Tiếng Việt
中文 (中国)
Circular 43/2014/TT-BYT: Functional food management and import-compliance notes
Circular 43/2014/TT-BYT provides a key regulatory framework for functional foods, including product classification, declaration, labeling, advertising, production/trading conditions, recall and traceability. This article places the regulation in the practical context of import-export operations, clarifying its scope, affected parties, and the checks required before it is relied on for a shipment dossier. Before implementation, businesses should verify the effective date, amendments, and relevant official guidance applicable to the transaction, while retaining the source and document version used for later explanation or audit.
QUICK SUMMARY
The Circular regulates functional food management, including product declaration, labeling, advertising, production/trading conditions, recall and traceability.
Issued on 24 November 2014 and effective from 01 February 2015. Current application should be reviewed together with Circular 17/2023/TT-BYT and Consolidated Text 11/VBHN-BYT.
Review product classification, declaration dossier, label/claims, test reports, import documents and post-clearance recordkeeping before finalizing shipment documents.
DOCUMENT INFORMATION
| Field | Details |
|---|---|
| Document title | Circular on the management of functional foods |
| Number | 43/2014/TT-BYT |
| Issuing authority | Ministry of Health |
| Issued date | 24 November 2014 |
| Effective date | 01 February 2015 |
| Signer | Nguyen Thanh Long |
| Application status | Apply together with the 2023 consolidated text 11/VBHN-BYT and the amendment Circular 17/2023/TT-BYT. |
KEY POINTS FOR ENTERPRISES
Separate supplemented foods, health supplements, foods for special medical purposes and foods for special dietary uses.
Controls conformity declaration, food-safety declaration, efficacy evidence and active-ingredient testing.
Controls product-group wording, health claims, mandatory disclaimer and non-medicine positioning.
AFFECTED PRODUCTS / ENTERPRISES
- Importers, distributors, brand owners: product classification, declaration dossier and Vietnamese label.
- Manufacturers and OEM/ODM suppliers: GMP/HACCP, formula, active substances and traceability.
- Procurement, legal, compliance, operation: cross-check import documents, test reports, scientific evidence and post-clearance records.
- Logistics providers: identify regulated goods early to avoid ETA without declaration/label readiness.
IMPACT ON IMPORT-EXPORT / LOGISTICS
- Customs declaration: goods description, function, formula and product group should be consistent with HS code and declaration dossier.
- Documents: Invoice, Packing List, B/L/AWB, C/O, contract, catalogue, original label, test report and declaration documents should match.
- Timeline: declaration, testing and Vietnamese label review should be completed before ETA planning.
- Compliance: maintain product dossiers, advertising claims, traceability and recall-readiness records.
ENTERPRISE CHECKLIST
| Review area | Documents to compare | Risk if inconsistent | Recommended timing |
|---|---|---|---|
| Product classification | Formula, label, claims, dosage form | Wrong declaration route or labeling obligations | Before contract and label artwork |
| Declaration dossier | Testing result, product standard, scientific evidence, GMP | Dossier rejected or supplemented | Before ETA planning |
| Label and claims | Original label, Vietnamese label, ad content | Excessive medical claims; missing non-medicine disclaimer | Before printing and approval |
| Import documents | Invoice, Packing List, B/L/AWB, C/O, HS code | Mismatch affecting customs and food-safety inspection | Before shipment departure |
| Post-clearance | Dossier archive, test results, declaration receipt | Difficult post-clearance explanation or recall handling | After clearance and before market circulation |
TECHNICAL TERMS
- Health supplement: product supporting body functions; not a medicine.
- RNI: recommended nutrition intake for Vietnamese people.
- Health claims: health-related statements requiring appropriate conditions and scientific evidence.
- GMP: Good Manufacturing Practice.
- DEM/DET/Storage: container yard, container detention and port/warehouse storage costs caused by delayed release.
RELATED LEGAL DOCUMENTS TO REVIEW
| Document group | Name / reference | Issuing authority | Effective date / timing | Role in compliance | Articles / appendices to note | Review note |
|---|---|---|---|---|---|---|
| Law | Law on Food Safety No. 55/2010/QH12 | National Assembly | Effective from 01 July 2011 | Foundation for food safety obligations, declaration, inspection and enterprise responsibilities. | Review according to product scope, enterprise responsibility and food safety management requirements. | Additional review is required if the dossier involves production, trading, advertising or market circulation. |
| Decree | Decree 15/2018/ND-CP | Government | Issued and effective on 02 February 2018 | Key implementing decree for product self-declaration, registered declaration, state inspection, labeling, advertising and health supplement production conditions. | Especially relevant to health supplements, declaration dossiers, state inspection and labeling. | Should be read together with Circular 43/2014/TT-BYT and the consolidated text. |
| Main Circular | Circular 43/2014/TT-BYT | Ministry of Health | Issued 24 November 2014, effective 01 February 2015 | Main document on functional food management. | Articles 1-21 and Appendices 01-02. | The signed PDF contains long numerical appendices; review the official PDF before applying. |
| Amending Circular | Circular 17/2023/TT-BYT | Ministry of Health | Issued 25 September 2023, effective 09 November 2023 | Amends, supplements and repeals several food safety legal documents. | Review amendments affecting Circular 43/2014/TT-BYT. | Do not rely solely on the 2014 original when the dossier is prepared after the amendments. |
| Consolidated text | Consolidated Text 11/VBHN-BYT | Ministry of Health | Issued 02 November 2023 | Consolidates the Circular on functional food management after amendments. | Use the consolidated text to check currently applicable wording. | Read alongside the signed 2014 PDF to distinguish original and amended content. |
| Labeling | Decree 43/2017/ND-CP and Decree 111/2021/ND-CP | Government | Decree 43 effective 01 June 2017; Decree 111 effective 15 February 2022 | General labeling and Vietnamese supplementary label requirements for goods imported into Vietnam. | Mandatory label contents, labeling responsibility and supplementary labels. | Apply together with specific functional food/health supplement labeling rules. |
| Repealed prior document | Circular 08/2004/TT-BYT | Ministry of Health | Repealed when Circular 43/2014/TT-BYT became effective | Former document on functional food management. | Article 19 of Circular 43/2014/TT-BYT. | Historical reference only, not a current legal basis. |
VIEW / DOWNLOAD ORIGINAL DOCUMENT
Use official sources and the signed PDF before applying the text to a real dossier.
FULL TEXT / LEGAL TEXT
The official signed Vietnamese PDF of Circular 43/2014/TT-BYT contains 20 pages, including long numerical appendices. To avoid truncation or altered figures, the full text is provided below as a direct official PDF preview. This English page is an operational reference and not an official legal translation.
Authoritative source: Government Legal Document Portal. The signed PDF is the reference document for the full official Vietnamese text, including appendices and numerical tables.
The consolidated text helps review amended content. For a real import dossier, compare the original document, amending document and product-specific dossier.
FAQ
1. When did Circular 43/2014/TT-BYT take effect?
It took effect on 01 February 2015. Current application should also consider Circular 17/2023/TT-BYT and consolidated text 11/VBHN-BYT.
2. Which products are covered?
Supplemented foods, health supplements, foods for special medical purposes and foods for special dietary uses; formulated nutrition products for young children are excluded.
3. Must imported functional foods be declared/registered?
A declaration or registration route may apply depending on the current decree, product group, formula, claims and dossier. Decree 15/2018/ND-CP must be reviewed.
4. What is the key labeling risk?
Labels must correctly state the product group, users, claims and required disclaimer; health supplements must not be presented as medicines.
5. Is efficacy testing always required?
No. It is triggered by specific claims, new active substances, new formulas or special conditions. Scientific evidence must be reviewed.
6. What should be checked before ETA?
Classification, claims, Vietnamese label, testing result, declaration dossier, HS code, import documents and post-clearance archive plan.
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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