RESOLUTION

ON FOOD PRODUCT STANDARD DECLARATION AND PRODUCT DECLARATION REGISTRATION

Pursuant to the Law on Organization of the Government No. 63/2025/QH15;

Pursuant to the Law on Food Safety No. 55/2010/QH12;

Pursuant to the Law on Product and Goods Quality No. 05/2007/QH12, as amended by Law No. 35/2018/QH14 and Law No. 78/2025/QH15;

Pursuant to Resolution No. 206/2025/QH15 of the National Assembly on special mechanisms to address difficulties and obstacles caused by legal provisions;

At the proposal of the Minister of Health;

The Government promulgates this Resolution on food product standard declaration and product declaration registration.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This Resolution provides for declaration of standards applied to food products and registration of food product declarations.

2. This Resolution applies to the following food products:

a) Prepackaged processed foods, food additives, food processing aids, and tools, packaging materials and containers in contact with foods where there is no technical regulation on quality criteria or safety criteria, or where no conformity certification organization has been established for the corresponding national technical regulation, or where no conformity assessment method is available under the law on standards and technical regulations;

b) Micronutrients;

c) Health supplements;

d) Foods for medical nutrition;

e) Foods for special dietary uses;

f) Supplemented foods;

g) Nutritional products for children up to 36 months of age.

Article 2. Regulated entities

This Resolution applies to Vietnamese agencies, organizations and individuals; foreign organizations and individuals in Vietnam engaged in food production and trading; and organizations and individuals involved in food safety activities in Vietnam (collectively referred to as organizations and individuals).

Article 3. Interpretation of terms

Scientific evidence means scientific information, scientific data and scientific documents proving a claim on the health function or effect of a product or its ingredient, derived from scientific research published in reputable national or international journals, ISI or SCOPUS journals, or from traditional medicine, medicinal plant, medicinal material, medical, pharmaceutical or food documents published in scientific publications.

Article 4. Application of law

In addition to food product declaration and registration under this Resolution, activities of production, sale, export, import, state inspection, advertising, labeling and traceability shall comply with food safety law and specialized legislation.

Chapter II

PROCEDURES FOR DECLARATION OF APPLIED STANDARDS

Article 5. Cases requiring declaration of applied standards

1. Organizations and individuals responsible for placing products on the market shall declare applied standards for:

a) Prepackaged processed foods, food additives, food processing aids, packaging and tools in direct contact with foods that have no technical regulation on quality or safety criteria, no conformity certification organization for the corresponding national technical regulation, or no conformity assessment method;

b) Micronutrients;

c) Supplemented foods containing only vitamins or minerals and making no health claims.

2. Cases exempt from declaration of applied standards:

a) Domestically produced or imported products and materials used solely for export production or processing;

b) Domestic raw materials and semi-finished products used solely for the producer’s own production and not sold domestically;

c) Imported raw materials and semi-finished products used solely for the importer’s own production and not sold domestically;

d) Imported products and materials used solely for aid purposes;

e) Imported products and materials used solely for testing serving product declaration;

f) Imported products and materials used solely for scientific research.

Article 6. Dossier and procedure for declaration of applied standards

1. A dossier for declaration of applied standards includes:

a) Declaration of applied standards made according to Form No. 01 in the Appendix;

b) Product test report made according to Form No. 06 in the Appendix, as a certified copy or certified electronic copy. The test report must be issued within 12 months before dossier submission by a testing organization accredited to ISO/IEC 17025 and must contain quality and safety criteria and assessment of conformity with international requirements or applicable safety regulations/standards declared by the organization or individual;

c) Authorization letter allowing the declarant to be named in the declaration of applied standards, issued by the manufacturer or food product owner, containing all contents under Article 11, where applicable.

2. The declaration procedure is as follows:

a) The declarant submits one dossier online, by post or directly to the competent state management agency designated by the provincial People’s Committee;

b) Within 15 days from receipt, if there is no written opinion, the receiving agency shall publish the declaration dossier on its website or online public service system. The declarant may publicize the declaration on labels, packaging, accompanying documents, mass media, its website or at its head office and may manufacture and trade the product. The declarant is fully responsible for the legality and accuracy of the dossier and the quality and safety of the product, and may place the product into production and trade only after the dossier is published by the receiving agency;

c) The receiving agency shall retain the dossier and publish it. Where an organization or individual has two or more production facilities producing the same product, the dossier shall be submitted to one local agency selected by the declarant; subsequent declarations must be submitted to the same agency.

3. Dossier documents must be in Vietnamese. English documents may be translated into Vietnamese by the declarant. Documents in other languages must be translated into Vietnamese and the translator’s signature certified; where this is not feasible, an English translation certified in the country of production or export may be submitted and translated into Vietnamese by the declarant. Product labels in multiple languages without English require translation of the language of the country of production or export only. Documents must remain valid at the time of declaration.

4. If the product name, origin or ingredient composition (except excipients) changes, the applied standards must be re-declared. Other changes must be notified in writing and the product may be manufactured and traded immediately after such notification.

5. Organizations and individuals manufacturing or trading products must disclose the declaration dossier when trading the product on e-commerce platforms in Vietnam.

Chapter III

PROCEDURES FOR ISSUANCE OF RECEIPT OF PRODUCT DECLARATION REGISTRATION

Article 7. Cases requiring product declaration registration

1. Registration is required for health supplements, medical nutrition foods, foods for special dietary uses, supplemented foods (except those containing only vitamins/minerals and making no health claims), and nutritional products for children up to 36 months.

2. Imported products above are exempt when used for aid, testing for product declaration, or scientific research.

3. Documents in the registration dossier must be in Vietnamese. English documents must be translated into Vietnamese except quality and safety standards, production process documents and stability reports. Documents in other languages must be translated into Vietnamese with certified translator signature or, where impossible, translated into English and certified in the producing/exporting country. Documents must remain valid at submission.

4. The market-responsible organization or individual is fully responsible for legality, accuracy, quality and safety and may only manufacture/trade after receiving the product declaration registration receipt.

Article 8. Registration dossier for imported food products

1. General dossier: product declaration (Form 02); Certificate of Free Sale, Certificate of Exportation, Health Certificate or relevant certificate issued by a competent authority of the producing/exporting country; product test report (Form 06); documents proving the function/effect of the product; authorization letter where registration is authorized.

2. Health supplement dossier includes the general dossier plus GMP or equivalent certificate, label sample and instructions (if any), product R&D report, quality and safety standard documents, production process documents, stability study report and other explanatory documents. Details follow Form 03.

3. Dossier for medical nutrition foods, foods for special dietary uses, nutritional products for children up to 36 months and supplemented foods (except vitamin/mineral-only products without health claims) includes the general dossier plus HACCP/ISO 22000/IFS/BRC/FSSC 22000 or equivalent certification or GMP food safety certificate, labels/instructions, R&D report, quality and safety documents, production process, stability report and other explanatory documents. Details follow Form 04.

Article 9. Registration dossier for domestically manufactured food products

1. General dossier includes product declaration (Form 02), product test report (Form 06), documents proving function/effect, and authorization letter where registration is authorized.

2. Health supplement dossier includes the general dossier plus label/instructions, R&D report, quality and safety documents, production process, stability report, packaging/contact material information and other documents. Details follow Form 03.

3. Dossier for medical nutrition foods, foods for special dietary uses, nutritional products for children up to 36 months and supplemented foods includes the general dossier plus HACCP/ISO 22000/IFS/BRC/FSSC 22000 or equivalent certification or GMP certificate, labels/instructions, R&D report, quality and safety documents, production process, stability report and other documents. Details follow Form 04.

Article 10. Registration procedure

1. Registration dossiers are submitted online, by post or directly: to the Ministry of Health for health supplements; to the competent provincial agency for other products under Article 7. Where there are multiple production facilities producing the same product, the declarant registers at one competent local agency selected by it, except products registered with the Ministry of Health.

2. Within a maximum of 90 days from receipt of a complete dossier, the receiving agency appraises the dossier and issues the receipt of product declaration registration under Form 05. Professional subcommittees and, where necessary, an advisory council shall be established.

3. If the dossier is refused or supplementation is required, the receiving agency must issue a written notice stating the requested amendment, reasons, legal and professional grounds. Only two supplementation requests may be made per dossier. The declarant has 60 days to supplement and may request an extension within 20 days; the extension must not exceed 120 days. Within 60 days from receipt of the supplemented dossier, the agency shall appraise and issue the receipt or notify that the dossier is no longer valid.

4. Re-registration is required upon changes to product name, origin, composition (except excipients), function, target users or dosage. Other changes require written notification.

5. The receiving agency shall publish information on registered products on its website and food safety database.

6. Product traders shall disclose the registration receipt when conducting e-commerce in Vietnam and pay appraisal fees as prescribed.

Article 11. Authorization letter

The authorization letter may be in Vietnamese, English or bilingual Vietnamese-English, must comply with relevant law and contain the names and addresses of manufacturer/product owner and authorized organization or individual, scope of authorization, and authorized product names. The authorizer must notify changes and both parties are jointly liable if product quality or food safety violations cause consequences.

Article 12. Revocation of registration receipt and removal of product information

The competent receiving agency shall revoke the receipt and remove product information within 05 working days upon any prescribed circumstance including revoked foreign basis documents, forged or untruthful dossiers, intellectual property violations, no production/import for 03 consecutive years, voluntary withdrawal, failure to meet quality/safety criteria, wrong authority, unnotified address change, investigation findings of counterfeit/prohibited substances, or failure to complete dossier under this Resolution and Decree No. 46/2026/ND-CP. Products may be suspended and recalled or allowed to circulate until expiry depending on the case.

Article 13. Suspension of dossier receipt and processing

The receiving agency may suspend dossier review for organizations or individuals producing or trading smuggled, fake or unknown-origin products; trading unregistered or undeclared products; failing to recall violations; lacking GMP/HACCP/ISO 22000/IFS/BRC/FSSC 22000 where required; using prohibited substances; importing or trading products banned in the producing country; having products inconsistent with the dossier or misleading labels; using forged documents, seals or signatures; or making untruthful declarations. Processing may resume after full remediation and reporting.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 14. Effect

This Resolution takes effect from the date of signing until a replacement for the Law on Food Safety dated 17 June 2010 is issued, but not later than 28 February 2027. Products not covered by Article 5.1 shall declare applied standards under Article 23 of the Law on Product and Goods Quality. Advertising registration for products under Article 7.1 must not use images, names or opinions of medical units, doctors, pharmacists, medical staff or patients in a manner that misleads or exaggerates food products as medicines; influencers must clearly disclose sponsorship relationships when advertising functional foods and nutritional products for children up to 36 months where advertising is not prohibited.

Article 15. Transitional provisions

Dossiers submitted before the effective date, products already granted registration receipts, and supplemented foods converted from self-declaration to registration must be completed within 24 months. Products self-declared before the effective date must complete declaration of applied standards within 12 months. After these periods, the dossier or receipt is no longer valid for production or import, while products manufactured within the transitional period may circulate until expiry.

Article 16. Implementation responsibilities

The Ministry of Health receives, manages, issues and revokes registration receipts for health supplements. Provincial People’s Committees organize receipt, management, issuance and revocation for the remaining products, receive applied standard declarations as assigned, conduct post-inspection and market sampling. Receiving agencies shall establish professional subcommittees and councils where necessary. Ministers, heads of ministerial-level agencies, heads of Governmental agencies, provincial People’s Committee Chairpersons and relevant organizations and individuals are responsible for implementation.

ON BEHALF OF THE GOVERNMENT

FOR THE PRIME MINISTER

DEPUTY PRIME MINISTER

Le Thanh Long

APPENDIX

Attached to Resolution No. 66.13/2026/NQ-CP dated 27 January 2026

Form No. 01: Declaration of applied standards

Form No. 02: Product declaration

Form No. 03: Dossier for registration of health supplement product declaration

Form No. 04: Dossier for registration of product declaration for medical nutrition foods, foods for special dietary uses, nutritional products for children up to 36 months, and supplemented foods (except vitamin/mineral-only products without health claims)

Form No. 05: Receipt of product declaration registration

Form No. 06: Test report

FORM NO. 01 – DECLARATION OF APPLIED STANDARDS

Number: …/Company name/Year of declaration

I. Information on declaring organization/individual: name, legal representative, address, phone, fax, email, enterprise code, food safety eligibility certificate if applicable.

II. Declaration of applied standards: product name, ingredients, shelf life, packaging specifications and material, manufacturer name/address, standard code/date/issuer, quality and safety criteria.

III. Product label sample attached. The declarant undertakes to comply with food safety law and to be fully responsible for dossier legality and product quality and safety.

Signed and sealed by the organization/individual.

FORM NO. 02 – PRODUCT DECLARATION

I. Information on declaring organization/individual.

II. Product information: product name, ingredients, quality criteria, shelf life, packaging specification and material, manufacturer name/address.

III. Product label sample attached.

IV. Quality and food safety requirements: conformity with internal standards and applicable safety standards/regulations.

V. Ingredient explanation: vitamin/mineral RNI and upper intake information; health supplement ingredient information, function and warnings. The declarant undertakes to comply with food safety law and only manufacture/trade after receipt of product declaration registration.

FORM NO. 03 – DOSSIER FOR HEALTH SUPPLEMENT PRODUCT DECLARATION REGISTRATION

Includes: product name and applicant; dossier table of contents; product declaration; legal documents such as CFS/Export Certificate/Health Certificate for imported products, GMP/equivalent certificate, authorization letter, intellectual property certificate if any; product label and instructions; R&D report; scientific evidence and clinical trial report if any; quality and safety standards; production process; stability report; other explanatory documents.

FORM NO. 04 – DOSSIER FOR MEDICAL NUTRITION, SPECIAL DIETARY USE, CHILDREN UNDER 36 MONTHS AND SUPPLEMENTED FOOD PRODUCT DECLARATION REGISTRATION

Includes: product/applicant information; dossier table of contents; product declaration; legal documents; HACCP/ISO 22000/IFS/BRC/FSSC 22000 or equivalent/GMP certificate; product label and instructions; R&D report; scientific evidence; quality and safety documents; production process; stability study; other explanatory documents.

FORM NO. 05 – RECEIPT OF PRODUCT DECLARATION REGISTRATION

The competent receiving authority certifies receipt of a product declaration from the market-responsible organization/individual for the stated product manufactured by the stated manufacturer and conforming to the stated technical regulation/rule/standard. The enterprise remains fully responsible for conformity of the declared product.

FORM NO. 06 – TEST REPORT

Issued by testing/manufacturing facility. It records sample name, sample code, sender, manufacturer, receipt date, sampling date, quantity, testing period, sample description, sample retention period, attached documents, testing results table (No.; parameter; method; unit; result; comparison standard), conclusion, notes and signature of the testing/manufacturing facility representative.