Tiếng Việt
中文 (中国)
IMPORT PROCEDURE GUIDE FOR PROBIOTICS INTO VIETNAM
Imported probiotics may create compliance risks when they are treated merely as ordinary packaged foods: incorrect HS classification, confusion between health supplements and microbial raw materials, missing product registration receipt, incomplete imported food safety inspection documents, insufficient Vietnamese supplementary label, or C/O inconsistency. These gaps may trigger document review, physical inspection, supplementary document requests, loss of preferential duty or DEM/DET exposure. This guide provides an E2E (End-to-End) map for reviewing HS code, duties, C/O, food safety documents, labeling and pre-ETA risks.
| Item | Review direction |
|---|---|
| Applicable product | Finished probiotic products in capsules, sachet powder, granules, chewable tablets, gummies or liquid form, imported for commercial distribution as health supplements/food supplements. |
| Primary reference HS | 2106.90.72 – other health supplements, where the product is a finished oral probiotic product packed for retail sale and is not a drug. |
| Reference duties | Ordinary import duty 22.5%; MFN duty 15%; reference VAT 8% based on current tariff data, subject to re-check at customs declaration date; valid C/O may allow special preferential duty, with many FTAs showing 0%. |
| Specialized policy | Key areas: product registration, state inspection of imported food safety, product labeling/supplementary labeling, and dossier requirements under Decree 15/2018/ND-CP while Resolution 15/2026/NQ-CP suspends the newer mechanism. |
| Classification warning | This guide does not automatically apply to probiotic medicines, medical biological products, microbial raw materials for manufacturing, research strains, animal/aquaculture probiotics, products for young children, or products carrying therapeutic claims. |
QUICK FACT
SCOPE OF APPLICATION
Applicable goods
This article applies to probiotics for human consumption imported as finished consumer products, including capsules, powder sachets, tablets, gummies or drinks, typically regulated as health supplements/food supplements.
Variants not automatically covered
It does not automatically cover medicines, medical biological products, microbial raw materials, culture media, probiotics for animal feed/aquaculture, products for children under 36 months, or foods for special medical purposes.
Shipment status
Commercial goods, samples, display goods, testing samples, warranty goods, goods for EPE/FDI plants or project cargo may require different dossier preparation.
Dossier-locking principle
Review must be based on catalogue, datasheet/specification, ingredients, probiotic count, serving size, original label, claims, shelf life, origin and actual import purpose.
CLASSIFICATION & TECHNICAL IDENTIFICATION
For probiotics, the decisive factors are not only the word “probiotic”, but also the declared function, finished product form, ingredients, target users and labeling dossier. If the product is presented as supporting digestive health, supplementing beneficial bacteria or balancing intestinal flora, it will likely need to be reviewed as a health supplement. If it carries disease treatment/prevention claims or is presented as medicine, the policy may shift to pharmaceutical/biological regulations.
| Criteria to check | Documents to compare | Risk if described incorrectly | Suggested goods description |
|---|---|---|---|
| Product form | Catalogue, specification, original label, packaging photos | Finished consumer goods may be confused with microbial raw materials | “Probiotic sachet/capsule, health supplement, item code…, packing…” |
| Ingredients & strains | Ingredient list, COA, test report, specification | Insufficient basis for product registration and product nature explanation | Use trade name plus nature: probiotic food supplement and main ingredients |
| CFU level & serving size | COA, label, product specification | Wrong testing parameters or declaration content | State data consistently with the product dossier; do not self-convert without basis |
| Claims/functions | Label, website, registration dossier, marketing materials | May be treated as therapeutic/drug claim or wrong regulatory group | Use functions consistent with the registered dossier and avoid disease-treatment wording |
| Target users | Original label, use instructions | May fall into young children/medical nutrition/special diet categories | State target users clearly; separately review products for children under 36 months |
| Shipment status | Invoice, packing list, contract, photos | Samples/testing goods may be treated incorrectly as commercial goods | Specify sample/commercial goods where supported by documents |
HS CODE – DUTIES – C/O
The HS Code for probiotics must be determined based on the actual nature of the imported goods. For finished oral probiotic products packed for retail sale as health supplements, the reference HS to review is usually 2106.90.72. This code should not be automatically used for microbial strains, manufacturing raw materials, medicines/biological products or animal/aquaculture probiotics.
| Reference HS | Applicable condition | Ordinary import duty | MFN | VAT | Special preferential duty with C/O | Risk if misapplied | Documents to compare |
|---|---|---|---|---|---|---|---|
| 2106.90.72 | Finished oral probiotic product packed for retail sale as other health supplement | 22.5% | 15% | 8%/10% reference; review under Decree 174/2025/ND-CP and tariff data at declaration date | May be 0% under eligible FTA/C/O | Wrong if product is medicine, biological product, raw material or not a food supplement | Original label, ingredient list, COA, product registration, catalogue, C/O |
| 2106.90.99 | Only considered where the product is another edible preparation but does not clearly fall under the specific food supplement line | 22.5% reference | 15% reference | 8%/10% depending on VAT policy at declaration date | Review by FTA and C/O form | May misrepresent the nature if the product is actually a health supplement | Specification, ingredients, claims, label, test dossier |
| 3002.xx or other headings | Review only where the goods are microbial strains, biological products, research/manufacturing materials or pharmaceutical-like goods | Not fixed generally | Not fixed generally | Not fixed generally | Separate review required | May trigger different HS and specialized policies | Technical catalogue, purpose of use, specialized management dossier |
| C/O scenario | Common risk | Pre-ETA check |
|---|---|---|
| C/O uses HS different from declaration | Preferential duty may be rejected or queried | Check draft C/O against the expected HS before issuance |
| Goods description is too generic | Hard to prove it matches the invoice/declaration goods | Compare goods name, packing, lot number, weight and origin |
| Third-party invoice | Missing third-party invoicing indication under applicable FTA rules | Check the relevant FTA rule before submission |
| Transit via third country | Missing through B/L or non-manipulation evidence | Prepare transport documents and supporting logistics records if required |
APPLICABLE SPECIALIZED POLICY
| Goods scenario | Potential policy | Documents to check | Authority/portal if identifiable | Recommended timing | Risk note |
|---|---|---|---|---|---|
| Finished probiotic food supplement | Product registration for health supplements | Product registration receipt, test report, label sample, ingredients, scientific evidence if any | Ministry of Health/Vietnam Food Administration or current public service portal | Before commercial importation or market circulation | Missing registration may delay clearance/circulation |
| Commercial import shipment | State inspection of imported food safety | Inspection application, registration dossier, Packing List, B/L/AWB, invoice | Designated food safety inspection authority or National Single Window if applicable | Before or when goods arrive at the border gate | Late filing after ETA may create storage and detention cost |
| Health/function claims | Control of claims, labeling and advertising of health supplements | Label, advertising materials, evidence of functions, registered dossier | Competent authority handling food advertising confirmation | Before advertising/sales | Therapeutic claim may push product outside food scope |
| Products for children/under 36 months | May fall into infant nutrition or special regulatory group | Label, use instructions, target users, composition | Ministry of Health/competent authority | Before PO and ETA | Do not apply this guide automatically to such products |
| Microbial raw materials or testing samples | May not be finished food supplement; HS and specialized policy must be reviewed separately | Technical catalogue, use purpose, contract, COA, MSDS if any | Authority based on actual product nature | Before booking | Wrong declared use may cause wrong HS/policy |
| Imports for EPE/FDI/factory use | Customs policy and internal use/production purpose may differ | Contract, import purpose, internal records | Customs and specialized authority if applicable | Before declaration | Do not assume exemption from food safety dossier if goods circulate domestically |
LEGAL DOCUMENTS TO REVIEW
| Document group | Name/number | Issuing authority | Effectiveness/timing | Role in procedure | Key article/appendix | Review note |
|---|---|---|---|---|---|---|
| Law | Law on Food Safety No. 55/2010/QH12 | National Assembly | Effective from 01 July 2011 | Primary legal framework for food safety, production/trading conditions, inspection and sanctions | General provisions on imported food, labeling and advertising | Review by actual product group |
| Decree | Decree 15/2018/ND-CP | Government | Effective from 02 Feb 2018 | Regulates self-declaration, product registration, imported food safety inspection, labeling and food advertising | Article 6 on product registration; Articles 15–19 on imported food inspection; Article 29 on GMP for health supplements | Applied while Resolution 15/2026 suspends the new mechanism |
| Resolution | Resolution 15/2026/NQ-CP | Government | Effective from 06 Apr 2026 | Suspends Decree 46/2026/ND-CP and Resolution 66.13/2026/NQ-CP; continues Decree 15/2018 during suspension | Article 1 and effect provisions | Re-check at filing date |
| Decree | Decree 43/2017/ND-CP and Decree 111/2021/ND-CP | Government | Decree 43 effective 01 Jun 2017; Decree 111 effective 15 Feb 2022 | Product labeling and labeling of imported goods | Mandatory contents on original and supplementary labels | Review together with food labeling rules |
| Circular | Circular 43/2014/TT-BYT | Ministry of Health | Effective from 01 Feb 2015 | Management of functional foods, including food supplements and health supplements | Scope, labeling, use instructions and claim management | Check amendments/effectiveness at application time |
| Circular | Circular 18/2019/TT-BYT | Ministry of Health | Effective from 17 Jul 2019 | GMP for health supplement production/trading; equivalent certificates for imported products | Article 1, Article 3 and GMP appendix | Important for product registration dossier |
| QCVN/TCVN | QCVN 8-3:2012/BYT and related food safety limits | Ministry of Health | Apply by product group | Basis for microbiological and safety testing indicators | Microbiological contaminants and relevant safety criteria | Apply based on ingredients and product form |
| Tariff | Current import-export tariff and FTA preferential tariff schedules | Ministry of Finance/Government | At declaration date | Determine ordinary duty, MFN, VAT and FTA duty with C/O | HS 2106.90.72 and alternatives if any | Do not use tax rates without re-checking at declaration date |
VIEW / DOWNLOAD ORIGINAL LEGAL DOCUMENTS
Enterprises may search by document number on the official legal document portal, the Government portal or the issuing authority website. Enterprises should additionally cross-check on the legal document portal or the issuing authority website before applying.
CUSTOMS CLEARANCE DOSSIER
Commercial documents
- Commercial Invoice.
- Packing List.
- Bill of Lading/Air Waybill.
- Sales Contract/Purchase Order if available.
- Certificate of Origin – C/O for preferential duty.
- Catalogue, specification, COA, original label and goods photos.
Specialized/food safety dossier
- Product registration receipt if classified as health supplement.
- Food safety test report.
- Imported food safety inspection dossier.
- Label sample, Vietnamese supplementary label and function evidence if any.
- GMP or equivalent manufacturing certificate if required by the dossier.
- Technical information on probiotic strains, CFU and storage conditions.
| Dossier group | Required documents | Used for which step | Usually prepared by | Common error | Pre-ETA check |
|---|---|---|---|---|---|
| Commercial documents | Invoice, Packing List, B/L/AWB, Contract/PO | Customs declaration, valuation, quantity and Incoterms | Importer, exporter, forwarder | Inconsistent goods name, quantity, weight or packing | Compare every item with label and packing |
| Product dossier | Specification, ingredient list, COA, label artwork | HS, registration, supplementary label and testing | Manufacturer, importer, compliance | Missing strain, CFU, serving size or shelf life | Lock final version before declaration |
| Registration dossier | Product registration receipt, test report, label sample | Market circulation and food safety basis | Importer, legal team, testing lab | Registration does not match label or product group | Compare product name, ingredients, claims and packing |
| Imported food inspection | Inspection application, registration dossier, packing list, shipment documents | Import clearance | Importer, customs broker, inspection authority | Filed late after ETA or lacking packing/registration documents | Prepare before arrival |
| C/O | Relevant C/O form, invoice, B/L, transport documents | Preferential duty claim | Exporter, importer | Wrong form, description or origin criterion | Check draft C/O before issuance |
| Labeling | Original label, supplementary label, responsible party, origin, shelf life, storage | Market circulation and inspection explanation | Importer, supplier, label designer | Missing warning, use instruction, target users or storage conditions | Use a label checklist before arrival |
DECISION POINTS THAT MAY HOLD THE SHIPMENT
| Decision point | Question to answer | Evidence | Consequence if unclear | Recommended handling |
|---|---|---|---|---|
| HS classification | Is it HS 2106.90.72 health supplement or another group? | Ingredient list, label, specification, COA | HS query, amendment or additional duty | Finalize HS before ETA and prepare classification rationale |
| Food safety group | Is product registration required? | Claims, label, registration dossier, test report | Insufficient basis for clearance/circulation | Review under Decree 15/2018 before booking |
| Function claims | Does it use treatment/prevention wording? | Label, leaflet, website, marketing materials | May be outside food scope | Align claims with legal dossier |
| Imported food inspection | Reduced, normal or strict inspection? | Import history, food safety dossier, alerts if any | Delay and DEM/DET exposure | File before or upon arrival |
| Supplementary label | Does it contain mandatory Vietnamese contents? | Original label, supplementary label, packaging photos | May require correction before circulation | Approve label before arrival |
| C/O | Is C/O valid for preferential duty? | C/O, B/L, invoice, transport records | Loss of preference or post-clearance duty recovery | Check draft C/O against expected HS |
PRACTICAL E2E PROCESS
Pre-ETA review
Finalize HS, food safety policy, duties, C/O, supplementary label, claims, storage conditions and whether product registration/import food inspection is required.
Lock documents and product dossier
Cross-check Invoice, Packing List, B/L/AWB, specification, ingredient list, COA, original label, supplementary label, C/O and registration dossier.
Prepare specialized dossier
Complete product registration, test report, imported food inspection dossier and GMP/equivalent certificate if required.
Open customs declaration
Handle Green/Yellow/Red channels and explain HS, customs value, origin, C/O, food safety and labeling if requested.
Clearance and post-clearance control
Move goods to warehouse, complete supplementary labeling, control storage conditions, archive shipment dossier and prepare post-clearance explanations.
PRE-ETA RISK CHECKLIST
| Risk | Consequence | Pre-ETA control | Documents to check |
|---|---|---|---|
| Confusing health supplement probiotics with medicines/biological products | Wrong HS and specialized policy | Review claims, product form, functions and manufacturer dossier | Label, leaflet, specification, COA |
| Missing product registration receipt | Delayed circulation or additional dossier request | Prepare product registration before commercial import | Registration dossier, test report, label sample |
| C/O wrong form or description | Preferential duty may be rejected | Check draft C/O against expected HS and goods description | C/O, invoice, B/L, PO |
| Supplementary label lacks warning or instructions | Correction request or sanction risk during circulation | Approve label under Decrees 43/2017 and 111/2021 plus functional food rules | Original label, supplementary label, registered dossier |
| Test report does not match required indicators | Insufficient basis for registration/inspection | Select testing parameters based on ingredients, form and applicable standards | Test report, COA, specification |
| Storage conditions not controlled | Quality concern for live bacteria | Confirm temperature, shelf life and transport conditions before booking | Label, COA, booking, storage instruction |
FAQ – COMMON BUSINESS QUESTIONS
Do imported probiotics require an import permit?
Do not answer solely by product name. For probiotic health supplements, the key issues are product registration, imported food safety inspection and labeling. Medicines/biological products or microbial raw materials follow different policies.
Is product registration required?
If the product is classified as a health supplement, it falls under product registration under Decree 15/2018/ND-CP before market circulation.
Is imported food safety inspection required?
It may be subject to state inspection of imported food safety under the appropriate inspection method. Prepare the dossier before ETA to avoid storage cost.
Is Vietnamese supplementary labeling required?
Yes, products circulating in Vietnam must be reviewed under goods labeling rules and specific requirements for health supplements.
Can C/O reduce import duty?
Possibly, if the C/O form, origin criteria, product description and HS match the declaration and applicable FTA.
What if the label claims disease treatment?
Treatment or prevention claims may push the product outside food scope. Review with legal/compliance before importing and advertising.
Are samples handled like commercial shipments?
Not automatically. Samples/testing/display goods may have a different dossier route but documents must clearly state the import purpose.
What if invoice name differs from original label?
Correct documents or prepare a rationale before declaration. Goods name, packing, lot number, origin and product information must be consistent across documents, label and registration dossier.
NEED TO REVIEW IMPORT PROCEDURES OR A SHIPPING PLAN?
Send us the product name, shipping route, current dossier, or implementation request in advance so we can suggest a suitable approach that is practical, focused, and aligned with your shipment.
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