CAS 1314-13-2 · TSCA · United States of America

Zinc oxide (ZnO) under TSCA

ZnO · 氧化锌

Status: Listed. Zinc oxide is on the TSCA Inventory and currently listed as TSCA Active. **OSHA PEL 5 mg/m^3 fume + dust value (verify exact fume vs total-dust vs respirable-dust split against https://www.osha.gov/annotated-pels Table Z-1 before invoicing; secondary sources cite 10 mg/m^3 and 15 mg/m^3 inconsistently for the dust form)** at 29 CFR 1910.1000 Table Z-1. NOT on EPA RMP threshold list. NOT on DEA scheduling. NOT on California Proposition 65 (verify against OEHHA https://oehha.ca.gov/proposition-65/proposition-65-list before relying on negative listing). **TRI Section 313 listed under "zinc compounds" category**: Form R annual reporting required. NO active US AD/CVD case on Chinese-origin zinc oxide currently (verify against https://access.trade.gov/ before invoicing). Section 301 List 3 25% additional duty applies on Chinese-origin zinc oxide (HS 281700). FDA 21 CFR 347 sunscreen monograph permits zinc oxide as Category I sunscreen active ingredient (verify current monograph status against https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs/sunscreen-otc-products before relying). Major US domestic producers (verify each company-site pair against the producer's public website before relying): Horsehead Holding (legacy capacity), American Zinc Recycling, Pasminco / Zinifex / Nyrstar (Clarksville Tennessee).

The US zinc oxide lane has **light regulatory profile**: NOT on Cal Prop 65, NOT on RMP, NOT on DEA, NO active AD. OSHA PEL 5 mg/m^3 fume + dust value (verify exact dust figure against https://www.osha.gov/annotated-pels Table Z-1; secondary sources split between 10 and 15 mg/m^3). **TRI Form R annual reporting under "zinc compounds" category**. FDA 21 CFR 347 sunscreen monograph (Category I) permits OTC sunscreen use. Section 301 List 3 25% additional duty applies. Major US producers: Horsehead Holding (legacy), American Zinc Recycling, Pasminco / Zinifex / Nyrstar.

Listing and threshold

Substance Zinc oxide (ZnO) (CAS 1314-13-2), ZnO
Regime US Toxic Substances Control Act (TSCA), administered by EPA
Jurisdiction United States of America
Status Listed
Tonnage threshold CDR threshold: 25,000 lb manufactured or imported per site per year

Classifications under this regime

  • OSHA HCS: GHS H400 / H410
  • OSHA PEL 29 CFR 1910.1000 Table Z-1: 5 mg/m^3 fume + dust value (verify against https://www.osha.gov/annotated-pels Table Z-1; secondary sources split between 10 mg/m^3 and 15 mg/m^3 for the dust form)
  • NIOSH REL: 5 mg/m^3 dust + 5 mg/m^3 fume STEL (verify against https://www.cdc.gov/niosh/npg/)
  • NOT subject to TSCA Section 6 Risk Evaluation
  • NOT on EPA RMP threshold list
  • NOT on DEA List I or List II
  • NOT on California Proposition 65 list (verify against OEHHA before relying on negative listing)
  • **TRI Section 313 listed under "zinc compounds" category**: Form R annual reporting required for facilities above thresholds
  • DOT 49 CFR 172.101: not regulated as DG (solid powder; marine pollutant designation may apply)
  • IARC: Group 3
  • FDA 21 CFR 347 sunscreen monograph: Category I active ingredient

Restrictions and conditions of use

  • OSHA-compliant SDS and workplace HazCom training required
  • NO active US AD/CVD case on Chinese-origin zinc oxide currently
  • Section 301 List 3 25% additional duty applies on Chinese-origin zinc oxide (HS 281700)
  • **TRI Form R annual reporting** under "zinc compounds" category
  • FDA 21 CFR 347 sunscreen monograph compliance for OTC sunscreen applications

Importer obligations

TSCA self-certification regime. Light-regulatory profile. Major US domestic producers: Horsehead Holding (legacy), American Zinc Recycling, Pasminco / Zinifex / Nyrstar (Clarksville Tennessee). FDA 21 CFR 347 sunscreen monograph permits zinc oxide as Category I OTC sunscreen active ingredient.

Required documents

  • TSCA Section 13 Import Certification on customs entry
  • OSHA SDS reflecting H400 / H410
  • CBP Form 7501 with HS 281700 + Section 301 List 3 25% duty
  • TRI Form R annual report under "zinc compounds" category
  • CDR filing every 4 years
  • FDA 21 CFR 347 sunscreen monograph compliance for OTC sunscreen lots

Common compliance traps

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

  • OSHA PEL 5 mg/m^3 fume + dust value (verify against https://www.osha.gov/annotated-pels Table Z-1; secondary sources split 10 vs 15 mg/m^3 for the dust form)
  • **TRI Form R annual reporting** under "zinc compounds" category
  • NO active US AD/CVD case on Chinese zinc oxide currently
  • Section 301 List 3 25% additional duty applies; structurally lighter than caprolactam batch 14 plus acetic acid batch 19 lanes
  • Major US producers: Horsehead Holding (legacy), American Zinc Recycling, Pasminco / Zinifex / Nyrstar (Clarksville Tennessee)
  • FDA 21 CFR 347 sunscreen monograph (Category I active ingredient)

Where to read next

For substance-level identifiers (formula, molecular weight, SMILES, InChIKey), GHS hazard profile, IMDG transport class, and full sourcing reference for zinc oxide (zno), see the CAS 1314-13-2 sourcing reference.

For grade-by-grade buying notes, freight maths, supplier-tier pricing, and a worked landed-cost example, the zinc oxide (zno) 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.

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Free PDF: the same MSDS verification template the Sourzi team uses to cross-reference factory documents against TSCA, REACH, AICIS, and CDR before booking.