Regulatory Status of Color Additives
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D&C Yellow No. 10
Permanently listed, certification required
The Federal Register citations are shown in groupings in chronological order.
| CAS Reg No or other ID code: | 8004-92-0 |
|---|---|
| Color: | D&C Yellow No. 10 |
| Status: | Permanently listed, certification required |
| Use: | Drugs, Cosmetics, Devices |
| Restrictions: | Drugs generally. Modification of uses and restrictions. Cosmetics generally. Contact lenses. |
| End Notes: | 3, 4, 5, 6, 7 |
| Other names: |
♦ Acid Yellow 3 ♦ C.I. 47005 ♦ C.I. Acid Yellow 3 ♦ FD&C Yellow No. 10 ♦ Quinoline Yellow ♦ Quinoline Yellow WS |
| 21 CFR (color additives): |
74.1710 74.2710 74.3710 82.1710 |
| Citations 1: | 4 FR 1922 (at page 1927); May 9, 1939; Specifications |
| Limitations 1: | Drug and cosmetic use. |
| Citations 2: | 25 FR 9759; Oct 12, 1960; Provisional Regulation |
| 30 FR 8333; Jun 30, 1965; Postponement of closing dates for provisional listing | |
| 32 FR 10930; Jul 26, 1967; Postponement of closing date | |
| Limitations 2: | Provisional drug and cosmetic use. |
| Citations 3: | 44 FR 48964; Aug 21, 1979; Final Rule |
| 45 FR 22904; Apr 4, 1980; Final Rule; confirmation of effective date | |
| Limitations 3: | Unlimited use cancelled. Temporary tolerance of 1% in lipsticks and 10 mg/daily dose ingested drugs. GMP in external drugs and cosmetics, dentifrices and mouthwashes. |
| Citations 4: | 48 FR 39217; Aug 30, 1983; Final Rule, permanent listing, drugs and cosmetics |
| 48 FR 50311; Nov 1, 1983; Final Rule; postponement of closing date and stay of effectiveness | |
| 48 FR 39220; Aug 30, 1983; Final Rule, postponement of closing date | |
| 48 FR 50312; Nov 1, 1983; Effective date, temporary stay | |
| 48 FR 41760; Aug 19, 1983; Correction | |
| Limitations 4: | Drugs generally limited to 10 mg/daily dose. Cosmetics GMP except lip cosmetics limited to 1% by weight. |
| Citations 5: | 49 FR 61; Jan 3, 1984; Final Rule; postponement of closing date |
| 49 FR 8429; Mar 7, 1984; Final Rule; confirmation of effective date, termination of stay | |
| 49 FR 27744; Jul 6, 1984; Final Rule; confirmation of effective date, drugs and cosmetics excluding eye area | |
| Limitations 5: | Previous limits never effective. Final order for listing in drugs and cosmetics general GMP. |
| Citations 6: | 48 FR 48870; Oct 21, 1983; Notice of Filing for contact lenses |
| 52 FR 28688; Aug 3, 1987; Final Rule | |
| 52 FR 45938; Dec 3, 1987; Final Rule; confirmation of effective date | |
| Limitations 6: | For coloring contact lenses to exceed minimum amount needed for intended purpose. |
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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