82 FR 51554 - Listing of Color Additives Exempt From Certification; Calcium Carbonate

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 214 (November 7, 2017)

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. We are taking this action in response to a color additive petition submitted by the Wm. Wrigley Jr. Company.

[Federal Register Volume 82, Number 214 (Tuesday, November 7, 2017)]
[Rules and Regulations]
[Pages 51554-51558]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-24194]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2016-C-2767]


Listing of Color Additives Exempt From Certification; Calcium 
Carbonate

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 calcium 
carbonate to color hard and soft candy, mints, and chewing gum. We are 
taking this action in response to a color additive petition submitted 
by the Wm. Wrigley Jr. Company.

DATES: This rule is effective December 8, 2017. See section X for 
further information on the filing of objections. Submit either 
electronic or written objections and requests for a hearing on the 
final rule by December 7, 2017. The incorporation by reference of 
certain publications listed in the rule is approved by the Director of 
the Federal Register as of December 7, 2017.

ADDRESSES: You may submit objections and requests for a hearing as 
follows. Please note that late, untimely filed objections will not be 
considered. Electronic objections must be submitted on or before 
December 7, 2017. The https://www.regulations.gov electronic filing 
system will accept comments until midnight Eastern Time at the end of 
December 7, 2017. 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-2016-C-2767 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 https://www.regulations.gov or with the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     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.thefederalregister.org/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition (CFSAN) (HFS-265), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740-3835, 240-402-1071.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    In the Federal Register on October 7, 2016 (81 FR 69740), we 
announced that we filed a color additive petition (CAP 6C0307) 
submitted by Wm. Wrigley Jr. Company (petitioner), c/o Exponent, 1150 
Connecticut Ave. NW., Suite 1100, Washington, DC 20036. The petition 
proposed to amend the color additive

[[Page 51555]]

regulations in part 73 (21 CFR part 73) Listing of Color Additives 
Exempt from Certification to provide for the safe use of calcium 
carbonate to color hard and soft candy, mints, and chewing gum. The 
proposed use excludes chocolate or the chocolate portion of candy, as 
the current standards of identity for chocolate do not allow for the 
addition of color additives (see 21 CFR 163.123, 163.124, 163.130, 
163.135, 163.140, 163.145, 163.153, 163.155). After the petition was 
filed, the petitioner clarified that calcium carbonate is intended for 
use only in ink applied to the surface of the chewing gum.

II. Background

    Calcium carbonate is obtained from ground limestone or produced 
synthetically through a precipitation process using calcium oxide, 
water, and carbon dioxide. Calcium is abundant in the human body and is 
an integral component of bones, teeth, and other biological structures. 
Calcium constantly diffuses in and out of the bone and is resorbed by 
the kidney. Excess intake of calcium may result in hypercalcemia, 
hypercalciuria, gastrointestinal issues, kidney stones, interference 
with iron and zinc absorption, possible vascular and soft tissue 
calcification, and renal and cardiovascular damage. Carbonate is 
present in the human body as a critical component of the pH buffering 
system. The components of carbonate (carbon and oxygen) are ubiquitous 
in the human diet and body, and carbonate itself does not belong to a 
class of structures that is associated with any adverse effects or 
toxicity.
    Calcium carbonate that is pharmaceutical grade is currently 
approved under Sec.  73.1070 for use as a color additive in drugs in 
amounts consistent with good manufacturing practices (GMP). 
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 Sec.  184.1191 and Sec.  184.1409 
(21 CFR 184.1191 and 184.1409), respectively. These regulations do not 
include limitations for use in food other than current GMP. The 
petitioner proposed that to ensure that only food grade calcium 
carbonate is used to color hard and soft candy, mints, and chewing gum, 
the substance must meet the specifications of the Food Chemicals Codex, 
10th edition (FCC 10). We have reviewed these specifications and agree 
that they should be incorporated into the regulation as set forth in 
this document. The petitioner proposed to use calcium carbonate to 
color soft and hard candy, mints, and chewing gum in amounts consistent 
with GMP. The maximum GMP use level for calcium carbonate in hard and 
soft candy, mints, and chewing gum will be determined by the desired 
coloring effect. We have determined that the amount of calcium 
carbonate used in these foods is self-limiting because the addition of 
the color additive above a certain level will not achieve the desired 
coloring effect and negatively interferes with organoleptic properties, 
such as taste and texture. Because the amount of the color additive 
used in these foods is self-limiting, we have determined that there is 
no need for a specific upper limit on the percent by weight of calcium 
carbonate in hard and soft candy, mints, and chewing gum (Ref. 1).

III. Safety Evaluation

    Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive cannot be 
listed for a particular use unless the data and information available 
to FDA establish that the color additive is safe for that use. 
Furthermore, under section 721(b)(4) of the FD&C Act, a color additive 
is deemed to be suitable and safe for the purpose of listing for use 
generally in or on food, while there is in effect a published finding 
declaring such substance exempt from the term ``food additive'' because 
of its being generally recognized by qualified experts as safe for its 
intended use, as provided in section 201(s) of the FD&C Act (21 U.S.C. 
321(s)). FDA's color additive regulations in 21 CFR 70.3(i) define 
``safe'' to mean that there is convincing evidence that establishes 
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 
an individual's estimated exposure, or estimated daily intake (EDI), of 
the color additive from all food sources to an acceptable daily intake 
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 or drugs 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.

A. Estimated Dietary Exposure

    The petitioner indicated that, given the types of candies to be 
colored and the variable conditions under which calcium carbonate would 
be used, the use of the assumption that all candies would contain 
calcium carbonate at the maximum GMP level would lead to an 
overestimate of exposure. However, because only hard and soft candy, 
mints, and chewing gum that are colored white would result in a 
potential exposure to calcium carbonate from the proposed use, the 
petitioner reviewed the 2009-2012 National Health and Examination 
Survey (NHANES) food codes and identified 51 food codes in which 
calcium carbonate could potentially be used as a color additive that 
represent the intended use in hard and soft candy, mints, and chewing 
gum. Although we identified additional food codes that could contain 
calcium carbonate, these codes were intentionally excluded by the 
petitioner because there were no associated eating occasions for these 
additional food codes over the survey years. We agree with the selected 
51 food codes and the exclusion of the other food codes (Ref. 2). 
Furthermore, the petitioner used market data to refine their exposure 
estimate; however, these data were limited to those products that were 
introduced in the last 5 years and may not fully represent the market. 
Therefore, to be conservative, we estimated exposure to calcium 
carbonate using 2-day food consumption data from the 2009-2012 NHANES 
for the identified 51 food codes at the GMP use levels and made no 
adjustment for market data. Exposure to calcium carbonate and to 
calcium was estimated for the U.S. population 2 years of age and older 
and children 2 to 5 years of age (Ref. 2).
    For the U.S. population 2 years of age and older, exposure 
estimates for calcium carbonate at the mean and 90th percentile from 
the proposed uses were 170 milligrams/person/day (mg/p/d) and 400 mg/p/
d, respectively. For children 2 to 5 years of age, exposure estimates 
for calcium carbonate at the mean and 90th percentile were 125 mg/p/d 
and 270 mg/p/d, respectively.
    Calcium carbonate is a source of calcium for the consumer once 
ingested and metabolized by the body. Therefore, as part of our 
evaluation, we also estimated exposure to calcium from the petitioned 
uses of calcium carbonate by assuming that the amount of calcium 
provided by calcium carbonate as a color additive is 40 percent of the 
total weight of calcium carbonate. For the U.S. population 2 years of 
age and older,

[[Page 51556]]

estimated exposure to calcium from the proposed uses of calcium 
carbonate at the mean and 90th percentile were 70 mg/p/d and 160 mg/p/
d, respectively. For children 2 to 5 years of age, estimated exposure 
to calcium at the mean and 90th percentile were 50 mg/p/d and 110 mg/p/
d, respectively.
    Additionally, we estimated exposure to calcium from background 
dietary sources, drugs, and dietary supplements using 2-day food 
consumption data for all foods and nutrient data for calcium in those 
foods based on the U.S. Department of Agriculture's National Nutrient 
Database for Standard Reference. This estimate also included exposure 
to calcium from dietary supplements (including non-prescription 
antacids that contain calcium) based on NHANES 2-day survey data (Ref. 
2).
    For the U.S. population 2 years of age and older, exposure to 
calcium from background dietary sources, drugs, and dietary supplements 
at the mean and 90th percentile were estimated to be 1,125 mg/p/d and 
1,900 mg/p/d, respectively. For children 2 to 5 years of age, exposure 
estimates at the mean and 90th percentile were 1,000 mg/p/d and 1,600 
mg/p/d, respectively. Because our exposure estimates for dietary 
supplements include calcium from all sources, not just calcium 
carbonate, we believe that this exposure estimate is sufficiently 
conservative to include any exposure to calcium from the use of calcium 
carbonate to color drugs (Ref. 2).
    We estimated exposure to calcium from background dietary sources, 
drugs, dietary supplements and the proposed uses of calcium carbonate 
at the mean and 90th percentile for the U.S. population 2 years of age 
and older and children 2 to 5 years of age. Based on these 
calculations, exposure estimates for calcium for the U.S. population 2 
years of age and older at the mean and 90th percentile were 1,150 mg/p/
d and 1,925 mg/p/d, respectively. For children 2 to 5 years of age, 
exposure estimates for calcium at the mean and 90th percentile were 
1,025 mg/p/d and 1,625 mg/p/d, respectively (Ref. 2).

B. Safety of the Petitioned Uses of Calcium Carbonate

    To support the safety of the petitioned use of calcium carbonate, 
the petitioner referenced safety information on calcium from the 2011 
Institute of Medicine (IOM) Report on Dietary Reference Intakes for 
Calcium and Vitamin D (Ref. 3) and the European Food Safety Authority 
(EFSA) Panel on Dietetic Products, Nutrition and Allergies' 
reevaluation of the safety of calcium (Ref. 4). In 2011, the Standing 
Committee on the Scientific Evaluation of Dietary Reference Intakes of 
the Food and Nutrition Board of the IOM conducted an extensive review 
of relevant published scientific literature on calcium to update 
current dietary reference intakes and Upper Tolerable Intake Levels 
(UL). In their 2011 assessment of calcium, the IOM established a UL of 
1,000 mg/p/d for infants 0 to 6 months of age and 1,500 mg/p/d for 
infants 6 to 12 months of age. For children 1 to 8 years of age, IOM 
did not change the UL of 2,500 mg/p/d from the previous IOM report in 
1997. For children 9 to 18 years of age, IOM increased the UL to 3,000 
mg/p/d. For adults 19 to 50 years of age, the IOM established a UL of 
2,500 mg/p/d; for adults 51 years and older, the IOM established a UL 
of 2,000 mg/p/d.
    The IOM considers the UL as the highest average daily intake level 
of a nutrient that poses no risk of adverse effects when the nutrient 
is consumed over long periods of time. The UL is determined using a 
risk assessment model developed specifically for nutrients. The dose-
response assessment, which concludes with an estimate of the UL, is 
built upon three toxicological concepts commonly used in assessing the 
risk of exposures to chemical substances: No-observed-adverse-effect 
level, lowest-observed-effect level, and application of an uncertainty 
factor. We considered the ULs established by the IOM relative to the 
exposure estimates for calcium as the primary basis for assessing the 
safety of the petitioned uses of calcium carbonate.
    The estimated dietary exposure to calcium from the petitioned uses, 
dietary sources, and dietary supplements at the 90th percentile for the 
U.S. population 2 years of age and older is estimated to be 1,925 mg/p/
d, which is below the IOM's UL of 2,000-3,000 mg/p/d. For children 2 to 
5 years of age, the exposure estimate at the 90th percentile is 1,625 
mg/p/d, which also is below the IOM's UL of 2,500 mg/p/d for this age 
group. Additionally, the body of literature on calcium carbonate and 
calcium does not present evidence of safety concerns at the expected 
dietary exposures discussed above. Thus, we conclude that the 
petitioned use of calcium carbonate as a color additive in soft and 
hard candy, mints, and chewing gum is safe (Ref. 5).

IV. Incorporation by Reference

    FDA is incorporating by reference the Food Chemicals Codex, 10th 
ed. (2016), pp. 213-214 (calcium carbonate) and p. 754 (limestone, 
ground), which was approved by the Office of the Federal Register. You 
may purchase a copy of the material from the United States 
Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 
(http://www.usp.org). Copies also may be examined at FDA's Main 
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, 
MD 20993, 301-796-2039.
    The FCC is a compendium of internationally recognized standards for 
the purity and identity of food ingredients. To ensure that only food 
grade calcium carbonate and ground limestone (consisting of not less 
than 94 percent calcium carbonate) are used in hard and soft candy, 
mints, and chewing gum, the additive must meet the specifications and 
identity in the appropriate FCC monograph.

V. Conclusion

    FDA reviewed the data and information in the petition and other 
available relevant material and determined the use of calcium carbonate 
to color hard and soft candy, mints, and chewing gum at GMP levels is 
safe. We further conclude that the additive will achieve its intended 
technical effect and is suitable for the petitioned uses. We note that 
these uses do not extend to chocolate or the chocolate portion of candy 
because the standards of identity for chocolate do not allow for the 
addition of color additives (see 21 CFR 163.123, 163.124, 163.130, 
163.135, 163.140, 163.145, 163.153, 163.155). Based on the available 
information, we are amending the color additive regulations in part 73 
as set forth in this document. In addition, based on the factors listed 
in 21 CFR 71.20(b), we conclude that certification of calcium carbonate 
to color hard and soft candy, mints, and chewing gum is not necessary 
for the protection of public health (Ref. 1).

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

    We previously considered the environmental effects of this rule, as 
stated in the October 7, 2016, Federal Register notice of petition for 
CAP 6C0307 (81 FR 69740). We stated that we had determined, under 21 
CFR

[[Page 51557]]

25.32(k), that this action ``is of a type that does not individually or 
cumulatively have a significant effect on the human environment'' such 
that neither an environmental assessment nor an environmental impact 
statement is required. We have not received any new information or 
comments that would affect our previous determination.

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 Federal Food, Drug, and Cosmetic 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 (ll)(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 
at 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 are on display with 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 
that are published articles and books are not on display.

1. Memorandum from N. Hepp, Color Technology Team, Office of 
Cosmetics and Colors (OCAC), CFSAN, FDA to C. Johnston, Division of 
Petition Review, Office of Food Additive Safety (OFAS), CFSAN, FDA, 
October 27, 2016.
2. Memorandum from D. Doell, Division of Petition Review, OFAS, 
CFSAN, FDA to J. Kidwell, Division of Petition Review, OFAS, CFSAN, 
FDA, February 16, 2017.
3. 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.
4. European Food Safety Authority (EFSA). ``Scientific Opinion on 
the Tolerable Upper Intake Level of Calcium.'' EFSA Journal, vol. 
10(7), p. 2814, 2012.
5. Memorandum from T. Thurmond, Division of Petition Review, OFAS, 
CFSAN, FDA to J. Kidwell, Division of Petition Review, OFAS, CFSAN, 
FDA, February 17, 2017.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Incorporation by reference, 
Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 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. Section 73.70 is added to subpart A to read as follows:


Sec.  73.70   Calcium carbonate.

    (a) Identity. (1) The color additive calcium carbonate is a fine, 
white powder consisting essentially of calcium carbonate 
(CaCO3) prepared either by grinding naturally occurring 
limestone or synthetically, by precipitation.
    (2) Color additive mixtures for food use made with calcium 
carbonate may contain only those diluents that are suitable and that 
are listed in this subpart as safe for use in color additive mixtures 
for coloring foods.
    (b) Specifications. The color additive meets the specifications of 
the Food Chemicals Codex, 10th ed. (2016), pp. 213-214 (calcium 
carbonate) and p. 754 (limestone, ground), which is incorporated by 
reference. The Director of the Office of the Federal Register approves 
this incorporation by reference in accordance with 5 U.S.C. 552(a) and 
1 CFR part 51. You may obtain copies from the United States 
Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 
(internet address http://www.usp.org). Copies may be examined at the 
Food and Drug Administration's Main Library, 10903 New Hampshire Ave., 
Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the 
National Archives and Records Administration (NARA). For information on 
the availability of this material at NARA, call 202-741-6030, or go to: 
http://www.archives.gov/federal_register/code_of_federal_regulations/cfr/ibr_locations.html.
    (c) Uses and restrictions. Calcium carbonate may be safely used in 
amounts consistent with good manufacturing practice to color 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 51558]]

and Cosmetic Act unless added color is authorized by such standards.
    (d) Labeling requirements. The label of the color additive and of 
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: November 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24194 Filed 11-6-17; 8:45 am]
 BILLING CODE 4164-01-P