ELABORATION OF SOME ARTICLES AND MEASURES FOR ORGANIZATION OF THE IMPLEMENTATION OF THE LAW ON FOOD SAFETY

This Decree elaborates some Articles and provides guidance on implementation of some Articles of the Law of Food Safety, including:

1. Elaboration of regulations on:

a) Registration of declarations of conformity and duration of declarations of conformity of foods subject to technical regulations on quality and safety criteria in one of the following cases: pre-packaged processed foods prescribed in Clause 3 Article 12; food additives, food processing aids prescribed in Clause 4 Article 17; packages and instruments having direct contact with foods (hereinafter referred to as "primary packaging of foods") prescribed in Clause 3 Article 18 of the Law on Food Safety;

b) Assurance of safety of genetically modified foods to human health and the environment prescribed in Clause 2 Article 15 of the Law on Food Safety;

c) Entities not required to obtain the Certificate of Food Safety prescribed in Clause 3 Article 34 of the Law of Food Safety;

d) Assurance of food safety of imported foods: Certificate of Free Sale or Health Certificate prescribed in Clause 2 Article 38 of the Law on Food Safety;

dd) Exemption of state inspection of food safety of certain imported foods; procedures for state inspection of food safety in countries from which foods will be exported to Vietnam under international treaty to which the Socialist Republic of Vietnam is a signatory prescribed in Clause 1 and Clause 3 Article 39 of the Law on Food Safety;

e) Food labeling, expiration dates of foods; specific regulations on genetically modified foods subject to labeling, concentration (%) of genetically modified ingredients in food subject to labeling a prescribed in Clause 3 Article 44 of the Law on Food Safety.

2. Guidance on implementation of the following contents:

a) Food safety requirements in manufacture and sale of foods prescribed in Chapter IV of the Law on Food Safety;

b) Revocation of Certificate of Food Safety prescribed in Article 35 of the Law of Food safety;

c) Procedures for issuance of Certificate of Food Safety prescribed in Clause 2 Article 36 of the Law of Food safety;

d) Procedures and methods for state inspection of imported food safety prescribed in Article 40 of the Law of Food safety;

dd) Advertising and labeling of foods prescribed in Chapter VII of the Law on Food Safety;

e) Assurance of food safety during production, sale, preservation of dietary supplements prescribed in Article 19 and Article 20 of the Law on Food Safety;

g) Assurance of food safety during sale and use of food additives prescribed in Article 22 of the Law on Food Safety;

h) Food testing serving state management prescribed in Section 1 Chapter VIII of the Law on Food Safety;

i) Food origin tracing prescribed in Section 4 Chapter VIII of the Law on Food Safety.

This Decree applies to Vietnamese and foreign organizations and individuals that manufacture and/or sell foods in Vietnam; organizations and individuals whose operations involve food safety in Vietnam (hereinafter referred to as "organizations and individuals").

For the purpose of this Decree, the following terms are construed as follows:

1. "functional foods" are foods used to support the functions of the human body, create a comfortable state for the body, improve immunity, reduce the risk of contracting diseases. Functional foods include dietary supplements, medical foods, foods for special dietary uses, and supplemented foods.

2. " dietary supplements" (also known as "health supplements" and "food supplements") are products added to the daily diet in order to maintain, enhance, and improve the functions of the human body, and reduce the risk of contracting diseases. Dietary supplements contain one or more of the following substances or mixtures of substances:

a) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other bioactive substances;

b) Substances derived from animals, minerals, plants in the form of extracts, isolates, concentrates or metabolites;

c) Sources of synthesis of the substances mentioned in Point a and Point b above.

Dietary supplements may be in the form of soft gels, pellets, tablets, granules, powder, liquid and other dosage form divided into smaller unit doses (for use).

3. “medical foods” (also known as "foods for special medical purposes") are foods that can be consumed orally or via tube feeding, prescribed to adjust the diet of patients according to the manufacturer’s instructions.

4. “foods for special dietary uses” are foods processed or mixed according to special formulae to meet specific dietary requirements based on the physical condition or pathological state and specific disorders of the user, or to enhance and improve the functions of the human body, reduce the risk of contracting diseases, but are not classified as dietary supplements. The composition of these foods must be clearly different from that of ordinary foods of the same nature, if any.

5. "supplemented foods" are foods supplemented with micronutrients and healthy elements such as vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics, and other bioactive substances, but not classified as one of the three product groups specified in Clauses 2, 3, and 4 of this Article.

6. "goods owner" means the organization or individual having ownership of the goods as prescribed by law.

7. An "article" or exports or imports means products of the same type, name, label, manufacturer and packaging materials.

For the purposes of this Decree, the word "article" covers: foods, food additives, food processing aids, primary packaging of foods.

8. “consignment” means an export or import shipment (having the same bill of lading number) of one or multiple articles.

9. “small-scale food manufacturer” means a household or individual that obtains foods by means of farming, husbandry, gathering, fishing without the Certificate of Enterprise Registration or other Certificates (certificates of registration of household business, cooperative, cooperative union, artel, branch, representative office, business location) under business registration laws.

10. “small-scale food processor” means a household or individual that preliminarily processes foods without the Certificate of Enterprise Registration or other Certificates (certificates of registration of household business, cooperative, cooperative union, artel, branch, representative office, business location) under business registration laws.

11. “small-scale food seller” means a household, individual or group of individuals that sells foods without the Certificate of Business Registration and the Certificate of Enterprise Registration or other Certificates (certificates of registration of household business, cooperative, cooperative union, artel, branch, representative office, business location) under business registration laws.

12. "food owner" means an organization or individual that owns the formula, manufacture process, standard or label of a food, or certified by the competent authority of the country of origin or exporting country.

13. "organizations or individuals responsible for placing products on the market" are manufacturers or owners of food products, or organizations or individuals authorized by the manufacturers or owners of food products to act as the declarant in the product declaration.

14. "quality management system" of a testing laboratory includes administrative documents, technical documents, and records related to testing such as: personnel, equipment, facilities, testing methods ensuring quality, accuracy, and transparency of test results.

15. "inter-laboratory comparison" means the organization, implementation, and evaluation of testing methods on the same or similar subjects by two or more testing laboratories under predetermined conditions.

16. "proficiency testing" is the evaluation of the performance of participating parties according to established criteria through inter-laboratory comparison.

Organizations and individuals shall register the declaration of conformity of foods subject to technical regulations on quality criteria and safety criteria in one of the following cases: 

1. Prepackaged processed foods;

2. Food additives; 

3. Food processing aids;

4. Instruments containing, having direct contact with foods;

5. Packaging containing, having direct contact with foods.

1. Application for registration of the conformity declaration:

a) The conformity declaration prepared in accordance with Form No. 01 in Appendix I hereof;

c) Results of conformity certification by a certification organization accredited in accordance with regulations of law on technical regulations, unless the conformity certification results have been uploaded to the national database in accordance with information technology laws (a copy bearing the seal of the organization or individual; or an authenticated electronic copy);

c) In case a third party is authorized by the manufacturer or owner of the food product to act as the declarant in the conformity declaration: the authorization letter containing all information specified in Article 7 of this Decree (a copy bearing the seal of the organization or individual; or an authenticated electronic copy).

2. Procedures for registration of the product declaration:

a) The organization or individual (the applicant) shall submit 01 application for registration of the declaration of conformity as prescribed in Clause 1 of this Article online (via the National Public Service Portal or the National Single Window Portal or the information system for handling administrative procedures at ministerial or provincial level), by post, or in person to the competent authority designated by the People’s Committee of the province where the applicant is based (hereinafter referred to as "receiving authority"). In case the applicant has multiple business locations, they may choose to submit the application in any of the registered administrative division having its business location;

b) Within 10 days after receiving the application, the receiving authority shall disclose the name of the applicant on the website of the receiving authority and the website of the People’s Committee of the province;

c) Food manufacturers and sellers shall disclose their unexpired applications for registration of the declaration of conformity of the products prescribed in Article 4 of this Decree when selling foods on e-commerce platforms in Vietnam.

1. The validity of a declaration of conformity is the same as that of the conformity certification result and shall not exceed 03 years.

2. In case of changes to technical regulations during business operations, organizations and individuals shall apply for certification of conformity with new technical regulations and re-apply for registration of the declaration of conformity in accordance with this Decree.

In case of other changes, the organization or individual shall send a written notification to the receiving authority prescribed in Point a Clause 2 Article 5 of this Decree and is entitled to carry on the production or sale of the product immediately after the notification is sent.

1. The language of presentation shall be Vietnamese, English, or both Vietnamese and English.

2. The authorization of product declarant shall comply with relevant regulations of law on authorization and has the following contents:

a) Name and address of the manufacturer; in case the authorizing party is the owner of the food product, both the name and address of the food product owner and the name and address of the manufacturer must be specified;

b) Name and address of the authorized party; 

c) Scope of authorization (to act as the product declarant and jointly bear responsibility for all matters related to the product);

d) Name of the product covered by the authorization.

3. In case of changes to the authorization contents, the authorizing party shall send a written notification to the competent authority.

4. The authorizing party and the authorized party shall be jointly responsible for the consequences caused by violations of the product against regulations on food safety and quality.

Conditions and procedures for issuance and revocation of the Certificate of GMO Qualified For Use as Foods and the list of GMOs granted such Certificate shall comply with the Government's Decree No. 69/2010/ND-CP, which is amended in 2011, 2018 and 2020.

1. Manufacturers and sellers of foods that contain GMOs, GMO products and has at least one genetically modified (GM) ingredient that exceeds 5% of total ingredients used for manufacture of such foods, in addition to compliance with regulations of law on goods labeling prescribed in Chapter VI of this Decree, shall make sure the goods labels contain information about the GMOs, except for the cases specified in Clause 2 of this Article.

2. Labeling of GM foods is exempted in the following cases:

a) The prepackaged GM food contains GM ingredients without discovery of the modified gene or products of the modified gene in the food;

b) Fresh GM foods, unpackaged processed GM foods sold directly to consumers;

c) GM foods serving recovery from a natural disaster or epidemic.

1. Imported terrestrial animal products, aquatic animal products, plant products used as foods, except prepackaged and processed foods, foods exported by Vietnamese organizations and individuals to other countries but returned, and the cases specified in Article 19 of this Decree shall satisfy the following requirements:

a) Their country of origin is a country or territory (hereinafter referred to as "country") that has a food safety control system satisfying Vietnam’s regulations and included in the list of registered countries that export foods derived from animals, plans and aquatic animals to Vietnam;

b) The terrestrial animals and aquatic animals used as foods must be manufactured by facilities that satisfy food safety requirements of Vietnam as certified by Vietnamese authorities;

c) Each imported consignment of animal or aquatic origin must be accompanied by a certificate of food safety issued by a competent authority of the exporting country (except fish caught and processed by foreign vessels, or purchased and transshipped at sea by fishing vessels and directly exported to Vietnam through designated ports).

2. The registration of the exporting countries and business establishments prescribed in Article 1 of this Article shall be carried out in accordance with Article 28 of this Decree.

1. When products and raw materials mentioned in Clauses 3, 4, 6, and 8 Article 19 of this Decree are repurposed for domestic consumption, procedures for repurposing shall be followed in accordance with customs laws and food safety regulations as those applicable to imported products, unless regulations are fully complied with during while following initial import procedures.

2. Food products manufactured for export as initially declared but later repurposed for domestic consumption undergo customs procedures for import of food products and comply with regulations of law on food safety applicable to food products for domestic consumption.

3. Provisions of Clauses 1 and 2 of this Article do not apply to exported products and raw materials that are returned and repurposed for domestic consumption.

1. Manufacturers of dietary supplements shall satisfy general food safety requirements specified in Clause 1 Article 19, Clause 1 Article 20 of the Law of Food safety, and the following regulations:

a) A quality control system must be established and maintained in accordance with principles and regulations of Good Manufacturing Practice (GMP) to control the manufacture and distribution processes in order to ensure that all products satisfy the declared standards and are safe for users until their expiration;

b) There must be sufficient staff who have professional qualifications appropriate for their assigned positions and are trained in basic knowledge of Good Manufacturing Practice (GMP), food safety, and relevant professional knowledge. The head of the production department and the head of the quality control department must be official, full-time employees and work independently of each other. The technical manager of the establishment must have a bachelor's degree or higher in medicine, pharmacy, nutrition, food safety, or food technology, and have at least 3 years' experience in a relevant field;

c) The factory, equipment and auxiliary utilities must be installed in a manner that is suitable for their purposes, following one-way rules, easy to clean, not confusing, able to prevent dust, pollution and other elements detrimental to product quality; they must be cleaned on a daily basis;

d) Documents about the manufacture process, quality control and distribution are fully retained to make sure the history of every batch and documents about other activities at the facility can be extracted;

dd) All production operations must be carried out according to procedures and instructions. Inspection and monitoring measures must be implemented during production to prevent risks of confusion, contamination, and cross-contamination. Results must be recorded immediately when performing operations or immediately after completing the production stages;

e) A quality control department must be established to ensure that the products are manufactured under conformable conditions and processes; necessary tests have been run; use of raw materials and sale of products are not approved before the quality is satisfactory; product stability must be monitored;

g) In case of testing or production under a contract, the contractor shall have adequate equipment and personnel to requirements of the hirer and satisfy requirements for testing or production of dietary supplements established by a competent authority;

h) There must be procedures for complaint settlement, product recall, self-inspection; documents about these tasks must be retained in full.

2. The Ministry of Health shall provide instructions on application of GMP requirements to dietary supplements.

3. Dietary supplement manufacturers shall apply instructions of the Ministry of Health on GMP for dietary supplements.

1. An application for the Certificate of food safety and GMP compliance for dietary supplements shall include:

a) The application form No. 12 in Appendix I hereof;

b) Overall diagram and detailed diagram of production areas, production lines, storage areas, and testing areas (confirmed by the applicant);

c) A list of primary equipment at the facility (confirmed by the applicant).

2. Procedures for receiving applications and issuing the Certificate of food safety and GMP compliance for dietary supplements.

a) An application specified in Clause 1 of this Article shall be submitted to the Ministry of Health in person, by post or through the online public service system;

b) If the application has to be amended or supplemented, the receiving authority shall send a written notification to the applicant within 05 working days after the application is received. If the applicant fails to amend or supplement the application as requested within 30 days, the application will be invalidated and a new application must be submitted in order to obtain the Certificate;

c) Within 15 working days from the receipt of the satisfactory application, the receiving authority shall establish an inspectorate, which will to carry out a site inspection and issue the inspection record according to form No. 13 in Appendix I hereof.

The inspectorate shall have 05 - 06 persons, at least 02 persons of whom are experienced in GMP, and 01 person is specialized in testing;

d) If the inspection result is satisfactory, the receiving authority shall issue the Certificate of food safety and GMP compliance for dietary supplements (Form No. 14 in Appendix I hereof) within 30 days from the receipt of the satisfactory application;

d) If the inspection results show that certain remedial actions must be taken, they must be specified by the inspectorate in the inspection record. After remedial actions are taken, the applicant shall send a written notification of remedy results to the inspectorate. Within 07 working days from the receipt of the notification of remedy results, the inspectorate shall review it and propose issuance of the Certificate to the Ministry of Health for. If the applicant fails to take remedial actions and send the notification of remedy results to the inspectorate within 03 months from the ending date of the inspection, the application will be invalidated; 

e) If the inspection results are unsatisfactory, within 15 working days, the receiving authority shall send a written notification to the applicant requesting the applicant to refrain from initiating operation until the Certificate of food safety and GMP compliance for dietary supplements is issued, and send a notification to a local authority for supervision.

3.         The Certificate of food safety and GMP compliance for dietary supplements shall be valid for 03 years from the date of issuance. 06 months before its expiration date, the Certificate holder shall submit an application for reissuance of the Certificate. The documentation and procedures for reissuance shall comply with Clause 1 and Clause 2 of this Article.

4. In cases where the Certificate of food safety and GMP compliance for dietary supplements is still unexpired but the establishment's name or address on the Certificate is changed, or the name of the establishment's legal representative is changed without changes in the establishment's location and the contents covered by the Certificate, the Certificate holder shall send promptly notify the issuing authority upon the occurrence of such changes.

5. Applicants for the Certificate of food safety and GMP compliance for dietary supplements shall pay fees for document processing to the receiving authority.

6. Manufacturers of dietary supplements shall prepare a periodic report every 12 months from the issuance date of the Certificate of food safety and GMP compliance for dietary supplements or an equivalent Certificate using Form No. 15 in Appendix I hereof and send it to the Ministry of Health (Vietnam Food Administration) within 15 days from the last day of the reporting period.

Manufacturers and sellers of food additives shall satisfy the following food safety requirements:

1. Satisfy general food safety requirements specified in specified in Clause 1 Article 19, Clause 1 Article 20 and Clause 1 Article 21 of the Law of Food Safety.

2. Only mix food additives on the list of permitted food additives complied by the Ministry of Health, provided the mixture does not cause any harm to human health.

3. The subdivision, decanting, transfer of food additives shall be carried out at a facility that satisfies food safety requirements. Food additives must be labeled in accordance with applicable regulations.

Responsibilities of manufacturers and sellers:

1. Only use the food additives on the list of permitted food additives compiled by the Ministry of Health.

2. Use food additives within permissible limits, for appropriate types of foods; only use food additives that have clear origins and are unexpired; satisfy administrative and technical requirements applied to food additives.

1. Every food manufacturer and seller must obtain the Certificate of Food Safety for operation, except for those specified in Clause 1 Article 17 of this Decree.

2. Requirements for issuance of the Certificate of Food Safety are specified in Clause 1 Article 34 of the Law of Food safety. Manufacturers of dietary supplements shall satisfy the requirements specified in Article 12 of this Decree.

3. Procedures for issuance of the Certificate of Food Safety in the sectors of Agriculture, Environment, Industry and Trade:

a) If the application has to be amended or supplemented, the receiving authority shall notify the applicant in writing within 05 working days from the receipt of the application.

If the applicant fails to amend or supplement the application as requested within 30 days, the application will be invalidated and a new application must be submitted in order to obtain the Certificate;

b) If no amendment or supplementation is required, the receiving authority shall establish an inspectorate (if an inferior authority is authorized to carry out the inspection, there shall be an authorization letter) and prepare the inspection record according to form No. 15 in Appendix I hereof within 15 working days from the receipt of the satisfactory application;

The inspectorate established by the Certificate-issuing authority (or the authorized inspecting authority) shall have 03 - 05 persons, at least 02 persons are specialized in food safety (appropriate food manufacture experts of the applicant may be invited to participate in the inspectorate).

c) If the inspection results are satisfactory, within 05 working days from the day on which the inspection results are available, the receiving authority shall the Certificate using form No. 24 in Appendix I hereof;

d) If the inspection results are unsatisfactory and remedial actions can be taken, the inspectorate shall specify the remedial actions and time limit (not more than 30 days) in the inspection record.

After remedial actions are taken by the applicant, within 05 working days, the inspectorate shall assess the remedy results and write the conclusion in the inspection results. If the remedy results are satisfactory, the Certificate shall be issued in accordance with Point c of this Clause. If the remedy results are unsatisfactory, the receiving authority shall notify the applicant and the local authority in writing.

d) If the inspection results are unsatisfactory, the receiving authority shall send a written notification to the local authority for supervision and request the applicant to refrain from initiating operation until the Certificate is issued.

4. The Minister of Agriculture and Environment and the Minister of Industry and Trade shall provide set forms for issuance of the Certificate of Food Safety within their jurisdiction.

1. The following establishments are not required to obtain the Certificate of Food Safety:

a) Small-scale food manufacturers;

b) Mobile food manufacturers and sellers;

c) Small-scale food processors;

d) Small-scale food sellers;

dd) Sellers of prepackaged foods, food additives, food processing aids, micronutrients;

e) Manufacturers and sellers of instruments and materials for wrapping and storing foods;

g) Restaurants within hotels, tourist apartment complexes, tourist villa complexes;

h) Industrial kitchens not registered as a food business;

i) Street food vendors;

2. The entities mentioned in Clause 1 of this Article must satisfy corresponding food safety requirements.

1. Authority for revocation:

The authorities that issued the Certificates of Food Safety, Certificates of Food Safety and GMP compliance for dietary supplements (hereinafter referred to as "Certificates of Food Safety") and competent authorities under regulations of law on administrative penalties have the right to revoke the Certificates of Food Safety issued.

2. The Certificate of Food Safety shall be revoked in the following cases:

a) Its holder does not have the Certificate of Business Registration, Certificate of Enterprise Registration, or its holder's Certificate of Business Registration or Certificate of Enterprise Registration does not cover the corresponding food business;

b) Its holder incurs 02 or more administrative penalties in 12 months for failure to satisfy food safety requirements specified in Chapter IV of the Law on Food Safety and legislative documents on food safety requirements.

c) Its holder uses banned substances on the list of substances banned from manufacture and sale of foods;

d) Its holder manufactures counterfeit goods that are foods, food additives, or food processing aids;

d) Within 12 months, there are 02 food poisoning incidents or 01 food poisoning incident causing death;

e) A fraudulent document, seal or signature is used in the application for the Certificates of Food Safety;

g) A fake certificate of analysis or false testing result is used in the food safety control dossier of the Certificate holder;

h) The Certificate holder fails to notify the competent authority of non-operation in 12 months at the location covered by the Certificate of Food Safety.

i) The revocation of the Certificates of Food Safety is requested by its holder.

1. Products that are gifts within duty-free allowances prescribed by tax laws.

2. Imports serving personal needs of persons eligible for diplomatic immunities.

3. Products in transit, merchanting trade, transshipment, temporarily imported for re-export, or in bonded warehouses.

4. Test samples whose quantities are suitable for the testing or research purposes and confirmed by the owners.

5. Products used for displayed at exhibitions or fairs.

6. Temporarily imported products for sale at duty-free shops.

7. Imports serving emergency purposes under orders of the Government or the Prime Minister.

8. Products, raw materials imported solely for processing or export manufacturing.

9. Goods serving defense and security under written confirmation of the Minister of National Defense or the Minister of Public Security.

10. Goods on the List of goods traded, exchanged by border residents within duty-free allowances under regulations of law on export and import duties serving production or consumption by border residents (except wholesale purchases).

1. Authorities carrying out state inspection of imported foods prescribed in Clause 1 Article 39 of the Law on Food Safety are state authorities delegated by the Ministry of Agriculture and Environment or the People’s Committees of provinces to carry out state inspection of food safety following the procedures and methods for state inspection of food safety of imported foods, food additives, food processing aids, primary packaging of foods in accordance with the Law on Food Safety.

2. Authorities carrying out state inspection of imported foods (hereinafter referred to as "inspecting authorities") have the following rights and responsibilities:

a) Carry out state inspection of imported foods, food additives, food processing aids, primary packaging of foods following the methods and procedures prescribed in this Decree;

b) Issue the notice of satisfactory/unsatisfactory inspection result using Form No. 02 in Appendix I hereof; issue the notice of articles eligible for switching from tightened inspection to normal inspection, and from normal inspection to reduced inspection using Form No. 03 in Appendix I hereof;

c) Assign food safety and quality criteria applicable to imports to corresponding inspection methods;

d) Select food testing laboratories designated to serve state management of food safety to test the food safety and quality criteria mentioned in Point c Clause 2 of this Article;

dd) Collect testing and inspection fees and charges in accordance with regulations of law on fees and charges;

e) Ensure the professional qualification of testing personnel, the accuracy and objectivity of the inspection and confirmation of food safety of import consignments and articles; take full responsibility for state inspection of food safety of import foods;

g) Facilitate the inspection, follow administrative and professional instructions of the People’s Committees of provinces, the Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade;

h) Receive and settle complaints of goods owners. Pay compensate for any damage caused for the goods owner, return all the fees and charges for testing and inspection to the goods owner as prescribed by law;

i) Retain inspection documents and present them at the request of competent authorities;

k) Submit reports every 06 months to the assigning authority using Form No. 04 in Appendix I hereof, or submit ad hoc reports to the supervisory Ministry;

l) Select food testing laboratories designated to serve state management of food safety to test the food safety and quality criteria of products imported for aid purposes; inspect label contents of products imported for aid purposes;

m) Take samples for testing and physical inspection of goods by the inspecting authority or by the food testing laboratories designated to serve state management of food safety selected by the inspecting authority. Sampling officials shall have certificates of training in food sampling.

Methods for state inspection of imported foods, food additives, food processing aids, primary packaging of foods include:

1. Tightened inspection: document inspection, physical inspection of goods, taking samples for testing food safety and quality criteria according to the declaration dossier and other criteria that are unsatisfactory of have warnings against as prescribed in Clause 3 Article 22 of this Decree (if any).

2. Normal inspection: document inspection, physical inspection of goods, taking samples for testing food safety and quality criteria selected from groups of food safety and quality criteria in the dossier.

On the basis of the composition and history of quality of the article, the process of transport and preservation of the article, the goods owner's import history, origin of the article, quality control system being used for the article, the inspecting authority shall select food safety and quality criteria from the groups of food safety and quality criteria in the dossier.

3. Reduced inspection: document inspection of the import article.

1. Reduced inspection shall be carried out in any of the following cases:

a) There is a confirmation of food safety issued by the competent authority of a country that has entered a mutual recognition agreement regarding food safety inspection to which Vietnam is also a signatory; the result of inspection of the consignment or article given by the competent authority of the exporting country is shown to be conformable with the law of Vietnam;

b) The inspecting authority issues the notice of switching from normal inspection to reduced inspection;

The article is eligible for reduced inspection for up to 12 months from the day on which the notice of switching from normal inspection to reduced inspection is issued by the inspecting authority (except for the case specified in Point a Clause 1 of this Article).

2. Normal inspection shall apply all import articles, except for the cases specified in Clause 1 and Clause 3 of this Article.

3. Tightened inspection shall be carried out in any of the following cases:

a) The result of the previous inspection is unsatisfactory;

b) There are conclusions from the inspectorates (if any) that the food safety and quality criteria are not fully satisfied;

c) A warning is issued by the Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade, the People’s Committee of the province, a competent authority of the foreign country, or the manufacturer.

1. Reduced inspection shall be applied when an import article is granted 03 consecutive notices of satisfactory results of normal inspections in 12 months. Reduced inspection shall be applied for up to 12 months from the day on which the last of the 3 consecutive notices of satisfactory inspection results is signed. Upon expiration of this 12-month period, normal inspection shall be applied to the article (except for the cases specified in Clause 3 Article 22 of this Decree).

Normal inspection and reduced inspection of import articles shall be rotated following the principles stated above.

2. Normal inspection shall be applied when an import article is granted 03 consecutive notices of satisfactory results of tightened inspections in 12 months. Normal inspection shall be applied from the day on which the notice of switching inspection method is signed (unless there are other warnings about the tightened inspection duration issued by competent authorities).

1. An application for reduced inspection shall include the following documents:

a) The imported food inspection application Form No. 05 in Appendix I hereof;

b) Conformity declaration for products subject to conformity declaration; declaration of applied standards for products subject to declaration of applied standards; dossier on registration of product declaration for products subject to product declaration registration (confirmation of product declaration registration, product declaration, label, product standards); product standards for products not subject to conformity declaration, declaration of applied standards and product declaration registration. If the application is submitted by post or in person, it shall include copies bearing the applicant's seal or authenticated electronic copies;

b) The inspecting authority's notice of switching from normal inspection to reduced inspection (original copy or authenticated electronic copy) if it is the case specified in Clause 1 Article 23 of this Decree;

d) A copy of the packing list;

dd) For the products prescribed in Article 10 of this Decree, the certificate of fulfillment of food safety requirements issued by a competent authority of the exporting country (copy bearing the applicant's seal or authenticated electronic copy), except for fish caught and processed at sea by foreign vessels and directly sold to Vietnam’s market.

2. An application for normal inspection shall include the following documents:

a) The imported food inspection application Form No. 05 in Appendix I hereof;

b) Conformity declaration for products subject to conformity declaration; declaration of applied standards for products subject to declaration of applied standards; dossier on registration of product declaration for products subject to product declaration registration (confirmation of product declaration registration, product declaration, label, product standards); product standards for products not subject to conformity declaration, declaration of applied standards and product declaration registration. If the application is submitted by post or in person, it shall include copies bearing the applicant's seal or authenticated electronic copies;

c) The inspecting authority's notice of switching from tightened inspection to normal inspection (original copy or authenticated electronic copy) if it is the case specified in Clause 2 Article 23 of this Decree;

d) A copy of the packing list;

dd) For the products prescribed in Article 10 of this Decree, the certificate of fulfillment of food safety requirements issued by a competent authority of the exporting country (copy bearing the applicant's seal or authenticated electronic copy), except for fish caught and processed at sea by foreign vessels and directly sold to Vietnam’s market.

3. An application for tightened inspection shall include the following documents:

a) The imported food inspection application Form No. 05 in Appendix I hereof;

b) Conformity declaration for products subject to conformity declaration; declaration of applied standards for products subject to declaration of applied standards; dossier on registration of product declaration for products subject to product declaration registration (confirmation of product declaration registration, product declaration, label, product standards); product standards for products not subject to conformity declaration, declaration of applied standards and product declaration registration. If the application is submitted by post or in person, it shall include copies bearing the applicant's seal or authenticated electronic copies;

c) A copy of the packing list;

d) For the products prescribed in Article 10 of this Decree, the certificate of fulfillment of food safety requirements issued by a competent authority of the exporting country (copy bearing the applicant's seal or authenticated electronic copy), except for fish caught and processed at sea by foreign vessels and directly sold to Vietnam’s market.

1. Procedures for reduced inspection:

a) Before or when the goods arrive at the border checkpoint, the goods owner shall submit the application for food safety inspection according to Clause 1 Article 24 of this Decree to the inspecting authority, whether online (via the National Public Service Portal, National Single-window Information Portal, ministerial or provincial administrative procedures information system), by post or in person;

b) Within 03 working days from the receipt of the complete application, the inspecting authority shall carry out document inspection and issue a notice of satisfactory/unsatisfactory inspection results using Form No. 02 in Appendix I hereof. If the application has to be supplemented, explanation shall be provided. The inspecting authority may request supplementation of the application once every time the goods owner submits the supplemented application;

c) The document inspection contents must specify the suitability of information about the import article presented in the entire application;

d) The goods owner shall submit the notice of satisfactory/unsatisfactory inspection results according to Form No. 02 in Appendix I hereof to the customs authority, which serves that the basis for grating customs clearance, unless such notice is issued via the National Single-window Information Portal or systems connected thereto, in which case the customs authority shall look up information on the Portal as the basis for grating customs clearance.

2. Procedures for normal inspection:

a) Before or when the goods arrive at the border checkpoint, the goods owner shall submit the application for food safety inspection according to Clause 2 Article 24 of this Decree to the inspecting authority, whether online (via the National Public Service Portal, National Single-window Information Portal, ministerial or provincial administrative procedures information system), by post or in person;

b) Within 02 working days from the receipt of the complete application, the inspecting authority shall carry out document inspection according to Point c Clause 1 of this Article, determine the food safety and quality criteria according to the product classification, risk level and product declaration, and select one of the food testing laboratories designated to serve state management of food safety to carry out the testing. If the application has to be supplemented, explanation shall be provided. The inspecting authority may request supplementation of the application once every time the goods owner submits the supplemented application;

c) Within 07 working days from the day on which the goods arrive at the border checkpoint, the testing laboratory mentioned in Point b of this Clause shall complete the sampling and physical inspection of goods, and provide the Test Report to the inspecting authority;

d) Within 01 working day from the receipt of the Test Report, the testing authority shall sign the notice of satisfactory/unsatisfactory inspection results according to Form No. 02 in Appendix I hereof;

dd) The goods owner shall submit the notice of satisfactory/unsatisfactory inspection results according to Form No. 02 in Appendix I hereof to the customs authority, which serves that the basis for grating customs clearance, unless such notice is issued via the National Single-window Information Portal or systems connected thereto, in which case the customs authority shall look up information on the Portal as the basis for grating customs clearance.

3. Procedures for tightened inspection:

a) Before or when the goods arrive at the border checkpoint, the goods owner shall submit the application for food safety inspection according to Clause 3 Article 24 of this Decree to the inspecting authority, whether online (via the National Public Service Portal, National Single-window Information Portal, ministerial or provincial administrative procedures information system), by post or in person;

b) Within 02 working days from the receipt of the complete application, the inspecting authority shall carry out document inspection according to Point c Clause 1 of this Article, determine the food safety and quality criteria according to the product classification, risk level and product declaration, and select a food testing laboratory designated to serve state management of food safety to carry out the testing. If the application has to be supplemented, explanation shall be provided. The inspecting authority may request supplementation of the application once every time the goods owner submits the supplemented application;

c) Within 09 working days from the day on which the goods arrive at the border checkpoint, the testing laboratory mentioned in Point b of this Clause shall complete the sampling and physical inspection of goods, and provide the Test Report for the inspecting authority;

d) Within 01 working day from the receipt of the Test Report, the testing authority shall sign the notice of satisfactory/unsatisfactory inspection results according to Form No. 02 in Appendix I hereof;

dd) The goods owner shall submit the notice of satisfactory/unsatisfactory inspection results according to Form No. 02 in Appendix I hereof to the customs authority, which serves that the basis for grating customs clearance, unless such notice is issued via the National Single-window Information Portal or systems connected thereto, in which case the customs authority shall look up information on the Portal as the basis for grating customs clearance.

4. In cases where the goods owner authorizes another organization or individual to submit the application for food safety inspection according to Clause 1, Clause 2 or Clause 3 of this Article, the authorization shall be carried out as  prescribed by law and the authorization letter (original copy or authenticated electronic copy) must be included in the application for food safety inspection.

5. If notice of unsatisfactory inspection results is issued, the inspecting authority shall take appropriate measures in accordance with Clause 3 Article 55 of the Law of Food Safety and submit a report on goods unqualified for import and results of disposal thereof foods to the People’s Committee of the province and the supervisory Ministry.

6. In cases where an import article is subject to both state inspection of food safety and quarantine according to regulations of law carried out by competent authorities assigned by the Ministry of Agriculture and Environment, food safety and quarantine shall be carried out simultaneously.

1. After disposal of the non-compliant foods unfit for import is completed under the decision issued by the inspecting authority, the goods owner shall submit the following documents to the inspecting authority and the receiving authority:

a) Re-export documents in case of re-export;

b) The destruction record certified by a competent authority;

c) The contract for repurposing between the goods owner and the buyer or recipient of the non-compliant goods. Buyer or recipient of the non-compliant goods must not use them as foods.

2. If the goods are unfit for import due to label-related violations or other violations that are not related to food safety and quality prescribed by law:

If the goods owner wishes to import the products to Vietnam after rectifying the violations, the goods owner shall apply for inspection in accordance with this Decree. If the goods are still unfit for import after remedial measures have been taken, one of the measures specified in Point c and Point d Clause 3 Article 55 of the Law on Food Safety shall be taken.

Goods owners have the following rights and obligations:

1. Request inspecting authorities to inspect imports following the methods in one of the cases specified in Article 21 of this Decree.

2. Request inspecting authorities to change the method for inspecting imports prescribed in Article 22 of this Decree. The request shall be prepared using Form No. 06 in Appendix I hereof.

3. Request inspecting authorities to review import inspection results. If the result of the re-inspection matches the initial result, the goods owner shall pay the re-inspection costs; if the result of re-inspection is satisfactory, the goods owner will be reimbursed for the re-inspection costs.

4. Propose the measures specified in Clause 3 Article 55 of the Law of Food safety if the goods are unfit for import.

5. Ensure the integrity of the consignment and the goods for sampling.

6. Take legal responsibility for the legality and accuracy of the application for inspection.

7. Implement the decision on goods disposal issued by the inspecting authority if the goods are non-compliant and unfit for import.

8. Organizations and individuals receiving aid shall request the inspecting authority to take samples, inspect the label contents and test the foods according to food safety criteria.

Organizations and individuals receiving aid may only receive the consignment after the inspecting authority issues the conclusion that the food safety criteria are satisfied and the label contents are compliant, and shall take full responsibility for the preservation and provision of instructions for use of the products as recommended by the manufacturer on the product labels. The aid must be used for intended purposes and users.

1. A competent authority of Vietnam shall develop an inspection plan, inform and cooperate with the competent authority of the exporting country in inspecting the food safety control system of the exporting country and the manufacturer or seller of foods that are exported to Vietnam (exporter) as follows:

a) The competent authority of the exporting country shall send 01 application to the Ministry of Agriculture and Environment, including information about its management system (laws, standards, food safety control system) and its capacity for food safety control according to Form No. 07 in Appendix I hereof; a list of manufacturers and sellers of foods derived from animals and aquatic organisms registered for export to Vietnam (registered exporters) according to Form No. 08 in Appendix I hereof, and summary about their fulfillment of food safety requirements according to Form No. 09 in Appendix I hereof.

b) Within 30 working days from the day on which adequate documents according to Point a of this Clause are received, the competent authorities of the exporting country and the supervisory Ministry shall verify them, inform the competent authority of the exporting country of the verification result and the inspection plan if inspection of the exporting country is necessary;

c) Contents of inspection in the exporting country include: regulations of law on food safety management and control; capacity of food safety authorities of the exporting country; fulfillment of food safety requirements by the registered exporters.

2. Processing of inspection results and publishing of the list of countries and establishments permitted to export to Vietnam:

a) If a site inspection in the exporting country is not necessary, the Ministry of Agriculture and Environment shall publish the inspection results, names of countries permitted to export to Vietnam. The list of terrestrial animal products and aquatic animal products must be published together with the list of permitted exporters.

b) If a site inspection in the exporting country is necessary, the Ministry of Agriculture and Environment shall process and publish the inspection results within 30 working days after the end of the inspection in the exporting country.

If the inspection results are unsatisfactory, the Ministry of Agriculture and Environment shall issue a notice and provide specific explanation for not permitting the export of foods to Vietnam;

c) In case of requesting addition to the list of permitted exporters of terrestrial animal products and aquatic animal products, the competent authority of the exporting country shall submit an application for document inspection or site inspection in the exporting country which contains a list and information about the exporters according to Form No. 08 and Form No. 09 mentioned in Point a Clause 1 of this Article to the Ministry of Agriculture and Environment. The inspection results shall be the basis for addition of exporters to the list.

The Minister of Health, the Minister of Agriculture and Environment, the Minister of Industry and Trade shall specify the authority, documentation and procedures for state inspection of safety of foods for export under their management in accordance with Articles 41, 42, 62, 63 and 64 of the Law of Food Safety at the request of the importing country.

1. Planned inspection:

Annually, on the basis of risk levels, history of compliance with regulations on food safety of food manufacturers and food sellers, competent authorities shall develop and issue the plan for contents and frequency of inspection of foods in circulation on the market, and organize the implementation of such plan.

2. An ad hoc inspection shall be carried out in any of the following cases:

a) The inspection is necessary or requested by a competent agency, organization or person responsible for food safety management;

b) It is suspected that requirements for manufacture or sale of foods are unfulfilled, and during food safety inspection campaigns;

c) A food safety incident occurs;

d) Signs of violations against regulations on food safety are reported by organizations and individuals in Vietnam and overseas in any shape or form;

dd) There is information or warning that the product in circulation does not comply with food safety regulations;

e) Survey results or food quality inspection results show that the food product has non-compliant labels or is suspected of non-compliance with declared standards or corresponding technical regulations.

3. Mandatory inspection contents:

a) Inspection of the conformity of the product with declared standards, technical regulations, goods labels and enclosed documents;

b) Product origin tracing as per regulations;

c) Other contents related to product quality and safety;

d) If there is suspicion of inferior quality of products, samples shall be taken.

dd) For food products being sold on e-commerce platforms, in addition to inspection as prescribed at Points a, b, c, and d of this Clause, the consistency of the actual products and information published on websites shall be verified in accordance with regulations of law on e-commerce.

1. Manufacturers and sellers of foods in Vietnam, in addition to common regulations of law on goods labeling, shall comply with the following regulations:

a) The label of medical foods shall contain the phrase " Thực phẩm dinh dưỡng y học” (“medical food”) and “Sử dụng cho người bệnh với sự giám sát của nhân viên y tế” (“used under supervision of health workers”);

b) The front label of foods for special dietary uses shall contain the phrase “Sản phẩm dinh dưỡng [cho đối tượng cụ thể]” ("nutritional products for [specific users]").

2. The label of imported products must specify name and address of the manufacturer, name and address of the organization or individual that submits the product declaration.

1. The secondary label is not required for goods in hand luggage serving personal use or meant as gifts within the duty-free allowance; imports of entities eligible for diplomatic immunity; goods in transit, merchanting trade, transshipment, temporarily imported goods; goods in bonded warehouses; test samples; goods for display at an exhibition or fair; raw materials imported for production or processing of exports or internal use and not sold domestically.

2. In addition to seasoning and herbs, small packages whose surface area is smaller than 10 cm² are not required to include ingredients, expiration date, storage conditions and instruction for use if there is a secondary label or secondary package which contains such information.

3. The date of manufacture is not required on primary packaging of foods.

1. Dietary supplements, medical foods, foods for special dietary uses, supplemented foods (except supplemented foods that only contain vitamins, minerals and do not have health claims).

2. Dietary products for children up to 36 months (except breast milk substitutes for children under 24 months of age, dietary supplements for children under 06 months of age prescribed in Article 7 of the Law on Advertising).

The registration of food advertisement contents shall comply with advertising laws and the following regulations:

1. Before advertising, the owner of the advertised product shall register the advertisement contents with the authority that issued confirmation of product declaration registration form according to applicable regulations.

2. The advertisement contents must be consistent with the uses, intended users, warnings, recommendations of the product specified in the product declaration.

3. Regarding dietary supplements:

a) It is required to have the text “Thực phẩm này không phải là thuốc và không có tác dụng thay thế thuốc chữa bệnh” (equivalent to the phrase “this product is not a medicine and not intended to diagnose, treat, cure or prevent any disease”);

b) The text in Point a of this Clause must be read aloud in case of audio and video advertisements;

c) The text in Point a of this Clause is not required if the duration of an audio or video advertisement is shorter than 15 seconds, but it must be displayed during the advertisement.

4. An application for certification of advertisement contents shall include the following documents:

a) The application Form No. 10 in Appendix I hereof;

b) For audio and video advertisements, an audio or video recording of the proposed advertisement script and the proposed advertisement contents (certified by the applicant); For other types of advertisement, a maquette (certified by the applicant).

In cases where the organization or individual responsible for placing products on the market authorizes another organization or individual to act as the holder of the advertisement content certification, an authorization letter (certified by the authorizing party and the authorized party).

The aforementioned documents must be written in Vietnamese language. The applicant shall provide Vietnamese translations of the documents written in English and take responsibility for the accuracy of such translations.
Documents in foreign languages other than English must be accompanied by Vietnamese translations bearing the translators' authenticated signatures. If the Vietnamese translations cannot be provided, the applicant shall submit the English translations bearing the translators' signatures authenticated in the country or origin or exporting country; The applicant shall provide the Vietnamese translations and take responsibility for the accuracy of such translations;

The documents must be unexpired when the application is submitted.

5. Procedures for issuance of the certificate of advertisement contents:

a) The advertised product owner shall send the application for certification of advertisement contents to the authority that issued the confirmation of product declaration registration, whether online (via the National Public Service Portal or the National Single Window Portal or the ministerial or provincial administrative procedures information system), by post, or in person;

b) Within 10 working days from the receipt of the satisfactory application, the receiving authority shall process it and issue form No. 11 in Appendix I hereof. This 10-day period shall be reckoned from the arrival date according to the date stamp appended by the receiving authority if the application is submitted by post or in person, or the date of receipt of the satisfactory application on the online public service system.

If advertisement content is not accepted or the application has to be supplemented, the receiving authority shall provide explanation in writing and specify the legal basis.

The applicant shall complete supplementing the application within 60 days from the receipt of the receiving authority's request for supplementation. The applicant may supplement the application up to 02 times. If the application is still unsatisfactory after the 60-day time limit expires, it shall be invalidated. The receiving authority may only request supplementation 02 times per application.

Within 10 days from the day on which the supplemented application is received, the receiving authority shall process it and issue the advertisement content certification or provide a written response;

c) The receiving authority shall publish the names and certified advertisement contents of organizations and individuals to which the advertisement content certification is granted on its website and the food safety database;

d) The applicant shall pay the fee for application processing to the receiving authority.

6. The owner of the advertised product and the advertiser may only advertise the product after having obtained the advertisement content certification and must adhere to the certified content. When selling or advertising food products subject to advertisement content certification on e-commerce platforms, websites, social networks, online applications, Internet-connected digital platforms in Vietnam, the advertisement content certification and the advertisement contents certified by competent authorities must be published.

7. Advertisements must not be run in the following cases:

a) Confirmation of product declaration registration is revoked;

b) The product is being suspended under a decision of a competent authority.

1. A food testing laboratory serving state management shall satisfy the following conditions:

a) The laboratory has been granted the certificate of registration of testing activities in accordance with regulations on conditions for provision of conformity assessment services which covers testing activities appropriate for the proposed operations or testing criteria on the lists promulgated by the Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade, the Ministry of Science and Technology;

b) The quality control system has been recognized as conformable with ISO/IEC 17025 on food testing and analysis;

c) The facilities and equipment are appropriate for the testing requirements and proposed operations;

d) There are at least 02 laboratory analysts who have bachelor's degrees appropriate for the proposed operations, are trained and have at least 03 years' experience of testing and analysis in the same field;

dd) The testing and analysis methods are up to date and certified; the capacity of testing the proposed criteria is conformable with corresponding technical regulations and other relevant requirements laid down by the supervisory Ministry;

e) The proposed testing and analysis methods have undergone proficiency testing or inter-laboratory comparison with satisfactory results;

If there is no Vietnamese entity capable of proficiency testing or inter-laboratory comparison of the proposed testing and analysis methods, there shall be adequate documentation about the testing and analysis methods, confirmation of usability of the testing and analysis methods, reference materials or reference strains.

2. Verifying laboratories on the list of verifying laboratories qualified for operation published by the supervisory Minister (except the Minister of Industry and Trade).

The verifying laboratory shall satisfy the following conditions:

a) It is a state-owned testing laboratory;

b) It has been designated as a food testing laboratory serving state management.

In case of disputes prescribed in Clause 1 Article 47 of the Law on Food Safety, the settling authority shall select a verifying laboratory from the list of verifying laboratories qualified for operation to carry out the verification testing.

1. The application for designation shall include the following documents:

a) The application form No. 16 in Appendix I hereof;

b) The procedures, reports confirming the usability of testing methods for the proposed criteria, procedures for receiving samples and providing results (copies);

c) Capacity profile, including: Report on the testing laboratory's capacity according to Form No. 17 in Appendix I hereof; documentary evidence of testing and analysis quality (copies): results of proficiency testing or inter-laboratory comparison or documentation about reference materials or reference strains used for quality control of testing and analysis methods while an entity capable of proficiency testing or inter-laboratory comparison is unavailable; reports on test results of the laboratory analysts' proficiency in testing the proposed criteria.

2. An application for change or expansion of designation scope shall include the following documents:

a) The application form No. 16 in Appendix I hereof;

b) The procedures, reports confirming the usability of testing and analysis methods for the proposed criteria being changed or expanded;

c) Capacity profile, including: Report on the testing laboratory's capacity according to Form No. 17 in Appendix I hereof; documentary evidence of testing and analysis quality regarding the change or expansion (copies): results of proficiency testing or inter-laboratory comparison or documentation about reference materials or reference strains used for quality control of testing and analysis methods while an entity capable of proficiency testing or inter-laboratory comparison is unavailable; reports on test results of the laboratory analysts' proficiency in testing the proposed criteria being changed or expanded.

3. An application for extension of designation shall include the following documents:

The designation scope of the issued designation decision shall not be affected by extension. An application for extension of designation shall include:

a) The application form No. 16 in Appendix I hereof;

b) The report on performance of the testing laboratory over the designation period according to Form No. 18 in Appendix I hereof.

1. The testing laboratory (the applicant) shall submit 01 application via the online public service system or by post or in person to the competent authority (hereinafter referred to as "designating authority) delegated by the People’s Committee of the province where the testing and analysis are conducted.

In case of extension of designation, the testing laboratory shall submit the application 90 days before the expiration date of the designation decision.

2. Time limit for the designating authority to process the application according to Article 36 of this Decree:

a) Within 10 days if the application has up to 20 proposed criteria;

b) Within 20 days if the application has 21 - 50 proposed criteria;

c) Within 30 days if the application has more than 50 proposed criteria.

If the application is unsatisfactory, the designating authority shall request the testing laboratory to supplement the application in writing. Only 01 supplementation request may be made per application. The testing laboratory shall complete supplementing the application within 30 days from the receipt of the designating authority's request for supplementation. The testing laboratory may only supplement the application 01 time. If the application is still unsatisfactory when the 30-day time limit expires, it shall be invalidated. Within 10 days from the receipt of the supplemented application, the designating authority shall process the application. If the application is unsatisfactory, the designating authority shall send a notification and provide explanation.

3. If the application is satisfactory, within 20 days, the designating authority shall issue the decision on establishment of an assessment team and carry out an on-site assessment at the testing facility. Depending on the proposed operations, the assessment team shall include 05 - 09 members who have professional knowledge about food testing and analysis.

The decision on assessment team establishment shall specify the assessment scope and contents, names and duties of each member who conducts the on-site assessment. Mandatory evaluation contents include:

a) The testing laboratory's fulfillment of the conditions specified in Article 35 of this Decree and relevant regulations of law;

b) The authenticity of the application for designation.

The testing laboratory assessment record shall be prepared accordance with Form No. 19 in Appendix I hereof.

4. Within 15 days from the receipt of the testing laboratory assessment record:

a) If the assessment results are satisfactory, the designating authority shall issue the decision on designation of food testing laboratory serving state management;

b) If the assessment results are unsatisfactory, the designating authority shall issue a notice of rejection;

c) If the testing laboratory assessment record requires the testing laboratory to take certain remedial actions, the testing laboratory shall send a report on remediation to the designating authority according to Form No. 20 in Appendix I hereof within 60 days from the receipt of the request for remediation.

If the testing laboratory's remediation is satisfactory, the designating authority shall issue the decision on designation of food testing laboratory serving state management within 30 days from the receipt of the report on remediation. In case of rejection, the designating authority shall provide written explanation for the testing laboratory.

5. The designating authority shall issue the decision on designation of food testing laboratory serving state management according to Form No. 21 in Appendix I hereof and concurrently issue a code to the designated laboratory. The decision on designation shall be valid for 03 years from the day on which it is signed.

1. Where it is necessary to test certain criteria to serve state management that were not previously assigned as testing criteria serving state management, the People’s Committee of the province, the supervisory Ministry shall select one of the designated testing laboratory to test these criteria.

2. Where it is necessary to carry out a verifying testing but none of the verifying laboratories on the list of verifying laboratories qualified for operation is capable of the testing, the dispute-settling authority shall request the supervisory Minister (except the Minister of Industry and Trade) to select and assign a testing laboratory to run the verifying testing.

Designating authorities shall issue testing laboratory codes to food testing laboratories serving state management. Composition of a testing laboratory code:

(ordinal number)/(symbol of the People’s Committee of the province)-KNTP-sector code (if any)

1. Responsibilities of designating authorities:

a) Designating authorities shall receive applications for initial designation, extension of designation, changes or expansion of designation scope; organize assessment and designation of testing laboratories;

b) Carry out inspection of food testing laboratories serving state management as prescribed by law;

c) Ensure objectivity and fairness in assessment, designation and inspection;

d) Protect confidentiality of information and data related to testing laboratories and verifying laboratories;

dd) Issue, suspend, un-suspend, revoke, partially or fully invalidate designation decisions. Consider reinstatement of the designation decision after the food testing laboratory serving state management completes and reports the remediation as requested;

e) Publish the list of testing laboratories whose designation decisions are issued, suspended, reinstated, revoked, invalidated and the scope of designation, suspension, reinstatement, revocation, invalidation;

g) Organize inspections, handle complaints and denunciations related to food testing laboratories serving state management as prescribed by law;

h) Retain dossiers on food testing laboratories serving state management;

i) Collect, use fees for assessment and designation of testing laboratories in accordance with regulations of law on fees.

2. Responsibilities of food testing laboratories serving state management:

a) Take legal responsibility for the test results;

b) Make sure the certificate of testing registration and the decision/certificate of recognition of testing laboratory's compliance with ISO/IEC 17025 are unexpired throughout the designation period;

c) Comply with requirements of the quality control system recognized as compliant with ISO/IEC 17025; ensure and maintain adherence with procedures related to the designation scope;

d) Notify the designating authority of any change to the recognized quality control system and reduction in scope of designation within 05 working days from the day on which the change occurs;

dd) Notify the designating authority of supervision results provided by the accrediting organization, results of participation in proficiency testing and inter-laboratory comparison (within 03 working days from the day on which the testing laboratory receives the results);

e) Submit periodic reports, ad hoc reports or thematic reports to the designating authority:

The periodic report on performance of the testing laboratory shall be prepared according to Form No. 18 in Appendix I hereof and submitted before December 20 every year.

Ad hoc reports or thematic reports shall be submitted as requested by the designating authority;

g) In addition to the regulations above, testing laboratories must also pay assessment fees in accordance with regulations of law on fees; ensure honesty, objectivity, and accuracy of test results; Test Reports must contain all information as prescribed in Form No. 22 Appendix I hereof; facilitate inspections of testing activities when required by state management authorities; 

h) Perform other duties of conformity assessment organizations prescribed by the Law on Technical regulations and standards.

The designating authority shall issue the notice of partial or full invalidation of a designation decision in the following cases:

1. The testing laboratory is dissolved, has its juridical personality revoked by a competent authority, or is no longer licensed for food testing under decisions of competent authorities.

2. It is requested by the food testing laboratory serving state management.

The manufacturer or seller, upon discovery that a food being manufactured or sold is not safe or at the request of a competent authority, shall trace its origin in accordance with Clause 1 and Clause 2 Article 54 of the Law of Food Safety.

1. Food manufacturers and sellers shall regularly create and fully retain information about the products, working days, semi-finished products, manufacturing facilities, suppliers of input materials, suppliers, distributors, sellers of products and customers who bought such products in the form of contracts, logbooks or other methods throughout the processes of manufacture, processing, preservation, transport, export, import sale to serve origin tracing. Such information shall be retained in the form of database connected to competent authorities' database. Information serving origin tracing include:

a) Information about operation of the food manufacturer or food seller;

b) Information about products, including names, images, brands, trademarks, identification code, product serial numbers, types, quantities, weights, batch numbers, lot numbers, expiry dates, packaging, additives, applied standards and technical regulations, information about raw materials, semi-finished products, testing certificates, time and place of manufacture/sale, and other related information;

c) Information about products suppliers, distributors, sellers, and customers (if any).

2. The Minister of Health, the Minister of Agriculture and Environment, the Minister of Industry and Trade shall promulgate specific regulations on tracing origins of products under their management and implementation roadmaps.

1. Conformity with the Law of Food Safety and relevant legislative documents.

2. Uniform state management of food safety.

3. Maintain management throughout the processes of manufacture and sale of foods.

4. Close cooperation between Ministries and central authorities.

5. Ensure that a product, a manufacturer or a seller is under the management of a single authority.

6. Ensure scientific nature, adequacy and feasibility.

7. Delegation of state management of food safety between central and local authorities.

8. Regarding a manufacturer whose products are under the management of more than one authority, the authority that is responsible for the largest quantity of the products shall be the supervisory authority.

9. Regarding a seller whose products are under the management of more than one authority, the industry and trade authority shall be the supervisory authority, except for wholesale farm produce markets.

10. A facility that both manufactures and sells products that are under the management of more than one authority, is entitled to select its supervise authority to follow administrative procedures.

1. Implement regulations on general responsibility for state management of food safety in Clause 1 Article 62 of the Law of Food Safety.

2. Submit periodic and ad hoc reports on management of food safety on the basis of supervision and consolidation of reports from other Ministries and the People’s Committees of provinces.

3. Promulgate national technical regulations on products under its jurisdiction according to Article 62 of the Law of Food Safety and the products in Appendix II hereof; promulgate national technical regulations or regulations on food safety limits after receiving the full drafts of national technical regulations or regulations on food safety limits from the Ministry of Agriculture and Environment and the Ministry of Industry and Trade.

4. Perform and delegate food safety management tasks throughout the processes of manufacture, processing, storage, transport, export, import, sale of the food products by specified in Appendix II hereof.

5. Organize receipt and management of applications, issuance, revocation of Certificates of food safety and GMP compliance for dietary supplements; advertisement content certifications for dietary supplements.

6. Issue the List of verifying laboratories under its jurisdiction.

7. Carry out inspection and handle violations against regulations of law on food safety during the processes of manufacture, export, import, sale of foods under its jurisdiction.

8. Carry out inspection, supervision, take actions against violations against regulations on advertising of products, goods and services under its jurisdiction.

9. Annually develop and implement periodic inspection plans and ad hoc inspection plans where necessary under its jurisdiction.

1. Promulgate national technical regulations on products and groups of products under its jurisdiction according to Article 63 of the Law of Food Safety and Appendix III hereof (except primary packages of foods specified by the Ministry of Health).

2. Establish safety limits applied to the groups of products in Appendix III hereof and send them to the Ministry of Health for promulgation.

3. Manage and inspect the delegation of management of food safety throughout the processes of farming, breeding, harvesting, catching, extraction, collection, slaughtering, preparation, processing, preservation, transport, export, import, sale of cereals, meat and meat products, aquatic products, vegetables, tubers, fruits, eggs and egg products, raw fresh milk, honey and honey products, genetically modified foods, salt, and other products and groups of products specified in Appendix III attached to this Decree.

4. Appoint regulatory authorities to carry out food safety inspection of products and groups of products under its jurisdiction as prescribed in this Decree.

5. Establish management hierarchy, documentation and procedures for issuing various certificates related to food export when required by the importing country in accordance with Article 42 of the Law on Food Safety and the provisions of this Decree.

Manage and inspect the issuance of various certificates related to food export when required by the importing country in accordance with Article 42 of the Law on Food Safety and the provisions of this Decree.

6. Issue the List of verifying laboratories under its jurisdiction.

7. Publish the list of countries and establishments permitted to export to Vietnam under its jurisdictions.

8. Carry out inspections and handle violations against regulations of law on food safety during the processes of manufacture, export, import, sale of foods under its jurisdiction.

9. Annually develop and implement periodic inspection plans and ad hoc inspection plans where necessary under its jurisdiction.

10. Organize and delegate the issuance of certificates of food safety to manufacturers and sellers of the products under its jurisdiction.

1. Promulgate national technical regulations on products and groups of products under its jurisdiction according to Article 64 of the Law of Food Safety and Appendix IV hereof.

2. Establish safety limits applied to the products in Appendix IV hereof and send them to the Ministry of Health for promulgation.

3. Provide instructions on origin tracing; develop and operate the system for tracing origin of foods under the jurisdiction of the Ministry of Industry and Trade.

4. Perform and delegate food safety management tasks throughout the processes of production, collecting, preparation, processing, storage, transport, export, import, sale of the products specified in Appendix IV hereof.

5. Perform food safety management at supermarkets, shopping malls, convenience stores, facilities of the storage and distribution system, and other types of business. Carry out inspection and supervision of food sale on e-commerce platforms, promptly detect and handle violations, remove violating contents as per regulations.

6. Organize and delegate the issuance of certificates of food safety to manufacturers and sellers of the products under its jurisdiction.

7. Carry out inspection to prevent counterfeit foods and trade fraud regarding every type of foods, food additives, food processing aids, food containers and packages.

8. Carry out inspection and handle violations against regulations on law on food safety during the processes of manufacture, export, import, sale of foods under its jurisdiction. Carry out inspection and handle manufacture and sale of counterfeit, banned, smuggled, fraudulent goods and foods on e-commerce platforms.

9. Annually develop and implement periodic inspection plans and ad hoc inspection plans where necessary under its jurisdiction.

Promptly provide the following information about food manufacturers and food sellers for the Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade, the People’s Committees of provinces:

1. Signs of unusual fluctuation in revenues.

2. Changes of enterprises' business locations.

3. Suspension, closure or dissolution of enterprises.

4. Information about import consignments exempted from state inspection of food safety when requested by supervisory Ministries.

5. Information about quantities and values of import and export consignments annually or when requested by supervisory Ministries.

6. Information about export and import consignments suspected of violations against regulations on food safety during customs inspection.

1. Promulgate annual plans for development of National Standards (TCVN) for foods at the request of the Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade.

2. Inspect and supervise the operation of organizations registered for recognition of testing laboratories under ISO/IEC 17025.

1. Cooperate with the Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade and the People’s Committees of provinces in inspecting and handing violations against regulations on advertising foods on means of advertising according to advertising laws.

2. Prevent and remove violating food advertisements following the procedures prescribed in legislative documents on advertising.

1. Carry out state management of food safety in their provinces; take responsibility to the Government of Vietnam for food safety in their provinces. Presidents of the People’s Committees of provinces shall directly hold the position of chief of the provincial food safety committee and carry out inspection and supervision of food safety in their provinces; inspect implementation of regulations of law on food safety by inferior authorities; take actions against cadres and civil servants who fail to fulfill their duties; organize settlement of complaints and denunciations; handle violations against regulations of law on food safety; take responsibility to the Government for occurrences of violations against food safety in their provinces.

2. Organize implementation of regulations on food safety of the Government, Ministries and central authorities in their provinces.

3. Operate the provincial food safety committees.

4. Organize dissemination and education of food safety laws in their provinces; encourage professional associations, socio-political organizations, organizations and individuals, the people to promptly report food safety-related violations committee in their provinces.

5. Provide resources for specialized agencies to perform their food safety management tasks.

6. Take responsibility for food safety management in their provinces; inspect fulfillment of food safety requirements by micro food manufacturers and sellers, street vendors, food and drink businesses and markets in their provinces and within their jurisdiction.

7. Manage food safety requirements applicable to manufacturers and sellers of primary packaging of foods, water and ice used for production and sale of agriculture, forestry, aquaculture products. Manage food safety at wholesale farm produce markets.

8. Develop and promulgate provincial technical regulations on food safety on local specialties.

9. Organize, delegate and assign performance of the following tasks:

a) Receive and manage applications; issue and revoke advertisement content certifications for medical foods, food for special dietary uses, dietary products for children up to 36 months, supplemented foods (except supplemented foods that only contain vitamins, minerals and do not have health claims);

b) Receive conformity declaration dossiers; Issue and revoke Certificates of food safety and GMP compliance for dietary supplements;

c) Issue, supplement, revise, reissue, revoke Certificates of Free Sale (CFS), Health Certificates and other certificates related to exported foods at the request of importing countries under assignment and delegation;

d) Issue, suspend, un-suspend, revoke, partially or fully invalidate decisions on designation of food testing laboratory serving state management of food safety and quality;

dd) Assign tasks, suspend, revoke decisions to assign tasks to food safety inspection authorities as delegated by the Minister of Health, the Minister of Industry and Trade, and organize inspection of the performance of assigned agencies.

10. Carry out inspection, supervision, handle violations against regulations on advertising products, goods and services under its jurisdiction.

11. Assign agencies receiving conformity declaration dossiers to develop and implement plans for document inspection after conformity declarations are submitted; take actions against non-compliant conformity declaration dossiers. Within allocated local funding, the receiving agency shall annually develop inspection plans, allocate funding for sampling to monitor quality and safety of products declared for circulation in the market, focusing on product groups used by high-risk groups such as children, the elderly, pregnant women, and patients. Based on monitoring results, conduct site inspections at manufacture and trading establishments, and handle violations if detected.

12. Promptly provide supervisory Ministries with the list of food testing laboratories whose certificates of testing registration have been granted, suspended, revoked, and sanctioned food testing laboratories. 

13. Organize the receipt of price declarations, update declared prices to the price database; use declared prices in market price collection, analysis and forecasting as per regulations; organize implementation of regulations of law on declaring prices of food products under their jurisdiction according to the Law on Prices and the Government’s Decree No. 85/2024/ND-CP dated July 10, 2024 elaborating the Law on Prices.

14. Inspect and supervise the operation of food testing laboratories serving state management of food safety; state inspection agencies for imported foods; registered food testing laboratories; inspect and supervise the operation of conformity assessment organizations registered for certification of Hazard Analysis and Critical Control Point (HACCP) systems; ISO/IEC 17025; International Food Standards (IFS); British Retail Consortium (BRC) standards; Food Safety System Certification (FSSC) or equivalent standards in Vietnam.

15. Annually develop and implement periodic inspection plans and ad hoc inspection plans where necessary under its jurisdiction.

1. Ministries, within the scope of their management, shall cooperate with the Ministry of Health in performing state management tasks to ensure uniform and effective state management of food safety.

2. The Ministry of Health shall preside over the development of a food safety education program; the Ministry of Agriculture and Environment, the Ministry of Industry and Trade, other Ministries and central authorities shall cooperate with the Ministry of Health in running the program.

3. The Ministry of Health, the Ministry of Agriculture and Environment and the Ministry of Industry and Trade shall plan and carry out inspections of products under their jurisdiction in cooperation with other Ministries and central authorities.

4. In case of food poisoning, the Ministry of Health shall be responsible for organizing emergency aid and treatment for food poisoning victims. Other Ministries shall provide adequate documents and information about the origin of the food suspected of poisoning; cooperate with the Ministry of Health in investigating and tracing the origin and disposal of the poisoning foods.

5. Upon discovery of non-compliant foods under jurisdiction of other Ministries and central authorities, the Ministry of Health shall take charge and cooperate with relevant Ministries and central authorities in carrying out inspection and giving conclusion.

6. Upon discovery of infringement of the civil rights of vulnerable groups or public interests, agencies, organizations and individuals shall file civil lawsuits as prescribed by law to protect the civil rights of vulnerable groups or to protect public interests.

7. The Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade, the Ministry of Finance, the People’s Committees of provinces shall complete the connection and sharing of data with the National Public Service Portal or National Single Window Information Portal to complete administrative procedures, manage food safety, ensure uniform food safety management among central and local authorities.

8. The Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade, the Ministry of Science and Technology, the People’s Committees of provinces shall, within the scope of their functions and duties, review, promptly update and amend National Technical Regulations, local technical regulations, National Standards for food safety.

9. Owners of e-commerce platforms and e-commerce applications (including food delivery applications) shall:

a) Establish a mechanism for content moderation, requesting sellers to provide and public legal documents about their products as per regulations;

b) Cooperate with regulatory authorities and promptly remove non-compliant products when requested;

c) Take joint responsibility for failure to implement content moderation causing food safety incidents and damage to consumers.

10. Food manufacturers and food sellers shall update warnings about their products and voluntarily recall the products upon discovery of risks to consumers' health.

1. This Decree enters into force from the day on which it is signed.

2. The Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some Articles of the Law on Food Safety shall cease to be effective from the effective date of this Decree.

3. The following regulations are annulled:

a) Clause 1 Article 24b of the Government’s Decree No. 77/2016/ND-CP dated July 01, 2016 on amendments to regulations on conditions for international trade in goods, chemicals, industrial explosives, fertilizers, gases, foods under the jurisdiction of the Ministry of Industry and Trade, which is amended by Article 13 of the Government’s Decree No. 17/2020/ND-CP dated February 05, 2023 on amendments to some Decrees on business conditions under the jurisdiction of the Ministry of Industry and Trade;

b) Clause 1 Article 3 of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations on business conditions under the jurisdiction of the Ministry of Health;

c) Article 29 of the Government’s Decree No. 136/2025/ND-CP dated June 12, 2025 on devolution and delegation in the agriculture and environment sector;

d) Clause 3 Article 27; regulations on procedures for designation of testing laboratories serving state management in sections I, II, III and procedures for designation of verifying laboratories in sections IV, V, VI of Appendix XI promulgated together with the Government’s Decree No. 146/2025/ND-CP dated June 12, 2025  on devolution and delegation in the industry and trade sector;

dd) Article 25; Clause 1 Article 28; Article 30, parts 1, 2 and 12 of Appendix V promulgated together with
the Government’s Decree No. 148/2025/ND-CP dated June 12, 2025 on devolution and delegation in the health sector.

4. In cases where any of the documents referred to in this Decree are amended or replaced, the newest document shall be applied.

1. Products that were self-declared before the effective date of this Decree may continue to be manufactured, sold and imported until the registration of their conformity declarations is completed. Registration of conformity declarations shall be completed within 12 months from the effective date of this Decree.

2. From December 12, 2026, manufacturers of medical foods, foods for special dietary uses, supplemented foods, nutritional products for children up to 36 months of age shall obtain the Certificate of Hazard Analysis and Critical Control Point (HACCP), ISO 22000 on Food Safety Management System, International Featured Standards (IFS), British Retail Consortium (BRC) standards, Food Safety System Certification (FSSC 22000), an equivalent certification, or Certificate of food safety and GMP compliance.

3. Applications for designation, change or expansion of scope of designation, extension of period of designation of food testing laboratories serving state management submitted before the effective date of this Decree shall be processed in accordance with regulations applicable when they were submitted, unless the applicants wish to apply the provisions of this Decree.

4. Decisions on designation of food testing laboratory serving state management, decisions on promulgation of the List of verifying laboratories qualified for operation that were issued before the effective date of this Decree shall remain effective until the expiration dates written on these decisions.

5. Decisions on designation of authorities carrying out state inspection of imported foods issued by supervisory Ministries before the effective date of this Decree shall remain effective until the end of March 31, 2026.

6. Establishments that were granted any of the following certificates of compliance with: GMP, HACCP, ISO 22000, IFS, BRC, FSSC 22000 or an equivalent certificate which is still unexpired and were not required to obtain the Certificates of Food Safety shall obtain the Certificates of Food Safety within 12 months from the effective date of this Decree, except establishments having unexpired certificates of food safety and GMP compliance for dietary supplements.

Ministers, Heads of ministerial-level agencies, Heads of Governmental agencies, President of the People’s Committees of provinces, relevant organizations and individuals are responsible for implementation of this Decree.