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Cross-Border Trade Guide

🇺🇸 United States → 🇦🇺 Australia

HS 3004 · MEDICAMENTS NESOI, MIXED OR NOT, IN DOSAGE ETC FMAnnual bilateral volume: $4.5B

Estimated Duties

0%

MFN Free + GST-exempt (listed meds)

Transit Time

18-25 days

End to end

Compliance

TGA

Therapeutic Goods Admin approval

Export Rebate

N/A

No export VAT (none applies)

Key Rules

United States 🇺🇸 → Australia 🇦🇺

›US Export Certifications
›Commercial Invoice [USX]
›Shipper's Letter of Instruction (SLI) [USX]
›Bill of Lading (B/L) or Air Waybill (AWB) [USX]
›Electronic Export Information (EEI) / AES Filing [USX]
›Certificate of Origin [USX]
›Packing List [USX]
△Destination Control Statement (DCS) [USX]
💰

Estimated Cost Breakdown

per $100K shipment · United States → Australia

DUTY CALCULATION — AUSTRALIA

Base Duty

0%

Unknown

Unknown

0%

on (CIF + duty)

Effective Total

~0%

duty only

Product cost (FOB)$100,000
Ocean freight (est.)$3,500
Marine insurance (0.4%)$400
Estimated total landed cost~$103,900

* Estimates based on $100K FOB shipment of electronics (HS 85). Actual costs vary by exact HS code, weight/volume, and current rates.

✓CERTIFICATIONS
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US Export Certifications
No general export certification required. However: EAR-controlled items: export license from BIS (Bureau of Industry and Security). ITAR-controlled defense articles: license from DDTC (Directorate of Defense Trade Controls). Nuclear materials: license from NRC. For most commercial goods (electronics, machinery): NO certification needed, only proper ECCN classification.
§REQUIRED DOCUMENTS
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Commercial Invoice [USX]
Required for all exports. Must include: exporter and consignee details, description of goods, quantity, unit value, total value (in USD), country of origin, Incoterms, ECCN or EAR99 designation, Schedule B number. No prescribed format but must be complete and accurate.
●
Shipper's Letter of Instruction (SLI) [USX]
Authorizes the freight forwarder to act on behalf of the exporter for EEI filing and export processing. Contains: exporter info, consignee, intermediate consignee, forwarding agent, transport details, ECCN, Schedule B number, value, license information. Not a government form but industry standard. Essential when using a freight forwarder.
●
Bill of Lading (B/L) or Air Waybill (AWB) [USX]
Transport document issued by carrier. Ocean: Bill of Lading (negotiable or non-negotiable). Air: Air Waybill (always non-negotiable). Must include ITN from AES filing. Serves as receipt of goods, contract of carriage, and (for negotiable B/L) document of title.
●
Electronic Export Information (EEI) / AES Filing [USX]
The electronic declaration filed via AESDirect or AES-compatible software. Contains: USPPI (exporter) info, ultimate consignee, intermediate consignee, Schedule B number, ECCN, quantity, value, export carrier, port of export, country of destination, license information. Results in ITN that must accompany shipment.
●
Certificate of Origin [USX]
Required by many destination countries to verify goods are of US origin. For preferential trade agreements (USMCA, KORUS FTA, etc.): specific certificate format required. General certificates: issued by local Chamber of Commerce. Some countries require consular legalization (additional step).
●
Packing List [USX]
Detailed list of goods in each package/container. Includes: description, quantity, weight, dimensions, marks and numbers. Used by customs at destination, carrier, and insurance company.
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Destination Control Statement (DCS) [USX]
Required on commercial invoice and B/L for items controlled under EAR or ITAR. Standard text: 'These commodities, technology, or software were exported from the United States in accordance with the Export Administration Regulations. Diversion contrary to U.S. law is prohibited.' Required per 15 CFR 758.6.
●
Export License (if applicable) [USX]
Physical or electronic license from BIS (EAR items) or DDTC (ITAR items). Must be referenced on EEI filing. License number must appear on commercial invoice. BIS licenses: typically valid for 4 years. DDTC licenses: typically valid for 4 years. Some transactions qualify for License Exceptions (no individual license but conditions apply).
›PROCESS STEPS
●
Register in ACE/AES System [USX]
US exporters must register with the Automated Commercial Environment (ACE) system to file Electronic Export Information (EEI). ACE is CBP's primary system; AES (Automated Export System) is the export component within ACE. Register via ACE portal or through a licensed customs broker/freight forwarder. No registration fee. Requires EIN (Employer Identification Number) or SSN for sole proprietors.
●
Classify Your Product (ECCN / Schedule B) [USX]
Before exporting, determine if your product is controlled. Two classification systems: (1) ECCN (Export Control Classification Number) — determines if an export license is needed under EAR. Check the Commerce Control List (CCL). Most commercial goods are 'EAR99' (no license needed for most destinations). (2) Schedule B Number — the 10-digit statistical classification used for EEI filing. BIS provides a free ECCN classification request service (commodity classification request, SNAP-R). Self-classification is allowed and most common.
●
Screen Parties and Check Restrictions [USX]
Before any export, screen all transaction parties against the Consolidated Screening List (CSL): Entity List (BIS), Denied Persons List (BIS), Unverified List (BIS), SDN List (OFAC/Treasury), Debarred List (DDTC/State). Free screening tool at trade.gov. Also check destination country for embargo/sanctions (OFAC). Failure to screen can result in civil penalties up to $364,992 per violation or criminal penalties up to $1,000,000 and 20 years imprisonment.
●
Obtain Export License (if required) [USX]
If your ECCN + destination + end-use/user combination requires a license, apply via BIS SNAP-R system. License types: Individual Validated License (IVL), License Exception (e.g., TMP, LVS, TSR, GOV). Processing time: typically 30-60 days. BIS must respond within 90 days by law. Many commercial electronics to allied countries qualify for License Exception (no individual license needed). ITAR items: apply via DDTC DSP-5 form (different system entirely).
●
File Electronic Export Information (EEI) via AES [USX]
EEI filing is REQUIRED when: (1) value per Schedule B number exceeds $2,500, OR (2) an export license is required regardless of value, OR (3) goods are destined for certain sanctioned countries. File via AESDirect portal (free) or through AES-compatible software. Deadline: non-ITAR items — 2 hours before export; ITAR items — 8 hours before export. Postdeparture filing: pre-approved exporters can file within 5 calendar days after export. EXEMPTION: Shipments to Canada under $2,500 are exempt from EEI filing. Upon filing, receive Internal Transaction Number (ITN) — must be provided to carrier.
●
Arrange Transport and Provide ITN to Carrier [USX]
After EEI filing, provide the ITN to the carrier (shipping line, airline, freight forwarder). The carrier must include the ITN on the manifest/bill of lading. For ocean freight: goods must be delivered to port for loading. For air freight: delivered to airline cargo facility. Freight forwarder handles physical logistics, carrier booking, and export customs clearance.
●
Post-Export Record Keeping [USX]
Exporters must retain all export records for 5 years from date of export. Records include: EEI data, commercial invoices, shipping documents, export licenses, correspondence with BIS/DDTC, end-use statements, screening records. BIS and Census Bureau may audit at any time. Penalty for failure to maintain records: up to $12,000 per violation.
›PROCESS STEPS
●
Register in ACE/AES System [USX]
US exporters must register with the Automated Commercial Environment (ACE) system to file Electronic Export Information (EEI). ACE is CBP's primary system; AES (Automated Export System) is the export component within ACE. Register via ACE portal or through a licensed customs broker/freight forwarder. No registration fee. Requires EIN (Employer Identification Number) or SSN for sole proprietors.
●
Classify Your Product (ECCN / Schedule B) [USX]
Before exporting, determine if your product is controlled. Two classification systems: (1) ECCN (Export Control Classification Number) — determines if an export license is needed under EAR. Check the Commerce Control List (CCL). Most commercial goods are 'EAR99' (no license needed for most destinations). (2) Schedule B Number — the 10-digit statistical classification used for EEI filing. BIS provides a free ECCN classification request service (commodity classification request, SNAP-R). Self-classification is allowed and most common.
●
Screen Parties and Check Restrictions [USX]
Before any export, screen all transaction parties against the Consolidated Screening List (CSL): Entity List (BIS), Denied Persons List (BIS), Unverified List (BIS), SDN List (OFAC/Treasury), Debarred List (DDTC/State). Free screening tool at trade.gov. Also check destination country for embargo/sanctions (OFAC). Failure to screen can result in civil penalties up to $364,992 per violation or criminal penalties up to $1,000,000 and 20 years imprisonment.
●
Obtain Export License (if required) [USX]
If your ECCN + destination + end-use/user combination requires a license, apply via BIS SNAP-R system. License types: Individual Validated License (IVL), License Exception (e.g., TMP, LVS, TSR, GOV). Processing time: typically 30-60 days. BIS must respond within 90 days by law. Many commercial electronics to allied countries qualify for License Exception (no individual license needed). ITAR items: apply via DDTC DSP-5 form (different system entirely).
●
File Electronic Export Information (EEI) via AES [USX]
EEI filing is REQUIRED when: (1) value per Schedule B number exceeds $2,500, OR (2) an export license is required regardless of value, OR (3) goods are destined for certain sanctioned countries. File via AESDirect portal (free) or through AES-compatible software. Deadline: non-ITAR items — 2 hours before export; ITAR items — 8 hours before export. Postdeparture filing: pre-approved exporters can file within 5 calendar days after export. EXEMPTION: Shipments to Canada under $2,500 are exempt from EEI filing. Upon filing, receive Internal Transaction Number (ITN) — must be provided to carrier.
●
Arrange Transport and Provide ITN to Carrier [USX]
After EEI filing, provide the ITN to the carrier (shipping line, airline, freight forwarder). The carrier must include the ITN on the manifest/bill of lading. For ocean freight: goods must be delivered to port for loading. For air freight: delivered to airline cargo facility. Freight forwarder handles physical logistics, carrier booking, and export customs clearance.
●
Post-Export Record Keeping [USX]
Exporters must retain all export records for 5 years from date of export. Records include: EEI data, commercial invoices, shipping documents, export licenses, correspondence with BIS/DDTC, end-use statements, screening records. BIS and Census Bureau may audit at any time. Penalty for failure to maintain records: up to $12,000 per violation.
→SHIPPING & TIMELINE
●
Shipping Timeline from US
US → China: Ocean (LA→Shanghai) 15-20 days, $2,500-4,000/FEU. Air 3-5 days, $5-8/kg. US → Japan: Ocean (LA→Tokyo) 10-14 days, $2,000-4,000/FEU. Air 2-3 days, $5-8/kg. US → EU: Ocean (NY→Rotterdam) 10-14 days, $2,000-3,500/FEU. Air 1-2 days, $4-7/kg. US → Korea: Ocean 12-16 days, $2,000-3,500/FEU. EEI filing: must be done before export. AES processing: near-instant.
△

Export-Side Restrictions

Controls imposed by United States

●
EAR Export Controls — Commerce Control List (CCL) [USX]
The Export Administration Regulations (EAR) govern export of commercial and dual-use items. The CCL has 10 categories: 0-Nuclear, 1-Materials, 2-Materials Processing, 3-Electronics, 4-Computers, 5-Telecom/InfoSec, 6-Sensors/Lasers, 7-Navigation, 8-Marine, 9-Aerospace. Each category has 5 product groups: A-Equipment, B-Test/Production, C-Materials, D-Software, E-Technology. Items NOT on CCL are designated EAR99 — generally exportable without license to most destinations. License requirements determined by ECCN + destination country + end-use + end-user. Country Chart (Supplement No. 1 to Part 738) maps ECCNs to country-specific requirements.
●
EAR — ECCN Classification and De Minimis Rules [USX]
ECCN is a 5-character code (e.g., 3A001 = certain ICs, 5A002 = encryption equipment). Self-classification is permitted; exporters can also request BIS classification (CCATS, free, 30-day response). DE MINIMIS RULE for re-exports: Foreign-made items incorporating US-origin controlled content are subject to EAR if US content exceeds 25% of total value (10% for embargoed destinations like Cuba, Iran, North Korea, Syria). This triggers license requirements for re-exports. FOREIGN DIRECT PRODUCT RULE (FDPR): Extended in 2022 to cover items produced using US technology/software for Entity List parties — applies globally, affects non-US semiconductor fabs.
●
EAR — Entity List Restrictions (April 2026) [USX]
The Entity List (Supplement No. 4 to Part 744) includes ~3,163 entities as of late 2025. Majority are Chinese entities in telecom, AI, biotech, quantum, and semiconductors. Export/re-export/transfer to listed entities requires BIS license with presumption of denial for most. Notable Chinese entities: Huawei, SMIC, YMTC, Sophgo, numerous AI/chip companies. BIS '50% Ownership Rule' (Oct 2025): extends restrictions to entities 50%+ owned by listed parties. Affiliates Rule: suspended for 1 year (Nov 2025) under Busan Agreement, reimposed Nov 10, 2026.
●
ITAR — International Traffic in Arms Regulations [USX]
ITAR regulates defense articles, defense services, and related technical data on the US Munitions List (USML). Administered by DDTC (Directorate of Defense Trade Controls) under State Department. USML has 21 categories (I-Firearms, II-Guns, III-Ammunition, IV-Launch vehicles, V-Explosives, etc.). KEY DISTINCTION: ITAR covers items 'specifically designed or modified' for military use. Commercial electronics are generally NOT ITAR-controlled unless specifically designed for defense. A commercial power supply is EAR99; a power supply 'specifically designed' for a fighter jet is ITAR. ITAR items require State Department license (DSP-5) for ANY export, regardless of destination. Penalties: civil up to $1,213,423/violation; criminal up to $1,000,000 and 20 years.
●
US Export to China — Semiconductor/AI Chip Controls (April 2026) [USX]
Advanced computing chip exports to China are heavily restricted under EAR. TIMELINE: Oct 2022 — initial controls on advanced chips and semiconductor equipment. Oct 2023 — expanded to close loopholes, tightened thresholds. Dec 2024 — new controls on HBM, advanced equipment, and 140+ new Entity List additions. Jan 2026 — license review policy revised: chips below 21,000 TPP and 6,500 GB/s DRAM bandwidth (roughly H200/MI325X class) evaluated case-by-case instead of presumption of denial. Chips above these thresholds: still presumption of denial. All advanced semiconductor manufacturing equipment: license required, presumption of denial. 16 new entities added to Entity List in Jan 2026 (including Sophgo). 25% tariff on covered AI chips NOT destined for US supply chain (Jan 2026 proclamation).
●
US Export to China — Technology Transfer Controls [USX]
Beyond physical goods, the US controls 'deemed exports' — release of controlled technology/source code to foreign nationals in the US is treated as an export to their home country. For Chinese nationals working at US companies: access to ECCN-controlled technology may require a deemed export license from BIS. This applies to Categories 3-5 especially (electronics, computers, telecom). Cloud computing: BIS 'IaaS Rule' (Jan 2024+) requires cloud providers to implement KYC for foreign users training large AI models. Expanded in 2025 to cover more compute thresholds. Technical data shared with Chinese subsidiaries/partners also requires EAR compliance review.
●
US Export to China — Broad EAR Restrictions Summary [USX]
China (including Hong Kong and Macau for many purposes) faces the most comprehensive US export restrictions: (1) Entity List: ~2,000+ Chinese entities. (2) Military End-User (MEU) List: license required for items in Supplement 2 to Part 744. (3) Advanced computing: TPP/bandwidth thresholds. (4) Semiconductor equipment: all advanced tools. (5) Quantum computing: all exports controlled. (6) Supercomputer technology. (7) Certain biotech equipment. (8) Surveillance technology (limited). However: most standard commercial electronics (consumer smartphones, laptops, basic networking) are EAR99 and can be exported to China without a license, as long as no listed entity/end-use is involved.
●
US Export to Japan — Minimal Restrictions [USX]
Japan is a close US ally and member of all major multilateral export control regimes (Wassenaar Arrangement, MTCR, Australia Group, NSG). Japan is in Country Group A:1 (most favorable treatment under EAR). RESULT: Most items on the CCL can be exported to Japan under License Exceptions, particularly STA (Strategic Trade Authorization) which covers the vast majority of controlled items. EAR99 items: no restrictions. Most ECCN items: License Exception available. Still requires screening against Consolidated Screening List (rare for Japanese entities). EEI filing still required for shipments over $2,500. Japan's own export controls on semiconductors (2023+) align with US controls on China, making Japan a trusted partner in the US export control ecosystem.
●
US Export to Korea — Minimal Restrictions [KRE]
Korea is a close US ally and member of all 4 multilateral export control regimes. Korea is in US Country Group A:1 (most favorable treatment under EAR). Most items on the CCL can be exported to Korea under License Exceptions, particularly STA (Strategic Trade Authorization). EAR99 items: no restrictions. Still requires Consolidated Screening List check (rare for Korean entities). US-Korea Strategic Trade and Investment Deal (Nov 2025) further strengthens alliance and includes semiconductor supply chain cooperation commitments.
※

Recent Advisories

Product recalls in the destination market

2026-04-09BISSELL Recalls Over One Million Steam Shot OmniReach Steam Cleaners Due to Risk of Serious Burn Hazard from Attachments
2026-04-09Easymake Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violates Mandatory Standard for Adult Portable Bed Rails; Imported by ZFZG-US
2026-04-09Halloween Pumpkin Carving Kits Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Button Cell Batteries; Sold on Amazon by Besslly Store
2026-04-09LED Lights Recalled Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries; Sold on Amazon by Happiness Light
2026-04-09Magnetic Drinkware Charms Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Magnets; Sold on Amazon by Maitys
Disclaimer: Figures are best-effort estimates based on April 2026 public regulations (§122, §232, §301, CBAM, RCEP, etc.). Verify with the relevant customs authority before trade decisions.Report data issue ↗