[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Proposed Rules]
[Page 17789]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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]
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