75490 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Rules and Regulations 

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). 

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) Domestic VOR Federal 

Airways. 

* * * * * 

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. 

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 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Rules and Regulations 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 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 

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 


lotter on DSK11XQN23PROD with RULES1
75492 Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Rules and Regulations 

1The 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. 

2The 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) × 0.364 = 1,127 mg/kg bw/d. 

3The 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. 

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). 

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 

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). 

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 


lotter on DSK11XQN23PROD with RULES1
Federal Register / Vol. 88, No. 212 / Friday, November 3, 2023 / Rules and Regulations 75493 

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. 

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 

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 

■ 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. 


lotter on DSK11XQN23PROD with RULES1
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: 

§ 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 

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 

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 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Publication of Web General 

Licenses. 

SUMMARY: 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: 

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 

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. 

OFFICE OF FOREIGN ASSETS 

CONTROL 

Nicaragua Sanctions Regulations 

31 CFR Part 582 

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 


lotter on DSK11XQN23PROD with RULES1