Document ID: FDA-2016-C-2767-0008
Agency: fda
Document Type: Rule
Title: Listing of Color Additives Exempt From Certification; Calcium Carbonate;
Confirmation of Effective Date
Posted Date: 2018-01-31T05:00Z

[Federal Register Volume 83, Number 21 (Wednesday, January 31, 2018)]
[Rules and Regulations]
[Page 4423]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01912]

[[Page 4423]]

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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; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA or we) is confirming the 
effective date of December 8, 2017, for the final rule that appeared in 
the Federal Register of November 7, 2017, and that amended the color 
additive regulations to provide for the safe use of calcium carbonate 
to color hard and soft candy, mints, and in inks used on the surface of 
chewing gum.

DATES: Effective date of final rule published in the Federal Register 
of November 7, 2017 (82 FR 51554) confirmed: December 8, 2017.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule 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, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1071.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 7, 2017 
(82 FR 51554), we amended the color additive regulations to add Sec.  
73.70, ``Calcium carbonate,'' (21 CFR 73.70) to provide for the safe 
use of calcium carbonate 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 
issued under section 401 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 341), unless added color is authorized by such standards.
    We gave interested persons until December 7, 2017, to file 
objections or requests for a hearing. We explained that to file an 
objection, among other things, persons must specify with particularity 
the provision(s) to which they object. We also explained that if a 
person who properly submits an objection wants a hearing, he or she 
must specifically request a hearing and that failure to do so will 
constitute a waiver of the right to a hearing (82 FR 51554 at 51557).
    We received two comments regarding our decision to amend the color 
additive regulations to provide for the safe use of calcium carbonate 
to color soft and hard candies and mints, and in inks used on the 
surface of chewing gum. Neither comment, however, specified with 
particularity the provision(s) of the regulation to which they objected 
nor specifically requested a hearing. Therefore, we find that the 
effective date of the final rule that published in the Federal Register 
of November 7, 2017, should be confirmed.

List of Subjects in 21 CFR Part 73

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

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and 
under authority delegated to the Commissioner of Food and Drugs, we are 
giving notice that no objections or requests for a hearing were filed 
in response to the November 7, 2017, final rule. Accordingly, the 
amendments issued thereby became effective December 8, 2017.

    Dated: January 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-01912 Filed 1-30-18; 8:45 am]
 BILLING CODE 4164-01-P