This Decree details the implementation of the Law on Food Safety and officially replaces Decree No. 15/2018/NĐ-CP.
1. Registration of Conformity Declaration
- Scope: Mandatory for food products with established national technical regulations (QCVN), including pre-packaged processed foods, food additives, processing aids, and food contact materials.
- Validity: The declaration is valid for the duration of the Conformity Certificate but shall not exceed 03 years.
- Submission: Applications can be submitted online or directly to the state authority designated by the Provincial People’s Committee.
2. Manufacturing Conditions for Health Supplements
- GMP Compliance: Manufacturers must establish and maintain a Good Manufacturing Practice (GMP) system specifically for health supplements.
- Personnel: The person in charge of expertise must hold a university degree (in Medicine, Pharmacy, Nutrition, etc.) and have at least 03 years of experience in a related field.
- Certification: The GMP certificate is valid for 03 years.
3. State Inspection of Imported Food
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Inspection Methods:
- Tightened Inspection: Includes dossier review, physical inspection of goods, and mandatory sampling for testing.
- Normal Inspection: Includes dossier review, physical inspection, and random sampling based on selected criteria.
- Reduced Inspection: Dossier review only (applicable if the product passes normal inspection 03 consecutive times within 12 months).
- Exemptions: Applied to gifts within duty-free limits, diplomatic goods, samples for research/testing, goods for exhibition, and materials for export processing.
4. Advertising and Labeling
- Mandatory Registration: Required for health supplements, medical nutrition food, special dietary food, and supplemented food with health claims.
- Mandatory Warning: Advertisements for health supplements must state: “This food is not a medicine and does not replace medicine for treatment”.
- GMO Labeling: Products containing at least one genetically modified ingredient exceeding 5% of the total ingredients must be labeled accordingly.
5. Transitional Provisions
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Manufacturers of medical nutrition food, supplemented food, etc., must obtain HACCP, ISO 22000, or GMP certification by December 31, 2026.
Attached File:
Decision No. 46/2026/NĐ-CP (Official PDF – signed & sealed).pdf