Listing of Color Additive Exempt From Certification; Spirulina Extract; Delay of Effective Date
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or we) is announcing a delay of the effective date of our February 6, 2026, final order to amend the color additive regulations to provide for the expanded safe use of spirulina (Arthrospira platensis) extract as a color additive in human foods generally (except for infant formula, certain foods subject to regulation by the U.S. Department of Agriculture (USDA), and foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), unless the use of the added color is authorized by such standards) at levels consistent with good manufacturing practice (GMP); to lower the heavy metal specifications for lead, arsenic, and mercury; and to add a specification for cadmium. The delay of the effective date is required by law following the filing of timely objections and a request for a hearing on the final order. This announcement does not reflect a change in our determination that there is a reasonable certainty of no harm from the use of this color additive under the conditions of its intended use. In addition, this announcement does not constitute a determination that all of the issues raised in the submission constitute objections or that a hearing is justified on any objections or requests for a hearing that have been filed.
Full Text
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<title>Federal Register, Volume 91 Issue 56 (Tuesday, March 24, 2026)</title>
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[Federal Register Volume 91, Number 56 (Tuesday, March 24, 2026)]
[Rules and Regulations]
[Pages 13966-13967]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-05733]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2024-C-3384]
Listing of Color Additive Exempt From Certification; Spirulina
Extract; Delay of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order; delay of effective date.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing a
delay of the effective date of our February 6, 2026, final order to
amend the color additive regulations to provide for the expanded safe
use of spirulina (Arthrospira platensis) extract as a color additive in
human foods generally (except for infant formula, certain foods subject
to regulation by the U.S. Department of Agriculture (USDA), and foods
for which standards of identity have been issued under section 401 of
the Federal Food, Drug, and Cosmetic Act (FD&C Act), unless the use of
the added color is authorized by such standards) at levels consistent
with good manufacturing practice (GMP); to lower the heavy metal
specifications for lead, arsenic, and mercury; and to add a
specification for cadmium. The delay of the effective date is required
by law following the filing of timely objections and a request for a
hearing on the final order. This announcement does not reflect a change
in our determination that there is a reasonable certainty of no harm
from the use of this color additive under the conditions of its
intended use. In addition, this announcement does not constitute a
determination that all of the issues raised in the submission
constitute objections or that a hearing is justified on any objections
or requests for a hearing that have been filed.
DATES: As of March 20, 2026, the effective date of the final order
published February 6, 2026 (91 FR 5291) is delayed indefinitely. The
Food and Drug Administration will publish a document in the Federal
Register announcing a new effective date or other administrative action
on the order.
FOR FURTHER INFORMATION CONTACT: Marissa Santos, Office of Pre-Market
Additive Safety, Human Foods Program, Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, 240-402-8160; or Meridith L.
Kelsch, 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: In the Federal Register of February 6, 2026
(91 FR 5291), FDA issued a final order, Listing of Color Additives
Exempt from Certification; Spirulina Extract, to provide for the
expanded safe use of spirulina (Arthrospira platensis) extract as a
color additive in human foods generally (except for infant formula,
certain foods subject to regulation by the USDA, and foods for which
standards of identity have been issued under section 401 of the FD&C
Act, unless the use of the added color is authorized by such standards)
at levels consistent with good manufacturing practice (GMP); to lower
the heavy metal specifications for lead, arsenic, and mercury; and to
add a specification for cadmium. Specifically, the final order amended
Sec. 73.530, titled ``Spirulina extract,'' (21 CFR 73.530). We issued
the final order in response to a color additive petition submitted by
GNT USA, LLC. We gave interested persons until March 9, 2026, to file
objections and requests for a hearing on the final order.
Obelisk Tech Systems Inc. submitted objections and a request for a
hearing. See Submission from Obelisk Tech Systems Inc., to the Dockets
Management Staff, Food and Drug Administration, submitted March 7,
2026. In addition to the objections and request for a hearing submitted
by Obelisk Tech Systems Inc, we received another comment that opposed
the final order, but does not appear to be an objection under 21 CFR
12.22 nor does it request a hearing. We plan to address the objections
and request for a hearing in a future document.
Under sections 701(e)(2) and 721(d) of the FD&C Act (21 U.S.C.
371(e)(2) and 379e(d)), within 30 days after publication of an order
relating to a color additive regulation, any person adversely affected
by such an order may file objections, specifying with
[[Page 13967]]
particularity the provisions of the order deemed objectionable, stating
the grounds therefor, and requesting a public hearing upon such
objections. The filing of the objections operates to delay the
effective date of the final order until we take final action on the
objections.\1\ Our announcement of the delay of the effective date of
the final order does not reflect a change in our determination that
there is a reasonable certainty of no harm from the use of this color
additive under the proposed conditions of its intended use. In
addition, this notification does not constitute a determination that
all of the issues raised in the submission constitute objections or
that a hearing is justified on any objections or requests for hearing
that have been filed.
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\1\ Although the statute uses the word ``stay,'' this delay
effectuates the same result.
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For access to the docket to read the objections received, go to
<a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number FDA-2024-C-
3384 into the ``Search'' box and follow the prompts and/or go to the
Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-05733 Filed 3-20-26; 4:15 pm]
BILLING CODE 4164-01-P
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