Regulatory Status of Color Additives
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Synthetic Iron Oxides / Iron Oxides
Permanently listed, exempt from certification
The Federal Register citations are shown in groupings in chronological order.
| CAS Reg No or other ID code: | 1332-37-2 |
|---|---|
| Color: | Synthetic Iron Oxides / Iron Oxides |
| Status: | Permanently listed, exempt from certification |
| Use: | Foods, Drugs, Cosmetics, Devices |
| Restrictions: | Sausage casings NTE 0.1 percent (by wt). Hard and soft candy, mints, and chewing gum. Dietary supplement tablets and capsules. For all human food uses, lead (as Pb) content NTE 5 mg/kg (5 ppm). Ingested or topically applied drugs ingested dosage by man NTE 5 mg/d (as Fe). Cosmetics generally including eye area use. Contact lenses. |
| End Notes: | 1, 3, 6 |
| Other names: |
♦ IRON OXIDE ♦ IRON OXIDES ♦ IRON OXIDE, SYNTHETIC |
| 21 CFR (color additives): |
73.1200 73.200 73.2250 73.3125 |
| Other regulations in 21 CFR: |
175.300 175.380 175.390 177.1350 177.1460 177.2600 178.3297 182.99 186.1374 |
| Citations 1: | 25 FR 9759; Oct 12, 1960; Provisional Regulation |
| Limitations 1: | Provisional food, drug and cosmetic use (as iron oxides). |
| Citations 2: | 26 FR 7578; Aug 16, 1961; Provisional Regulation (as ferric hydroxide (hydrated iron oxide)) |
| 29 FR 17089; Dec 15, 1964; Postponement of closing date | |
| Limitations 2: | Provisional regulation for cosmetic use (as ferric hydroxide (hydrated iron oxide)) |
| Citations 3: | 28 FR 3693; Apr 16, 1963; Final Rule (as synthetic iron oxide) |
| 28 FR 5719; Jun 12, 1963; Stay of Order Listing | |
| 31 FR 2653; Feb 11, 1966; Final Rule | |
| 31 FR 5127; Mar 30, 1966; Final Rule; confirmation of effective date | |
| Limitations 3: | Ingested and topical drugs generally. Limit 5 mg as Fe/day (as synthetic iron oxide). |
| Citations 4: | 29 FR 17089; Dec 15, 1964; Postponement of Closing Date; restriction to pet foods |
| 31 FR 9105; Jul 2, 1966; Delisting | |
| 31 FR 9105; Jul 2, 1966; Last date of permitted use for non-certified color additive | |
| Limitations 4: | Pet foods only (as iron oxides) |
| Citations 5: | 32 FR 50; Jan 5, 1967; Restoration to provisional list, dog and cat food only (as iron oxide) |
| 33 FR 9953; Jul 11, 1968; Final Rule (iron oxide, synthetic iron oxide) | |
| 33 FR 12228; Aug 30, 1968; Final Rule; confirmation of effective date | |
| Limitations 5: | 0.25% in finished dog and cat food (as synthetic iron oxide). |
| Citations 6: | 33 FR 982; Jan 26, 1968; Postponement of closing date |
| 33 FR 982; Jan 26, 1968; Include hydrated iron oxide (ferric hydroxide) for cosmetic use. | |
| Limitations 6: | Provisional regulations: postponement of closing date for food use; hydrated iron oxide included for cosmetic use. |
| Citations 7: | 33 FR 10844; Jul 31, 1968; Termination of use in mink feed. |
| Limitations 7: | Provisional regulation for mink feed terminated. |
| Citations 8: | 38 FR 21200; Aug 6, 1973; Notice of Filing |
| 41 FR 52445; Nov 30, 1976; Final Rule (identity, specifications; iron oxides consist of synthetically prepared iron oxides, including the hydrated forms) | |
| 42 FR 12425; Mar 4, 1977; Final Rule; confirmation of effective date | |
| Limitations 8: | Cosmetics generally GMP including eye area use. |
| Citations 9: | 50 FR 50234; Dec 9, 1985; Notice |
| 51 FR 24815; Jul 9, 1986; Final Rule | |
| 51 FR 33032; Sep 18, 1986; Final Rule; confirmation of effective date | |
| Limitations 9: | For use in contact lenses GMP; identify and specifications same as for cosmetic use. |
| Citations 10: | 56 FR 1197; Jan 11, 1991; Notice of Filing |
| 59 FR 10578; Mar 7, 1994; Final Rule (as synthetic iron oxide) | |
| 59 FR 28765; Jun 3, 1994; Final Rule; confirmation of effective date | |
| Limitations 10: | For coloring of sausage casing intended for human consumption (as synthetic iron oxide). |
| Citations 11: | 69 FR 24511; May 4, 2004; Final Rule; technical amendments |
| Limitations 11: | Technical amendment. |
| Citations 12: | 78 FR 57105; Sep 17, 2013; Notice of petition (synthetic iron oxide) |
| 80 FR 14839; Mar 20, 2015; Final Rule (as synthetic iron oxide) | |
| 80 FR 31466; Jun 30, 2015; Final Rule; confirmation of effective date | |
| Limitations 12: | Food use, soft and hard candy, mints and chewing gum. Lead specification in human food reduced from 10 mg/kg (10 ppm) to 5 mg/kg (5 ppm). |
| Citations 13: | 82 FR 52037; Nov 9, 2017; Notification of petition |
| 83 FR 54869; Nov 1, 2018; Final Rule (as synthetic iron oxide) | |
| 84 FR 16205; Apr 18, 2019; Final Rule; confirmation of effective date | |
| Limitations 13: | Dietary supplement tablets and capsules |
| E Number: | E172 |
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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