Decree 46/2026/ND-CP detailing the Law on Food Safety
ATTRIBUTE
| Issuing body: | Government | Effective date: | Known Please log in to a subscriber account to use this function. Don’t have an account? Register here |
| Official number: | 46/2026/ND-CP | Signer: | Le Thanh Long |
| Type: | Decree | Expiry date: | Updating |
| Issuing date: | 26/01/2026 | Effect status: | Known Please log in to a subscriber account to use this function. Don’t have an account? Register here |
| Fields: | Food and drug |
THE GOVERNMENT _________ No. 46/2026/ND-CP | THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness ____________ Hanoi, January 26, 2026 |
DECREE
Detailing the implementation of a number of articles and measures for organizing, guiding the implementation of the Law on Food Safety
Pursuant to the Law on Organization of the Government No. 63/2025/QH15;
Pursuant to the Law on Food Safety No. 55/2010/QH12;
At the proposal of the Minister of Health;
The Government promulgates the Decree detailing the implementation of a number of articles and measures for organizing, guiding the implementation of the Law on Food Safety.
Chapter I
GENERAL PROVISIONS
Article 1. Scope of regulation
This Decree details and guides the implementation of a number of articles of the Law on Food Safety, including:
1. Provide detailed regulations on the following matters:
a) Registration of the declaration of conformity and the validity period of the registration of declaration of conformity for foods subject to technical regulations on quality criteria and safety criteria falling under one of the following cases: prepackaged processed foods pursuant to Clause 3 Article 12; food additives and food processing aids pursuant to Clause 4 Article 17; and packaging and utensils in direct contact with food pursuant to Clause 3 Article 18 of the Law on Food Safety;
b) Assurance of safety for human health and the environment regarding genetically modified foods pursuant to Clause 2 Article 15 of the Law on Food Safety;
c) Entities not subject to the issuance of the Certificate of eligibility of the establishment for food safety pursuant to Clause 3 Article 34 of the Law on Food Safety;
d) Conditions for ensuring food safety for imported foods: certificates of free sale or health certificates pursuant to Clause 2 Article 38 of the Law on Food Safety;
dd) Exemption from state inspection of food safety for certain imported foods; order and procedures for state inspection of food safety at the country exporting food into Vietnam in accordance with treaties to which the Socialist Republic of Vietnam is a party, pursuant to Clauses 1 and 3 Article 39 of the Law on Food Safety;
e) Food labeling, shelf life of foods; specific regulations on genetically modified foods subject to labeling, and the threshold percentage of genetically modified ingredients subject to labeling pursuant to Clause 3 Article 44 of the Law on Food Safety.
2. Guide the implementation of the following matters:
a) Conditions for ensuring food safety in food production and trading pursuant to Chapter IV of the Law on Food Safety;
b) Revocation of the Certificate of eligibility of the establishment for food safety pursuant to Article 35 of the Law on Food Safety;
c) Procedures for issuance of the Certificate of eligibility of the establishment for food safety pursuant to Clause 2 Article 36 of the Law on Food Safety;
d) Order, procedures, and methods of state inspection of imported food safety pursuant to Article 40 of the Law on Food Safety;
dd) Advertising and labeling of foods pursuant to Chapter VII of the Law on Food Safety;
e) Assurance of food safety in production, trading, and storage of health protection foods pursuant to Articles 19 and 20 of the Law on Food Safety;
g) Assurance of food safety in the trading and use of food additives pursuant to Article 22 of the Law on Food Safety;
h) Food testing for the purpose of state management pursuant to Section 1 Chapter VIII of the Law on Food Safety;
i) Food traceability pursuant to Section 4 Chapter VIII of the Law on Food Safety.
Article 2. Subjects of application
This Decree applies to Vietnamese agencies, organizations, and individuals; foreign organizations and individuals in Vietnam participating in food production and trading; organizations and individuals engaged in activities related to food safety in Vietnam (hereinafter collectively referred to as organizations and individuals).
Article 3. Interpretation of terms
In this Decree, the following terms are construed as follows:
1. Functional foods are foods used to support functions of the human body, create a state of comfort for the body, enhance resistance, and reduce the risk of disease, including health protection foods, foods for special medical purposes, foods for special dietary uses, and supplemented foods.
2. Health protection foods (Health Supplement, Dietary Supplement, Food Supplement) are products used to supplement the daily diet to maintain, enhance, and improve functions of the human body and reduce the risk of disease. Health protection foods contain one or more substances or mixtures of the following substances:
a) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other biologically active substances;
b) Substances of natural origin, including those derived from animals, minerals, and plants in the form of extracts, isolates, concentrates, and transformed substances;
c) Synthetic sources of the components specified at Points a and b of this Clause.
Health protection foods are presented in processed forms such as capsules, pills, tablets, granules, powders, liquids, and other dosage forms, and are portioned (for use) into small unit doses.
3. Foods for special medical purposes, also known as medical nutrition foods for special medical purposes (Food for Special Medical Purposes, Medical Food), are foods that may be consumed orally or administered via feeding tubes, and are indicated for dietary management of patients in accordance with the instructions of the manufacturing establishment.
4. Foods for special dietary uses are foods that are processed or formulated according to special formulas to meet specific dietary requirements based on the physical condition, pathological condition, or specific disorders of users, or to enhance and improve functions of the human body and reduce the risk of disease, but which do not fall within the group of health protection foods. The composition of such foods must be clearly distinct from that of conventional foods of the same nature, where applicable.
5. Supplemented foods are foods fortified with micronutrients and other health-beneficial factors such as vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics, and other biologically active substances, but which do not fall within any of the three product groups specified in Clauses 2, 3, and 4 of this Article.
6. Goods owner means an organization or individual having ownership rights over goods in accordance with the law.
7. Exported or imported goods are products of the same type, same name, bearing the same goods label, produced by the same manufacturing establishment, and using the same packaging materials.
In this Decree, the term “goods” includes: foods, food additives, food processing aids, packaging, and utensils in direct contact with food.
8. Exported or imported consignment means an imported or exported shipment (having the same bill of lading number) of one goods item or multiple goods.
9. Small-scale primary production establishment means an establishment engaged in cultivation, animal husbandry, harvesting, fishing, or extraction at the household or individual scale, which is not granted a Certificate of enterprise registration or other certificates (household business registration, cooperative, cooperative union, cooperative group, branch, representative office, or business location) in accordance with the law on business registration.
10. Small-scale preliminary processing establishment means an establishment engaged in preliminary food processing at the household or individual scale, which is not granted a Certificate of enterprise registration or other certificates (household business registration, cooperative, cooperative union, cooperative group, branch, representative office, or business location) in accordance with the law on business registration.
11. Small-scale food trading establishment means an establishment operated by an individual, a group of individuals, or a household engaged in food trading, which is not granted a Certificate of business registration and is not granted a Certificate of enterprise registration or other certificates (household business registration, cooperative, cooperative union, cooperative group, branch, representative office, or business location) in accordance with the law on business registration.
12. Owner of food products means an organization or individual owning the formula, manufacturing process, standards, or trademark of food products, or being certified by a competent authority of the country of origin or the exporting country.
13. Organization or individual responsible for placing products on the market means the manufacturing establishment, the owner of food products, or an organization or individual authorized by the manufacturing establishment or the owner of food products to be named in the product declaration dossier.
14. Quality management system of a testing establishment includes the system of management documents, technical documents, and records related to testing activities, such as personnel, equipment, facilities, and testing methods, ensuring the quality, accuracy, and transparency of testing results.
15. Interlaboratory comparison means the organization, implementation, and evaluation of testing methods on the same object or on similar objects by two or more testing or laboratory establishments under predetermined conditions.
16. Proficiency testing means the evaluation of the performance of participating parties against established criteria through interlaboratory comparison.
Chapter II
REGISTRATION OF DECLARATION OF CONFORMITY
Article 4. Cases subject to registration of declaration of conformity
Organizations and individuals shall register a declaration of conformity for foods subject to technical regulations on quality criteria and safety criteria falling under one of the following cases:
1. Prepackaged processed foods;
2. Food additives;
3. Food processing aids;
4. Containers and utensils in direct contact with food;
5. Packaging materials in direct contact with food.
Article 5. Dossiers, order, and procedures for registration of declaration of conformity
1. Dossier for registration of declaration of conformity:
a) The declaration of conformity made in accordance with Form No. 01 in Appendix I promulgated together with this Decree;
b) Results of conformity certification issued by a certification organization accredited in accordance with the law on technical regulations, except where the results of conformity have been interoperable on the national database in accordance with the law on information technology (a copy certified by the organization or individual; or a certified electronic copy);
c) Letter of authorization to be named as the registrant of the declaration of conformity from the manufacturing establishment or the owner of food product containing all contents pursuant to Article 7 of this Decree (in the case of authorization) (a copy certified by organization or individual; or a certified electronic copy).
2. Order and procedures for registration of declaration of conformity:
a) Organizations and individuals shall submit 01 (one) dossier for registration of declaration of conformity pursuant to Clause 1 of this Article by electronic means (via the National Public Service Portal, the National Single Window Portal, or the ministerial- or provincial-level administrative procedure information system), via postal services, or by direct submission to the competent state management authority designated by the provincial-level People’s Committee of the locality where the organization or individual has head office (hereinafter referred to as the dossier-receiving authority). In case there are multiple business locations, the organization or individual may choose to submit the dossier in one of the localities where a registered business location is located;
b) Within 10 days from the date of receipt of the dossier for registration of declaration of conformity, the dossier-receiving authority shall be responsible for publicly disclosing the name and product of the organization or individual whose dossier has been received on the electronic information portal of the dossier-receiving authority and on the electronic information portal of the provincial-level People’s Committee;
c) Organizations and individuals producing and trading products shall be responsible for publicly disclosing the valid dossier for registration of declaration of conformity of products specified in Article 4 of this Decree when conducting business on e-commerce platforms in Vietnam.
Article 6. Validity period of the declaration of conformity
1. The declaration of conformity shall have a validity period corresponding to the validity of the conformity certification results and shall not exceed 03 years.
2. During business operations, where technical regulations are amended, organizations and individuals shall carry out conformity certification in accordance with the new technical regulations and re-perform the procedures for registration of declaration of conformity in accordance with this Decree.
In other cases of changes, organizations and individuals shall notify in writing the contents of changes to the dossier-receiving authority specified at Point a Clause 2 Article 5 of this Decree and may produce and trade the products immediately after sending such notification.
Article 7. Regulations on letters of authorization
1. The language of presentation shall be Vietnamese, English, or bilingual Vietnamese English.
2. Authorization to be named as the declarant of a product shall comply with relevant laws on authorization and contain the following contents:
a) Name and address of the manufacturing establishment; where the authorizing party is the owner of food product, the name and address of the food product owner and the name and address of the manufacturing establishment must be clearly stated;
b) Name and address of the authorized organization or individual;
c) Scope of authorization (to be named as the declarant and to be jointly responsible for all matters related to the product);
d) Name of the authorized product.
3. The authorizing party shall be responsible for notifying in writing the competent state management authority in the event of any changes to the contents of the authorization.
4. The authorizing party and the authorized party shall be joint liability if the product violates quality or food safety regulations and causes consequences.
Chapter III
ENSURING FOOD SAFETY IN CERTAIN CASES
Section 1
ENSURING SAFETY FOR GENETICALLY MODIFIED FOODS
Article 8. Ensuring safety for foods containing ingredients derived from genetically modified organisms and products of genetically modified organisms
The conditions for issuance, order and procedures for issuance and revocation of the Confirmation of eligibility of genetically modified organisms for use as food, and the list of genetically modified organisms granted the Confirmation of eligibility for use as food shall be implemented in accordance with the Government’s Decree No. 69/2010/ND-CP dated June 21, 2010 on biosafety for genetically modified organisms, genetic specimens, and products of genetically modified organisms, as amended and supplemented in 2011, 2018, and 2020.
Article 9. Labeling of goods containing genetically modified organisms and products of genetically modified organisms used as food
1. Organizations and individuals producing and trading foods on the market that contain genetically modified organisms or products of genetically modified organisms, where at least one genetically modified ingredient exceeds 5% of the total raw materials used to produce the food, shall complying with the law on goods labeling pursuant to Chapter VI of this Decree, and display information related to genetically modified organisms on the goods labels, except for the cases specified in Clause 2 of this Article.
2. Cases exempt from labeling requirements for goods containing genetically modified organisms and products of genetically modified organisms used as food include:
a) Prepackaged genetically modified foods containing genetically modified ingredients but in which no genetically modified genes or gene products can be detected in the food;
b) Fresh genetically modified foods and processed genetically modified foods that are not prepackaged and are sold directly to consumers;
c) Genetically modified foods used in emergency situations for the purpose of remedying natural disasters or epidemics.
Section 2
ENSURING FOOD SAFETY FOR IMPORTED TERRESTRIAL ANIMAL PRODUCTS, AQUATIC ANIMAL PRODUCTS, PLANT PRODUCTS USED AS FOOD, AND EXPORTED FOOD PRODUCTS CONVERTED FOR DOMESTIC CONSUMPTION
Article 10. Conditions applicable to imported terrestrial animal products, aquatic animal products, plant products used as food, and exported food products converted for domestic consumption
1. Imported terrestrial animal products, aquatic animal products, plant products used as food, except for processed prepackaged foods, foods exported by Vietnamese organizations or individuals to foreign countries but returned, and the cases specified in Article 19 of this Decree, shall meet the following requirements:
a) Originate from countries, territories having food safety control systems that meet Vietnam’s regulations and are included by competent Vietnamese authorities in the list of countries and territories registered for exporting animal-, plant-, and aquatic-origin foods into Vietnam;
b) In term of terrestrial animal products used as food and aquatic animal products used as food: must be produced by production or business establishments recognized by competent Vietnamese authorities as fully meeting Vietnam’s requirements for ensuring food safety;
c) Each imported consignment of animal-origin or aquatic-origin products shall be accompanied by a certificate certifying compliance with food safety regulations issued by the competent authority of the exporting country (except for aquatic products caught and processed by foreign fishing vessels, or purchased and transshipped at sea by fishing vessels, and exported directly into Vietnam through designated ports).
2. Procedures for registration of countries, territories, and production or business establishments specified in Clause 1 of this Article for inclusion in the list eligible for export into Vietnam shall be implemented in accordance with Article 28 of this Decree.
Article 11. Customs procedures applicable to food ingredients and food products exported and converted for domestic consumption
1. Products and ingredients falling under the cases specified in Clauses 3, 4, 6, and 8 Article 19 of this Decree, when changed intended use to domestic consumption, shall be carried out procedures for change of use purpose in accordance with the law on customs and be complied with food safety regulations applicable to imported products, except where full compliance was already achieved at the time of the initial importation procedures.
2. Food products manufactured for export according to the initial declaration but subsequently converted for domestic consumption shall be carried out customs procedures applicable to imported food products and concurrently be complied with food safety regulations applicable to food products manufactured for domestic consumption.
3. The provisions of Clauses 1 and 2 of this Article shall not apply to cases where exported products or ingredients are returned and subsequently converted for domestic consumption.
Section 3
CONDITIONS FOR ENSURING FOOD SAFETY IN THE PRODUCTION OF HEALTH PROTECTION FOODS
Article 12. Conditions for ensuring food safety in the production of health protection foods
1. Establishments producing health protection foods shall comply with the general conditions for ensuring food safety pursuant to Clause 1 Article 19, Clause 1 Article 20 of the Law on Food Safety, and the following requirements:
a) Establish and maintain a quality management system in accordance with the principles, regulations of Good Manufacturing Practice (GMP) for health protection foods to control the manufacturing process and distribution circulation, ensuring that all products manufactured by the establishment meet the declared standards and are safe for users throughout shelf life;
b) Have enough personnel with appropriate professional qualifications to assigned positions and who have been trained in basic knowledge of GMP, food safety, and relevant professional knowledge. The head of the production department and the head of the quality control department shall be official personnel working full-time for the establishment and shall be independent of each other. The professional supervisor of the establishment shall hold a bachelor’s degree or higher in one of the following majors: medicine, pharmacy, nutrition, food safety, or food technology, and shall have at least 03 years of working experience in a relevant specialized field;
c) The factory system, equipment, and auxiliary utilities shall be designed, constructed, installed in a manner suitable for intended use, in accordance with the one-way principle, easy to clean, preventing and minimizing risks of confusion, avoiding accumulation of dirt, contamination, and other factors adversely affecting products, and daily sanitation activities shall be carried out and maintained;
d) Implement and retain complete dossiers and documents on production, quality control, and distribution circulation to enable traceability of the history of all product batches and records of all other activities carried out at the establishment;
dd) All production operations shall be performed in accordance with prescribed procedures and instructions. Inspection and supervision measures shall be applied during the production process to prevent and avoid risks of confusion, contamination, and cross-contamination. Results shall be recorded immediately upon performing the operation or immediately after completion of each production stage in the records;
e) Have a quality control unit to ensure that products are manufactured under appropriate conditions and procedures and meet established standards; that necessary tests have been performed; that raw materials are not approved for release for use and products are not approved for sale unless they have been evaluated as meeting quality requirements; that product stability is monitored;
g) In cases of contracted testing or manufacturing, the contractor shall have adequate factories, equipment, and personnel to meet the requirements of the contracting party and shall comply with the regulations of the competent management authority regarding conditions for testing or manufacturing health protection foods;
h) Have procedures governing complaint handling, product recall, and self-inspection activities; such activities shall be implemented in accordance with procedures and fully recorded and documented.
2. The Ministry of Health shall provide guidance on GMP for health protection foods for production establishments to implement.
3. Establishments producing health protection foods shall apply GMP for health protection foods in accordance with the guidance of the Ministry of Health.
Article 13. Dossiers, order, and competence for issuance and re-issuance of the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods
1. The dossier for issuance of the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods shall include:
a) An application for issuance of the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods in accordance with Form No. 12 in Appendix I promulgated together with this Decree;
b) A master layout and detailed layouts of production areas, production lines, storage areas, and testing areas (certified by the organization or individual);
c) A list of major equipment used at the establishment (certified by the organization or individual).
2. Order and procedures for receipt and issuance of the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods:
a) The establishment shall prepare a dossier in accordance with Clause 1 of this Article and submit via the online public service system, by postal service, or directly to the Ministry of Health;
b) Where amendment or supplementation of the dossier is required, the dossier-receiving authority shall notify the establishment in writing within 05 working days from the date of receipt of a complete dossier. If, within 30 days of receiving the notification, the establishment fails to supplement or complete the required documents, dossier shall no longer be valid. The organization or individual shall submit a new dossier to obtain a certificate, where required;
c) Within 15 days from the date of receipt of a complete and valid dossier, the dossier-receiving authority shall be responsible for establishing an appraisal team to conduct an on-site assessment at the establishment and to prepare an appraisal record in accordance with Form No. 13 in Appendix I promulgated together with this Decree.
The appraisal team shall consist of 05 to 06 members, including at least 02 members with experience in GMP, 01 member with expertise in testing;
d) Where the appraisal result meets the requirements, the dossier-receiving authority shall issue the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods in accordance with Form No. 14 in Appendix I promulgated together with this Decree. The time for issuance of the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods shall not exceed 30 days from the date of receipt of a complete and valid dossier;
dd) Where the appraisal result at the establishment requires remedial actions, the appraisal team shall clearly specify the required remedial contents in the appraisal record. After completing the remedial actions, the establishment shall send a written notification of the remedial results to the appraisal team. Within 07 working days from the date of receipt of notification of remedial action results, the appraisal team shall be responsible for reviewing and submitting to the Ministry of Health for issuance of the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods. If, after 03 months from the date of completion of the appraisal, the establishment fails to complete the remedial actions as required and notify the appraisal team of the remedial results, the dossier for issuance of the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods shall no longer be valid;
e) Where the appraisal result fails to meet the requirements, within 15 working days, the dossier-receiving authority shall notify the establishment in writing and require the establishment to cease operations until the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods is granted, and shall notify the local management authority for supervision.
3. The Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods shall be valid for 03 years from the date of issuance. At least 06 months prior to its expiry, the establishment shall submit a dossier for re-issuance of the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods. The dossier and procedures for re-issuance shall be implemented in accordance with Clauses 1 and 2 of this Article.
4. Where the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods remains valid and there is a change in the name or address of the establishment stated on the Certificate, or a change in the legal representative of the organization or individual, without any change in the location of the establishment and without any change to the contents within the scope already certified, the organization or individual shall notify the authority that issued the Certificate immediately after change occurs.
5. Organizations and individuals requesting issuance of the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods shall be responsible for paying the dossier appraisal fee to the dossier-receiving authority.
6. Organizations and individuals producing health protection foods shall prepare a periodic report every 12 months from the date of issuance of the Certificate of eligibility of the establishment for food safety meeting GMP requirements for health protection foods or an equivalent certificate, using the form specified in Form No. 15 in Appendix I promulgated together with this Decree, and submit it to the Ministry of Health (the Food Safety Department) within 15 days from the last day of the reporting period.
Section 4
CONDITIONS FOR ENSURING FOOD SAFETY IN PRODUCTION, TRADING AND USE OF FOOD ADDITIVES
Article 14. Regulations on conditions for ensuring food safety regarding food additives
Establishments producing or trading food additives shall comply with the following conditions for ensuring food safety:
1. Comply with the general provisions on conditions for ensuring food safety pursuant to Clause 1 Article 19, Clause 1 Article 20, and Clause 1 Article 21 of the Law on Food Safety.
2. Food additives may only be blended when food additives fall within the list of food additives permitted for use in foods as prescribed by the Ministry of Health, and the final product of blending does not cause any harm to human health.
3. The repackaging, subdividing and decanting of food additives shall be carried out at establishments meeting food safety conditions and shall be labeled in accordance with applicable regulations.
Article 15. Regulations on the use of food additives
Organizations and individuals producing or trading products shall be responsible for:
1. Only using food additives is included in the List of food additives permitted for use in foods as prescribed by the Ministry of Health.
2. Using food additives within the permitted maximum limits; the correct food categories; with clear origin and traceability; within shelf life; in full conformity with management requirements and technical requirements applicable to food additives.
Chapter IV
CERTIFICATE OF ELIGIBILITY OF THE ESTABLISHMENT FOR FOOD SAFETY CONDITIONS
Article 16. Issuance of the Certificate of eligibility of the establishment for food safety conditions
1. Establishments producing or trading foods shall possess a Certificate of eligibility of the establishment for food safety conditions during operation, except for the cases specified in Clause 1 Article 17 of this Decree.
2. Conditions for issuance of the Certificate of eligibility of the establishment for food safety conditions shall be implemented in accordance with Clause 1 Article 34 of the Law on Food Safety. Regarding establishments producing health protection foods, the requirements specified in Article 12 of this Decree shall be complied with.
3. Procedures for issuance of the Certificate of eligibility of the establishment for food safety conditions in the fields of Agriculture and Environment, and Industry and Trade shall be implemented as follows:
a) Where amendment or supplementation of the dossier is required, the dossier-receiving authority shall notify the establishment in writing within 05 working days from the date of receipt of a complete dossier.
If, within 30 days of receiving the notification, the establishment fails to supplement or complete the dossier as requested, the dossier shall no longer be valid. The organization or individual shall submit a new dossier to obtain a certificate, where required;
b) Where no amendment or supplementation of the dossier is required, the dossier-receiving authority shall establish an appraisal team or authorize appraisal and prepare an appraisal record in accordance with Form No. 23 in Appendix I promulgated together with this Decree within 15 working days from the date of receipt of a complete dossier. In cases of authorized appraisal to a competent subordinate authority, a written authorization shall be required.
The appraisal team, established by the authority competent to issue the Certificate or by the authorized appraisal authority, shall consist of 03 to 05 members. In which, at least 02 members engaged in food safety activities (experts appropriate to the food production field of the establishment may be invited to participate in the appraisal team);
c) Where the appraisal result meets the requirements, within 05 working days from the date of the appraisal result, the dossier-receiving authority shall issue the Certificate in accordance with Form No. 24 in Appendix I promulgated together with this Decree;
d) Where the appraisal result at the establishment fails to meet the requirements but is remediable, the appraisal team shall clearly specify the contents, requirements, and period for remediation in the appraisal record, with a remediation period not exceeding 30 days.
After receipt of the establishment’s report on remediation results, within 05 working days, the appraisal team shall evaluate the remediation results and record conclusion in the appraisal record. Where the remediation results meet the requirements, the Certificate shall be issued in accordance with Point c of this Clause. Where the remediation results fail to meet the requirements, the dossier-receiving authority shall notify the establishment and the local management authority in writing that the appraisal result at the establishment fails to meet the requirements;
dd) Where the appraisal result fails to meet the requirements, the dossier-receiving authority shall notify the local management authority in writing for supervision and require the establishment to cease operations until the Certificate is granted.
4. The Minister of Agriculture and Environment and the Minister of Industry and Trade shall provide guidance on dossier forms for applications for issuance of the Certificate of eligibility of the establishment for food safety conditions within management scopes.
Article 17. Establishments not subject to the issuance of the Certificate of eligibility of the establishment for food safety conditions
1. The following establishments shall not be subject to the issuance of the Certificate of eligibility of the establishment for food safety conditions:
a) Small-scale primary production establishments;
b) Establishments producing or trading foods without a fixed location;
c) Small-scale preliminary processing establishments;
d) Small-scale food trading establishments;
dd) Establishments trading in prepackaged foods, food additives, food processing aids, and micronutrients;
e) Establishments producing or trading utensils and packaging materials for containing foods;
g) Restaurants located within hotels, tourist apartment complexes, and tourist villa complexes;
h) Collective kitchens that do not register food business activities;
i) Street food businesses.
2. Establishments specified in Clause 1 of this Article shall comply with the corresponding requirements for ensuring food safety conditions.
Article 18. Revocation of the Certificate of eligibility of the establishment for food safety conditions
1. Competence for revocation:
The authority that issued the Certificate of eligibility of the establishment for food safety conditions, the Certificate of eligibility of the establishment for food safety conditions meeting GMP requirements for health protection foods (hereinafter collectively referred to as the Certificate of eligibility of the establishment for food safety conditions), and the competent authority in accordance with the law on handling of administrative violations shall have the authority to revoke an issued Certificate of eligibility of the establishment for food safety conditions.
2. Cases of revocation:
a) Failure to possess an Enterprise Registration Certificate or Business Registration Certificate, or possession of Enterprise Registration Certificate or Business Registration Certificate that does not include registration of appropriate food-related business lines;
b) Within a period of 12 months, being administratively sanctioned two or more times for violations of conditions for ensuring food safety pursuant to Chapter IV of the Law on Food Safety and legal documents on food safety conditions;
c) Use of prohibited substances included in the list of substances prohibited from use in food production and trading;
d) Production of counterfeit foods, food additives, or food processing aids;
dd) Within a period of 12 months, occurrence of two or more food poisoning incidents, or occurrence of at least one food poisoning incident resulting in death;
e) Use of forged documents, forged seals, or forged signatures in the dossier for issuance of the Certificate of eligibility of the establishment for food safety conditions;
g) Use of forged testing reports or falsification of testing results in the quality control and food safety dossiers for the establishment’s products;
h) Organizations and individuals fail to notify the competent authority of cessation of production or business activities for a period of 12 months at the location for which the Certificate of eligibility of the establishment for food safety conditions has been issued;
i) At the request of the organization or individual holding the Certificate of eligibility of the establishment for food safety conditions.
Chapter V
STATE INSPECTION OF IMPORTED AND EXPORTED FOOD SAFETY AND INSPECTION DURING MARKET CIRCULATION
Article 19. Cases eligible for exemption from state inspection of food safety for certain imported foods (except for cases subject to food safety warnings)
1. Products being gifts or presents within the import duty-free limits in accordance with the law on taxation.
2. Imported products for personal use by persons entitled to diplomatic privileges and immunities.
3. Products in transit, transshipment, transloading, temporary import for re-export, or consigned to bonded warehouses.
4. Products used as test or research samples in quantities appropriate to the testing or research purposes, with certification by the organization or individual.
5. Products used for display at fairs, exhibitions.
6. Products temporarily imported for sale at duty-free shops.
7. Imported goods serving urgent requirements in accordance with directives of the Government or the Prime Minister.
8. Imported products and raw materials used solely for processing or manufacturing goods for export.
9. Specialized goods serving national security or defense purposes, with written certification from the Minister of National Defence or the Minister of Public Security.
10. Goods included in the List of goods purchased, sold, or exchanged by border residents and within duty-free limits in accordance with the law on export and import duties, serving the production and consumption needs of border residents (except for cases of bulk purchasing).
Article 20. State inspection authorities for imported foods
1. State inspection authorities for food safety regarding imported foods pursuant to Clause 1 Article 39 of the Law on Food Safety are state management authorities assigned by the Ministry of Agriculture and Environment or by provincial-level People’s Committees, in accordance with decentralization, to carry out State food safety inspection in accordance with the order, procedures and methods of State food safety inspection applicable to imported foods, food additives, food processing aids, packaging and utensils in direct contact with food, as provided for in the Law on Food Safety.
2. State inspection authorities for food safety regarding imported foods (hereinafter referred to as state inspection authorities) shall have the following powers and responsibilities:
a) To conduct state inspection of food safety for imported foods, food additives, food processing aids, packaging, and utensils in direct contact with food in accordance with the methods, order, and procedures prescribed in this Decree;
b) To issue the Notification of results confirming whether the food meets or fails to meet import requirements in accordance with Form No. 02 in Appendix I promulgated together with this Decree; the Notice of goods eligible for conversion of inspection methods from strict inspection to normal inspection, or from normal inspection to reduced inspection, in accordance with Form No. 03 in Appendix I promulgated together with this Decree;
c) To designate quality and food safety criteria applicable to imported goods in accordance with the corresponding inspection method;
d) To select food testing establishments designated to serve state management of food safety to conduct testing of the quality and food safety criteria specified at Point c Clause 2 of this Article;
dd) To collect inspection and testing fees and charges in accordance with the law on fees and charges;
e) To ensure professional competence, accuracy, honesty, and objectivity in the inspection, confirmation of food safety for imported consignments and goods; and to be fully responsible for state inspection of food safety regarding imported foods;
g) Be subject to the direction, inspection and guidance on organizational and professional matters of the provincial-level People’s Committees, the Ministry of Health, the Ministry of Agriculture and Environment, and the Ministry of Industry and Trade;
h) To receive and settle complaints of goods owners. Where damage is caused to goods owners, state inspection authorities shall refund in full the inspection and testing fees and charges and shall compensate for damages (if any) in accordance with the law;
i) To archive inspection dossiers in accordance with the law and to present archived dossiers upon request by competent authorities;
k) To submit biannual reports to the authorities assigning corresponding tasks in accordance with Form No. 04 in Appendix I promulgated together with this Decree, or ad hoc reports at the request of Line ministry;
l) To select food testing establishments designated to serve state management of food safety to conduct testing of quality and food safety criteria for imported products intended for aid purposes; to inspect labeling contents of imported products for such purposes;
m) Sampling for testing and inspection of the actual condition of goods shall be conducted by the State inspection authority, or carried out by a designated food testing establishment assigned by the State inspection authority to serve State management of food safety. Sampling officers shall possess certificates or attestations of participation in training courses covering food sampling.
Article 21. Methods of state inspection of food safety
Methods of state inspection of food safety applicable to imported foods, food additives, food processing aids, packaging, and utensils in direct contact with food shall include:
1. Strict inspection: is the implementation dossier inspection, inspection of the actual status of goods, and sampling for testing of groups of quality and food safety criteria in accordance with the declaration dossier and other criteria that have failed or are subject to warnings pursuant to Clause 3 Article 22 of this Decree (if any).
2. Normal inspection: is the implementation of dossier inspection, inspection of the actual status of goods, and sampling for testing of selected quality and food safety criteria from among the groups of quality and food safety criteria in the dossier.
Based on the nature and composition, quality history, transportation and storage process of the goods, import history of the goods owner, origin of the goods, and the quality management system applied to the goods, the state inspection authority shall select the quality and food safety criteria from among the groups of criteria in the dossier.
3. Reduced inspection: is the implementation of dossier inspection for imported goods.
Article 22. Application of state inspection methods for imported foods
1. Reduced inspection shall be applied to goods falling under one of the following cases:
a) Goods that have been confirmed as meeting food safety requirements by competent authorities or organizations of countries that have concluded treaties on mutual recognition in food safety inspection to which Vietnam is a party; and which have inspection results issued by competent authorities of the exporting country for consignments or goods that are consistent with the provisions of Vietnamese law;
b) Goods for which the state inspection authority has issued a Notice on conversion of the inspection method from normal inspection to reduced inspection.
Goods shall be eligible for reduced inspection for a maximum period of 12 months from the date on which the state inspection authority issues the Notice on conversion of the inspection method from normal inspection to reduced inspection (except for the case specified at Point a Clause 1 of this Article).
2. Normal inspection shall be applied to all imported goods, except for the cases specified in Clauses 1 and 3 of this Article.
3. Strict inspection shall be applied to imported goods falling under one of the following cases:
a) Failure to meet import requirements at the previous inspection;
b) Conclusions of non-compliance with quality or food safety criteria issued by inspection or examination teams (if any);
c) Warnings issued by the Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade, provincial-level People’s Committees, competent authorities of foreign countries, or manufacturers.
Article 23. Conversion between inspection methods
1. A goods item that has 03 consecutive importations within a period of 12 months and has been issued the Notice of results of confirmation of foods meeting import requirements under the normal inspection method shall be applied the reduced inspection method. The duration of application of the reduced inspection method shall be no more than 12 months from the date of signing the Notice of results of confirmation of foods meeting import requirements for the last importation in three consecutive importations. Upon expiry of the reduced inspection period, subsequently imported goods shall continue to be subject to the normal inspection method (except for the case specified in Clause 3 Article 22 of this Decree).
The conversion between the normal inspection method and the reduced inspection method for imported goods shall be applied on a rotating basis in accordance with the above principle.
2. Imported goods that have 03 consecutive instances within a period of 12 months of being issued the Notice of results of confirmation of foods meeting import requirements under the strict inspection method shall be applied the normal inspection method from the date on which the state inspection authority signs the Notice on conversion of inspection method (except where there are other warnings related to the duration of application of the strict inspection method issued by competent state management authorities).
Article 24. Dossiers for registration of state inspection of food safety for imported foods
1. Dossier for registration of reduced inspection shall include:
a) Application for registration of inspection of imported foods in accordance with Form No. 05 in Appendix I promulgated together with this Decree;
b) Dossier of declaration of conformity for products subject to declaration of conformity; dossier of declaration of applicable standards for products subject to declaration of applicable standards; dossier for registration of product declaration for products subject to registration of product declaration (Receipt of registration of product declaration, product declaration, labels, and product standards); Product specification for products not subject to declaration of conformity, declaration of applicable standards, or registration of product declaration. In the case of submission of dossiers via postal services or by direct submission, organizations and individuals shall submit copies certified by the organization or individual, or certified electronic copies;
c) Notice issued by the state inspection authority on conversion of the inspection method for the goods from normal inspection to reduced inspection (original or certified electronic copy) for the case specified in Clause 1 Article 23 of this Decree;
d) Copy of the Packing list;
dd) For products specified in Article 10 of this Decree, a certificate evidencing compliance with food safety requirements issued by the competent authority of the exporting country shall be required (copies certified by the organization or individual; or certified electronic copies), except for fishery products caught and processed at sea by foreign fishing vessels and sold directly to Vietnam.
2. Dossier for registration of normal inspection shall include:
a) Application for registration of inspection of imported foods in accordance with Form No. 05 in Appendix I promulgated together with this Decree;
b) Dossier of declaration of conformity for products subject to declaration of conformity; dossier of declaration of applicable standards for products subject to declaration of applicable standards; dossier for registration of product declaration for products subject to registration of product declaration (Receipt of registration of product declaration, product declaration, labels, and product standards); Product specification for products not subject to declaration of conformity, declaration of applicable standards, or registration of product declaration. In the case of submission of dossiers via postal services or by direct submission, organizations and individuals shall submit copies certified by the organization or individual, or certified electronic copies;
c) Notice issued by the state inspection authority on conversion of the inspection method for the goods item from strict inspection to normal inspection (original or certified electronic copy) for cases subject to conversion under Clause 2 Article 23 of this Decree;
d) Copy of the packing list;
dd) For products specified in Article 10 of this Decree, a certificate evidencing compliance with food safety requirements issued by the competent authority of the exporting country shall be required (copies certified by the organization or individual; or certified electronic copies), except for fishery products caught and processed at sea by foreign fishing vessels and sold directly to Vietnam.
3. Dossier for registration of strict inspection shall include:
a) Application for registration of inspection of imported foods in accordance with Form No. 05 in Appendix I promulgated together with this Decree;
b) Dossier of declaration of conformity for products subject to declaration of conformity; dossier of declaration of applicable standards for products subject to declaration of applicable standards; dossier for registration of product declaration for products subject to registration of product declaration (Receipt of registration of product declaration, product declaration, labels, and product standards); Product specification for products not subject to declaration of conformity, declaration of applicable standards, or registration of product declaration. In the case of submission of dossiers via postal services or by direct submission, organizations and individuals shall submit copies certified by the organization or individual, or certified electronic copies;
c) Copy of the Packing list;
d) For products specified in Article 10 of this Decree, a certificate evidencing compliance with food safety requirements issued by the competent authority of the exporting country shall be required (copies certified by the organization or individual; or certified electronic copies), except for fishery products caught and processed at sea by foreign fishing vessels and sold directly to Vietnam.
Article 25. Order of state inspection of food safety for imported foods
1. Order for conducting reduced inspection:
a) Before or upon arrival of goods at the border gate, the goods owner shall submit the dossier for registration of inspection pursuant to Clause 1 Article 24 of this Decree to the state inspection authority by electronic means (via the National Public Service Portal, the National Single Window Portal, or the ministerial- or provincial-level administrative procedure information system), via postal services, or by direct submission;
b) Within 03 working days from the date of receipt of a complete dossier, the state inspection authority shall be responsible for examining the dossier and issuing the Notification of results confirming whether the food meets or fails to meet import requirements in accordance with Form No. 02 in Appendix I promulgated together with this Decree. Where supplementation of the dossier is required, reasons must be clearly stated. The state inspection authority may request amendment or supplementation only once for each submission of an amended or supplemented dossier by the goods owner;
c) The dossier examination contents shall confirm the conformity of information related to the imported goods as presented throughout the entire dossier;
d) The goods owner shall submit the Notification of results confirming whether the food meets or fails to meet import requirements in accordance with Form No. 02 in Appendix I promulgated together with this Decree to the customs authority as a basis for customs clearance, except where such Notice is issued via the National Single Window Portal or systems connected with the National Single Window Portal, in which case the customs authority shall retrieve the information for customs clearance purposes.
2. Order for conducting normal inspection:
a) Before or upon arrival of goods at the border gate, the goods owner shall submit the dossier for registration of inspection pursuant to Clause 2 Article 24 of this Decree to the state inspection authority by electronic means (via the National Public Service Portal, the National Single Window Portal, or the ministerial- or provincial-level administrative procedure information system), via postal services, or by direct submission;
b) Within 02 working days from the date of receipt of a complete dossier, the state inspection authority shall be responsible for examining the dossier in accordance with Point c Clause 1 of this Article, determine quality and food safety criteria based on product classification, risk level, and the declaration dossier, and select a designated food testing establishment to conduct testing. Where supplementation of the dossier is required, reasons must be clearly stated. The state inspection authority may request amendment or supplementation only once for each submission of an amended or supplemented dossier by the goods owner;
c) Within 07 working days from the date the goods arrive at the border gate, the testing establishment specified at Point b of this Clause shall complete sampling, inspection of the actual status of goods, and send the Testing Result Sheet for state management purposes to the state inspection authority;
d) Within 01 working day from the date of receipt of the Testing Result Sheet, the state inspection authority shall be responsible for inspecting and signing the Notification of results confirming whether the food meets or fails to meet import requirements in accordance with Form No. 02 in Appendix I promulgated together with this Decree;
dd) The goods owner shall submit the Notification of results confirming whether the food meets or fails to meet import requirements in accordance with Form No. 02 in Appendix I promulgated together with this Decree to the customs authority as a basis for customs clearance, except where such Notice is issued via the National Single Window Portal or systems connected with the National Single Window Portal, in which case the customs authority shall retrieve the information for customs clearance purposes.
3. Order for conducting strict inspection:
a) Before or upon arrival of goods at the border gate, the goods owner shall submit the dossier for registration of inspection pursuant to Clause 3 Article 24 of this Decree to the state inspection authority by electronic means (via the National Public Service Portal, the National Single Window Portal, or the ministerial- or provincial-level administrative procedure information system), via postal services, or by direct submission;
b) Within 02 working days from the date of receipt of a complete dossier, the state inspection authority shall be responsible for examining the dossier in accordance with Point c Clause 1 of this Article, determine quality and food safety criteria based on product classification, risk level, and the declaration dossier, and select a designated food testing establishment to conduct testing. Where supplementation of the dossier is required, reasons must be clearly stated. The state inspection authority may request amendment or supplementation only once for each submission of an amended or supplemented dossier by the goods owner;
c) Within 09 working days from the date the goods arrive at the border gate, the testing establishment specified at Point b of this Clause shall complete sampling, inspection of the actual status of goods, and send the Testing Result Sheet for state management purposes to the state inspection authority;
d) Within 01 working day from the date of receipt of the Testing Result Sheet, the state inspection authority shall be responsible for inspecting and signing the Notification of results confirming whether the food meets or fails to meet import requirements in accordance with Form No. 02 in Appendix I promulgated together with this Decree;
dd) The goods owner shall submit the Notification of results confirming whether the food meets or fails to meet import requirements in accordance with Form No. 02 in Appendix I promulgated together with this Decree to the customs authority as a basis for customs clearance, except where such Notice is issued via the National Single Window Portal or systems connected with the National Single Window Portal, in which case the customs authority shall retrieve the information for customs clearance purposes.
4. Where the goods owner authorizes an organization or individual to submit the dossier for registration of inspection under Clause 1, 2, or 3 of this Article, the authorization shall comply with the law, and a Letter of authorization (original or certified electronic copy) shall be enclosed in the inspection registration dossier.
5. For imported goods for which a Notice of results of confirmation of foods failing to meet import requirements is issued, the state inspection authority shall decide on handling measures in accordance with the forms specified in Clause 3 Article 55 of the Law on Food Safety, report information on the non-compliant imported goods and the handling results to the provincial-level People’s Committee and Line ministry.
6. For imported goods that are subject both to state inspection of food safety and to quarantine in accordance with the law, the competent state authority assigned by the Ministry of Agriculture and Environment shall concurrently conduct state inspection of food safety and quarantine.
Article 26. Handling of foods failing to meet import requirements
1. After completion of handling measures for foods failing to meet import requirements in accordance with the decision of the state inspection authority, the goods owner shall be responsible for reporting to the state inspection authority and the authority receiving the declaration dossier through one of the following documents:
a) Re-export documents, in cases where the form of re-export is applied;
b) Record of destruction certified by a competent authority;
c) Contract on conversion of use purpose between the goods owner and the purchaser or transferee of the goods. The purchaser or transferee of goods failing to meet import requirements shall not use such goods as food.
2. For goods failing to meet import requirements due to errors in goods labeling or other errors not related to food quality or food safety in accordance with the law:
After completion of remedial measures, if goods are to be imported into Vietnam, the goods owner shall carry out inspection registration procedures in accordance with this Decree. Where remedial measures have been applied but the goods still fail to meet import requirements, one of the handling forms specified at Points c and d Clause 3 Article 55 of the Law on Food Safety shall be applied.
Article 27. Rights and obligations of goods owners and organizations or individuals receiving aid
Goods owners shall have the following rights and obligations:
1. To request the state inspection authority to apply an inspection method to imported goods in accordance with one of the cases specified in Article 21 of this Decree.
2. To request the state inspection authority to convert the inspection method applicable to imported goods in accordance with Article 22 of this Decree. The application form shall be made in accordance with Form No. 06 in Appendix I promulgated together with this Decree.
3. To request the state inspection authority to re-examine the inspection results of imported goods. Where the re-examination results are consistent with the initial inspection results, the goods owner shall bear the costs of re-examination; where the re-examination results meet import requirements, the re-examination costs already paid shall be refunded.
4. To be entitled to propose handling measures specified in Clause 3 Article 55 of the Law on Food Safety for goods failing to meet import requirements.
5. To ensure the original condition of the consignment and the integrity of the goods for sampling purposes.
6. To be legally responsible for the legality and accuracy of the inspection registration dossier.
7. To implement the handling decisions of the state inspection authority where goods fail to meet import requirements.
8. Organizations and individuals receiving aid shall be responsible for requesting the state inspection authority for imported food safety to take samples, inspect labeling contents, and test food safety criteria.
Organizations and individuals receiving aid shall only receive consignments after obtaining conclusions of conformity regarding food safety criteria and labeling contents from the state inspection authority, and shall be fully responsible for storage and guidance on use of the products in accordance with the manufacturer’s recommendations stated on product labels. The use of aid goods shall be consistent with intended purposes and target beneficiaries.
Article 28. Procedures for registration of countries, territories, and production or business establishments on the list eligible for exporting foods into Vietnam and for state inspection of food safety in the exporting country
1. Competent Vietnamese state management authorities shall develop inspection plans, notify, and coordinate with competent authorities of the exporting country to conduct inspection of the food safety control system of the exporting country and of production and business establishments exporting foods into Vietnam, in accordance with the following procedures:
a) The competent authority of the exporting country shall submit 01 dossier of registration to the Ministry of Agriculture and Environment, including: information on the management system of the country or territory (including the legal system, standards, and organizational system for food safety management) and the food safety control capacity of the competent authority of the exporting country or territory in accordance with Form No. 07 in Appendix I promulgated together with this Decree; a list of production and business establishments of animal-origin and aquatic-origin foods registered for export into Vietnam in accordance with Form No. 08 in Appendix I promulgated together with this Decree and a summary of information on food safety conditions of production and business establishments in accordance with Form No. 09 in Appendix I promulgated together with this Decree;
b) Within 30 working days from the date of receipt of a complete dossier registering the list of production and business establishments as specified at Point a of this Clause from the competent authority of the exporting country, the competent authority of Line ministry shall appraise the dossier, notify the competent authority of the exporting country the appraisal results and the inspection plan where inspection of the exporting country into Vietnam is required;
c) The inspection contents in the exporting country shall include: the legal system on management and control of food safety; the capacity of the food safety control authority of the exporting country; and the food safety conditions of production and business establishments registered for export into Vietnam.
2. Handling of inspection results and announcement of the list of countries, territories, and lists of production and business establishments permitted to export into Vietnam shall be carried out as follows:
a) Where it is not necessary to conduct on-site inspection of the exporting country into Vietnam, the Ministry of Agriculture and Environment shall announce the results and the names of countries or territories permitted to export into Vietnam. For terrestrial animal products and aquatic animal products, the announcement shall be made together with the list of production and business establishments permitted to export;
b) Where inspection of the exporting country is required, within 30 working days from the date of completion of the inspection in the exporting country, the Ministry of Agriculture and Environment shall process and announce the inspection results.
Where the inspection results do not fully meet the prescribed requirements, the Ministry of Agriculture and Environment shall notify and clearly state the specific reasons for cases not permitted to export foods into Vietnam;
c) In cases where supplementation of the list of production and business establishments exporting terrestrial animal products or aquatic animal products into Vietnam is requested, the competent authority of the exporting country shall submit a dossier including the list and establishment information in accordance with Form No. 08 and Form No. 09 as prescribed at Point a Clause 1 of this Article to the Ministry of Agriculture and Environment for dossier appraisal or on-site inspection in the exporting country, on the basis of which a decision on supplementation to the list shall be considered.
Article 29. State inspection of exported foods
The Minister of Health, the Minister of Agriculture and Environment, and the Minister of Industry and Trade shall provide the competence, dossiers, order, and procedures for state inspection of food safety regarding exported foods under management scopes as provided in Articles 41, 42, 62, 63, and Article 64 of the Law on Food Safety, where required by the importing country.
Article 30. Inspection during circulation on the market
1. Planned inspection:
Annually, competent authorities shall, based on risk levels and the compliance history with food safety regulations of production and business establishments, develop and promulgate plans specifying inspection contents and frequencies during circulation on the market, and organize the implementation of plans.
2. Ad hoc inspection shall be conducted when the occurrence of one of the following grounds:
a) At the request of management authorities or upon proposals from competent agencies, organizations, or individuals regarding food products;
b) Upon detection of signs of violations related to food production or trading activities, and during peak inspection campaigns on food safety;
c) Upon occurrence of food safety incidents;
d) Reported information in any form, from domestic or foreign organizations or individuals regarding signs of food safety violations;
dd) Information, warnings regarding products circulating on the market that do not conform to prescribed food safety conditions;
e) Results of surveys or inspections of the quality of food products circulating on the market that detect food products with non-compliant labeling or with signs of quality not conforming to the declared applicable standards or corresponding technical regulations.
3. Minimum contents to be conducted during inspection:
a) Examination of the conformity of products with technical regulations, declared applicable standards, goods labeling, and accompanying documents;
b) Examination of product traceability in accordance with regulations;
c) Examination of other contents related to product quality and safety;
d) During inspection, where products show signs of failing to ensure quality or safety, sampling shall be conducted in accordance with regulations;
dd) For food products traded via e-commerce activities, in addition to inspections specified at Points a, b, c, and d of this Clause, comparison shall be conducted to assess the consistency of information published on e-commerce websites in accordance with the law on e-commerce on digital e-commerce platforms with the actual status of the inspected products.
Chapter VI
FOOD LABELING
Article 31. Mandatory labeling contents
1. Organizations and individuals producing or trading products in Vietnam, in addition to compliance with the law on goods labeling, shall also comply with the following requirements:
a) Foods for special medical purposes shall bear the following statements:
“Food for special medical purposes” and “Use for patients under the supervision of medical professionals”;
b) Foods for special dietary uses shall bear the statement: “Nutritional product (for specific subjects)” on the principal display panel of the label to distinguish from ordinary foods.
2. Regarding imported products, the name of the organization or individual responsible as indicated on the product label shall include: the name and address of the manufacturing organization or individual, and the name and address of the organization or individual declaring the product.
Article 32. Exemption from certain mandatory labeling contents
1. Exemption from supplementary labeling shall apply to products carried by inbound passengers for personal consumption, gifts or presents within the import duty-free limits, imported products of subjects entitled to diplomatic privileges and immunities, products in transit, transshipment, transloading, temporary import for re-export, or consigned to bonded warehouses, products used as test or research samples, products displayed at fairs or exhibitions, products or raw materials manufactured or imported solely for production or processing of export goods or for internal production use by organizations or individuals, not for domestic market consumption.
2. Except for spices and herbs, for small packages with the largest surface area of less than 10 cm², exemption shall be granted from indicating ingredients, shelf life, storage instructions, and directions for use, provided that a supplementary label or outer packaging has fully indicated such contents.
3. Exemption from indicating the date of manufacture shall apply to packaging and utensils in direct contact with food.
Chapter VII
FOOD ADVERTISING
Article 33. Foods subject to registration of advertising content prior to advertising
1. Health protection foods, foods for special medical purposes, foods for special dietary uses, and supplemented foods (except for supplemented foods containing only vitamins and minerals and not bearing any health claims).
2. Nutritional products for children up to 36 months of age (except for breast-milk substitutes for children under 24 months of age and complementary nutritional products for children under 06 months of age pursuant to Article 7 of the Law on Advertising).
Article 34. Registration of food advertising content
The registration of food advertising content, in addition to compliance with the law on advertising, shall comply with the following provisions:
1. Prior to advertising, organizations or individuals having products to be advertised shall register the advertising content with the authority that issued the Receipt of registration of the product declaration in accordance with current regulations.
2. Advertising content must be consistent with the uses, target users, warnings, and recommendations of the product as declared in the product declaration.
3. Regarding health protection foods:
a) The following warning statement must be included: “This product is not a medicine and does not have the effect of replacing medicines for treatment”;
b) For advertisements using images and audio, the warning specified at Point a of this Clause must be clearly read;
c) For advertisements using images with a short duration of less than 15 seconds, it is not required to read the warning statement specified at Point a of this Clause, but the warning must still be displayed in the advertisement.
4. Dossier for registration for confirmation of advertising content shall include:
a) Application for registration for confirmation of advertising content in accordance with Form No. 10 in Appendix I promulgated together with this Decree;
b) For advertisements using images or audio, a proposed advertising script (certified by the organization or individual) and the proposed advertising content recorded in video and audio recordings shall be provided; for advertisements on other media, a proposed advertising mock-up (content sample) (certified by the organization or individual) shall be provided.
Where the organization or individual responsible for placing the product on the market authorizes another organization or individual to be named on the Certificate of confirmation of advertising content, a letter of authorization (certified by the authorizing party and the authorized party) shall be provided.
Documents in the dossier for registration for confirmation of advertising content must be presented in Vietnamese. Where documents are in English, organizations or individuals shall translate into Vietnamese and bear responsibility for the accuracy of the translation. Where documents are in a foreign language other than English, they must be translated into Vietnamese and the translator’s signature must be notarized. Where translation into Vietnamese and notarization are not possible, organizations or individuals shall submit an English translation notarized in the country of origin or exporting country, and shall translate such English version into Vietnamese and bear responsibility for the accuracy of the translation.
Documents must remain valid at the time of submission of the dossier for registration for confirmation of advertising content.
5. Procedures for issuance of the Certificate of confirmation of advertising content:
a) Organizations or individuals having products to be advertised shall submit the dossier for registration for confirmation of advertising content to the authority issuing the Receipt of registration of the product declaration by electronic means (via the National Public Service Portal, the National Single Window Portal, or the ministerial- or provincial-level administrative procedure information system), by postal service, or by direct submission to the competent state management authority;
b) Within 10 days from the date of receipt of a complete and valid dossier, the dossier-receiving authority shall be responsible for examining the dossier and sending the results in accordance with Form No. 11 in Appendix I promulgated together with this Decree. This period shall be calculated from the date of receipt seal of the dossier-receiving authority for dossiers submitted by postal service or by direct submission, or from the date on which the complete dossier is received on the online public service system.
Where the advertising content of the organization or individual is not accepted, or where amendment or supplementation of the dossier is required, the dossier-receiving authority must issue a written notice clearly stating the reasons and legal grounds.
Within 60 days from the date of receipt of the written request for amendment or supplementation from the dossier-receiving authority, the organization or individual shall complete and submit the amended or supplemented dossier. Each organization or individual may amend or supplement the dossier no more than two (02) times. Upon expiry of this amendment or supplementation period, the dossier shall no longer be valid. The dossier-receiving authority may request amendment or supplementation no more than two (02) times for each dossier.
Within 10 days from the date of receipt of the amended or supplemented dossier, the dossier-receiving authority shall appraise the dossier and issue the Certificate of confirmation of advertising content or issue a written response;
c) Dossier-receiving authorities shall publicly disclose the names and confirmed advertising contents of food products of organizations or individuals granted the Certificate of confirmation of advertising content on electronic information portals of dossier-receiving authorities and in the food safety database;
d) Organizations or individuals registering for confirmation of advertising content shall be responsible for paying dossier appraisal fees to the dossier-receiving authority.
6. Organizations or individuals having products to be advertised; organizations or individuals disseminating advertisements, may only advertise products that have been granted the Certificate of confirmation of advertising content and may only advertise in accordance with the confirmed content. When conducting business or advertising food products subject to registration for confirmation of advertising content on e-commerce platforms, websites, social networks, online applications, or digital platforms connected to the Internet in Vietnam, organizations or individuals shall publicly disclose the Certificate of confirmation of advertising content together with the advertising content confirmed by the competent authority.
7. Cases in which advertising is prohibited:
a) The Receipt of registration of the product declaration has been revoked;
b) During the period in which the product is suspended from circulation pursuant to a decision of a competent authority.
Chapter VIII
FOOD TESTING FOR THE PURPOSE OF STATE MANAGEMENT
Article 35. Conditions applicable to food testing establishments serving state management and verification testing establishments
1. Food testing establishments serving state management shall comply with the following conditions:
a) Have been granted a Certificate of registration for testing activities in accordance with regulations on business conditions for conformity assessment services, including testing fields consistent with the scope of registration for designation or with the testing criteria in the lists promulgated by the Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade, and the Ministry of Science and Technology;
b) Quality management system has been accredited as conforming to ISO/IEC 17025 in the field of food testing and examination;
c) Equipment and facilities are suitable for testing requirements and the scope of registration for designation;
d) Have at least 02 analysts or testing personnel who are technical staff holding bachelor’s degrees relevant to the registered scope for designation, who have been trained and have at least 03 years of practical experience in testing and examination in the same field;
dd) Testing and examination methods are updated and validated for usability, the capacity for testing the registered criteria for designation meets the relevant regulations or corresponding technical regulations and other related requirements as prescribed by Line ministry;
e) Conduct proficiency testing or interlaboratory comparisons for testing and examination methods registered for designation and achieve satisfactory results.
For testing and examination methods for which there is no proficiency testing provider or for which interlaboratory comparisons cannot be conducted due to the absence of domestic testing and examination establishments, complete method documentation, method validation records, and reference standards or reference strains or reference materials shall be available.
2. Verification testing establishments shall be included in the list of verification testing establishments eligible for operation published by the Minister of Line ministry (except the Ministry of Industry and Trade).
Verification testing establishments shall comply with the following conditions:
a) Be state-owned testing establishments;
b) Have been designated as food testing establishments serving state management.
Where a dispute arises pursuant to Clause 1 Article 47 of the Law on Food Safety, the competent dispute resolution authority shall select a verification testing establishment from the list of eligible verification testing establishments to be designated to conduct verification testing.
Article 36. Dossiers for registration for designation of food testing establishments serving state management
1. The dossier for registration for designation shall include:
a) Application for registration for designation of a food testing establishment serving state management in accordance with Form No. 16 in Appendix I promulgated together with this Decree;
b) Procedures and reports on validation of testing and examination methods for the registered criteria for designation, and procedures for sample receipt and issuance of testing results (copies);
c) Capacity dossier, including: the Capacity report of the testing establishment in accordance with Form No. 17 in Appendix I promulgated together with this Decree; supporting documents on assurance of testing and examination quality (copies),: results of proficiency testing or interlaboratory comparisons, or dossiers of reference standards or reference strains or reference materials for quality control of testing and examination for methods for which there is no proficiency testing provider or interlaboratory comparisons cannot be conducted; and a report on results of skills proficiency assessment of analysts or testing personnel for the registered criteria for designation.
2. The dossier for registration for change or supplementation of the designated scope shall include:
a) Application for registration for change or supplementation of the designated scope of the food testing establishment serving state management in accordance with Form No. 16 in Appendix I promulgated together with this Decree;
b) Procedures and reports on validation of testing and examination methods for the criteria registered for change or supplementation of the designated scope (copies);
c) Capacity dossier, including: the Capacity report of the testing establishment in accordance with Form No. 17 in Appendix I promulgated together with this Decree; supporting documents on assurance of testing and examination quality for the changed or supplemented designated scope (copies), including: results of proficiency testing or interlaboratory comparisons, or dossiers of reference standards or reference strains or reference materials for quality control of testing and examination for methods for which there is no proficiency testing provider or interlaboratory comparisons cannot be conducted; and a report on results of skills proficiency assessment of analysts or testing personnel for the criteria registered for change or supplementation.
3. Dossier for registration for extension of designation:
The dossier for registration for extension of designation shall apply where the scope registered for extension is consistent with the scope designated under the issued Decision, and shall include:
a) Application for registration for extension of designation of the food testing establishment serving state management in accordance with Form No. 16 in Appendix I promulgated together with this Decree;
b) Report on operational results of the testing establishment during the designation period in accordance with Form No. 18 in Appendix I promulgated together with this Decree.
Article 37. Order and procedures for designation
1. The testing establishment shall submit 01 dossier via the online public service system, by postal service, or by direct submission to the competent state management authority in accordance with decentralization (hereinafter referred to as the designating authority) of the provincial-level People’s Committee of the locality where testing and examination activities are conducted.
For registration for extension of designation, the testing establishment shall submit the dossier 90 days prior to the expiry of the designation Decision.
2. Period for dossier review by the designating authority pursuant to Article 36 of this Decree are as follows:
a) Within 10 days for dossiers with a maximum of 20 criteria registered for designation;
b) Within 20 days for dossiers with from 21 up to a maximum of 50 criteria registered for designation;
c) Within 30 days for dossiers with more than 50 criteria registered for designation.
Where the dossier is incomplete or invalid, the designating authority shall request the testing establishment, in writing, to amend or supplement the dossier and may request such amendment or supplementation only once. Within 30 days from the date of receipt of the written request for amendment or supplementation, the testing establishment shall complete and submit the amended or supplemented dossier. The testing establishment may amend or supplement no more than once. Upon expiry of this amendment or supplementation period, the dossier of the testing establishment shall no longer be valid. Within 10 days from the date of receipt of the amended or supplemented dossier, the designating authority shall review the dossier. Where the dossier fails to meet the requirements, the designating authority shall notify the dossier review result, clearly stating the reasons.
3. Where the dossier meets the requirements, within a maximum period of 20 days, the designating authority shall issue a decision establishing an assessment team and organize an on-site assessment of actual capacity at the testing establishment. Depending on the proposed scope of designation, the assessment team shall consist of 05 to 09 members with professional knowledge in the field of food testing and examination.
The decision establishing the assessment team shall clearly specify the scope, contents of the assessment, the list of members, and the assignment of responsibilities of each member conducting the on-site assessment at the testing establishment, in which the minimum on-site assessment contents shall include:
a) The testing establishment’s compliance with the conditions specified in Article 35 of this Decree and relevant legal provisions;
b) The authenticity of the dossier for registration for designation.
The assessment record of the testing establishment shall be made in accordance with Form No. 19 in Appendix I promulgated together with this Decree.
4. Within 15 days from the date of receipt of the assessment record of the testing establishment:
a) Where the conclusion is that the testing establishment meets the requirements as prescribed, the designating authority shall issue the Decision designating the food testing establishment serving state management;
b) Where the conclusion is that the testing establishment fails to meet the prescribed requirements, the designating authority shall issue a written refusal of designation;
c) Where the assessment record concludes that the testing establishment has not yet met the prescribed requirements and recommends that the testing establishment take remedial measures, within 60 days from the date of receipt of the remedial action request, the testing establishment shall submit a report on remedial action results to the designating authority in accordance with Form No. 20 in Appendix I promulgated together with this Decree.
Within 30 days from the date of receipt of the remedial action results report, where the testing establishment satisfies the prescribed requirements, the designating authority shall issue the Decision designating the food testing establishment serving state management. In case of refusal of designation, the designating authority shall notify the reasons in writing to the testing establishment.
5. The designating authority shall issue the Decision designating the food testing establishment serving state management in accordance with Form No. 21 in Appendix I promulgated together with this Decree, and concurrently issue and manage identification codes for food testing establishments serving state management. The designation Decision shall be valid for 03 years from the date of signing for promulgation.
Article 38. Assignment of testing for state management purposes and verification testing
1. For criteria that have not yet been designated for state management purposes, where a need arises for testing of such criteria in service of state management, provincial-level People’s Committees, Line ministries shall select a designated testing establishment to assign testing tasks meeting management requirements.
2. Where a need arises for verification testing but verification testing establishments in the list of eligible verification testing establishments are unable to perform as required, the dispute resolution authority shall propose that Line ministry (except the Ministry of Industry and Trade) select and assign a testing establishment to perform verification testing tasks.
Article 39. Issuance of identification codes for testing establishments
The designating authority shall be responsible for issuing and managing identification codes for food testing establishments serving state management. The identification code of a food testing establishment serving state management shall be structured as follows:
(serial number)/(code of the provincial-level People’s Committee)-KNTP-classification code by management sector (if any)
Article 40. Responsibilities of designating authorities and food testing establishments serving state management
1. Responsibilities of the designating authority:
a) To receive dossiers for initial designation registration, extension of designation registration, and registration for change or supplementation of the designated scope of food testing establishments serving state management; to organize assessment and designation of testing establishments;
b) To inspect food testing establishments serving state management in accordance with the law;
c) To ensure objectivity and fairness in assessment, designation, examination, inspection activities;
d) To keep confidential information and data related to testing establishments and verification testing establishments;
dd) To issue, suspend, reinstate, revoke, or partially or fully suspend the validity of designation Decisions. After the food testing establishment serving state management completes and reports remedial actions as required, the designating authority shall review reinstatement of the designation Decision;
e) To publish the list of designated testing establishments and the lists of suspension, reinstatement, revocation, and suspension of validity together with the corresponding designated scopes, suspended scopes, reinstated scopes, revoked scopes, or suspended scopes of validity;
g) To organize inspections and settle complaints and denunciations related to food testing establishments serving state management in accordance with the law;
h) To archive dossiers of food testing establishments serving state management;
i) To collect and use assessment and designation fees for testing establishments in accordance with the law on fees.
2. Responsibilities of food testing establishments serving state management:
a) To bear legal responsibility for testing results;
b) To ensure that the Certificate of registration for testing activity fields and the Decision/Certificate of accreditation of laboratory competence meeting ISO/IEC 17025 requirements remain valid throughout the designation period;
c) To comply with the requirements of the quality management system accredited as conforming to ISO/IEC 17025; to maintain and comply with procedures within the designated scope;
d) To notify the designating authority of any changes to the accredited quality management system and any reduction of the designated scope within 05 working days from the date changes occur;
dd) To notify the designating authority of supervision results of the accreditation body and results of participation in proficiency testing programs or interlaboratory comparisons (no later than 03 working days from the date the testing establishment receives the results);
e) To submit periodic reports, ad hoc reports, or thematic reports to the designating authority:
The periodic operational results report of the testing establishment shall be made in accordance with Form No. 18 in Appendix I promulgated together with this Decree. The report shall be submitted no later than December 20 each year.
Ad hoc reports or thematic reports: as requested by the designating authority;
g) In addition to the above provisions, the testing establishment shall also: pay testing establishment appraisal fees in accordance with the law on fees; ensure honesty, objectivity, and accuracy of testing results; ensure that testing result sheets contain full information pursuant to Form No. 22 in Appendix I promulgated together with this Decree; be subject to inspection and examination of testing activities upon request by competent state management authorities;
h) To perform other obligations of conformity assessment organizations as prescribed by the Law on Standards and Technical Regulations.
Article 41. Cases of partial or full expiry of validity of designation decisions
The designating authority shall notify the partial or full expiry of validity of the designation decision in the following cases:
1. Dissolution, revocation of legal entity status by a competent authority, or no longer having functions, tasks, or powers related to food testing pursuant to a decision of a competent authority.
2. At the request of the food testing establishment serving state management.
Chapter IX
FOOD TRACEABILITY
Article 42. Traceability of unsafe products
When discovering that food products manufactured or traded by themselves are unsafe, or upon request by a competent state authority, organizations or individuals manufacturing or trading products shall be responsible for carrying out traceability in accordance with Clauses 1 and 2 Article 54 of the Law on Food Safety.
Article 43. Implementation of traceability for unsafe products
1. Organizations or individuals manufacturing or trading products shall regularly establish and fully retain information related to products, raw materials, semi-finished products, manufacturing establishments, suppliers of input materials, suppliers, distributors, traders of products, and customers in cases where customers have purchased such products through contracts, accounting books, records, or other methods throughout the processes of production, processing, preservation, transportation, export, import, and trading, for the purpose of traceability, which shall be stored in the form of databases and connected to the database systems of competent state authorities. Information serving traceability shall include:
a) Information on production and business activities of food manufacturing and trading establishments;
b) Product information, including name, images, brand, trademark, code symbols, product serial numbers, types, quantities, weights, lot numbers, batch numbers, expiry dates, packaging, additives, applied standards and technical regulations, information on raw materials and semi-finished products, testing certification, time and place of production and trading of products, and other related information;
c) Information on organizations or individuals supplying, distributing, and trading products, and customers (if any).
2. The Minister of Health, the Minister of Agriculture and Environment, and the Minister of Industry and Trade shall prescribe traceability requirements for products within assigned management sectors and the roadmap for implementation.
Chapter X
ALLOCATION OF STATE MANAGEMENT RESPONSIBILITIES FOR FOOD SAFETY
Article 44. Principles for allocation of state management responsibilities for food safety
1. Based on the provisions of the Law on Food Safety and ensuring conformity with relevant legal documents;
2. Based on unified state management of food safety;
3. Ensuring management throughout the entire process of food production and trading;
4. Ensuring close coordination among ministries and sectors;
5. Ensuring the principle of one-stop management, whereby one product and one manufacturing or trading establishment are subject to management by only one state management authority;
6. Ensuring scientific, comprehensive, and feasible management;
7. Decentralizing state management between the central level and local authorities at all levels in food safety management;
8. For establishments producing multiple types of food products under the management authority of two or more specialized state management agencies, the agency managing the product with the largest output shall be the managing authority;
9. For establishments that do not conduct production activities but trade multiple types of food products under the management authority of two or more specialized state management agencies managed by the Ministry of Industry and Trade, except for wholesale markets and agricultural product auction centers;
10. For establishments that both manufacture and trade multiple types of food products under the management authority of two or more specialized state management agencies, organizations or individuals shall have the right to choose the specialized food safety management authority to carry out administrative procedures.
Article 45. State management responsibilities for food safety of the Ministry of Health
1. To perform the provisions on general responsibilities for state management of food safety pursuant to Clause 1 Article 62 of the Law on Food Safety;
2. To submit periodic and ad hoc reports to the Government on food safety management, based on monitoring and consolidation of reports from Line ministries and provincial-level People’s Committees;
3. To promulgate national technical regulations for products within the assigned management sectors pursuant to Article 62 of the Law on Food Safety and product groups listed in Appendix II promulgated together with this Decree; to promulgate national technical regulations or regulations on food safety limit levels after receiving complete dossiers of draft national technical regulations or draft regulations on food safety limit levels from the Ministry of Agriculture and Environment and the Ministry of Industry and Trade;
4. To manage and decentralize food safety management throughout the processes of production, processing, preservation, transportation, export, import, trading, and manufacturing and trading establishments regarding food products specified in Appendix II promulgated together with this Decree;
5. To organize the receipt and management of dossiers, and to issue and revoke Certificates of eligibility of establishment for food safety conditions meeting GMP requirements for health protection foods; and Certificates of confirmation of advertising content for health protection foods;
6. To promulgate the list of verification testing establishments within the assigned management scope;
7. To inspect and handle violations of food safety law during production, export, import, and trading of food products within the assigned management scope;
8. To inspect, supervise, and handle violations related to advertising of products, goods, and services within the assigned management scope;
9. To annually develop and implement periodic inspection plans; to conduct ad hoc inspections when required for sectors within the assigned management scope.
Article 46. State management responsibilities for food safety of the Ministry of Agriculture and Environment
1. To promulgate national technical regulations for products and product groups within the assigned management scope pursuant to Article 63 of the Law on Food Safety and Appendix III promulgated together with this Decree (except for packaging and utensils in direct contact with food, which are promulgated by the Ministry of Health).
2. To formulate and submit to the Ministry of Health regulations on safety limit levels applicable to the product groups specified in Appendix III promulgated together with this Decree.
3. To manage and inspect the implementation of decentralized food safety management throughout the entire process from primary production (cultivation, animal husbandry, harvesting, fishing, extraction), collection, slaughtering, preliminary processing, processing, preservation, transportation, export, import, and trading of cereals, meat and meat products, aquatic products and aquatic product derivatives, vegetables, tubers, fruits and vegetable, tuber and fruit products, eggs and egg products, raw fresh milk, honey and honey products, genetically modified foods, salt and salt products, and other product groups specified in Appendix III promulgated together with this Decree.
4. To organize the assignment of tasks to state inspection authorities for imported food safety regarding products and product groups within the assigned management scope in accordance with this Decree.
5. To organize decentralization of management and to prescribe dossiers and procedures for issuance of relevant certificates for food products within the export management scope, in cases where required by importing countries, in accordance with Article 42 of the Law on Food Safety and this Decree;
To manage and inspect the implementation of decentralization regarding the issuance of relevant certificates for exported food products within the assigned management scope in cases where required by importing countries, in accordance with Article 42 of the Law on Food Safety and this Decree.
6. To promulgate the list of verification testing establishments within the assigned management scope.
7. To publish the list of countries and territories and the list of production and business establishments permitted to export into Vietnam within the assigned management scope.
8. To inspect and handle violations of food safety law during the processes of production, export, import, and trading of food products within the assigned management scope.
9. To annually develop and implement periodic inspection plans; to conduct ad hoc inspections when required, for sectors within the assigned management scope.
10. To organize the issuance and decentralization of issuance of Certificates of eligibility of establishment for food safety conditions to organizations and individuals producing and trading products within the assigned management scope.
Article 47. State management responsibilities for food safety of the Ministry of Industry and Trade
1. To promulgate national technical regulations for products and product groups within the assigned management scope pursuant to Article 64 of the Law on Food Safety and Appendix IV promulgated together with this Decree.
2. To formulate and submit to the Ministry of Health regulations on safety limit levels applicable to the product groups specified in Appendix IV promulgated together with this Decree.
3. To provide guidance on traceability implementation; to develop and operate traceability systems for food products within the management scope of the Ministry of Industry and Trade.
4. To manage and decentralize food safety management throughout the entire process of production, processing, preservation, transportation, export, import, and trading of products and manufacturing and trading establishments for food products specified in Appendix IV promulgated together with this Decree.
5. To manage food safety for supermarkets, commercial centers, convenience stores, establishments within reserve and distribution systems, and other forms of business. To inspect, review, and supervise food trading activities on e-commerce platforms; and to promptly detect and handle violations and remove infringing content in accordance with regulations.
6. To organize the issuance and decentralization of issuance of Certificates of eligibility of establishment for food safety conditions to organizations and individuals producing and trading products within the assigned management scope.
7. To conduct inspection and prevention of counterfeit food and trade fraud in the market for all types of food, food additives, processing aids, utensils, and packaging and containment materials for food.
8. To inspect and handle violations of food safety law during the processes of production, export, import, and trading of food products within the assigned management scope. To inspect and handle violations in the production and trading of counterfeit goods, prohibited goods, smuggled goods, trade fraud, and food products on e-commerce platforms.
9. To annually develop and implement periodic inspection plans; to conduct ad hoc inspections when required, for sectors within the assigned management scope.
Article 48. State management responsibilities for food safety of the Ministry of Finance
To be responsible for promptly providing the Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade, and provincial-level People’s Committees with the following information concerning enterprises engaged in food production and trading:
1. Indications of abnormal fluctuations in revenue;
2. Changes in business operation locations of enterprises;
3. Enterprises that suspend business operations, temporarily suspend business operations, or are dissolved;
4. Information related to imported consignments of products exempt from state food safety inspection, upon request by Line ministries;
5. Information related to the quantity, value of exported and imported consignments on an annual basis or upon ad hoc request by Line ministries;
6. Information related to exported and imported consignments showing signs of food safety violations detected during state customs inspection.
Article 49. State management responsibilities for food safety of the Ministry of Science and Technology
1. To periodically and annually promulgate plans for development of national standards (TCVN) for food products based on proposals from the Ministry of Health, the Ministry of Agriculture and Environment, and the Ministry of Industry and Trade;
2. To inspect and supervise the activities of organizations that have registered for accreditation of testing laboratories in accordance with ISO/IEC 17025.
Article 50. State management responsibilities for food safety of the Ministry of Culture, Sports and Tourism
1. To coordinate with the Ministry of Health, the Ministry of Agriculture and Environment, the Ministry of Industry and Trade, and provincial-level People’s Committees in inspecting and handling violations related to food advertising activities in advertising media in accordance with the law on advertising;
2. To prevent and remove unlawful food advertisements in accordance with handling procedures prescribed in legal normative documents in the field of advertising.
Article 51. State management responsibilities for food safety of provincial-level People’s Committees
1. To perform state management of food safety within the locality and bear responsibility before the Government for food safety in the locality. The Chairperson of the provincial-level People’s Committee shall directly serve as Head of the provincial or centrally governed city inter-sectoral steering committee on food safety; proactively to organize inspection and supervisory forces to ensure food safety within the locality; directly to direct and regularly urge and inspect compliance with food safety law by subordinate state authorities; to handle officials and civil servants who are irresponsible or lax in management within the assigned management scope; to organize the settlement of complaints and denunciations and handle violations of food safety law in accordance with law; and to bear responsibility before the Government and before the law where food safety violations occur within the locality.
2. To organize the implementation of regulations of the Government and line ministries on food safety within the locality.
3. To organize and operate the provincial or centrally governed city inter-sectoral steering committee on food safety.
4. To organize dissemination and advocacy for implementation of legal provisions on ensuring food safety within the locality; to encourage participation in assessment by industry associations, socio-political organizations, organizations, individuals, and citizens, to promptly reflect violations related to food safety within the locality.
5. To allocate resources to specialized agencies to perform state management of food safety.
6. To take responsibility for food safety management within the locality; to manage food safety conditions for small-scale food manufacturing and trading establishments, street food vendors, catering service establishments, food safety in markets within the locality, and other entities in accordance with decentralized management.
7. To manage food safety conditions for establishments manufacturing and trading packaging and utensils in direct contact with food; water and ice used in agricultural, forestry, and fishery production and trading; and to manage food safety for wholesale markets and agricultural product auction centers.
8. To formulate and promulgate local technical regulations on food safety for food products specific to the locality.
9. To organize, decentralize, and assign the following tasks:
a) Receipt and management of dossiers, issuance and revocation of Certificates of confirmation of advertising content for foods for special medical purposes, foods for special dietary uses, nutritional products for children up to 36 months of age, and supplemented foods (except for supplemented foods containing only vitamins and minerals and bearing no health claims);
b) Receipt of conformity declaration dossiers; issuance and revocation of Certificates of eligibility of establishment for food safety conditions (except for Certificates of eligibility of establishment for food safety conditions meeting GMP requirements for health protection foods);
c) Issuance, supplementation, amendment, re-issuance, and revocation of Certificates of Free Sale (CFS), Health Certificates, and other relevant certificates for exported food products as required by importing countries and in accordance with assigned responsibilities and decentralization;
d) Issuance, suspension, reinstatement, revocation, and partial or full suspension of validity of Decisions designating food testing establishments serving state management for quality and food safety;
dd) Assignment of tasks, suspension, and revocation of decisions assigning tasks to state food safety inspection authorities for imported food, in accordance with decentralization by the Ministers of Health, Industry and Trade, and organization of inspection of the implementation by assigned authorities.
10. To inspect, supervise, and handle violations related to advertising of products, goods, and services within the assigned management scope.
11. To direct dossier-receiving authorities for conformity declarations to formulate and implement plans for post-declaration dossier inspection after organizations and individuals have made declarations, where declared dossiers are found to be non-compliant, to handle violations in accordance with law. Based on allocated local budgets, annually to formulate inspection plans and allocate funding for sampling and monitoring of quality and safety indicators for declared products circulating on the market, focusing on product groups used by high-risk populations such as children, the elderly, pregnant women, and patients. Based on monitoring results, to conduct inspections at manufacturing and trading establishments and handle violations in accordance with law where detected.
12. To promptly provide information on the list of testing organizations registered to conduct testing of food products whose certificates of registration for testing activities have been granted, suspended, revoked, or which have been subject to violation handling, to the line ministries.
13. To organize the implementation of the receipt of price declarations, update declared price information in the price database, use declared prices for the purposes of aggregation, analysis, and forecasting of market prices in accordance with regulations; to organize the inspection of compliance with the law on price declaration with respect to food products assigned for management under the Law on Prices and the Government’s Decree No. 85/2024/ND-CP dated July 10, 2024 detailing the implementation of a number of articles of the Law on Prices.
14. To inspect and supervise the operations of testing facilities serving state management of food safety; state inspection authorities for imported food; and testing organizations that have registered to conduct testing of food products; to inspect and supervise the operations of conformity assessment bodies that have registered to certify Hazard Analysis and Critical Control Points (HACCP) systems; ISO/IEC 17025 standards; International Featured Standards (IFS); British Retail Consortium (BRC) Global Standards for Food Safety; Food Safety System Certification (FSSC), or equivalent standards in Vietnam.
15. To annually develop and implement periodic inspection plans; to conduct ad hoc inspections when required, for sectors within the assigned management scope.
Article 52. Coordination in activities to ensure food safety
1. Line ministries, within their state management scope, shall be responsible for coordinating with the Ministry of Health in carrying out state management activities to ensure unified and effective state management of food safety.
2. The Ministry of Health shall take the lead in developing the information, education and communication program on food safety; the Ministry of Agriculture and Environment, the Ministry of Industry and Trade, and other ministries and sectors, according to functions and tasks, shall be responsible for coordinating with the Ministry of Health in implementing the information, education and communication program on food safety.
3. The Ministry of Health, the Ministry of Agriculture and Environment, and the Ministry of Industry and Trade shall be responsible for taking the lead in developing programs and plans and implementing inspection and examination activities for products within assigned management sectors, other ministries and sectors shall be responsible for coordination.
4. When food poisoning occurs, the Ministry of Health shall be responsible for organizing prompt emergency aid and treatment for persons suffering from food poisoning. Line ministry shall be responsible for providing full dossiers and information related to the origin of food suspected of causing poisoning within its assigned management sector; coordinating with the Ministry of Health in investigating the causes, and taking the lead in traceability and handling of food causing poisoning within its assigned management sector.
5. Where products within the assigned management sector of another ministry or sector are detected as violating regulations and posing a risk of seriously affecting consumers’ health, the Ministry of Health shall take the lead, and coordinate with Line ministries in conducting inspection and examination and issuing conclusions.
6. Where acts infringing civil rights of subjects in vulnerable groups or public interests are detected, agencies, organizations, and individuals, shall act in accordance with the law on initiation of lawsuits and the filing of civil cases to protect the civil rights of subjects in vulnerable groups or to protect public interests.
7. The Ministries of Health, Agriculture and Environment, Industry and Trade, Finance, and provincial-level People’s Committees shall be responsible for completing the connection and data sharing with the National Public Service Portal or the National Single Window Information Portal to resolve administrative procedures, manage food safety, and unify food safety management from the central level to the local level.
8. The Ministries of Health, Agriculture and Environment, Industry and Trade, Science and Technology, and provincial-level People’s Committees, according to their functions and tasks, shall be responsible for reviewing, updating, and promptly amending and supplementing national technical regulations (QCVN), local technical regulations (QCDP), and national standards (TCVN) in the field of food quality and safety.
9. Owners of e-commerce trading platforms and applications providing e-commerce services (including food delivery applications) shall have the responsibility to:
a) Establish moderation mechanisms, require sellers to provide and publicly disclose legal documents for products in accordance with regulations;
b) Cooperate with state management authorities and promptly remove violating products upon request;
c) Bear joint responsibility in cases where they fail to implement necessary moderation measures, resulting in food safety incidents causing damage to consumers.
10. Organizations and individuals manufacturing and trading food shall be responsible for updating information on risk warnings for products and for voluntarily recalling products upon detecting risks affecting consumers’ health.
Chapter XI
IMPLEMENTATION PROVISIONS
Article 53. Effect
1. This Decree takes effect from the date of signing for promulgation.
2. The Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 detailing the implementation of a number of articles of the Law on Food Safety shall cease to be effective from the effective date of this Decree.
3. The following provisions shall be annulled:
a) Clause 1 Article 24b of the Government’s Decree No. 77/2016/ND-CP dated July 01, 2016 amending and supplementing a number of provisions on investment and business conditions in the fields of international goods trading, chemicals, industrial explosives, fertilizers, gas trading, and food trading under the state management of the Ministry of Industry and Trade, as supplemented under Article 13 of the Government’s Decree No. 17/2020/ND-CP dated February 05, 2020 amending and supplementing a number of articles of Decrees concerning business investment conditions under the state management 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 some articles related to business conditions under state management of the Ministry of Health;
c) Article 29 of the Government’s Decree No. 136/2025/ND-CP dated June 12, 2025 providing for delegation of powers and decentralization in the field of agriculture and environment;
d) Clause 3 Article 37; provisions on procedures for designation of testing establishments serving state management in Sections I, II, and III and procedures for designation of verification testing in Sections IV, V, and VI of Appendix XI promulgated together with the Government’s Decree No. 146/2025/ND-CP dated June 12, 2025 on the delegation of powers and decentralization in the field of industry and trade;
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 providing for delegation and decentralization of authority in the health sector.
4. Where the referenced documents in this Decree are amended, supplemented, or replaced, the amended, supplemented, or replaced documents shall apply accordingly.
Article 54. Transitional provisions
1. For products that have been self-declared before the effective date of this Decree, organizations and individuals may continue to manufacture, trade, and import products until completion of the registration of the conformity declaration. Organizations and individuals shall be responsible for completing the registration of the conformity declaration in accordance with this Decree within 12 months from the effective date of this Decree.
2. For establishments producing foods for special medical purposes, foods for special dietary uses, supplemented foods, and nutritional products for children up to 36 months of age, it shall be required to apply a Hazard Analysis and Critical Control Points (HACCP) certification, or an ISO 22000 food safety management system, or International Featured Standards (IFS), or the Global Standard for Food Safety (BRC), or Food Safety System Certification (FSSC 22000), or an equivalent certification, or a Certificate of eligibility of establishment for food safety conditions meeting GMP requirements in production and trading activities from December 31, 2026.
3. Dossiers for registration for designation, dossiers for registration for change or supplementation of the designated scope, and dossiers for registration for extension of designation of food testing establishments serving state management that were submitted before the effective date of this Decree shall continue to be processed in accordance with the regulations effective at the time of dossier submission; except where organizations or individuals voluntarily apply the provisions of this Decree.
4. Decisions designating food testing establishments serving state management, and decisions promulgating the list of verification testing establishments eligible for operation that were issued before the effective date of this Decree shall remain effective until expiry as specified in Decisions.
5. Decisions assigning or designating state inspection authorities for imported food by Line ministries that were issued before the effective date of this Decree shall remain effective until March 31, 2026.
6. Establishments that have been granted one of the following certificates Good Manufacturing Practice (GMP), Hazard Analysis and Critical Control Points (HACCP), ISO 22000 food safety management system, International Featured Standards (IFS), the Global Standard for Food Safety (BRC), Food Safety System Certification (FSSC 22000), or equivalent that remains valid and that are not subject to issuance of a Certificate of eligibility of establishment for food safety conditions shall be required to obtain a Certificate of eligibility of establishment for food safety conditions within 12 months from the effective date of this Decree, except for manufacturing establishments that have been granted a valid Certificate of eligibility of establishment for food safety conditions meeting Good Manufacturing Practice (GMP) requirements for health protection foods
Article 55. Implementation responsibilities
Ministers, heads of ministerial-level agencies, heads of Government-attached agencies, Chairpersons of provincial-level People’s Committees, and relevant organizations and individuals shall be responsible for implementing this Decree.
| ON BEHALF OF THE GOVERNMENT FOR THE PRIME MINISTER DEPUTY PRIME MINISTER
Le Thanh Long |
VIETNAMESE DOCUMENTS
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