Document ID: FDA-2018-C-0617-0006
Agency: fda
Document Type: Rule
Title: Listing of Color Additives Exempt From Certification; Silver Nitrate
Posted Date: 2021-10-06T04:00Z

[Federal Register Volume 86, Number 191 (Wednesday, October 6, 2021)]
[Rules and Regulations]
[Pages 55494-55498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21755]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2018-C-0617]

Listing of Color Additives Exempt From Certification; Silver 
Nitrate

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 silver 
nitrate as a color additive in professional-use only cosmetics to color 
eyebrows and eyelashes. This action is in response to a color additive 
petition (CAP) filed by GW Cosmetics GmbH.

DATES: This rule is effective November 8, 2021. See section VIII for 
further information on the filing of objections. Submit either 
electronic or written objections and requests for a hearing on the 
final rule by November 5, 2021.

ADDRESSES: You may submit objections and requests for a hearing as 
follows. Please note that late, untimely filed objections will not be 
considered.

[[Page 55495]]

Electronic objections must be submitted on or before November 5, 2021. 
The https://www.regulations.gov electronic filing system will accept 
comments until 11:59 p.m. Eastern Time at the end of November 5, 2021. 
Objections received by mail/hand delivery/courier (for written/paper 
submissions) will be considered timely if they are postmarked or the 
delivery service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your objection, that information will be 
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets 
Management Staff, FDA will post your objection, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-C-0617 for ``Listing of Color Additives Exempt from 
Certification; Silver Nitrate.'' 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: Rachel Morissette, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740-3835, 240-402-1212.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of March 7, 2018 (83 
FR 9715), we announced that we filed a color additive petition (CAP 
8C0312) submitted by GW Cosmetics GmbH (GW), c/o EAS Consulting Group, 
LLC, 1700 Diagonal Rd., Suite 750, Alexandria, VA 22314. The petition 
and its supporting documents 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 silver 
nitrate as a color additive, at a level of up to 4 percent by weight in 
the final product, in professional-use only cosmetics to color eyebrows 
and eyelashes in persons age 16 and older.
    Silver nitrate is a highly purified inorganic compound obtained as 
the recrystallized precipitate from the concentrated reaction mixture 
of silver and excess nitric acid at elevated temperatures, followed by 
drying the decanted, filtered, and washed crystals. Silver nitrate has 
the chemical formula AgNO3. Although silver nitrate is 
colorless, when it comes into contact with argentaffin, the melanin-
rich protein filaments in the hair, it is reduced to black-brown 
metallic silver, which remains in the filaments (Ref. 1). GW formulates 
the silver nitrate into a viscous gel, which limits migration of the 
gel components into the eye during and after the application procedure, 
thereby minimizing potential extraneous staining or irritation.

II. Safety Evaluation

    Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379e(b)(4)), a color additive cannot 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 in Sec.  70.3(i) (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. 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 color additive's manufacturing and 
stability; the projected human exposure to the color additive and any 
impurities resulting from the petitioned use of the color additive; the 
additive's toxicological data; and other relevant information (such as 
published literature) available to us.

A. Estimated Dermal Exposure

    To support the safety of the intended use of silver nitrate, GW 
provided estimates of the systemic exposure to silver from the 
petitioned use of silver nitrate using various published dermal 
absorption values. However, as we explain in a separate memorandum 
(Ref. 2), we consider the most comprehensive measure of skin 
penetration of silver to come from a recent published mass

[[Page 55496]]

balance percutaneous penetration study that determined the distribution 
of silver penetrating the different layers of human skin (Ref. 3). 
Therefore, we used these published dermal absorption values, expressed 
as a dermal absorption percentage of the amount of silver applied, and 
assumptions made in GW's exposure estimate, to estimate that the dermal 
exposure to silver from the intended use of silver nitrate would be 
0.15 micrograms ([micro]g) silver/person (p)/day (d) per application. 
Since the exposure to silver could also be affected by the duration of 
the silver nitrate's contact with the skin at the application site, we 
further refined the exposure based on an exaggerated upper-bound 
application time of 3 minutes (Ref. 2). Thus, the maximum estimated 
dermal exposure to silver from the intended use of silver nitrate to 
color eyebrows and eyelashes is estimated to be 0.3 nanograms (ng)/p/d 
per application and exposure to silver nitrate is estimated to be 0.5 
ng/p/d per application (Ref. 2).

B. Acceptable Intake Level for Silver

    In the evaluation of the safe use of an ingredient or substance 
that can be absorbed systemically (e.g., a color additive for use in a 
cosmetic), we consider overall probable exposure (Ref. 4). We 
calculated the oral cumulative estimated daily intake (CEDI) of silver 
to be 72 [micro]g/p/d in our previous evaluations (Ref. 5). The 
conservative estimate of systemic exposure to silver from its color 
additive use in a high-viscosity gel formulation applied to eyebrows 
and eyelashes (0.3 ng/p/d per application) is approximately 0.0004 
percent of the CEDI (Ref. 4). However, the systemic exposure to silver 
is likely to be far less than the estimate of 0.3 ng/p/d per 
application due to three default factors and assumptions used in that 
estimate. First, a dermal retention factor of 0.1 (10 percent) for a 
``leave-on'' (i.e., not intended to be rinsed off) product was used, 
although excess gel is intended to be removed as directed; second, a 20 
percent skin ``reach'' factor (i.e., 20 percent of the applied silver 
nitrate gel is in contact with the skin) was used, though this number 
is likely much less, provided the gel is thoroughly removed from the 
eyebrows or eyelashes as directed; and third, a 1 in 10 day use factor 
was used, which is likely to be conservative when considering exposure 
over a lifetime. For example, GW notes that the coloring effects should 
last up to 6 weeks. Therefore, if an individual decreases their use 
from once every 10 days to once every 2 weeks, there would be a 30 
percent decrease in the exposure to silver. Furthermore, silver binds 
tightly to protein and would not be expected to transfer from the 
protein in the hair follicles (Ref. 4).
    Considering the very low percentage (0.0004 percent) of the CEDI 
represented by our estimated systemic exposure from the intended use of 
silver nitrate as a color additive for dyeing eyebrows and eyelashes, 
and the likelihood that probable systemic exposure to silver is orders 
of magnitude lower than the 0.3 ng/p/d per application estimate, we 
conclude that the exposure to silver from the petitioned intended use 
is negligible, and it does not impact the CEDI of silver (Ref. 4).

C. Toxicological Considerations

    To establish that silver nitrate is safe for use as a color 
additive to color eyebrows and eyelashes, GW provided data from two in 
vitro ocular irritation assays conducted with the proposed silver 
nitrate gel. Both of these in vitro studies, using colorimetric 
measurements as predictors of ocular irritancy, indicate that the 
silver nitrate gel product contains severe eye irritating 
ingredient(s). However, the color of this product interferes with 
colorimetric measurement portion of these studies, limiting the utility 
of these studies to non-colorimetric dependent portions of the 
assessment. Colorimetric results cannot be used to determine the ocular 
irritancy of a colorant such as silver nitrate; therefore, the assays 
provided only limited value to the current safety assessment. 
Nevertheless, the color of silver nitrate does not affect the 
histological assessment portion included in one of the in vitro 
studies. The histopathological results from one in vitro assay 
performed on bovine corneas treated with the silver nitrate gel did not 
reveal any significant physical effects or potential for damage, even 
following a 10-minute continuous exposure with full immersion (Refs. 5 
and 6). In comparison, GW's proposed upper-bound application time of 
the silver nitrate gel is only 3 minutes. Additionally, the viscosity 
of the silver nitrate gel formulation limits entry into the eye during 
and after application to eyelashes. The ocular exposure to silver 
nitrate would be incidental and would initiate ocular tearing, which 
would dilute the silver nitrate concentration (Ref. 6). Additionally, 
we are requiring the instruction ``Rinse eyes immediately if product 
comes into contact with them'' on the label of cosmetic products 
containing this color additive. We expect this instruction will further 
minimize the chances of potential harm. Therefore, we expect no 
permanent ocular damage (Ref. 6).
    GW also submitted results from a single-application, intended-use 
study in human subjects. The study included a pretreatment step with a 
preparation gel not containing silver nitrate to open hair cuticles 
prior to application of GW's silver nitrate gel to both eyebrows and 
eyelashes. During and after the study, only two adverse effects were 
identified in a limited number of users, which included burning 
sensations in the eyes (most occurrences were ``slight'' in degree and 
lasted less than 1 minute after the removal of the product, as self-
reported by the study subjects) and skin staining primarily beneath the 
eyebrows (which was infrequent). We also found no clinically 
significant findings related to the eye (Ref. 7), which is consistent 
with the corneal histopathology findings. Based on these results, we 
conclude that potential ocular irritancy (i.e., burning sensations) and 
skin staining present minimal risks to safety. Furthermore, we expect 
they will be mitigated by statements required to be on the label of a 
cosmetic product containing silver nitrate. See 21 CFR 73.2550(d)(2).
    This final rule includes an age use limitation to help ensure that 
professionals apply silver nitrate cosmetics only to individuals with 
fully mature facial size and structural development. The human eye and 
associated structures generally reach full adult size and structural 
development by 12 years of age. Therefore, limiting the age use to 16 
years and older provides a safety margin for those few individuals 
whose facial size and structures might not have fully developed by age 
12 (Ref. 7).
    This final rule includes a restriction on distribution or direct 
sale to consumers and a professional-use only limitation to increase 
the likelihood that professionals who are trained in and knowledgeable 
about applying cosmetics will apply the silver nitrate product. 
``Professional'' in this rule means an individual who, as part of an 
occupation, is permitted by the jurisdiction in which the individual 
practices to apply cosmetics for dyeing eyebrows and eyelashes.
    This final rule includes a limited application time to limit the 
amount of any potential systemic absorption of the silver nitrate. 
Silver nitrate absorption in the skin is time dependent; therefore, 
limiting the skin contact time will result in a negligible level of 
systemic absorption. We did not identify any evidence suggesting that 
GW's intended conditions of use of silver nitrate are of toxicological 
concern (Ref. 6).
    Based on the totality of the safety data and our conclusion that 
the systemic

[[Page 55497]]

exposure to silver nitrate under the conditions of use is negligible, 
we conclude that there is a reasonable certainty of no harm from the 
intended use of silver nitrate in professional-use only cosmetics to 
color eyebrows and eyelashes of persons age 16 and older at a level of 
up to 4 percent by weight in the final product. To mitigate the risk of 
adverse effects from the use of silver nitrate in these cosmetic 
products, the labeling of the cosmetic product must include statements 
about the potential ocular irritancy and skin staining, an age use 
limitation, professional-use only designation, and limited application 
time.

III. Response to Comment

    We received two comments in response to our filing of the color 
additive petition. One comment, however, did not address silver nitrate 
or color additives. The other comment claimed that the assumption that 
only trained beauticians or cosmetologists will be applying this 
product to consumers poses public health concerns because States have 
their own requirements regarding the licensure of makeup artists. The 
comment also stated that applying this product to the eyes and the 
surrounding area poses serious health concerns. The comment claimed 
that silver nitrate is considered highly toxic and that the gel 
containing the silver nitrate will travel down the hair shaft directly 
onto the skin and into the eye.
    Regarding the professional-use only status of the product, we 
acknowledge that FDA does not regulate the professional practice of 
applying those cosmetics to consumers. This final rule includes a 
professional-use only limitation, along with a restriction on 
distribution or direct sale to consumers, to increase the likelihood 
that professionals who are trained in and knowledgeable about applying 
cosmetics will apply the silver nitrate product. As explained above, we 
reviewed data and information to establish that silver nitrate when 
applied as a gel under the conditions described herein is safe for its 
intended use. As demonstrated in the testing conditions that were 
described in the submitted petition, the silver nitrate gel product, 
when applied as intended, was not toxic and did not result in ocular 
damage. In this case, the intended use of silver nitrate is in specific 
professional-use only cosmetics, and we have determined that this 
intended use is safe.
    Regarding the safety of applying this product to the eyes and the 
surrounding areas, we have determined, as explained in the discussion 
of our safety evaluation, that the intended use of silver nitrate as a 
color additive in certain cosmetic products is safe.

IV. Conclusion

    FDA reviewed the data and information in the petition, and other 
available relevant material, and determined the petitioned use of 
silver nitrate, at a level of up to 4 percent by weight in the final 
viscous gel product, in professional-use only cosmetics to color 
eyebrows and eyelashes is safe. We further conclude that the color 
additive will achieve its intended technical effect and is suitable for 
the petitioned use. Consequently, 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 upon the 
factors listed in 21 CFR 71.20(b), we conclude that certification of 
silver nitrate is not necessary for the protection of public health.

V. 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.

VI. Analysis of Environmental Impact

    We considered the environmental effects of this rule, as stated in 
the March 7, 2018, Federal Register notice of petition for CAP 8C0312. 
We have concluded that the action will not have a significant impact on 
the human environment, and that an environmental impact statement is 
not required. We did not receive any new information or comments that 
would affect this determination. Our finding of no significant impact 
and the evidence supporting that finding, contained in an environmental 
assessment, may be seen in the Dockets Management Staff (see ADDRESSES) 
between 9 a.m. and 4 p.m., Monday through Friday.

VII. 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.

VIII. 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.

IX. 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. Hepp, Color Technology Branch, Office of 
Cosmetics and Colors, Center for Food Safety and Applied Nutrition 
(CFSAN), FDA to R. Morissette, Regulatory Review Branch (RRB), DFI, 
OFAS, CFSAN, FDA, September 10, 2021.
*2. Memorandum from H. Lee, Chemistry Review Branch (CRB), Division 
of Food Ingredients (DFI), Office of Food Additive Safety (OFAS), 
CFSAN, FDA to

[[Page 55498]]

R. Morissette, RRB, DFI, OFAS, CFSAN, FDA, June 22, 2021.
3. Kraeling, M.E.K., V.D. Topping, Z.M. Keltner, et al. ``In Vitro 
Percutaneous Penetration of Silver Nanoparticles in Pig and Human 
Skin.'' Regulatory Toxicology and Pharmacology (2018) 95: 314-322.
*4. Memorandum from M. DiNovi, OFAS, CFSAN, FDA to R. Morissette, 
RRB, DFI, OFAS, CFSAN, FDA, June 22, 2021.
*5. Memorandum from A. GonzalezBonet, CRB, Division of Food Contact 
Substances, OFAS, CFSAN, FDA to M. Swain, CRB, DFI, OFAS, CFSAN, 
FDA, April 7, 2017.
*6. Memorandum from M. Wyatt, Cosmetics Division, Office of 
Cosmetics and Colors, CFSAN, FDA to R. Morissette, RRB, DFI, OFAS, 
CFSAN, FDA, September 10, 2021.
*7. Memorandum from W. Chambers, Ophthalmology, Office of New Drugs, 
Center for Drug Evaluation and Research, FDA to R. Morissette, RRB, 
DFI, OFAS, CFSAN, FDA, September 2, 2021.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
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.

0
2. Add Sec.  73.2550 to read as follows:

Sec.  73.2550  Silver nitrate.

    (a) Identity. The color additive silver nitrate is a purified 
inorganic compound obtained as the recrystallized precipitate from the 
concentrated reaction mixture of silver and excess nitric acid at 
elevated temperatures, followed by drying the decanted, filtered, and 
washed crystals. The color additive has the chemical formula 
AgNO3.
    (b) Specifications. Silver nitrate shall conform to the following 
specifications and shall be free from impurities other than those named 
to the extent that such impurities may be avoided by good manufacturing 
practice:
    (1) Arsenic, not more than 3 milligrams/kilogram (mg/kg) (3 parts 
per million (ppm)).
    (2) Cadmium, not more than 5 mg/kg (5 ppm).
    (3) Lead, not more than 10 mg/kg (10 ppm).
    (4) Mercury, not more than 1 mg/kg (1 ppm).
    (5) Volatile matter, calculated as water, not more than 0.1 
percent.
    (6) Total color, not less than 99.9 percent.
    (c) Uses and restrictions. The color additive silver nitrate may be 
safely used in externally applied professional-use only cosmetics 
intended to impart color to the eyebrows and eyelashes subject to the 
following restrictions:
    (1) The amount of silver nitrate in the cosmetic product shall not 
be more than 4 percent by weight.
    (2) The viscosity of the cosmetic formulation shall be not less 
than 120 Pascal-seconds (Pa[sdot]s) and not more than 180 Pa[sdot]s at 
normal temperature and pressure.
    (3) The cosmetic containing silver nitrate is not intended for use 
on persons under the age of 16.
    (4) Application of the cosmetic containing silver nitrate is not 
intended to exceed 1 minute and is intended to be followed by immediate 
removal.
    (5) The cosmetic containing silver nitrate is applied by a 
professional.
    (6) The cosmetic containing silver nitrate is not distributed or 
directly sold to consumers.
    (d) Labeling requirements. (1) The label of the color additive and 
any mixture prepared therefrom intended solely or in part for coloring 
purposes shall conform to the requirements of Sec.  70.25 of this 
chapter and include adequate directions to prepare a final product 
complying with the limitations prescribed in paragraph (c) of this 
section.
    (2) The label of any cosmetic containing the color additive silver 
nitrate, in addition to other information required by law, shall 
contain the following statements: Contains silver nitrate. Silver 
nitrate may permanently stain skin with which it comes into contact. 
Silver nitrate may irritate the eyes. For application by professionals 
only for dyeing eyebrows and eyelashes, in accordance with the 
directions for use. Not for use on persons under the age of 16. Apply 
to eyebrows and eyelashes for no more than 1 minute, followed by 
immediate removal. Rinse eyes immediately if product comes into contact 
with them. Consult a physician if any irritation persists. Not for 
distribution or direct sale to consumers.
    (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: September 30, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21755 Filed 10-5-21; 8:45 am]
BILLING CODE 4164-01-P