§ 73.70 - xxx

§ 73.70 Calcium carbonate.

Cross Reference

Link to an amendment published at 87 FR 58448, Sept. 27, 2022.

(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/ibr_locations.html.

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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, 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 § 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.

(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: [e-mail]; website: www.archives.gov/federal-register/cfr/ibr-locations.html. You may obtain the material from the U.S. Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852; website: www.usp.org.

(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).

[82 FR 51557, Nov. 7, 2017, as amended at 87 FR 58448, Sept. 27, 2022]