[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]


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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.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
color additive regulations to provide for the safe use of 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.
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    \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.
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    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).
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    \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.
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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\
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    \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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    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