Calcium Carbonate

Permanently listed, exempt from certification

The Federal Register citations are shown in groupings in chronological order.

• CAS Reg No or other ID code: 471-34-1
• Color: Calcium Carbonate
• Status: Permanently listed, exempt from certification
• Use: Foods, Drugs
• Restrictions: Drugs generally. Hard and soft candy, mints, and chewing gum.
• End Notes: 5
• Other names: ♦ C.I. 77220; ♦ C.I. PIGMENT WHITE 18; ♦ CALCIUM CARBONATE, PRECIPITATED; ♦ CARBONIC ACID CALCIUM SALT (1:1); ♦ PIGMENT WHITE 18; ♦ PRECIPITATED CHALK
• Color additive regulations in 21 CFR: 73.70; 73.1070
• Other regulations in 21 CFR: 178.3297; 181.29; 184.1191
• Citations 1: 25 FR 9759; Oct 12, 1960; Provisional Regulation

• Limitations 1: Provisional cosmetic use.
• Citations 2: 26 FR 7578; Aug 16, 1961; Provisional Regulation ; 32 FR 50; Jan 5, 1967; Delisting ; 32 FR 50; Jan 1, 1967; Last date of permitted use for non-certified color additive
• Limitations 2: Delisting for food use.
• Citations 3: 28 FR 7424; Jul 20, 1963; Provisional List
• Limitations 3: Provisional drug use.
• Citations 4: 32 FR 2645; Feb 8, 1967; Notice of Proposal to List ; 32 FR 6685; May 2, 1967; Final Rule; identity, specifications ; 32 FR 8814; Jun 21, 1967; Confirmation of effective date
• Limitations 4: Drugs generally GMP.
• Citations 5: 40 FR 15087; Apr 4, 1975; Delisting
• Limitations 5: Termination of provisional cosmetic use.
• Citations 6: 49 FR 3804; Jan 30, 1984; Incorporation by Reference; proposed updating of text ; 49 FR 10087; Mar 19, 1984; Final Rule ; 49 FR 23832; Jun 8, 1984; Final Rule; confirmation of effective date
• Limitations 6: Drug use. Incorporated by reference the United States Pharmacopeia XX (1980), specifications; no substantive changes to regulations.
• Citations 7: 81 FR 69740; Oct 7, 2016; Notice of petition ; 82 FR 51554; Nov 7, 2017; Final Rule ; 83 FR 4423; Jan 31, 2018; Final Rule; confirmation of effective date
• Limitations 7: Color hard and soft candy, mints, and chewing gum. GMP.
• Citations 8: 85 FR 74304; Nov 20, 2020; Notification of Petition ; 87 FR 58445; Sep 27, 2022; Final Rule ; 88 FR 4085; Jan 24, 2023; Final Rule; confirmation of effective date
• Limitations 8: To color dietary supplement tablets and capsules (including coatings and printing inks). Update incorporation by reference.
• EEC No: E170

Definitions of Terms Used

• FID
  Food Inspection Decision (issued by USDA prior to 1927)
• CAS Reg. No. or other ID
  Chemical Abstract Service (CAS) Registry® Number for the substance or a numerical code assigned by CFSAN (977nnn-nn-n-series) to those substances that do not have a CAS Reg. No.
• Other names
  Recognized synonyms for color additives
• Lakes
  Insoluble pigments formed by chemically reacting water-soluble straight colors with precipitants and substrata.

 

End Notes

1. The color additives Antarctic krill meal, Astaxanthin, Astaxanthin dimethyldisuccinate, Ultramarine blue, Canthaxanthin, Haematococcus algae meal, Synthetic iron oxide, Dried algae meal, Tagetes (Aztec marigold) meal and extract, Corn endosperm oil, Paracoccus pigment, and Phaffia yeast are approved for specific uses in animal food (see 21 CFR 73.32. 73.35, 73.37, 73.50, 73.75, 73.185, 73.200, 73.275, 73.295, 73.315, 73.352, and 73.355, respectively).
2. The year approved is based on the date listed in the "Confirmation of Effective Date" notice for the action as published in the Federal Register.
3. Petitioned for use after the 1960 amendments; never provisionally listed.
4. Color additives listed in 21 CFR Parts 74 and 82 must be analyzed and batch certified by FDA before they can be used in any FDA-regulated product marketed in the U.S. This requirement applies to products imported into this country as well as those manufactured domestically. Manufacturers of certified color additives must include on the label the name of the certified color additive, a statement indicating general use limitations, any quantitative limitations in products, and the certification lot number assigned to the batch. Straight colors required to be certified are listed in 21 CFR Part 74. Most lakes are provisionally listed under 21 CFR 81.1 for use as listed in 21 CFR 82.51 (food, drugs, and cosmetics), 21 CFR 82.1051 (drugs and cosmetics), or 21 CFR 82.2051 (externally applied drugs and cosmetics). All FD&C Red No. 40 lakes are permanently listed under 21 CFR 74.340 (food), 74.1340 (drugs), and 74.2340 (cosmetics). FD&C Blue No. 1 and FD&C Yellow No. 5 aluminum lakes for drug and cosmetic use are permanently listed in 21 CFR sections 74.1101, 74.1705, 74.2101, and 74.2705.
5. Color additives that are permitted for general use may not be used in the area of the eye, in injections, or in surgical sutures unless such use is specified in the color additive listing regulation. Currently no color additives are listed for use in injected products (such as tattoos or permanent makeup).
6. Color additives that are permitted for external application may not be used in the area of the eye, in injections, or in surgical sutures unless such use is specified in the color additive listing regulation. Currently no color additives are listed for use in injected products (such as tattoos or permanent makeup). Some color additives that are permitted for external application also may be permitted in mouthwashes, dentifrices, or lipsticks in limited amounts specified in the color additive listing regulations.
7. NTE - not to exceed.
8. The listed color additives are the reaction products produced by copolymerizing the reactive dyes with various monomers such that the dyes are chemically bound in the resulting polymer matrix.