Regulatory Status of Color Additives
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D&C Blue No. 6
Permanently listed, certification required
The Federal Register citations are shown in groupings in chronological order.
| CAS Reg No or other ID code: | 482-89-3 |
|---|---|
| Color: | D&C Blue No. 6 |
| Status: | Permanently listed, certification required |
| Use: | Devices |
| Restrictions: | Polyethylene terephthalate sutures NTE 0.2%, plain or chromic collagen absorbable sutures NTE 0.25%, polypropylene sutures NTE 0.5%, general surgicial use; plain or chromic collagen absorbable sutures NTE 0.5%, ophthalmic surgical use; polydioxanone synthetic absorbably sutures NTE 0.5% ophthalmic and general surgical use |
| End Notes: | none |
| Other names: |
♦ (DELTA2,2'-BIINDOLINE)-3,3'-DIONE ♦ 2,2'-BISINDOLE INDIGO ♦ 2-(1,3-DIHYDRO-3-OXO-2H-INDOL-2-YLIDENE)-1,2-DIHYDRO-3H-INDOL-3-ONE ♦ 3H-INDOL-3-ONE, 2-(1,3-DIHYDRO-3-OXO-2H-INDOL-2-YLIDENE)-1,2-DIHYDRO- ♦ C.I. 73000 ♦ FD&C BLUE NO. 6 ♦ INDIGO ♦ INDIGOTIN |
| 21 CFR (color additives): |
74.3106 81.10 81.30 |
| Citations 1: | 4 FR 1922 (at page 1930); 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: | 33 FR 17205; Nov 20, 1968; Notice of Filing of Petition |
| Limitations 3: | Proposed use in externally applied drugs and cosmetics, sutures in general surgery, and ingested drugs and cosmetics; Petition incomplete. |
| Citations 4: | 38 FR 9176; Apr 11, 1973; Notice of filing (polyethylene terephthalate sutures) |
| 38 FR 9176; Apr 11, 1973; Notice of filing (collagen sutures) | |
| 38 FR 9176; Apr 11, 1973; Notice of filing (polypropylene sutures) | |
| 42 FR 62471; Dec 13, 1977; Final Rule | |
| Limitations 4: | Coloring sutures for general surgical use: polyethylene terephthalate NTE 0.2%, plain or chromic collagen NTE 0.25%, polypropylene NTE 0.5%; coloring sutures for opthmalic use: plain or chromic collagen NTE 0.5%. |
| Citations 5: | 42 FR 62471 (at page 62472); Dec 13, 1977; Delisting |
| Limitations 5: | Removes from Provisional list. |
| Citations 6: | 48 FR 27835; Jun 17, 1983; Notice of Filing |
| 49 FR 29955; Jul 25, 1984; Final Rule | |
| Limitations 6: | Coloring polydioxanone synthetic absorbable sutures for ophthalmic and general surgical use, NTW 0.5%; relists sutures from drugs to medical devices. |
| Citations 7: | 50 FR 30697; Jul 29, 1985; Final Rule |
| 51 FR 5990; Feb 19, 1986; Final Rule; confirmation of effective date | |
| Limitations 7: | Provision barring migration from sutures removed as unnecessary. |
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
- 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).
- 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.
- Petitioned for use after the 1960 amendments; never provisionally listed.
- 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.
- 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).
- 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.
- NTE - not to exceed.
- 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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