Regulations of Reduced Iron
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Identifiers
FormulaC30H21FeN3O15-3·CAS61481-53-6
How does the regulatory treatment of Reduced Iron differ by market or product category?
Regulatory treatment of Reduced Iron varies by market and product category. In the EU, iron is an active REACH registered substance, and iron oxide (a related form) is listed under Annex IV of the EU cosmetics regulation with no specific restrictions or maximum concentration limits. In the US, iron is an active TSCA commercial substance, subject to EPA Chemical Data Reporting for manufacturers and importers, and is listed as a California Safe Cosmetics Program reportable ingredient due to environmental toxicity traits. In Australia, iron appears on the AICIS inventory. In New Zealand, iron lacks individual approval but may be used under an appropriate group standard. For food, iron is recognized as a nutrient supplement and food contaminant metal, with a JECFA provisional maximum tolerable daily intake of 0.8 mg/kg bw/day.
Which United States federal regulations apply to Reduced iron?
2 regulations
FDA Technical Effects
Regulatory records
| Regulation | Status |
|---|---|
| FDA Technical Effect: NUTRIENT SUPPLEMENT | authorized |
What EU regulatory requirements apply to Reduced iron?
1 regulation
COSING Annex IV Colorants (Reg 1223/2009)
- Published
- 22 Dec 2009
- Effective
- 11 Jan 2010
- Transition
- 11 Jul 2013
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 134 | EU 1223/2009 | IV | authorized |
Record details
EU 1223/2009
- professional use only
- No
What regulations apply to Reduced iron in Canada?
1 regulation
DSL / NDSL
- Published
- 04 May 1994
- Effective
- 04 May 1994
Regulatory records
| Entry | Regulation | Type | Status |
|---|---|---|---|
| 7439-89-6 | SOR/94-311 | DSL | authorized |
| 1332-37-2 | SOR/94-311 | DSL | authorized |
Conditions
This substance is on the Domestic Substances List (DSL). This substance was added to the DSL as an “Existing Substance” given that it meets the criteria set out in CEPA for substances that were in commerce in Canada between 1984 and 1986.
Record details
SOR/94-311
- professional use only
- No
SOR/94-311
- professional use only
- No
Which conditions, limits, and use contexts most affect a compliance assessment for Reduced Iron?
Key conditions and limits include: for food, a provisional maximum tolerable daily intake of 0.8 mg/kg bw/day for iron from all sources except iron oxides used as colorants and supplemental iron in specific clinical situations. For occupational exposure, an 8-hour TWA TLV of 5 mg/m³ for respirable iron oxide, with an A4 carcinogenicity classification (not classifiable as human carcinogen). A chronic oral reference dose of 0.7 mg/kg-day is established. GHS classifications include flammable solid (H228), self-heating (H251), eye irritation (H319), and respiratory irritation (H335). US EPA drinking water standard for iron is 300 µg/L. These limits affect formulation, labeling, and safety assessment, particularly for food and occupational exposure scenarios.
What should be in place before a product containing Reduced Iron is assessed for launch?
Before launch, ensure the following are in place: for US TSCA compliance, verify that manufacturing or import reporting obligations under the Chemical Data Reporting rule are met, as iron is an active commercial substance. For EU REACH, confirm the substance is covered by an active registration dossier. For cosmetics, check if the ingredient is listed in the EU Annex IV (as iron oxide is) and comply with any applicable restrictions; note that some related substances have concentration limits of 0.1% by weight. For food use, ensure compliance with the JECFA PMTDI of 0.8 mg/kg bw/day and any relevant food additive regulations. Also prepare GHS-compliant safety data sheets reflecting flammability and irritation hazards, and child-proof packaging for iron preparations as recommended by US EPA.
Where does the available regulatory position stop short of supporting a decision on Reduced Iron?
The available regulatory position stops short of a definitive decision on Reduced Iron because most evidence pertains to iron generally or iron oxide, not elemental Reduced Iron specifically. For instance, the EU cosmetics listing is for iron oxide (CI 77489), not Reduced Iron. The REACH registration and TSCA active status cover iron broadly, but do not specify Reduced Iron as a distinct substance. The JECFA PMTDI applies to iron from all sources except certain exclusions, but does not address Reduced Iron's bioavailability or safety in all product categories. GHS classifications are based on company notifications and may not reflect all hazards. Therefore, a compliance assessment cannot rely solely on this evidence; additional substance-specific data are needed.
Which recent regulatory changes or effective dates are material for Reduced Iron?
A material recent regulatory update is the EU REACH registration dossier for iron, which was last updated on 14 May 2023, indicating an active registration status. This update is relevant for EU market access, as it confirms the substance is currently registered. No other recent regulatory changes or effective dates are provided in the evidence. For the US, the TSCA Chemical Data Reporting rule (40 eCFR Part 711) is an ongoing obligation, but no specific effective date is given. For cosmetics, the EU Annex IV listing for iron oxide is active, but no recent amendment is noted. Therefore, the only time-sensitive element is the REACH dossier update, which should be verified for continued compliance.