Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue, 75490-75494 [2023-24352]
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Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Rules and Regulations
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Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that only affects air traffic
procedures and air navigation, it is
certified that this rule, when
promulgated, does not have a significant
economic impact on a substantial
number of small entities under the
criteria of the Regulatory Flexibility Act.
Environmental Review
The FAA has determined that this
action of amending VOR Federal
airways V–158 and V–172, due to the
planned decommissioning of the VOR
portion of the Polo, IL, VOR/DME
NAVAID, qualifies for categorical
exclusion under the National
Environmental Policy Act (42 U.S.C.
4321 et seq.) and its implementing
regulations at 40 CFR part 1500, and in
accordance with FAA Order 1050.1F,
Environmental Impacts: Policies and
Procedures, paragraph 5–6.5a, which
categorically excludes from further
environmental impact review
rulemaking actions that designate or
modify classes of airspace areas,
airways, routes, and reporting points
(see 14 CFR part 71, Designation of
Class A, B, C, D, and E Airspace Areas;
Air Traffic Service Routes; and
Reporting Points); and paragraph 5–6.5i,
which categorically excludes from
further environmental impact review
the establishment of new or revised air
traffic control procedures conducted at
3,000 feet or more above ground level
(AGL); procedures conducted below
3,000 feet AGL that do not cause traffic
to be routinely routed over noise
sensitive areas; modifications to
currently approved procedures
conducted below 3,000 feet AGL that do
not significantly increase noise over
noise sensitive areas; and increases in
minimum altitudes and landing
minima. As such, this action is not
expected to result in any potentially
significant environmental impacts. In
accordance with FAA Order 1050.1F,
paragraph 5–2 regarding Extraordinary
Circumstances, the FAA has reviewed
this action for factors and circumstances
in which a normally categorically
excluded action may have a significant
environmental impact requiring further
analysis. The FAA has determined that
no extraordinary circumstances exist
that warrant preparation of an
environmental assessment or
environmental impact study.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
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The Amendment
In consideration of the foregoing, the
Federal Aviation Administration
amends 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order JO 7400.11H,
Airspace Designations and Reporting
Points, dated August 11, 2023, and
effective September 15, 2023, is
amended as follows:
■
Paragraph 6010(a)
Airways.
*
*
*
Domestic VOR Federal
*
Electronic Submissions
*
V–158 [Amended]
From Mason City, IA; INT Mason City 106°
and Dubuque, IA, 293° radials; to Dubuque.
*
*
*
*
*
V–172 [Amended]
From Columbus, NE; Omaha, IA; INT
Omaha 066° and Newton, IA, 262° radials;
Newton; to Cedar Rapids, IA.
*
*
*
*
*
Issued in Washington, DC.
Karen L. Chiodini,
Acting Manager, Rules and Regulations
Group.
[FR Doc. 2023–24078 Filed 11–2–23; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA–2020–C–2131]
Listing of Color Additives Exempt
From Certification; Jagua (GenipinGlycine) Blue
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or we) is
amending the color additive regulations
to provide for the safe use of jagua
(genipin-glycine) blue as a color
additive in various food categories at
levels consistent with good
SUMMARY:
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manufacturing practice (GMP). We are
taking this action in response to a color
additive petition (CAP) submitted by
Exponent, Inc. on behalf of Ecoflora
SAS (Ecoflora).
DATES: This rule is effective December 4,
2023. See section X for further
information on the filing of objections.
Either electronic or written objections
and requests for a hearing on the final
rule must be submitted by December 4,
2023.
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 comments
until 11:59 p.m. Eastern Time at the end
of December 4, 2023. Objections
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are received
on or before that date.
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 Submisisons
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
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Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Rules and Regulations
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–
2020–C–2131 for ‘‘Listing of Color
Additives Exempt from Certification;
Jagua (Genipin-Glycine) Blue.’’ 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-201509-18/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:
Shayla West-Barnette, Center for Food
Safety and Applied Nutrition, Food and
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Drug Administration, 5001 Campus Dr.,
College Park, MD 20740–3835, 240–
402–1262.
SUPPLEMENTARY INFORMATION:
I. Introduction
In a notification published in the
Federal Register on November 20, 2020
(85 FR 74304), we announced that we
filed a color additive petition (CAP
0C0317) submitted by Ecoflora SAS,
c/o Exponent, Inc., 1150 Connecticut
Ave. 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 jagua
(genipin-glycine) blue, derived from the
pulp of the unripe jagua fruit (Genipa
americana), as a color additive at levels
consistent with GMP in flavored milk;
dairy drinks and substitutes; dairy and
dairy alternative yogurt; ice cream,
frozen dairy and dairy alternative
desserts, puddings, gelatins, ices,
sorbets; ready-to-eat multicolored
cereals; flavored potato chips, tortilla,
corn, and other chips; candy and
chewing gum; non-alcoholic fruit based/
flavored drinks, nutritional beverages
and smoothies; flavored cream cheesebased spreads; and icings, frostings,
jams, syrups, and fruit toppings and
fillings.
II. Background
The color additive that is the subject
of this petition is a dark blue liquid or
powder produced by reacting genipin
(CAS Reg. No. 6902–77–8) in the juice
of the unripe fruit of Genipa americana
with an equivalent amount of the amino
acid glycine (CAS Reg. No. 56–40–6)
using mild heat. The principal coloring
component in jagua (genipin-glycine)
blue is a genipin-glycine polymer (CAS
Reg. No. 1314879–21–4) consisting of
repeating dimeric units containing two
genipin moieties reacted to add glycine
units as side chains. We will
subsequently refer to this principal
coloring component as ‘‘the polymer.’’
Iridoids, of which genipin is an
example, are found in a wide variety of
plants, and glycine is a common
building block of proteins. The color
additive jagua (genipin-glycine) blue
also contains three dimers as minor
coloring components (CAS Reg. No.
1313734–13–2, CAS Reg. No. 104359–
67–3, and CAS Reg. No. 1313734–14–3)
that are structural units of the polymer.
The petitioner proposed the following
specifications for jagua (genipin-glycine)
blue: appearance, dark blue; color value
(E10 percent), 240–280 for the powder
form and 120–240 for the liquid form;
polymer, 20 to 40 percent for the
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powder form and 10 to 35 percent for
the liquid form; aflatoxins (B1, B2, G1,
and G2), not more than 0.01 milligram
per kilogram (mg/kg); fumonisine (B1,
B2), not more than 0.5 mg/kg;
Escherichia coli, negative in 1 gram (g);
aerobic plate count, not more than 1,000
colony forming units per gram (cfu/g);
yeast and mold, not more than 300 cfu/
g, and Staphylococcus aureus, negative
in 1 g.
FDA amended the proposed
specifications to add the following:
arsenic, not more than 1 mg/kg;
cadmium, not more than 1 mg/kg;
mercury, not more than 1 mg/kg; and
lead, not more than 1 mg/kg (Ref. 1). We
also amended the proposed
specification for genipin, not more than
20 mg/kg, to be consistent with the
petitioner’s analytical results.
Furthermore, we concluded that the
petitioner’s proposed specifications for
appearance, color value, polymer,
glycine, the minor coloring components,
carbohydrate, modified starch, total fat,
total protein, and ash content are not
needed in the codified regulation (Ref.
1).
III. Safety Evaluation
Under section 721(b)(4) of the Federal
Food, Drug, and Cosmetic Act (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, 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
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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 the Petitioned Use of the
Color Additive
A. Dietary Exposure Estimate
The petitioner requested that jagua
(genipin-glycine) blue be permitted at
levels consistent with GMP and
provided the representative maximum
use levels for the color additive for each
proposed food use. The petitioner used
food consumption data from the 2013–
2016 National Health and Nutrition
Examination Survey (NHANES) to
estimate the dietary exposure to jagua
(genipin-glycine) blue and to the
polymer from the proposed uses. The
petitioner stated that the use of the
liquid form of jagua (genipin-glycine)
blue would be substitutional for the
powder form and that, on the polymer
basis, the use levels are the same for
both forms.
The petitioner estimated the eatersonly (i.e., only those individuals in the
population that consume the foods of
interest) dietary exposure to jagua
(genipin-glycine) blue to be 34 mg/
person/day (mg/p/d) at the mean and 78
mg/p/d at the 90th percentile for the
U.S. population aged 2 years and older,
and 34 mg/p/d at the mean and 76 mg/
p/d at the 90th percentile for children
aged 2 to 5 years.
The petitioner provided a
specification limit of 20 to 40 percent
for the polymer in jagua (genipinglycine) blue powder. We estimated the
eaters-only dietary exposure to the
polymer to be 14 mg/p/d at the mean
and 31 mg/p/d at the 90th percentile for
the U.S. population aged 2 years and
older, and 14 mg/p/d at the mean and
30 mg/p/d at the 90th percentile for
children aged 2 to 5 years (Ref. 2).
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B. Toxicological Considerations
To establish that jagua (genipinglycine) blue is safe for consumption at
the proposed levels, the petitioner used
aqueous jagua (genipin-glycine) blue
containing a specified percentage of the
polymer to conduct the following
studies: (1) bacterial reverse mutation
assay, mouse lymphoma assay, and in
vitro mouse micronucleus assay
addressing potential mutagenicity and
genotoxicity of the polymer; (2) studies
conducted in rats to address the
potential toxic effects of acute oral
exposure to the polymer; (3) 28-day oral
toxicity studies in rats and beagle dogs
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and 90-day repeated dose oral toxicity
studies in rats and beagle dogs to
address the potential toxic effects of
subchronic oral exposure to the
polymer; and (4) 12 months repeated
dose toxicity study including in utero
exposure in rats to address the potential
toxic and/or reproductive effects of
chronic oral exposure to the polymer.1
FDA searched the publicly available
literature to identify any new studies
that might have examined toxicological
effects of jagua (genipin-glycine) blue, or
genipin or related compounds; however,
no relevant studies were found.
We reviewed the mutagenicity and
genotoxicity studies (a bacterial reverse
mutation assay, an in vitro mouse
lymphoma, and an in vivo mammalian
micronucleus induction assay) and
concluded that the polymer is not
mutagenic or genotoxic under the
experimental procedures and conditions
applied (Ref. 3).
We reviewed the acute oral toxicity
studies and concluded that the oral
median lethal dose is greater than 661
mg/kg body weight (bw) of the polymer
for the female rats used in the study
(Ref. 3).
We reviewed the 28-day studies
conducted in rats and in beagle dogs
and consider these only as range-finding
studies due to the limited number of
animals tested per group and other
study limitations, and thus not
appropriate to establish a no-observedeffect-level (NOEL) or no-observedadverse-effect-level (NOAEL). We
reviewed the 90-day repeated dose oral
toxicity study conducted in rats and
concur with the study authors that the
NOAEL for the rats under the conditions
of the study was 330.5 mg/kg bw/d of
the polymer for both sexes of the rats.
We also reviewed the 90-day repeated
dose oral toxicity study in dogs;
however, due to the low number of dogs
tested per group, and other inadequacies
and limitations in the experimental
design, we concluded that a NOAEL for
the polymer could not be established
from this study (Ref. 3).
We reviewed the 12-months repeated
dose toxicity study including in utero
exposure in rats. The lowest of all the
NOAELs for F0 (parental) generation
male rats was 1,127 mg/kg bw/d of
polymer 2 (Ref. 3).
1 The polymer content of the test material used
for toxicological studies varied slightly from batch
to batch; therefore, the toxicological evaluation of
studies and the resulting safety conclusions were
based on the polymer content of the batch used.
2 The NOAEL of the polymer (1,127 mg/kg bw/d)
was derived from the NOAEL of the test material
(3,094.7 mg/kg bw/d) used in the study. The
polymer content of this test material was 36.4
percent. The NOAEL of the polymer (1,127 mg/kg
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The study chosen to establish an
acceptable daily intake (ADI) for the
polymer was the 12 months repeated
dose toxicity study including in utero
exposure to rats over the 90-day study
in rats. This study combined the in
utero phase and a 1-year chronic
toxicity phase of sufficient length and
overall complexity to produce
information on chronic exposure to the
polymer. Based on the NOAEL of the
polymer (1,127 mg/kg bw/d)) in the 12
months repeated dose toxicity study in
rats including in utero exposure, and
applying a safety factor of 500 (10 to
account for possible increased
sensitivity of humans compared to test
animals, 10 to account for sensitive
individuals in determining safe intake
for humans, and 5 for the lack of
metabolism and pharmacokinetics and
long-term chronic study), the ADI for
the polymer is calculated as follows:
1,127 mg/kg bw/d (NOAEL)/500 = 2.3
mg/kg bw/d or 138 mg/p/d (based upon
60 kg bw/p) (Ref. 3).3
The petitioner estimated the highest
dietary exposure (37 mg/p/d at 90th
percentile based on the polymer) for
children aged 6–12 years as well as
adolescents aged 13–18 years. The
highest estimated dietary exposure
value of 37 mg/p/d at the 90th
percentile based on the polymer is
lower than the ADI value of 138 mg/p/
d polymer.
Therefore, we conclude that the
proposed use of jagua (genipin-glycine)
blue as a color additive at levels
consistent with GMP is considered to
have reasonable certainty of no harm
(Ref. 3).
V. Conclusion
Based on the data and information in
the petition and other available relevant
information, we conclude that the
petitioned use of jagua (genipin-glycine)
blue as a color additive in flavored milk;
dairy drinks and substitutes; dairy and
dairy alternative yogurt; ice cream,
frozen dairy and dairy alternative
desserts, puddings, gelatins, ices,
sorbets; ready-to-eat multicolored
cereals, flavored potato chips, tortilla,
corn, and other chips; candy and
chewing gum; non-alcoholic fruit based/
flavored drinks, nutritional beverages
bw/d) = NOAEL of the test material (3,094.7 mg/kg
bw/d) × 0.364 = 1,127 mg/kg bw/d.
3 The Joint Expert Committee on Food Additives
(2020) (Ref. 4) evaluated the 12 months repeated
dose toxicity study including in utero exposure in
rats with jagua (genipin-glycine) blue and reported
that the dietary exposure of jagua (genipin-glycine)
blue did not produce any treatment-related effects
in this study. Therefore, the committee identified a
NOAEL of 3,094.7 mg/kg bw/d (1,127 mg/kg bw/d
based on 36.4 percent polymer content) and no
effects observed in F0 parental male rats.
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and smoothies; flavored cream cheesebased spreads; and icings, frostings,
jams, syrups, and fruit toppings and
fillings, provided the amount of jagua
(genipin-glycine) blue does not exceed
levels consistent with GMP.
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 jagua (genipinglycine) blue is not necessary to protect
the public health.
VI. Public Disclosure
In accordance with § 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
§ 71.15, we will delete from the
documents any materials that are not
available for public disclosure.
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VII. Analysis of Environmental Impact
As stated in the November 20, 2020,
Federal Register notice of filing, the
petitioner claimed that this action is
categorically excluded under § 25.32(k)
(21 CFR 25.32(k)) because jagua
(genipin-glycine) blue 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
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 § 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
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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
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75493
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. *Memorandum from N. Belai, Division of
Color Certification and Technology,
Office of Cosmetics and Colors, Color
Technology Branch to Division of Food
Ingredients, Office of Food Additive
Safety, Regulatory Review Branch, Team
1, Attention: Shayla West-Barnette,
August 16, 2023.
2. *Memorandum from R. Kolanos, Division
of Food Ingredients, Chemistry Review
Group 2, Office of Food Additive Safety
to Division of Food Ingredients,
Regulatory Review Group 2, Attention: S.
West-Barnette, August 7, 2023.
3. *Memorandum from Abu T. Khan, Office
of Food Additive Safety, Division of
Food Ingredients, to Mical Honigfort,
Regulatory Review Branch, Office of
Food Additive Safety, Division of Food
Ingredients, August 16, 2023.
4. Food Agriculture Organization of the
United Nations (FAO)/World Health
Organization (WHO) Joint Expert
Committee on Food Additives, Summary
and Conclusions of Virtual Meeting,
issued on July 10, 2020.
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
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.
E:\FR\FM\03NOR1.SGM
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75494
Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Rules and Regulations
2. Add § 73.225 to subchapter A to
read as follows:
■
lotter on DSK11XQN23PROD with RULES1
§ 73.225
Jagua (genipin-glycine) blue.
(a) Identity. (1) The color additive
jagua (genipin-glycine) blue is a dark
blue powder or liquid prepared from the
juice of the unripe fruit of Genipa
americana by reacting the genipin in the
juice with glycine using mild heat. The
color additive contains a polymer as the
principal coloring component and three
dimers as minor coloring components.
(2) Color additive mixtures for food
use made with jagua (genipin-glycine)
blue 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. Jagua (genipinglycine) blue 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) Arsenic, not more than 1
milligram/kilogram (mg/kg) (1 part per
million (ppm)).
(2) Cadmium, not more than 1 mg/kg
(1 ppm).
(3) Lead, not more than 1 mg/kg (1
ppm).
(4) Mercury, not more than 1 mg/kg (1
ppm).
(5) Genipin, not more than 20 mg/kg
(20 ppm).
(c) Uses and restrictions. Jagua
(genipin-glycine) blue may be safely
used for coloring flavored milk; dairy
drinks and substitutes; dairy and dairy
alternative yogurt; ice cream, frozen
dairy and dairy alternative desserts,
puddings, gelatins, ices, sorbets; readyto-eat multicolored cereals; flavored
potato chips, tortilla, corn, and other
chips; candy and chewing gum; nonalcoholic fruit based/flavored drinks,
nutritional beverages and smoothies;
flavored cream cheese-based spreads;
and icings, frostings, jams, syrups, and
fruit toppings and fillings at levels
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 § 70.25
of this chapter.
(e) Exemption from certification.
Certification of this color additive is not
necessary for the protection of the
VerDate Sep<11>2014
16:19 Nov 02, 2023
Jkt 262001
public health and therefore batches
thereof are exempt from the certification
requirements of section 721(c) of the
Federal Food, Drug, and Cosmetic Act.
Dated: October 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
and was later incorporated into the NSR
(85 FR 43436). Each GL was made
available on OFAC’s website (https://
ofac.treasury.gov) when it was issued.
The text of GLs 1, 2, and 2A is provided
below.
[FR Doc. 2023–24352 Filed 11–2–23; 8:45 am]
OFFICE OF FOREIGN ASSETS
CONTROL
BILLING CODE 4164–01–P
Nicaragua Sanctions Regulations
31 CFR Part 582
DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
31 CFR Part 582
Publication of Nicaragua Sanctions
Regulations Web General Licenses 1,
2, and 2A
Office of Foreign Assets
Control, Treasury.
ACTION: Publication of Web General
Licenses.
AGENCY:
The Department of the
Treasury’s Office of Foreign Assets
Control (OFAC) is publishing three
general licenses (GLs) issued pursuant
to the Nicaragua Sanctions Regulations:
GLs 1, 2, and 2A, each of which was
previously made available on OFAC’s
website.
DATES: GLs 1 and 2 were issued on
March 5, 2020. See SUPPLEMENTARY
INFORMATION for additional relevant
dates.
FOR FURTHER INFORMATION CONTACT:
OFAC: Assistant Director for Licensing,
202–622–2480; Assistant Director for
Regulatory Affairs, 202–622–4855; or
Assistant Director for Compliance, 202–
622–2490.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Electronic Availability
This document and additional
information concerning OFAC are
available on OFAC’s website: https://
ofac.treasury.gov.
Background
On March 5, 2020, OFAC issued GLs
1 and 2 to authorize certain transactions
otherwise prohibited by the Nicaragua
Sanctions Regulations, 31 CFR part 582
(NSR). On March 25, 2020, OFAC issued
GL 2A, which superseded GL 2,
pursuant to the NSR and the Nicaragua
Investment Conditionality Act of 2018
(50 U.S.C. 1701 note) (NICA Act),
previously known as the ‘‘Nicaragua
Human Rights and Anticorruption Act
of 2018.’’ GL 2A expired on May 6,
2020. Also on March 25, 2020, OFAC
issued GL 1A pursuant to the NSR and
the NICA Act; GL 1A superseded GL 1
PO 00000
Frm 00018
Fmt 4700
Sfmt 4700
GENERAL LICENSE NO. 1
Official Business of the United States
Government
(a) Except as provided in paragraph
(b) of this general license, all
transactions that are for the conduct of
the official business of the United States
Government by employees, grantees, or
contractors thereof are authorized.
(b) This general license does not
authorize any transaction that is
prohibited by any part of 31 CFR
chapter V other than part 582.
Andrea Gacki,
Director, Office of Foreign Assets Control
Dated: March 5, 2020.
OFFICE OF FOREIGN ASSETS
CONTROL
Nicaragua Sanctions Regulations
31 CFR Part 582
GENERAL LICENSE NO. 2
Authorizing the Wind Down of
Transactions Involving the Nicaraguan
National Police
(a) Except as provided in paragraph
(b) of this general license, all
transactions and activities prohibited by
the Nicaragua Sanctions Regulations, 31
CFR part 582 (the NSR), that are
ordinarily incident and necessary to the
wind down of transactions involving the
Nicaraguan National Police (NNP), or
any entity in which the NNP owns,
directly or indirectly, a 50 percent or
greater interest, including the
processing of salary payments from the
NNP, or any entity in which the NNP
owns, directly or indirectly, a 50
percent or greater interest, to its
employees, are authorized through
12:01 a.m. eastern daylight time, May 6,
2020.
(b) This general license does not
authorize:
(1) Any debit to an account of the
NNP, or any entity in which the NNP
owns, directly or indirectly, a 50
percent or greater interest, on the books
of a U.S. financial institution; or
(2) Any transactions or activities
prohibited by any part of 31 CFR
chapter V other than the NSR, or any
transactions or activities with any
blocked person other than the blocked
E:\FR\FM\03NOR1.SGM
03NOR1
]]>Agencies
[Federal Register Volume 88, Number 212 (Friday, November 3, 2023)]
[Rules and Regulations]
[Pages 75490-75494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-24352]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2020-C-2131]
Listing of Color Additives Exempt From Certification; Jagua
(Genipin-Glycine) Blue
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the safe use of jagua
(genipin-glycine) blue as a color additive in various food categories
at levels consistent with good manufacturing practice (GMP). We are
taking this action in response to a color additive petition (CAP)
submitted by Exponent, Inc. on behalf of Ecoflora SAS (Ecoflora).
DATES: This rule is effective December 4, 2023. See section X for
further information on the filing of objections. Either electronic or
written objections and requests for a hearing on the final rule must be
submitted by December 4, 2023.
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 comments until 11:59 p.m. Eastern Time at the end of
December 4, 2023. 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 Submisisons
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
[[Page 75491]]
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-2020-C-2131 for ``Listing of Color Additives Exempt from
Certification; Jagua (Genipin-Glycine) Blue.'' 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: Shayla West-Barnette, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740-3835, 240-402-1262.
SUPPLEMENTARY INFORMATION:
I. Introduction
In a notification published in the Federal Register on November 20,
2020 (85 FR 74304), we announced that we filed a color additive
petition (CAP 0C0317) submitted by Ecoflora SAS, c/o Exponent, Inc.,
1150 Connecticut Ave. 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 jagua (genipin-glycine)
blue, derived from the pulp of the unripe jagua fruit (Genipa
americana), as a color additive at levels consistent with GMP in
flavored milk; dairy drinks and substitutes; dairy and dairy
alternative yogurt; ice cream, frozen dairy and dairy alternative
desserts, puddings, gelatins, ices, sorbets; ready-to-eat multicolored
cereals; flavored potato chips, tortilla, corn, and other chips; candy
and chewing gum; non-alcoholic fruit based/flavored drinks, nutritional
beverages and smoothies; flavored cream cheese-based spreads; and
icings, frostings, jams, syrups, and fruit toppings and fillings.
II. Background
The color additive that is the subject of this petition is a dark
blue liquid or powder produced by reacting genipin (CAS Reg. No. 6902-
77-8) in the juice of the unripe fruit of Genipa americana with an
equivalent amount of the amino acid glycine (CAS Reg. No. 56-40-6)
using mild heat. The principal coloring component in jagua (genipin-
glycine) blue is a genipin-glycine polymer (CAS Reg. No. 1314879-21-4)
consisting of repeating dimeric units containing two genipin moieties
reacted to add glycine units as side chains. We will subsequently refer
to this principal coloring component as ``the polymer.'' Iridoids, of
which genipin is an example, are found in a wide variety of plants, and
glycine is a common building block of proteins. The color additive
jagua (genipin-glycine) blue also contains three dimers as minor
coloring components (CAS Reg. No. 1313734-13-2, CAS Reg. No. 104359-67-
3, and CAS Reg. No. 1313734-14-3) that are structural units of the
polymer.
The petitioner proposed the following specifications for jagua
(genipin-glycine) blue: appearance, dark blue; color value (E10
percent), 240-280 for the powder form and 120-240 for the liquid form;
polymer, 20 to 40 percent for the powder form and 10 to 35 percent for
the liquid form; aflatoxins (B1, B2, G1, and G2), not more than 0.01
milligram per kilogram (mg/kg); fumonisine (B1, B2), not more than 0.5
mg/kg; Escherichia coli, negative in 1 gram (g); aerobic plate count,
not more than 1,000 colony forming units per gram (cfu/g); yeast and
mold, not more than 300 cfu/g, and Staphylococcus aureus, negative in 1
g.
FDA amended the proposed specifications to add the following:
arsenic, not more than 1 mg/kg; cadmium, not more than 1 mg/kg;
mercury, not more than 1 mg/kg; and lead, not more than 1 mg/kg (Ref.
1). We also amended the proposed specification for genipin, not more
than 20 mg/kg, to be consistent with the petitioner's analytical
results. Furthermore, we concluded that the petitioner's proposed
specifications for appearance, color value, polymer, glycine, the minor
coloring components, carbohydrate, modified starch, total fat, total
protein, and ash content are not needed in the codified regulation
(Ref. 1).
III. Safety Evaluation
Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act
(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, 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
[[Page 75492]]
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 the Petitioned Use of the Color Additive
A. Dietary Exposure Estimate
The petitioner requested that jagua (genipin-glycine) blue be
permitted at levels consistent with GMP and provided the representative
maximum use levels for the color additive for each proposed food use.
The petitioner used food consumption data from the 2013-2016 National
Health and Nutrition Examination Survey (NHANES) to estimate the
dietary exposure to jagua (genipin-glycine) blue and to the polymer
from the proposed uses. The petitioner stated that the use of the
liquid form of jagua (genipin-glycine) blue would be substitutional for
the powder form and that, on the polymer basis, the use levels are the
same for both forms.
The petitioner estimated the eaters-only (i.e., only those
individuals in the population that consume the foods of interest)
dietary exposure to jagua (genipin-glycine) blue to be 34 mg/person/day
(mg/p/d) at the mean and 78 mg/p/d at the 90th percentile for the U.S.
population aged 2 years and older, and 34 mg/p/d at the mean and 76 mg/
p/d at the 90th percentile for children aged 2 to 5 years.
The petitioner provided a specification limit of 20 to 40 percent
for the polymer in jagua (genipin-glycine) blue powder. We estimated
the eaters-only dietary exposure to the polymer to be 14 mg/p/d at the
mean and 31 mg/p/d at the 90th percentile for the U.S. population aged
2 years and older, and 14 mg/p/d at the mean and 30 mg/p/d at the 90th
percentile for children aged 2 to 5 years (Ref. 2).
B. Toxicological Considerations
To establish that jagua (genipin-glycine) blue is safe for
consumption at the proposed levels, the petitioner used aqueous jagua
(genipin-glycine) blue containing a specified percentage of the polymer
to conduct the following studies: (1) bacterial reverse mutation assay,
mouse lymphoma assay, and in vitro mouse micronucleus assay addressing
potential mutagenicity and genotoxicity of the polymer; (2) studies
conducted in rats to address the potential toxic effects of acute oral
exposure to the polymer; (3) 28-day oral toxicity studies in rats and
beagle dogs and 90-day repeated dose oral toxicity studies in rats and
beagle dogs to address the potential toxic effects of subchronic oral
exposure to the polymer; and (4) 12 months repeated dose toxicity study
including in utero exposure in rats to address the potential toxic and/
or reproductive effects of chronic oral exposure to the polymer.\1\ FDA
searched the publicly available literature to identify any new studies
that might have examined toxicological effects of jagua (genipin-
glycine) blue, or genipin or related compounds; however, no relevant
studies were found.
---------------------------------------------------------------------------
\1\ The polymer content of the test material used for
toxicological studies varied slightly from batch to batch;
therefore, the toxicological evaluation of studies and the resulting
safety conclusions were based on the polymer content of the batch
used.
---------------------------------------------------------------------------
We reviewed the mutagenicity and genotoxicity studies (a bacterial
reverse mutation assay, an in vitro mouse lymphoma, and an in vivo
mammalian micronucleus induction assay) and concluded that the polymer
is not mutagenic or genotoxic under the experimental procedures and
conditions applied (Ref. 3).
We reviewed the acute oral toxicity studies and concluded that the
oral median lethal dose is greater than 661 mg/kg body weight (bw) of
the polymer for the female rats used in the study (Ref. 3).
We reviewed the 28-day studies conducted in rats and in beagle dogs
and consider these only as range-finding studies due to the limited
number of animals tested per group and other study limitations, and
thus not appropriate to establish a no-observed-effect-level (NOEL) or
no-observed-adverse-effect-level (NOAEL). We reviewed the 90-day
repeated dose oral toxicity study conducted in rats and concur with the
study authors that the NOAEL for the rats under the conditions of the
study was 330.5 mg/kg bw/d of the polymer for both sexes of the rats.
We also reviewed the 90-day repeated dose oral toxicity study in dogs;
however, due to the low number of dogs tested per group, and other
inadequacies and limitations in the experimental design, we concluded
that a NOAEL for the polymer could not be established from this study
(Ref. 3).
We reviewed the 12-months repeated dose toxicity study including in
utero exposure in rats. The lowest of all the NOAELs for F0
(parental) generation male rats was 1,127 mg/kg bw/d of polymer \2\
(Ref. 3).
---------------------------------------------------------------------------
\2\ The NOAEL of the polymer (1,127 mg/kg bw/d) was derived from
the NOAEL of the test material (3,094.7 mg/kg bw/d) used in the
study. The polymer content of this test material was 36.4 percent.
The NOAEL of the polymer (1,127 mg/kg bw/d) = NOAEL of the test
material (3,094.7 mg/kg bw/d) x 0.364 = 1,127 mg/kg bw/d.
---------------------------------------------------------------------------
The study chosen to establish an acceptable daily intake (ADI) for
the polymer was the 12 months repeated dose toxicity study including in
utero exposure to rats over the 90-day study in rats. This study
combined the in utero phase and a 1-year chronic toxicity phase of
sufficient length and overall complexity to produce information on
chronic exposure to the polymer. Based on the NOAEL of the polymer
(1,127 mg/kg bw/d)) in the 12 months repeated dose toxicity study in
rats including in utero exposure, and applying a safety factor of 500
(10 to account for possible increased sensitivity of humans compared to
test animals, 10 to account for sensitive individuals in determining
safe intake for humans, and 5 for the lack of metabolism and
pharmacokinetics and long-term chronic study), the ADI for the polymer
is calculated as follows: 1,127 mg/kg bw/d (NOAEL)/500 = 2.3 mg/kg bw/d
or 138 mg/p/d (based upon 60 kg bw/p) (Ref. 3).\3\
---------------------------------------------------------------------------
\3\ The Joint Expert Committee on Food Additives (2020) (Ref. 4)
evaluated the 12 months repeated dose toxicity study including in
utero exposure in rats with jagua (genipin-glycine) blue and
reported that the dietary exposure of jagua (genipin-glycine) blue
did not produce any treatment-related effects in this study.
Therefore, the committee identified a NOAEL of 3,094.7 mg/kg bw/d
(1,127 mg/kg bw/d based on 36.4 percent polymer content) and no
effects observed in F0 parental male rats.
---------------------------------------------------------------------------
The petitioner estimated the highest dietary exposure (37 mg/p/d at
90th percentile based on the polymer) for children aged 6-12 years as
well as adolescents aged 13-18 years. The highest estimated dietary
exposure value of 37 mg/p/d at the 90th percentile based on the polymer
is lower than the ADI value of 138 mg/p/d polymer.
Therefore, we conclude that the proposed use of jagua (genipin-
glycine) blue as a color additive at levels consistent with GMP is
considered to have reasonable certainty of no harm (Ref. 3).
V. Conclusion
Based on the data and information in the petition and other
available relevant information, we conclude that the petitioned use of
jagua (genipin-glycine) blue as a color additive in flavored milk;
dairy drinks and substitutes; dairy and dairy alternative yogurt; ice
cream, frozen dairy and dairy alternative desserts, puddings, gelatins,
ices, sorbets; ready-to-eat multicolored cereals, flavored potato
chips, tortilla, corn, and other chips; candy and chewing gum; non-
alcoholic fruit based/flavored drinks, nutritional beverages
[[Page 75493]]
and smoothies; flavored cream cheese-based spreads; and icings,
frostings, jams, syrups, and fruit toppings and fillings, provided the
amount of jagua (genipin-glycine) blue does not exceed levels
consistent with GMP.
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 jagua (genipin-glycine) blue 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 20, 2020, Federal Register notice of
filing, the petitioner claimed that this action is categorically
excluded under Sec. 25.32(k) (21 CFR 25.32(k)) because jagua (genipin-
glycine) blue 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 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. *Memorandum from N. Belai, Division of Color Certification and
Technology, Office of Cosmetics and Colors, Color Technology Branch
to Division of Food Ingredients, Office of Food Additive Safety,
Regulatory Review Branch, Team 1, Attention: Shayla West-Barnette,
August 16, 2023.
2. *Memorandum from R. Kolanos, Division of Food Ingredients,
Chemistry Review Group 2, Office of Food Additive Safety to Division
of Food Ingredients, Regulatory Review Group 2, Attention: S. West-
Barnette, August 7, 2023.
3. *Memorandum from Abu T. Khan, Office of Food Additive Safety,
Division of Food Ingredients, to Mical Honigfort, Regulatory Review
Branch, Office of Food Additive Safety, Division of Food
Ingredients, August 16, 2023.
4. Food Agriculture Organization of the United Nations (FAO)/World
Health Organization (WHO) Joint Expert Committee on Food Additives,
Summary and Conclusions of Virtual Meeting, issued on July 10, 2020.
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.
[[Page 75494]]
0
2. Add Sec. 73.225 to subchapter A to read as follows:
Sec. 73.225 Jagua (genipin-glycine) blue.
(a) Identity. (1) The color additive jagua (genipin-glycine) blue
is a dark blue powder or liquid prepared from the juice of the unripe
fruit of Genipa americana by reacting the genipin in the juice with
glycine using mild heat. The color additive contains a polymer as the
principal coloring component and three dimers as minor coloring
components.
(2) Color additive mixtures for food use made with jagua (genipin-
glycine) blue 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. Jagua (genipin-glycine) blue 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) Arsenic, not more than 1 milligram/kilogram (mg/kg) (1 part per
million (ppm)).
(2) Cadmium, not more than 1 mg/kg (1 ppm).
(3) Lead, not more than 1 mg/kg (1 ppm).
(4) Mercury, not more than 1 mg/kg (1 ppm).
(5) Genipin, not more than 20 mg/kg (20 ppm).
(c) Uses and restrictions. Jagua (genipin-glycine) blue may be
safely used for coloring flavored milk; dairy drinks and substitutes;
dairy and dairy alternative yogurt; ice cream, frozen dairy and dairy
alternative desserts, puddings, gelatins, ices, sorbets; ready-to-eat
multicolored cereals; flavored potato chips, tortilla, corn, and other
chips; candy and chewing gum; non-alcoholic fruit based/flavored
drinks, nutritional beverages and smoothies; flavored cream cheese-
based spreads; and icings, frostings, jams, syrups, and fruit toppings
and fillings at levels 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 thereof are exempt from the certification
requirements of section 721(c) of the Federal Food, Drug, and Cosmetic
Act.
Dated: October 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24352 Filed 11-2-23; 8:45 am]
BILLING CODE 4164-01-P
