Iodine (I2) under REACH
I2 · 碘
Status: Registered. Iodine is fully registered under REACH. **Distinguishing pattern: extracted globally from Chilean caliche-ore brines (SQM Atacama Desert dominant) plus Japanese gas-well brines (Iwate + Chiba prefectures) plus US Oklahoma gas-well brines (Iofina) plus Russian gas-well brines; China is structurally a net-importer of iodine for pharma + LCD-polariser-PVA-film + animal-feed (EDDI + iodised salt) + povidone-iodine disinfectant downstream chains. Verify each producer-site pair against the producer's public website before relying.** NOT SVHC. NOT Annex XIV. NO active EU AD case on Chinese-origin iodine currently (verify against EUR-Lex https://eur-lex.europa.eu/ before invoicing). **NOT on EU Drug Precursors Regulation (EC) No 273/2004 + Regulation (EU) 2015/1011 scheduled list** despite US DEA List II essential chemical status under 21 CFR 1310.02(b) (verify against EUR-Lex https://eur-lex.europa.eu/ and against https://www.deadiversion.usdoj.gov/ before relying; US DEA scheduling does NOT extend to EU).
Iodine is fully REACH-registered with mid hazard profile (Skin Irrit. 2 + Eye Irrit. 2 + STOT SE 3 + Acute Tox. 4 inhalation). NOT SVHC, NOT Annex XIV. **NOT on EU Drug Precursors Regulation (EC) 273/2004 + Reg 2015/1011 scheduled list** despite US DEA List II status under 21 CFR 1310.02(b) (verify against https://www.deadiversion.usdoj.gov/). ADR UN 3495 Class 8 PG III. **Pharma + LCD-polariser-film + animal-feed + povidone-iodine disinfectant downstream chains**. China is structurally a net-importer; major global producers are SQM (Chile, Atacama caliche-ore), Iofina (USA, Oklahoma gas-well), and Japanese gas-well producers (Nippon Soda + Toho Earth-tech + ISE Chemicals).
Listing and threshold
| Substance | Iodine (I2) (CAS 7553-56-2), I2 |
|---|---|
| Regime | EU Regulation (EC) No 1907/2006: Registration, Evaluation, Authorisation and Restriction of Chemicals |
| Jurisdiction | European Union (EU-27 plus EEA: Iceland, Liechtenstein, Norway) |
| Status | Registered |
| Tonnage threshold | Registration required for any importer or manufacturer placing >1 t/year on the EU market |
Classifications under this regime
- Skin Irrit. 2: H315 + Eye Irrit. 2: H319 + STOT SE 3: H335 + Acute Tox. 4 inhalation: H332 (verify exact harmonised classification against ECHA Annex VI to CLP Table 3.1 before relying)
- IARC: Not classified (verify against https://monographs.iarc.who.int/ before relying)
- **NOT on EU Drug Precursors Regulation (EC) No 273/2004 + Regulation (EU) 2015/1011 scheduled list** (verify against EUR-Lex https://eur-lex.europa.eu/ before relying; US DEA List II scheduling under 21 CFR 1310.02(b) does NOT extend to EU)
- ADR / RID: UN 3495 IODINE Class 8 PG III corrosive solid (verify against current ADR at https://unece.org/transport/dangerous-goods/adr-2025-files before consigning)
- **Ph. Eur. monograph** for pharma-grade iodine + iodine tincture + povidone-iodine (verify monograph reference against EDQM / Ph. Eur. before relying)
- **EU Regulation (EU) No 528/2012 biocidal products (BPR)** evaluation for iodine + iodophors (povidone-iodine) as biocidal active in human-hygiene PT 1 + veterinary-hygiene PT 3 + food + feed PT 4 (verify against ECHA BPR database https://echa.europa.eu/ before relying)
Restrictions and conditions of use
- NOT on REACH Annex XIV authorisation list (verify against ECHA https://echa.europa.eu/authorisation-list)
- NOT classified as SVHC (verify against ECHA https://echa.europa.eu/candidate-list-table)
- NOT subject to any Annex XVII restriction
- NO active EU AD case on Chinese-origin iodine currently (verify against EUR-Lex https://eur-lex.europa.eu/ before invoicing)
- NOT in CBAM Phase 1 scope
Importer obligations
A non-EU producer cannot register directly under REACH. The EU importer of record must hold a registration or rely on an Only Representative (OR). **Major global iodine producers** (China is structurally a net-importer, NOT a major exporter): SQM (Chile, Atacama Desert caliche-ore brines), Iofina (USA, Oklahoma gas-well brines), Nippon Soda + Toho Earth-tech + ISE Chemicals (Japan, Iwate / Chiba gas-well brines), Russian gas-well producers; verify each producer-site pair against the producer's public website before relying.
Required documents
- REACH registration number on EU side
- SDS (Skin Irrit. 2 + Eye Irrit. 2 + STOT SE 3 + Acute Tox. 4 inhalation)
- Customs entry HS code 280120 (iodine)
- ADR transport documentation UN 3495 Class 8 PG III where consigned in transport quantity (verify against current ADR at https://unece.org/transport/dangerous-goods/adr-2025-files before consigning)
- Ph. Eur. monograph documentation for pharma-grade
- BPR documentation where placed as biocidal active (PT 1 / PT 3 / PT 4)
Common compliance traps
The pitfalls that have bitten importers on this lane in the past. None of these is theoretical.
- **Globally extracted from Chilean caliche-ore brines (SQM Atacama dominant) + Japanese gas-well brines (Iwate / Chiba) + US Oklahoma gas-well brines (Iofina) + Russian gas-well brines; China is structurally a net-importer**
- **NOT on EU Drug Precursors Regulation (EC) 273/2004 + Reg 2015/1011 scheduled list** despite US DEA List II status (21 CFR 1310.02(b); verify against https://www.deadiversion.usdoj.gov/)
- ADR UN 3495 Class 8 PG III corrosive solid
- NOT SVHC, NOT Annex XIV, NO active EU AD
- **Pharma intermediate (iohexol + iopromide + amiodarone contrast media + povidone-iodine) + LCD-polariser-PVA-film + animal-feed (EDDI + iodised salt via KIO3 / KI) + disinfectant + dye-intermediate 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 REACH, see the REACH 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
Regulatory
Iodine (I2) under TSCA
United States of America listing status, classifications, importer obligations.
Regulatory
Iodine (I2) under IECSC
People's Republic of China listing status, classifications, importer obligations.
Regulatory
Iodine (I2) under AICIS
Australia listing status, classifications, importer obligations.
Regulatory
Iodine (I2) under K-REACH
Republic of Korea listing status, classifications, importer obligations.
CAS
CAS 7553-56-2 sourcing reference
Identifiers, hazard profile, IMDG transport class, and supplier geography for Iodine (I2).
Glossary
REACH, Registration, Evaluation, Authorisation and Restriction of Chemicals
EU chemical regulation requiring importers and manufacturers to register every substance manufactured or imported into the EU above 1 tonne per year. Registration is identity-based and dossier-based, not inventory-lookup-based, which makes it stricter than TSCA in the US.
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.
Free download
Free PDF: the same MSDS verification template the Sourzi team uses to cross-reference factory documents against TSCA, REACH, AICIS, and CDR before booking.