[Federal Register Volume 86, Number 168 (Thursday, September 2, 2021)]
[Rules and Regulations]
[Pages 49230-49234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-18995]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2018-C-4117]
Listing of Color Additives Exempt From Certification; Butterfly
Pea Flower Extract
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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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 an aqueous
extract of butterfly pea flower (Clitoria ternatea) as a color additive
in various food categories at levels consistent with good manufacturing
practice. We are taking this action in response to a color additive
petition (CAP) submitted by Exponent, Inc., on behalf of Sensient
Colors, LLC (Sensient).
DATES: This rule is effective October 5, 2021. See section X for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing on the
final rule by October 4, 2021.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. Electronic objections must be submitted on or before
October 4, 2021. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
October 4, 2021. Objections received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is 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-2018-C-4117 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 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://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: Stephen DiFranco, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740-3835, 240-402-2710.
SUPPLEMENTARY INFORMATION:
I. Introduction
In a notification published in the Federal Register of November 13,
2018 (83 FR 56258), we announced that we filed a color additive
petition (CAP 8C0313) submitted by Sensient Colors, LLC, c/o Exponent,
Inc., 1150 Connecticut Avenue NW, Suite 1100, Washington, DC 20036. 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 an aqueous extract of
butterfly pea flower (Clitoria ternatea) as a color
[[Page 49231]]
additive in: (1) Alcoholic beverages (liquor, liqueurs, and flavored
alcoholic beverages); \1\ (2) ready-to-drink non-alcoholic beverages;
(3) liquid coffee creamers (dairy and non[hyphen]dairy); (4) ice cream
and frozen dairy desserts; (5) fruit preparation in yogurt; (6) chewing
gum; (7) coated nuts; (8) hard candy; and (9) soft candy, at levels
consistent with good manufacturing practice (GMP).
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\1\ The proposed scope was subsequently amended to include all
alcoholic beverages.
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The petition describes butterfly pea flower extract as a dark blue
water-soluble extract derived from the flower petals of Clitoria
ternatea.
II. Background
The color additive that is 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. The extract also contains flavonols,
mainly quercetin and kaempferol derivatives as minor components. These
anthocyanins and flavonols are naturally present in various fruits and
vegetables commonly consumed in the U.S. diet (Ref. 1).
The color additive is manufactured by sourcing dried flowers of
Clitoria ternatea. An infusion is prepared by adding demineralized
water to the flower petals, which is separated from the plant mass via
filtration. The butterfly pea flower extract is further processed by
ultrafiltration to remove any residues of plant products greater than
2,500 daltons (Da). The extract is then concentrated to a standardized
liquid with an anthocyanin content of approximately 2 percent and
pasteurized. Citric acid may be added to control the pH of the extract
(Ref. 2).
The petitioner proposed specifications for butterfly pea flower
extract of less than 1 milligram per kilogram (mg/kg) (1 part per
million (ppm)) of arsenic, less than 1 mg/kg (1 ppm) of cadmium, less
than 1 mg/kg (1 ppm) of lead, and less than 1 mg/kg (1 ppm) of mercury,
and pH 3.75 0.75 in the butterfly pea flower extract. Upon
consideration of the data in the petition and other information
available to FDA, we amended the proposed specification for pH to not
less than 3.0 and not more than 4.5 at 25 [deg]C (Ref. 2).
The petitioner manufactures the extract starting with butterfly pea
flowers grown without the use of added pesticide substances. The
petition provides data to support its assertion that no detectable
levels of 340 substances commonly used as pesticide are found in the
finished extract. The flowers were analyzed using the California
Department of Food and Agriculture multi-residue pesticide analysis
(Ref. 3).
Currently, there are no residual pesticide tolerance levels for
Clitoria ternatea codified by the U.S. Environmental Protection Agency
in 40 CFR part 180. In cases where no tolerance levels are set, the
allowable residual pesticide levels that may remain on the raw
agricultural commodity are zero (40 CFR 180.5). Under section
402(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 342(a)(2)(B)), food is adulterated if it bears or contains
pesticide chemical residue that is unsafe within the meaning of section
408(a) of the FD&C Act (21 U.S.C. 346a(a)).
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 proposed 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 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 or 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) through (C) 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.
IV. Safety of Petitioned Use of the Color Additive
A. Exposure Estimate
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 each proposed food
use (Ref. 4). The petitioner used food consumption data from the 2011-
2014 National Health and Nutrition Examination Survey (NHANES) to
estimate exposure to butterfly pea flower extract from the proposed
uses. Upon further clarification of the proposed uses to include all
alcoholic beverages (Ref. 5), we amended the petitioner's exposure
estimate to include all alcoholic beverages (Ref. 4).
Using food consumption data from the 2011-2014 NHANES, we estimated
the eaters-only exposure to butterfly pea flower extract to be 198
milligrams per person per day (198 mg/p/d) at the mean and 453 mg/p/d
at the 90th percentile for the U.S. population aged 2 years and older
and 56 mg/p/d at the mean and 118 mg/p/d at the 90th percentile for
children 2 to 5 years of age (Ref. 4).
The petition indicated that butterfly pea flower extract could
contain up to 2 percent anthocyanins (by weight). Assuming a maximum of
2 percent, we estimated the dietary exposure to anthocyanins from the
proposed uses to be 4 mg/p/d at the mean and 9 mg/p/d at the 90th
percentile for the U.S. population 2 years of age and older (Ref. 4).
Because delphinidin was stated to be the principal anthocyanin in
butterfly pea flower extract, the exposure to anthocyanins represents
the exposure to delphinidin from the proposed uses of butterfly pea
flower extract.
Similarly, we estimated the dietary exposure to quercetin resulting
from the proposed uses of butterfly pea flower extract. The petition
indicates that butterfly pea flower contains approximately 3 percent
(by weight) of flavonols, which are comprised of various quercetin and
kaempferol derivatives. We conservatively presumed that all the
flavonols present in butterfly pea flower extract were present as
quercetin (see below) and estimated quercetin exposure to be 6 mg/p/d
at the mean and 14 mg/p/d at the 90th percentile for the U.S.
population 2 years of age and older (Ref. 4).
[[Page 49232]]
B. Toxicological Considerations
To establish that butterfly pea flower extract is safe for use as a
color additive for the proposed uses, the petitioner used a weight-of-
evidence approach based on: (1) Toxicological information about the
extract's major coloring component, delphinidin, including a 2013
European Food Safety Authority (EFSA) review of anthocyanins (Ref. 6);
(2) a 28-day subacute range finding feeding study in rats; (3) a 90-day
feeding study in rats; (4) a bacterial reverse mutation test and an in
vitro micronucleous test addressing possible mutagenicity and
genotoxicity of butterfly pea flower extract; (5) an in vivo somatic
mutation and recombination test conducted on the unprocessed butterfly
pea flower parts; (6) in vivo genotoxicity data from published
literature on anthothyanins (including delphinidin) and flavonol
components (Refs. 7 and 8); (7) clinical human studies of anthocyanins
(including delphinidin) and spray-dried butterfly pea flower extract;
(8) clinical studies of quercetin and kaempferol, the primary flavonols
present; (9) a proteomic assessment of butterfly pea flower extract
aimed at establishing that cyclotides found in the tissues of Clitoria
ternatea are not present in the butterfly pea flower extract; and (10)
an allergenicity assessment of butterfly pea flower extract.
We reviewed the oral toxicity studies and agree with the
petitioner's conclusions that the no observed adverse effect level in
the 90-day study is the highest dose tested (3,500 mg/kg/d of butterfly
pea flower extract), which is nearly 500-fold of the 90th percentile
daily exposure for U.S. population 2 years and older (Ref. 9). While
chronic studies were not provided by the petitioner nor available from
the published literature, we believe that chronic toxicity from the
intended use of butterfly pea flower extract is unlikely because: (1)
We did not identify any potential toxicity effects associated with the
use of either butterfly pea flower extract or its anthocyanins and
flavonol components from literature that warrant further chronic
toxicity studies (Refs. 9 and 10); (2) the systemic oral absorption of
anthocyanins and flavonols is generally low (Ref. 9); (3) there are
available human clinical studies indicating that the main anthocyanins
and flavonol components of butterfly pea flower extract are well
tolerated in humans (Ref. 9); and (4) anthocyanins and flavonols are
naturally present and widely distributed in many plants used as food,
and the exposures to anthocyanins and flavonols from the use of
butterfly pea flower extract were estimated to be comparable or lower
than the exposure from a typical diet (Ref. 11).
We also did not find any scientific data suggesting reproductive or
developmental toxicity; moreover, the genotoxicity studies demonstrate
that butterfly pea flower extract is non-mutagenic and non-genotoxic
(Ref. 9).
Based on the totality of evidence and a weight of evidence analysis
that considered the lack of overall genotoxicity, mode of action, and
the level of exposure, we conclude that butterfly pea flower extract is
not likely to pose a carcinogenic risk to humans at its intended use
levels (Refs. 9 and 10).
Among the available relevant clinical studies, one study of
butterfly pea flower extract indicated no acute adverse effect at doses
up to 2 grams per person. Other clinical studies, using either
anthocyanins or flavonols, suggested tolerance at doses much higher
than the exposure level from the consumption of butterfly pea flower
extract under the intended condition of use (Ref. 9).
The petitioner provided analytical evidence demonstrating that the
cyclotides identified in butterfly pea flower petals were not detected
in the butterfly pea flower extract. Therefore, there is no toxicity
concern for cyclotides from the consumption of the extract (Ref. 9).
Although 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, we note that butterfly pea flower extract
contains 8 to 12 percent protein by weight. To address the
allergenicity potential of butterfly pea flower extract, the petitioner
provided bioinformatic analyses of the 193 protein sequences of
Clitoria ternatea identified in the National Center for Biotechnology
Information protein database. These protein sequences were compared for
similarity with the known allergenic protein sequences collected in the
AllergenOnline database (Ref. 12). The analysis revealed five protein
sequence matches (defined as 35 percent or higher identity over an 80-
amino-acid sliding window); however, these proteins are expected to be
over 5,000 Da and not likely to pass through the 2,500 Da
ultrafiltration system used in the manufacturing process. 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. We agree with the petitioner that the totality of the
evidence supports the conclusion that it is extremely unlikely that the
proteins in butterfly pea flower extract could act as allergens (Ref.
9).
V. Conclusion
Based on the data and information in the petition and other
available relevant information, we conclude that the petitioned use of
butterfly pea flower extract as a color additive in: 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 is safe, provided the amount of
butterfly pea flower extract does not exceed levels consistent with
good manufacturing practice.
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 this color additive as set forth in this
document. In addition, based on the factors in 21 CFR 71.20(b), we
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 (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.
VII. Analysis of Environmental Impact
As stated in the November 13, 2018, Federal Register notification
of filing, 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 macronutrients in food. We further stated that if FDA
determines a categorical exclusion applies, neither an environmental
assessment nor an
[[Page 49233]]
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 Sec.
25.32(k). Therefore, neither an environmental assessment nor an
environmental impact statement is required.
VIII. Paperwork Reduction Act of 1995
This final rule 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 final rule 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 final rule 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 rules 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 rule 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.
XI. References
The following references marked with an asterisk (*) 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 also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. 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. *Wu, X., G. R. Beecher, J. M. Holden, et al.,
``Concentrations of Anthocyanins in Common Foods in the United
States and Estimation of Normal Consumption.'' Journal of
Agricultural and Food Chemistry, 54: 4069-4075, 2006.
2. *Memorandum from B. Petigara Harp, Color Technology Branch,
Division of Color Certification and Technology, Office of Cosmetics
and Colors, Center for Food Safety and Applied Nutrition (CFSAN),
FDA, to S. DiFranco, Division of Food Ingredients (DFI), Office of
Food Additive Safety (OFAS), CFSAN, FDA, June 4, 2021.
3. Lee, S. M., M. L. Papathakis, H-M. C. Feng, et al.,
``Multipesticide Residue Method for Fruits and Vegetables:
California Department of Food and Agriculture.'' Fresenius' Journal
of Analytical Chemistry, 339, 376-383, 1991.
4. *Memorandum from D. Doell, Chemistry Review Team, DFI, OFAS,
CFSAN, FDA, to S. DiFranco, DFI, OFAS, CFSAN, FDA, June 7, 2021.
5. *Memorandum of Teleconference from S. DiFranco, Regulatory
Review Team, DFI, OFAS, CFSAN, FDA, to the file, April 7, 2020.
6. *EFSA, ``Scientific Opinion on the Re-evaluation of
Anthocyanins (E163) as a Food Additive.'' EFSA Journal, 11(4): 3145,
2013.
7. *NTP, ``Toxicology and Carcinogenesis Studies of Quercetin
(CAS No. 117-39-5) in F344 Rats (Feed Studies).'' NTP Technical
Report Series, No. 409, 1992.
8. Hard, G. C., J. C. Seeley, L. J. Betz, et al., ``Re-
evaluation of the Kidney Tumors and Renal Histopathology Occurring
in a 2-Year Rat Carcinogenicity Bioassay of Quercetin.'' Food and
Chemical Toxicology, 45: 600-608, 2007.
9. *Memorandum from Y. Zang, Toxicology Review Team, DFI, OFAS,
CFSAN, FDA, to S. DiFranco, DFI, OFAS, CFSAN, FDA, June 9, 2021.
10. *Memorandum from S. Mog and S. Francke to Y. Zang. Pathology
Consultation Review on Renal Neoplasms in Male F344 rats from
National Toxicology Program Technical Report (NTP TR 409) on
Quercetin in F344/N Rats (feed studies), October 31, 2019.
11. *USDA. ``Table 1a. Flavonoids from Food and Beverages: Mean
Intake (standard error) per Individuals, by Gender and Age, in the
United States, What We Eat in America.'' NHANES 2007-2010, 2016.
12. Goodman R. E., M. Ebisawa, F. Ferreira, et al.,
``AllergenOnline: A Peer-reviewed, Curated Allergen Database to
Assess Novel Food Proteins for Potential Cross-reactivity.''
Molecular Nutrition and Food Research, 60(5):1183-1198, 2016.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Foods, Medical devices.
Therefore, 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. 73.69 to subpart A to read as follows:
Sec. 73.69 Butterfly pea flower extract.
(a) Identity. (1) The color additive butterfly pea flower extract
is a dark blue liquid prepared by the aqueous extraction of dried
butterfly pea flowers from Clitoria ternatea. The extract is further
processed by ultrafiltration to remove residues of plant products,
followed by concentration and pasteurization. Citric acid may be used
to control the pH. The color additive
[[Page 49234]]
contains anthocyanins as the principal coloring component.
(2) Color additive mixtures for food use made with butterfly pea
flower extract 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. Butterfly pea flower 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) pH, not less than 3.0 and not more than 4.5 at 25 [deg]C.
(2) Lead, not more than 1 milligram per kilogram (mg/kg) (1 part
per million (ppm)).
(3) Arsenic, not more than 1 mg/kg (1 ppm).
(4) Mercury, not more than 1 mg/kg (1 ppm).
(5) Cadmium, not more than 1 mg/kg (1 ppm).
(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, and soft candy in amounts
consistent with good manufacturing practice, 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,
unless the use of added color is authorized by such standards.
(d) Labeling requirements. The label of the color additive and 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 are exempt from the certification requirements of
section 721(c) of the Federal Food, Drug, and Cosmetic Act.
Dated: August 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18995 Filed 9-1-21; 8:45 am]
BILLING CODE 4164-01-P