[Federal Register Volume 91, Number 25 (Friday, February 6, 2026)]
[Rules and Regulations]
[Pages 5291-5295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-02314]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2024-C-3384]
Listing of Color Additives Exempt From Certification; Spirulina
Extract
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; order.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the expanded 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, and foods for which
standards of identity have been issued under section 401 of the Federal
Food, Drug, and Cosmetic 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.
We are taking this action in response to a color additive petition
(CAP) submitted by GNT USA, LLC (GNT or petitioner).
DATES: This order is effective March 23, 2026 See section IX of this
document for further information on the filing of objections. Either
electronic or written objections and requests for a hearing on the
order must be submitted by March 9, 2026.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. The https://www.regulations.gov electronic filing system
will accept objections until 11:59 p.m. Eastern Time at the end of
March 9, 2026. Objections 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 objections in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection 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 objection, that information will be
posted on https://www.regulations.gov.
If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
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.
For written/paper objections 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-2024-C-3384 for ``Listing of Color Additives Exempt from
Certification; Spirulina Extract.'' Received objections, those filed in
a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections 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 https://www.regulations.gov.
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 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://
[[Page 5292]]
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, 240-402-7500.
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, Regulations, and Information, Human Foods
Program, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Introduction
In the Federal Register of August 5, 2024 (89 FR 63330), FDA
announced that we filed a color additive petition (CAP 4C0334)
submitted on behalf of GNT by Exponent, 1150 Connecticut Ave. NW, Suite
1100, Washington, DC 20036. The petition proposed that FDA amend the
color additive regulations in part 73 (21 CFR 73.530), ``Listing of
Color Additives Exempt from Certification,'' to provide for the
expanded safe use of spirulina extract as a color additive at levels
consistent with GMP in human foods generally, excluding infant formula
and certain foods subject to regulation by the U.S. Department of
Agriculture (USDA).
II. Background
Spirulina extract is approved under Sec. 73.530 for coloring
confections (including candy and chewing gum), frostings, ice cream and
frozen desserts (including non-dairy frozen dessert), dessert coatings
and toppings, beverage mixes and powders, yogurts (including non-dairy
yogurt alternatives), custards, puddings (including non-dairy
puddings), cottage cheese, gelatin, breadcrumbs, ready-to-eat cereals
(excluding extruded cereals), alcoholic beverages with less than 20
percent alcohol-by-volume content, non-alcoholic beverages, seasoning
mixes (unheated), salad dressings, condiments and sauces, dips, coating
formulations applied to dietary supplement tablets and capsules, at
levels consistent with GMP, and to seasonally color the shells of hard-
boiled eggs, except that it may not be used to color foods for which
standards of identity have been issued under section 401 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341), unless the use
of the added color is authorized by such standards. Spirulina extract
is exempt from certification under section 721(c) of the FD&C Act (21
U.S.C. 379e(c)) because we previously determined that certification was
not necessary for the protection of public health (78 FR 49117 at
49119, August 13, 2013).
The spirulina extract that is the subject of this final order is a
blue-colored powder or liquid prepared by the water extraction and
filtration of the dried biomass of A. platensis (also known as
Spirulina platensis), an edible blue-green cyanobacterium. The
extraction and filtration remove oil, oil soluble substances, and
fibers. The color additive contains phycocyanins as the principal
coloring components, and consists of proteins, carbohydrates, and
minerals. Based on data and information provided in the petition on the
identity, physical and chemical properties, manufacturing process, and
composition of the color additive, we have determined that the color
additive meets the current specifications for spirulina extract in
Sec. 73.530 (Refs. 1 and 2). During the review of the petition, FDA
noted that the specifications for heavy metals could be lowered based
on the results of the petitioner's batch analyses, and a specification
for cadmium should be added. These modifications to the heavy metal
specifications would align with FDA's work to reduce dietary exposure
to contaminants. Therefore, in addition to expanding the use of
spirulina extract, the petitioner proposed to lower the heavy metal
specifications for lead (<=0.2 mg/kg), arsenic (<=0.3 mg/kg), and
mercury (<=0.1 mg/kg) that are currently in the regulation, and to add
a specification for cadmium (<=0.3 mg/kg).
There is no generally recognized as safe (GRAS) exception in the
definition of a color additive in section 201(t) of the FD&C Act (21
U.S.C. 321(t)), and, therefore, the intended use of a color additive
requires our approval. However, we note that spirulina-based
ingredients have been the subject of several GRAS notices (GRNs)
reviewed by FDA (discussed in 78 FR 49117 at 49118). (Under section
201(s) of the FD&C Act, a substance is GRAS, and excepted from the
definition of a food additive, if it is generally recognized, among
experts qualified by scientific training and experience to evaluate its
safety, to be safe under the conditions of its intended use.) In
particular, the spirulina substance that was the subject of GRN 000424
is similar in chemical composition to the subject color additive, with
phycocyanin content ranging from 42 to 47 percent (id.). If a substance
imparts color to a food, it may be subject to regulation as a color
additive even if its use is also considered GRAS.
III. Safety Evaluation
A. Determination of Safety
Under section 721(b) of the FD&C Act (21 U.S.C. 379e(b)), a color
additive may not be listed for a proposed use unless the data and other
information available to FDA establish that the color additive is safe
for that use. Our color additive regulations at 21 CFR 70.3(i) define
``safe'' to mean that there is convincing evidence establishing with
reasonable certainty that no harm will result from the intended use of
the color additive.
To determine whether a color additive is safe under the general
safety clause, the FD&C Act requires FDA to conduct a fair evaluation
of the available data and consider, among other relevant factors: (1)
probable consumption of, or other relevant exposure from, the additive
and of any substance formed in or on food, drugs, devices, or cosmetics
because of the use of the additive; (2) cumulative effect, if any, of
such additive in the diet of man or animals, taking into account
chemically or pharmacologically related substance or substances in such
diet; and (3) safety factors recognized by experts as appropriate for
the use of animal experimentation data (see section 721(b)(5)(A)(i)
through (iii) of the FD&C Act).
As part of our safety evaluation to establish with reasonable
certainty that a color additive is not harmful under its intended
conditions of use, we consider the additive's manufacturing and
stability, the projected human dietary exposure to the additive and any
impurities resulting from the petitioned use of the additive, the
additive's toxicological data, and other relevant information (such as
published literature) available to us. We compare the estimated dietary
exposure to the color additive from all sources to an acceptable daily
intake (ADI) level established by toxicological data. The dietary
exposure is estimated based on the amount of the color additive
proposed for use in particular foods or drugs and on data regarding the
amount consumed from all sources of the color additive. We commonly use
the dietary exposure for the 90th percentile consumer of a color
additive as a measure of high chronic dietary exposure.
B. Safety of the Petitioned Use of the Color Additive
During our safety review of this petition (CAP 4C0334), we
considered the estimated dietary exposure to
[[Page 5293]]
spirulina extract and c-phycocyanin (the main coloring component) from
the petitioned uses of the subject color additive. Specifically, the
petition sought to expand the intended uses of this color additive to
include all foods, except infant formula and certain foods subject to
regulation by the USDA (i.e., products subject to regulation by the
USDA under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the
Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg
Products Inspection Act (21 U.S.C. 1031 et seq.)). C-phycocyanin is the
predominant phycocyanin present in spirulina, although low levels of
allophycocyanin are also present; due to the predominance of c-
phycocyanin, the concentration of c-phycocyanin in spirulina extract is
assumed to represent all ``phycocyanins'' in spirulina. The petitioner
provided the eaters-only 90th percentile dietary exposure to spirulina
extract and c-phycocyanin from the petitioned uses for the U.S.
population aged 2 years and older, and various subpopulations.
The petitioner provided information on the proposed expanded food
uses of spirulina extract, including food categories in which spirulina
extract is intended to be used and the corresponding maximum use levels
that represent GMP for the petitioned uses (Ref. 2). The petitioner
used food consumption data from the combined 2015-2016 and 2017-2018
National Health and Nutrition Examination Survey (NHANES) to estimate
the dietary exposure to spirulina extract from the petitioned uses. The
petitioner estimated the eaters-only (i.e., only those individuals in
the population that consume the foods of interest) dietary exposure to
spirulina extract from the petitioned uses to be 6.3 grams/person/day
(g/p/d) at the mean and 14.1 g/p/d at the 90th percentile for the U.S.
population aged 2 years and older; and 5.1 g/p/d at the mean and 10.7
g/p/d at the 90th percentile for children aged 2-5 years (Ref. 2). We
independently confirmed the petitioner's dietary exposure using food
consumption data from the combined 2015-2016 and 2017-2018 NHANES and
concur with the petitioner's dietary exposure to spirulina extract
(Ref. 2).
The petitioner also estimated the eaters-only dietary exposure to
c-phycocyanin from the petitioned uses of spirulina extract to be 0.13
g/p/d at the mean and 0.28 g/p/d at the 90th percentile for the U.S.
population aged 2 years and older; and 0.1 g/p/d at the mean and 0.21
g/p/d at the 90th percentile for children aged 2-5 years (Ref. 2).
The petitioner did not provide an updated cumulative dietary
exposure estimate for c-phycocyanin in this petition. However, the
petitioner indicated that: (1) the overall maximum GMP use level in the
current petition is comparable to that in GRN 000424 on a c-phycocyanin
basis; GRN 000424 pertains to the use of a spirulina-based substance
similar in chemical composition to the subject color additive, but with
a higher phycocyanin content; GRN 000424 pertains to the intended use
in all foods (except infant formula and foods under the USDA's
jurisdiction) (i.e., products subject to regulation by the USDA under
the Federal Meat Inspection Act, the Poultry Products Inspection Act,
or the Egg Products Inspection Act) at levels consistent with GMP; (2)
the petitioner's spirulina extract would not be added to foods already
containing other sources of spirulina; (3) the number of servings in
the daily diet that could be colored with spirulina extract would
reasonably be well below the assumption of 50% of the daily servings in
the current cumulative dietary exposure of 1.14 g/p/d from the notified
GRAS uses of spirulina; and (4) the current cumulative dietary exposure
for c-phycocyanin is inclusive of the dietary exposure to c-phycocyanin
from the approved uses of spirulina extract as a color additive under
Sec. 73.530 as well as the expanded uses in the current petition. As
such, the petitioner concluded that the intended uses of spirulina
extract in this petition would be substitutional to other sources of
spirulina in foods (on a c-phycocyanin basis), and the dietary exposure
to c-phycocyanin from the petitioned uses would be subsumed by the
dietary exposure to c-phycocyanin from the uses in GRN 000424.
Therefore, the petitioned uses would not increase the current upper-
bound cumulative dietary exposure to c-phycocyanin of 1.14 g/p/d in GRN
000424. We concur with the petitioner's statement regarding the
cumulative dietary exposure to c-phycocyanin (Ref. 2).
To support the safety of the petitioned use of spirulina extract,
the petitioner referenced the safety determinations made by FDA for
spirulina extract in CAPs 2C0293 (78 FR 49117, August 13, 2013), 2C0297
(79 FR 20095, April 11, 2014), 4C0300 (80 FR 50762, August 21, 2015),
6C0306 (82 FR 30731, July 3, 2017), and 0C0316 (87 FR 67785, November
10, 2022). The petitioner also conducted an updated search of the peer-
reviewed scientific literature on spirulina and submitted the published
studies that they identified as being relevant to their petition. The
petitioner concluded that these publications did not reveal any
significant new toxicological effects and should not alter the
conclusion of FDA's previous reviews on spirulina.
FDA's most recent evaluation of the use of spirulina extract as a
color additive in alcoholic beverages with less than 20 percent
alcohol-by-volume content, non-alcoholic beverages, condiments and
sauces, dips, dairy product alternatives (non-dairy yogurt
alternatives, non-dairy frozen desserts, and non-dairy puddings), salad
dressings, and unheated seasoning mixes (87 FR 67785, November 10,
2022), included a comprehensive review of studies submitted by the
petitioner and a review of all available literature. From our
evaluation, we did not have any concerns regarding the safety of the
use of spirulina extract and its principal coloring components,
phycocyanins.
Of the publications submitted by the petitioner, some studies had
been previously reviewed by FDA (Ref. 3), including a chronic toxicity
study which identified a NOAEL (``No Observed Adverse Effect Level'')
of 15,000 mg/kg bw/d of spirulina powder. Our review of the new
information submitted by the petitioner, the information submitted in
previously reviewed publications, as well as our own independent
literature search and review of spirulina and phycocyanins, did not
reveal any safety concerns relating to spirulina or phycocyanins, nor
did it identify any information or data that would change the ADI of
1.8 g/p/d for phycocyanins (Ref. 3).
We discussed the potential allergenicity of spirulina phycocyanins
in our final rule for the use of spirulina extract as a color additive
in candy and chewing gum (78 FR 49117 at 49119, August 13, 2013). We
stated that, based on our review of a comparison of the known amino
acid sequences of c-phycocyanin, which is the predominant phycocyanin
present in spirulina (Ref. 2), with the sequences of known protein
allergens, there is a low probability that the spirulina c-phycocyanin
is a protein allergen. Additionally, while allophycocyanin is present
at very low levels in spirulina, we consider these levels and any
allergenicity risk to be negligible. Therefore, we concluded that
spirulina phycocyanins present an insignificant allergy risk to
consumers of the color additive. In addition, after a review of all
available literature relevant to the potential allergenicity of
spirulina, we have determined that while spirulina extract and
specifically c-phycocyanin are possible allergens for certain
individuals, reactivity is not
[[Page 5294]]
widespread and spirulina sensitization appears to be rare (Ref. 3).
Therefore, we continue to conclude that spirulina extract as a color
additive presents an insignificant allergy risk for the general
population (Ref. 3). We are not aware of any new information that would
cause us to change this conclusion.
Our review considered the safety data provided by the petitioner,
including our independent review of the current published literature,
which did not present evidence of safety concerns for spirulina extract
at the expected dietary exposures. Given that the upper-bound
cumulative dietary exposure estimate for c-phycocyanin of 1.14 g/p/d is
not expected to increase with the new petitioned uses, exposure remains
below the previously determined ADI for phycocyanins of 1.8 g/p/d.
Therefore, we conclude that spirulina extract is safe for the
petitioned uses (Refs. 2 and 3).
IV. Conclusion
Based on the data and information in the petition and other
available relevant information, we conclude that the petitioned use of
spirulina extract as a color additive at levels consistent with GMP (in
human foods generally except for infant formula and products subject to
regulation by the USDA under the Federal Meat Inspection Act, the
Poultry Products Inspection Act, or the Egg Products Inspection Act) is
safe.
We further conclude that this color additive will achieve its
intended technical effect and is suitable for the petitioned use.
Therefore, we are amending the color additive regulations in 21 CFR
part 73 to provide for the safe use of this color additive as set forth
in this document. In addition, based on the factors in 21 CFR 71.20(b)
and consistent with our conclusions in our earlier published approvals
of spirulina extract for petitioned uses, we continue to conclude that
batch certification of spirulina extract is not necessary to protect
the public health.
V. Public Disclosure
In accordance with Sec. 71.15 (21 CFR 71.15), the petition and the
documents that we considered and relied upon in reaching our decision
to approve the petition will be made available for public disclosure
(see FOR FURTHER INFORMATION CONTACT). As provided in Sec. 71.15, we
will delete from the documents any materials that are not available for
public disclosure.
VI. Analysis of Environmental Impact
We previously considered the environmental effects of this order,
as stated in the August 5, 2024, Federal Register notification of
petition for CAP 4C0334 (89 FR 63330 at 63331). The petitioner claimed
that this action is categorically excluded under Sec. 25.32(k) (21 CFR
25.32(k)) because the substance is intended to be added directly to
food, remain in food through ingestion by consumers, and is not
intended to replace macronutrients in food. We have not received any
new information or comments regarding this claim of categorical
exclusion. We considered the petitioner's claim of categorical
exclusion and determined that this action is categorically excluded
under Sec. 25.32(k) (Ref. 4). Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VII. Paperwork Reduction Act of 1995
This order contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VIII. Section 301(ll) of the FD&C Act
Our review of this petition was limited to section 721 of the FD&C
Act (21 U.S.C. 379e). This order is not a statement regarding
compliance with other sections of the FD&C Act. For example, section
301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction
or delivery for introduction into interstate commerce of any food that
contains a drug approved under section 505 of the FD&C Act (21 U.S.C.
355), a biological product licensed under section 351 of the Public
Health Service Act (42 U.S.C. 262), or a drug or biological product for
which substantial clinical investigations have been instituted and
their existence has been made public, unless one of the exemptions in
section 301(ll)(1) to (4) of the FD&C Act applies. In our review of
this petition, we did not consider whether section 301(ll) of the FD&C
Act or any of its exemptions apply to food containing this color
additive. Accordingly, this order should not be construed to be a
statement that a food containing this color additive, if introduced or
delivered for introduction into interstate commerce, would not violate
section 301(ll) of the FD&C Act. Furthermore, this language is included
in all color additive final orders that pertain to food and therefore
should not be construed to be a statement of the likelihood that
section 301(ll) of the FD&C Act applies.
IX. Objections
This order is effective as shown in the DATES section, except as to
any provisions that may be stayed by the filing of proper objections.
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Dockets Management Staff (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) to which you object, and
the grounds for your objection. Within each numbered objection, you
must specifically state whether you are requesting a hearing on the
particular provision that you specify in that numbered objection. If
you do not request a hearing for any particular objection, you waive
the right to a hearing on that objection. If you request a hearing,
your objection must include a detailed description and analysis of the
specific factual information you intend to present in support of the
objection in the event that a hearing is held. If you do not include
such a description and analysis for any particular objection, you waive
the right to a hearing on the objection.
Any objections received in response to the regulation may be seen
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.
X. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov.
1. Memorandum from N. Belai, Color Technology Branch, Division of
Color Certification and Technology, Office of Cosmetics and Colors,
Office of the Chief Scientist, FDA to M. Santos, Regulatory
Management Branch (RMB), Division of Food Ingredients (DFI), Office
of Pre-Market Additive Safety (OPMAS), Office of Food Chemical
Safety, Dietary Supplements, and Innovation (OFCSDSI), Human Foods
Program (HFP), FDA, February 3, 2026.
2. Memorandum from H. Lee, Chemistry Evaluation Branch, DFI, OPMAS,
OFCSDSI, HFP, FDA to M. Santos, RMB, DFI, OPMAS, OFCSDSI, HFP, FDA,
February 3, 2026.
3. Memorandum from R. Arechavala, Toxicology Review Branch, DFI,
OPMAS, OFCSDSI, HFP, FDA to M. Santos, RMB, DFI, OPMAS, OFCSDSI,
HFP, FDA, February 3, 2026.
4. Memorandum from A. Thompson-Woods, Environmental Review Team,
OPMAS, OFCSDSI, HFP, FDA to M. Santos, RMB,
[[Page 5295]]
DFI, OPMAS, OFCSDSI, HFP, FDA, February 3, 2026.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Foods, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
the authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 73 is amended as follows:
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
0
1. The authority citation for part 73 continues to read as follows:
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.
Sec. 73.530 [Amended]
0
2. Section 73.530 is amended by revising paragraphs (b) and (c) to read
as follows:
Sec. 73.530 Spirulina extract.
* * * * *
(b) Specifications. Spirulina extract must conform to the following
specifications and must be free from impurities, other than those
named, to the extent that such other impurities may be avoided by good
manufacturing practice:
(1) Lead, not more than 0.2 milligrams per kilogram (mg/kg) (0.2
parts per million (ppm));
(2) Arsenic, not more than 0.3 mg/kg (0.3 ppm);
(3) Mercury, not more than 0.1 mg/kg (0.1 ppm);
(4) Cadmium, not more than 0.3 mg/kg (0.3 ppm); and
(5) Negative for microcystin toxin.
(c) Uses and restrictions. Spirulina extract may be safely used for
coloring human foods generally at levels consistent with good
manufacturing practice, except that it may not be used to color
products that are subject to regulation by the U.S. Department of
Agriculture under the Federal Meat Inspection Act (21 U.S.C. 601 et
seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or
the Egg Products Inspection Act (21 U.S.C. 1031 et seq.); infant
formula; or foods for which standards of identity have been issued
under section 401 of the Federal Food, Drug, and Cosmetic Act, unless
the use of the added color is authorized by such standards.
* * * * *
Lowel M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-02314 Filed 2-5-26; 8:45 am]
BILLING CODE 4164-01-P