Proposed Rule2023-09366
Filing of Color Additive Petition From Environmental Defense Fund, et al.; Request To Revoke Color Additive Listing for Use of Titanium Dioxide in Food
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 3, 2023
Effective
April 14, 2023
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 Environmental Defense Fund, et al., proposing that FDA repeal the color additive regulation providing for the use of titanium dioxide in foods.
Full Text
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<title>Federal Register, Volume 88 Issue 85 (Wednesday, May 3, 2023)</title>
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[Federal Register Volume 88, Number 85 (Wednesday, May 3, 2023)]
[Proposed Rules]
[Pages 27818-27819]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09366]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2023-C-1487]
Filing of Color Additive Petition From Environmental Defense
Fund, et al.; Request To Revoke Color Additive Listing for Use of
Titanium Dioxide in Food
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
Environmental Defense Fund, et al., proposing that FDA repeal the color
additive regulation providing for the use of titanium dioxide in foods.
DATES: The color additive petition was filed on April 14, 2023. Either
electronic or written comments must be submitted by July 3, 2023.
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 July 3, 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 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 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-2023-C-1487 for ``Filing of Color Additive Petition from
Environmental Defense Fund, et al.; Request To Revoke Color Additive
Listing for Use of Titanium Dioxide in Food.'' Received comments, those
filed in a timely manner (see DATES), 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 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
[[Page 27819]]
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: Paulette M. Gaynor, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1192.
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 3C0325), submitted by
Environmental Defense Fund, Center for Environmental Health, Center for
Food Safety, Center for Science in the Public Interest, and
Environmental Working Group, c/o Tom Neltner, 1875 Connecticut Ave. NW,
Washington, DC 20009. The petition proposes that we repeal the color
additive regulation for titanium dioxide in Sec. 73.575 (21 CFR
73.575), which permits the use of titanium dioxide in foods.
II. Request To Repeal Section 73.575
In accordance with the procedure in section 721(d) of the FD&C Act
for issuance, amendment, or repeal of regulations, the petition asks us
to repeal section 73.575 to no longer provide for the use of titanium
dioxide in foods. The petitioners assert that the intended use of this
color additive no longer meets the safety standard under 21 CFR
70.3(i), and cite, as evidence, an opinion by the European Food Safety
Authority (EFSA) entitled ``Safety assessment of titanium dioxide
(E171) as a food additive'' that was published in May 2021 (we are
using EFSA's title for this document, rather than the one cited by the
petitioners), and other publications.
We invite comments, additional scientific data, and other
information related to the issues raised by this petition. If we
determine that the available data justify repealing section 73.575 to
no longer provide for the safe use of titanium dioxide in foods, we
will publish our decision in the Federal Register in accordance with 21
CFR 71.20.
The petitioners have 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 petitioners have 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.
Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09366 Filed 5-2-23; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on May 3, 2023.
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