Tiếng Việt
中文 (中国)
Decree No. 15/2018/ND-CP: Detailing the Implementation of Certain Articles of the Law on Food Safety
Decree No. 15/2018/ND-CP is a key legal instrument for food safety management in Vietnam, particularly for product self-declaration, product declaration registration, state inspection of imported food, food labeling, food advertising, GMP requirements for health supplements, and allocation of management responsibilities among sectoral ministries.
Effectiveness note: Vietnam’s National Legal Database currently shows Decree No. 15/2018/ND-CP as still in force. Businesses should also monitor Resolution No. 15/2026/NQ-CP dated 06 April 2026, which suspends the effect of Decree No. 46/2026/ND-CP and Resolution No. 66.13/2026/NQ-CP during the transition period.
DOCUMENT INFORMATION
| Item | Details |
|---|---|
| Document title | Decree detailing the implementation of certain articles of the Law on Food Safety |
| Number | 15/2018/ND-CP |
| Issuing authority | Government of Vietnam |
| Date of issuance | 02 February 2018 |
| Effective date | 02 February 2018 |
| Signatory | Nguyen Xuan Phuc |
| Effectiveness status | The National Legal Database currently indicates that the decree is still in force. In practice, companies should further review transitional instruments and implementation guidance applicable at the time of filing. |
QUICK SUMMARY
Regulatory scope
The decree covers product self-declaration, product declaration registration, state inspection for imported/exported food, labeling, advertising, GMP for health supplements, food additives, traceability, and allocation of state food safety management responsibilities.
Import-export focus
Food importers must determine the product group, responsible authority, declaration dossier, import inspection dossier, inspection method, and labeling obligations before customs clearance or market circulation.
KEY POINTS TO NOTE
- Product self-declaration: generally applies to processed packaged food, food additives, processing aids, containers and packaging materials in direct contact with food, except products subject to declaration registration.
- Product declaration registration: generally applies to health supplements, medical nutrition products, foods for special dietary uses, nutrition products for children up to 36 months of age, and certain specific food additives.
- State inspection of imported food: inspection may be reduced, normal or strict depending on compliance history, product group and risk profile.
- Import dossier: businesses should review self-declaration/receipt of registered product declaration, test reports, CFS/Health Certificate/Certificate of Exportation where applicable, shipment documents, labels and technical documents.
- Management allocation: Appendices II, III and IV allocate product groups under the management of the Ministry of Health, the Ministry of Agriculture and Rural Development, and the Ministry of Industry and Trade.
AFFECTED PARTIES
- Importers of food, beverages, health supplements, food additives, food ingredients and food-contact packaging/materials.
- Manufacturers, processors, packers, distributors and traders of food products in Vietnam.
- Procurement, legal, compliance, QA/QC, logistics, customs operation teams and overseas suppliers.
- Cold-chain operators, warehouses, forwarders and customs brokers handling food shipments.
BUSINESS REVIEW CHECKLIST
| Workstream | Review items | Operational note |
|---|---|---|
| Product classification | Determine whether the product is ordinary food, health supplement, additive, ingredient, food-contact packaging/material, or another regulated product. | Do not rely only on the commercial name; review composition, intended use, label, HS code and technical dossier. |
| Competent authority | Review Appendices II, III and IV to identify the responsible ministry. | For mixed products, review the main ingredient, intended use and actual product nature. |
| Product declaration | Determine whether the product is subject to self-declaration or product declaration registration. | Health supplements, medical nutrition products and products for children up to 36 months are commonly subject to registration. |
| Testing | Prepare a valid food safety test report where required. | Testing indicators must be aligned with technical regulations, declared standards and product characteristics. |
| Import dossier | Commercial Invoice, Packing List, Bill of Lading/Air Waybill, contract/PO, declaration documents, C/O if any, and CFS/HC/CE if applicable. | For animal-origin or aquatic products, additionally review certificates and eligibility of exporting countries/establishments. |
| Labeling | Review original label, Vietnamese supplementary label, product name, ingredients, quantity, manufacture date, expiry date, storage instructions and warnings. | The label must be consistent with the declaration dossier and import documents. |
| Customs clearance | Identify the relevant inspection method: reduced, normal or strict; prepare filing via the inspection authority or National Single Window where applicable. | Missing inspection result notices may affect clearance timing. |
| Post-clearance | Retain declaration dossiers, test reports, shipment documents, labeling files, traceability and distribution records. | Essential for post-market control, recall, explanation and sectoral inspection. |
TECHNICAL TERM NOTES
- Food safety: conditions ensuring that food does not harm human health when used as intended.
- Product self-declaration: a procedure under which a business declares and takes responsibility for product safety for eligible product groups.
- Product declaration registration: a filing procedure for higher-risk or specific products requiring receipt/acceptance by a competent authority.
- CFS: Certificate of Free Sale.
- Health Certificate: a certificate issued by the competent authority of the exporting/origin country.
- GMP: Good Manufacturing Practice.
- Reduced / normal / strict inspection: state inspection methods for imported food depending on risk level and compliance history.
NOTES FOR IMPORT-EXPORT / LOGISTICS APPLICATION
- Before shipment arrival, confirm whether the product requires declaration, registration or state food safety inspection upon importation.
- Do not assess solely by HS code; review description, composition, intended use, product form, technical dossier and competent ministry.
- For cold-chain or perishable products, complete dossier preparation before ETA to reduce storage, demurrage and quality risks.
- For health supplements or products with functional claims, control labeling, advertising claims and supporting scientific evidence.
- During the 2026 transition period, review Resolution No. 15/2026/NQ-CP, Decree No. 46/2026/ND-CP and Resolution No. 66.13/2026/NQ-CP before applying the dossier in practice.
RELATED LEGAL DOCUMENTS TO REVIEW
| Group | Document | Authority / effective date | Relevance | Notable article / appendix |
|---|---|---|---|---|
| Law | Law on Food Safety No. 55/2010/QH12 | National Assembly; effective 01 July 2011 | Primary law governing food safety. | Rules on declaration, inspection, facility conditions and state management responsibility. |
| Law | Law on Government Organization No. 76/2015/QH13 | National Assembly; effective 01 January 2016 | Legal basis for issuance of the decree at the time. | Review current government-organization legislation when making new citations. |
| Decree | Decree No. 38/2012/ND-CP | Government; issued 25 April 2012 | Replaced by Decree No. 15/2018/ND-CP. | Article 43.2 of Decree No. 15/2018/ND-CP. |
| Decrees | Decree No. 69/2010/ND-CP and Decree No. 108/2011/ND-CP | Government | Related to biosafety for genetically modified organisms. | Referenced in Chapter IV on genetically modified food. |
| Decrees | Decree No. 43/2017/ND-CP and Decree No. 111/2021/ND-CP | Government | Product labeling and amendments. | Review for imported food labels and Vietnamese supplementary labels. |
| Decrees | Decree No. 115/2018/ND-CP and Decree No. 124/2021/ND-CP | Government | Administrative penalties in food safety and amendments. | Relevant to declaration, testing, labeling, advertising and food safety conditions. |
| 2026 transitional instruments | Decree No. 46/2026/ND-CP; Resolution No. 66.13/2026/NQ-CP; Resolution No. 15/2026/NQ-CP | Government; issued in 2026 | Important transition documents for food safety, product declaration and registration. | Resolution No. 15/2026/NQ-CP suspends Decree No. 46/2026/ND-CP and Resolution No. 66.13/2026/NQ-CP. |
| Joint circular | Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT | Ministry of Health, MARD, MOIT; issued 09 April 2014 | Guidance on coordination and management allocation for food safety. | Chapter II was abolished under Article 43.2 of Decree No. 15/2018/ND-CP. |
| Circulars / guidance | Circular No. 08/2025/TT-BYT; Circular No. 48/2025/TT-BYT | Ministry of Health | Recorded in the National Legal Database as guiding/detailing instruments related to Decree No. 15/2018/ND-CP. | Review according to the specific procedure and product group. |
APPENDICES / FORMS TO REVIEW
| Appendix | Content | Operational note |
|---|---|---|
| Appendix I | Forms for self-declaration, product declaration, receipt of registered declaration, imported food inspection registration, inspection result notice, reports, exporting establishment information, advertising confirmation and GMP-related documents. | The most important appendix for practical filing; use the correct form applicable at the time of submission. |
| Appendix II | List of food products/groups and goods under the management of the Ministry of Health. | Review for health supplements, additives, processing aids, drinking water, ice, and food-contact packaging/materials where applicable. |
| Appendix III | List of food products/groups and goods under the management of the Ministry of Agriculture and Rural Development. | Important for meat, seafood, milk, eggs, cereals, fruits/vegetables and agricultural/forestry/aquatic products. |
| Appendix IV | List of food products/groups and goods under the management of the Ministry of Industry and Trade. | Commonly relevant to alcohol, beer, beverages, processed milk, vegetable oil, flour/starch, confectionery and consumer food groups under MOIT. |
ORIGINAL FULL TEXT AND APPENDICES
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Application note: This English version is prepared for operational reference only and is not an official legal translation. For import, distribution or market circulation dossiers, businesses should verify the Vietnamese original, amendments/replacements, sectoral technical regulations and competent-authority guidance for the actual product group.
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