CAS 7553-56-2 · TSCA · United States of America

Iodine (I2) under TSCA

I2 · 碘

Status: Active. Iodine is on the TSCA Active Inventory. **NOT Cal Prop 65 listed at elemental level** (verified against OEHHA https://oehha.ca.gov/proposition-65/proposition-65-list 2026-05-12; specific iodine compounds may have separate listings). NO active US AD/CVD case on Chinese-origin iodine; China is structurally a net-importer (verify against access.trade.gov before invoicing). **DEA List II essential chemical under 21 CFR 1310.02(b)** for iodine in red-phosphorus reduction of pseudoephedrine to methamphetamine; **DEA registration + record-keeping + suspicious-order reporting required for all distributors and importers** with cumulative threshold for reporting at 0.4 kg per 21 CFR 1310.04 (verify exact concentration thresholds + matrix scope against https://www.deadiversion.usdoj.gov/ and 21 CFR 1310.04 before invoicing).

Iodine is TSCA-Active with **DEA List II essential-chemical overlay (21 CFR 1310.02(b)): registration + record-keeping + suspicious-order reporting + 21 CFR 1313 import / export declarations required for ALL distributors / importers; cumulative reporting threshold 0.4 kg per 21 CFR 1310.04**. OSHA PEL 0.1 ppm ceiling per 29 CFR 1910.1000 Table Z-1 (verified against https://www.osha.gov/annotated-pels 2026-05-12). NO active US AD/CVD; US is structurally a net-importer with Chile (SQM Atacama) + Japan (Iwate / Chiba gas-well) + Iofina (Oklahoma gas-well) as primary sources. **Pharma + LCD-polariser-film + animal-feed + povidone-iodine disinfectant downstream chains**. **DEA List II is the import-screening pivot, not AD/CVD.**

Listing and threshold

Substance Iodine (I2) (CAS 7553-56-2), I2
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 II essential chemical (21 CFR 1310.02(b))** for iodine + iodine matrix solutions; cumulative threshold for reporting at 0.4 kg per 21 CFR 1310.04 (verify exact concentration thresholds + matrix scope against https://www.deadiversion.usdoj.gov/ and 21 CFR 1310.04 before relying)
  • OSHA PEL: 0.1 ppm ceiling per 29 CFR 1910.1000 Table Z-1 (verify against https://www.osha.gov/annotated-pels before relying)
  • NIOSH REL: 0.1 ppm ceiling
  • ACGIH TLV-STEL: 0.1 ppm + TLV-TWA: 0.01 ppm (verify against current ACGIH TLV documentation at https://www.acgih.org/ before relying)
  • IARC: Not classified (verify against https://monographs.iarc.who.int/ before relying)
  • **NOT Cal Prop 65 listed at elemental iodine level** (verified against https://oehha.ca.gov/proposition-65/proposition-65-list 2026-05-12)
  • DOT 49 CFR: UN 3495 IODINE Class 8 PG III
  • **USP / NF monograph** for pharma-grade iodine + iodine tincture + povidone-iodine

Restrictions and conditions of use

  • **DEA List II essential chemical (21 CFR 1310.02(b)): registration mandatory for distributors / importers; record-keeping + suspicious-order reporting + 21 CFR 1313 import / export declarations; cumulative reporting threshold 0.4 kg per 21 CFR 1310.04** (verify against https://www.deadiversion.usdoj.gov/ before relying)
  • NO active US AD/CVD case on Chinese-origin iodine; China is structurally a net-importer (verify against access.trade.gov before invoicing)
  • OSHA PEL 0.1 ppm ceiling per 29 CFR 1910.1000 Table Z-1
  • EPA FIFRA registration where placed as biocide (povidone-iodine teat-dip + udder-wash + hard-surface disinfectant)
  • No CBP-specific restriction beyond DEA List II (21 CFR 1310.02(b)) and HS 280120

Importer obligations

TSCA Section 13 import certification (positive). **DEA List II registration mandatory for any importer of record; 21 CFR 1310 record-keeping + 21 CFR 1313 import / export declarations; cumulative reporting threshold 0.4 kg per 21 CFR 1310.04** (verify against https://www.deadiversion.usdoj.gov/ before invoicing). US is structurally a net-importer; primary sources are Chile (SQM Atacama caliche-ore), Japan (Nippon Soda + Toho Earth-tech + ISE Chemicals; Iwate / Chiba gas-well), Russia, plus domestic US producer Iofina (Oklahoma gas-well brines).

Required documents

  • TSCA Section 13 import certification
  • **DEA List II registration certificate (DEA Form 510)** (verify current form + filing requirements against https://www.deadiversion.usdoj.gov/ before invoicing)
  • **DEA Form 486 import declaration where applicable per 21 CFR 1313** (verify before consignment)
  • CBP entry HS 280120 (iodine)
  • SDS (Skin Irrit. 2 + Eye Irrit. 2 + STOT SE 3 + Acute Tox. 4 inhalation)
  • DOT shipping papers UN 3495 Class 8 PG III
  • USP / NF + FIFRA documentation where applicable

Common compliance traps

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

  • **DEA List II essential chemical (21 CFR 1310.02(b)): registration + record-keeping + suspicious-order reporting + 21 CFR 1313 import / export declarations required for ALL distributors / importers; cumulative reporting threshold 0.4 kg per 21 CFR 1310.04**
  • OSHA PEL 0.1 ppm ceiling (29 CFR 1910.1000 Table Z-1)
  • **US is structurally a net-importer**; primary sources are Chile (SQM Atacama caliche-ore) + Japan (Iwate / Chiba gas-well brines) + Iofina (Oklahoma gas-well brines)
  • NO active US AD/CVD case on Chinese-origin iodine; China is structurally a net-importer
  • DOT UN 3495 Class 8 PG III corrosive solid
  • **Pharma + LCD-polariser-PVA-film + animal-feed (EDDI + iodised salt) + povidone-iodine disinfectant 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 iodine (i2), see the CAS 7553-56-2 sourcing reference.

For grade-by-grade buying notes, freight maths, supplier-tier pricing, and a worked landed-cost example, the iodine (i2) 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

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