Proposed Rule2026-06295
Filing of 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
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Published
April 1, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing that we have filed a color additive petition, submitted by the International Association of Color Manufacturers (IACM or petitioner), proposing that we amend the color additive regulations to no longer provide for the use of three specified solvents (methylene chloride, trichloroethylene, and ethylene dichloride) for preparing certain color additives because these uses have been permanently abandoned.
Full Text
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<title>Federal Register, Volume 91 Issue 62 (Wednesday, April 1, 2026)</title>
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[Federal Register Volume 91, Number 62 (Wednesday, April 1, 2026)]
[Proposed Rules]
[Pages 16169-16172]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-06295]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2026-C-3071]
Filing of 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: Notification of petition.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a color additive petition, submitted by the
International Association of Color Manufacturers (IACM or petitioner),
proposing that we amend the color additive regulations to no longer
provide for the use of three specified solvents (methylene chloride,
trichloroethylene, and ethylene dichloride) for preparing certain color
additives because these uses have been permanently abandoned.
DATES: The color additive petition was filed on March 20, 2026. Submit
either electronic or written comments by June 1, 2026.
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 June 1, 2026. 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 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 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-2026-C-3071 for ``Filing of 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 comments, those
filed in a timely manner (see ADDRESSES), will be placed
[[Page 16170]]
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 comment 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: 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 Policy and
International Engagement, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 379e(d)(1)), we are giving notice that we have
filed a color additive petition (CAP 5C0340), submitted by IACM, 1101
17th St. NW, Suite 700, Washington, DC 20036. The petition proposes
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 proposes 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 fruits and vegetables. The
petition requests that we make these amendments on the basis that these
uses of the solvents have been permanently abandoned.
The substances that are 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 petition identifies 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). Therefore, while the
petition's request would not amend the codified language in Sec.
73.1030 or 73.2030, amending Sec. 73.30(a)(1) to remove methylene
chloride, trichloroethylene, and ethylene dichloride as permitted
extraction solvents for the manufacture of annatto extract used in
coloring foods (Sec. 73.30) would result in the removal of methylene
chloride, trichloroethylene, and ethylene dichloride as permitted
extraction solvents for the manufacture of annatto extract used in
coloring drugs (Sec. 73.1030) and annatto used in coloring cosmetics
(Sec. 73.2030).
II. Abandonment
The 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, certain medical devices, or
cosmetics are deemed unsafe and prohibited except to the extent that we
approve their use through issuance of a regulation (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. 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). 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).
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.
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,
[[Page 16171]]
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 the recipients to verify that they do not:
<bullet> Currently manufacture, purchase, use, or import annatto
extract (Sec. 73.30), turmeric oleoresin (Sec. 73.615), and/or
paprika oleoresin (Sec. 73.345) 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
<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 U.S. 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).
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.
We specifically seek comments regarding IACM's petition to amend
Sec. Sec. 73.1, 73.30 (which is cross-referenced in Sec. Sec. 73.1030
and 73.2030), 73.345, and 73.615 of the color additive regulations to
no longer allow the use of methylene chloride, trichloroethylene, and
ethylene dichloride in the specified applications because these uses in
the manufacture of color additives have been abandoned. Accordingly, we
request comments that address whether the uses of these substances in
the identified applications have been abandoned. For example, we
request information regarding whether annatto extract, paprika
oleoresin, or turmeric oleoresin manufactured using these substances or
inks for marking fruit and vegetables using methylene chloride are
currently being introduced or delivered for introduction into the U.S.
market for use as color additives in foods (and with respect to annatto
extract and annatto, for use in drugs and cosmetics, respectively). Any
comments indicating that the specified uses of one or more of the
substances have not been abandoned should specify the substance(s), the
specific use(s), any relevant regulation(s) authorizing the use, and a
description of the product that contains the substance(s).
We are currently unaware of information demonstrating the continued
use of these substances in the manufacture of the color additive uses
listed. We are providing the public 60 days to submit comments. We
anticipate that some interested persons may wish to provide us with
certain information they consider to be trade secret or confidential
commercial information (CCI) under Exemption 4 of the Freedom of
Information Act (5 U.S.C. 552). Interested persons may claim
information that is submitted to us as CCI or trade secret by clearly
marking both the document and the specific information as
``confidential.'' Information so marked will not be disclosed except in
accordance with the Freedom of Information Act and our disclosure
regulations (21 CFR part 20). Interested persons must also submit a
copy of the comment that does not contain the information claimed as
confidential for inclusion in the public version of the official
record. Information not marked confidential will be included in the
public version of the official record without prior notice.
We are not requesting comments on the safety of these uses of the
substances in the manufacture of these color additives because such
information is not relevant to abandonment, which is the basis of the
proposed action. We will not consider any comments addressing safety in
our evaluation of this petition.
The petition is available in the docket. We invite comments,
additional data, and other information related to the issues raised by
this petition. If we determine that the available data justify amending
Sec. Sec. 73.30 (which is cross-
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referenced in Sec. Sec. 73.1030 and 73.2030), 73.345, and 73.615 to no
longer provide for use of the three specified substances in the
manufacture of annatto extract, paprika oleoresin, and turmeric
oleoresin, respectively, and amending Sec. 73.1 to no longer provide
for the use of methylene chloride as a diluent in color additive
mixtures in inks for marking fruit and vegetables, we will publish our
decision in the Federal Register in accordance with 21 CFR 71.20.
The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(m), which applies to an action to prohibit
or otherwise restrict or reduce the use of a substance in food, food
packaging, or cosmetics. In addition, the petitioner has stated that,
to their knowledge, no extraordinary circumstances exist (see 21 CFR
25.21). If FDA determines a categorical exclusion applies, neither an
environmental assessment nor an environmental impact statement is
required. If FDA determines a categorical exclusion does not apply, we
will request an environmental assessment and make it available for
public inspection.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-06295 Filed 3-31-26; 8:45 am]
BILLING CODE 4164-01-P
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