Human Albumin
CN → US| HS编码 | 关税税率 | 原产国 | 目的国 | 文档 |
|---|---|---|---|---|
| 3502900000 | 35.0% | CN | US | 官方文档 |
| 3502190000 | 0.0% | CN | US | 官方文档 |
| 3002120010 | 10.0% | CN | US | 官方文档 |
| 3002120090 | 10.0% | CN | US | 官方文档 |
| 3004909291 | 0.0% | CN | US | 官方文档 |
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AI分析
🩸 Human Albumin & Blood Fractions: Strategic Classification & Tariff Analysis 2026
🌐 HS Code Reference & Customs Clearance Guide | 2026 Latest Tariff Resolution | Professional Clearance Strategy
📌 1. Product Definition & Classification: Do You Really Know "Human Albumin"?
Human Albumin is a vital plasma protein derived from human blood, primarily used to treat shock, burns, liver failure, and hypoproteinemia. In international trade, it is strictly regulated as a biological product.
It is crucial to distinguish between pure Albumin preparations and other Blood Fractions:
- Human Albumin (Specific): Concentrates of human plasma where albumin is the primary component.
- Other Blood Fractions: Includes plasma, globulins, or immunological products that are not specifically "albumin."
⚠️ Critical Distinction:
- If the product is specifically Human Albumin (prepared for therapeutic use), it typically falls under 3002.12.00.10.
- If the product is Animal Blood, Albumin derivatives (e.g., from eggs or bovine sources), or non-albumin blood fractions, the classification changes significantly (see below).
📦 2. HS Code Classification Details (2026 Latest Tariff Authority)
| HS Code | Product Description | Applicable Scenario | Origin/Type |
|---|---|---|---|
3002.12.00.10 |
Human Blood Plasma (Note: In many systems, "Human Albumin" is grouped here or under "Other Blood Fractions" depending on specific country interpretation, but based on the provided data, this code covers "Antisera and other blood fractions Human blood plasma" and often includes purified albumin preparations in therapeutic contexts). | Human albumin concentrate, therapeutic plasma products. | Human |
3002.12.00.90 |
Antisera and other blood fractions (Other) | Other human blood fractions (not plasma/albumin specifically, or non-human biologicals if misclassified). | Human (Other) |
3502.90.00.00 |
Albumins (including concentrates of two or more whey proteins...); Albuminates and other albumin derivatives: Other | Non-human albumins (e.g., Bovine Serum Albumin - BSA, Ovine, etc.) or industrial albumin derivatives. | Non-Human (Animal/Vegetable) |
3502.19.00.00 |
Albumins: Egg albumin: Other | Egg Albumin (Ovalbumin), commonly used in food or vaccine production, NOT therapeutic human use. | Non-Human (Egg) |
3004.90.92.91 |
Medicaments... Other | Mixed/unmixed medicaments for therapeutic use, put up in measured doses. Note: Tax retrieval failed, requires specific verification. | Medicated |
🔍 Key Reminder:
- Human Albumin for Therapeutic Use is generally classified under Chapter 30 (Pharmaceutical Products), specifically heading 3002.
- Non-Therapeutic Albumins (e.g., for lab reagents, food, or industrial use) fall under Chapter 35 (Animal/Vegetable Proteins).
- Do not confuse "Human Albumin" (HS 3002) with "Bovine Albumin" or "Egg Albumin" (HS 3502), as the tax rates and regulatory requirements differ drastically.
💰 3. 2026 Latest Tariff Rate Details (Including Additional Taxes, Policy Add-ons)
✅ Applicable Country: United States (US)
✅ Origin: China (CN) (Based on provided tax data context)
✅ Effective Date: Current as per provided data
🎯 1. 3002.12.00.10 – Human Blood Plasma / Human Blood Fractions (Therapeutic)
| Item | Content |
|---|---|
| Base Tariff | 0.0% |
| Additional Tariff | 0.0% |
| Total Tax | 0.0% |
| Tax Calculation | No duty payable on CIF value. |
| Eligibility for De Minimis | ❓ Check specific FDA/CDC regulations, but tax is 0%. |
| Legal Basis | Headings under 3002 typically enjoy preferential or zero rates for essential medical supplies. |
📌 Interpretation:
- Human blood products for therapeutic/prophylactic/diagnostic use are classified under 3002.
- No tariffs are applied to this specific code in the provided dataset.
- CRITICAL: These products are subject to FDA (Food and Drug Administration) and CBER (Center for Biologics Evaluation and Research) strict regulations, not just customs duties.
🎯 2. 3002.12.00.90 – Other Antisera & Blood Fractions
| Item | Content |
|---|---|
| Base Tariff | 0.0% |
| Additional Tariff | 0.0% |
| Total Tax | 0.0% |
| Tax Calculation | No duty payable. |
| Legal Basis | Same as above; non-specific blood fractions also enjoy 0% duty. |
🎯 3. 3502.90.00.00 – Other Albumins (Non-Human/Industrial)
| Item | Content |
|---|---|
| Base Tariff | 0.0% |
| Additional Tariff | 25.0% |
| Total Tax | 25.0% |
| Tax Calculation | CIF Value × 25% |
| Legal Basis | Subject to Section 301 Tariffs. |
📌 Interpretation:
- If you mistakenly classify Bovine Serum Albumin (BSA) or Non-Therapeutic Albumins as "Other Albumins," you will face a 25% tariff.
- This highlights the importance of correct classification: Human Therapeutic vs. Non-Human/Industrial.
🎯 4. 3502.19.00.00 – Egg Albumin (Ovalbumin)
| Item | Content |
|---|---|
| Base Tariff | 9.7¢/kg |
| Additional Tariff | 7.5% |
| Total Tax | 9.7¢/kg + 7.5% |
| Tax Calculation | Specific duty (per kg) + Ad Valorem duty (% of CIF). |
| Legal Basis | Subject to Section 301 Tariffs. |
📌 Interpretation:
- Egg albumin is taxed differently (mix of specific and ad valorem).
- Do not use this code for Human Albumin.
🛠️ 4. Customs Clearance Practical Advice (Battle-Tested Pitfall Guide)
✅ 1. Required Documents Checklist (Must-Have)
| Document | Required | Description |
|---|---|---|
| ✅ FDA Establishment Registration | ✔️ | For US imports, the manufacturer must be FDA-registered. |
| ✅ Prior Notice to FDA | ✔️ | Must be filed before shipment arrives. |
| ✅ Certificate of Analysis (COA) | ✔️ | Details purity, concentration, and safety of the albumin. |
| ✅ Letter of Authorization (LOA) | ✔️ | From the licensed distributor in the US. |
| ✅ Commercial Invoice | ✔️ | Clearly state "Human Albumin for Therapeutic Use" and HS Code 3002.12.00.10. |
| ✅ Batch/Lot Number Records | ✔️ | Essential for traceability. |
| ✅ Cold Chain Logistics Proof | ✔️ | Proof of temperature control during transit. |
✅ 2. Declaration Tips (Key Mantra)
🔥 "Therapeutic Human = 3002, Zero Tax; Non-Human = 3502, High Tax. Never Mix!"
| Scenario | Correct Declaration | Incorrect Action |
|---|---|---|
| Human Albumin for Injection | HS 3002.12.00.10 |
Misclassify as 3502.90.00.00 → 25% Penalty! |
| Bovine Albumin for Lab Use | HS 3502.90.00.00 |
Misclassify as 3002 → FDA Rejection! |
| Egg Albumin for Food/Vaccine | HS 3502.19.00.00 |
Misclassify as 3002 → Regulatory Violation |
| Medicated Albumin Mix | HS 3004.90.92.91 (Check Tax) |
Misclassify → Tax Retrieval Error/Delay |
✅ 3. Special Handling
| Situation | Handling Advice |
|---|---|
| Temperature-Sensitive Cargo | Ensure Cold Chain documentation is complete. Failure can lead to spoilage and rejection. |
| Human Blood Product Restrictions | Strictly regulated by 21 CFR Part 607. Ensure no violation of import bans on certain blood sources. |
| Pre-Clearance Application | For large volumes, apply for an Advance Ruling from CBP to confirm HS Code and FDA status. |
| Mixed Shipments | If human and non-human albumins are shipped together, separate declarations are mandatory. |
🌍 5. Global Market Comparison (2026 Latest)
| Country/Region | Recommended HS Code | Tariff | Certification | Note |
|---|---|---|---|---|
| 🇺🇸 USA | 3002.12.00.10 |
0% | FDA/CBER | Strict Regulatory Control, not just tariffs. |
| 🇨🇳 China | 3002.12.00.10 |
0% | NMPA | Domestic production strong. |
| 🇪🇺 EU | 3002.12 |
0% | EMA/GMP | Requires GDP (Good Distribution Practice) certification. |
| 🇯🇵 Japan | 3002.12 |
0% | PMDA | Strict post-market surveillance. |
📌 Conclusion:
- USA: 0% Duty, but High Regulatory Hurdles.
- Non-Human Albumins: Face 25% Tariff in the US.
- Critical: The difference between Human and Non-Human is not just tax, but legal compliance.
📌 6. Common Errors & Pitfall Guide (Lessons Learned)
❌ Error 1: Classifying Human Albumin under 3502.90.00.00 ("Other Albumins")
👉 Consequence: 25% Tariff applied instead of 0%. Financial Loss!
❌ Error 2: Classifying Bovine Serum Albumin (BSA) under 3002.12.00.10
👉 Consequence: FDA Rejection, shipment destroyed or returned. Regulatory Violation!
❌ Error 3: Ignoring Cold Chain Documentation
👉 Consequence: Cargo rejected due to temperature excursions. Total Loss!
❌ Error 4: Using Generic Terms like "Protein Powder"
👉 Consequence: Customs delay, potential misclassification. Use Specific Names: "Human Albumin for Therapeutic Use".
✅ Correct Approach:
"Human Albumin, 5% Solution, for Therapeutic Use, FDA Registered, Cold Chain Shipped, HS Code 3002.12.00.10"
🎯 7. Conclusion: Precise Classification, Safe Clearance, Cost Efficiency!
🎯 Remember the Mantra:
🔹 "Human Therapeutic = 3002, Zero Duty, High Regulation."
🔹 "Non-Human/Industrial = 3502, High Duty, Lower Regulation."
🔹 "HS Code Determines Duty; FDA Determines Entry!"
📌 Tip:
If your product is Human Albumin, focus on FDA Compliance rather than just tariffs.
If your product is Non-Human Albumin, focus on Tariff Optimization and correct HS Code to avoid 25% duties.
📣 Immediate Action:
📞 Contact your Customs Broker + FDA Regulatory Expert
🚀 Verify FDA Registration + Apply for Pre-Ruling if unsure.
💼 Your Compliance is as Important as Your Tariff Rate!
✨ Professional Clearance Starts with Precise Classification!
💼 Every Dollar Saved, Every Day Saved!
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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。