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U.S. Department of Health and Human Services

Regulatory Status of Color Additives
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D&C Red No. 6

Permanently listed, certification required

The Federal Register citations are shown in groupings in chronological order.
CAS Reg No or other ID code: 5858-81-1
Color: D&C Red No. 6
Status: Permanently listed, certification required
Use: Drugs, Cosmetics
Restrictions: Drugs such that total with D&C Red No. 7 NTE 5 mg/daily dose of drug. Ether soluble matter specification changed to1-[(4-methylphenyl)azo]-2-naphthalenol, not more than 0.015 percent. Cosmetics generally.
End Notes: 5
Other names: ♦ 2-NAPHTHALENECARBOXYLIC ACID, 3-HYDROXY-4-((4-METHYL-2-SULFOPHENYL)AZO)-, DISODIUM SALT
♦ C.I. 15850
♦ C.I. PIGMENT RED 57
♦ C.I. PIGMENT RED 57, DISODIUM SALT
♦ DISODIUM 3-HYDROXY-4-((4-METHYL-2-SULFOPHENYL)AZO)-2-NAPHTHALENECARBOXYLATE
♦ JAPAN RED 201
♦ LITHOL RUBINE
♦ PIGMENT RED 57
21 CFR (color additives): 74.1306
74.2306
82.1306
Citations 1: 4 FR 1922 (at page 1927); May 9, 1939; Specifications
Limitations 1: Drugs and cosmetic use.
Citations 2: 25 FR 9759; Oct 12, 1960; Provisional Regulation
Limitations 2: Provisional drugs and cosmetic use.
Citations 3: 38 FR 21199; Aug 6, 1973; Notice of Filing
47 FR 57687; Dec 28, 1982; Final Rule
48 FR 3946; Jan 28, 1983; Correction
Limitations 3: Drugs daily dose not to exceed 5mg total of D&C Red No. 6 and D&C Red No. 7. Cosmetic use generally GMP.
Citations 4: 76 FR 20992; Apr 14, 2011; Notice of Filing
77 FR 39921; Jul 6, 2012; Final Rule
77 FR 55693; Sep 11, 2012; Final Rule; confirmation of effective date
Limitations 4: Change in specification.


 

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.
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