Decree 15/2018/NĐ-CP – guiding the Food Safety Law

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

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

According to the proposal of the Minister of Health;

The Government promulgates a Decree detailing the implementation of certain articles of the Law on Food Safety.

Chapter I. GENERAL PROVISIONS

Article 1. Scope of regulation

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

1. Procedures for self-declaration of products.

2. Procedures for registration of product declaration dossiers.

3. Ensuring the safety of genetically modified food.

4. Issuing Certificates of food safety eligibility for establishments.

5. State inspection of imported and exported food safety.

6. Food labeling.

7. Food advertising.

8. Conditions to ensure food safety in the production of health-protecting foods.

9. Conditions to ensure food safety in the production, business, and use of food additives.

10. Traceability of food sources.

11. Assignment of responsibilities for state management of 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 business; 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 understood as follows:

1. Health Food (Health Supplement, Dietary Supplement) refers to products used to supplement the daily diet to maintain, enhance, and improve the functions of the human body, and reduce the risk of disease. Health food contains 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 animals, minerals, and plants in the form of extracts, isolates, concentrates, and metabolized products;

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

Health-protecting foods are presented in processed forms such as capsules, pills, tablets, granules, powders, liquids, and other formulations and are dosed (for use) into small dose units.

2. Medical nutritional foods, also known as foods for special medical purposes (Food for Special Medical Purposes, Medical Food), are foods that can be consumed orally or via a feeding tube, prescribed to adjust the diet of patients, and are only to be used under the supervision of healthcare professionals.

3. Foods for special dietary uses (Food for Special Dietary Uses) are intended for people on diets, the elderly, and other special groups according to the regulations of the Codex Alimentarius Commission (CODEX). These are foods that are specially processed or formulated to meet specific dietary requirements based on the individual's physical condition or medical status, and specific disorders. The composition of these foods must be markedly different from the composition of ordinary foods of the same nature, if any.

4. Scientific evidence is information and scientific documents from scientific research works that have been approved by the competent state management agency on scientific research or published by domestic or international scientific journals, or documents on traditional medicine, medicinal plants, and medicinal ingredients published in scientific editions.

5. The consignor is an organization or individual responsible for the goods in the product announcement/self-declaration dossiers or an organization or individual authorized to carry out the import or export of food products.

6. Exported or imported items are food products of the same type, name, brand, production facility, and packaging material.

7. An exported or imported shipment is the totality of food products in one import or export shipment (with the same bill of lading). A shipment may consist of a single item or multiple items.

8. Small-scale initial production facilities are facilities for planting, animal husbandry, harvesting, fishing, and exploiting food raw materials on a household or individual basis, with or without a business registration certificate.

9. Small-scale processing facilities are facilities for processing food on a household or individual basis, with or without a business registration certificate.

10. Small-scale food business facilities are facilities operated by individuals, groups of individuals, or households that register a household business and facilities that are not granted a Business Registration Certificate, Enterprise Registration Certificate, or Investment Registration Certificate according to the law.

Chapter II. PROCEDURES FOR SELF-DECLARING PRODUCTS

Article 4. Self-declaration of products

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

2. Products and raw materials produced or imported solely for the purpose of manufacturing or processing goods for export, or for internal production use by organizations or individuals without consumption in the domestic market, are exempt from the procedure of product self-declaration.

Article 5. Dossiers and procedures for product self-declaration

1. The product self-declaration dossier includes:

a) Product self-declaration form according to Form No. 01, Appendix I issued together with this Decree;

b) Food safety testing result certificate of the product within 12 months up to the date of dossier submission, issued by a designated testing laboratory or a laboratory accredited according to ISO 17025, including safety indicators promulgated by the Ministry of Health under the risk management principle in accordance with international regulations, or safety indicators according to the corresponding standards or regulations published by organizations or individuals in case there are no provisions by the Ministry of Health (original or certified copy).

2. The self-declaration of the product is carried out in the following order:

a) Organizations and individuals shall self-declare their products on mass media or on their own electronic information pages, or publicly post them at the headquarters of the organization or individual, and submit one (1) copy by mail or directly to the competent state management agency designated by the People's Committee of the province or centrally-affiliated city (hereinafter collectively referred to as the provincial-level People's Committee);

b) Immediately after self-declaring the product, organizations and individuals have the right to manufacture and trade the product and are fully responsible for the safety of that product;

c) The competent state management agency shall receive the self-declaration copy from organizations and individuals for record storage and post the names of the organizations, individuals, and self-declared products on the electronic information page of the receiving agency.

In the case where an organization or individual has two (2) or more production facilities producing the same product, the organization or individual shall submit the dossier to only one local state management agency at the production facility chosen by the organization or individual. Once the state management agency is chosen for dossier submission, all subsequent self-declarations must be submitted to the previously chosen agency.

3. The documents in the self-declaration dossier must be presented in Vietnamese; in the case of documents in a foreign language, they must be translated into Vietnamese and notarized. The documents must be valid at the time of self-declaration.

4. In cases where the product has changes in product name, origin, or composition, the organization or individual must self-declare the product again. In cases of other changes, the organization or individual shall notify in writing the competent state management agency about the content of the changes and may produce and trade the product immediately after sending the notice.

Chapter III. PROCEDURES FOR REGISTERING PRODUCT DECLARATION

Article 6. Registering a product declaration

Organizations and individuals that produce and trade food must register a product declaration for the following products:

1. Health protection foods, medical nutrition foods, foods for special dietary purposes.

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

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

Article 7. Product announcement registration dossier

1. The product announcement registration dossier for imported products includes:

a) The product announcement form specified in Form No. 02 Appendix I issued together with this Decree;

b) Certificate of Free Sale or Certificate of Exportation or Health Certificate issued by the competent authority of the country of origin/export, indicating safety for users or that the product is freely sold in the market of the producing/exporting country (consular legalization required);

c) Food safety test report of the product within 12 months up to the date of application submission, issued by a designated testing laboratory or a laboratory recognized as complying with ISO 17025, including safety indicators issued by the Ministry of Health according to risk management principles in accordance with international regulations, or safety indicators according to relevant standards published by organizations or individuals in cases where there is no regulation by the Ministry of Health (original or certified copy);

d) Scientific evidence proving the effectiveness of the product or of the ingredient that provides the announced effectiveness (original or certified copy by an organization or individual). When using scientific evidence of the ingredient's effectiveness to claim the product's effectiveness, the product's daily usage dose must be at least equal to or greater than 15% of the ingredient amount stated in the document;

d) Certificate of a facility meeting food safety requirements and Good Manufacturing Practices (GMP) or an equivalent certificate in case of imported products being health supplements, applicable from July 1, 2019 (certified copy by an organization or individual).

2. The product announcement registration dossier for domestically produced products includes:

a) The product announcement form specified in Form No. 02 Appendix I issued together with this Decree;

b) Food safety test result certificate of the product within 12 months up to the date of submission, issued by a designated testing laboratory or a testing laboratory accredited in accordance with ISO 17025, including safety indicators issued by the Ministry of Health based on risk management principles in line with international regulations, or safety indicators according to corresponding standards or regulations announced by organizations or individuals in case there are no regulations by the Ministry of Health (original or certified copy);

c) Scientific evidence proving the efficacy of the product or of the components contributing to the declared efficacy (original or copy certified by the organization or individual). When using scientific evidence of the efficacy of the product's components to assert the efficacy of the product, the daily dosage of the product must be at least equal to 15% of the usage amount of that component stated in the documentation;

d) Certificate of eligibility for food safety in cases where the establishment is subject to the issuance of a certificate of eligibility for food safety according to regulations (a certified copy by the organization or individual);

d) Certificate of eligibility for food safety meeting Good Manufacturing Practice (GMP) requirements in cases where domestically produced products are health foods, applied from July 1, 2019 (a certified copy by the organization or individual).

3. The documents in the product announcement registration dossier must be presented in Vietnamese; in case there are documents in a foreign language, they must be translated into Vietnamese and notarized. The documents must still be valid at the time of submission of the product announcement registration dossier.

Article 8. Procedure for registering a product announcement

1. Organizations and individuals producing or trading food shall submit the product announcement registration dossier via the online public service system, by post, or directly to the receiving agency according to the following regulations:

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

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

c) In cases where organizations or individuals produce many types of food that fall under the authority of both the Ministry of Health and the competent state management agency designated by the Provincial People's Committee, organizations or individuals have the right to choose to submit the dossier to the Ministry of Health, or for the products under the authority of a given agency, they must submit the registration dossier to the agency that receives the registration.

In the case where an organization or individual has two (2) or more production facilities producing the same product, the organization or individual shall only complete the procedure for registering the product announcement at one state management agency in the locality where the chosen production facility is located (except for products registered with the Ministry of Health). Once the state management agency for registration has been chosen, all subsequent registrations must be made at the chosen agency.

2. Within 07 (seven) working days from the receipt of a complete product announcement dossier for mixed food additives with new functions, food additives not included in the list of permitted additives, or improperly used in food as regulated by the Minister of Health, medical nutritional foods, foods for special dietary purposes, nutrition products for children up to 36 months old, and 21 working days for health supplements, the receiving agency specified in Clause 1 of this Article is responsible for appraising the dossier and issuing the Product Announcement Registration Receipt according to Form No. 03, Appendix I, promulgated together with this Decree.

The dossier appraisal time is calculated from the time the dossier is submitted on the online public service system or according to the received stamp of the receiving agency (in the case of submitting the dossier by postal service or submitting the dossier directly).

3. In case of disagreement with the product announcement dossier of an organization or individual, or a request for amendment or supplementation, the receiving authority must issue a written document specifying the reasons and legal basis for the request. The receiving authority may only request amendments or supplements once.

Within 07 (seven) working days from the receipt of the amended or supplemented dossier, the receiving authority shall evaluate the dossier and provide a written response. After 90 working days from the issuance of the official request for amendment or supplementation, if the organization or individual does not make the amendments or supplements, the dossier will no longer be valid.

4. In cases where there are changes in the product name, origin, or composition, the organization or individual must re-announce the product. For other types of changes, the organization or individual shall notify in writing the content of the change to the authority receiving the dossier as stipulated in Clause 1 of this Article and may produce and trade the product immediately after sending the notification.

5. The authority receiving the product announcement registration dossier is responsible for publicly notifying the names and products of organizations and individuals whose product announcements have been received on its electronic information portal (website) and on the food safety database.

6. Organizations and individuals producing or trading products are responsible for paying the dossier appraisal fee for product announcement registration in accordance with the law on fees and charges.

Chapter IV. ENSURING THE SAFETY OF GENETICALLY MODIFIED FOODS

Article 9. Ensuring safety for food containing genetically modified organisms and products of genetically modified organisms

Conditions for issuance, procedures, and processes for granting and revoking the Certificate of Genetically Modified Organisms eligible for use as food, as well as the list of genetically modified organisms granted the Certificate of eligibility for use as food, shall be carried out in accordance with the provisions of Decree No. 69/2010/NĐ-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic specimens, and products of genetically modified organisms, and Decree No. 108/2011/NĐ-CP dated November 30, 2011 of the Government amending certain articles of Decree No. 69/2010/NĐ-CP dated June 21, 2010 of the Government on biosafety for genetically modified organisms, genetic specimens, and products of genetically modified organisms.

Article 10. Labeling of goods containing genetically modified organisms and products of genetically modified organisms used as food

1. Organizations and individuals producing and trading food on the market that contain genetically modified organisms or products of genetically modified organisms with at least one genetically modified ingredient accounting for more than 5% of the total ingredients used to produce the food, in addition to complying with the legal regulations on goods labeling, must also include information related to genetically modified organisms on the product label, except for cases specified in clause 2 of this Article.

2. Cases exempt from labeling for goods containing genetically modified organisms or products of genetically modified organisms used as food:

a) Pre-packaged genetically modified foods containing genetically modified ingredients but in which the modified gene or its products are not detectable in the food;

b) Genetically modified fresh food, unpackaged processed genetically modified food directly sold to consumers;

c) Genetically modified food used in emergency cases to overcome natural disasters and epidemics.

Chapter V. ISSUANCE OF FACILITY CERTIFICATES

QUALIFIED FOR FOOD SAFETY

Article 11. Issuance of Certificate of Food Safety Eligibility for Establishments

1. Food production and business establishments must have a Certificate of Food Safety Eligibility when operating, except in cases specified in Clause 1, Article 12 of this Decree.

2. The conditions for granting a Certificate of Food Safety Eligibility for establishments are implemented in accordance with the provisions of Clause 1, Article 34 of the Law on Food Safety. Specifically, for establishments producing health-protective foods, they must comply with the requirements stipulated in Article 28 of this Decree.

Article 12. Establishments not subject to the issuance of a Certificate of Food Safety Eligibility

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

a) Small-scale primary production;

b) Food production and business without a fixed location;

c) Small-scale processing;

d) Small-scale food businesses;

e) Pre-packaged food businesses;

f) Production and business of equipment, materials for packaging and containing food;

g) Restaurants in hotels;

h) Collective kitchens without registration for food business;

i) Street food business;

k) The establishment has been granted one of the following certificates: Good Manufacturing Practice (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 an equivalent valid certificate.

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

Chapter VI. STATE INSPECTION

ON IMPORTED AND EXPORTED FOOD SAFETY

Article 13. Cases exempt from state inspection of imported food safety (except for cases with food safety warnings)

1. Products that have been granted the Certificate of Acceptance of Product Declaration Registration.

Provisions repealed

2. Products carried by the entrant, sent before or after the entrant's trip to serve living needs or travel purposes; gifts within the duty-free limit as prescribed by tax law.

3. Imported products for personal use of individuals entitled to diplomatic privileges and immunities.

4. Transit, transshipment, temporary import, re-export, or sent to bonded warehouses.

5. Products that are test or research samples in quantities appropriate for the purpose of testing or research, with confirmation from an organization or individual.

6. Products used for exhibition or fair display.

7. Products, production materials, imported solely for the production, processing of export goods, or for internal use by an organization or individual, not consumed in the domestic market.

8. Products temporarily imported for sale at duty-free shops.

9. Imported goods serving urgent needs as directed by the Government or the Prime Minister.

Article 14. Requirements for terrestrial animal products, aquatic animal products, and plant products used as imported food

1. Terrestrial animal products, aquatic animal products, and plant products used as imported food, except for processed, pre-packaged food, food exported abroad by Vietnamese organizations or individuals but returned, and cases specified in Article 13 of this Decree, must meet the following requirements:

a) Originates from countries or territories with food safety control systems that meet Vietnamese regulations and are listed by the competent authority of Vietnam as countries or territories allowed to export food of animal, plant, or aquatic origin to Vietnam;

b) For terrestrial animal products used as food and aquatic animal products used as food: They must be produced by production or business establishments recognized by the competent authority of Vietnam as fully meeting the food safety requirements according to Vietnamese regulations;

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

2. The procedures for registering countries, territories, and production or business establishments mentioned in Clause 1 of this Article on the list for export to Vietnam shall be carried out in accordance with the provisions of Article 22 of this Decree.

3. The Ministry of Agriculture and Rural Development is responsible for providing the customs authority with the list of countries, territories, and organizations or individuals authorized to export the above products to Vietnam.

Article 15. State inspection agency for imported food

1. The state inspection agency for imported food is the 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 that an imported shipment contains multiple types of food under the management jurisdiction of multiple ministries, the state inspection agency shall be the agency assigned or designated by the Ministry of Agriculture and Rural Development.

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

a) Decide to apply the method of inspection conversion from the regular inspection method to the reduced inspection method and apply the regular inspection method after 03 (three) consecutive satisfactory inspections for imported food;

b) Conduct food inspection according to the methods and procedures stipulated in this Decree;

c) Comply with sampling and sample preservation according to legal regulations;

d) Collect inspection and testing fees according to the regulations on fees and charges;

e) Ensure professional qualifications, accuracy, honesty, and objectivity when inspecting and certifying food safety for imported batches and items;

f) Be subject to the direction, inspection, and guidance on organization and professional matters from the Ministry of Health, the Ministry of Agriculture and Rural Development, and the Ministry of Industry and Trade;

g) Receiving and resolving complaints from the shipper. If damage is caused to the shipper, the state inspection authority must reimburse the full inspection fee and testing fee, and must also compensate the shipper for any damages (if any) in accordance with the law;

h) Storing inspection records in accordance with legal regulations and presenting stored records when requested by competent authorities;

i) Submit a report every 6 months to the corresponding specialized management authority according to the form specified in Form No. 06 of Appendix I issued together with this Decree or submit an ad-hoc report when there is a warning from the Ministry of Health, Ministry of Agriculture and Rural Development, Ministry of Industry and Trade of Vietnam or from a competent authority abroad or from the manufacturer, or report on the results of handling non-compliant imported food.

Article 16. Inspection methods

The inspection of imported food safety shall be conducted according to one of the following methods:

1. Reduced inspection method, whereby a maximum of 5% of the import lots within one year are inspected based on documents, randomly selected by the customs authority.

2. Regular inspection method, whereby only the documents of the imported lot are inspected.

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

Article 17. Application of inspection methods

1. Reduced inspection applies to consignments or goods in any of the following cases:

a) Confirmed to meet food safety requirements by competent authorities or organizations of a country that has signed an international treaty recognizing mutual inspection activities in which Vietnam is a member; with inspection results from the competent authority of the exporting country for consignments or goods in accordance with Vietnamese law;

b) Have passed 03 (three) consecutive inspections within 12 months using the normal inspection method;

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

2. Normal inspection applies to all goods of imported consignments, except in cases specified in clause 1 and clause 3 of this Article.

3. Strict inspection applies to import shipments or goods in any of the following cases:

a) Shipments or goods did not meet import requirements during the previous inspection;

b) Shipments or goods did not meet requirements in other inspections or checks (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 provincial People's Committee, or from the competent authority abroad or from the manufacturer.

4. Switch from strict inspection to regular inspection in the following cases:

a) For the cases specified in points a and b, clause 3 of this Article, if after applying the strict inspection method three consecutive times, the results meet import requirements;

b) In the case specified in point c, clause 3 of this Article, when there is a written notice to stop strict inspections from the Ministry of Health, the Ministry of Agriculture and Rural Development, or the Ministry of Industry and Trade of Vietnam.

Article 18. Inspection registration dossier

1. The inspection registration dossier under the reduced inspection method includes:

a) Product self-declaration;

b) 03 (three) consecutive notices of confirmed food meeting import requirements under the normal inspection method or a notarized copy or the original legalized by consular of one of the GMP, HACCP, ISO 22000, IFS, BRC, FSSC 22000 certificates or equivalent valid at the time of submission;

c) In the case of products of aquatic and terrestrial animal origin, except for products that have been processed and pre-packaged, a certificate of compliance with food safety regulations issued by the competent authority of the exporting country (original) must be available.

2. The registration dossier for inspection under the normal inspection method and the stringent inspection method includes:

a) Import food inspection registration form as prescribed in Form No. 04 Appendix I issued together with this Decree;

b) Product self-declaration;

c) Three (03) consecutive notifications of results confirming that the food meets import requirements under the stringent inspection method for shipments/items that are switched from stringent inspection to normal inspection (original);

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

d) In the case of products prescribed in Article 14 of this Decree, a certificate of compliance with food safety regulations issued by the competent authority of the exporting country (original copy) is required, except in the case of seafood caught and processed on foreign fishing vessels sold directly to Vietnam.

Article 19. Procedures for inspecting imported food

1. Procedures for inspection in the case of reduced inspection:

a) When carrying out customs procedures, the consignee is responsible for submitting the dossier in accordance with the provisions of Clause 1, Article 18 of this Decree;

b) The customs authority is responsible for randomly selecting up to 5% of the total imported consignments under the reduced inspection category within one (01) year to check the dossiers in accordance with the regulations.

Within 03 (three) working days from the date of receiving the dossier, the customs authority is responsible for checking the dossier and clearing the goods. In case additional documents are required, the reason and legal basis for the request must be clearly stated.

2. Procedure for inspection in the case of regular inspection:

a) Before or when the goods arrive at the border gate, the consignee submits the inspection registration dossier in accordance with the provisions of Clause 2, Article 18 of this Decree to the state inspection authority or the national single-window portal module of the Ministry of Health, the Ministry of Agriculture and Rural Development, and the Ministry of Industry and Trade (if already applied);

b) Within 03 (three) working days from the date of receiving the dossier, the state inspection authority is responsible for checking the dossier and issuing a notification of whether the food meets or does not meet the import requirements according to Form No. 05, Appendix I issued together with this Decree. In case additional documents are required, the reason and legal basis for the request must be clearly stated.

c) The consignor is responsible for submitting the Notification of food import approval results to the customs authority for customs clearance of the goods.

3. Procedures for inspection in the case of strict inspection:

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

b) Within 07 (seven) working days from the date of receipt of the dossier, the state inspection agency is responsible for checking the dossier, taking samples, testing food safety indicators as required, and issuing a notification of whether the food meets or does not meet import requirements according to Form No. 05, Appendix I, issued together with this Decree. In case additional documents are requested, the reasons and legal basis for the request must be clearly stated;

c) The consignor is responsible for submitting the Notification of food import approval results to the customs authority for customs clearance of the goods.

4. In case of issuing a Notification of Non-compliance with Imported Food Requirements as prescribed in point b, clause 2, and point b, clause 3 of this Article, the state inspection agency shall decide on handling measures according to the forms prescribed in clause 3, Article 55 of the Law on Food Safety and report the handling results of non-compliant imported food to the specialized management Ministry.

Article 20. Handling of Imported Food That Fails to Meet Requirements

1. After completing the handling of imported food that fails to meet requirements according to the decision of the state inspection agency, the consignee is responsible for reporting to the state inspection agency and the dossier receiving agency one of the following documents:

a) Re-export certificate in case of applying the re-export form;

b) Destruction minutes certified by the competent authority;

c) Contract for changing the purpose of use between the shipper and the buyer or the transferee of the shipment or goods. The buyer or transferee of the shipment or goods that does not meet import requirements shall not use that shipment or goods as food.

2. After correcting product defects or labeling errors, if intending to import into Vietnam, the shipper is responsible for carrying out the inspection registration procedure in accordance with the provisions of Article 19 of this Decree.

In the case where measures to correct product defects or labeling errors have been applied but the shipment or goods still do not meet import requirements, one of the handling methods provided at points c and d, clause 3, Article 55 of the Law on Food Safety must be applied.

Article 21. Rights and obligations of the shipper

The shipper has the following rights and obligations:

1. The reduced inspection method shall be applied to shipments or imported goods that fall under one of the cases stipulated in Clause 1, Article 17 of this Decree.

2. Request the state inspection agency to review the inspection results or request the agency receiving the product announcement to select a designated testing and verification facility to re-inspect the testing results. If the re-inspection results are consistent with the initial inspection results, the consignee must bear the cost of the re-inspection; if the re-inspection results meet the requirements for imported food, the re-inspection fee paid shall be refunded.

3. Have the right to propose handling measures as prescribed in Clause 3, Article 55 of the Law on Food Safety for shipments or goods that do not meet the requirements for imported food.

4. Ensure the original condition of the shipment or goods for the state inspection agency to collect samples.

5. Implement the decision to handle shipments and items of the competent state inspection agency if the shipments or items do not meet the requirements for imported food.

Article 22. Procedures for registering countries, territories, and production or business establishments on the list of entities allowed to export food to Vietnam and state inspection on food safety in the exporting country.

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

a) The competent authority of the exporting country shall send one (1) set of registration documents to the Ministry of Agriculture and Rural Development, including information about the management system of the country or territory (including the legal system, standards, food safety management organization system) and the food safety control capacity of the national or territorial competent authority of the exporting country according to Form No. 08, Appendix I, issued together with this Decree; a list of food production and business establishments of animal and aquatic origin registered for export to Vietnam according to Form No. 07, Appendix I, and information about the food safety assurance conditions of these production and business establishments according to Form No. 09, Appendix I, issued together with this Decree;

b) Within 30 working days from the date of receiving a complete registration dossier of the list of production and business establishments as prescribed in point a of this clause from the competent authority of the exporting country, the competent authority of the ministry managing the sector shall verify the dossier, notify the competent authority of the exporting country of the verification results and the inspection plan if an inspection is necessary for products exported to Vietnam;

c) The content of the inspection in the exporting country includes: the legal system on food safety management and control; the capacity of the food safety control agencies of the exporting country; the conditions ensuring food safety of the production and business establishments registered to export to Vietnam.

2. The handling of inspection results and the notification of the list of countries, territories, and the list of production and business establishments permitted to export to Vietnam are regulated as follows:

a) In cases where it is not necessary to carry out an actual inspection of the exporting country to Vietnam, the Ministry of Agriculture and Rural Development shall announce the results, the names of countries, and territories allowed to export to Vietnam. Specifically, for terrestrial animal products and aquatic animal products, the announcement must include a list of production and business establishments permitted to export;

b) In cases where it is necessary to carry out an inspection of the exporting country, within 30 working days from the date the inspection in the exporting country is completed, the Ministry of Agriculture and Rural Development shall process and announce the inspection results.

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

c) In the case of a proposal to supplement the list of establishments producing or trading in the export of terrestrial animal products and aquatic animal products to Vietnam, the competent authority of the exporting country shall send a dossier including the list and establishment information according to Form No. 07 and Form No. 08 as prescribed in point a, clause 1 of this Article to the Ministry of Agriculture and Rural Development for dossier verification or actual inspection in the exporting country, based on which a decision will be made on the inclusion in 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 define the authority for state inspection on food safety for exported food under their respective management areas as stipulated in Articles 62, 63, and 64 of the Law on Food Safety upon the request of the importing country.

2. The Ministry of Agriculture and Rural Development is responsible for inspecting export food consignments containing multiple products under the management authority of two or more ministries.

Chapter VII. FOOD LABELING

Article 24. Mandatory labeling content

1. Organizations and individuals producing or trading products in Vietnam, besides complying with the legal regulations on goods labeling, must also comply with the following provisions:

a) Medical nutritional food must include the following phrases: "Medical nutritional food" and "For use by patients under the supervision of healthcare personnel";

b) Foods intended for special dietary use must have the phrase: "Nutritional product (for specific target group)" on the main label to distinguish them from ordinary foods.

2. For imported products, the name of the organization or individual responsible must be indicated on the product label, including: the name and address of the manufacturing organization or individual, and the name and address of the organization or individual that self-declares or registers the product declaration.

Article 25. Exemption of certain mandatory labeling contents

1. Exemption from additional labeling for products carried by individuals entering the country for personal consumption, gifts, or presents within the duty-free quota; imported products of subjects entitled to diplomatic preferences or exemptions; products in transit, transshipment, temporary import, re-export, or sent to bonded warehouses; products that are test or research samples; products that are exhibition samples at fairs or expos; products or production materials imported solely for manufacturing or processing export goods or serving the internal production needs of organizations or individuals without being sold in the domestic market.

2. Except for spices and herbs, for small packages with a maximum surface area of less than 10 cm², there is no requirement to indicate the composition, expiration date, storage instructions, or usage instructions if there is additional labeling or outer packaging that fully displays this information.

3. No need to record the production date for utensils that hold food, packaging materials in direct contact with food.

Chapter VIII. FOOD ADVERTISING

Article 26. Foods must register content before advertising

1. Health protection foods, medical nutrition foods, foods for special dietary purposes.

2. Nutritional products for children up to 36 months old are not subject to the advertising prohibition specified in Article 7 of the Advertising Law.

Article 27. Registration of food advertising content

The registration of food advertising content, in addition to complying with the legal regulations on advertising, must also comply with the following provisions:

1. Before advertising, the organization or individual with the product to be advertised must register the advertising content with the agency that issues the Product Advertisement Registration Receipt according to current regulations.

2. The content of the advertisement must be consistent with the uses and effects of the product as stated in the product declaration. Do not use images, equipment, clothing, names, correspondence of units, medical facilities, doctors, pharmacists, medical staff, thank-you letters from patients, or articles written by doctors, pharmacists, or medical staff to advertise food products.

3. For health supplement foods:

a) Must include the warning "This food is not a medicine and does not have the effect of replacing medicine"; the text must be clear and in a color that contrasts with the background;

b) Advertisements on radio and television must clearly read the warning as specified in point a of this clause;

c) Advertising on television or radio with a duration of less than 15 seconds does not have to read "This food is not a medicine and does not have the effect of replacing medicine," but the warning must still be shown in the advertisement.

4. The registration dossier for advertising content confirmation includes:

a) Application for advertising content confirmation according to Form No. 10, Appendix I, issued together with this Decree;

b) Receipt of product announcement registration and the product announcement confirmed by the competent authority (certified copy by an organization or individual);

c) Product label sample (certified copy by an organization or individual);

d) For advertising on radio and television, a proposed advertising script and the proposed advertising content recorded on video or audio disc must be provided; for advertising on other media, a mock-up (sample content) of the proposed advertisement is required (certified copy by an organization or individual);

đ) For advertising content beyond the effects and features of the product stated in the product announcement, scientific evidence must be provided (certified copy by an organization or individual).

The documents in the application dossier for advertising content confirmation must be presented in Vietnamese; in case there are documents in a foreign language, they must be translated into Vietnamese and notarized.

5. Procedures for granting the Advertising Content Confirmation Certificate:

a) Organizations and individuals with advertising products submit the dossier for advertising content confirmation to the authority that issues the Certificate, which receives the product announcement registration;

b) Within 10 working days from the date of receiving a complete and valid dossier, the receiving authority is responsible for reviewing the dossier and returning the result according to Form No. 11, Appendix I, issued together with this Decree. This time limit is calculated from the date of stamping by the receiving authority if the dossier is sent by mail, or from the date a complete dossier is received on the online public service system.

In case of disagreement with the advertising content of the organization or individual, or requests for amendments or supplements, the agency receiving the application must issue a written document specifying the reasons and legal basis for the request. The agency receiving the application can only request amendments or supplements once.

Within 10 working days from the receipt of the amended or supplemented application, the agency receiving the application shall appraise the application and provide a written response. After 90 working days from the issuance of the official letter requesting amendments or supplements, if the organization or individual does not make the amendments or supplements, the application will no longer be valid.

c) The agencies receiving the application for advertisement content confirmation are responsible for publicly announcing the name and product of the organization or individual that has been granted the Certificate of Advertisement Content Confirmation for food products on their electronic information portal (website) and in the food safety database;

d) Organizations or individuals registering for advertisement content confirmation are responsible for paying the dossier appraisal fee at the agency receiving the application.

6. Organizations or individuals with advertised products; organizations or individuals issuing advertisements may only advertise products that have been granted a Certificate of Advertisement Content Confirmation and may only advertise in accordance with the content that has been confirmed.

Chapter IX. CONDITIONS FOR ENSURING FOOD SAFETY IN

HEALTH SUPPLEMENT PRODUCTION

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

1. Health supplement food production facilities must meet the general conditions for ensuring food safety prescribed in Clause 1, Article 19, Clause 1, Article 20, Clause 1, Article 21 of the Law on Food Safety and the following regulations:

a) A quality management system must be established and maintained to control the production and distribution process in order to ensure that all products manufactured by the facility meet the declared standards and are safe for users until the expiration date;

b) Sufficient staff with professional qualifications suitable for the assigned job positions and 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 must be full-time official staff of the facility and independent of each other. The facility's professional in charge must have at least a university degree in one of the specialties: Medicine, Pharmacy, Nutrition, Food Safety, Food Technology, and must have at least 3 years of work experience in the relevant specialized field;

c) The system of workshops, equipment, and auxiliary facilities is designed, constructed, and installed suitable for the intended purpose, following the one-way principle, easy to clean, preventing and minimizing the risk of confusion, avoiding the accumulation of dirt, contamination, and adverse factors affecting the product, and ensuring daily hygiene maintenance;

d) Fully implement and retain records and documents on production, quality control, and distribution circulation to be able to trace the history of all product batches and records of all other activities carried out at the facility;

đ) All production operations must be carried out according to procedures and instructions. Apply inspection and monitoring measures during production to prevent the risk of confusion, contamination, and cross-contamination. Record the results immediately when performing the operation or immediately after completing the production step into the records;

e) There is a quality control department to ensure that products are manufactured according to appropriate conditions and processes and meet established standards; necessary tests have been carried out; materials are not approved for use, products are not approved for sale before being evaluated as meeting quality requirements; products must be monitored for stability;

g) In the case of testing or contract manufacturing, the contract recipient must have sufficient factories, equipment, and personnel to meet the requirements of the contracting party and comply with the regulations of the competent authority regarding the conditions for testing or manufacturing health supplements;

h) There must be a procedure stipulating the resolution of complaints, product recalls, and self-inspection activities; the procedure must be followed and full records must be kept for these activities.

2. The Ministry of Health guides Good Manufacturing Practice (GMP) for health supplements so that health supplement manufacturing facilities can implement it.

3. From July 1, 2019, health supplement manufacturing facilities must apply Good Manufacturing Practice (GMP) for health supplements according to the guidance of the Ministry of Health.

Article 29. Dossiers, procedures, and authority for issuance and re-issuance of Certificates of Eligibility for Food Safety Meeting Good Manufacturing Practice (GMP) Requirements for Health Supplement Foods

1. The dossier for issuing the Certificate of Eligibility for Food Safety Meeting Good Manufacturing Practice (GMP) Requirements for Health Supplement Foods includes:

a) An application for the Certificate of Eligibility for Food Safety Meeting Good Manufacturing Practice (GMP) Requirements for Health Supplement Foods according to Form No. 12, Appendix I issued together with this Decree;

b) A diagram of the production areas and production lines (certified by an organization or individual);

c) A list of the main equipment used at the facility (certified by an organization or individual).

2. Procedure for issuing the Certificate of Eligibility for Food Safety Meeting Good Manufacturing Practice (GMP) Requirements for Health Supplement Foods

a) Establish a dossier in accordance with the provisions of clause 1 of this Article and submit it through the online public service system, by postal mail, or directly to the Ministry of Health;

b) Within 15 working days from the date of receiving a complete valid dossier, the receiving agency is responsible for establishing an appraisal team and conducting an on-site evaluation at the facility and preparing the Appraisal Minutes according to Form No. 13 Appendix I issued together with this Decree.

The appraisal team shall consist of at least 5 members, including at least 2 members with experience in good manufacturing practice (GMP), and 1 member specialized in testing;

c) In the case that the appraisal results meet the requirements, the agency receiving the application shall issue a Certificate of Eligibility for Food Safety according to Good Manufacturing Practices (GMP) for health protection foods in the form of Form No. 14 Appendix I enclosed with this Decree. The time to issue the Certificate of Eligibility for Food Safety according to Good Manufacturing Practices (GMP) for health protection foods shall not exceed 30 working days from the date of receipt of a complete and valid application;

d) In case the assessment results at the facility do not meet the requirements, the Assessment Team shall clearly record the non-compliant content in the assessment minutes for the facility to remedy. After remediation, the facility shall send a written notification of the remediation results to the Assessment Team. Within 07 (seven) working days from the date of receiving the written notification of the remediation results, the Assessment Team is responsible for reviewing it to submit to the Ministry of Health for the issuance of a Certificate of Eligibility for Food Safety meeting the requirements of Good Manufacturing Practice (GMP) for health supplements. If, after 03 (three) months from the date of completion of the assessment, the facility does not complete the remediation as required and notify the Assessment Team of the remediation results, the dossier for issuing the Certificate of Eligibility for Food Safety meeting the requirements of Good Manufacturing Practice (GMP) for health supplements shall no longer be valid.

3. The certificate of a facility meeting the food safety conditions and complying with Good Manufacturing Practices (GMP) for health supplements is valid for 03 (three) years from the date of issue. Before 06 months prior to expiration, the facility is responsible for submitting the application for re-issuance of the certificate of a facility meeting the food safety conditions and complying with Good Manufacturing Practices (GMP) for health supplements. The documents and procedures for re-issuance shall be carried out in accordance with the provisions in Clauses 1 and 2 of this Article.

4. Organizations and individuals requesting the issuance of a certificate of a facility meeting the food safety conditions and complying with Good Manufacturing Practices (GMP) for health supplements are responsible for paying the dossier appraisal fee at the agency receiving the application.

Chapter X. CONDITIONS FOR ENSURING FOOD SAFETY IN PRODUCTION,

BUSINESS AND USE OF FOOD ADDITIVES

Article 30. Regulations on conditions for ensuring food safety for food additives

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

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

2. Only mix food additives when these additives are on the list of substances permitted for use in food by the Ministry of Health, and the final product of the mixture does not cause any harm to human health; in the case of creating a new product with a new effect, it is necessary to prove the effect, usage target, and maximum usage level.

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

Article 31. Regulations on single-substance food additives

1. Food additives listed in the category of additives allowed for use in food as prescribed by the Ministry of Health are subject to self-declaration.

2. The procedure for self-declaration of products for single-ingredient food additives is carried out in accordance with the provisions of Article 5 of this Decree.

Article 32. Regulations on mixed food additives with new functions

1. Mixed food additives with new functions must have a product declaration registered with the Ministry of Health.

2. Mixed food additives with new functions must have each additive listed with its quantitative composition in the ingredients.

3. Procedure for registering a product announcement for mixed food additives with new functions according to the provisions of Articles 7 and 8 of this Decree.

Article 33. Regulations on the use of food additives

Organizations and individuals producing or trading products are responsible for:

1. Only using food additives from the list of additives permitted for use in food as prescribed by the Ministry of Health. In case the food additive is not included in the list of additives permitted for use in food or is not used for the target objects prescribed by the Ministry of Health; organizations and individuals producing or trading food additives must register a product announcement with the Ministry of Health according to the provisions of Articles 7 and 8 of this Decree.

2. Use food additives not exceeding the maximum allowable usage; for the correct type of food; with clear origin and source; within the expiration date; fully meeting management requirements and technical requirements for food additives.

Chapter XI. FOOD TRACEABILITY

Article 34. Traceability for unsafe products

When detecting food products produced or traded that are not guaranteed to be safe, or when requested by competent state agencies, organizations and individuals producing or trading the products must be responsible for carrying out traceability in accordance with the provisions of Clause 1 and Clause 2, Article 54 of the Law on Food Safety.

Article 35. Implementing traceability for unsafe products

1. Organizations and individuals producing or trading products must store information related to the manufacturer, product supplier, and customers in case the customers have purchased those products through contracts, records, or other methods to serve the purpose of traceability. Information for traceability includes:

a) Name, type of product purchased or sold;

b) Date, month, year, quantity, weight, batch number, and lot number of the product (if any) purchased or sold.

2. The Minister of Health, the Minister of Agriculture and Rural Development, and the Minister of Industry and Trade shall specifically regulate product traceability for products in the fields under their management.

Chapter XII. ALLOCATION OF STATE MANAGEMENT RESPONSIBILITIES

ABOUT FOOD SAFETY

Article 36. Principles of allocation of state management responsibilities for food safety

1. Based on the provisions of the Law on Food Safety and ensuring compliance with relevant legal documents.

2. Based on the unified state management of food safety.

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

4. Close coordination between ministries and sectors.

5. Ensuring the principle of one-stop, one product, one production or business facility is subject to management by only one state management agency.

6. Ensuring scientific, complete, and feasible measures.

7. Decentralization of state management between the central government and local authorities at all levels in state management of food safety.

8. For production facilities producing multiple types of food products under the authority of two or more specialized management agencies, the management agency for the product with the largest output among the facility's products is the responsible management agency.

9. For establishments that do not carry out production stages but trade in multiple types of food products under the management authority of two or more specialized management agencies governed by the Ministry of Industry and Trade, except in the case of wholesale markets or agricultural product auctions.

10. For establishments that both produce and trade in multiple types of products under the management authority of two or more specialized management agencies, organizations or individuals have the right to choose the specialized food safety management agency to carry out administrative procedures.

Article 37. State management responsibilities for food safety of the Ministry of Health

1. Implementing the provisions on general responsibilities in state management of food safety as prescribed in Clause 1, Article 62 of the Law on Food Safety.

2. Periodically and unexpectedly report to the Government on food safety management based on monitoring and aggregating reports from specialized management ministries and provincial People's Committees.

3. Issue national technical standards for products in the fields assigned for management as stipulated in Article 62 of the Law on Food Safety and the product groups in Appendix II issued together with this Decree; issue national technical standards or regulations on safety limit levels for product groups at the proposal of the specialized management ministries.

4. Manage food safety throughout the process of production, processing, preservation, transportation, export, import, business, and production and business establishments for food products specified in Appendix II issued together with this Decree.

5. Organize the reception and management of dossiers, issue the Receipt for Product Announcement Registration, Certificate of Eligibility for Food Safety for: health supplements, mixed food additives with new uses, food additives not listed in the permitted substances or used incorrectly in food as regulated by the Ministry of Health; Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements; Advertising Content Confirmation for health supplements; Certificate of Free Sale for products under the assigned management field, Medical Certificate.

6. Designate food testing facilities serving state management, verification testing facilities within the assigned management scope; designate facilities for arbitration testing and final conclusions when there are discrepancies in test results of food testing facilities within and outside the Health sector.

7. Designate state inspection agencies for imported food safety regarding products under the assigned management field.

Article 38. Responsibilities of the Ministry of Agriculture and Rural Development for state management of food safety

1. Issue national technical standards for products in the management field as prescribed in Article 63 of the Law on Food Safety and product groups in Appendix III issued together with this Decree.

2. Develop and submit to the Ministry of Health to issue regulations on safety limit levels for product groups in Appendix III issued together with this Decree.

3. Management and delegation of food safety management for primary production of agricultural, forestry, aquatic products, and salt include: the processes of cultivation, livestock raising, harvesting, fishing, exploitation of agricultural, forestry, aquatic products; salt production.

4. Management and delegation of food safety management throughout the processes of production, collection, slaughtering, preliminary processing, processing, preservation, transportation, export, import, and trading for products and establishments producing and trading the food products specified in Appendix III issued together with this Decree.

5. Organize the issuance of Certificates of Free Sale for products within the assigned management sector.

6. Organize the issuance and delegation of the issuance of Certificates of Food Safety Eligibility to organizations and individuals producing and trading products within the assigned management sectors as specified in clauses 3 and 4 of this Article.

7. Food safety management for wholesale markets and agricultural product auction markets.

8. Designate food testing facilities serving state management, verification testing facilities; provide the final conclusion when there is a difference in test results between testing facilities under the assigned management field.

9. Designate state inspection agencies for food safety of imported products in the field assigned for management.

10. Announce the list of countries, territories, and the list of production and business establishments permitted to export to Vietnam in the assigned field of management.

Article 39. Responsibilities of the Ministry of Industry and Trade for state management of food safety

1. Issue national technical regulations for products in the field assigned for management as prescribed in Article 64 of the Law on Food Safety and product groups in Appendix IV issued together with this Decree.

2. Develop and submit to the Ministry of Health for issuance regulations on safety limit levels for product groups listed in Appendix IV issued together with this Decree.

3. Manage and decentralize food safety management throughout the process of production, processing, preservation, transportation, export, import, and business for products and production and business establishments of food products specified in Appendix IV issued together with this Decree.

4. Manage food safety for supermarkets, shopping centers, convenience stores, establishments belonging to the reserve and distribution systems, and other types of business.

5. Organize the issuance of Certificates of Free Circulation for products under the assigned management sector.

6. Organize the issuance and decentralization of issuing certificates of food safety eligibility for organizations and individuals producing and trading products under the assigned management sector.

7. Carry out inspections for the prevention of counterfeit food and commercial fraud in the market for all types of food, food additives, food processing aids, utensils, packaging materials, and food containers.

8. Designate food testing facilities serving state management, verification testing facilities; provide the final conclusion when there is a difference in test results between testing facilities under the assigned management field.

9. Designate state inspection agencies for food safety of imported products in the field assigned for management.

Article 40. State management responsibilities for food safety of the Provincial People's Committee

1. Implement state management of food safety at the local level, being responsible to the Government for food safety in the locality. The chairman of the provincial-level People's Committee directly performs the role of Head of the inter-sectoral steering committee on provincial or centrally-run city food hygiene and safety; proactively organize inspection, supervision, and monitoring forces to ensure food safety in the area; directly direct and regularly urge and inspect the compliance with food safety laws by subordinate state agencies; handle officials and civil servants who are negligent or fail to manage the areas assigned to them; organize the resolution of complaints and denunciations, handle violations of food safety laws according to legal regulations; be responsible to the Government and the law for any violations of food safety laws that occur in the area.

2. Organize the implementation of the regulations of the Government and ministries on food safety in the locality.

3. Organize and direct the Intersectoral Steering Committee on provincial/centrally-run city food hygiene and safety.

4. Organize propaganda and mobilization for the implementation of legal regulations to ensure food safety in the locality.

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

6. Be responsible for managing food safety in the locality; manage conditions ensuring food safety for small-scale food production and business establishments, street food, catering service businesses, food safety in local markets, and subjects under the management decentralization.

7. Develop and promulgate local technical standards on food safety for local specialty food products.

8. Organize the reception and management of dossiers, issue the Receipt of Product Registration for announcement, and the Confirmation of Advertising Content for medical nutritional products, foods for special dietary uses, and nutritional products for children up to 36 months old.

9. Organize the reception of self-declared product documents; certify establishments meet food safety conditions according to assignment and delegation.

Article 41. Coordination in food safety assurance activities

1. Sectoral management ministries, within the scope of their state management, are responsible for coordinating with the Ministry of Health in implementing state management activities to ensure unified and effective state management of food safety.

2. The Ministry of Health shall take the lead in developing information, education, and communication programs on food safety, while the Ministry of Agriculture and Rural Development, the Ministry of Industry and Trade, and other ministries and sectors according to their functions and duties are responsible for coordinating with the Ministry of Health to implement the information, education, and communication programs on food safety.

3. The Ministry of Health, the Ministry of Agriculture and Rural Development, and the Ministry of Industry and Trade are responsible for taking the lead in developing programs and plans, and implementing inspection and examination activities for products under their assigned management areas, while other ministries and sectors are responsible for coordinating.

4. In the event of food poisoning, the Ministry of Health is responsible for organizing emergency response and timely treatment for those affected by food poisoning. The specialized management ministry is responsible for providing complete records and information related to the origin of food suspected of causing poisoning within its assigned management sector; coordinating with the Ministry of Health to investigate the cause and taking the lead in tracing the origin and handling of the food causing poisoning within its assigned management sector.

5. When food products within the management area of another ministry or sector are found to be in violation and pose a serious risk to consumer health, the Ministry of Health takes the lead, coordinating with the relevant management ministries to conduct inspections, checks, and conclusions.

Chapter XIII. IMPLEMENTATION PROVISIONS

Article 42. Transitional provisions

1. Products that have been granted the Certificate of Conformity Announcement and the Certificate of Food Safety Conformity Announcement prior to the effective date of this Decree may continue to be used until the expiration date stated on the certificate and the product's shelf life.

2. Management agencies, within their scope, duties, and powers, shall review and announce the invalidity of regulations contrary to this Decree.

Article 43. Effectiveness

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 articles of the Food Safety Law; abolishes Chapter II of the Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT dated April 9, 2014 of the Ministry of Health, Ministry of Agriculture and Rural Development, and Ministry of Industry and Trade guiding the assignment and coordination in state management of food safety.

Article 44. Responsibility for Implementation

Ministers, heads of ministerial-level agencies, heads of agencies under the Government, Chairpersons of the People's Committees of provinces and centrally-run cities, and relevant organizations and individuals shall be responsible for implementing this Decree./.

APPENDIX I

(Attached to Government Decree No. 15/2018/NĐ-CP dated February 02, 2018)

Form No. 01

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

-------------

PRODUCT SELF-DECLARATION

Number: ………………/Business Name/Year of Declaration

I. Information about the organization or individual self-declaring the product

Name of the organization or individual: .......................................................................................................

Address: ..............................................................................................................................

Phone: …………………………………………….. Fax: ................................................

E-mail.................................................................................................................................

Business registration number:..........................................................................................................

Certificate number of eligible food safety establishment: ……………….. Date of Issue/Place of Issue: ……………. (for establishments required to be issued a certificate of eligibility for food safety according to regulations)

II. Product information

1. Product name: ................................................................................................................

2. Ingredients: ....................................................................................................................

3. Product shelf life: ..........................................................................................

4. Packaging specifications and packaging materials: ...........................................................................

5. Name and address of the product manufacturing facility (in case of outsourcing production): ..................

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

III. Product label sample (attach a product label sample or a proposed product label sample)

IV. Food safety requirements

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

- National technical regulation No....; or

- Circulars of ministries or sectors; or

- Local technical regulations; or

- National standards (in cases where there are no national technical regulations, Circulars of Ministries and Agencies, local technical regulations); or

- Standards of the Codex Alimentarius Commission (Codex), regional standards, foreign standards (in cases where there are no national technical regulations, Circulars of Ministries and Agencies, local technical regulations, national standards); or

- Accompanying manufacturer standards (in cases where there are no national technical regulations, Circulars of Ministries and Agencies, local technical regulations, national standards, standards of the Codex Alimentarius Commission (Codex), regional standards, foreign standards).

We commit to fully complying with the legal regulations on food safety and take full responsibility for the legality of the product announcement dossier as well as the quality and safety of the announced product./.

Form No. 02

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

-------------

PRODUCT ANNOUNCEMENT FORM

No.:……………….

I. Information about the organization or individual announcing the product

Name of organization or individual: ..........................................................................................

Address: .................................................................................................................................

Phone: ……………………………………… Fax: ..........................................................

E-mail ..................................................................................................................................

Business registration number: ..........................................................................................................

Certificate of food safety eligibility number: ………………… Date of issue/Place of issue: .........

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

(for establishments required to be issued a Certificate of Food Safety Eligibility according to regulations)

II. Product information

1. Product name: ..................................................................................................................

2. Ingredients: .....................................................................................................................

3. Main quality indicators that create the product's efficacy (for health supplements):

4. Product shelf life: ...........................................................................................

5. Packaging specifications and packaging material: ............................................................................

6. Name and address of the product manufacturing facility: ........................................................................

III. Product label sample (attach a product label sample or a proposed product label sample)

IV. Food safety requirements

Organizations or individuals producing or trading food that meets food safety requirements according to:

- National technical regulation No....; or

- Circulars of ministries or sectors; or

- Local technical regulations; or

- National standards (in cases where there are no national technical regulations, Circulars of Ministries and Agencies, local technical regulations); or

- Standards of the Codex Alimentarius Commission (Codex), regional standards, foreign standards (in cases where there are no national technical regulations, Circulars of Ministries and Agencies, local technical regulations, national standards); or

- Accompanying manufacturer standards (in cases where there are no national technical regulations, Circulars of Ministries and Agencies, local technical regulations, national standards, standards of the Codex Alimentarius Commission (Codex), regional standards, foreign standards).

We hereby commit to fully comply with all legal regulations on food safety and take full responsibility for the legality of the declaration dossier and the quality and safety of the declared product, and will only put the product into production and business after receiving the Product Declaration Registration Receipt./.

Form No. 03

PRODUCT DECLARATION REGISTRATION RECEIPT

No.: /year/PD

……… (Name of the agency receiving the product announcement registration)……. confirms having received the Product Announcement of: ………………………. (name of the organization or individual) address……………………………….. phone, ……………………. Fax……………………….. Email …………………………… for the product:………………………. manufactured by ……………………….. (name, address of the manufacturer and country of origin) ……………., in accordance with technical standards/regulations/standards... (number, symbol, name) ……………………….

The enterprise must be fully responsible for the conformity of the announced product./.

Form No. 04

IMPORT FOOD INSPECTION REGISTRATION CERTIFICATE

No ..../20..../IFC

1. Name, address, phone number of the consignor: .............................................................................

2. Name, address, phone number of the trader responsible for the quality of goods: ................................................................

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

3. Name, address, phone number of the exporting trader: .......................................................

4. Expected import time: ..........................................................................................

5. Departure border gate: ....................................................................................................................

6. Arrival border gate: .................................................................................................................

7. Inspection time: ...........................................................................................................

8. Inspection location: .............................................................................................................

9. Expected name of the inspecting authority: ..........................................................................................

10. Detailed information of the shipment:

* The document number confirming the inspection method is the notification number from the competent authority notifying that the goods are inspected according to the inspection method.

Form No. 05

NOTICE OF FOOD CONFIRMATION RESULTS MEETING/

NOT MEETING IMPORT REQUIREMENTS

No ……/20…../TBNK

1. Name, address, phone number of the consignor: .............................................................................

2. Name, address, phone number of the trader responsible for the quality of goods: .....

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

3. Name, address, phone number of the exporting trader: .......................................................

4. Customs declaration number: ..............................................................................................

5. Departure border gate: ....................................................................................................................

6. Port of entry: ..................................................................................................................

7. Inspection time: ..............................................................................................................

8. Inspection location: .............................................................................................................

9. Detailed information of the shipment:

Form No. 06

REPORT

On the implementation of state inspection of imported food

From date ..../…./… to ……../……../……..

Name of inspection agency: .......................................................................................................

Address: ..............................................................................................................................

Phone number: ……………………………………………. Fax number: .........................................

Name of reporting officer: ....................................................................................................

I. CONTENT OF IMPLEMENTATION:

A. General Information:

B. Statistics Table of Batches and Items Failing Import Requirements

II. RECOMMENDATIONS:

Form No. 07

LIST OF FOOD PRODUCTION AND BUSINESS ENTERPRISES REGISTERING TO EXPORT TO VIETNAM

Form No. 08

INFORMATION ON MANAGEMENT SYSTEM AND FOOD SAFETY CONTROL CAPACITY OF THE COMPETENT AUTHORITY OF THE EXPORTING COUNTRY

1. Organizational system and management apparatus:

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

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

2. Task-executing personnel (number, qualifications, technical training courses…):

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

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

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

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

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

4. System for inspecting and monitoring residues, pathogenic microorganisms... for production and business establishments:

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

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

5. Program for inspecting and monitoring food safety:

Form No. 09

SUMMARY INFORMATION ON FOOD SAFETY CONDITIONS OF THE PRODUCTION AND BUSINESS ESTABLISHMENT

1. Name of the production or business establishment: .....................................................................................

2. Address: .............................................................................................................................

3. Products: .......................................................................................................................

4. Description of the production process: .................................................................................................

5. Quality management system applied: ..................................................................................

Form No. 10

REGISTRATION FORM

Confirmation of advertising content

To: 2 ………………………………………………….

1. Name of the unit registering for confirmation: .......................................................................................

2. Headquarters address:3 ..............................................................................................................

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

Phone: ………………………………….. Fax: ................................................................

Request to register for confirmation of advertising content for:

Advertising media: .....................................................................................................

The file includes documents, materials: ...................................................................................

I hereby certify that the above information and documents are true and commit to advertising food products in accordance with the content once it has been approved.

I respectfully request your agency to review and issue a certificate confirming the advertising content./.

_________________

1. Place name

2. Agency receiving the application: The competent authority specified in Articles 37 and 40 of this Decree.

3. Record according to the address on the business registration certificate

Form No. 11

ADVERTISING CONTENT CONFIRMATION CERTIFICATE

Name of organization or individual: .........................................................................................................

Address: ................................................................................................................................

Phone: ……………………………………………………. Fax: .........................................

Advertising media:

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

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

Contains advertising content (attached) that has been approved to comply with current regulations.

Request organizations, individuals to be responsible for advertising in accordance with the confirmed content.

________________

1 Abbreviation of the authority confirming the content

Form No. 12

SOCIALIST REPUBLIC OF VIETNAM

Independence - Freedom - Happiness

-------------

APPLICATION

For issuance of Certificate of Food Safety Compliance for health food production facilities meeting Good Manufacturing Practice (GMP) requirements

To:………………….

Name of organization or individual: .........................................................................................................

Address: ................................................................................................................................

Business registration number: ..........................................................................................................

Name, address of the production facility: ................................................................................................

Request for the issuance of a Certificate of Eligibility for Food Safety complying with Good Manufacturing Practice (GMP) for health protection food./.

Form No. 13

APPRAISAL MINUTES

Food safety conditions for establishments meeting Good Manufacturing Practice (GMP) for health supplements

Implemented according to Decision No., dated.... month… year.... of…………………….

Today, day.... month…. year….., the appraisal team includes:

1. Head of the team (full name, position, agency/unit): ............................................................

2. Team secretary (full name, position, agency/unit): .............................................................

3. Members (full name, position, agency/unit): ...............................................................

Conducting appraisal of food safety conditions for the establishment applying Good Manufacturing Practice (GMP) for health supplements at ………………..

Representative of the organization or individual:

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

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

GENERAL INFORMATION

1. Information about the establishment requesting the Certificate:

- Name, address of the production facility: ..............................................................................................

- Enterprise code: .................................................................................................................

- Legal representative: ......................................................................................................

2. Information about the evaluation session:

- Evaluation time: .............................................................................................................

- Time of the most recent evaluation: .............................................................................

- Evaluation method: Listening to reports, reviewing actual conditions, and cross-checking documents to assess compliance with the principles and GMP regulations issued together with Decision No. ……/QĐ-BYT dated …../……/20……

- Scope of appraisal: According to the application file of (name of establishment) dated ……/…../……

APPRAISAL RESULTS

I. Actual observations

1. Facilities and equipment: ......................................................................................

2. Sanitation conditions and control of sanitation status: ...........................................................

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 establishment is competent to perform.

5. Records and documents: ..................................................................................................................

6. Other contents prescribed in the Good Manufacturing Practice (GMP) guidance documents: ...........

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

II. Existing issues and classification of issues

III. Conclusion

IV. Opinions of the facility being evaluated

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

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

The minutes are agreed upon by all parties and made into 03 (three) identical copies, with the facility being evaluated keeping 01 copy, the evaluation team keeping 01 copy, and the competent authority keeping 01 copy.

1. Head of the team:

2. Secretary of the team:

3. Member:

Form No. 14

CERTIFICATE

FACILITY MEETS FOOD SAFETY REQUIREMENTS

NAME OF THE FACILITY

ADDRESS

MEETING GOOD MANUFACTURING PRACTICE (GMP) REQUIREMENTS

HEALTH SUPPLEMENT FOODS

FOR THE FOLLOWING TYPES OF PRODUCTS:

…………………………………………………………………………………….

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

APPENDIX II

LIST OF FOOD PRODUCTS/PRODUCT GROUPS; GOODS UNDER THE MANAGEMENT AUTHORITY OF THE MINISTRY OF HEALTH

(Attached to Government Decree No. 15/2018/NĐ-CP dated February 02, 2018)

APPENDIX III

LIST OF FOOD PRODUCTS/PRODUCT GROUPS; GOODS UNDER THE MANAGEMENT AUTHORITY OF THE MINISTRY OF AGRICULTURE AND RURAL DEVELOPMENT

(Attached to Government Decree No. 15/2018/NĐ-CP dated February 02, 2018)

APPENDIX IV

LIST OF FOOD PRODUCTS/PRODUCT GROUPS; GOODS UNDER THE MANAGEMENT AUTHORITY OF THE MINISTRY OF INDUSTRY AND TRADE

(Attached to Government Decree No. 15/2018/NĐ-CP dated February 02, 2018)