Regulatory Status of Color Additives
-
D&C Green No. 5
Permanently listed, certification required
The Federal Register citations are shown in groupings in chronological order.
| CAS Reg No or other ID code: | 4403-90-1 |
|---|---|
| Color: | D&C Green No. 5 |
| Status: | Permanently listed, certification required |
| Use: | Drugs, Cosmetics, Devices |
| Restrictions: | Drugs generally. Eye area use. Cosmetics generally. Eye area use. Nylon 66 nonabsorbable sutures; NTE 0.6% general surgery. Nylon 6; NTE 0.6% general surgery. |
| End Notes: | 5 |
| Other names: |
♦ ALIZARIN CYANINE GREEN F ♦ ALIZARIN CYANINE GREEN G ♦ BENZENESULFONIC ACID, 2,2'-((9,10-DIHYDRO-9,10-DIOXO-1,4-ANTHRACENEDIYL)DIIMINO)BIS(5-METHYL-, DISODIUM SALT ♦ C.I. 61570 ♦ DISODIUM 2,2'-((9,10-DIHYDRO-9,10-DIOXO-1,4-ANTHRACENEDIYL)DIIMINO)BIS(5-METHYLBENZENESULFONATE) ♦ DISODIUM 6,6'-(1,4-ANTHRAQUINONYLENEDIIMINO)DI-M-TOLUENESULFONATE ♦ M-TOLUENESULFONIC ACID, 6,6'-(1,4-ANTHRAQUINONYLENEDIIMINO)DI-, DISODIUM SALT |
| 21 CFR (color additives): |
74.1205 74.2205 82.1205 |
| Citations 1: | 4 FR 1922 (at page 1926); 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 |
| Limitations 3: | Proposed use in ingested drugs, lipsticks, and externally applied drugs and cosmetics. Petition incomplete. |
| Citations 4: | 38 FR 20614; Aug 2, 1973; Final Rule |
| 38 FR 29997; Oct 31, 1973; Final Rule; confirmation of effective date | |
| Limitations 4: | Nylon 66 sutures, 0.6% by weight general surgery. |
| Citations 5: | 41 FR 43754; Oct 4, 1976; Filing of Petition |
| 42 FR 52395; Sep 30, 1977; Final Rule | |
| Limitations 5: | Nylon 6 sutures, 0.6% by weight general surgery. |
| Citations 6: | 47 FR 24278; Jun 4, 1982; Final Rule |
| 47 FR 27551; Jun 25, 1982; Correction | |
| 47 FR 38883; Sep 3, 1982; Final Rule; postponement of closing date and stay of effectiveness | |
| 47 FR 49628; Nov 19, 1982; Final rule; termination of stay and confirmation of effective date | |
| 47 FR 52145; Nov 19, 1982; Final Rule; correction | |
| Limitations 6: | Permanent drug and cosmetic excluding in the area of the eye. |
| Citations 7: | 47 FR 24285; Jun 4, 1982; Final Rule |
| Limitations 7: | Provisional use as ingested and externally applied drugs and cosmetics, postponement of closing date. |
| Citations 8: | 59 FR 40802; Aug 10, 1994; Final Rule |
| 59 FR 53584; Oct 25, 1994; Final Rule; confirmation of effective date | |
| Limitations 8: | For coloring drugs and cosmetics intended for use in eye area. |
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.
-
