Rule2025-08248
Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract
Primary source
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Published
May 12, 2025
Effective
June 26, 2025
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 expanded safe use of butterfly pea flower extract as a color additive in ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) submitted by Sensient Colors, LLC (Sensient or petitioner).
Full Text
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<title>Federal Register, Volume 90 Issue 90 (Monday, May 12, 2025)</title>
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[Federal Register Volume 90, Number 90 (Monday, May 12, 2025)]
[Rules and Regulations]
[Pages 20101-20104]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08248]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2024-C-0971]
Listing of Color Additives Exempt From Certification; Butterfly
Pea Flower Extract
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 expanded safe use of
butterfly pea flower extract as a color additive in ready-to-eat
cereals, crackers, snack mixes, hard pretzels, plain potato chips
(restructured or baked), and plain corn chips, tortilla chips, and
multigrain chips at levels consistent with good manufacturing practice
(GMP). This action is in response to a color additive petition (CAP)
submitted by Sensient Colors, LLC (Sensient or petitioner).
DATES: This order is effective June 26, 2025. See section X 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
June 11, 2025.
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 June
11, 2025. 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:
<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-0971 for ``Listing of Color Additives Exempt from
Certification; Butterfly Pea Flower 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 <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 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 <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 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: Stephen DiFranco, Office of Food
Chemical Safety, Dietary Supplements, and Innovation, Human Foods
Program, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2710; or Philip Chao, 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 February 8, 2024 (89 FR 8537), we
announced that we filed a color additive petition (CAP 4C0328)
submitted by Exponent, Inc., on behalf of Sensient Colors, LLC, 1150
Connecticut Ave. NW, Suite 1100, Washington, DC 20036. The petition
proposed to amend the color additive regulations in part 73 (21 CFR
73.69), ``Listing of Color Additives Exempt from Certification'' to
provide for the expanded safe use of butterfly pea flower extract to
include ready-to-eat cereals, crackers, snack mixes, hard pretzels,
plain potato chips (restructured or baked), and plain corn chips,
tortilla chips, and multigrain chips, at levels consistent with GMP.
We note that the notification of filing stated that documents
related to this petition would be deposited in docket FDA-2018-C-4117.
This petition has been reassigned to a new docket, docket number FDA-
2024-C-0971. All relevant files from the previous docket
[[Page 20102]]
have been moved into docket number FDA-2024-C-0971.
This final order is expected to result in expanded production
options and is considered an E.O. 14192 deregulatory action.
II. Background
Butterfly pea flower extract is approved under Sec. 73.69 for
coloring alcoholic beverages, sport and energy drinks, flavored or
carbonated water, fruit drinks (including smoothies and grain drinks),
carbonated soft drinks (fruit-flavored or juice, ginger ale, and root
beer), fruit and vegetable juice, nutritional beverages, chewing gum,
teas, coated nuts, liquid coffee creamers (dairy and non-dairy), ice
cream and frozen dairy desserts, hard candy, dairy and non-dairy
drinks, fruit preparations in yogurts, and soft candy in amounts
consistent with GMP, except that it may not be used for coloring 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
added color is authorized by such standards. Butterfly pea flower
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 (86
FR 49230, September 2, 2021).
The color additive that is the subject of this petition is the dark
blue liquid produced through the water extraction of the dried flower
petals of Clitoria ternatea, commonly known as the butterfly pea plant.
Butterfly pea flower extract contains 42 to 62 percent water, 22 to 43
percent carbohydrates, and 8 to 12 percent proteins. The principal
coloring components in butterfly pea flower extract are anthocyanins,
mainly delphinidin derivatives (Ref. 1). The extract also contains
flavonols, mainly quercetin and kaempferol derivatives, as minor
components. Based on data and information provided in this petition
(CAP 4C0328) on the identity, physical and chemical properties,
manufacturing process, and composition of the color additive, we have
determined that the color additive meets the specifications for
butterfly pea flower extract in Sec. 73.69 (Ref. 1).
III. Safety Evaluation
A. Determination of Safety
Under section 721(b)(4) of the FD&C Act (21 U.S.C. 379e(b)(4)), a
color additive cannot be listed for a particular use unless the data
and 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 establish with reasonable certainty that a color additive
intended for use in food is not harmful under its intended conditions
of use, we consider the projected human dietary exposure to the color
additive, the additive's toxicological data, and other relevant
information (such as published literature) available to us. We compare
the estimated dietary exposure of the color additive from all sources
to an acceptable daily intake (ADI) level established by toxicological
data. The estimated dietary exposure is based on the amount of the
color additive proposed for use in particular foods and on data
regarding the amount consumed from all sources of the color additive.
We commonly use the estimated dietary exposure for the 90th percentile
consumer of a color additive as a measure of high chronic dietary
exposure.
B. Safety of Petitioned Use of the Color Additive
During our safety review of this petition (CAP 4C0328), we
considered the estimated dietary exposure to butterfly pea flower
extract, anthocyanins (the main coloring component), total flavonols,
and quercetin from the petitioned uses of the subject color additive
(Ref. 2). The petition provided the eaters-only 90th percentile dietary
exposure for butterfly pea flower extract for the petitioned uses for
the U.S. population aged 2 years and older, and various subpopulations.
From that dietary exposure and compositional information incorporated
by reference from CAP 8C0313, the petitioner also estimated the eaters-
only 90th percentile dietary exposure to anthocyanins, total flavonols,
and quercetin (Ref. 2).
The petitioner requested that butterfly pea flower extract be
permitted at levels consistent with GMP and provided the maximum use
levels for the color additive, representing GMP, for the petitioned and
approved food uses (Ref. 2). Using food consumption data from the 2015-
2018 National Health and Nutrition Examination Survey (NHANES), the
petitioner estimated the eaters-only cumulative dietary exposure to
butterfly pea flower extract to be 215 milligrams/person/day (mg/p/d)
at the mean and 467 mg/p/d at the 90th percentile for the U.S.
population aged 2 years and older and 94 mg/p/d at the mean and 183 mg/
p/d at the 90th percentile for children aged 2-5 years (Ref. 2).
Assuming a maximum content of 2% anthocyanins (the principal
coloring component) in butterfly pea flower extract, the petitioner
estimated the eaters-only cumulative dietary exposure to anthocyanins
to be 4.3 mg/p/d at the mean and 9.3 mg/p/d at the 90th percentile for
the U.S. population aged 2 years and older (Ref. 2). The petitioner
also indicated that the color additive could contain up to 3% flavonols
and assumed that 50% of the flavonol content was quercetin. Based on
these assumptions, the petitioner estimated the eaters-only cumulative
dietary exposure to flavonols (6.4 mg/p/d at the mean and 14 mg/p/d at
the 90th percentile) and to quercetin (3.2 mg/p/d at the mean and 7 mg/
p/d at the 90th percentile) for the U.S. population aged 2 years and
older (Ref. 2).
To support the safety of the petitioned uses of butterfly pea
flower extract, the petitioner referenced the safety determinations
made by FDA for CAP 8C0313 (86 FR 49230, September 2, 2021). The
petitioner also conducted an updated search of the peer-reviewed
scientific literature on butterfly pea flower extract and Hibiscus
sabdariffa flower extract (a known source of anthocyanins with a high
content of delphinidin), as well as on other sources of anthocyanins
and delphinidins. The petitioner concluded that these publications did
not reveal any significant new toxicological effects and should not
alter the conclusions of FDA's previous reviews on butterfly pea flower
extract. Of the publications submitted by the petitioner, some studies
had been previously reviewed by FDA. Our review of the new information,
the information submitted in previously reviewed publications, as well
as our own independent literature search and review did not reveal any
safety concerns relating to the consumption of butterfly pea flower
extract or its major components (Ref. 3).
In our most recent evaluation of the use of butterfly pea flower
extract as a color additive in various foods (86 FR 49230, September 2,
2021), we did not have any concerns regarding the safety of the use of
butterfly pea flower extract and its principal coloring components,
anthocyanins and delphinidins. This finding was based on a weight-of-
evidence approach and agreed with the petitioner's conclusion that the
no observed adverse effect level (NOAEL) in the submitted 90-day study
was the highest dose tested (3,500 mg/kg/d of butterfly pea flower
extract), which is nearly 500-fold of the estimated 90th
[[Page 20103]]
percentile dietary exposure for the U.S. population aged 2 years and
older from the originally petitioned uses. To establish a reasonable
certainty of no harm for the petitioned expanded uses of butterfly pea
flower extract, we compared the cumulative estimated dietary exposure
to the article of commerce and its constituents in the current petition
to that of the previous petition, as well as to the petitioner's NOAEL
from their previous 90-day study to develop a margin of exposure (MOE)
(Ref. 3). Based on the slight increase in the estimated dietary
exposure to butterfly pea flower extract and its constituents resulting
from the petitioned expanded uses in this petition above those seen in
the previous petition, and the high MOE between the observed NOAEL, we
conclude that these new uses of the color additive are reasonably safe
under the intended conditions of use (Ref. 3).
We discussed the potential allergenicity of butterfly pea flower
extract in our previous approval of a petition for its use in various
foods (86 FR 49230, September 2, 2021). We stated that there is no
evidence in the scientific literature specifically suggesting that
either Clitoria ternatea flowers or the coloring component delphinidin
is associated with allergic or hypersensitive reactions. The petitioner
submitted an updated search of the peer-reviewed scientific literature
and found no new additional publications which suggested an
allergenicity concern. Further, to mitigate the possible risk that
allergenic proteins and other large peptides might pose, our regulation
at 21 CFR 73.69(a)(1) requires that the aqueous extract used to produce
the color additive undergo ultrafiltration. Therefore, we concluded
that butterfly pea flower extract presents an insignificant allergy
risk to consumers of the color additive (Ref. 4).
V. Conclusion
Based on the data and information in the petition, the referenced
material, and other relevant material, we conclude that the petitioned
use of butterfly pea flower extract as a color additive in ready-to-eat
cereals, crackers, snack mixes, hard pretzels, plain potato chips
(restructured or baked), and plain corn chips, tortilla chips, and
multigrain chips, at levels consistent with GMP is safe. We further
conclude that the color additive will achieve its intended technical
effect and is suitable for the petitioned uses. Therefore, we are
amending the color additive regulations in 21 CFR part 73 as set forth
in this document. In addition, based upon the factors listed in 21 CFR
71.20(b), we continue to conclude that batch certification of butterfly
pea flower extract is not necessary to protect the public health.
VI. 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.
VII. Analysis of Environmental Impact
As stated in the February 8, 2024, Federal Register notification of
filing for CAP 4C0328, the petitioner claimed that this action is
categorically excluded under Sec. 25.32(k) (21 CFR 25.32(k)) because
butterfly pea flower extract would be added directly to food and is
intended to remain in the food through ingestion by consumers and is
not intended to replace nutrients in food (89 FR 8537 at 8538). We
further stated that, if FDA determines a categorical exclusion applies,
neither an environmental assessment nor an environmental impact
statement is required (id.). 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 Sec. 25.32(k). Therefore,
neither an environmental assessment nor an environmental impact
statement is required.
VIII. 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.
IX. 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) through (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
orders authorizing new uses of color additives 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.
X. 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.
XI. 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://
[[Page 20104]]
www.regulations.gov. FDA has verified the website addresses, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
1. Memorandum from B. Petigara-Harp, Color Technology Branch,
Division of Color Certification and Technology, Office of Cosmetics
and Colors (OCAC), Office of Commissioner, Office of Chief
Scientist, FDA to S. DiFranco, Regulatory Management Branch (RMB),
Division of Food Ingredients (DFI), Office of Pre-market Additive
Safety (OPMAS), HFP, FDA, April 21, 2025.
2. Memorandum from H. Thapa, Chemistry Evaluation Branch, DFI,
OPMAS, HFP, FDA to S. DiFranco, RMB, DFI, OPMAS, HFP, FDA, April 21,
2025.
3. Memorandum from T. Thurmond, Toxicology Review Branch (TRB), DFI,
OPMAS, HFP, FDA to S. DiFranco, RMB, DFI, OPMAS, HFP, FDA, April 21,
2025.
4. Memorandum from Y. Zang, Toxicology Review Team, DFI, Office of
Food Additive Safety (OFAS), Center for Food and Human Nutrition
(CFSAN), FDA, to S. DiFranco, DFI, OFAS, CFSAN, FDA, June 9, 2021.
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 the 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. Section 73.69 is amended by revising paragraph (c) to read as
follows:
Sec. 73.69 Butterfly pea flower extract.
* * * * *
(c) Uses and restrictions. Butterfly pea flower extract may be
safely used for coloring alcoholic beverages, sport and energy drinks,
flavored or carbonated water, fruit drinks (including smoothies and
grain drinks), carbonated soft drinks (fruit-flavored or juice, ginger
ale, and root beer), fruit and vegetable juice, nutritional beverages,
chewing gum, teas, coated nuts, liquid coffee creamers (dairy and non-
dairy), ice cream and frozen dairy desserts, hard candy, dairy and non-
dairy drinks, fruit preparations in yogurts, soft candy, ready-to-eat
cereals, crackers, snack mixes, hard pretzels, plain potato chips
(restructured or baked), and plain corn chips, tortilla chips, and
multigrain chips. Amounts must be consistent with good manufacturing
practice. Butterfly pea flower extract may not be used for coloring
foods for which standards of identity have been issued under section
401 of the Federal Food, Drug, and Cosmetic Act, unless the use of
added color is authorized by such standards.
* * * * *
Dated: May 6, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08248 Filed 5-9-25; 8:45 am]
BILLING CODE 4164-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.