Decree No. 15/2018/ND-CP

DECREE

DETAILING THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE LAW ON FOOD SAFETY

Pursuant to the Law on Organisation of the Government dated 19 June 2015;

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

At the request of the Minister of Health;

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

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Decree details the implementation of a number of articles of the Law on Food Safety regarding:

1. The procedure for self-declaration of products.

2. The procedure for registering a product declaration.

3. Ensuring the safety of genetically modified food.

4. The issuance of Certificates of Eligibility for Food Safety.

5. State inspection of the safety of imported and exported food.

6. Food labelling.

7. Food advertising.

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

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

10. Food traceability.

11. The assignment of responsibilities for state management of food safety.

Article 2. Subjects of application

This Decree applies to Vietnamese agencies, organisations and individuals; foreign organisations and individuals in Viet Nam engaged in food production and trading; and organisations and individuals engaged in activities relating to food safety in Viet Nam (hereinafter collectively referred to as organisations and individuals).

Article 3. Interpretation of terms

In this Decree, the terms below are construed as follows:

1. Health supplement (Health Supplement, Dietary Supplement) means a product used to supplement the daily diet in order to maintain, enhance or improve the functions of the human body and to reduce the risk of disease. A health supplement contains one or more of the following substances or mixtures of substances:

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

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

c) Synthetic sources of the ingredients referred to in Points a and b above.

A health supplement is presented in a processed form such as capsules, pills, tablets, granules, powders, liquids and other dosage forms, and is divided (for use) into small dose units.

2. Medical nutritional food, also known as food for special medical purposes (Food for Special Medical Purposes, Medical Food), means food that may be taken orally or by tube feeding, is prescribed to adjust a patient's diet and may be used only under the supervision of a health worker.

3. Food for special dietary uses (Food for Special Dietary Uses), for persons on special diets, elderly persons and other special subjects as prescribed by the Codex Alimentarius Commission (CODEX), means food processed or formulated to a special formula in order to meet the particular dietary requirements arising from the user's physical condition or pathological state and specific disorders. The composition of such food must differ markedly from the composition of ordinary food of the same nature, if any.

4. Scientific evidence means scientific information and materials from scientific research works accepted by the competent State authority for scientific research, or published in domestic or foreign scientific journals, or materials on traditional medicine, medicinal plants and medicinal substances published in scientific publications.

5. Goods owner means the organisation or individual responsible for the goods in the dossiers for product declaration/self-declaration, or the organisation or individual authorised to import or export the food product.

6. Exported or imported item means food products of the same kind, the same name, goods label, goods producer and packaging material.

7. Exported or imported consignment means all the food products of one import or export shipment (having the same bill of lading number). A consignment may comprise only one item or several items.

8. Small-scale primary production establishment means an establishment growing, raising, gathering, catching or exploiting food raw materials on a household or individual-household scale, with or without an enterprise registration certificate.

9. Small-scale preliminary processing establishment means a food preliminary processing establishment on a household or individual-household scale, with or without an enterprise registration certificate.

10. Small-scale food trading establishment means an establishment for which an individual, a group of individuals or a household has registered a business household, and an establishment not issued with a Business Registration Certificate, an Enterprise Registration Certificate or an Investment Certificate in accordance with the law.

Chapter II

PROCEDURE FOR SELF-DECLARATION OF PRODUCTS

Article 4. Self-declaration of products

1. Organisations and individuals producing and trading food shall self-declare processed pre-packaged food, food additives, food processing aids, food containers and packaging materials in direct contact with food (hereinafter collectively referred to as products), except for the products prescribed in Clause 2 of this Article and in Article 6 of this Decree.

2. Products and raw materials produced or imported solely for the production or processing of exported goods, or serving the internal production of the organisation or individual and not consumed on the domestic market, are exempt from the procedure for self-declaration of products.

Article 5. Dossier and order of self-declaration of products

1. The dossier for self-declaration of products comprises:

a) The product self-declaration, using Form No. 01 of Appendix I promulgated together with this Decree;

b) The food safety testing result sheet for the product, issued within 12 months up to the date of submission of the dossier by a designated testing laboratory or a testing laboratory accredited to ISO 17025, covering the safety indicators promulgated by the Ministry of Health under the principle of risk management consistent with international regulations, or the safety indicators under the corresponding technical regulations and standards declared by the organisation or individual where the Ministry of Health has not yet issued regulations (original or certified copy).

2. Self-declaration of products shall be carried out in the following order:

a) The organisation or individual shall self-declare the product in the mass media or on its own website, or post it publicly at its office, and shall submit 01 (one) copy by post or directly to the competent State management authority designated by the People's Committee of the province or centrally run city (hereinafter collectively referred to as the provincial-level People's Committee);

b) Immediately after self-declaring the product, the organisation or individual has the right to produce and trade the product and is fully responsible for the safety of that product;

c) The competent State management authority shall receive the organisation's or individual's self-declaration for record-keeping and shall publish the name of the organisation or individual and the names of the self-declared products on the website of the receiving authority.

Where an organisation or individual has 02 (two) or more production establishments producing the same product, the organisation or individual shall submit the dossier to only one local State management authority in a locality where a production establishment is located, as chosen by the organisation or individual. Once a State management authority has been chosen for submission of the dossier, subsequent self-declarations must be submitted to the authority previously chosen.

3. The documents in the self-declaration dossier must be in Vietnamese; where there are documents in a foreign language, they must be translated into Vietnamese and notarised. The documents must be valid at the time of self-declaration.

4. Where there is a change in the product name, origin or composition, the organisation or individual must self-declare the product again. In other cases of change, the organisation or individual shall notify the competent State management authority in writing of the contents of the change and may produce and trade the product immediately after sending the notice.

Chapter III

PROCEDURE FOR REGISTERING A PRODUCT DECLARATION

Article 6. Registration of a product declaration

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

1. Health supplements, medical nutritional food and food for special dietary uses.

2. Nutritional products for children up to 36 months of age.

3. Mixed food additives with a new use, and food additives not on the list of additives permitted for use in food or not for the correct subjects of use as prescribed by the Ministry of Health.

Article 7. Dossier for registering a product declaration

1. The dossier for registering a product declaration for an imported product comprises:

a) The product declaration prescribed in Form No. 02 of Appendix I promulgated together with this Decree;

b) The Certificate of Free Sale, the Certificate of Exportation or the Health Certificate issued by the competent authority of the country of origin/export, stating that the product is safe for users or is freely sold on the market of the producing/exporting country (consularly legalised);

c) The food safety testing result sheet for the product, issued within 12 months up to the date of submission of the dossier by a designated testing laboratory or a testing laboratory accredited to ISO 17025, covering the safety indicators promulgated by the Ministry of Health under the principle of risk management consistent with international regulations, or the safety indicators under the corresponding technical regulations and standards declared by the organisation or individual where the Ministry of Health has not yet issued regulations (original or certified copy);

d) Scientific evidence proving the use of the product or of the ingredient creating the declared use (original or copy certified by the organisation or individual). Where scientific evidence on the use of an ingredient of the product is used to establish the use of the product, the daily dose of the product must be at least equal to 15% of the amount of that ingredient used as stated in the material;

đ) The Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements, or an equivalent certification, where the imported product is a health supplement, applicable from 01 July 2019 (copy certified by the organisation or individual).

2. The dossier for registering a product declaration for a domestically produced product comprises:

a) The product declaration prescribed in Form No. 02 of Appendix I promulgated together with this Decree;

b) The food safety testing result sheet for the product, issued within 12 months up to the date of submission of the dossier by a designated testing laboratory or a testing laboratory accredited to ISO 17025, covering the safety indicators promulgated by the Ministry of Health under the principle of risk management consistent with international regulations, or the safety indicators under the corresponding technical regulations and standards declared by the organisation or individual where the Ministry of Health has not yet issued regulations (original or certified copy);

c) Scientific evidence proving the use of the product or of the ingredient creating the declared use (original or copy certified by the organisation or individual). Where scientific evidence on the use of an ingredient of the product is used to establish the use of the product, the daily dose of the product must be at least equal to 15% of the amount of that ingredient used as stated in the material;

d) The Certificate of Eligibility for Food Safety, where the establishment is required to be issued with a Certificate of Eligibility for Food Safety under the regulations (copy certified by the organisation or individual);

đ) The Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements, where the domestically produced product is a health supplement, applicable from 01 July 2019 (copy certified by the organisation or individual).

3. The documents in the dossier for registering a product declaration must be in Vietnamese; where there are documents in a foreign language, they must be translated into Vietnamese and notarised. The documents must be valid at the time of submission of the dossier for registering the product declaration.

Article 8. Order of registering a product declaration

1. An organisation or individual producing or trading food shall submit the dossier for registering a product declaration through the online public service system, by post or directly to the dossier-receiving authority in accordance with the following provisions:

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

b) Submission to the competent State management authority designated by the provincial-level People's Committee for medical nutritional food, food for special dietary uses, and nutritional products for children up to 36 months of age;

c) Where an organisation or individual produces several types of food falling within the competence of both the Ministry of Health and the competent State management authority designated by the provincial-level People's Committee to receive dossiers for registering product declarations, the organisation or individual has the right to choose to submit the dossier to the Ministry of Health, or to submit the registration dossier to whichever authority is competent to receive the registration dossier for the product concerned.

Where an organisation or individual has 02 (two) or more production establishments producing the same product, the organisation or individual shall carry out the procedure for registering the product declaration at only one local State management authority in a locality where a production establishment is located, as chosen by the organisation or individual (except for products registered with the Ministry of Health). Once a State management authority has been chosen for registration, subsequent registrations must be made at the authority previously chosen.

2. Within 07 (seven) working days from receipt of a complete dossier for registering a product declaration in respect of mixed food additives with a new use, food additives not on the list of additives permitted for use or not for the correct subjects of use in food as prescribed by the Minister of Health, medical nutritional food, food for special dietary uses and nutritional products for children up to 36 months of age, and within 21 working days in respect of health supplements, the receiving authority prescribed in Clause 1 of this Article shall be responsible for appraising the dossier and issuing the Certificate of Receipt of the Product Declaration Registration, using Form No. 03 of Appendix I promulgated together with this Decree.

The dossier appraisal period runs from the time the dossier is submitted on the online public service system, or from the date stamped as received by the receiving authority (where the dossier is submitted by post or directly).

3. Where the receiving authority does not agree with the organisation's or individual's product declaration dossier, or requires amendment or supplementation, it must issue a document clearly stating the reason and the legal basis for the requirement. The receiving authority may require amendment or supplementation only once.

Within 07 (seven) working days from receipt of the amended or supplemented dossier, the receiving authority shall appraise the dossier and reply in writing. After 90 working days from the date of the official letter requiring amendment or supplementation, if the organisation or individual has not made the amendment or supplementation, the dossier shall cease to be valid.

4. Where there is a change in the product name, origin or composition, the organisation or individual must declare the product again. In other cases of change, the organisation or individual shall notify the receiving authority prescribed in Clause 1 of this Article in writing of the contents of the change and may produce and trade the product immediately after sending the notice.

5. The authority receiving dossiers for registering product declarations shall be responsible for publicly announcing the name and products of the organisations and individuals whose product declaration registrations have been received on its website and in the food safety database.

6. Organisations and individuals producing and trading products shall be responsible for paying the fee for appraising the dossier for registering the product declaration in accordance with the legislation on fees and charges.

Chapter IV

ENSURING THE SAFETY OF GENETICALLY MODIFIED FOOD

Article 9. Ensuring the safety of food containing ingredients from genetically modified organisms and of products of genetically modified organisms

The conditions for, and the order and procedure for issuing and revoking, the Certificate of Eligibility of a Genetically Modified Organism for Use as Food, and the list of genetically modified organisms issued with a Certificate of Eligibility for Use as Food, shall be as prescribed in the Government's Decree No. 69/2010/ND-CP dated 21 June 2010 on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms, and the Government's Decree No. 108/2011/ND-CP dated 30 November 2011 amending a number of articles of the Government's Decree No. 69/2010/ND-CP dated 21 June 2010 on biosafety for genetically modified organisms, genetic specimens and products of genetically modified organisms.

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

1. An organisation or individual producing or trading on the market food containing genetically modified organisms or products of genetically modified organisms with at least one genetically modified ingredient accounting for more than 5% of the total raw materials used to produce the food must, in addition to complying with the legislation on goods labelling, show the information relating to the genetically modified organism on the goods label, except in the cases prescribed in Clause 2 of this Article.

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

a) Pre-packaged genetically modified food containing genetically modified ingredients where neither the modified gene nor the product of the modified gene can be detected in the food;

b) Fresh genetically modified food and processed genetically modified food that is unpackaged and sold directly to consumers;

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

Chapter V

ISSUANCE OF CERTIFICATES OF ELIGIBILITY FOR FOOD SAFETY

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

1. A food production or trading establishment must hold a Certificate of Eligibility for Food Safety when operating, except in the cases prescribed in Clause 1 Article 12 of this Decree.

2. The conditions for the issuance of the Certificate of Eligibility for Food Safety shall be as prescribed in Clause 1 Article 34 of the Law on Food Safety. In particular, establishments producing health supplements must comply with the requirements prescribed in Article 28 of this Decree.

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

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

a) Small-scale primary production;

b) Food production and trading without a fixed location;

c) Small-scale preliminary processing;

d) Small-scale food trading;

đ) Trading in pre-packaged food;

e) Production and trading of food utensils, packaging materials and containers;

g) Restaurants within hotels;

h) Collective kitchens without food business line registration;

i) Street food trading;

k) Establishments already issued with one of the following Certificates: Good Manufacturing Practice (GMP), Hazard Analysis and Critical Control Points (HACCP), ISO 22000 Food Safety Management System, International Featured Standards (IFS), British Retail Consortium Global Standard for Food Safety (BRC), Food Safety System Certification (FSSC 22000), or an equivalent certificate that remains valid.

2. The establishments prescribed in Clause 1 of this Article must comply with the corresponding requirements on the conditions for ensuring food safety.

Chapter VI

STATE INSPECTION OF THE SAFETY OF IMPORTED AND EXPORTED FOOD

Article 13. Cases exempt from State inspection of the safety of imported food (except where there is a food safety warning)

1. Products already issued with a Certificate of Receipt of the Product Declaration Registration.

2. Products carried by a person entering the country, or sent before or after that person's trip, to serve daily needs or the purpose of the trip; and gifts and presents within the import duty exemption quotas under the tax legislation.

3. Products imported for the personal use of entities enjoying diplomatic privileges and immunities.

4. Products in transit, merchanting trade, transhipment, temporary importation for re-export, or deposit in a bonded warehouse.

5. Products that are test or research samples in a quantity appropriate to the testing or research purpose, as certified by the organisation or individual.

6. Products used for display at fairs and exhibitions.

7. Products and raw materials produced or imported solely for the production or processing of exported goods, or serving the internal production of the organisation or individual and not consumed on the domestic market.

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

9. Goods imported to meet urgent requirements under the direction of the Government or the Prime Minister.

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

1. Imported products of terrestrial animals, products of aquatic animals and plant products used as food, other than processed and pre-packaged food, food exported abroad by Vietnamese organisations and individuals but returned, and the cases prescribed in Article 13 of this Decree, must satisfy the following requirements:

a) Originating in a country or territory whose food safety control system meets Viet Nam's regulations and which has been placed by the competent Vietnamese authority on the list of countries and territories registered to export food of animal, plant or aquatic origin to Viet Nam;

b) For products of terrestrial animals used as food and products of aquatic animals used as food: they must be produced by a production or trading establishment recognised by the competent Vietnamese authority as fully meeting the requirements for ensuring food safety under Viet Nam's regulations;

c) Each imported consignment of animal or aquatic origin must be accompanied by a certificate of compliance with the 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 and sold directly to Viet Nam).

2. The procedure for registering the countries, territories and production and trading establishments referred to in Clause 1 of this Article on the list of exporters to Viet Nam shall be as prescribed in Article 22 of this Decree.

3. The Ministry of Agriculture and Rural Development shall be responsible for providing the customs authority with the list of countries, territories, organisations and individuals permitted to export the above products to Viet Nam.

Article 15. State inspection bodies for imported food

1. The State inspection body for imported food is a body assigned or designated by the Ministry of Health, the Ministry of Agriculture and Rural Development or the Ministry of Industry and Trade.

Where an imported consignment contains several types of food falling within the management competence of several ministries, the State inspection body shall be the body assigned or designated by the Ministry of Agriculture and Rural Development.

2. The State inspection body has the following rights and responsibilities:

a) Deciding to convert the inspection method from the normal inspection method to the reduced inspection method, and to apply the normal inspection method after 03 (three) strict inspections in which the imported food met the requirements;

b) Carrying out food inspections in accordance with the methods and procedures prescribed in this Decree;

c) Complying with sampling and sample retention in accordance with the law;

d) Collecting inspection and testing fees and charges in accordance with the legislation on fees and charges;

đ) Ensuring professional competence, accuracy, truthfulness and objectivity when inspecting and certifying the food safety of imported consignments and items;

e) Being subject to the direction, inspection and guidance on organisation and professional matters of the Ministry of Health, the Ministry of Agriculture and Rural Development and the Ministry of Industry and Trade;

g) Receiving and settling complaints from goods owners. If damage is caused to the goods owner, the State inspection body must refund the full testing fee and inspection fee and must also compensate the goods owner for the damage (if any) in accordance with the law;

h) Retaining inspection records in accordance with the law and producing the retained records when requested by the competent authority;

i) Reporting every 06 months to the corresponding managing ministry using Form No. 06 of Appendix I promulgated together with this Decree, or reporting on an ad hoc basis where there is a warning from the Ministry of Health, the Ministry of Agriculture and Rural Development or the Ministry of Industry and Trade of Viet Nam, or from a competent foreign authority or the producer, or reporting on the results of handling food that failed to meet the requirements for imported food.

Article 16. Inspection methods

The inspection of the safety of imported food shall be carried out by one of the following methods:

1. The reduced inspection method, under which the dossiers of not more than 5% of the total imported consignments within 01 year, selected at random by the customs authority, are examined.

2. The normal inspection method, under which only the dossier of the imported consignment is examined.

3. The strict inspection method, under which the dossier is examined together with sampling and testing.

Article 17. Application of the inspection methods

1. Reduced inspection applies to consignments and items falling within one of the following cases:

a) They have been certified as meeting food safety requirements by a competent agency or organisation of a country that has signed an international treaty on mutual recognition in food safety inspection activities to which Viet Nam is a party; or there is an inspection result of the competent authority of the exporting country in respect of the consignment or item that conforms to Vietnamese law;

b) They have met the import requirements under the normal inspection method on 03 (three) consecutive occasions within 12 months;

c) They are produced at establishments applying one of the quality management systems GMP, HACCP, ISO 22000, IFS, BRC, FSSC 22000 or an equivalent system.

2. Normal inspection applies to all items of an imported consignment, except in the cases prescribed in Clauses 1 and 3 of this Article.

3. Strict inspection applies to imported consignments and items falling within one of the following cases:

a) The consignment or item failed to meet the import requirements at the previous inspection;

b) The consignment or item failed to meet the requirements during inspections or examinations (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-level People's Committee, a competent foreign authority or the producer.

4. Conversion from the strict inspection method to the normal inspection method shall take place in the following cases:

a) For the cases prescribed in Points a and b Clause 3 of this Article, where the results meet the import requirements after the strict inspection method has been applied on 03 (three) consecutive occasions;

b) For the case prescribed in Point c Clause 3 of this Article, upon a written notice of cessation of strict inspection from the Ministry of Health, the Ministry of Agriculture and Rural Development or the Ministry of Industry and Trade of Viet Nam.

Article 18. Dossier for registering an inspection

1. The dossier for registering an inspection under the reduced inspection method comprises:

a) The product self-declaration;

b) 03 (three) consecutive Notices of the result confirming that the food met the import requirements under the normal inspection method, or a certified copy or a consularly legalised original of one of the GMP, HACCP, ISO 22000, IFS, BRC or FSSC 22000 Certificates or an equivalent certificate that is valid at the time of submission;

c) Where the products are of aquatic or terrestrial animal origin, other than processed and pre-packaged products, a certificate of compliance with the food safety regulations issued by the competent authority of the exporting country (original) is required.

2. The dossier for registering an inspection under the normal inspection method and the strict inspection method comprises:

a) The application for inspection of imported food as prescribed in Form No. 04 of Appendix I promulgated together with this Decree;

b) The product self-declaration;

c) 03 (three) consecutive Notices of the result confirming that the food met the import requirements under the strict inspection method, in respect of consignments and items converted from strict inspection to normal inspection (originals);

d) A copy of the packing list;

đ) For the products prescribed in Article 14 of this Decree, a certificate of compliance with the food safety regulations issued by the competent authority of the exporting country (original) is required, except for aquatic products caught and processed at sea by foreign fishing vessels and sold directly to Viet Nam.

Article 19. Order of inspection of imported food

1. Order of inspection in the case of reduced inspection:

a) When carrying out customs procedures, the goods owner shall be responsible for submitting the dossier prescribed in Clause 1 Article 18 of this Decree;

b) The customs authority shall be responsible for randomly selecting not more than 5% of the total imported consignments subject to reduced inspection within 01 (one) year in order to examine the dossiers in accordance with the regulations.

Within 03 (three) working days from the date of receipt of the dossier, the customs authority shall be responsible for examining the dossier and granting customs clearance for the goods. Where supplementation of the dossier is required, the reason and the legal basis for the requirement must be clearly stated.

2. Order of inspection in the case of normal inspection:

a) Before or when the goods arrive at the border gate, the goods owner shall submit the dossier for registering the inspection prescribed in Clause 2 Article 18 of this Decree to the State inspection body or to the National Single Window Portal, subsystem of the Ministry of Health, the Ministry of Agriculture and Rural Development or the Ministry of Industry and Trade (where already applied);

b) Within 03 (three) working days from the date of receipt of the dossier, the State inspection body shall be responsible for examining the dossier and issuing a notice that the food does or does not meet the import requirements, using Form No. 05 of Appendix I promulgated together with this Decree. Where supplementation of the dossier is required, the reason and the legal basis for the requirement must be clearly stated;

c) The goods owner shall be responsible for submitting the Notice of the result confirming that the food meets the import requirements to the customs authority in order for the goods to be granted customs clearance.

3. Order and procedure for inspection in the case of strict inspection:

a) Carry out the provisions of Point a Clause 2 of this Article;

b) Within 07 (seven) working days from the date of receipt of the dossier, the State inspection body shall be responsible for examining the dossier, taking samples, testing the food safety indicators as required and issuing a notice that the food does or does not meet the import requirements, using Form No. 05 of Appendix I promulgated together with this Decree. Where supplementation of the dossier is required, the reason and the legal basis for the requirement must be clearly stated;

c) The goods owner shall be responsible for submitting the Notice of the result confirming that the food meets the import requirements to the customs authority in order for the goods to be granted customs clearance.

4. Where a Notice of the result confirming that the food does not meet the import requirements is issued under Point b Clause 2 and Point b Clause 3 of this Article, the State inspection body shall decide on the handling measures in the forms prescribed in Clause 3 Article 55 of the Law on Food Safety and shall report the results of handling the food that failed to meet the import requirements to the managing ministry.

Article 20. Handling of food that fails to meet the requirements for imported food

1. After completing the handling of food that failed to meet the import requirements in accordance with the decision of the State inspection body, the goods owner shall be responsible for reporting to the State inspection body and to the authority receiving the declaration dossier one of the following papers:

a) The re-export documents, where the form of re-exportation is applied;

b) The destruction record certified by the competent authority;

c) The contract for the change of purpose of use between the goods owner and the buyer or the transferee of the consignment or item. The buyer or transferee of the consignment or item that failed to meet the import requirements may not use that consignment or item as food.

2. After completing the remedying of the product defect or labelling error, if it wishes to import into Viet Nam, the goods owner shall be responsible for carrying out the procedure for registering an inspection under Article 19 of this Decree.

Where measures to remedy the product defect or labelling error have been applied but the consignment or item still fails to meet the import requirements, one of the handling forms prescribed in Points c and d Clause 3 Article 55 of the Law on Food Safety must be applied.

Article 21. Rights and obligations of goods owners

A goods owner has the following rights and obligations:

1. To have the reduced inspection method applied to imported consignments and items falling within one of the cases prescribed in Clause 1 Article 17 of this Decree.

2. To request the State inspection body to review the inspection result, or to request the authority receiving the product declaration to select a designated verification testing establishment to re-examine the testing result. Where the re-examination result is consistent with the initial inspection result, the goods owner shall bear the cost of the re-examination; where the re-examination result meets the requirements for imported food, the re-examination cost already paid shall be refunded.

3. To be entitled to propose the handling measures prescribed in Clause 3 Article 55 of the Law on Food Safety in respect of a consignment or item that fails to meet the requirements for imported food.

4. To keep the consignment or item in its original state so that the State inspection body may take samples.

5. To implement the decision of the competent State inspection body on the handling of the consignment or item where the consignment or item fails to meet the requirements for imported food.

Article 22. Procedure for registering countries, territories and production and trading establishments on the list of exporters of food to Viet Nam, and State inspection of food safety in the exporting country

1. The competent State management authority of Viet Nam shall draw up an inspection plan, notify and coordinate with the competent authority of the exporting country in inspecting the exporting country's food safety control system and the establishments producing and trading food for export to Viet Nam, according to the following procedure:

a) The competent authority of the exporting country shall send 01 (one) set of the registration dossier to the Ministry of Agriculture and Rural Development, comprising information on the management system of the country or territory (including the legal system, standards and the organisational system for food safety management) and the food safety control capability of the competent authority of the exporting country or territory, using Form No. 08 of Appendix I promulgated together with this Decree; the list of establishments producing and trading food of animal and aquatic origin registered to export to Viet Nam, using Form No. 07 of Appendix I; and information on the conditions for ensuring food safety of those production and trading establishments, using Form No. 09 of Appendix I promulgated together with this Decree;

b) Within 30 working days from the date of receipt of a complete dossier registering the list of production and trading establishments prescribed in Point a of this Clause from the competent authority of the exporting country, the competent authority of the managing ministry shall appraise the dossier and notify the competent authority of the exporting country of the appraisal result and of the inspection plan where it is necessary to carry out an inspection of the country exporting to Viet Nam;

c) The contents of the inspection in the exporting country comprise: the legal system for food safety management and control; the capability of the exporting country's food safety control authority; and the conditions for ensuring food safety of the production and trading establishments registered to export to Viet Nam.

2. The handling of the inspection results and the announcement of the list of countries and territories and the list of production and trading establishments permitted to export to Viet Nam are prescribed as follows:

a) Where it is not necessary to carry out a physical inspection of the country exporting to Viet Nam, the Ministry of Agriculture and Rural Development shall announce the result and the name of the country or territory permitted to export to Viet Nam. In particular, for products of terrestrial animals and products of aquatic animals, the list of production and trading establishments permitted to export must also be announced;

b) Where it is necessary to carry out an inspection of the exporting country, within 30 working days from the end of the inspection visit to the exporting country the Ministry of Agriculture and Rural Development shall process and announce the inspection results.

Where the inspection results do not yet fully meet the prescribed requirements, the Ministry of Agriculture and Rural Development shall give notice, clearly stating the specific reasons for the cases not permitted to export food to Viet Nam;

c) Where an addition to the list of establishments producing and trading products of terrestrial animals and products of aquatic animals for export to Viet Nam is requested, the competent authority of the exporting country shall send a dossier comprising the list and the establishment information, using Form No. 07 and Form No. 08 under Point a Clause 1 of this Article, to the Ministry of Agriculture and Rural Development for appraisal of the dossier or for a physical inspection in the exporting country, on the basis of which the addition to the list shall be considered and decided.

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 prescribe the competence for State inspection of food safety in respect of exported food within the fields assigned to them for management under Articles 62, 63 and 64 of the Law on Food Safety, where the importing country so requires.

2. The Ministry of Agriculture and Rural Development shall be responsible for inspecting consignments of exported food comprising several items falling within the management competence of two or more ministries.

Chapter VII

FOOD LABELLING

Article 24. Compulsory labelling contents

1. Organisations and individuals producing and trading products in Viet Nam must, in addition to complying with the legislation on goods labelling, comply with the following provisions:

a) Medical nutritional food must bear the following phrases: “Medical nutritional food” and “For use by patients under the supervision of a health worker”;

b) Food for special dietary uses must bear the phrase “Nutritional product (for the specific subjects)” on the principal display panel of the label so as to distinguish it from ordinary food.

2. In particular, for imported products, the name of the organisation or individual responsible, stated on the product label, must show: the name and address of the producing organisation or individual and the name and address of the organisation or individual that self-declared or registered the product declaration.

Article 25. Exemption from certain compulsory labelling contents

1. Supplementary labels are not required for products carried by a person entering the country for personal consumption, gifts and presents within the import duty exemption quotas; products imported by entities enjoying diplomatic privileges and immunities; products in transit, merchanting trade, transhipment, temporary importation for re-export or deposit in a bonded warehouse; products that are test or research samples; products that are samples displayed at fairs and exhibitions; and products and raw materials produced or imported solely for the production or processing of exported goods, or serving the internal production of the organisation or individual and not consumed on the domestic market.

2. Apart from spices and herbs, for small packages with a largest surface area of less than 10 cm2, the labelling of the composition, shelf life, storage instructions and instructions for use is not required if a supplementary label or the outer packaging already shows those particulars in full.

3. The date of manufacture need not be stated for food utensils and packaging materials in direct contact with food.

Chapter VIII

FOOD ADVERTISING

Article 26. Foods whose advertising content must be registered before advertising

1. Health supplements, medical nutritional food and food for special dietary uses.

2. Nutritional products for children up to 36 months of age that do not fall within the cases where advertising is prohibited under Article 7 of the Law on Advertising.

Article 27. Registration of food advertising content

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

1. Before advertising, the organisation or individual having the product to be advertised must register the advertising content with the authority issuing the Certificate of Receipt of the Product Declaration Registration in accordance with the regulations in force.

2. The advertising content must be consistent with the uses and effects of the product declared in the product declaration. Images, equipment, uniforms, names or letters of medical units and establishments, doctors, pharmacists or health workers, letters of thanks from patients, or articles by doctors, pharmacists or health workers may not be used to advertise food.

3. For health supplements:

a) The warning “This food is not a medicine and has no effect as a substitute for medicine” must be given; the text must be legible and in a colour contrasting with the background;

b) For advertising on radio and television, the warning under Point a of this Clause must be read out clearly;

c) For advertising on television or radio of a short duration of less than 15 seconds, the phrase “This food is not a medicine and has no effect as a substitute for medicine” need not be read out, but the warning must be shown in the advertisement.

4. The dossier for registering confirmation of the advertising content comprises:

a) The application for confirmation of the advertising content, using Form No. 10 of Appendix I promulgated together with this Decree;

b) The Certificate of Receipt of the Product Declaration Registration and the Product Declaration confirmed by the competent authority (copy certified by the organisation or individual);

c) The product label specimen (copy certified by the organisation or individual);

d) For advertising on radio or television, the proposed advertising script and the proposed advertising content recorded on a video disc or audio disc; for advertising by other means, the proposed advertising mock-up (content specimen) (copy certified by the organisation or individual);

đ) For advertising content beyond the uses and features of the product stated in the product declaration, scientific materials providing proof are required (copy certified by the organisation or individual);

The documents in the dossier for registering confirmation of the advertising content must be in Vietnamese; where there are documents in a foreign language, they must be translated into Vietnamese and notarised.

5. Procedure for issuing the Certificate of Confirmation of Advertising Content:

a) The organisation or individual having the product to be advertised shall send the dossier for registering confirmation of the advertising content to the authority issuing the Certificate of Receipt of the Product Declaration Registration;

b) Within 10 working days from the date of receipt of a complete and valid dossier, the receiving authority shall be responsible for considering the dossier and returning the result using Form No. 11 of Appendix I promulgated together with this Decree. That period runs from the date stamped as received by the receiving authority where the dossier is sent by post, or from the date the completed dossier is received on the online public service system.

Where the receiving authority does not agree with the organisation's or individual's advertising content, or requires amendment or supplementation, it must issue a document clearly stating the reason and the legal basis for the requirement. The receiving authority may require amendment or supplementation only once.

Within 10 working days from receipt of the amended or supplemented dossier, the receiving authority shall appraise the dossier and reply in writing. After 90 working days from the date of the official letter requiring amendment or supplementation, if the organisation or individual has not made the amendment or supplementation, the dossier shall cease to be valid;

c) The authorities receiving dossiers for registering confirmation of advertising content shall be responsible for publicly announcing the name and products of the organisations and individuals issued with a Certificate of Confirmation of Food Product Advertising Content on their websites and in the food safety database;

d) Organisations and individuals registering confirmation of advertising content shall be responsible for paying the dossier appraisal fee to the receiving authority.

6. Organisations and individuals having products to be advertised, and organisations and individuals disseminating advertisements, may advertise only products issued with a Certificate of Confirmation of Advertising Content and may advertise only in conformity with the content confirmed.

Chapter IX

CONDITIONS FOR ENSURING FOOD SAFETY IN THE PRODUCTION OF HEALTH SUPPLEMENTS

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

1. An establishment producing health supplements must satisfy the general conditions for ensuring food safety prescribed in Clause 1 Article 19, Clause 1 Article 20 and Clause 1 Article 21 of the Law on Food Safety and the following provisions:

a) It must establish and maintain a quality management system to control the production process and distribution so as to ensure that every product produced by the establishment meets the quality declared under the declared standard and is safe for the user until the end of its shelf life;

b) It must have sufficient staff with professional qualifications appropriate to the positions assigned who have been trained in the basic knowledge of GMP, food safety and related professional knowledge. The head of the production division and the head of the quality control division must be official, full-time staff of the establishment and must be independent of each other. The person in charge of professional matters of the establishment must hold a university degree or higher in one of the disciplines of Medicine, Pharmacy, Nutrition, Food Safety or Food Technology and must have at least 3 years' working experience in the related specialised field;

c) The premises, equipment and auxiliary utilities must be designed, built and installed appropriately to their intended use, on a one-way principle, easy to clean, so as to prevent and minimise the risk of mix-ups and to avoid the accumulation of dust and dirt, contamination and factors adversely affecting the products, and daily cleaning must be maintained;

d) Records and documents on production, quality control and distribution must be kept in full so that the history of every batch of product can be traced, and records must be kept of all other activities carried out at the establishment;

đ) Every production operation must be carried out in accordance with a procedure or instruction. Inspection and supervision measures must be applied during production in order to prevent the risk of mix-ups, contamination and cross-contamination. The results must be recorded in the records as soon as the operation is carried out or immediately after the production stage is completed;

e) There must be a quality control division to ensure that products are produced under appropriate conditions and procedures and meet the standards established; that the necessary tests have been carried out; that raw materials are not released for use and products are not released for sale before being assessed as meeting the required quality; and that the stability of products is monitored;

g) Where testing or production is carried out under contract, the contract acceptor must have sufficient premises, equipment and personnel meeting the requirements of the contract giver and must comply with the competent management authority's regulations on the conditions for testing or producing health supplements;

h) There must be procedures governing the handling of complaints, product recalls and self-inspection activities; those activities must be carried out in accordance with the procedures and full records must be made and retained.

2. The Ministry of Health shall issue guidance on Good Manufacturing Practice (GMP) for health supplements for establishments producing health supplements to apply.

3. From 01 July 2019, establishments producing health supplements must apply Good Manufacturing Practice (GMP) for health supplements in accordance with the guidance of the Ministry of Health.

Article 29. Dossier, order and competence for the issuance and re-issuance of the Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements

1. The dossier for the issuance of the Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements comprises:

a) The application for the Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements, using Form No. 12 of Appendix I promulgated together with this Decree;

b) The layout of the production areas and production lines (certified by the organisation or individual);

c) The list of the main equipment used at the establishment (certified by the organisation or individual).

2. Order of issuance of the Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements

a) The establishment shall compile the dossier under Clause 1 of this Article and submit it through the online public service system, by post or directly to the Ministry of Health;

b) Within 15 working days from receipt of a complete and valid dossier, the receiving authority shall be responsible for setting up an appraisal team and carrying out an on-site assessment at the establishment, and shall draw up an appraisal record using Form No. 13 of Appendix I promulgated together with this Decree.

The appraisal team shall comprise 05 or more members, of whom at least 02 members have experience in good manufacturing practice (GMP) and 01 member has expertise in testing;

c) Where the appraisal result meets the requirements, the receiving authority shall issue the Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements, using Form No. 14 of Appendix I promulgated together with this Decree. The time for issuing the Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements shall not exceed 30 working days from the date of receipt of a complete and valid dossier;

d) Where the appraisal result at the establishment does not meet the requirements, the appraisal team shall clearly state the non-conforming matters in the appraisal record so that the establishment may remedy them. After remedying them, the establishment shall send written notice of the remedial results to the appraisal team. Within 07 (seven) working days from the date of receipt of the written notice of the remedial results, the appraisal team shall be responsible for considering the matter and submitting it to the Ministry of Health for the issuance of the Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements. If, after 03 (three) months from the end of the appraisal, the establishment has not completed the required remedial action and notified the remedial results to the appraisal team, the dossier for the issuance of the Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements shall cease to be valid.

3. The Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements is valid for 03 (three) years from the date of issue. Six months before its expiry, the establishment shall be responsible for submitting a dossier applying for re-issuance of the Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements. The dossier and order of re-issuance shall be as prescribed in Clauses 1 and 2 of this Article.

4. Organisations and individuals applying for the Certificate of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements shall be responsible for paying the dossier appraisal fee to the receiving authority.

Chapter X

CONDITIONS FOR ENSURING FOOD SAFETY IN THE PRODUCTION, TRADING AND USE OF FOOD ADDITIVES

Article 30. Provisions on the conditions for ensuring food safety in respect of food additives

An establishment producing or trading food additives must satisfy the following conditions for ensuring food safety:

1. Satisfying the general provisions on the conditions for ensuring food safety prescribed in Clause 1 Article 19, Clause 1 Article 20 and Clause 1 Article 21 of the Law on Food Safety.

2. Food additives may be blended only where those food additives are on the list of additives permitted for use in food as prescribed by the Ministry of Health and the final product of the blending does not cause any harm to human health; where a new product with a new use is created, the use, the subjects of use and the maximum level of use must be proved.

3. The repacking, decanting and filling of food additives must be carried out at an establishment eligible for food safety and must be labelled in accordance with the regulations in force.

Article 31. Provisions on single-substance food additives

1. Food additives on the list of additives permitted for use in food as prescribed by the Ministry of Health are subject to self-declaration.

2. The procedure for self-declaration of products in respect of single-substance food additives shall be as prescribed in Article 5 of this Decree.

Article 32. Provisions on mixed food additives with a new use

1. A product declaration for mixed food additives with a new use must be registered with the Ministry of Health.

2. For mixed food additives with a new use, the quantitative composition of each additive in the formulation must be listed.

3. The order and procedure for registering a product declaration in respect of mixed food additives with a new use shall be as prescribed in Articles 7 and 8 of this Decree.

Article 33. Provisions on the use of food additives

Organisations and individuals producing and trading products shall be responsible for:

1. Using only food additives on the list of additives permitted for use in food as prescribed by the Ministry of Health. Where a food additive is not on the list of additives permitted for use in food, or is not for the correct subjects of use as prescribed by the Ministry of Health, the organisation or individual producing or trading the food additive must register a product declaration with the Ministry of Health under Articles 7 and 8 of this Decree.

2. Using food additives not exceeding the maximum permitted level of use; for the correct food subjects; with a clear origin and provenance; within the shelf life; and fully meeting the management requirements and technical requirements for food additives.

Chapter XI

FOOD TRACEABILITY

Article 34. Traceability of products that are not safe

Upon detecting that a food product it produces or trades is not safe, or when the competent State authority so requires, the organisation or individual producing or trading the product shall be responsible for carrying out traceability under Clauses 1 and 2 Article 54 of the Law on Food Safety.

Article 35. Carrying out traceability of products that are not safe

1. Organisations and individuals producing and trading products must retain the information relating to the producer and supplier of the product and to the customer, where the customer has purchased that product, through contracts, record books or other means, in order to serve traceability. The information serving traceability comprises:

a) The name and type of the product purchased or sold;

b) The date, quantity, weight, lot number and batch 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 prescribe in detail the traceability of products within the fields assigned to them for management.

Chapter XII

ASSIGNMENT OF RESPONSIBILITIES FOR STATE MANAGEMENT OF FOOD SAFETY

Article 36. Principles for assigning responsibilities for State management of food safety

1. On the basis of the provisions of the Law on Food Safety and ensuring conformity with the relevant legal documents.

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

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

4. Close coordination among the ministries and sectors.

5. Ensuring the principle of one window, one product: one production or trading establishment is subject to the management of only one State management authority.

6. Ensuring that the assignment is scientific, complete and feasible.

7. Decentralisation of State management between the central level and local authorities at all levels in the State management of food safety.

8. For an establishment producing several types of food product falling within the management competence of two or more specialised management authorities, the authority managing the product with the largest output among the establishment's products shall be the managing authority.

9. An establishment that does not carry out a production stage but trades several types of food product falling within the management competence of two or more specialised management authorities shall be managed by the Industry and Trade sector, except where it is a wholesale market or an agricultural produce auction.

10. For an establishment that both produces and trades several types of product falling within the management competence of two or more specialised management authorities, the organisation or individual has the right to choose the specialised management authority for food safety with which to carry out the administrative procedures.

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

1. Performing the provisions on general responsibilities in the State management of food safety prescribed in Clause 1 Article 62 of the Law on Food Safety.

2. Reporting periodically and on an ad hoc basis to the Government on food safety management work, on the basis of monitoring and consolidating the reports of the specialised managing ministries and the provincial-level People's Committees.

3. Promulgating national technical regulations for the products within the field assigned to it for management prescribed in Article 62 of the Law on Food Safety and the product groups in Appendix II promulgated together with this Decree; promulgating national technical regulations or provisions on safety limits for product groups at the request of the specialised managing ministries.

4. Managing food safety throughout the production, processing, storage, transport, export, import and trading process, and managing production and trading establishments, in respect of the food products prescribed in Appendix II promulgated together with this Decree.

5. Organising the receipt and management of dossiers and the issuance of Certificates of Receipt of Product Declaration Registration and Certificates of Eligibility for Food Safety in respect of: health supplements, mixed food additives with a new use, and food additives not on the list of additives permitted for use or not for the correct subjects of use in food as prescribed by the Ministry of Health; Certificates of Eligibility for Food Safety meeting Good Manufacturing Practice (GMP) requirements for health supplements; Certificates of Confirmation of Advertising Content for health supplements; Certificates of Free Sale for products within the field assigned to it for management; and Health Certificates.

6. Designating food testing establishments serving State management and verification testing establishments within its assigned scope of management; designating establishments to carry out arbitration testing and to give the final conclusion where there is a difference between the testing results of food testing establishments inside and outside the Health sector.

7. Designating the State inspection bodies for the safety of imported food in respect of the products within the field assigned to it for management.

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

1. Promulgating national technical regulations for the products within the field assigned to it for management prescribed in Article 63 of the Law on Food Safety and the product groups in Appendix III promulgated together with this Decree.

2. Drawing up and sending to the Ministry of Health for promulgation the provisions on safety limits for the product groups in Appendix III promulgated together with this Decree.

3. Managing and decentralising the management of food safety in respect of the primary production of agricultural, forestry and fishery products and salt, comprising: the growing, raising, gathering, catching and exploiting of agricultural, forestry and fishery products; and salt production.

4. Managing and decentralising the management of food safety throughout the production, collection, slaughter, preliminary processing, processing, storage, transport, export, import and trading process, in respect of the products and the establishments producing and trading the food products prescribed in Appendix III promulgated together with this Decree.

5. Organising the issuance of Certificates of Free Sale for the products within the field assigned to it for management.

6. Organising and decentralising the issuance of Certificates of Eligibility for Food Safety to organisations and individuals producing and trading the products within the field assigned to it for management under Clauses 3 and 4 of this Article.

7. Managing food safety at wholesale markets and agricultural produce auctions.

8. Designating food testing establishments serving State management and verification testing establishments; giving the final conclusion where there is a difference between the testing results of testing establishments within the field assigned to it for management.

9. Designating the State inspection bodies for the safety of imported food in respect of the products within the field assigned to it for management.

10. Announcing the list of countries and territories and the list of production and trading establishments permitted to export to Viet Nam within the field assigned to it for management.

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

1. Promulgating national technical regulations for the products within the field assigned to it for management prescribed in Article 64 of the Law on Food Safety and the product groups in Appendix IV promulgated together with this Decree.

2. Drawing up and sending to the Ministry of Health for promulgation the provisions on safety limits for the product groups in Appendix IV promulgated together with this Decree.

3. Managing and decentralising the management of food safety throughout the production, processing, storage, transport, export, import and trading process, in respect of the products and the establishments producing and trading the food products prescribed in Appendix IV promulgated together with this Decree.

4. Managing food safety at supermarkets, commercial centres, convenience stores, establishments within the reserve and distribution system and other forms of business.

5. Organising the issuance of Certificates of Free Sale for the products within the field assigned to it for management.

6. Organising and decentralising the issuance of Certificates of Eligibility for Food Safety to organisations and individuals producing and trading the products within the field assigned to it for management.

7. Carrying out inspections to prevent and combat counterfeit food and trade fraud on the market in respect of all types of food, food additives, food processing aids, food utensils, packaging materials and containers.

8. Designating food testing establishments serving State management and verification testing establishments; giving the final conclusion where there is a difference between the testing results of testing establishments within the field assigned to it for management.

9. Designating the State inspection bodies for the safety of imported food in respect of the products within the field assigned to it for management.

Article 40. Responsibilities of the provincial-level People's Committees for State management of food safety

1. Carrying out State management of food safety within the locality and being responsible before the Government for food safety in the locality. The Chairperson of the provincial-level People's Committee shall personally act as the Head of the inter-sectoral steering committee on food hygiene and safety of the province or centrally run city; shall proactively organise forces to inspect, examine and supervise the ensuring of food safety in the area; shall directly direct and regularly urge and inspect the observance of the food safety legislation by lower-level State authorities; shall handle officials and public employees who lack responsibility or exercise lax management within the field assigned to them for management; shall organise the settlement of complaints and denunciations and the handling of breaches of the food safety legislation in accordance with the law; and shall be responsible before the Government and before the law where breaches of the food safety legislation occur in the area.

2. Organising the implementation of the provisions of the Government and of the ministries and sectors on food safety in the area.

3. Organising and running the inter-sectoral steering committee on food hygiene and safety of the province or centrally run city.

4. Organising communication and advocacy on the implementation of the legislation on ensuring food safety in the area.

5. Allocating resources to the specialised agencies to carry out State management of food safety.

6. Being responsible for managing food safety in the area; managing the conditions for ensuring food safety in respect of small-scale food production and trading establishments, street food, catering business and service establishments, food safety at markets in the area, and the entities under the decentralised management.

7. Drawing up and promulgating local technical regulations on food safety for the locality's particular food products.

8. Organising the receipt and management of dossiers and the issuance of Certificates of Receipt of Product Declaration Registration and Certificates of Confirmation of Advertising Content in respect of medical nutritional products, food for special dietary uses and nutritional products for children up to 36 months of age.

9. Organising the receipt of product self-declarations; certifying establishments as eligible for food safety under the assignment and decentralisation.

Article 41. Coordination in food safety activities

1. The managing ministries shall, within their scope of State management, be responsible for coordinating with the Ministry of Health in carrying out State management activities so as to ensure unified and effective State management of food safety.

2. The Ministry of Health shall take the lead in drawing up the information, education and communication programme on food safety; the Ministry of Agriculture and Rural Development, the Ministry of Industry and Trade and the other ministries and sectors shall, according to their functions and tasks, be responsible for coordinating with the Ministry of Health in implementing the information, education and communication programme on food safety.

3. The Ministry of Health, the Ministry of Agriculture and Rural Development and the Ministry of Industry and Trade shall be responsible for taking the lead in drawing up programmes and plans for, and carrying out, inspection and examination activities in respect of the products within the fields assigned to them for management; the other ministries and sectors shall be responsible for coordinating.

4. Where food poisoning occurs, the Ministry of Health shall be responsible for organising timely emergency care and treatment for the persons poisoned. The specialised managing ministry shall be responsible for providing in full the dossiers and information relating to the origin of the food suspected of causing the poisoning within the field assigned to it for management; for coordinating with the Ministry of Health in investigating the cause; and for taking the lead in tracing the origin of, and handling, the food causing the poisoning within the field assigned to it for management.

5. Upon detecting that a food product within the field assigned to another ministry or sector for management is in breach and poses a risk of seriously affecting consumers' health, the Ministry of Health shall take the lead and coordinate with the managing ministries in carrying out inspection and examination and reaching a conclusion.

Chapter XIII

IMPLEMENTATION PROVISIONS

Article 42. Transitional provisions

1. Products already issued with a Certificate of Receipt of the Declaration of Conformity and a Certificate of Declaration of Conformity with Food Safety Regulations before the effective date of this Decree may continue to be used until the expiry of the period stated on the certificate and until the end of the shelf life of the product.

2. The managing ministries shall, within their scope, tasks and powers, review and announce the cessation of effect of the provisions contrary to this Decree.

Article 43. Effect

1. This Decree comes into force from 02 February 2018.

2. It replaces the Government's Decree No. 38/2012/ND-CP dated 25 April 2012 detailing the implementation of a number of articles of the Law on Food Safety; and annuls Chapter II of Joint Circular No. 13/2014/TTLT-BYT-BNNPTNT-BCT dated 09 April 2014 of the Ministry of Health, the Ministry of Agriculture and Rural Development and the Ministry of Industry and Trade guiding the assignment of and coordination in the State management of food safety.

Article 44. Responsibility for implementation

The Ministers, the Heads of ministerial-level agencies, the Heads of agencies attached to the Government, the Chairpersons of the People's Committees of the provinces and centrally run cities, and the organisations and individuals concerned shall be responsible for implementing this Decree./.

APPENDIX I

(Promulgated together with the Government's Decree No. 15/2018/ND-CP dated 02 February 2018)