Decree No. 15/2018/NĐ-CP provides detailed regulations for implementation of certain provisions of the Food Safety Law.

 

DECREE

Detailed regulations on implementation of certain provisions of the Law on Food Safety

Pursuant to the Law on Government Organization dated June 19, 2015;

Pursuant to the Food Safety Law dated June 17, 2010;

At the proposal of the Minister of Health;

The Government promulgates this Decree to provide detailed regulations on implementation of certain provisions of the Law on Food Safety.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Decree provides detailed regulations on implementation of certain provisions of the Law on Food Safety regarding:

1. Procedures for self-declaration of products.

2. Procedures for registration of product declarations.

3. Ensuring food safety of genetically modified foods.

4. Issuance of Certificates of Food Safety Conditions for establishments.

5. State inspection of imported and exported food safety.

6. Food labeling.

7. Food advertising.

8. Conditions for ensuring food safety in the production of health supplements.

9. Conditions for ensuring food safety in the production, business, and use of food additives.

10. Traceability of food origin.

11. Allocation of responsibilities for state management of food safety.

Article 2. Applicability

This Decree applies to agencies, organizations, and individuals in Vietnam; foreign organizations and individuals operating in Vietnam in the production, business, and import/export of food; and organizations and individuals engaged in activities related to food safety in Vietnam (hereinafter referred to collectively as organizations and individuals).

Article 3. Explanation of Terms

In this Decree, the following terms shall be understood as follows:

1. Health supplements (Dietary Supplements) are products used to supplement daily diets with the aim of maintaining, enhancing, or improving human body functions, reducing disease risk. Health supplements contain one or more of the following substances or their mixtures:

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

b) Substances of natural origin, including animal, mineral, and plant sources in the form of extracts, isolates, concentrates, and derivatives;

c) Synthetic sources of the components mentioned in points a and b above.

Health supplements are presented in processed forms such as capsules, tablets, powders, liquids, and other preparations, and are divided into small dosage units for consumption.

2. Medical nutrition products, also known as special medical purpose foods (Medical Foods), are foods that can be consumed orally or through feeding tubes, prescribed to adjust patients' diets, and used under the supervision of healthcare personnel.

3. Foods for special dietary uses, used for people on restricted diets, elderly persons, and other specific groups according to the Codex Alimentarius Commission's regulations, are foods prepared or mixed according to special formulas to meet specific dietary requirements based on physical condition or disease states and specific disorders of users. The composition of these foods must clearly differ from that of similar common foods.

4. Scientific evidence consists of scientific information and documents from research projects accepted by competent state authorities for scientific research or published in domestic and international scientific journals, or documents on traditional medicine, medicinal plants, and herbs published in scientific publications.

5. Shipper is an organization or individual responsible for goods in declaration/self-declaration documents of products or an organization or individual authorized to import or export food products.

6. Export/import items are food products of the same type, name, brand, production facility, and packaging material.

7. Export/import consignment is the entire batch of food products of one import or export shipment (with the same bill of lading number). A consignment may consist of one or multiple items.

8. Small-scale primary production facility is a household or individual facility for planting, breeding, harvesting, fishing, or extracting food raw materials at a family scale, with or without a business registration certificate.

9. Small-scale processing facility is a household or individual facility for processing food at a family scale, with or without a business registration certificate.

10. Small-scale food business facility is a facility operated by an individual, group of individuals, or a household registered as a business household and not granted a Business Registration Certificate, a Business Registration Certificate, or an Investment Certificate in accordance with the law.

Chapter II
PROCEDURES FOR SELF-DECLARATION OF PRODUCTS

Article 4. Self-declaration of products

1. Organizations and individuals producing and trading food shall self-declare processed packaged foods, food additives, food processing aids, food storage containers, and food packaging materials that come into direct contact with food (hereinafter referred to as products), except for products specified in Clause 2 of this Article and Article 6 of this Decree.

2. Products and raw materials solely used for export production or internal production of organizations and individuals not intended for domestic consumption are exempted from the product self-declaration procedure.

Article 5. Documents and procedures for self-declaration of products

1. The documents for self-declaration of products include:

a) A self-declaration form of the product according to Form No. 01 of Appendix I issued together with this Decree;

b) A certificate of food safety testing results of the product within twelve months from the date of submission, issued by a designated laboratory or an ISO 17025-accredited laboratory, including safety criteria established by the Ministry of Health based on risk management principles consistent with international regulations or safety criteria according to relevant standards published by organizations and individuals when there are no regulations by the Ministry of Health (original or certified copy).

2. The self-declaration of products shall be carried out in the following sequence:

a) Organizations and individuals declare their products through mass media or their own electronic websites or publicly post them at their headquarters and submit one (1) copy via postal service or directly to the competent state management agency designated by the provincial People's Committee (hereinafter referred to as the provincial People's Committee);

b) Immediately after self-declaring the product, organizations and individuals have the right to produce and trade the product and bear full responsibility for its safety;

c) The competent state management agency receives the self-declaration documents of organizations and individuals for record keeping and publishes the names of organizations and individuals and the names of self-declared products on its electronic information website.

In cases where an organization or individual has two (2) or more production facilities producing the same product, the organization or individual only needs to submit the documents to one state management agency in the locality where the production facility is located, chosen by the organization or individual. Once a state management agency is selected for document submission, subsequent self-declarations must be submitted to the previously chosen agency.

3. All documents in the self-declaration dossier must be in Vietnamese; if there are foreign language documents, they must be translated into Vietnamese and notarized. The documents must remain valid at the time of self-declaration.

4. If there is a change in the product name, origin, or composition, the organization or individual must re-declare the product. For other changes, the organization or individual must notify the competent state management agency in writing about the changes and may immediately produce and trade the product after submitting the notification.

Chapter III
PROCEDURE FOR REGISTERING THE SELF-DECLARATION OF PRODUCTS

Article 6. Registration of Product Declaration

Organizations and individuals producing and trading food must register the product declaration for the following products:

1. Health foods, medical nutrition foods, special diet foods.

2. Nutritional products for children up to 36 months old.

3. Mixed food additives with new functions, food additives not included in the list of permitted food additives or not suitable for the intended use as prescribed by the Ministry of Health.

Article 7. Documents for Registration of Product Declaration

1. The documents for registration of product declaration for imported products include:

a) The product declaration as specified in Model No. 02 of Appendix I issued together with this Decree;

b) A free sale certificate (Certificate of Free Sale) or export certificate (Certificate of Exportation) or health certificate (Health Certificate) issued by the competent authority of the exporting/exporting country containing contents ensuring safety for users or being sold freely in the market of the producing/exporting country (legalized consular);

c) Food safety testing result report of the product within 12 months from the date of submission issued by a designated laboratory or a laboratory recognized as compliant with ISO 17025 including safety criteria issued by the Ministry of Health according to risk management principles consistent with international regulations or safety criteria according to corresponding standards published by organizations or individuals when there is no regulation by the Ministry of Health (original or certified copy);

d) Scientific evidence proving the efficacy of the product or of the components that create the declared efficacy (original or certified copy confirmed by organizations or individuals). When using scientific evidence on the efficacy of the product's components to prove the efficacy of the product, the daily dose of the product must be at least 15% greater than the amount of the component mentioned in the documentation;

đ) Certificate of a facility meeting food safety conditions reaching Good Manufacturing Practice (GMP) requirements or equivalent certification in cases where imported products are health foods applicable from July 1, 2019 (original with confirmation by organizations or individuals).

2. The documents for registration of product declaration for domestically produced products include:

a) The product declaration as specified in Model No. 02 of Appendix I issued together with this Decree;

b) Food safety testing result report of the product within 12 months from the date of submission issued by a designated laboratory or a laboratory recognized as compliant with ISO 17025 including safety criteria issued by the Ministry of Health according to risk management principles consistent with international regulations or safety criteria according to corresponding standards published by organizations or individuals when there is no regulation by the Ministry of Health (original or certified copy);

c) Scientific evidence proving the efficacy of the product or of the components that create the declared efficacy (original or certified copy confirmed by organizations or individuals). When using scientific evidence on the efficacy of the product's components to prove the efficacy of the product, the daily dose of the product must be at least 15% greater than the amount of the component mentioned in the documentation;

d) Certificate of a facility meeting food safety conditions in cases where the facility falls under the category required to obtain a certificate of a facility meeting food safety conditions according to regulations (certified copy confirmed by organizations or individuals);

đ) Certificate of a facility meeting food safety conditions reaching Good Manufacturing Practice (GMP) requirements in cases where domestically produced products are health foods applicable from July 1, 2019 (certified copy confirmed by organizations or individuals).

3. All documents in the registration dossier of product declaration must be in Vietnamese; in cases where documents are in foreign languages, they must be translated into Vietnamese and notarized. The documents must remain valid at the time of submitting the registration dossier of product declaration.

Article 8. Procedures for registering product declaration forms

1. Organizations and individuals producing and trading food shall submit registration application files for product declaration forms through the online public service system, by postal service, or directly to the file receiving agency as follows:

a) Submit to the Ministry of Health for health supplements, mixed food additives with new functions, and food additives not included in the list of permitted food additives as prescribed by the Minister of Health;

b) Submit to the competent state management agency designated by the provincial People's Committee for medical nutrition foods, special diet foods, and nutritional products for children up to 36 months old;

c) In cases where organizations and individuals produce multiple types of food under the jurisdiction of both the Ministry of Health and the competent state management agency designated by the provincial People's Committee, such organizations and individuals have the right to choose to submit the application file to the Ministry of Health or to the agency responsible for receiving the application file for the relevant product.

In cases where organizations and individuals have two or more production facilities producing the same product, they only need to complete the product declaration form registration procedures at one local state management agency chosen by the organization or individual (except for products registered with the Ministry of Health). Once a state management agency is selected for registration, subsequent registrations must be made at the previously chosen agency.

2. Within seven working days from the date of receipt of the complete application file for the declaration of new function mixed food additives, food additives not included in the list of permitted food additives or not in accordance with the usage objects in food as prescribed by the Minister of Health, medical nutrition foods, special diet foods, and nutritional products for children up to 36 months old, and within twenty-one working days for health supplements, the agency receiving the application as stipulated in Clause 1 of this Article shall be responsible for reviewing the application file and issuing the Product Declaration Registration Receipt according to Model No. 03 Appendix I accompanying this Decree.

The review period for the application file starts from the date the file is submitted through the online public service system or the date the agency receives the file (in cases of submission via postal service or direct submission).

3. In cases where the agency receiving the application does not agree with the product declaration of the organization or individual or requests modifications or additions, the agency must provide a written explanation detailing the reasons and legal basis for the request. The agency receiving the application may only request modifications or additions once.

Within seven working days from the date of receipt of the modified and supplemented application file, the agency receiving the application shall review the file and issue a written response. If, ninety working days after the issuance of the request for modification and supplementation, the organization or individual has not made the necessary changes, the application file will lose its validity.

4. In cases where there are changes in the product name, origin, or composition, the organization or individual must re-declare the product. For other changes, the organization or individual must notify the agency receiving the application as stipulated in Clause 1 of this Article in writing about the changes and can immediately produce and trade the product after sending the notification.

5. The agency receiving the application for the registration of product declaration forms shall be responsible for publicly announcing the names and products of organizations and individuals whose applications have been accepted on their website and food safety database.

6. Organizations and individuals producing and trading products shall be responsible for paying the fees for the review of the application for the registration of product declaration forms in accordance with the laws on fees and charges.

Chapter IV
FOOD SAFETY FOR GENETICALLY MODIFIED FOODS

Article 9. Safeguarding safety for food containing components from genetically modified organisms (GMOs) and products derived from GMOs

The conditions, procedures, and steps for issuing, revoking the Certificate of Approval for GMOs fit for use as food, and the list of GMOs approved for use as food shall be carried out in accordance with the provisions of Government Decree No. 69/2010/NĐ-CP dated June 21, 2010 on biosafety for GMOs, genetic material, and products derived from GMOs, and Government Decree No. 108/2011/NĐ-CP dated November 30, 2011 amending certain articles of Government Decree No. 69/2010/NĐ-CP dated June 21, 2010 on biosafety for GMOs, genetic material, and products derived from GMOs.

Article 10. Labeling for goods containing GMOs, products derived from GMOs used as food

1. Organizations and individuals producing and trading food on the market containing GMOs, products derived from GMOs with at least one component of genetically modified raw materials exceeding 5% of the total raw materials used to produce the food must comply with the regulations of the law on labeling goods and also indicate information related to GMOs on the product label, except in cases provided for in Clause 2 of this Article.

2. Cases exempted from labeling for goods containing GMOs, products derived from GMOs used as food:

a) Genetically modified packaged foods containing genetically modified raw materials but where the gene or product of the modified gene cannot be detected in the food;

b) Fresh genetically modified foods, processed genetically modified foods not packaged and sold directly to consumers;

c) Genetically modified foods used in emergency situations to address natural disasters and epidemics.

Chapter V
ISSUANCE OF THE CERTIFICATE OF SATISFACTORY FOOD SAFETY CONDITIONS

 SATISFACTORY FOOD SAFETY CONDITIONS

Article 11. Issuance of the Certificate of Satisfactory Food Safety Conditions

1. Food production and business establishments must have the Certificate of Satisfactory Food Safety Conditions when operating, except in cases stipulated in Clause 1 of Article 12 of this Decree.

2. The conditions for issuing the Certificate of Satisfactory Food Safety Conditions shall be implemented according to the provisions of Clause 1 of Article 34 of the Food Safety Law. Specifically, for food production establishments that manufacture health supplements, they must comply with the requirements set forth in Article 28 of this Decree.

Article 12. Establishments Not Subject to Issuance of the Certificate of Satisfactory Food Safety Conditions

1. The following establishments are not subject to issuance of the Certificate of Satisfactory Food Safety Conditions:

a) Small-scale primary production;

b) Production and trade of food without a fixed location;

c) Small-scale processing;

d) Small-scale trade of food;

đ) Trade of pre-packaged food;

e) Production and trade of food packaging and containment materials;

g) Restaurants within hotels;

h) Collective kitchens without registration for food business operations;

i) Street food trade;

k) Establishments already holding one of the following Certificates: Good Manufacturing Practices (GMP), Hazard Analysis and Critical Control Points (HACCP) System, Food Safety Management System ISO 22000, International Food Standard (IFS), Global Food Safety Standard (BRC), Food Safety System Certification (FSSC 22000) or equivalent certificates still in effect.

2. Establishments specified in Clause 1 of this Article must comply with corresponding requirements for ensuring food safety conditions.

Chapter VI
INSPECTION AGENCY

ON IMPORT AND EXPORT FOOD SAFETY

Article 13. Cases Exempted from State Inspection for Food Safety of Imported Goods (excluding cases with food safety warnings)

1. Products that have been issued a Registration Acceptance Certificate for Product Declaration.

3. Goods imported for personal use by individuals entitled to diplomatic privileges and immunities.

4. Goods in transit, transshipment, through shipment, temporary import for re-export, or stored in bonded warehouses.

5. Samples for testing or research purposes in quantities appropriate to such purposes, confirmed by organizations or individuals.

6. Goods used for exhibition or display at trade fairs.

7. Raw materials or products imported solely for the production of goods for export or internal production not intended for domestic consumption.

8. Goods temporarily imported for sale in duty-free shops.

9. Goods imported to meet urgent needs as directed by the Government or the Prime Minister.

Article 14. Requirements for Imported Animal Products, Aquatic Animal Products, and Plant Products Used as Food

1. Imported animal products, aquatic animal products, and plant products used as food, excluding processed foods ready for packaging, foods exported by Vietnamese organizations or individuals to foreign countries but returned, and cases exempted under Article 13 of this Decree, must comply with the following requirements:

a) Originating from a country or region with a food safety control system meeting Vietnam's regulations and included in the list of countries and regions authorized to export food of animal, plant, or aquatic origin to Vietnam by the competent authority of Vietnam.

b) For animal products and aquatic animal products used as food: They must be produced by establishments recognized by the competent authority of Vietnam as fully complying with food safety requirements as stipulated by Vietnam.

c) Each consignment of imported animal or aquatic products must be accompanied by a certificate confirming compliance with food safety regulations issued by the competent authority of the exporting country (except for seafood caught and processed on foreign fishing vessels sold directly to Vietnam).

2. Procedures for registering countries, regions, and production and business establishments mentioned in Clause 1 of this Article into the export list to Vietnam shall be carried out according to the provisions of Article 22 of this Decree.

3. The Ministry of Agriculture and Rural Development is responsible for providing the customs authorities with a list of countries, regions, and organizations and individuals authorized to export these products to Vietnam.

Article 15. State Inspection Authority for Imported Foods

1. The state inspection authority for imported foods is an agency assigned or designated by the Ministry of Health, the Ministry of Agriculture and Rural Development, or the Ministry of Industry and Trade.

In the case where a single consignment contains multiple types of foods under the jurisdiction of different ministries, the state inspection authority shall be an agency assigned or designated by the Ministry of Agriculture and Rural Development.

2. The state inspection authority has the following rights and responsibilities:

a) To decide on switching the inspection method from regular inspection to reduced inspection and revert to regular inspection after three consecutive successful inspections of imported food.

b) To conduct inspections according to methods and procedures specified in this Decree.

c) To comply with sampling and sample retention regulations as stipulated by law.

d) To collect inspection and testing fees as prescribed by law on fees and charges.

đ) To ensure professional expertise, accuracy, honesty, and objectivity in inspecting and certifying the safety of imported consignments and products.

e) To be subject to direction, supervision, and guidance on organization and professional practices by the Ministry of Health, the Ministry of Agriculture and Rural Development, and the Ministry of Industry and Trade.

g) To accept and resolve complaints from consignees. If damage is caused to the consignee, the state inspection authority must refund all testing and inspection fees and compensate for losses (if any) as prescribed by law.

h) To store inspection records as required by law and provide them when requested by the competent authority.

i) To submit semi-annual reports to the relevant specialized management body according to Model No. 06 of Appendix I attached to this Decree or submit special reports upon warning from the Ministry of Health, the Ministry of Agriculture and Rural Development, the Ministry of Industry and Trade of Vietnam, or the competent authority abroad, or from the manufacturer, or report on the handling results of non-compliant imported food.

Article 16. Inspection Methods

Food safety inspection for imported goods shall be carried out according to one of the following methods:

1. Reduced inspection method, whereby up to 5% of total import consignments are randomly selected by customs authorities for file inspection within one year.

2. Normal inspection method, whereby only the file of the import consignment is inspected.

3. Strict inspection method, whereby file inspection is combined with sampling for testing.

Article 17. Application of Inspection Methods

1. The reduced inspection method shall apply to consignments and items under any of the following circumstances:

a) Confirmed to meet food safety requirements by the competent authority of the country that has signed reciprocal international agreements on food safety inspections, of which Vietnam is a member, and has the inspection results from the exporting country's competent authority for the consignment or item in compliance with Vietnamese law;

b) Have achieved three consecutive successful imports within twelve months through the normal inspection method;

c) Produced in facilities applying one of the quality management systems such as GMP, HACCP, ISO 22000, IFS, BRC, FSSC 22000, or equivalent.

2. The normal inspection method shall apply to all items of the imported consignment, except in cases stipulated in Clause 1 and Clause 3 of this Article.

3. The strict inspection method shall apply to consignments and items under any of the following circumstances:

a) The consignment or item did not meet import requirements at the previous inspection;

b) The consignment or item did not meet requirements during previous inspections (if any);

c) There is a warning from the Ministry of Health, the Ministry of Agriculture and Rural Development, the Ministry of Industry and Trade, the People's Committee of the province, or the competent authority abroad, or from the manufacturer.

4. Transition from the strict inspection method to the normal inspection method shall occur in the following cases:

a) For the cases stipulated in point a and b of Clause 3 of this Article, if after applying the strict inspection method for three consecutive times, the import requirements are met;

b) For the case stipulated in point c of Clause 3 of this Article, when there is a notification to stop strict inspections issued by the Ministry of Health, the Ministry of Agriculture and Rural Development, or the Ministry of Industry and Trade of Vietnam.

Article 18. Registration Documents for Inspection

1. The registration documents for reduced inspection include:

a) Declaration of self-certification of the product;

b) Three consecutive notifications confirming that the food meets import requirements through the normal inspection method, or certified copies or legalized original copies of one of the certificates of GMP, HACCP, ISO 22000, IFS, BRC, FSSC 22000, or equivalent still valid at the time of submission;

c) In the case of aquatic products and terrestrial animal products, excluding processed and pre-packaged products, a certificate confirming compliance with food safety regulations issued by the competent authority of the exporting country (original copy) must be provided.

2. The registration documents for normal inspection and strict inspection include:

a) Food Import Inspection Registration Certificate as prescribed in Form No. 04 of Appendix I accompanying this Decree;

b) Declaration of self-certification of the product;

c) Three consecutive notifications confirming that the food meets import requirements through the strict inspection method for consignments and items transferred from strict inspection to normal inspection (original copy);

d) Copy of the Goods Description List (Packing List);

đ) In the case of products specified in Article 14 of this Decree, a certificate confirming compliance with food safety regulations issued by the competent authority of the exporting country (original copy) must be provided, except for aquatic products directly sold to Vietnam by foreign fishing vessels.

Article 19. Procedures for inspecting imported food

1. Procedures for reduced inspection cases:

a) When processing customs clearance procedures, the consignee is responsible for submitting documents as prescribed in Clause 1, Article 18 of this Decree;

b) The customs authority is responsible for randomly selecting up to 5% of the total number of imported consignments subject to reduced inspection within one year to review documents as prescribed.

Within three working days from the date of receiving the documents, the customs authority is responsible for reviewing the documents and clearing the goods. In case of requesting additional documents, the reasons and legal basis for such request must be clearly stated.

2. Procedures for regular inspection cases:

a) Before or when the goods arrive at the border gate, the consignee submits the application for inspection according to the provisions of Clause 2, Article 18 of this Decree to the State management inspection agency or the National Single Window portal under the Ministry of Health, the Ministry of Agriculture and Rural Development, or the Ministry of Industry and Trade (if applicable);

b) Within three working days from the date of receiving the documents, the State management inspection agency is responsible for reviewing the documents and issuing a notification on whether the food meets the import requirements according to Form No. 05 of Appendix I promulgated together with this Decree. In case of requesting additional documents, the reasons and legal basis for such request must be clearly stated;

c) The consignee is responsible for submitting the Notification of Confirmation that the Food Meets Import Requirements to the customs authority for clearance of the goods.

3. Procedures and formalities for strict inspection cases:

a) Implement the provisions stipulated in point a, Clause 2 of this Article;

b) Within seven working days from the date of receiving the documents, the State management inspection agency is responsible for reviewing the documents, taking samples, testing food safety indicators as required, and issuing a notification on whether the food meets the import requirements according to Form No. 05 of Appendix I promulgated together with this Decree. In case of requesting additional documents, the reasons and legal basis for such request must be clearly stated;

c) The consignee is responsible for submitting the Notification of Confirmation that the Food Meets Import Requirements to the customs authority for clearance of the goods.

4. In case of issuing a Notification of Confirmation that the Food Does Not Meet Import Requirements as prescribed in point b, Clause 2, and point b, Clause 3 of this Article, the State management inspection agency decides on measures to handle the situation according to the forms prescribed in Clause 3, Article 55 of the Food Safety Law and reports the results of handling non-compliant imported food to the specialized management ministry.

Article 20. Handling of Non-Compliant Imported Food

1. After completing the handling of non-compliant imported food according to the decision of the State management inspection agency, the consignee is responsible for reporting to the State management inspection agency and the agency receiving the declaration one of the following documents:

a) Re-export documentation in cases where re-export is applied;

b) A destruction record confirmed by the competent authority;

c) An agreement on changing the purpose of use between the consignee and the buyer or transferee of the consignment or item. The buyer or transferee of the non-compliant consignment or item shall not use it as food.

2. After completing the correction of product defects or labeling errors, if wishing to import into Vietnam, the consignee is responsible for implementing the registration and inspection procedures as prescribed in Article 19 of this Decree.

If the consignment or item still does not meet the import requirements despite applying corrective measures for product defects or labeling errors, one of the handling methods prescribed in points c and d, Clause 3, Article 55 of the Food Safety Law must be applied.

Article 21. Rights and obligations of the consignee

The consignee has the following rights and obligations:

1. To apply the reduced inspection method for batches of imported goods belonging to one of the cases prescribed in Clause 1, Article 17 of this Decree.

2. To request the state inspection agency to review the inspection results or to request the agency receiving the product declaration to select a testing facility that has been designated to re-inspect the test results. In case the re-inspection results are consistent with the initial inspection results, the consignee must bear the cost of the re-inspection; in case the re-inspection results meet the requirements for imported food, the consignee will be refunded the re-inspection costs already paid.

3. To propose measures for handling batches of goods not meeting the requirements for imported food as provided for in Clause 3, Article 55 of the Food Safety Law.

4. To ensure the original condition of the batch of goods for the state inspection agency to take samples.

5. To implement the decision on handling the batch of goods issued by the competent state inspection agency if the batch of goods does not meet the requirements for imported food.

Article 22. National registration procedures, territorial regions, and production and business establishments for exporting food to Vietnam and state food safety inspections at the exporting country

1. The competent state management agency of Vietnam shall develop plans for inspections, notify, and coordinate with the competent authority of the exporting country to conduct inspections of the food safety control system of the exporting country and food production and business establishments exporting to Vietnam according to the following procedures:

a) The competent authority of the exporting country shall submit one set of registration files to the Ministry of Agriculture and Rural Development, including information about the management system of the country or region (including laws, standards, organizational management systems for food safety), and the capacity of the national or regional authority to control food safety, according to Model No. 08 of Appendix I attached to this Decree; a list of food production and business establishments from animal and aquatic sources registered for export to Vietnam according to Model No. 07 of Appendix I, and information about the conditions ensuring food safety of these production and business establishments according to Model No. 09 of Appendix I attached to this Decree;

b) Within thirty working days from the date of receipt of the complete registration file of the production and business establishments specified in point a of this clause from the competent authority of the exporting country, the competent authority of the sectoral management agency shall examine the file, notify the competent authority of the exporting country of the examination results, and plan for inspection if necessary to inspect the exporting country;

c) The content of inspection in the exporting country includes: Legal system for managing and controlling food safety; capacity of the food safety control agency of the exporting country; conditions ensuring food safety of production and business establishments registered for export to Vietnam.

2. Handling of inspection results and notification of lists of countries, regions, and production and business establishments permitted to export to Vietnam are regulated as follows:

a) In cases where it is not necessary to conduct actual inspections of the exporting country, the Ministry of Agriculture and Rural Development shall announce the results and names of countries and regions permitted to export to Vietnam. For terrestrial animal products and aquatic animal products, the list of production and business establishments permitted to export must also be announced;

b) In cases where it is necessary to conduct inspections of the exporting country, within thirty working days from the end date of the inspection in the exporting country, the Ministry of Agriculture and Rural Development shall process and announce the inspection results.

If the inspection results do not fully meet the requirements as stipulated, the Ministry of Agriculture and Rural Development shall notify and specify the specific reasons for those cases not permitted to export food to Vietnam;

c) In cases where there is a request to supplement the list of production and business establishments exporting terrestrial animal products and aquatic animal products to Vietnam, the competent authority of the exporting country shall submit a file including the list and information about the establishment according to Model No. 07 and Model No. 08 as prescribed in point a of Clause 1 of this Article to the Ministry of Agriculture and Rural Development for file examination or on-site inspection in the exporting country, based on which to consider and decide on supplementation to the list.

Article 23. State Inspection of Exported Food

1. The Minister of Health, the Minister of Agriculture and Rural Development, and the Minister of Industry and Trade shall stipulate the authority for state inspection on food safety for exported food within their respective areas of management as provided for in Articles 62, 63, and 64 of the Food Safety Law when requested by the importing country.

2. The Ministry of Agriculture and Rural Development shall be responsible for inspecting export consignments of food products comprising multiple items under the jurisdiction of two or more ministries.

Chapter VII
FOOD LABELING

Article 24. Mandatory Labeling Content

1. Organizations and individuals producing and trading products in Vietnam, in addition to complying with the provisions of the law on product labeling, must also comply with the following provisions:

a) Medical nutrition foods must include the following phrases: "Medical Nutrition Food" and "For use under medical supervision."

b) Special diet foods must include the phrase: "Nutritional Product (for specific individuals)" on the main label surface to distinguish them from regular foods.

2. For imported products, the name and address of the organization or individual responsible for labeling the product must be shown: the name and address of the producer and the name and address of the self-declared or registered product announcer.

Article 25. Exemption from Certain Mandatory Labeling Requirements

1. Exempt from secondary labeling for personal-use products carried by travelers upon entry for consumption within tax-free limits; imported products of persons entitled to preferential treatment or diplomatic immunity; transiting, transferring, in-transit storage, temporary importation for re-export, or stored in bonded warehouses; samples for testing or research; exhibition or trade fair display products; raw materials or products imported solely for production, processing for export, or internal use by organizations and individuals not intended for domestic market consumption.

2. Except for spices and herbs, for small packages with the largest surface area less than 10 cm², exempt from the requirement to label ingredients, shelf life, storage instructions, and usage instructions if such information is fully displayed on the secondary label or outer packaging.

3. Exempt from labeling the date of manufacture for food containers and direct contact food packaging materials.

Chapter VIII
FOOD ADVERTISING

Article 26. Foods Required to Register Advertising Content Prior to Promotion

1. Health foods, medical nutrition foods, special diet foods.

2. Nutritional products for children up to 36 months old that are not prohibited from advertising as specified in Article 7 of the Advertising Law.

Article 27. Registration of Food Advertising Content

In addition to complying with the provisions of the law on advertising, registration of food advertising content must also comply with the following provisions:

1. Before advertising, organizations and individuals with advertised products must register the advertising content with the agency issuing the receipt for the product announcement registration according to current regulations.

2. The advertising content must be consistent with the declared functions and effects of the product in the product announcement. Do not use images, devices, costumes, names, letters, or emails from healthcare units, hospitals, doctors, pharmacists, healthcare workers, or patient thank-you letters, doctor or pharmacist articles, or healthcare worker writings for food advertising.

3. For health maintenance foods:

a) Must include the warning "This food is not medicine and does not replace the therapeutic effect of medicine"; the writing must be clear and have contrasting colors with the background;

b) When advertising on radio or television, the warning must be clearly read as stipulated in point a of this clause;

c) For radio or television advertisements with a duration of less than 15 seconds, it is not necessary to read "This food is not medicine and does not replace the therapeutic effect of medicine," but the warning must be included in the advertisement.

4. The application dossier for confirming advertising content includes:

a) An application form for confirming advertising content according to Form No. 10 of Appendix I issued together with this Decree;

b) Receipt for product announcement registration and the product announcement confirmed by the competent authority (certified copy);

c) Product label sample (certified copy);

d) For radio or television advertising, a draft script and proposed advertising content recorded on video or audio discs; for other media advertising, a draft layout (content sample) of the proposed advertisement (certified copy);

đ) For advertising content beyond the declared functions and features of the product in the product announcement, scientific evidence must be provided (certified copy);

All documents in the application dossier for confirming advertising content must be in Vietnamese; in cases where there are foreign language documents, they must be translated into Vietnamese and certified.

5. Procedure for Issuing a Certificate Confirming Advertising Content:

a) Organizations and individuals with advertised products submit the application dossier for confirming advertising content to the agency issuing the receipt for product announcement registration;

b) Within ten working days from the date of receiving complete and valid applications, the receiving agency is responsible for reviewing the application and providing results according to Form No. 11 of Appendix I issued together with this Decree. This period starts from the date the agency's seal is affixed if the application is sent via postal service or the date the completed application is received through the online public service system.

In case the agency disagrees with the advertising content of the organization or individual or requests modifications, the agency must provide a written explanation of the reasons and legal basis for the request. The agency may only request modifications once.

Within ten working days from the date of receiving modified applications, the agency reviews the application and provides a written response. If the organization or individual does not modify the application within ninety working days from the date of the modification request, the application will lose its validity.

c) The agencies receiving registration files for confirmation of advertising content shall be responsible for publicly announcing the name and product of organizations and individuals who have been issued a Certificate of Advertising Content Confirmation for food products on their electronic information websites (websites) and food safety databases.

d) Organizations and individuals registering to confirm advertising content shall be responsible for paying the review fee for the file at the agency receiving the file.

6. Organizations and individuals with advertised products; organizations and individuals issuing advertisements may only proceed with advertising products that have been issued a Certificate of Advertising Content Confirmation and may only advertise in accordance with the confirmed content.

Chapter IX
CONDITIONS FOR ENSURING FOOD SAFETY IN

THE PRODUCTION OF HEALTH-PROMOTING FOODS

Article 28. Conditions for ensuring food safety in the production of health-promoting foods

1. Health-promoting food production facilities must meet general conditions for ensuring food safety as stipulated in Clause 1, Article 19, Clause 1, Article 20, and Clause 1, Article 21 of the Food Safety Law, and the following provisions:

a) Must establish and maintain a quality management system to control the production process and distribution circulation to ensure that all products produced by the facility meet the published standards and are safe for users until the expiration date;

b) Have sufficient staff with appropriate professional qualifications for the assigned positions and trained in basic knowledge about Good Manufacturing Practices (GMP), food safety, and related professional knowledge. The head of the production department and the head of the quality control department must be full-time employees of the facility and independent from each other. The facility's technical manager must have a bachelor's degree or higher in one of the following fields: Medicine, Pharmacy, Nutrition, Food Safety, Food Technology, and must have at least three years of work experience in a relevant field;

c) The factory systems, equipment, and auxiliary utilities must be designed, constructed, and installed in accordance with their intended use, following the principle of unidirectional flow, easy cleaning, prevention, and reduction of confusion risks, avoiding dust accumulation, contamination, and factors adversely affecting the product, and maintaining daily hygiene operations;

d) Implement and retain complete records and documents regarding production, quality control, and distribution circulation to trace the history of every batch of products and record all other activities carried out at the facility;

đ) All production operations must be performed according to procedures and guidelines. Apply inspection and supervision measures during production to prevent and avoid confusion, contamination, and cross-contamination. Record results immediately when performing operations or after completing production stages in the file;

e) Have a quality control department to ensure that products are produced under appropriate conditions and processes and meet established standards; necessary tests have been conducted; raw materials not approved for use, and products not approved for sale if they have not been assessed as meeting quality requirements; products must be monitored for stability;

g) In cases of testing or production under contracts, the party accepting the contract must have adequate factory space, equipment, and personnel to meet the requirements of the contracting party and comply with the competent authority's regulations on testing or health-promoting food production conditions;

h) Have procedures for handling complaints, recalling products, and self-inspection activities; implement these procedures and fully document and retain records for these activities.

2. The Ministry of Health shall guide Good Manufacturing Practices (GMP) for health-promoting foods so that health-promoting food production facilities can implement and apply them.

3. From July 1, 2019, health-promoting food production facilities must apply Good Manufacturing Practices (GMP) for health-promoting foods according to the Ministry of Health's guidance.

Article 29. Documents, procedures, and authority for issuing and reissuing the Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) Requirements for Health-Promoting Foods

1. Documents for issuing the Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) Requirements for Health-Promoting Foods include:

a) An application for the Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) Requirements for Health-Promoting Foods according to Form No. 12 in Appendix I issued together with this Decree;

b) A diagram of production areas and production lines (with confirmation from organizations or individuals);

c) A list of main equipment used at the facility (with confirmation from organizations or individuals).

2. Procedures for issuing the Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) Requirements for Health-Promoting Foods

a) The facility shall prepare the documents as prescribed in Clause 1 of this Article and submit them through the online public service system or via postal service or directly to the Ministry of Health;

b) Within fifteen working days from the date of receiving complete and valid documents, the agency receiving the documents shall establish an inspection team and conduct on-site inspections at the facility and prepare the Inspection Report according to Form No. 13 in Appendix I issued together with this Decree.

The inspection team shall consist of at least five members, including at least two members with experience in Good Manufacturing Practices (GMP) and one member with expertise in testing;

c) In case the inspection results meet the requirements, the agency receiving the documents shall issue the Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) Requirements for Health-Promoting Foods according to Form No. 14 in Appendix I issued together with this Decree. The time limit for issuing the Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) Requirements for Health-Promoting Foods shall not exceed thirty working days from the date of receiving complete and valid documents;

d) In case the inspection results at the facility do not meet the requirements, the inspection team shall clearly record the non-compliance in the inspection report for the facility to rectify. After rectification, the facility shall send a written notification of the rectification results to the inspection team. Within seven working days from the date of receipt of the written notification of the rectification results, the inspection team shall be responsible for reviewing and submitting to the Ministry of Health for issuance of the Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) Requirements for Health-Promoting Foods. If the facility fails to complete the rectification within three months from the end of the inspection and notify the inspection team of the rectification results, the application for the Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) Requirements for Health-Promoting Foods will lose its validity;

3. The Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) Requirements for Health-Promoting Foods shall be valid for three years from the date of issuance. Six months before the expiration date, the facility shall be responsible for submitting documents for reissuance of the Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) Requirements for Health-Promoting Foods. The documents and procedures for reissuance shall be carried out according to the provisions of Clauses 1 and 2 of this Article.

4. Organizations and individuals applying for the Certificate of Food Safety Conditions Meeting Good Manufacturing Practices (GMP) Requirements for Health-Promoting Foods shall be responsible for paying the fee for document inspection at the agency receiving the documents.

Chapter X
PROVISIONS ON FOOD SAFETY CONDITIONS FOR THE PRODUCTION, DISTRIBUTION AND USE OF FOOD ADDITIVES

FOOD SAFETY CONDITIONS FOR THE PRODUCTION, DISTRIBUTION AND USE OF FOOD ADDITIVES

Article 30. Conditions for Ensuring Food Safety for Food Additives

Food additive production and business establishments must meet the following food safety conditions:

1. Comply with general food safety conditions stipulated in Clause 1, Article 19, Clause 1, Article 20, and Clause 1, Article 21 of the Food Safety Law.

2. Only mix food additives when such additives are listed in the permitted food additive list issued by the Ministry of Health and the final product of the mixture does not cause any harm to human health; in cases where a new product with new functions is created, proof of function, target users, and maximum usage levels must be provided.

3. The division, portioning, and bottling of food additives must be carried out at facilities that meet food safety conditions and labeled according to current regulations.

Article 31. Provisions on Single-Component Food Additives

1. Single-component food additives listed in the permitted food additive list issued by the Ministry of Health are subject to self-declaration.

2. Procedures for self-declaration of single-component food additives shall be implemented in accordance with Article 5 of this Decree.

Article 32. Provisions on Mixed Food Additives with New Functions

1. Mixed food additives with new functions must register their product declaration with the Ministry of Health.

2. Mixed food additives with new functions must list the quantitative components for each additive in the composition.

3. The procedures for registering the product declaration for mixed food additives with new functions shall be carried out in accordance with Articles 7 and 8 of this Decree.

Article 33. Provisions on the Use of Food Additives

Organizations and individuals engaged in production and distribution have the responsibility to:

1. Only use food additives listed in the permitted food additive list issued by the Ministry of Health. In cases where the food additive is not included in the permitted food additive list or does not comply with the specified usage targets set by the Ministry of Health, organizations and individuals producing and distributing food additives must register their product declaration with the Ministry of Health in accordance with Articles 7 and 8 of this Decree.

2. Use food additives within the maximum allowable usage level; correctly apply them to the appropriate food types; ensure clear origin and source; remain within the shelf life period; fully comply with management requirements and technical standards for food additives.

Chapter XI
TRACKING THE ORIGIN OF FOOD

Article 34. Tracking the Origin of Non-Safe Products

When discovering that products they produce or distribute do not meet safety standards or upon request from competent state authorities, organizations and individuals producing and distributing products must take responsibility for implementing origin tracking in accordance with Clause 1 and Clause 2, Article 54 of the Food Safety Law.

Article 35. Implementation of Origin Tracking for Non-Safe Products

1. Organizations and individuals producing and distributing products must retain information related to the manufacturer, supplier, and customer in cases where customers have purchased the product through contracts, record books, or other methods to facilitate origin tracking. Information for origin tracking includes:

a) Name and type of purchased and sold products;

b) Date, month, year, quantity, weight, batch number, and production run number of purchased and sold products (if applicable).

2. The Minister of Health, the Minister of Agriculture and Rural Development, and the Minister of Industry and Trade shall provide detailed regulations on origin tracking for products under their respective areas of management.

Chapter XII
The Ministry of Science and Technology is responsible to the Government for uniformly managing state affairs concerning the quality of products circulating domestically and exported/imported goods with the following specific tasks:

ON FOOD SAFETY

Article 36. Principles for Allocation of Responsibilities in State Management of Food Safety

1. Based on the provisions of the Food Safety Law and ensuring consistency with related legal documents.

2. On the basis of unified state management of food safety.

3. Ensuring comprehensive management throughout the entire process of food production and business.

4. Close cooperation among ministries and sectors.

5. Ensuring the principle of one window, one product, one production and business entity being subject to the management of only one state administrative agency.

6. Ensuring scientific, completeness, and feasibility.

7. Delegation of state management responsibilities between the central level and local authorities at various levels in state management of food safety.

8. For production facilities producing multiple types of food products under the jurisdiction of two or more specialized management agencies, the agency managing the product with the largest volume within the facility shall be responsible for management.

9. For entities not involved in the production process but trading in multiple types of food products under the jurisdiction of two or more specialized management agencies under the Ministry of Industry and Trade, except for wholesale markets and agricultural auctions.

10. For entities both producing and trading in multiple types of products under the jurisdiction of two or more specialized management agencies, organizations and individuals have the right to choose a specialized food safety management agency to handle administrative procedures.

Article 37. Responsibilities of the Ministry of Health in State Management of Food Safety

1. Implementing general responsibility regulations in state management of food safety as stipulated in Clause 1, Article 62 of the Food Safety Law.

2. Reporting periodically and urgently to the Government on food safety management work based on supervision and consolidation of reports from specialized management ministries and provincial People's Committees.

3. Issuing national technical standards for products under its assigned management as specified in Article 62 of the Food Safety Law and groups of products listed in Appendix II attached to this Decree; issuing national technical standards or setting safe limit levels for groups of products upon request from specialized management ministries.

4. Managing food safety throughout the production, processing, storage, transportation, export, import, trade, and production and business establishments for food products specified in Appendix II attached to this Decree.

5. Organizing the receipt and management of registration files, issuing Product Registration Acceptance Certificates, Certificates of Food Safety Conditions for health foods, mixed food additives with new functions, food additives not included in the list of permitted substances or not used according to the intended purpose as prescribed by the Ministry of Health; Certificates of Food Safety Conditions meeting Good Manufacturing Practices (GMP) for health foods; Advertising Content Confirmation Certificates for health foods; Free Circulation Certificates for products under its assigned management, and Health Certificates.

6. Designating food testing facilities serving state management, testing verification facilities within the scope of its assigned management; designating arbitration testing facilities and making final conclusions when there are discrepancies in test results from food testing facilities inside and outside the health sector.

7. Designating state inspection agencies for imported food safety for products under its assigned management.

Article 38. State Management Responsibilities for Food Safety of the Ministry of Agriculture and Rural Development

1. Issuing national technical standards for products under its assigned management as stipulated in Article 63 of the Food Safety Law and the groups of products listed in Appendix III attached to this Decree.

2. Developing and submitting to the Ministry of Health for issuance regulations on safety limits for the groups of products listed in Appendix III attached to this Decree.

3. Managing and classifying food safety management for primary production of agriculture, forestry, fishery, and salt including planting, breeding, harvesting, fishing, aquaculture, and salt production.

4. Managing and classifying food safety management throughout the production, collection, slaughtering, preliminary processing, processing, storage, transportation, export, import, and business activities for products and production and business establishments of food products listed in Appendix III attached to this Decree.

5. Organizing the issuance of Free Circulation Certificates for products under its assigned management.

6. Organizing the issuance and classification of issuance of certificates of food safety conditions for organizations and individuals producing and trading in products under its assigned management as stipulated in Clause 3 and 4 of this Article.

7. Managing food safety for wholesale markets and agricultural product auctions.

8. Designating food testing facilities serving state management, verification testing facilities; making final conclusions when there are differences in test results among testing facilities under its assigned management.

9. Designating state inspection agencies for imported food safety for products under its assigned management.

10. Announcing lists of countries and territories and lists of production and trading establishments permitted to export to Vietnam for products under its assigned management.

Article 39. State Management Responsibilities for Food Safety of the Ministry of Industry and Trade

1. Issuing national technical standards for products under its assigned management as stipulated in Article 64 of the Food Safety Law and the groups of products listed in Appendix IV attached to this Decree.

2. Developing and submitting to the Ministry of Health for issuance regulations on safety limits for the groups of products listed in Appendix IV attached to this Decree.

3. Managing and classifying food safety management throughout the production, processing, storage, transportation, export, import, and business activities for products and production and trading establishments of food products listed in Appendix IV attached to this Decree.

4. Managing food safety for supermarkets, shopping centers, convenience stores, establishments in the reserve and distribution system, and other types of business.

5. Organizing the issuance of Free Circulation Certificates for products under its assigned management.

6. Organizing the issuance and classification of issuance of certificates of food safety conditions for organizations and individuals producing and trading in products under its assigned management.

7. Implementing inspections to prevent counterfeit food, trade fraud on the market for all types of food, food additives, food processing aids, packaging materials, and containers for food.

8. Designating food testing facilities serving state management, verification testing facilities; making final conclusions when there are differences in test results among testing facilities under its assigned management.

9. Designating state inspection agencies for imported food safety for products under its assigned management.

Article 40. Responsibilities of the Provincial People's Committee for State Management of Food Safety

1. Implement state management of food safety within their jurisdiction, and be responsible before the Government for food safety in their locality. The Chairman of the Provincial People's Committee directly performs the role of Head of the Inter-sectoral Steering Committee on Food Safety in the province or centrally-administered city; proactively organize inspection forces to ensure food safety within their administrative area; directly direct and regularly urge and inspect the implementation of food safety laws by subordinate state agencies; handle officials and civil servants who are negligent or lax in management within their assigned areas; organize the resolution of complaints and denunciations, and handle violations of food safety laws according to the law; bear responsibility before the Government and under the law when violations of food safety laws occur within their administrative area.

2. Organize the implementation of regulations of the Government, ministries, and sectors on food safety within their administrative area.

3. Organize and manage the Inter-sectoral Steering Committee on Food Safety in the province or centrally-administered city.

4. Organize propaganda and mobilization for the implementation of legal provisions ensuring food safety within their administrative area.

5. Allocate resources for specialized agencies to carry out state management of food safety.

6. Be responsible for managing food safety within their administrative area; manage conditions ensuring food safety for small-scale production and business establishments, street food vendors, catering service businesses, food safety at markets within their administrative area, and other entities according to the delegated management level.

7. Develop and promulgate local technical standards on food safety for specific food products of the locality.

8. Organize the acceptance and management of files, issue Certificates of Product Registration Acceptance, and Certificates of Advertisement Content Confirmation for medical nutrition products, special diet foods, and nutritional products for children up to 36 months old.

9. Organize the acceptance of self-declared product information; certify food safety facilities according to assigned and delegated levels.

Article 41. Coordination in Activities Ensuring Food Safety

1. Ministries managing industries within their scope of state management have the responsibility to coordinate with the Ministry of Health in implementing state management activities to ensure effective unified state management of food safety.

2. The Ministry of Health leads in building programs for food safety information education and communication, while the Ministry of Agriculture and Rural Development, the Ministry of Industry and Trade, and other ministries and sectors according to their functions and responsibilities cooperate with the Ministry of Health to implement these programs.

3. The Ministry of Health, the Ministry of Agriculture and Rural Development, and the Ministry of Industry and Trade are responsible for leading the development of plans and implementation of inspection and supervision activities for products within their assigned management areas; other ministries and sectors are responsible for coordination.

4. When food poisoning occurs, the Ministry of Health is responsible for organizing timely rescue and treatment for those affected. The specialized management ministry is responsible for providing complete documentation and information related to the suspected source of the food poisoning within their assigned management area; they must cooperate with the Ministry of Health to investigate the cause and lead in tracing the origin and handling of the food causing the poisoning within their assigned management area.

5. When discovering food products managed by another ministry or sector that violate regulations and pose serious health risks to consumers, the Ministry of Health will take the lead and coordinate with relevant industry management ministries to conduct inspections, investigations, and make conclusions.

Chapter XIII
IMPLEMENTING PROVISIONS

Article 42. Transitional Provisions

1. Products that have been issued a Certificate of Declaration of Conformity and a Certificate of Compliance with Food Safety Regulations before this Decree takes effect may continue to be used until the expiration date indicated on the certificate and the product's shelf life.

2. Ministries within their scope of duties and authority shall review and announce the termination of regulations that conflict with this Decree.

Article 43. Effective Date

1. This Decree takes effect from February 2, 2018.

2. Replaces Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing the implementation of certain provisions of the Law on Food Safety; abolishes Chapter II of Circular Joint No. 13/2014/TTLT-BYT-BNNPTNT-BCT dated April 9, 2014 of the Ministry of Health, the Ministry of Agriculture and Rural Development, and the Ministry of Industry and Trade guiding the division of labor and coordination in state management of food safety.

Article 44. Responsibility for Implementation

Ministers, heads of ministerial-level agencies, heads of government agencies, Chairmen of provincial people's committees of centrally-administered cities, and related organizations and individuals are responsible for implementing this Decree./.

 

ANNEX I

(Attached to Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government)

 

Form No. 01

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------

SELF-DECLARATION OF PRODUCT

No.: ... /Name of Enterprise/Year of Declaration

I. Information about the Organization or Individual Declaring the Product

Legal Representative of the Organization or Individual: …

Address: …

Telephone: …Fax: …

Business Registration Number: …

Food Safety Permit Number: …Date of Issue/Issuing Authority: …(for establishments required to obtain a Food Safety Permit under regulations)

Number of Food Safety Condition Certificate: ... Date of Issue/Issuing Authority: ... (for facilities required to obtain a Food Safety Condition Certificate under the regulations)

1. Product Name: …

2. Ingredients: …

3. Product Quality Indicators: …

3. Product Usage Period: ...

4. Packaging Specifications and Packaging Material: ...

5. Name and Address of the Product Manufacturing Facility (in case of leasing a manufacturing facility):...

.............................................................................................................................................

(attached product label sample or proposed product label sample) We hereby commit to fully comply with all laws related to food safety and take full responsibility for the legal validity of the announcement filing and the quality and safety of the announced product.

IV. FOOD SAFETY REQUIREMENTS

Organizations and individuals producing and trading food must meet food safety requirements according to:

- Circulars of Ministries and Sectors; or

- Local Technical Regulations; or

- National Standards (in cases where there are no national technical regulations, circulars of ministries and sectors, local technical regulations); or

- National Standards (in cases where there are no national technical regulations, Circulars of relevant ministries, local technical standards); or

- International Food Standards Commission (Codex) Standards, Regional Standards, Foreign Standards (in cases where there are no national technical regulations, Circulars of relevant ministries, local technical standards, national standards); or

- Manufacturer's Standards attached (in cases where there are no national technical regulations, Circulars of relevant ministries, local technical standards, national standards, International Food Standards Commission (Codex) Standards, Regional Standards, Foreign Standards).

We hereby commit to fully comply with all legal provisions on food safety and take full responsibility for the legality of the product announcement dossier and the quality and safety of the announced products./.

 

 

Form No. 02

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------

ANNOUNCEMENT DOCUMENT

No.:...

Name of Organization or Individual: …

Legal Representative of the Organization or Individual: …

Address: …

Telephone: …Fax: …

Email: …

Business Registration Number:...

Number of Food Safety Condition Certificate: ... Date of Issue/Issuing Authority: ...

.............................................................................................................................................

(for facilities required to obtain a Food Safety Condition Certificate under the regulations)

1. Product Name: …

2. Ingredients: …

3. Product Quality Indicators: …

3. Main Quality Indicators Creating the Functionality of the Product (for health foods):  

5. Packaging Specifications and Packaging Material: …

6. Name and Address of the Product Manufacturer: …

IV. Requirements for Quality and Food Safety

(attached product label sample or proposed product label sample) We hereby commit to fully comply with all laws related to food safety and take full responsibility for the legal validity of the announcement filing and the quality and safety of the announced product.

IV. FOOD SAFETY REQUIREMENTS

Organizations and individuals producing and trading food must meet food safety requirements according to:

- Circulars of Ministries and Sectors; or

- Local Technical Regulations; or

- National Standards (in cases where there are no national technical regulations, circulars of ministries and sectors, local technical regulations); or

- National Standards (in cases where there are no national technical regulations, Circulars of relevant ministries, local technical standards); or

- International Food Standards Commission (Codex) Standards, Regional Standards, Foreign Standards (in cases where there are no national technical regulations, Circulars of relevant ministries, local technical standards, national standards); or

- Manufacturer's Standards attached (in cases where there are no national technical regulations, Circulars of relevant ministries, local technical standards, national standards, International Food Standards Commission (Codex) Standards, Regional Standards, Foreign Standards).

We hereby commit to fully comply with all legal provisions on food safety and take full responsibility for the legality of the product announcement dossier and the quality and safety of the announced products and will only put the products into production and trade after receiving the Registration Acceptance Notice for Product Announcement./.

 

 

Implementation Report of Production Projects of Supporting Industry Products Confirmed with Incentives

 

CERTIFICATE OF RECEIPT FOR PRODUCT REGISTRATION APPLICATION

Number:                   /year/DP

……… (Name of the authority accepting the product announcement registration)……. confirms receipt of the Product Announcement Dossier of: …(name of organization, individual) address…telephone, …Fax…Email …for the product:…manufactured by …(name, address of manufacturer and country of origin) …, in compliance with technical regulations/requirements/standards... (number, code, name) …

The enterprise shall be fully responsible for the suitability of the announced product./.

 

 

Form number 04

 

IMPORT FOOD INSPECTION REGISTRATION FORM

No. …/20…/IMNK

1. Name, address, telephone of consignor: …

2. Name, address, telephone of trader responsible for product quality: …

.............................................................................................................................................

3. Name, address, telephone of exporter: …

4. Expected import date: …

5. Port of departure: …

6. Port of arrival: …

7. Inspection time: …

8. Inspection location: …

9. Expected inspection agency: …

10. Detailed information about the batch of goods:

* Confirmation document number for inspection method is the notification number of the competent authority notifying the goods subject to inspection according to the inspection method.

 

 

Form number 05

 

NOTIFICATION OF INSPECTION RESULTS FOR IMPORTED FOOD PRODUCTS MEETING/
NOT MEETING IMPORT REQUIREMENTS

No. ……/20…../INSR

1. Name, address, telephone of consignor: …

2. Name, address, telephone of trader responsible for product quality: …

.............................................................................................................................................

3. Name, address, telephone of exporter: …

4. Customs declaration form number: …

5. Port of departure: …

6. Port of arrival: …

7. Inspection time: …

8. Inspection location: …

9. Detailed information about the batch of goods:

 

 

Form number 06

 

REPORT

Regarding the implementation of state inspections for imported food products

From …/…./… to …/…/…

Inspection agency name: …

Address: …

Telephone number: …Fax number: …

Report preparer's name: …

I. IMPLEMENTATION CONTENT:

A. General Information:

B. STATISTICAL TABLE OF NON-COMPLIANT BATCHES AND GOODS

II. RECOMMENDATIONS:

 

 

Form No. 07

LIST OF FOOD PRODUCTION AND TRADE FACILITIES REGISTERING FOR EXPORT TO VIETNAM

 

 

Form No. 08

INFORMATION ON THE MANAGEMENT SYSTEM AND CAPACITY FOR FOOD SAFETY CONTROL OF THE EXPORTING COUNTRY'S AUTHORITY

1. Organizational structure and management system:

.............................................................................................................................................

.............................................................................................................................................

2. Staff executing tasks (quantity, qualifications, training courses on technology...):

.............................................................................................................................................

.............................................................................................................................................

3. System of documents, standards, control procedures and certification for food safety:

.............................................................................................................................................

.............................................................................................................................................

4. System for monitoring residues, pathogenic microorganisms... in production and trade facilities:

.............................................................................................................................................

.............................................................................................................................................

5. Food safety inspection and monitoring program:

 

 

Form No. 09

SUMMARY OF INFORMATION ON FOOD SAFETY CONDITIONS OF PRODUCTION AND TRADE FACILITIES

1. Name of production and trade facility: …

3. Telephone: …;   Fax: …; Email: …

3. Product: …

4. Production process description: …

5. Quality management system applied: …

 

 

Form No. 10

 

APPLICATION FOR REGISTRATION

Confirmation of advertising content

Respectfully submitted to: ² ………………………………………………….

1. Name of entity applying for confirmation: …

2. Head office address:³ ..............................................................................................................

............................................................................................................................................

Telephone: …Fax: …

Request for confirmation of advertising content for:

Advertising medium: …

Documents included in the dossier: …

I hereby certify that the above information and dossier are true and commit to advertising food products in accordance with the confirmed content.

We respectfully request the authority to consider and issue an advertisement content confirmation certificate./.

 

_________________

¹ Place name

² Receiving authority: The authority with jurisdiction as stipulated in Article 37 and Article 40 of this Decree.

³ As per the address on the business registration certificate

 

Form No. 11

 

CERTIFICATE OF APPROVAL FOR ADVERTISING CONTENT

Legal Representative of the Organization or Individual: …

Address: …

Telephone: …Fax: …

Advertising medium:

.............................................................................................................................................

.............................................................................................................................................

Contains advertising content (attached) has been approved as consistent with current regulations.

Request organizations and individuals responsible for advertising to comply strictly with the approved content.

 

________________

¹ Abbreviation of the approval authority

 

Form No. 12

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
-------------

PETITION FOR APPLICATION

Issuing Certificate of Food Safety Conditions for Health-Promoting Foods Production Practices (GMP) Facilities

Respectfully submitted to:...

Legal Representative of the Organization or Individual: …

Address: …

Business Registration Number:...

Name and address of production facility: …

Application for issuance of Certificate of Food Safety Conditions for Health-Promoting Foods Production Practices (GMP) Facilities./.

 

 

Model Number 13

 

RECORD OF DETERMINATION

Food safety conditions for facilities meeting Good Manufacturing Practices (GMP) requirements for health-promoting foods

Implementing Decision number, date…month… year…of…

Today, date…month…. year….., the inspection team consists of:

1. Team Leader (name, position, organization/unit): …

2. Team Secretary (name, position, organization/unit): …

3. Team Member (name, position, organization/unit): …

Conducting food safety condition inspection for facilities applying Good Manufacturing Practices (GMP) for health-promoting foods at …

Representative of organization or individual:

.............................................................................................................................................

.............................................................................................................................................

GENERAL INFORMATION

1. Information on the facility requesting certification:

- Name, address of production facility: …

- Business registration code: …

- Legal representative: …

2. Information on the inspection period:

- Inspection period: …

- Most recent inspection period: …

- Inspection method: Listening to reports, reviewing actual conditions, and checking documents to assess compliance with GMP principles and regulations issued together with Decision number ……/QĐ-BYT dated …../……/20……

- Scope of inspection: As proposed by (facility name) dated ……/…../……

INSPECTION RESULTS

I. Actual observations

1. Infrastructure and equipment: …

2. Sanitation conditions and sanitation control: …

3. Raw materials, food additives, processing aids: …

4. Testing activities, quality control of raw materials, semi-finished products, finished products, and types of tests that the facility is capable of performing.

5. Documents and records: …

6. Other contents specified in the Good Manufacturing Practices (GMP) guidelines:…

.............................................................................................................................................

II. Issues and classification of issues

III. Conclusion

IV. Comments from the inspected facility

.............................................................................................................................................

.............................................................................................................................................

The minutes are unanimously agreed upon and made into three identical copies, one copy retained by the inspected facility, one by the inspection team, and one by the competent authority.

 

1. Team Leader:

2. Team Secretary:

3. Team Member:

 

Model No. 14

 

CERTIFICATE OF INSURANCE OR OTHER FINANCIAL SECURITY
FOOD SAFETY CONDITIONS MET

NAME OF ESTABLISHMENT
ADDRESS

GOOD MANUFACTURING PRACTICES (GMP) REQUIREMENTS MET
HEALTH-PROMOTING FOODS

FOR THE FOLLOWING TYPES OF PRODUCTS:
…………………………………………………………………………………….

 

THIS CERTIFICATE IS VALID FOR 3 YEARS FROM THE DATE OF SIGNATURE

 

 

ANNEX II

LIST OF FOOD PRODUCTS/HOUSING PRODUCTS UNDER THE MANAGEMENT AUTHORITY OF THE MINISTRY OF HEALTH
(Attached to Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government)

 

ANNEX III

LIST OF FOOD PRODUCTS/HOUSING PRODUCTS UNDER THE MANAGEMENT AUTHORITY OF THE MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT
(Attached to Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government)

 

ANNEX IV

LIST OF FOOD PRODUCTS/GROUPS OF FOOD PRODUCTS; GOODS UNDER THE MANAGEMENT AUTHORITY OF THE MINISTRY OF INDUSTRY AND TRADE
(Attached to Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government)