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U.S. Department of Health and Human Services

Regulatory Status of Color Additives
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D&C Orange No. 5

Permanently listed, certification required

The Federal Register citations are shown in groupings in chronological order.
CAS Reg No or other ID code: 596-03-2
Color: D&C Orange No. 5
Status: Permanently listed, certification required
Use: Drugs, Cosmetics
Restrictions: Externally applied drugs (NTE 5 mg/daily dose of drug). Externally applied cosmetics. Mouthwashes, dentrifices, lipsticks, and other lip cosmetics NTE 5%.
End Notes: 6
Other names: ♦ 4',5'-DIBROMO-3',6'-DIHYDROXYSPIRO(ISOBENZOFURAN-1(3H),9'-(9H)XANTHEN)-3-ONE
♦ 4',5'-DIBROMOFLUORESCEIN
♦ C.I. 45370:1
♦ C.I. SOLVENT RED 72
♦ FLUORESCEIN, 4',5'-DIBROMO-
♦ SOLVENT RED 72
♦ SPIRO(ISOBENZOFURAN-1(3H),9'-(9H)XANTHEN)-3-ONE, 4',5'-DIBROMO-3',6'-DIHYDROXY-
21 CFR (color additives): 74.1255
74.2255
82.1255
Citations 1: 4 FR 1922 (at page 1928); May 9, 1939; Specifications
Limitations 1: Drugs and cosmetic use.
Citations 2: 25 FR 9759; Oct 12, 1960; Provisional Regulation
25 FR 9759; Oct 12, 1960; Delisting for unrestricted use; temporary tolerances; limitations of certificates
Limitations 2: Provisional drugs and cosmetics. Temporary tolerance of 6% in lipsticks. 0.75 mg/day dosage in ingested drugs and in other preparations subject to ingestion. External drug and cosmetic use limited.
Citations 3: 44 FR 48964; Aug 21, 1979; Temporary Tolerance
45 FR 22904; Apr 4, 1980; Final Rule; confirmation of effective date
Limitations 3: Prior limited use cancelled. Temporary tolerance of 6% in lipsticks. GMP in external drugs and cosmetics, mouthwashes and dentifrices.
Citations 4: 38 FR 21199; Aug 6, 1973; Notice of Filing
47 FR 49632; Nov 2, 1982; Final Rule; ingested drugs; cosmetic lip products
47 FR 52694; Nov 23, 1982; Final Rule; correction
49 FR 13339; Apr 7, 1984; Final Rule; external drug use, external cosmetic use generally.
49 FR 31852; Aug 9, 1984; Final Rule; confirmation of effective date
Limitations 4: Coloring mouthwashes and dentifrices that are ingested. 5% in lipsticks. Externally applied drugs in amounts not exceeding 5mg/day dosage. Externally applied cosmetics GMP.
Citations 5: 49 FR 31852; Aug 9, 1984; Delisting; cancellation of certificate
Limitations 5: Termination of provisional listing and tolerances; cancellation of certificates


 

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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