CAS 13463-67-7 · TSCA · United States of America

Titanium dioxide under TSCA

TiO2 · 二氧化钛

Status: Listed. Titanium dioxide is on the TSCA Inventory as a grandfathered pre-1979 substance and is currently listed as TSCA Active. No PMN is required. TiO2 is NOT classified as a carcinogen under US Federal frameworks (unlike the contested EU classification) but California Proposition 65 lists "TiO2 (airborne, unbound particles of respirable size)" as a Carcinogen since 2 September 2011 (verified against OEHHA P65 chemical page). IARC Group 2B classification is independently relevant for occupational health.

The US TiO2 lane is comparatively cleaner than the EU lane: FDA approves TiO2 as food / drug / cosmetic colorant (no E171 ban), IARC 2B classification is independent of TSCA, no current AD/CVD case. CalProp 65 is the most-litigated US regulatory issue for TiO2, driving plaintiff-friendly private-action lawsuits. The Section 301 List 3 25% additional duty plus US domestic production capacity (Chemours, Tronox, Kronos, Venator) keeps Chinese-origin TiO2 import volumes below merchant-replacement parity but specialty grades do flow. NIOSH REL for nano-grade is substantially below OSHA PEL; verify hazard-communication standard before invoicing nano-grade product.

Listing and threshold

Substance Titanium dioxide (CAS 13463-67-7), TiO2
Regime US Toxic Substances Control Act (TSCA), administered by EPA
Jurisdiction United States of America
Status Listed
Tonnage threshold CDR (Chemical Data Reporting) threshold: 25,000 lb (11,340 kg) manufactured or imported per site per year triggers reporting in the next CDR cycle

Classifications under this regime

  • NOT subject to TSCA Section 4 test rule
  • NOT currently subject to TSCA Section 6 unreasonable-risk evaluation (TSCA Risk Evaluation for TiO2 was discussed but not formally initiated as of 2024-2025)
  • NOT on the TSCA Section 5(a)(2) Significant New Use Rule list
  • OSHA Hazard Communication Standard (HCS, 29 CFR 1910.1200): nuisance dust thresholds plus IARC 2B carcinogen labelling for some grades
  • NOT on EPA RMP threshold list
  • NOT on DEA List I or List II
  • IARC Group 2B (possibly carcinogenic, IARC Monograph 93, 2010): independently relevant for occupational-health rules
  • California Proposition 65 listed for "TiO2 (airborne, unbound particles of respirable size)" as Carcinogen since 2 September 2011 (verified against OEHHA P65 chemical page)
  • FDA approved as colorant for foods, drugs, cosmetics, and medical devices (separate from EU's E171 food-additive ban)

Restrictions and conditions of use

  • No TSCA-specific use restrictions for TiO2
  • OSHA does not have a TiO2-specific PEL; TiO2 dust falls under the Particulates Not Otherwise Regulated (PNOR) category at 29 CFR 1910.1000 Table Z-1 (PEL 15 mg/m³ total dust, 5 mg/m³ respirable; verify against https://www.osha.gov/annotated-pels/table-z-1). OSHA does not separately regulate nano-TiO2
  • NIOSH Recommended Exposure Limit (REL): 2.4 mg/m³ for fine TiO2, 0.3 mg/m³ for ultrafine / nano TiO2
  • CalProp 65 warning required for products in California containing or generating airborne unbound respirable TiO2 above the No Significant Risk Level
  • FDA 21 CFR 73.575 approves TiO2 as colorant for food, drug, cosmetics, medical devices (US treats E171 differently from EU)
  • NO active US AD/CVD case on Chinese-origin TiO2 currently (2017 investigation resulted in negative determinations)
  • Section 301 List 3 25% additional duty applies to Chinese-origin TiO2 (HS 3206.11.0000)

Importer obligations

TSCA is a self-certification regime: importers attest at customs entry. The TSCA Section 13 Import Certification statement is filed via the customs broker. For TiO2 specifically, the US regulatory layer is comparatively light vs the contested EU framework: FDA approves TiO2 as food / drug / cosmetic colorant (no E171 equivalent ban), no active AD/CVD case currently. CalProp 65 warning applies for California-distributed products containing or generating airborne respirable TiO2 above the No Significant Risk Level.

Required documents

  • TSCA Section 13 Import Certification statement on customs entry
  • OSHA-compliant SDS (Safety Data Sheet) in 16-section GHS format with IARC 2B carcinogen labelling
  • CalProp 65 warning labelling for California-distributed products (Code of Civil Procedure §17782 standard)
  • FDA 21 CFR 73.575 compliance certification for food / drug / cosmetic / medical-device colorant applications
  • CDR filing every 4 years if site exceeds 25,000 lb/yr threshold (next cycle 2026)

Common compliance traps

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

  • CalProp 65 notification is the single most-litigated US TiO2 issue; private-action lawsuits are common, plaintiff-friendly fee-shifting drives settlements
  • NIOSH ultrafine / nano TiO2 REL of 0.3 mg/m³ TWA (per NIOSH Current Intelligence Bulletin 63, 2011; verify against https://www.cdc.gov/niosh/docs/2011-160/) is significantly below the OSHA PNOR PEL; for nano-grade product, manufacturer-side hazard communication should reflect NIOSH not OSHA
  • FDA 21 CFR 73.575 for food colorant USE differs from EU E171 ban; do not extrapolate EU regulatory positions to US market
  • Section 301 List 3 25% additional duty applies to Chinese-origin TiO2 (HS 3206.11.0000)
  • No active US AD/CVD case currently but periodic petitions are filed; monitor Department of Commerce investigations before invoicing volume contracts
  • Cosmetic-grade and pharmaceutical-grade TiO2 require additional FDA / USP compliance; verify destination grade before invoicing

Where to read next

For substance-level identifiers (formula, molecular weight, SMILES, InChIKey), GHS hazard profile, IMDG transport class, and full sourcing reference for titanium dioxide, see the CAS 13463-67-7 sourcing reference.

For grade-by-grade buying notes, freight maths, supplier-tier pricing, and a worked landed-cost example, the titanium dioxide 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

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