Rule2026-02313
Listing of Color Additives Exempt From Certification; Beetroot Red
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
February 6, 2026
Effective
March 23, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of beetroot red for the coloring of human foods generally, at levels consistent with current good manufacturing practice, except in products under the jurisdiction of the United States Department of Agriculture (USDA), infant formula, or 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. We are taking this action in response to a color additive petition (CAP) submitted by Phytolon, Ltd. (Phytolon or petitioner).
Full Text
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<title>Federal Register, Volume 91 Issue 25 (Friday, February 6, 2026)</title>
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[Federal Register Volume 91, Number 25 (Friday, February 6, 2026)]
[Rules and Regulations]
[Pages 5295-5299]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-02313]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2024-C-1085]
Listing of Color Additives Exempt From Certification; Beetroot
Red
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; order.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the safe use of beetroot red
for the coloring of human foods generally, at levels consistent with
current good manufacturing practice, except in products under the
jurisdiction of the United States Department of Agriculture (USDA),
infant formula, or 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. We are taking this action in response to a color additive
petition (CAP) submitted by Phytolon, Ltd. (Phytolon or petitioner).
DATES: This order is effective March 23, 2026. See section XI for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing on the
order 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system
will accept comments 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 comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-1085 for ``Listing of Color Additives Exempt From
Certification; Beetroot Red.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 its 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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
[[Page 5296]]
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper 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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Christopher Kampmeyer, Office of Pre-
Market Additive Safety, Human Foods Program, Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1255;
or Meadow Platt, 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:
I. Introduction
In the Federal Register of March 12, 2024 (89 FR 17789), we
announced that we filed a color additive petition (CAP 4C0326)
submitted by Phytolon, Ltd., Ha-Tsmikha St, Yokne'am Illit, Israel. The
petition proposed 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, except in products under the jurisdiction of
the USDA, in infant formula, and foods for which standards of identity
have been promulgated under section 401 of the FD&C Act unless added
color is authorized by such standards.
II. Background
Beetroot red is a reddish-purple liquid or powder produced by
fermentation using a modified strain of the yeast, Saccharomyces
cerevisiae (S. cerevisiae), expressing the genes for betanin
biosynthesis from red beets (Beta vulgaris L. var. rubra). The
principal coloring component in beetroot red is betanin (CAS Reg. No.
7659-95-2). Betanin is a type of betacyanin, which in turn is a type of
betalain. Betalains are a class of water-soluble pigments present
primarily in red beets and in plants belonging to the order,
Caryophyllales (e.g., quinoa, spinach, amaranths, and others).
Betalains are divided into two subclasses: betacyanins (reddish to
violet, including betanin) and betaxanthins (yellow to orange).
Beetroot red contains a similar betacyanin pigment composition to
dehydrated beets (21 CFR 73.40).
The color additive is manufactured by the following steps: (1)
construction of the S. cerevisiae production strain that is genetically
engineered to express the genes involved in the biosynthesis of
betanin; (2) expression of betanin product via controlled fermentation
by the S. cerevisiae production strain; (3) removal of the production
organism from the fermentation broth; and (4) water evaporation to
produce the liquid form of the product and optional drying to produce a
powder form of the product.
The petitioner proposed the following specifications for beetroot
red: total betacyanin, not less than 0.6 percent by weight; betanin
purity, not less than 75 percent of the total betacyanin; total
betacyanin other than betanin, not more than 20 percent; lead, not more
than 0.15 milligram per kilogram (mg/kg); arsenic, not more than 0.05
mg/kg; mercury, not more than 0.01 mg/kg; cadmium, not more than 0.05
mg/kg. FDA concluded that the petitioner's proposed specifications for
total betacyanin, betanin purity, and total betacyanin other than
betanin are not needed in the codified regulation (Ref. 1).
III. Safety Evaluation
Under section 721(b)(4) of the FD&C Act (21 U.S.C. 379e(b)(4)), a
color additive may not be listed for a particular 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.
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 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.
IV. Safety of the Petitioned Use of the Color Additive
A. Dietary Exposure Estimate
The petitioner requested that beetroot red be permitted at levels
consistent with current good manufacturing practice and provided the
representative maximum use levels for the proposed uses of the color
additive. The petitioner used food consumption data from the 2017-2018
National Health and Nutrition Examination Survey (NHANES) to estimate
the dietary exposure to betanin from the proposed use of beetroot red.
The petitioner stated that the use of the color additive would be
substitutional for current food uses of beetroot powder (21 CFR 73.40),
and therefore, the proposed use of the color additive will not increase
the current dietary exposure to betanin in the diet.
The petitioner estimated the eaters-only (that is, only those
individuals in the population who consume the foods of interest)
dietary exposure to betanin, the principal coloring component, from the
intended uses of beetroot red (Ref. 2). However, FDA noted that the
petitioner did not provide an estimate of dietary exposure to the
powder or liquid forms of beetroot red. Therefore, we conducted our own
estimate of dietary exposure to betanin and beetroot red. In addition,
the petitioner included food codes for meat and poultry in the dietary
exposure estimate and indicated that removal of these food codes would
not impact the dietary exposure estimate because beetroot red is
proposed for uses in plant-based meat analog products, and due to the
limited availability of plant-based meat codes, the petitioner used the
comminuted meat and poultry product food codes as surrogates. We noted
that NHANES contains food codes for meat substitutes and, therefore,
including the surrogate food codes is not necessary.
We estimated the dietary exposure to betanin from the use of
beetroot red using 2-day food consumption data from the 2015-2020
NHANES for food and dietary supplements to be 27 mg/person/day (mg/p/d)
at the mean and 53 mg/p/d at the 90th percentile for the U.S.
population aged 2 years and older and 19 mg/p/d at the mean and 37 mg/
p/d at the 90th percentile for children aged 2 to 5 years.
Additionally, using the average total betacyanin and percent betanin
from betacyanins, we estimated the dietary exposure to beetroot red
powder and liquid forms to be 1.8 gram (g)/p/d and 4.4 g/p/d at the
mean, respectively and 3.7 g/p/d and 8.9 g/p/d at the 90th percentile,
respectively, for the U.S. population aged 2 years and older and 1.3 g/
p/d and 3.2 g/p/d at the
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mean, respectively and 2.5 g/p/d and 6.1 g/p/d at the 90th percentile,
respectively, for children aged 2-5 years (Ref. 2).
B. Toxicological Considerations
To establish that beetroot red is safe for use as a color additive,
the petitioner used a weight-of-evidence approach based on the
following: (1) the history of widespread and safe consumption of
betalains, including the betacyanin, betanin; (2) the results of safety
studies conducted with beetroot red as the test article; and (3) an
allergenicity assessment of protein sequences introduced into the
production strain.
Betanin, as part of beetroot red, is a natural dietary constituent,
and FDA acknowledges the long history of safe consumption of betanin
from existing dietary sources, including red beetroot and purple dragon
fruit (Ref. 3). In 1967, FDA published a regulation authorizing the use
of dehydrated beets (beet powder) (21 CFR 73.40), which contains
betanin, but we did not specify a maximum daily intake because no
significant safety concerns existed. Furthermore, FDA acknowledges that
S. cerevisiae has a prior history of safe use in a variety of food
applications, and we conclude the S. cerevisiae strain developed by the
petitioner for the production of beetroot red is non-toxicogenic and
non-pathogenic (Ref. 3).
We reviewed the mutagenicity and genotoxicity studies (a bacterial
reverse mutation assay, an in vitro mammalian chromosome aberration
assay, an in vitro mammalian cell micronucleus assay, an in vivo
mammalian erythrocyte Pig-a gene mutation assay, and an in vivo
mutagenicity assessment using duplex sequencing in liver, stomach, and
intestine tissues collected from a Pig-a gene mutation assay) using
beetroot red as a test article (id.). We agree with the petitioner that
beetroot red is not mutagenic or genotoxic under the experimental
procedures and conditions applied.
We reviewed the subchronic (90-day) toxicity study in rats using
beetroot red as a test article (id.). The no-observed-adverse-effect-
levels (NOAELs) established in this study are 3,581 mg beetroot red/kg
body weight (bw)/d in male rats and 4,055 mg beetroot red/kg bw/d in
female rats, the highest dose tested (id.).
We consider the subchronic toxicity study on betanin-enriched
beetroot red in rats to provide an important new set of data that
corroborates the existing safety information for beetroot red (see
id.). The petitioner states that the beetroot color test article used
in the subchronic toxicity study was specifically manufactured to
include pigment at the highest concentration possible (approximately
4.5% of betanin) to maximize the margin of exposure for the safety
assessment (see id.).
In its assessment of the allergenicity of beetroot red, the
petitioner examined the incidence of beetroot allergy in consumers and
conducted bioinformatic analyses to determine if protein sequences
introduced into the production strain share significant identity with
the protein sequences of known allergens (see id.). The petitioner
identified several reports of allergic reactions associated with
consumption of beetroot but concluded there is no evidence that
betalains are associated with these cases of allergic reactions (see
id.). The petitioner did not identify known allergens sharing
significant sequence identity with the introduced protein sequences,
and we independently verified the results of the allergenicity
assessment (see id.). We agree with the petitioner that there is no
evidence of allergenic potential of the introduced protein sequences.
Based on the weight of evidence, such as the long history of
consumption of beetroot and its color components, including betanin,
the safety of orally administered betanin-enriched beetroot red in the
subchronic rat study, and the lack of evidence of allergenic potential
of introduced protein sequences, we conclude that beetroot red is safe
for the petitioned uses (id.).
V. Comments
We received one comment in response to FDA's filing of the beetroot
red color additive petition. The commenter requested that we decline to
name the color additive ``beetroot red'' or any similar name using the
term ``beetroot'' because the color additive is not derived from
beetroot. The commenter further requested that the color additive be
named ``betanin.'' After consideration of the comment, we are listing
this color additive as ``beetroot red'' because (1) the color additive
is expressed by genes from red beets (Beta vulgaris L. var. rubra), and
we consider the phrase ``beetroot red'' appropriately descriptive of
the identity of the color additive; and (2) while the color additive
contains betanin as its principal coloring component, the color
additive is composed of other pigments and non-pigment constituents (as
discussed previously in II. Background), and therefore the color
additive would not accurately be identified solely as ``betanin.''
VI. Conclusion
Based on the data and information in the petition and other
available relevant information, we conclude that the petitioned use of
beetroot red is safe for use as a color additive in foods generally and
at levels consistent with current good manufacturing practices, except
that it may not be used to color products under the jurisdiction of the
USDA, infant formula, and foods for which standards of identity have
been promulgated under section 401 of the FD&C Act unless added color
is authorized by such standards.
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 part 73 to
provide for the safe use of beetroot red as set forth in this document.
In addition, based on the factors in 21 CFR 71.20(b), we conclude that
batch certification of beetroot red is not necessary to protect the
public health.
VII. Public Disclosure
In accordance with Sec. 71.15(a) (21 CFR 71.15(a)), 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(b), we will delete from the documents any materials that are not
available for public disclosure.
VIII. Analysis of Environmental Impact
As stated in the March 12, 2024, Federal Register notification of
petition for CAP 4C0326, the petitioner claimed that this action is
categorically excluded under 21 CFR 25.32(r) because it 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. We stated that, if FDA determines a categorical
exclusion applies, neither an environmental assessment nor an
environmental impact statement is required. We did not receive 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 21 CFR
25.32(r) (Ref. 4). Therefore, neither an environmental assessment nor
an environmental impact statement is required.
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IX. 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.
X. Section 301(ll) of the FD&C Act
Our review of this petition was limited to section 721 of the FD&C
Act. 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 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.
XI. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.
XII. 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 <a href="https://regulations.gov">https://regulations.gov</a>.
1. Memorandum from B. Petigara, Division of Color Certification and
Technology, Color Technology Branch, Office of Cosmetics and Colors,
Office of the Chief Scientist, FDA to C. Kampmeyer, 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 2, 2026.
2. Memorandum from T. Todorov, Chemistry Evaluation Branch, DFI,
OPMAS, OFCSDSI, HFP, FDA to C. Kampmeyer, DFI, OPMAS, OFCSDSI, HFP,
FDA, February 2, 2026.
3. Memorandum from A. Khan, Toxicology Evaluation Branch, DFI,
OPMAS, OFCSDSI, HFP, FDA to C. Kampmeyer, DFI, OPMAS, OFCSDSI, HFP,
FDA, February 2, 2026.
4. Memorandum from D. Wafula, Environmental Review Team, OPMAS, HFP,
FDA to C. Kampmeyer, DFI, OMPAS, OFCSDSI, HFP, FDA, February 2,
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.
0
2. Add Sec. 73.39 to subpart A to read as follows:
Sec. 73.39 Beetroot red.
(a) Identity. (1) The color additive beetroot red is a powder or
liquid prepared from controlled fermentation of a non-pathogenic and
non-toxicogenic strain of the yeast, Saccharomyces cerevisiae,
genetically engineered to express genes from Caryophyllales sp. (e.g.,
Beta vulgaris L. var. rubra) involved in the synthesis of betanin. The
product is further processed by filtration. Betanin is the principal
coloring component of the color additive and imparts a reddish-purple
color.
(2) Color additive mixtures made with beetroot red may contain only
those diluents that are suitable and are listed in this subpart as safe
for use in color additive mixtures for coloring foods.
(b) Specifications. Beetroot red must conform to the following
specifications and must be free from impurities, other than those
named, to the extent that such impurities may be avoided by good
manufacturing practice:
(1) Lead, not more than 0.15 milligrams per kilogram (mg/kg) (0.15
part per million (ppm));
(2) Arsenic, not more than 0.05 mg/kg (0.05 ppm);
(3) Mercury, not more than 0.01 mg/kg (0.01 ppm); and
(4) Cadmium, not more than 0.05 mg/kg (0.05 ppm).
(c) Uses and restrictions. Beetroot red may be safely used for
coloring human foods generally, in amounts consistent with good
manufacturing practice, except that it may not be used to color
products that are subject to regulation by the United States 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.
(d) Labeling. The label of the color additive and of any mixtures
prepared therefrom intended solely or in part for coloring purposes
must conform to the requirements of Sec. 70.25 of this chapter.
(e) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health, and
therefore batches of the color additive are exempt from the
certification requirements of section
[[Page 5299]]
721(c) of the Federal Food, Drug, and Cosmetic Act.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2026-02313 Filed 2-5-26; 8:45 am]
BILLING CODE 4164-01-P
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