Rule2022-20819
Listing of Color Additives Exempt From Certification; Calcium Carbonate
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
September 27, 2022
Effective
October 28, 2022
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 carbonate in dietary supplement tablets and capsules. We are taking this action in response to a color additive petition (CAP) submitted by Colorcon, Inc. (Colorcon or petitioner).
Full Text
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<title>Federal Register, Volume 87 Issue 186 (Tuesday, September 27, 2022)</title>
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[Federal Register Volume 87, Number 186 (Tuesday, September 27, 2022)]
[Rules and Regulations]
[Pages 58445-58449]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-20819]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2017-C-6238]
Listing of Color Additives Exempt From Certification; Calcium
Carbonate
AGENCY: Food and Drug Administration, Department of Health and Human
Services (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 calcium
carbonate in dietary supplement tablets and capsules. We are taking
this action in response to a color additive petition (CAP) submitted by
Colorcon, Inc. (Colorcon or petitioner).
DATES: This rule is effective October 28, 2022. Submit either
electronic or written objections and requests for a hearing on the
final rule by October 27, 2022. See section XI for further information
on the filing of objections. The incorporation of reference of certain
material listed in this rule is approved by the Director of the Federal
Register as of October 27, 2022.
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
October 27, 2022. 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-2017-C-6238 for ``Listing of Color Additives Exempt from
Certification; Calcium Carbonate.'' 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
[[Page 58446]]
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: Christopher Kampmeyer, Office of Food
Additive Safety (HFS-255), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740-3835, 240-402-1255; or Alexandra Jurewitz, Office of
Regulations and Policy (HFS-024), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740, 240-402-2378.
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 0C0318) submitted by Colorcon, Inc., 275 Ruth Rd.,
Harleysville, PA 19438. The petition proposed to amend the color
additive regulations in Sec. 73.70 ``Calcium Carbonate,'' by expanding
the permitted uses of calcium carbonate to include use in dietary
supplement tablets and capsules, including coatings and printing inks,
in amounts consistent with good manufacturing practice.
II. Background
Calcium carbonate (CAS 471-34-1) is a fine, white powder prepared
either by grinding naturally occurring limestone or produced
synthetically through a precipitation process using heat, water, and
carbon dioxide. Calcium carbonate is slightly soluble in water and
dissociates into calcium and carbonate ions in an aqueous environment.
Calcium is abundant in the human body and is an integral component of
bones, teeth, and other biological structures. Carbonate is also
present in the human body, e.g., as a critical component of the pH
buffering system.
Calcium carbonate is authorized under Sec. 73.70 for use as a
color additive in soft and hard candies, mints, and in inks used on the
surface of chewing gum, in amounts consistent with good manufacturing
practice, except that it may not be used to color chocolate or the
chocolate portion of candy, as the standards of identity for chocolate
do not provide for the use of color additives. Calcium carbonate is
also authorized under Sec. 73.1070 for use as a color additive in
drugs; generally, in amounts consistent with good manufacturing
practice. Additionally, food grade calcium carbonate and ground
limestone (consisting of not less than 94 percent calcium carbonate)
are affirmed as generally recognized as safe in 21 CFR 184.1191 and
184.1409, respectively. These two regulations do not include
limitations for use in food other than current good manufacturing
practice, which our regulations define at Sec. 184.1(b).
The petitioner stated that calcium carbonate complies with the
specifications in the 10th edition of the Food Chemicals Codex (FCC
10), which was incorporated by reference into Sec. 73.70 (82 FR 51554,
November 7, 2017). Since this regulation became effective, the 13th
edition of the FCC (FCC 13) has published. The specifications for
calcium carbonate and ground limestone are the same in both FCC 10 and
FCC 13. Therefore, we are updating our incorporation by reference to
FCC 13. In an email dated May 26, 2022, the petitioner concurred with
updating the FCC reference from FCC 10 to FCC 13.
The petitioner concluded that the amount of calcium carbonate
petitioned for use in dietary supplement tablets and capsules is self-
limiting because the addition of the color additive above a certain
level would be uneconomical and/or have adverse consequences on the
quality of the dietary supplements. Because the petitioner concluded
that the amount of calcium carbonate used as a color additive in
dietary supplement tablets and capsules would be self-limiting, they
did not propose any tolerances or other limitations. We determined
there is no need for a specific upper limit for this use of calcium
carbonate (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 particular 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 establish with reasonable certainty that a color additive
intended for use in foods is not harmful under its intended conditions
of use, we consider the projected human dietary exposure to the color
additive; the additive's toxicological data; and other relevant
information (such as published literature) available to us. We compare
the estimated dietary exposure, or estimated daily intake (EDI), of the
color additive from all dietary sources to an acceptable daily intake
(ADI) level established by toxicological data. The EDI is determined by
projections based on the amount of the color additive proposed for use
in particular foods and on data regarding the amount consumed from all
sources of the color additive. We commonly use the EDI for the 90th
percentile consumer of a color additive as a measure of high chronic
exposure.
IV. Safety of the Petitioned Use of the Color Additive
A. Dietary Exposure Estimate
The petitioner estimates that the amount of calcium carbonate as a
color additive in dietary supplements would not exceed 24 milligrams
(mg) per dietary supplement (Ref. 2). The petitioner used data for
dietary supplements from the 2011-2014 National Health and Nutrition
Examination Survey (NHANES) to estimate dietary exposure to calcium
carbonate and elemental calcium from the proposed use. From the NHANES
data, the petitioner determined that the U.S. population aged 2 years
and older consumes two dietary supplements in a 24-hour period at the
mean and five at the 90th percentile. We note that these values could
represent two or five of the same or different dietary supplements. In
estimating dietary exposure, the petitioner assumed that all dietary
supplements consumed would contain calcium carbonate as a color
additive and that each dietary supplement consumed contains 24 mg
calcium carbonate. This results in a dietary exposure estimate to
calcium carbonate of 48 milligrams/person/day (mg/p/d) at the mean and
120 mg/p/d at the 90th percentile. Because calcium carbonate is
comprised of 40 percent calcium, the petitioner noted that the maximum
dietary exposure to calcium from this use of calcium carbonate is
estimated to be 19 mg/p/d at the mean and 48 mg/p/d at the 90th
percentile.
The petitioner stated that the maximum amount of calcium carbonate
deposited as a printing ink on the surface of the dietary supplement
would
[[Page 58447]]
be 0.009 mg, which corresponds to approximately 0.004 mg of calcium per
dietary supplement. The petitioner concluded that the contribution to
the dietary exposure from use in printing ink on the surface of dietary
supplements is accounted for in the dietary exposure estimate for the
use of calcium carbonate as a color additive at the maximum proposed
use level in dietary supplements. FDA concurred with this approach
regarding the dietary exposure estimate for calcium and calcium
carbonate from the petitioned uses of calcium carbonate (Ref. 2).
FDA previously determined the cumulative estimated dietary intake
(CEDI) for calcium from all sources to be 1,150 mg/p/d at the mean and
1,925 mg/p/d at the 90th percentile for the U.S. population aged 2
years and older (Ref. 3). The petitioner summed FDA's mean cumulative
dietary exposure to calcium (1,150 mg/p/d) (Ref. 3) with the mean
dietary exposure to calcium from the petitioned uses (19 mg/p/d) (Ref.
2) to estimate a revised mean CEDI for elemental calcium from the
existing uses as well as the petitioned use of calcium carbonate as a
color additive in dietary supplement tablets and capsules, including
coatings and printing inks. This resulted in a mean CEDI for calcium of
1,169 mg/p/d for the U.S. population aged 2 years and older. Using an
analogous approach, the 90th percentile CEDI for calcium, determined
previously (1,925 mg/p/d; Ref. 3), was summed with the 90th percentile
value (48 mg/p/d) from the petitioned uses to derive an upper bound
90th percentile CEDI for calcium of <2,000 mg/p/d for the U.S.
population aged 2 years and older (Ref. 2).
B. Toxicological Considerations
To support the safety of the petitioned use of calcium carbonate,
the petitioner noted that calcium carbonate and ground limestone are
affirmed as generally recognized as safe under Sec. Sec. 184.1191 and
184.1409, respectively. The petition referenced FDA's safety review of
calcium carbonate in CAP 6C0307 (Ref. 4), which resulted in FDA's
listing of calcium carbonate in Sec. 73.70. Calcium carbonate can
dissociate into calcium and carbonate ions in aqueous environments,
making those two ions relevant to a safety evaluation of ingested
calcium carbonate. Based on carbonate's chemical structure and
physiological functions, no further safety analysis of carbonate
exposure was necessary (Ref. 4). FDA also considered safety evaluations
by the Institute of Medicine (IOM) and safety information resulting
from a search of the published literature (Ref. 4). In the IOM's 2011
report on dietary reference intakes for calcium and vitamin D, the IOM
updated recommended tolerable upper limits (ULs) for calcium ranging
from 2,000 to 3,000 mg/p/d for the U.S. population aged 1 year and
older, based on a comprehensive literature review (Ref. 5). The IOM
considered the UL as the highest average daily exposure that is likely
to pose no risk of adverse effects to almost all individuals in the
general population (Ref. 5).
We conducted a search of the literature from January 2016 until
December 2021 to identify publications germane to our safety evaluation
using several different databases (i.e., PubMed, Web of Science and
ToxNet). We reviewed the articles found in this search and other
relevant studies available to FDA on the safety of calcium and calcium
carbonate (Ref. 6). We also noted that in our previous safety review
(Ref. 4) we determined that no further safety analysis of carbonate was
necessary, based on its chemical structure and physiological functions
(Ref. 6).
Based on our review, we considered the UL established by IOM for
calcium (2,000 mg/p/d) to remain an appropriate benchmark for assessing
the safety of dietary exposure to calcium from the petitioned use of
calcium carbonate (Ref. 6). For the U.S. population aged 2 years and
older, the dietary exposure estimate at the 90th percentile is below
the IOM's UL of 2,000 mg/p/d. Additionally, the body of literature on
calcium carbonate and calcium does not present evidence of safety
concerns at the expected dietary exposure (Ref. 6). Based on our review
of the recently published literature, and because the 90th percentile
dietary exposure to calcium from all dietary sources, including the
petitioned uses of calcium carbonate, is less than the UL determined by
IOM, the dietary exposure to calcium from the proposed use of calcium
carbonate as a color additive in dietary supplement tablets and
capsules, including coatings and printing inks, does not raise safety
concerns (Ref. 6). Therefore, we conclude that there is a reasonable
certainty of no harm from this proposed use as a color additive.
V. Incorporation by Reference
FDA is incorporating by reference the monographs for calcium
carbonate and limestone, ground from the Food Chemicals Codex, 13th
ed., 2022, which was approved by the Office of the Federal Register in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may purchase a
copy of the material from the United States Pharmacopeial Convention,
12601 Twinbrook Pkwy., Rockville, MD 20852, 1-800-227-8772, <a href="https://www.usp.org">https://www.usp.org</a>. You may inspect a copy at the Dockets Management Staff
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday
through Friday. Because materials incorporated by reference will no
longer be available at FDA's main library, we are revising Sec. 73.70
to update the location where referenced materials cited in FDA
regulations can be found; the new location will be at the Dockets
Management Staff.
The FCC monographs establish a standard for purity and identity for
calcium carbonate. The monographs provide specifications and analytical
methodologies used to identify the substance and establish acceptable
purity criteria. The current color additive regulation for the use of
calcium carbonate (Sec. 73.70) indicates that the additive must meet
the specifications in the FCC 10. The most current version of the FCC
is the FCC 13, and the specifications for calcium carbonate in FCC 13
are identical to those in FCC 10. Therefore, we are amending Sec.
73.70 by adopting, and incorporating by reference, the specifications
for calcium carbonate and ground limestone in FCC 13 in place of FCC
10.
VI. Conclusion
Based on the data and information in the petition and other
available relevant information, we conclude that the petitioned use of
calcium carbonate for use as a color additive in dietary supplement
tablets and capsules, including coatings and printing inks, is safe. We
further conclude that the 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 calcium carbonate, proposed for use as a color
additive in dietary supplement tablets and capsules, including coatings
and printing inks, is not necessary for the protection of public health
(Ref. 1).
VII. Public Disclosure
In accordance with Sec. 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
[[Page 58448]]
(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.
VIII. Analysis of Environmental Impact
As stated in the November 20, 2020, Federal Register notification
of filing, the petitioner claimed that this action is categorically
excluded under Sec. 25.32(k) because the substance 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
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.
IX. 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.
X. 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.
XI. 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 <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.
XII. 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>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 C. Kampmeyer, Division of Food Ingredients (DFI),
Office of Food Additive Safety (OFAS), CFSAN, FDA, May 11, 2022.
* 2. Memorandum from D. Doell, Chemistry Review Team, DFI, OFAS,
CFSAN, FDA to C. Kampmeyer, DFI, OFAS, CFSAN, FDA, May 11, 2022.
* 3. Memorandum from D. Doell, Division of Petition Review (DPR),
OFAS, CFSAN, FDA to J. Kidwell, DPR, OFAS, CFSAN, FDA, February 16,
2017.
* 4. Memorandum from T.S. Thurmond, DPR, OFAS, CFSAN, FDA to J.
Kidwell, DPR, OFAS, CFSAN, FDA, February 17, 2017.
5. Committee to Review Dietary Reference Intakes for Vitamin D and
Calcium, Food and Nutrition Board, Institute of Medicine, ``Dietary
Reference Intakes for Calcium and Vitamin D,'' National Academies
Press, Washington, DC 2011. Available at <a href="https://www.nap.edu/read/13050/chapter/1">https://www.nap.edu/read/13050/chapter/1</a> (accessed July 27, 2021).
* 6. Memorandum from R. Chanderbhan, Toxicology Review Team, DFI,
OFAS, CFSAN, FDA to C. Kampmeyer, DFI, OFAS, CFSAN, FDA, May 11,
2022.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Foods, Incorporation by
reference, 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.
0
2. Amend Sec. 73.70 by revising paragraphs (b) and (c) and adding
paragraph (f) to read as follows:
Sec. 73.70 Calcium carbonate.
* * * * *
(b) Specifications. Calcium carbonate must meet the specifications
given in calcium carbonate (FCC 13) and limestone, ground (FCC 13).
(c) Uses and restrictions. Calcium carbonate may be safely used in
amounts consistent with good manufacturing practice to color dietary
supplement tablets and capsules (including coatings and printing inks),
soft and hard candies and mints, and in inks used on the surface of
chewing gum, except that it may not be used to color chocolate for
which standards of identity have been promulgated under section 401 of
the Federal Food, Drug,
[[Page 58449]]
and Cosmetic Act unless added color is authorized by such standards.
* * * * *
(f) Incorporation by reference. Material listed in this paragraph
(f) is incorporated by reference into this section with the approval of
the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR
part 51. All approved material is available for inspection at the Food
and Drug Administration and at the National Archives and Records
Administration (NARA). Contact the Food and Drug Administration between
9 a.m. and 4 p.m., Monday through Friday at: Dockets Management Staff,
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240-402-7500. For information on the availability
of this material at NARA, email: <a href="/cdn-cgi/l/email-protection#593f2b7730372a293c3a2d3036371937382b38773e362f"><span class="__cf_email__" data-cfemail="284e5a0641465b584d4b5c4147466846495a49064f475e">[email protected]</span></a>; website:
<a href="http://www.archives.gov/federal-register/cfr/ibr-locations.html">www.archives.gov/federal-register/cfr/ibr-locations.html</a>. You may
obtain the material from the U.S. Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852; website: <a href="http://www.usp.org">www.usp.org</a>.
(1) Limestone, Ground, Food Chemicals Codex, 13th edition,
effective June 1, 2022 (FCC 13).
(2) Calcium Carbonate, Food Chemicals Codex, 13th edition,
effective June 1, 2022 (FCC 13).
Dated: September 20, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20819 Filed 9-26-22; 8:45 am]
BILLING CODE 4164-01-P
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