CAS 7681-11-0 · TSCA · United States of America

Potassium iodide (KI) under TSCA

KI · 碘化钾

Status: Active. Potassium iodide is on the TSCA Active Inventory. **NOT typically Cal Prop 65 listed** (verify against OEHHA https://oehha.ca.gov/proposition-65/proposition-65-list before relying). NO active US AD/CVD case on Chinese-origin potassium iodide currently (verify against access.trade.gov before invoicing). **DEA List I drug precursor under 21 CFR 1310, KI as iodine matrix may fall within scope at certain concentrations** (verify exact scope + concentration thresholds for iodine salts vs elemental iodine against https://www.deadiversion.usdoj.gov/ + 21 CFR 1310.04 before relying). **FDA-approved OTC anti-thyroid radiation tablet (potassium iodide tablets) for nuclear-incident prophylaxis** (verify against https://www.fda.gov/drugs/ before relying). **Food additive E916 / FDA GRAS for iodised salt fortification** (verify against 21 CFR 184 + https://www.fda.gov/food/ before relying).

Potassium iodide is TSCA-Active with **DEA List I scope-determination required (verify concentration thresholds against deadiversion.usdoj.gov + 21 CFR 1310.04 before invoicing)**. **FDA-approved OTC KI tablets for nuclear-incident radiation prophylaxis** (HHS Strategic National Stockpile + 10-mile EPZ distribution). **FDA GRAS for iodised salt fortification**. NO active US AD/CVD; iodised salt + pharma thyroid blocker + expectorant + animal-feed + photographic emulsion downstream chains.

Listing and threshold

Substance Potassium iodide (KI) (CAS 7681-11-0), KI
Regime US Toxic Substances Control Act (TSCA), administered by EPA
Jurisdiction United States of America
Status Active
Tonnage threshold TSCA Section 8(a) Chemical Data Reporting (CDR) at >25,000 lb/year per US site

Classifications under this regime

  • TSCA Active Inventory
  • **DEA List I drug precursor (21 CFR 1310): verify exact scope + concentration threshold for iodine salts vs elemental iodine against https://www.deadiversion.usdoj.gov/ before relying**
  • OSHA PEL: not specifically established for KI; iodine fume PEL 0.1 ppm ceiling under 29 CFR 1910.1000 Table Z-1 may apply during processing (verify against https://www.osha.gov/annotated-pels before relying)
  • IARC: Not classified (verify against https://monographs.iarc.who.int/ before relying)
  • **NOT typically Cal Prop 65 listed** (verify against https://oehha.ca.gov/proposition-65/proposition-65-list before relying)
  • DOT 49 CFR: NOT regulated as dangerous goods at solid form
  • **USP / NF monograph** for pharma-grade potassium iodide
  • **FDA-approved OTC potassium iodide tablets for radiation prophylaxis (NDA + monograph)** (verify against https://www.fda.gov/drugs/ before relying)
  • **FDA GRAS / food additive 21 CFR 184 for iodised salt fortification** (verify against https://www.fda.gov/food/ before relying)

Restrictions and conditions of use

  • **DEA List I: registration required where in scope; verify exact concentration thresholds for KI as iodine matrix against https://www.deadiversion.usdoj.gov/ before invoicing**
  • NO active US AD/CVD case on Chinese-origin potassium iodide currently (verify against access.trade.gov before invoicing)
  • No CBP-specific restriction beyond DEA List I scope determination and HS 283120
  • EPA FIFRA registration where placed as biocide / pesticide active

Importer obligations

TSCA Section 13 import certification (positive). **Determine whether KI as iodine matrix falls within DEA List I (21 CFR 1310) scope before invoicing (concentration thresholds may apply)** (verify against https://www.deadiversion.usdoj.gov/ before invoicing). FDA-approved OTC KI tablets for radiation prophylaxis distributed by HHS Strategic National Stockpile to populations within 10-mile EPZ of nuclear power plants per NRC + FDA cooperation.

Required documents

  • TSCA Section 13 import certification
  • **DEA List I registration certificate where in scope** (verify against https://www.deadiversion.usdoj.gov/ before invoicing)
  • CBP entry HS 283120 (potassium iodide)
  • SDS (Eye Irrit. 2 + STOT RE 1 thyroid chronic high-dose)
  • USP / NF monograph documentation for pharma-grade
  • FDA NDA / monograph documentation for OTC KI tablets
  • FDA GRAS / 21 CFR 184 documentation for iodised salt fortification

Common compliance traps

The pitfalls that have bitten importers on this lane in the past. None of these is theoretical.

  • **DEA List I scope determination required for KI as iodine matrix (verify exact concentration thresholds against https://www.deadiversion.usdoj.gov/ + 21 CFR 1310.04 before invoicing)**
  • **FDA-approved OTC potassium iodide tablets for nuclear-incident radiation prophylaxis (HHS Strategic National Stockpile + 10-mile EPZ distribution per NRC)**
  • **FDA GRAS / 21 CFR 184 food additive for iodised salt fortification**
  • NO active US AD/CVD case on Chinese-origin potassium iodide
  • NOT regulated as dangerous goods at solid form
  • **Iodised salt + pharma thyroid blocker + expectorant + animal-feed + photographic emulsion downstream chains**

Where to read next

For substance-level identifiers (formula, molecular weight, SMILES, InChIKey), GHS hazard profile, IMDG transport class, and full sourcing reference for potassium iodide (ki), see the CAS 7681-11-0 sourcing reference.

For grade-by-grade buying notes, freight maths, supplier-tier pricing, and a worked landed-cost example, the potassium iodide (ki) cornerstone hub covers the full sourcing chain.

For the structure and history of TSCA, see the TSCA glossary entry.

Need cross-jurisdiction compliance support on this substance? Run it through the REACH / TSCA / IECSC / AICIS / K-REACH checker, or send us the substance and the destination and we will quote FOB China and CIF / DDP landed including the regulatory work on the destination side.

Read next

Cross-jurisdiction profile and sourcing references

Referenced in

5 pages across the Sourzi moat

This term shows up in 4 regulatory pages, 1 CAS profiles. Sample backlinks per content type below.

Regulatory (4)

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CAS (1)

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