Regulatory Status of Color Additives
-
FD&C Red No. 4
Permanently listed, certification required
The Federal Register citations are shown in groupings in chronological order.
| CAS Reg No or other ID code: | 4548-53-2 |
|---|---|
| Color: | FD&C Red No. 4 |
| Status: | Permanently listed, certification required |
| Use: | Drugs, Cosmetics |
| Restrictions: | Externally applied drugs. Externally applied cosmetics. |
| End Notes: | 6 |
| Other names: |
♦ 1-NAPHTHALENESULFONIC ACID, 3-((2,4-DIMETHYL-5-SULFOPHENYL)AZO)-4-HYDROXY-, DISODIUM SALT ♦ C.I. 14700 ♦ C.I. FOOD RED 1 ♦ C.I. FOOD RED 1, DISODIUM SALT ♦ D&C RED NO. 4 ♦ DISODIUM 2-(5-SULFO-2,4-XYLYLAZO)-1-NAPHTHOL-4-SULFONATE ♦ DISODIUM 3-((2,4-DIMETHYL-5-SULFOPHENYL)AZO)-4-HYDROXY-1-NAPHTHALENESULFONATE ♦ EXT. D&C RED NO. 24 ♦ PONCEAU SX ♦ RED SHADE #24 |
| 21 CFR (color additives): |
74.1304 74.2304 81.10 81.30 82.304 |
| Citations 1: | SRAFD #3 Sup. #1; Apr 2, 1929; (April 1929) |
| Limitations 1: | Food use. |
| Citations 2: | 4 FR 1922 (at page 1926); May 9, 1939; Specifications |
| Limitations 2: | Food, drug and cosmetic use. |
| Citations 3: | 25 FR 9759; Oct 12, 1960; Provisional Regulation |
| 29 FR 16983; Dec 11, 1964; Delisting; cancellation of certification | |
| Limitations 3: | Provisional food, drug and cosmetic use. Listed as Ext. D&C Red No. 24. |
| Citations 4: | 30 FR 10289; Aug 19, 1965; Provisional Regulation |
| 41 FR 41852; Sep 23, 1976; Delisting | |
| 29 FR 16983; Dec 11, 1964; Cancellation of certification | |
| Limitations 4: | Provisional food, drug and cosmetic use. Certifications cancelled and reinstated for use in maraschino cherries at 150 ppm. Unlimited use in external drugs and cosmetics. |
| Citations 5: | 30 FR 13056; Oct 14, 1965; Final Rule |
| Limitations 5: | Ingested drug use with color consumption limited to 5mg/day for six week period. |
| Citations 6: | 41 FR 41854; Sep 23, 1976; Final Rule |
| 41 FR 56306; Dec 28, 1976; Final Rule; confirmation of effective date | |
| 41 FR 41852; Sep 23, 1976; Delisting | |
| Limitations 6: | Delisted for maraschino cherries and ingested drugs. Provisional external drug and cosmetic use. |
| See also: | Ext. D&C Red No. 24 |
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.
-
