Decree 15/2018/ND-CP: Food Safety Law implementation and notes for import-export enterprises

Legal document | Ministry of Health

DECREE 15/2018/ND-CP: DETAILED IMPLEMENTATION OF THE LAW ON FOOD SAFETY AND COMPLIANCE NOTES FOR IMPORT-EXPORT ENTERPRISES

Decree 15/2018/ND-CP is a key legal basis for food safety dossiers in Vietnam. For imported F&B goods, businesses should classify the product before locking shipping documents, because a mismatch between self-declaration, registered product declaration or state food-safety inspection may delay customs clearance and market circulation.

QUICK SUMMARY

Summary item Operational meaning
What does the decree regulate? Food safety management for food products, including self-declaration, registered product declaration and state food-safety inspection for imports.
Effective date / transition Issued and effective from 02/02/2018; replacing Decree 38/2012/ND-CP and Joint Circular 13/2014/TTLT-BYT-BNNPTNT-BCT.
Affected businesses / goods Food importers, product owners, distributors, F&B companies, health supplements, food additives, non-alcoholic beverages, packaging and tools in direct contact with food.
Immediate action Review product classification, competent authority, self-declaration/registered declaration dossier, testing report, labeling, imported-food inspection dossier, C/O and documents before ETA.

DOCUMENT INFORMATION

Field Content
Document title Decree detailing the implementation of a number of articles of the Law on Food Safety
Reference number 15/2018/ND-CP
Issuing authority Government of Vietnam
Issuance date 02/02/2018
Effective date 02/02/2018
Signed by Nguyen Xuan Phuc
Application status According to the Government’s April 2026 notice, Decree 15/2018/ND-CP continues to apply while Decree 46/2026/ND-CP and Resolution 66.13/2026/NQ-CP are temporarily suspended. Verify the latest status before applying.
Scope Self-declaration; registered product declaration; genetically modified food safety; food safety eligibility certificates; state inspection of imported/exported food; food labeling; food advertising; production conditions for health supplements.
Translation note: This English version is for operational reference only and is not an official legal translation.

KEY POINTS TO REVIEW

Scope of regulation

Article 1 covers self-declaration, registered product declaration, genetically modified food, eligibility certificates, imported/exported food inspection, labeling, advertising and health supplement production conditions.

Self-declaration

Relevant for many conventional foods, food additives, processing aids, packaging and tools in direct contact with food. The enterprise is responsible for the dossier and product quality.

Registered product declaration

Typically relevant to higher-risk categories such as health supplements, medical nutrition foods, foods for special dietary uses, products for children up to 36 months and certain additives.

State inspection for imported food

Chapter V regulates exemptions, reduced/normal/tight inspection methods and handling of inspection dossiers at or before import clearance.

Labeling and advertising

Review original label, Vietnamese supplementary label, claims, ingredients, warnings, directions and target users.

Post-market control

The mechanism shifts toward post-market control; therefore, enterprises must retain dossiers, testing reports, labels and import records for audits.

AFFECTED PRODUCTS / BUSINESS GROUPS

Product / business group Operational impact Review timing
Conventional foods / non-alcoholic beverages Review self-declaration, labeling, testing indicators and state inspection for imports. Before shipment and before ETA.
Health supplements / functional foods Often subject to registered product declaration, more stringent technical dossier, testing and advertising control. Before import/distribution.
Food additives / processing aids Review permitted list, dosage, intended use and declaration/testing dossier. Before booking to avoid specialized inspection issues.
Foods for special diets / children products Classify by function, target user and registered declaration requirements. Before import and before market circulation.
Packaging/tools in direct food contact Review material/QCVN, test results and self-declaration where applicable. Before import or domestic sale.
F&B logistics shipments Commercial documents, C/O, labels, COA/test report and declaration/inspection dossiers must match. Before ETD/ETA.

IMPACT ON IMPORT-EXPORT / LOGISTICS OPERATIONS

Operation stage Compliance impact
Customs declaration Although not a tariff schedule, the decree directly affects commodity policy for imported food, especially declaration and inspection dossiers.
Documents Product name, ingredients, function, packing, manufacturer, shelf life, origin and label must be consistent across invoice, packing list, B/L/AWB, labels, test reports and declarations.
Timeline If the product group is not classified before ETA, the importer may lack testing, declaration, inspection registration or supplementary labeling.
Post-clearance compliance Keep declaration, testing report, labels, import documents and inspection records for post-market checks.
Cost exposure Testing, translation, legalization where applicable, relabeling, storage, DEM/DET, tight inspection and dossier supplementation may create additional costs.

BUSINESS REVIEW CHECKLIST

Checklist group Documents to prepare Purpose
Product classification Product name, function, ingredients, dosage form, target user, manufacturer and origin. Select the correct declaration/inspection route.
Commercial documents Contract/PO, Invoice, Packing List, B/L/AWB, C/O, product photos and original label. Customs declaration and food-safety inspection matching.
Technical / food-safety dossier Testing report, product declaration, registered declaration receipt, product standard, COA and technical documents if any. Market circulation, clearance and post-market control.
Labeling Original label, Vietnamese supplementary label, ingredients, expiry date, storage/use instructions and warnings. Avoid relabeling or circulation stoppage.
Imported-food inspection Inspection registration, inspection result, inspection method, exemption/reduced inspection dossier if any. Import clearance.
Dossier retention Customs declaration, commercial documents, declaration dossier, testing report, inspection result, label and distribution records. Post-clearance and market surveillance.

RELATED LEGAL DOCUMENTS TO REVIEW

Group Document Issuer Role Review note
Law Law on Food Safety 55/2010/QH12 National Assembly Foundational food safety law. Review product responsibilities.
Decree Decree 15/2018/ND-CP Government Main document effective from 02/02/2018. Self-declaration, registered declaration, import/export food inspection, labeling, advertising.
Decree Decree 38/2012/ND-CP Government Replaced by Decree 15/2018/ND-CP. Do not use as current basis unless a transition applies.
Joint Circular Joint Circular 13/2014/TTLT-BYT-BNNPTNT-BCT MOH / MARD / MOIT Replaced/terminated according to the official publication relationship. Review competent authority by product group.
Resolution Resolution 15/2026/NQ-CP Government Temporarily suspends Decree 46/2026/ND-CP and Resolution 66.13/2026/NQ-CP; Decree 15/2018 continues to apply until new regulations. Monitor new Food Safety Law and implementing decree.
Labeling rules Decree 43/2017/ND-CP; Decree 111/2021/ND-CP Government Goods labeling and Vietnamese supplementary labeling. Mandatory for food circulated in Vietnam.

VIEW / DOWNLOAD ORIGINAL DOCUMENT

Verify the official Vietnamese source before applying to a specific shipment.

FULL TEXT OF THE DOCUMENT

OPEN FULL TEXT OF DECREE 15/2018/ND-CP
LIVE PDF PREVIEW – DECREE 15/2018/ND-CP

Primary source: Government Legal Document Portal. If the PDF frame is blocked by browser or WordPress theme, use the Open/Signed PDF button above.

REFERENCE TRANSLATION NOTE

This section provides an operational reference translation of the main structure and compliance meaning. The official Vietnamese PDF above is the controlling legal source.

Core title: Decree detailing the implementation of a number of articles of the Law on Food Safety.

Main regulated matters: self-declaration, registered product declaration, genetically modified food safety, food safety eligibility certificate, state inspection of imported/exported food, labeling, advertising and production conditions for health supplements.

TERMINOLOGY NOTES

Term Explanation
Food safety Conditions ensuring food does not harm consumers when used as intended.
Self-declaration A mechanism where the enterprise declares and assumes responsibility for product quality and safety.
Registered product declaration A registration route for product categories requiring stricter control.
State inspection of imported food Official inspection of import dossiers and/or samples before clearance/circulation.
ETA Estimated Time of Arrival; operational milestone for locking dossiers.
DEM/DET/Storage Container yard/container detention/storage costs caused by delays.

FAQ

When did Decree 15/2018/ND-CP take effect?

The decree was issued and took effect on 02/02/2018. This immediate effective date is important when reviewing import and market-circulation dossiers.

Does Decree 15/2018/ND-CP still apply?

According to the Government’s April 2026 notice, while Decree 46/2026/ND-CP and Resolution 66.13/2026/NQ-CP are temporarily suspended, Decree 15/2018/ND-CP continues to apply until new regulations are issued.

Which imported foods normally require registered product declaration?

Common groups include health supplements, medical nutrition foods, foods for special dietary uses, nutrition products for children up to 36 months and certain food additives. The final conclusion depends on ingredients, intended use and claims.

Do conventional foods need self-declaration?

Many conventional food products fall under the self-declaration mechanism, but the importer still needs to review the product group, testing report, labeling and market-circulation conditions.

Does this decree change HS code, duties or C/O treatment?

The decree is not a tariff schedule and does not directly prescribe duty rates. However, food-safety classification and commodity policy can affect the customs clearance dossier and inspection requirements.

If goods are already in transit, must the decree be applied immediately?

Review the customs declaration date, ETA, already-submitted dossier, inspection method and guidance from the receiving authority at the actual filing time.

How should products with health or functional claims be handled?

They should not be treated automatically as conventional foods. Review claims, ingredients, function, target users and whether registered product declaration or advertising approval is required.

Which sources should enterprises verify before applying?

Prioritize the Government Legal Document Portal, Official Gazette, Vietnam Food Administration/Ministry of Health, public service portals and current guidance for the specific product group.

IMPLEMENTATION SUPPORT FROM TGIMEX

For imported food, operational control means classifying the product correctly, standardizing documents, locking food-safety dossiers before ETA and keeping a complete audit trail.

Legal review

Review Decree 15/2018/ND-CP, current suspensions/amendments, product group and competent authority based on the actual dossier.

Document control

Cross-check Invoice, Packing List, B/L/AWB, C/O, labels, test report, declaration and food-safety inspection registration.

Operational coordination

Set an ETA-based timeline, identify risk gates and coordinate specialized procedures, customs, international transport and delivery.

Post-clearance readiness

Maintain dossiers by shipment for post-clearance audit, market surveillance, label review and distribution compliance.

Operational recommendation: review food-safety dossier, labels, testing reports and commercial documents before booking or before ETA to limit storage, customs channel change, supplementation and delivery delay risks.
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