2018-01912. 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.

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 § 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.