to submit comments on the filed color additive petition, which 
was made available in the docket.

II. Background

    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'' 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 (``color'' includes black, white, and intermediate 
grays) thereto (see section 201(t) of the FD&C Act (21 U.S.C. 321(t))). 
Color additives used in or on a food, drug, certain medical devices, or 
cosmetics are deemed unsafe and prohibited except to the extent that we 
approve their use (see section 721(a) of the FD&C Act).
    The FD&C Act provides a process through which any person who wishes 
to use a color additive in or on food, drugs, certain medical devices, 
or cosmetics may submit a petition proposing the issuance of a color 
additive regulation listing such use with supporting information. A 
color additive petition may also be submitted to propose the amendment 
or repeal of an existing color additive regulation (see section 
721(b)(5)(C) and (d) of the FD&C Act). In response to a color additive 
petition, FDA may issue a regulation listing a color additive for use 
in or on food, drugs, certain medical 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).
    Section 701(e) through (g) of the FD&C Act (21 U.S.C. 371(e) 
through (g)) applies 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 showing reasonable grounds. It further requires that FDA 
publish such a proposal, provide an opportunity for all interested 
persons to present their views, and then by order act upon such 
proposal.

III. Evaluation of Abandonment

A. 21 CFR 73.30 ``Annatto Extract,'' 21 CFR 73.345 ``Paprika 
Oleoresin,'' and 21 CFR 73.615 ``Turmeric Oleoresin''

    As support for the assertion that the uses of methylene chloride, 
trichloroethylene, and ethylene dichloride in the manufacture of 
annatto extract and annatto, paprika oleoresin, and turmeric oleoresin 
have been abandoned, the petition includes a summary of the results of 
a survey that IACM sent to its members and other non-member firms. The 
petitioner describes IACM members as comprising a meaningful proportion 
of the current global color industry representing manufacturers and 
users of color additives. The other non-member firms that IACM surveyed 
included members of the American Spice Trade Association, the Flavor 
and Extract Manufacturers Association, and the Natural Food Colors 
Association, and independent firms, to cover the total U.S. market and 
support their conclusion that the uses of these substances have been 
permanently abandoned.
    The petitioner asked recipients of the survey to verify that they 
do not:
    <bullet> Currently manufacture, purchase, use, or import annatto 
extract (Sec.  73.30), paprika oleoresin (Sec.  73.345), and/or 
turmeric oleoresin (Sec.  73.615) for color additive use using 
methylene chloride, trichloroethylene, and/or ethylene dichloride as 
extraction solvents whether individually or in combination;
    <bullet> Intend to manufacture or import for use in food in the 
United States the color additives annatto extract (Sec.  73.30), 
paprika oleoresin (Sec.  73.345), or turmeric oleoresin (Sec.  73.615) 
using methylene chloride, trichloroethylene, or ethylene dichloride 
whether individually or in combination as extraction solvents; and

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    <bullet> Currently maintain any inventory of the color additives 
annatto extract (Sec.  73.30), paprika oleoresin (Sec.  73.345), or 
turmeric oleoresin (Sec.  73.615) that were manufactured using 
methylene chloride, trichloroethylene, or ethylene dichloride whether 
individually or in combination as extraction solvents which will be 
used in food in the United States.
    In its summary of the survey results, the petitioner stated that 
the survey included 44 unique companies and 3 trade associations that 
collectively represent an additional 375 companies. All the companies 
that participated in the survey confirmed that they have abandoned 
methylene chloride, trichloroethylene, and ethylene dichloride for use 
in the manufacture of annatto extract (Sec.  73.30), paprika oleoresin 
(Sec.  73.345), and turmeric oleoresin (Sec.  73.615).
    With respect to Sec.  73.30, while the petitioner's survey focused 
on the use of methylene chloride, trichloroethylene, and/or ethylene 
dichloride as extraction solvents to manufacture annatto extract as 
specified in Sec.  73.30, the petitioner asserts that the color 
industry manufactures the colors according to the specifications in 
FDA's color additive regulations, without consideration of end use. 
Therefore, the petitioner asserts that since the survey confirmed that 
methylene chloride, trichloroethylene, and ethylene dichloride have 
been abandoned in the United States for the manufacturing, purchasing, 
use, or import of annatto extract as specified in Sec.  73.30, the 
abandonment of the use of these solvents to manufacture annatto extract 
applies not only to use of the solvents to manufacture annatto extract 
used in coloring foods (Sec.  73.30), but also to the use of the 
solvents to manufacture annatto extract used in coloring drugs (Sec.  
73.1030) and annatto used in coloring cosmetics (Sec.  73.2030).
    In addition, when we published the notification of filing of CAP 
5C0340, stakeholders had an opportunity to provide information 
regarding whether any of the three solvents were still being used in 
the manufacture of the subject color additives. We received no comments 
that demonstrated current use, which is further evidence supporting the 
petitioner's claim that these uses are abandoned.
    In light of the evidence submitted in the petition, as well as the 
absence of any evidence demonstrating lack of abandonment, we are 
granting the petition's requests with respect to Sec. Sec.  73.30, 
73.345, and 73.615. We conclude that methylene chloride, 
trichloroethylene, and ethylene dichloride have been abandoned with 
respect to their use in the manufacture of color additives. 
Accordingly, FDA is removing the authorizations for the use of these 
substances in Sec. Sec.  73.30, 73.345, and 73.615.

B. 21 CFR 73.1 ``Diluents in Color Additive Mixtures for Food Use 
Exempt From Certification''

    As support for the assertion that the use of methylene chloride as 
a diluent in color additive mixtures in inks for marking fruit and 
vegetables has been abandoned, the petitioner engaged in discussions 
with both the International Fresh Produce Association (IFPA), which 
represents the full fresh produce supply chain, and the National 
Association of Printing Ink Manufacturers (NAPIM), which represents 85 
percent of domestic ink manufacturing. The petitioner found that the 
use of inks for marking fruit and vegetables is limited and that no 
chlorinated organics are used in production ink systems or the 
manufacturing process. IACM received confirmation from NAPIM that 
NAPIM's members do not manufacture nor market their products for 
marking fruits and vegetables. IACM also confirmed with IFPA that 
IFPA's members do not:
    <bullet> Currently manufacture for use in food in the United States 
inks for marking fruit and vegetables (Sec.  73.1(b)(1)(ii)) using 
methylene chloride as a diluent;
    <bullet> Currently import for use in food in the United States inks 
for marking fruit and vegetables (Sec.  73.1(b)(1)(ii)) using methylene 
chloride as a diluent;
    <bullet> Intend to manufacture or import for use in food in the 
United States inks for marking fruit and vegetables (Sec.  
73.1(b)(1)(ii)) using methylene chloride as a diluent; and
    <bullet> Currently maintain any inventory of inks for marking fruit 
and vegetables (Sec.  73.1(b)(ii)) using methylene chloride as a 
diluent which will be used in food in the United States.
    Related to CAP 5C0340, elsewhere in this issue of the Federal 
Register, we published a final order in response to CAP 4C0327 granting 
that petition, in part, and amending Sec.  73.1 to no longer provide 
for the use of methylene chloride as a diluent in color additive 
mixtures for use in inks for marking fruit and vegetables on the basis 
of the Delaney Clause (section 721(b)(5)(B) of the FD&C Act). Because 
the final order issued in response to CAP 4C0327 removes methylene 
chloride from Sec.  73.1, the petitioner's request based on abandonment 
is moot.

IV. Comments Related to the Petition

    We provided 60 days for comments on the petition. We received one 
comment, which supported the petitioner's conclusion that the uses of 
methylene chloride, trichloroethylene, and ethylene dichloride as 
described in the petition have been abandoned. We received no other 
comments in response to the notification of petition.

V. Conclusion

    FDA reviewed the data and other information in the petition and 
other available relevant material to evaluate whether the uses of these 
extraction solvents in the manufacture of color additives have been 
abandoned. Based on the available information, we have determined that 
these uses have been abandoned. Therefore, we are amending Sec. Sec.  
73.30, 73.345, and 73.615 of the color additive regulations to no 
longer provide for the uses of methylene chloride, trichloroethylene, 
or ethylene dichloride in the manufacture of color additives because 
these uses have been abandoned. Although the regulatory text in 
Sec. Sec.  73.1030 and 73.2030 will not be amended, these regulations 
are also affected because they authorize the use of these substances by 
cross-referencing Sec.  73.30. Therefore, in removing the authorization 
of the use of these substances from Sec.  73.30, their use is no longer 
authorized under Sec. Sec.  73.1030 and 73.2030.
    We are denying as moot the request to remove methylene chloride 
from Sec.  73.1 because elsewhere in this issue of the Federal 
Register, FDA has revoked the authorization for methylene chloride as a 
diluent in color additive mixtures in inks for marking fruit and 
vegetables on the basis of the Delaney Clause.

VI. Public Disclosure

    In accordance with Sec.  71.15 (21 CFR 71.15), the petition and the 
documents that we considered and relied upon in reaching our decision 
to approve the petition will be made available for public disclosure 
(see FOR FURTHER INFORMATION CONTACT). As provided in Sec.  71.15, we 
will delete from the documents any materials that are not available for 
public disclosure. As stated in the notification of filing for CAP 
5C0340, the petition is available in the docket.

VII. Analysis of Environmental Impacts

    As stated in the April 1, 2026, Federal Register notification of 
petition for CAP 5C0340 (91 FR 16169), the petitioner claimed that this 
action is categorically excluded under Sec.  25.32(m) (21 CFR 
25.32(m)), which applies to ``action(s) to prohibit or otherwise 
restrict or reduce

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the use of a substance in food, food packaging, or cosmetics.'' We 
further stated that, if FDA determines a categorical exclusion applies, 
neither an environmental assessment nor an environmental impact 
statement is required. We did not receive any new information or 
comments regarding this claim of categorical exclusion. We considered 
the petitioner's claim of categorical exclusion and determined that 
this action is categorically excluded under Sec.  25.32(m) (Ref. 1). 
Therefore, neither an environmental assessment nor an environmental 
impact statement is required.

VIII. Paperwork Reduction Act of 1995

    This order contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

IX. Objections

    This order is effective as shown in the DATES section, except as to 
any provisions that may be stayed by the filing of proper objections. 
If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Dockets Management Staff (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify with particularity the provision(s) to which you object, and 
the grounds for your objection. Within each numbered objection, you 
must specifically state whether you are requesting a hearing on the 
particular provision that you specify in that numbered objection. If 
you do not request a hearing for any particular objection, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must include a detailed description and analysis of the 
specific factual information you intend to present in support of the 
objection in the event that a hearing is held. If you do not include 
such a description and analysis for any particular objection, you waive 
the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen 
in the Dockets Management Staff office between 9 a.m. and 4 p.m., 
Monday through Friday, and will be posted to the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. We will publish notice of the objections that we 
have received or lack thereof in the Federal Register.

X. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.

1. Memorandum from A. Thompson-Wood, Environmental Review Team, 
Office of Pre-Market Additive Safety, Office of Food Chemical 
Safety, Dietary Supplements and Innovation, Human Foods Program, FDA 
to D. Hlavaty, Division of Additives and Ingredients, Office of 
Post-Market Assessment, Office of Food Chemical Safety, Dietary 
Supplements and Innovation, Human Foods Program, FDA, October 21, 
2026.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for part 73 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 
361, 362, 371, 379e.


Sec.  73.30  [Amended]

0
2. Amend Sec.  73.30(a)(1)(ii) by removing ``ethylene dichloride'', 
``methylene chloride'', and ``trichloroethylene''.


Sec.  73.345  [Amended]

0
3. Amend the list in Sec.  73.345(a)(1) by removing ``Ethylene 
dichloride'', ``Methylene chloride'', and ``Trichloroethylene''.


Sec.  73.615  [Amended]

0
4. Amend the list in Sec.  73.615(a)(1) by removing ``Ethylene 
dichloride'', ``Methylene chloride'', and ``Trichloroethylene''.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-22866 Filed 11-9-26; 8:45 am]
BILLING CODE 4164-01-P


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