Proposed Rule2024-05216
Filing of Color Additive Petition From Phytolon Ltd.
Primary source
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Published
March 12, 2024
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 petition, submitted by Phytolon Ltd., proposing that the color additive regulations be amended to provide for the safe use of beetroot red for the coloring of foods generally in amounts consistent with current good manufacturing practice.
Full Text
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<title>Federal Register, Volume 89 Issue 49 (Tuesday, March 12, 2024)</title>
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[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Proposed Rules]
[Page 17789]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-05216]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2024-C-1085]
Filing of Color Additive Petition From Phytolon Ltd.
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 petition, submitted by Phytolon Ltd., proposing
that the color additive regulations be amended to provide for the safe
use of beetroot red for the coloring of foods generally in amounts
consistent with current good manufacturing practice.
DATES: The color additive petition was filed on November 22, 2023.
ADDRESSES: For access to the docket to read background documents or
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.
FOR FURTHER INFORMATION CONTACT: Christopher Kampmeyer, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1255.
SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food,
Drug, and Cosmetic Act ((21 U.S.C. 379e(d)(1)), we are giving notice
that we have filed a color additive petition (CAP 4C0326), submitted by
Phytolon Ltd., Ha-Tsmikha St, Yokne'am Illit, Israel. The petition
proposes to amend the color additive regulations in part 73 (21 CFR
part 73), ``Listing of Color Additives Exempt From Certification,'' to
provide for the safe use of beetroot red for the coloring of foods
generally in amounts consistent with current good manufacturing
practice.
The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(r), which applies to an action for
substances which occur naturally in the environment, and for which the
action does not alter significantly the concentration or distribution
of the substance, its metabolites, or degradation products in the
environment. In addition, the petitioner has stated that, to their
knowledge, no extraordinary circumstances exist. 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: March 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05216 Filed 3-11-24; 8:45 am]
BILLING CODE 4164-01-P
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