Proposed Rule2025-04034
Impossible Foods, Inc.; Filing of Color Additive Petition
Primary source
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Published
March 14, 2025
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 Impossible Foods, Inc., proposing that the color additive regulations be amended to expand the safe use of soy leghemoglobin as a color additive to include use in plant-based meat, poultry, and fish analogue products (ground and whole cut).
Full Text
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<title>Federal Register, Volume 90 Issue 49 (Friday, March 14, 2025)</title>
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[Federal Register Volume 90, Number 49 (Friday, March 14, 2025)]
[Proposed Rules]
[Page 12118]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04034]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2025-C-0380]
Impossible Foods, Inc.; Filing of Color Additive Petition
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 Impossible Foods, Inc.,
proposing that the color additive regulations be amended to expand the
safe use of soy leghemoglobin as a color additive to include use in
plant-based meat, poultry, and fish analogue products (ground and whole
cut).
DATES: The color additive petition was filed on March 7, 2025.
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: Ellen Anderson, Human Foods Program,
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-1309.
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 5C0336), submitted on
behalf of Impossible Foods, Inc. by Exponent, 1150 Connecticut Ave. NW,
Suite 1100, Washington, DC 20036. The petition proposes to amend the
color additive regulations in 21 CFR 73.520, ``Soy leghemoglobin,'' to
expand the safe use of soy leghemoglobin to include use in plant-based
meat, poultry, and fish analogue products (ground and whole cut).
The petitioner has claimed that this action is categorically
excluded under 21 CFR 25.32(k) because the substance is intended to
remain in food through ingestion by consumers and is not intended to
replace macronutrients in food. 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.
Dated: March 7, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04034 Filed 3-13-25; 8:45 am]
BILLING CODE 4164-01-P
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