Albumin based Plasma Substitute
CN → US| HS编码 | 关税税率 | 原产国 | 目的国 | 文档 |
|---|---|---|---|---|
| 3002120010 | 10.0% | CN | US | 官方文档 |
| 3002120090 | 10.0% | CN | US | 官方文档 |
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AI分析
💉 Albumin-Based Plasma Substitute (Human Blood Plasma)
🌐 HS Code Reference & Customs Clearance Guide | 2026 Latest Tariff Analysis | Professional Clearance Strategy
📌 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.
⚠️ Critical Classification Point:
- If the product is "Human Blood Plasma" intended for therapeutic use →归入 3002.12.00.10
- If the product is "Other Blood Fractions" (including processed albumin preparations not explicitly listed as plasma) →归入 3002.12.00.90
📦 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 | ✅ Human Origin, Plasma Form |
3002.12.00.90 |
Antisera and other blood fractions: Other | Processed albumin fractions, synthetic substitutes, non-human plasma | ✅ Other Fractions / Processed |
🔍 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.
💰 III. 2026 Latest Tariff Rate Details (Zero Duty Policy)
✅ Applicable Country: United States (US)
✅ Origin: China (CN) or General
✅ Effective Date: 2025–2026 Current Tariff Schedule
🎯 1. 3002.12.00.10 —— 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 × 0% = $0.00 |
| De Minimis Exemption | ✅ Eligible (if applicable under $800 de minimis rule, subject to FDA/CDSCB restrictions) |
| Legal Basis | HTSUS 3002.12.00.10 |
📌 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.
🎯 2. 3002.12.00.90 —— 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 × 0% = $0.00 |
| De Minimis Exemption | ✅ Eligible (subject to regulatory approvals) |
| Legal Basis | HTSUS 3002.12.00.90 |
📌 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%–25% tariffs.
🛠️ IV. Customs Clearance Practical Advice (Combat Guide)
✅ 1. Required Documentation Checklist (No Exceptions)
| Document | Must Provide | Description |
|---|---|---|
| ✅ FDA Prior Notice | ✔️ | Mandatory for all human cells, tissues, and cellular/tissue-based products (HCT/Ps). Submit via FDA Prior Notice of Imported Foods/Drugs system. |
| ✅ Letter of Authorization | ✔️ | From FDA-registered facility (if applicable). |
| ✅ Certificate of Analysis (CoA) | ✔️ | Proof of safety, sterility, and viral inactivation. |
| ✅ Bill of Lading / Air Waybill | ✔️ | Must match invoice and packing list. |
| ✅ Commercial Invoice | ✔️ | Must clearly state: "Human Blood Plasma for Therapeutic Use" or "Albumin Fraction". |
| ✅ Packing List | ✔️ | Details of cold chain packaging (dry ice, gel packs). |
| ✅ Cold Chain Documentation | ✔️ | Temperature logs during transit (critical for blood products). |
⚠️ Critical Warning:
- No FDA Prior Notice = Automatic Rejection/Return.
- Blood products are regulated under 21 CFR Part 1271. Customs will verify FDA clearance.
✅ 2. Declaration Tips (Key Mnemonics)
🔥 “Plasma for Therapeutic Use, Code 3002.12.10, Zero Duty, FDA First!”
| Scenario | Correct Declaration | Error to Avoid |
|---|---|---|
| Human Plasma for Transfusion | 3002.12.00.10 |
Misdeclare as "Medical Supplies" (generic) → Risk of audit |
| Processed Albumin Concentrate | 3002.12.00.90 |
Misdeclare as "Plasma" if it’s a fraction → Misclassification |
| Synthetic Albumin Substitute | Check HTSUS Chapter 39 or 35 | May not be 3002! Verify if it’s human-derived. |
| Animal Blood Products | Not in this specific subheading | Must check 3002.11 or other subheadings |
✅ 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). |
🌍 V. Global Market Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Tariff | Regulatory Requirements | Remarks |
|---|---|---|---|---|
| 🇺🇸 USA | 3002.12.00.10 / .90 |
0% | FDA Prior Notice + 21 CFR 1271 | Zero duty, strict FDA control |
| 🇨🇳 China | 3002.12.00 |
0% | NMPA License | Zero duty, requires import license |
| 🇪🇺 EU | 3002.12 |
0% | EMA/GMP Certification | Zero duty under TARIC, strict GMP |
| 🇬🇧 UK | 3002.12 |
0% | MHRA Approval | Post-Brexit, still 0% for medical blood |
| 🇯🇵 Japan | 3002.12 |
0% | PMDA Approval | Zero duty, stringent safety checks |
📌 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.
📌 VI. Common Errors & Pitfalls (Lessons Learned)
❌ Error 1: Missing FDA Prior Notice
👉 Consequence: Shipment held at port, returned, or destroyed. No exceptions.
❌ Error 2: Declaring "Albumin" as "Food Supplement"
👉 Consequence: Misclassification (HS 3501/2106), potential duty + penalty + FDA violation.
❌ Error 3: Using "Plasma Substitute" vaguely
👉 Consequence: Customs requests clarification. If not human-derived, may be classified differently. Specify "Human" or "Animal."
❌ Error 4: Ignoring Cold Chain Logs
👉 Consequence: Customs may refuse entry due to suspected product degradation.
✅ Correct Practice:
"Human Blood Plasma, Lyophilized, for Therapeutic Use, FDA Prior Notice No. XXX, Stored at 2-8°C, HS Code 3002.12.00.10"
🎯 VII. Conclusion: Precise Classification, Seamless Clearance
🎯 Remember the Mnemonic:
🔹 "Plasma for Therapeutic, 3002.12.10, Zero Duty, FDA First!"
🔹 "0% Tariff, 100% Regulatory Compliance!"
📌 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.
📣 Immediate Action:
📞 Contact FDA Liaison + Prepare Cold Chain Logs + Submit Prior Notice
🚀 Ensure your human blood plasma flows smoothly through US customs!
✨ Professional Clearance Starts with Accurate Classification!
💼 Zero Duty is Just the Beginning; Regulatory Compliance is Key!
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关于 HS 编码归类
协调制度（HS）是由世界海关组织（WCO）制定的国际贸易商品分类标准。全球 200 多个国家采用 HS 系统作为海关关税、贸易统计和进出口监管的基础。
每个 HS 编码遵循以下层级结构：
- 章（2 位）——商品大类（例如：第 84 章：机器和机械设备）
- 品目（4 位）——章内的更具体分类
- 子目（6 位）——国际通用细分，所有 WCO 成员国统一使用
- 本国细分（8-10 位）——各国自行扩展的细分编码，如美国 HTSUS 10 位编码
正确的 HS 编码归类对于顺利通关、准确缴纳关税和遵守贸易法规至关重要。错误归类可能导致海关延误、多缴关税或罚款。
从CN进口到US时，适用的关税税率可能包括：
- 最惠国（MFN）税率——适用于 WTO 成员国的标准关税税率
- 普通税率——适用于无贸易协定国家
- 贸易救济关税——附加关税，如 301 条款（反倾销）、232 条款（国家安全）或反补贴税
本页内容仅供参考。如需正式归类，请咨询当地海关或持牌报关代理。