Regulatory Status of Color Additives
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FD&C Yellow No. 5
Permanently listed, certification required
The Federal Register citations are shown in groupings in chronological order.
| CAS Reg No or other ID code: | 1934-21-0 |
|---|---|
| Color: | FD&C Yellow No. 5 |
| Status: | Permanently listed, certification required |
| Use: | Foods, Drugs, Cosmetics |
| Restrictions: | Foods generally. Ingested drugs generally. Externally applied drugs. Eye area use (includes lakes). Cosmetics generally. Eye area use (includes Al lake). |
| End Notes: | 4, 5, 6, 7, 8 |
| Other names: |
♦ 1H-PYRAZOLE-3-CARBOXYLIC ACID, 4,5-DIHYDRO-5-OXO-1-(4-SULFOPHENYL)-4-((4-SULFOPHENYL)AZO)-, TRISODIUM SALT ♦ ACID YELLOW 23 ♦ C.I. 19140 ♦ C.I. ACID YELLOW 23 ♦ C.I. ACID YELLOW 23, TRISODIUM SALT ♦ C.I. FOOD YELLOW 4 ♦ D&C YELLOW NO. 5 ♦ FOOD YELLOW NO. 4 ♦ TARTRAZINE ♦ TARTRAZINE LAKE ♦ TARTRAZINE O ♦ TARTRAZINE YELLOW ♦ TRISODIUM 4,5-DIHYDRO-5-OXO-1-(4-SULFOPHENYL)-4-((4-SULFOPHENYL)AZO)-1H-PYRAZOLE-3-CARBOXYLATE ♦ YELLOW LAKE 69 |
| 21 CFR (color additives): |
74.1705 74.2705 74.705 82.705 |
| Other regulations in 21 CFR: |
178.1010 178.3297 |
| Citations 1: | FID 164; Jan 1, 1916; (1916) |
| Limitations 1: | Food use. |
| Citations 2: | 4 FR 1922 (at page 1925); May 9, 1939; Specifications |
| Limitations 2: | Food, drug and cosmetic use. |
| Citations 3: | 25 FR 9759; Oct 12, 1960; Provisional Regulation |
| Limitations 3: | Provisional food, drug and cosmetic use. |
| Citations 4: | 31 FR 3008; Feb 22, 1966; Final Rule; listing for food and drugs subject to certification |
| 31 FR 8369; Jun 15, 1966; Final Rule; Stay of effective date | |
| 34 FR 7447; May 8, 1969; Final Rule; response to objections; change in quantitative limit and specifications | |
| 34 FR 11542; Jul 12, 1969; Final Rule; confirmation of effective date | |
| Limitations 4: | Food and ingested drugs generally. GMP. |
| Citations 5: | 39 FR 2358; Jan 21, 1974; Final Rule; identity, specifications, certification |
| 42 FR 6805; Feb 4, 1977; Response to objections; stay of effectiveness. | |
| 50 FR 35774; Sep 4, 1985; Final Rule; removal of stay; identity and specifications for cosmetics and external drugs | |
| 51 FR 24517; Jul 7, 1986; Final Rule; amend regulations for food and ingested drugs | |
| 51 FR 24519; Jul 7, 1986; Final rule; termination of stay, confirmation of effective date, and further amendment | |
| 51 FR 39653; Oct 30, 1986; Final Rule; confirmation of effective date; identity and specifications | |
| Limitations 5: | Externally applied drugs. Cosmetics generally GMP. Revised identity and specifications for use in foods and ingested drugs to be the same as those for cosmetics and externally applied drugs. |
| Citations 6: | 42 FR 6835; Feb 4, 1977; Proposed Rule; food and drug labeling |
| 44 FR 37212; Jun 26, 1979; Final Rule; food and drug labeling | |
| 44 FR 45614; Aug 3, 1979; Final Rule; change in effective date for drugs | |
| 45 FR 60419; Sep 12, 1980; Confirmation of effective date; revised regulations for certain drugs for human use. | |
| 46 FR 31004; Jun 12, 1981; Extension and confirmation of effective date; amendment of effective date for labeling of ice cream and frozen custard | |
| Limitations 6: | Labeling of foods and ingested drugs. |
| Citations 7: | 50 FR 35789; Sep 4, 1985; Postponement of closing date for the provisional listing for use in cosmetics generally and externally applied drugs |
| 50 FR 45909; Nov 5, 1985; Final Rule; stay of effective date | |
| 51 FR 375; Jan 6, 1986; Final Rule; postponement of closing date; continued stay of effectiveness | |
| 51 FR 16674; May 6, 1986; Final Rule; postponement of closing date; provisional listing, continued stay of effectiveness | |
| Limitations 7: | Provisional listing for cosmetics and externally applied drugs. |
| Citations 8: | 57 FR 35594; Aug 10, 1992; Notice; petition proposing use in the area of the eye |
| 59 FR 60893; Nov 29, 1994; Final Rule | |
| 59 FR 61929; Dec 2, 1994; Correction | |
| 60 FR 5131; Jan 26, 1995; Final Rule; confirmation of effective date | |
| Limitations 8: | For coloring drugs and cosmetics intended for use in eye area. |
| Citations 9: | 60 FR 37611; Jul 21, 1995; Proposed Rule |
| 61 FR 8372; Mar 4, 1996; Proposed Rule | |
| Limitations 9: | Proposed rules: to require declaration in ingredient list of butter, cheese and ice cream and on labels of drug products administered to mucous membranes. Confirm to same requirements as FD&C Yellow No. 6 listing on cold pack and club cheese. To amend regulation for the use of abbreviated name. Include lakes. |
| E Number: | E102 |
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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