Albumin based Plasma Substitute
CN β US| HS Code | Tariff Rate | Origin | Destination | Doc |
|---|---|---|---|---|
| 3002120010 | 10.0% | CN | US | Official Doc |
| 3002120090 | 10.0% | CN | US | Official Doc |
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π Albumin-Based Plasma Substitute (Human Blood Plasma)
π HS Code Reference & Customs Clearance Guide | 2026 Latest Tariff Analysis | Professional Clearance Strategy
π I. Product Definition & Classification: What is "Albumin-Based Plasma Substitute"?
Human blood plasma, specifically prepared for therapeutic use, is classified under Chapter 30 (Pharmaceutical Products). In international trade, "Albumin-Based Plasma Substitutes" primarily refer to Human Plasma or Human Serum Albumin derived from human blood, intended for therapeutic, prophylactic, or diagnostic purposes.
Key Distinction:
- Human Plasma (Raw/Prepared): Liquid portion of blood, separated for transfusion or fractionation.
- Albumin (Fraction): A specific protein fraction derived from plasma. While often processed further, the base product "Human Blood Plasma" falls under heading 3002.
β οΈ Critical Classification Point:
- If the product is "Human Blood Plasma" intended for therapeutic use βε½ε ₯ 3002.12.00.10
- If the product is "Other Blood Fractions" (including processed albumin preparations not explicitly listed as plasma) βε½ε ₯ 3002.12.00.90
π¦ II. HS Code Classification Details (2026 Latest Tariff Authority Alignment)
| HS Code | Product Description | Applicable Scenario | Key Identifier |
|---|---|---|---|
3002.12.00.10 |
Antisera and other blood fractions: Human blood plasma | Therapeutic human plasma, plasma for fractionation | β Human Origin, Plasma Form |
3002.12.00.90 |
Antisera and other blood fractions: Other | Processed albumin fractions, synthetic substitutes, non-human plasma | β Other Fractions / Processed |
π Important Reminder:
- Both codes fall under Heading 3002: Human blood; animal blood prepared for therapeutic... antisera, other blood fractions and immunological products...
- The distinction lies in the sub-category:
-.10is specifically for Human Blood Plasma.
-.90is a "basket" code for other blood fractions (including albumin concentrates if not classified as pure plasma).
- Note: Vaccines, toxins, and cultures are excluded from this subheading and fall under different 8-digit codes within 3002.
π° III. 2026 Latest Tariff Rate Details (Zero Duty Policy)
β Applicable Country: United States (US)
β Origin: China (CN) or General
β Effective Date: 2025β2026 Current Tariff Schedule
π― 1. 3002.12.00.10 ββ Human Blood Plasma
| Item | Content |
|---|---|
| Base Tariff Rate | 0.0% |
| Section 301 Additional Tariff | 0.0% |
| Total Effective Tax Rate | 0.0% |
| Tax Calculation | CIF Value Γ 0% = $0.00 |
| De Minimis Exemption | β Eligible (if applicable under $800 de minimis rule, subject to FDA/CDSCB restrictions) |
| Legal Basis | HTSUS 3002.12.00.10 |
π Explanation:
- Human blood plasma and its fractions enjoy 0% duty in the US.
- This reflects the strategic importance of medical supplies and the lack of protective tariffs on essential pharmaceuticals/biologicals.
- No Section 301 tariffs apply to these specific medical blood products.
π― 2. 3002.12.00.90 ββ Other Blood Fractions (e.g., Processed Albumin)
| Item | Content |
|---|---|
| Base Tariff Rate | 0.0% |
| Section 301 Additional Tariff | 0.0% |
| Total Effective Tax Rate | 0.0% |
| Tax Calculation | CIF Value Γ 0% = $0.00 |
| De Minimis Exemption | β Eligible (subject to regulatory approvals) |
| Legal Basis | HTSUS 3002.12.00.90 |
π Note:
- Even processed albumin products (if classified under "other blood fractions") retain 0% duty.
- This makes albumin-based plasma substitutes highly competitive in price compared to non-medical goods subject to 7.5%β25% tariffs.
π οΈ IV. Customs Clearance Practical Advice (Combat Guide)
β 1. Required Documentation Checklist (No Exceptions)
| Document | Must Provide | Description |
|---|---|---|
| β FDA Prior Notice | βοΈ | Mandatory for all human cells, tissues, and cellular/tissue-based products (HCT/Ps). Submit via FDA Prior Notice of Imported Foods/Drugs system. |
| β Letter of Authorization | βοΈ | From FDA-registered facility (if applicable). |
| β Certificate of Analysis (CoA) | βοΈ | Proof of safety, sterility, and viral inactivation. |
| β Bill of Lading / Air Waybill | βοΈ | Must match invoice and packing list. |
| β Commercial Invoice | βοΈ | Must clearly state: "Human Blood Plasma for Therapeutic Use" or "Albumin Fraction". |
| β Packing List | βοΈ | Details of cold chain packaging (dry ice, gel packs). |
| β Cold Chain Documentation | βοΈ | Temperature logs during transit (critical for blood products). |
β οΈ Critical Warning:
- No FDA Prior Notice = Automatic Rejection/Return.
- Blood products are regulated under 21 CFR Part 1271. Customs will verify FDA clearance.
β 2. Declaration Tips (Key Mnemonics)
π₯ βPlasma for Therapeutic Use, Code 3002.12.10, Zero Duty, FDA First!β
| Scenario | Correct Declaration | Error to Avoid |
|---|---|---|
| Human Plasma for Transfusion | 3002.12.00.10 |
Misdeclare as "Medical Supplies" (generic) β Risk of audit |
| Processed Albumin Concentrate | 3002.12.00.90 |
Misdeclare as "Plasma" if itβs a fraction β Misclassification |
| Synthetic Albumin Substitute | Check HTSUS Chapter 39 or 35 | May not be 3002! Verify if itβs human-derived. |
| Animal Blood Products | Not in this specific subheading | Must check 3002.11 or other subheadings |
β 3. Special Case Handling
| Scenario | Handling Advice |
|---|---|
| Cold Chain Breach | If temperature logs show excursion, customs may detain. Provide re-validation certificate. |
| Small Sample Shipments | Even small volumes require FDA Prior Notice. Do not use de minimis to bypass FDA. |
| Dual-Use Products | If labeled "Diagnostic Use Only," still classify under 3002 if derived from blood. |
| Viral Safety Claims | Must provide documentation of viral inactivation steps (e.g., pasteurization, nanofiltration). |
π V. Global Market Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Tariff | Regulatory Requirements | Remarks |
|---|---|---|---|---|
| πΊπΈ USA | 3002.12.00.10 / .90 |
0% | FDA Prior Notice + 21 CFR 1271 | Zero duty, strict FDA control |
| π¨π³ China | 3002.12.00 |
0% | NMPA License | Zero duty, requires import license |
| πͺπΊ EU | 3002.12 |
0% | EMA/GMP Certification | Zero duty under TARIC, strict GMP |
| π¬π§ UK | 3002.12 |
0% | MHRA Approval | Post-Brexit, still 0% for medical blood |
| π―π΅ Japan | 3002.12 |
0% | PMDA Approval | Zero duty, stringent safety checks |
π Conclusion:
- Globally, human blood plasma and its fractions are taxed at 0%.
- The primary barrier is regulatory compliance (FDA/EMA/NMPA), not tariffs.
- Ensure cold chain integrity and prior regulatory notification are flawless.
π VI. Common Errors & Pitfalls (Lessons Learned)
β Error 1: Missing FDA Prior Notice
π Consequence: Shipment held at port, returned, or destroyed. No exceptions.
β Error 2: Declaring "Albumin" as "Food Supplement"
π Consequence: Misclassification (HS 3501/2106), potential duty + penalty + FDA violation.
β Error 3: Using "Plasma Substitute" vaguely
π Consequence: Customs requests clarification. If not human-derived, may be classified differently. Specify "Human" or "Animal."
β Error 4: Ignoring Cold Chain Logs
π Consequence: Customs may refuse entry due to suspected product degradation.
β Correct Practice:
"Human Blood Plasma, Lyophilized, for Therapeutic Use, FDA Prior Notice No. XXX, Stored at 2-8Β°C, HS Code 3002.12.00.10"
π― VII. Conclusion: Precise Classification, Seamless Clearance
π― Remember the Mnemonic:
πΉ "Plasma for Therapeutic, 3002.12.10, Zero Duty, FDA First!"
πΉ "0% Tariff, 100% Regulatory Compliance!"
π Pro Tip:
- Always apply for an FDA Import Alert Clearance or use a FDA-registered broker.
- For albumin fractions, verify if they are considered "blood fractions" (3002.12) or "proteins" (3501/3502). Most therapeutic albumin remains under 3002.12.00.90.
π£ Immediate Action:
π Contact FDA Liaison + Prepare Cold Chain Logs + Submit Prior Notice
π Ensure your human blood plasma flows smoothly through US customs!
β¨ Professional Clearance Starts with Accurate Classification!
πΌ Zero Duty is Just the Beginning; Regulatory Compliance is Key!
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About HS Code Classification
The Harmonized System (HS) is an internationally standardized nomenclature developed by the World Customs Organization (WCO) to classify traded products. Over 200 countries use the HS system as the basis for customs tariffs, trade statistics, and import/export regulations.
Each HS code follows a hierarchical structure:
- Chapter (2 digits) β Broad category of goods (e.g., Chapter 84: Machinery and Mechanical Appliances)
- Heading (4 digits) β More specific grouping within the chapter
- Subheading (6 digits) β Internationally standardized breakdown, used by all WCO member countries
- National subdivisions (8-10 digits) β Country-specific extensions for further classification, such as US HTSUS 10-digit codes
Correct HS code classification is essential for smooth customs clearance, accurate duty payment, and compliance with trade regulations. Misclassification can lead to customs delays, overpayment of duties, or penalties.
When importing from CN to US, the applicable tariff rates may include:
- Most-Favored-Nation (MFN) rate β The standard duty rate applied to WTO members
- General rate β Applied to countries without trade agreements
- Trade remedy duties β Additional tariffs such as Section 301 (anti-dumping), Section 232 (national security), or countervailing duties
The information provided on this page is for reference purposes only. For official classification, please consult with your local customs authority or a licensed customs broker.