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U.S. Department of Health and Human Services

Regulatory Status of Color Additives
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FD&C Red No. 40

Permanently listed, certification required

The Federal Register citations are shown in groupings in chronological order.
CAS Reg No or other ID code: 25956-17-6
Color: FD&C Red No. 40
Status: Permanently listed, certification required
Use: Foods, Drugs, Cosmetics
Restrictions: Foods generally. Drugs generally. Cosmetics generally (includes lakes). Eye area use (includes aluminum lake). No oxidizing or reducing agents that may affect integrity.
End Notes: 4, 5, 6
Other names: ♦ 2-NAPHTHALENESULFONIC ACID, 6-HYDROXY-5-((2-METHOXY-5-METHYL-4-SULFOPHENYL)AZO)-, DISODIUM SALT
♦ 2-NAPHTHALENESULFONIC ACID, 6-HYDROXY-5-((6-METHOXY-4-SULFO-M-TOLYL)AZO)-, DISODIUM SALT
♦ ALLURA RED
♦ ALLURA RED AC
♦ C.I. 16035
♦ C.I. FOOD RED 17
♦ D&C RED NO. 40
♦ DISODIUM 6-HYDROXY-5-((2-METHOXY-5-METHYL-4-SULFOPHENYL)AZO)-2-NAPHTHALENESULFONATE
♦ DISODIUM 6-HYDROXY-5-((6-METHOXY-4-SULFO-M-TOLYL)AZO)-2-NAPHTHALENESULFONATE
♦ FOOD RED 17
♦ FOOD RED NO. 40
Color additive regulations in 21 CFR: 74.1340
74.2340
74.340
Citations 1: 35 FR 10529; Jun 27, 1970; Notice of Filing
36 FR 6892; Apr 10, 1971; Final Rule
36 FR 11645; Jun 17, 1971; Final rule; confirmation of effective date.
36 FR 23552; Dec 10, 1971; Correction, specifications
Limitations 1: Food and drugs GMP.
Citations 2: 36 FR 12908; Jul 9, 1971; Proposed rule
36 FR 23552; Dec 10, 1971; Final Rule, FD&C Red No. 40 lakes
Limitations 2: Food and drugs GMP.
Citations 3: 39 FR 28278; Aug 6, 1974; Final Rule
39 FR 38222; Oct 30, 1974; Final Rule; confirmation of effective date
Limitations 3: Coloring dentifrices that are cosmetics. GMP
Citations 4: 39 FR 44198; Dec 23, 1974; Final Rule
40 FR 15087; Apr 4, 1975; Final Rule; confirmation of effective date
Limitations 4: Cosmetics generally, including lakes; may not be exposed to oxidizing or reducing agents which may affect the integrity of the color. GMP. Specific rule for coloring dentifrices is removed.
Citations 5: 57 FR 35833; Aug 11, 1992; Notice of Filing
59 FR 7635; Feb 16, 1994; Final Rule
59 FR 8507; Feb 22, 1994; Correction
Limitations 5: For coloring drugs and cosmetics intended for use in eye area, including the aluminum lake.
E Number: E129

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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