Rule2025-08249
Listing of Color Additives Exempt From Certification; Calcium Phosphate
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 12, 2025
Effective
June 26, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies. This action is in response to a color additive petition (CAP) filed by Innophos, Inc. (Innophos or petitioner).
Full Text
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<title>Federal Register, Volume 90 Issue 90 (Monday, May 12, 2025)</title>
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[Federal Register Volume 90, Number 90 (Monday, May 12, 2025)]
[Rules and Regulations]
[Pages 20097-20101]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08249]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2023-C-0544]
Listing of Color Additives Exempt From Certification; Calcium
Phosphate
AGENCY: Food and Drug Administration, HHS.
ACTION: Final amendment; order.
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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 calcium
phosphate as a color additive in ready-to-eat chicken products, white
candy melts, doughnut sugar, and sugar for coated candies. This action
is in response to a color additive petition (CAP) filed by Innophos,
Inc. (Innophos or petitioner).
DATES: This order is effective June 26, 2025. See section VIII for
further information on the filing of objections. Either electronic or
written objections and requests for a hearing on the final order must
be submitted by June 11, 2025.
ADDRESSES: You may submit objections and requests for a hearing as
follows. Please note that late, untimely filed objections will not be
considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of June
11, 2025. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2023-C-0544 for ``Listing of Color Additives Exempt from
Certification; Calcium Phosphate.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, Office of Food
Chemical Safety, Dietary Supplements, and Innovation, Human Foods
Program, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-1212; or Barbara Little, Office of Policy,
Regulations, and Information, Human Foods Program, Food and Drug
[[Page 20098]]
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378.
SUPPLEMENTARY INFORMATION:
I. Introduction
In a document published in the Federal Register of February 27,
2023 (88 FR 12281), we announced that we filed a color additive
petition (CAP 3C0324) submitted on behalf of Innophos by Steptoe &
Johnson LLP, 1330 Connecticut Avenue NW, Washington, DC 20036-1795. 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 calcium phosphate as a color additive,
by weight of the finished food, in ready-to-eat chicken products;
icing; white candy melts; doughnut sugar; and sugar for coated candies.
In the petition and filing notice, the color additive was identified as
``tricalcium phosphate.'' During the course of our review, we
determined that the correct nomenclature for the color additive is
``calcium phosphate.'' Additionally, during the course of our review
and in consultation with FDA, Innophos amended the intended uses to
remove icing in order to reduce overall dietary exposure to calcium.
Calcium phosphate is a white, synthetically prepared powder
consisting predominantly of precipitated
Ca<INF>5</INF>OH(PO<INF>4</INF>)<INF>3</INF>. Innophos proposed the
following specifications for calcium phosphate: loss on ignition, not
more than 10 percent; assay (Ca), 36.0-40.0 percent; fluoride, not more
than 75 milligrams/kilogram (mg/kg) (75 parts per million (ppm)); lead,
not more than 0.25 mg/kg (0.25 ppm); and arsenic, not more than 3 mg/kg
(3 ppm) (Ref. 1).
Calcium phosphate is generally recognized as safe (GRAS) for use as
a nutrient or multiple purpose ingredient in food with no limitation
other than use in accordance with good manufacturing practice under 21
CFR 182.8217 and 21 CFR 182.1217. Additionally, we have previously
evaluated the safety of substances containing calcium and/or phosphate
as constituent ions in numerous food and color additive regulations and
in GRAS notices.
This final order is expected to result in expanded production
options and is considered an E.O. 14192 deregulatory action.
II. 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 cannot be listed
for an intended use unless the data and information available to us
establishes 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 dietary 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 Dietary Exposure
To support the safety of the intended use of calcium phosphate,
Innophos provided dietary exposure estimates for calcium phosphate,
calcium, and phosphorus from the petitioned uses. The petitioned uses
included in ready-to-eat chicken products in an amount not exceeding
1.5 percent; in white candy melts in an amount not exceeding 0.25
percent; in doughnut sugar in an amount not exceeding 2.0 percent; and
in sugar for coated candies in an amount not exceeding 5.25 percent by
weight of the finished food. During review of the petition, Innophos
revised the use level in sugar for coated candies from 7.5% to 5.25%.
Innophos provided a cumulative dietary exposure for: (1) calcium from
background dietary sources, including dietary supplements and drugs, as
well as the intended uses of the color additive and (2) for phosphorus
based on the intended uses (Ref. 2).
Innophos provided a cumulative dietary exposure to calcium from the
intended uses and calcium from background dietary sources, including
dietary supplements, by utilizing a simplistic model of the National
Cancer Institute (NCI) usual intakes method for estimating dietary
exposure (Ref. 2). We noted that Innophos did not include all relevant
food codes, may have overestimated exposure by summing the food
category exposures, and did not provide a 90th percentile dietary
exposure for phosphorus. Therefore, we conducted a dietary exposure
estimate and estimated the updated dietary exposure for calcium
phosphate, calcium, and phosphorus from the petitioned uses based on
the 2015-2020 Nutritional Health and Nutrition Examination Survey
(NHANES) to be 535 milligrams (mg)/person (p)/day (d), 214 mg/p/d, and
99 mg/p/d, respectively, at the mean and 1200 mg/p/d, 480 mg/p/d, and
222 mg/p/d, respectively, at the 90th percentile for the U.S.
population ages 2 years and older (Ref. 2). Additionally, using 2015-
2020 NHANES food consumption data combined with the NCI usual intakes
method, we estimated the cumulative dietary exposure to calcium from
the background dietary sources, including dietary supplements and
drugs, and the petitioned uses to be 1195 mg/p/d at the mean and 1789
mg/p/d at the 90th percentile for the U.S. population ages 2 years and
older (Ref. 2). Using 2015-2020 NHANES food consumption data, we also
estimated the cumulative dietary exposure to phosphorus from the
background dietary sources, including dietary supplements and drugs,
and the petitioned uses to be 1330 mg/p/d at the mean and 2010 mg/p/d
at the 90th percentile for the U.S. population ages 2 years and older
(Ref. 2).
B. Toxicological Considerations
Innophos submitted peer-reviewed published data sourced from a
literature review and additional information relevant to the safety of
calcium phosphate for the intended use as a color additive. Based on
the physiochemical properties of calcium phosphate and the rapid
dissolution of the salt into its component ions, the safety conclusion
predominantly focuses on the safety of calcium and phosphorus.
Based on the cumulative dietary exposure for calcium from the
petitioned uses of calcium phosphate and the contribution of calcium
from background dietary sources, including dietary supplements, we
concluded that the estimated 90th percentile cumulative dietary
exposure for calcium from all dietary calcium sources does not exceed
the current Institute of Medicine (IOM) Upper Limit (UL) of 2000 mg/p/d
for calcium intake for all assessed populations (Refs. 2 and 3).
Based on the cumulative dietary exposure for phosphorus from the
petitioned uses of calcium phosphate and the contribution of phosphorus
from background dietary sources, including dietary supplements, we
concluded that the estimated 90th percentile cumulative dietary
exposure for phosphorus from all dietary phosphorus sources does not
exceed the current IOM UL of 3000 mg/p/d for phosphorus intake for all
assessed populations (Refs. 2 and 3).
Innophos conducted a comprehensive evaluation of the available
literature for information pertinent to the safety of
[[Page 20099]]
calcium phosphate, as well as available safety assessments of dietary
calcium and phosphorus by other regulatory bodies, including the IOM
report on Dietary Reference Intakes (DRI), Joint Food and Agriculture
Organization/World Health Organization Expert Committee on Food
Additives (JECFA), and the European Food Safety Authority (EFSA).
Innophos provided a safety summary for calcium phosphate and its
components, calcium and phosphorus, noting that when used in food,
calcium phosphate is expected to dissociate in the gastrointestinal
tract to conjugate ionic salts of calcium and inorganic phosphate
(phosphorus).
Calcium is an essential micronutrient necessary for numerous
physiological processes, including formation/metabolism of bone, and
intracellular signaling related to muscular function, vascular
contraction/dilation, nerve transmission, and hormonal secretion.
Maintenance of calcium balance in the body within a narrow
physiological range is essential for normative function. In 2011, the
IOM reassessed the DRI for calcium based on newly available scientific
information/data generated since its previous assessment. The IOM panel
noted that excess intake of calcium was unlikely related to calcium
intake from conventional foods, and higher intake levels often
corresponded with use of calcium dietary supplements. The IOM panel
specified that the efficiency of calcium absorption is in reverse
proportion to the amount of calcium consumed at one time to maintain
physiologic calcium balance and may vary based on vitamin D status. The
IOM panel identified several potential indicators of adverse outcomes
for excess calcium intake, including hypercalcemia, hypercalciuria,
vascular and soft tissue calcification, nephrolithiasis (kidney
stones), prostate cancer, interactions with iron and zinc, and
constipation. As a result, IOM established a calcium UL between 2000
and 3000 mg/d for each DRI life-stage group. Our literature search
identified no new publications relevant to the safe use of calcium in
food. Therefore, the current state of the science supports the
continued use of the IOM UL for calcium intake as a dietary reference
value to support public health (Ref. 3).
Phosphorus is ubiquitously present across the food supply as
organic phosphorus in various sources, such as dairy, meats, legumes,
and nuts, or inorganic phosphorus related to the use of phosphorus
salts. Phosphorus is an essential mineral that is a major component of
healthy bones and teeth, and critical for numerous physiological
functions, including pH homeostasis, energy metabolism, and cellular
signaling mediated via phosphorylation and dephosphorylation events.
Phosphorus is also a key component of phospholipid membranes and
nucleic acids. The IOM panel noted that dietary phosphorus supports
tissue growth and replacement of phosphorus lost due to excretion and
desquamation of skin cells.
Innophos summarized the scientific literature on the safety of
phosphorus and other phosphate salts, including genotoxicity
assessments, systemic toxicity studies, carcinogenicity studies, and
reproductive and developmental studies, focusing on studies using oral
administration. Innophos summarized additional data/studies of various
phosphate salts in support of the safety of calcium phosphate.
Additionally, Innophos discussed published scientific opinions from
JECFA, the EFSA Panel on Food Additives and Flavourings, and the IOM
DRI to establish upper limits for phosphorus intake. The IOM panel
noted that all adverse effects of excess phosphorous consumption
corresponded to elevated inorganic phosphorus in the extracellular
fluid. Hyperphosphatemia from dietary sources is a potential concern
for individuals diagnosed with end-stage renal disease and is
associated with reduced calcium absorption and potential calcification
of non-skeletal tissues, particularly the kidney. Based on the weight
of evidence, the IOM panel utilized intakes of phosphorus corresponding
to normal circulating levels of inorganic phosphate in healthy adults
and the application of a factorial approach for other relevant
populations to support DRI derivation. The panel recognized the likely
need for higher recommended daily allowances of phosphorus during
periods of rapid growth in children. As a result, the IOM established a
phosphorus UL between 3000 and 4000 mg/d for each DRI life-stage group.
Our literature search identified no new publications relevant to the
safe use of phosphorous in food. Therefore, the current state of the
science supports the continued use of the IOM UL for phosphorus intake
as a dietary reference value to support public health (Ref. 3).
Based on the totality of the safety data provided by Innophos and
otherwise available to us, including supporting literature on the
safety of calcium phosphate and its constituent ions, expert opinions
from other regulatory bodies on safe dietary intake levels of calcium
and phosphorous, and that the estimated 90th percentile cumulative
dietary exposures for calcium and phosphorus from all sources
(petitioned intended uses, and background dietary sources, including
dietary supplements and drugs) does not exceed the IOM UL established
for dietary calcium and phosphorous, we conclude that there is a
reasonable certainty of no harm from the intended uses of calcium
phosphate as a color additive in ready-to-eat chicken products, white
candy melts, doughnut sugar, and sugar for coated candies.
III. Conclusion
Based on the data and information in the petition and other
relevant material, we conclude that the petitioned use of calcium
phosphate as a color additive, by weight of the finished food, in
ready-to-eat chicken products in an amount not exceeding 1.5 percent;
in white candy melts in an amount not exceeding 0.25 percent; in
doughnut sugar in an amount not exceeding 2.0 percent; and in sugar for
coated candies in an amount not exceeding 5.25 percent 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 21 CFR part 73 as set
forth in this document. In addition, based upon the factors listed in
21 CFR 71.20(b), we conclude that certification of calcium phosphate is
not necessary for the protection of public health.
IV. 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.
V. Analysis of Environmental Impact
As stated in the February 27, 2023 (88 FR 12281) Federal Register
notification of petition for CAP 3C0324, the petitioner claimed that
this action is categorically excluded under 21 CFR 25.32(k) because
calcium phosphate added directly to food is intended to remain in 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
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categorical exclusion and determined that this action is categorically
excluded under 21 CFR 25.32(k). Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Paperwork Reduction Act of 1995
This order contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
VII. Section 301(ll) of the FD&C Act
Our review of this petition was limited to section 721 of the FD&C
Act. This order 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) through (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 order 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 orders 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.
VIII. Objections
This order 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 are also available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 J. Barrows, Color Technology Branch, Office of
Cosmetics and Colors, Office of the Chief Scientist, FDA to R.
Morissette, Regulatory Management Branch (RMB), Division of Food
Ingredients (DFI), Office of Pre-Market Additive Safety (OPMAS),
Office of Food Chemical Safety, Dietary Supplements, and Innovation
(OFCSDSI), Human Foods Program (HFP), FDA, April 23, 2025.
* 2. Memorandum from T. Todorov, Chemistry Review Branch, DFI,
OPMAS, OFCSDSI, FDA to R. Morissette, RMB, DFI, OPMAS, OFCSDSI, HFP,
FDA, April 22, 2025.
* 3. Memorandum from T. Hubbard, Toxicology Review Branch, DFI,
OPMAS, OFCSDSI, HFP, FDA to R. Morissette, RMB, DFI, OPMAS, OFCSDSI,
HFP, FDA, April 22, 2025.
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 the 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. 73.80 to read as follows:
Sec. 73.80 Calcium phosphate.
(a) Identity. (1) The color additive calcium phosphate is a white,
synthetically prepared powder consisting predominantly of precipitated
Ca<INF>5</INF>OH(PO<INF>4</INF>)<INF>3.</INF>
(2) Color additive mixtures for food use made with calcium
phosphate 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. Calcium phosphate 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) Loss on ignition, not more than 10 percent.
(2) Assay (Ca): 36.0-40.0 percent.
(3) Fluoride, not more than 75 milligrams/kilogram (mg/kg) (75
parts per million (ppm)).
(4) Lead, not more than 0.25 mg/kg (0.25 ppm).
(5) Arsenic, not more than 3 mg/kg (3 ppm).
(c) Uses and restrictions. Calcium phosphate may be safely used for
coloring foods intended for human consumption, subject to the following
restrictions:
(1) In ready-to-eat chicken products in an amount not exceeding 1.5
percent by weight of the finished food.
(2) In white candy melts in an amount not exceeding 0.25 percent by
weight of the finished food.
(3) In doughnut sugar in an amount not exceeding 2.0 percent by
weight of the finished food.
(4) In sugar for coated candies in an amount not exceeding 5.25
percent by weight of the finished food.
(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.
[[Page 20101]]
Dated: May 6, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-08249 Filed 5-9-25; 8:45 am]
BILLING CODE 4164-01-P
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