Nghị định 163/2004/NĐ-CP của Chính phủ về việc quy định chi tiết thi hành một số điều của Pháp lệnh Vệ sinh an toàn thực phẩm

DECREE

DETAILING THE IMPLEMENTATION OF A NUMBER OF ARTICLES OF THE ORDINANCE ON FOOD HYGIENE AND SAFETY

THE GOVERNMENT

Pursuant to December 25, 2001 Law No. 32/2001/QH10 on Organization of the Government;

Pursuant to July 26, 2003 Ordinance No. 12/2003/PL-UBTVQH11 on Food Hygiene and Safety;

At the proposal of the Health Minister,

DECREES:

Chapter I

GENERAL PROVISIONS

Article 1.- Scope of regulation

This Decree details the implementation of a number of articles of the Ordinance on Food Hygiene and Safety regarding food production and trading; the State management responsibilities of the ministries, branches and People's Committees at all levels for food hygiene and safety, food poisoning prevention and overcoming, food-borne diseases, and examination and inspection of food hygiene and safety.

Article 2.- Subjects of application

This Decree applies to Vietnamese State agencies, economic organizations, socio-political organizations, social organizations, socio-professional organizations, people's armed force units, households and individuals as well as foreign organizations and individuals engaged in producing, trading and using food in Vietnam; where the international agreements which Vietnam has signed or acceded provide otherwise, such international agreements shall apply.

Article 3.- Rights and responsibilities of consumers

1. Consumers have the rights:

a/ To use, select safe and hygienic food and food supply services;

b/ To be provided with information about food hygiene and safety and ways of safely using food;

c/ To be redeemed or compensated for harms caused by the use of unsafe or unhygienic food according to law provisions;

d/ To contribute opinions in the process of formulating and implementing policies and laws on food hygiene and safety when solicited.

2. Consumers have the responsibilities:

a/ To protect themselves in the consumption of food and use of food supply services;

b/ To strictly observe instructions on safe food use;

c/ Not to use food and food supply services that cause harms to their and community's health;

d/ To voluntarily report to the nearest health agencies on food poisoning or food-borne diseases upon their occurence;

e/ To detect and denounce acts that violate the food hygiene and safety legislation.

Chapter II

HYGIENE AND SAFETY IN FOOD PRODUCTION AND TRADING

Section 1. PROVISIONS ON FOOD HYGIENE AND SAFETY CONDITIONS

Article 4.- Conditions for assuring food hygiene and safety

When producing and/or trading in food, Vietnamese organizations, households and individuals as well as foreign organizations and individuals must fully satisfy the food hygiene and safety conditions prescribed as follows:

1. Establishment conditions, including:

a/ Location, environment;

b/ Workshop design and arrangement requirements;

c/ Workshop structure;

d/ Water supply system;

e/ Icy water supply system;

f/ Steam supply system;

g/ Compressed gas;

h/ Waste treatment system;

i/ Labor-protective clothing cloak room;

j/ Toilets.

2. Conditions on equipment and tools, including:

a/ Hand-cleaning and -disinfecting means;

b/ Antiseptic liquids;

c/ Equipment for killing harmful insects and animals;

d/ Quality control equipment and instruments;

e/ Processing, packing, preservation and transport equipment and tools.

3. Human conditions, including:

a/ Health of food producers and traders;

b/ Food safety and hygiene knowledge and practices of food producers and traders.

Article 5.- Responsibilities for prescribing food hygiene and safety conditions

1. The Health Ministry shall be responsible for promulgating general requirements on food hygiene and safety conditions prescribed in Article 4 of this Decree.

2. The specialized management ministries shall, according to their assigned functions, tasks and powers for State management over food hygiene and safety, have to issue specific regulations on food hygiene and safety conditions in compliance with the regulations of the Health Ministry and other relevant law provisions.

Section 2. PROCEDURES AND COMPETENCE TO EXAMINE HYGIENE AND SAFETY OF IMPORTED AND EXPORTED FOOD

Article 6.- Conditions on hygiene and safety of imported food

Food imported into Vietnam must ensure the following conditions:

1. Being granted the product standard publicization certificates as prescribed in Article 19 of this Decree.

2. Having written certifications of satisfaction of food hygiene and safety requirements, issued by competent Vietnamese State agencies. For food materials and food additives, their remaining use time must be at least over two thirds of their use life inscribed on their labels as from the time the good lots are imported into Vietnam.

3. Unprocessed food of animal or plant origin must have phytosanitary certificates, granted by competent Vietnamese State agencies according to law provisions or the provisions of international agreements which Vietnam has signed or acceded to and contain different provisions.

Article 7.- Principles for examination of hygiene and safety of imported food

1. All imported materials, chemicals used in food processing, packages in direct contact with food, food additives and imported food must be subject to food hygiene and safety examination.

2. The following kinds of food shall not be subject to food hygiene and safety examination:

a/ Food carried along for personal consumption, food being gifts, diplomatic bags, consular bags according to law provisions;

b/ Food temporarily imported for re-export;

c/ Food in transit;

d/ Food kept in bonded warehouses.

3. Imported food which has been certified to satisfy hygiene and safety requirements by competent organizations of the countries that have signed international agreements with Vietnam on mutual recognition in quality certification or quality management systems may be examined if it is detected to show signs of violation of the Vietnamese legislation on food hygiene and safety.

4. Imported food which has been given quality conformity certification, food of producing and/or trading organizations and individuals that have been certified to have food hygiene, safety and quality management systems compatible with Vietnamese standards or foreign or international standards permitted for application in Vietnam may enjoy a reduced number of food hygiene and safety examinations.

5. To reduce the number of examinations for subsequently imported lots of goods of the same kind and origin if the last five consecutive lots were examined and satisfied food hygiene and safety requirements. Only their dossiers shall be checked and competent State bodies may reduce the examination frequency or contents prescribed in Clauses 2 and 3, Article 11, and shall only examine random samples of such goods lots.

6. Through examinations, if detecting that the dossiers show signs of violation or that the random sample examination results fail to satisfy the food hygiene and safety requirements, competent State agencies shall apply the normal examination regime prescribed in Clauses 1, 2 and 3 of Article 11.

Article 8.- Dossiers of application for registration of examination of imported- food hygiene and safety

A dossier of application for registration of examination of imported-food hygiene and safety consists of:

1. An examination registration application (made according to a form set by a competent State agency);

2. The written publicization of the establishment’s standards, made by the food-importing organization, household or individual;

3. A lawful copy of the bill of lading;

4. A lawful copy of the invoice;

5. A lawful copy of the certificate of origin;

6. A lawful copy of the packing list;

7. A lawful copy of the foreign-trade contract;

8. The certificate of analysis, granted by the accredited laboratory or by the manufacturer, for products whose standards have not yet been publicized;

9. The certificate of free sale, granted by a competent authority of the manufacturing country, for high-risk food products whose standards have not yet been publicized.

Article 9.- Responsibilities of food-importing organizations, households and individuals

Food-importing organizations, households and individuals (hereinafter generally called goods owners) shall take responsibility before Vietnamese laws for assuring hygiene and safety of imported goods and comply with the following requirements:

1. Before their goods arrive at the border gates, the goods owners must register for food hygiene and safety examination at the food hygiene and safety-examining agencies (hereinafter called the examining agencies).

2. Within the prescribed time limit starting from the time the food enjoys customs clearance, the goods owners must produce the food in its intact conditions together with the customs dossier sets used for customs clearance and other dossiers and documents as prescribed to the examining agency for examining the food's hygiene and safety at the places the goods owners have registered with the examining agency.

3. Imported food shall enjoy customs clearance only when it has food hygiene and safety examination registration papers and shall be put into circulation only when it is granted the notices on satisfaction of hygiene and safety requirements on imported food;

Article 10.- Responsibilities of the imported-food hygiene and safety-examining agencies

1. After receiving the goods owners' valid examination registration dossiers, within 3 days, the examining agencies must issue food hygiene and safety examination registration papers to the goods owners so that the latter can be permitted to carry out customs clearance procedures to take their food to the storage places where exist full preservation conditions. Then the examining agencies shall examine each type of food within the law-prescribed time limit.

2. To issue the notices on examination results to the goods owners as soon as such results are available.

3. Where the food fails to comply with the regulations on imported-food hygiene and safety, it may be withdrawn from circulation, recycled, has its use purpose changed, be destroyed or re-exported under decisions of competent State bodies; the examining agencies shall decide on the handling thereof according to law provisions.

Article 11.- Methods of examining imported food-hygiene and safety

1. Checking of dossiers: compulsory for all good lots registered for food hygiene and safety examination;

2. Observational examination: based on the publicized product standards and the regulations of the relevant Vietnamese and branch standards;

3. Analysis at a laboratory: performed according to the regulations of the Health Ministry and the concerned ministries as well as branches on each kind of food so as to make plans on taking samples for analysis. When there are doubts of food safety, the examining agencies may take more samples than the established number of samples for applying relevant analytical methods.

4. Examination of random samples according to their physical, chemical and micro-organic indicators at the requests of competent State agencies.

Article 12.- Competence to examine imported-food hygiene and safety

1. The Health Ministry shall assume the prime responsibility for, and coordinate with the specialized management ministries in, designating the imported-food hygiene and safety-examining agencies or the accredited test laboratories to perform relevant tests.

2. The designated food hygiene and safety-examining agencies prescribed in Clause 1 of this Article shall have to examine hygiene and safety of imported food.

Article 13.- Examination of hygiene and safety of exported food

1. Exported food products must ensure food hygiene and safety according to the regulations of the importing countries.

2. The specialized management ministries shall, according to their assigned functions and tasks, have to provide detailed guidance on dossiers, procedures and competence related to the examination of hygiene and safety of exported food.

Section 3. PROCEDURES, COMPETENCE TO GRANT FOOD HYGIENE AND SAFETY CERTIFICATES TO HIGH-RISK FOOD PRODUCING- AND/OR-TRADING ESTABLISHMENTS

Article 14.- The high-risk food list covers the following groups:

1. Meat and meat products;

2. Milk and milk products;

3. Eggs and products processed from eggs;

4. Fresh and raw and processed aquatic products;

5. Ice creams and icy water of all kinds; natural mineral water;

6. Functional food; food complemented with micronutrients, supplementary food, food additives.

7. Processed food and drinks for instant consumption;

8. Frozen food;

9. Soya milk and products processed from soya;

10. Assorted fresh and raw vegetables, tubes and fruits for instant consumption.

Article 15.- Procedures for grant of food hygiene and safety certificates to high-risk food-producing and/or -trading establishments

1. Organizations, households and individuals producing and/or trading in high-risk food must send to competent State agencies dossiers of application for food hygiene and safety certificates required for high-risk food-producing and/or trading establishments (hereinafter called certificates).

2. A dossier of application for a certificate consists of:

a/ An application;

b/ The business registration certificate (a lawful copy, if any);

c/ A written description of material foundations, equipment and tools to assure food hygiene and safety conditions according to the regulations of competent State agencies;

d/ A written commitment to assure food hygiene and safety for food materials and food products which the establishment produces and/or trades in;

e/ The health certificates of the establishment owner and the persons directly engaged in food production and/or trading according to the regulations of the Health Ministry;

f/ The certificates of food hygiene and safety training of the establishment owner and the persons directly engaged in food production and/or trading, according to the regulations of competent State agencies.

3. Within 15 days after receiving full and valid dossiers, the competent State agencies shall have to conduct field evaluation and examination and grant food hygiene and safety certificates to the establishments. In case of refusal to grant, they must clearly state the reasons therefor.

Article 16.- Competence to grant certificates

1. The Health Ministry shall grant certificates to establishments producing and/or trading in functional food, food complemented with micronutrients, supplementary food, food additives and natural mineral water.

2. The State-run health agencies in the provinces or centrally-run cities (provincial/municipal Health Services), which are decentralized by the Health Ministry; urban and rural districts, townships (People's Committees) shall grant certificates to high-risk food-producing and/or -trading establishments for food other than those prescribed in Clause 1 of this Article.

3. Competent State agencies shall examine and inspect the food hygiene and safety conditions of production and trading establishments. Any establishments that fail to satisfy the prescribed food hygiene and safety conditions shall be handled according to law provisions.

Section 4. PUBLICIZATION OF FOOD HYGIENE AND SAFETY STANDARDS OF PRODUCTS

Article 17.- Publicization of food hygiene and safety standards of products (called product standard publicization for short)

1. Food-producing and/or -trading organizations and individuals that have business registrations and representatives of foreign companies, when putting food products into circulation and consumption on the Vietnamese market, must publicize product standards. Product standard publicization certificates shall be valid for 3 years as from the date they are issued by competent State agencies.

2. Food-producing and/or -trading organizations and individuals that have business registrations and are obliged to publicize food hygiene and safety standards shall have the responsibility:

a/ To ensure that their produced and traded food strictly satisfy the publicized hygiene and safety standards;

b/ To observe the food hygiene and safety regulations at their establishments and to withdraw, recycle, change use purposes of, destroy or re-export, their produced and/or traded food products which fail to satisfy hygiene and safety standards.

Article 18.- Publicization dossiers

1. For home-made food, a publicization dossier consists of:

a/ 01 written standard publicization document prescribed by the Health Ministry, enclosed with 2 copies of the document on the establishment's standards, issued by the enterprise (affixed with the enterprise's stamp) and containing the following details: observational, physical and chemical, micro-organic indicators, heavy metal, food additives, use duration, use instructions, and packing specifications, preservation and production process, made according to a form set by the Health Ministry;

b/ The card of the results of the tests of the publicized major quality criteria and hygiene and safety criteria of the food, issued by a test laboratory which is accredited or designated by a competent State agency. Particularly for natural mineral water, the card of the result of the water source test is also required.

c/ A labeled specimen and a label or the draft contents of the label in accordance with the labeling legislation (affixed with the enterprise's stamp);

d/ Documents certifying the enterprise's right to lawfully own the industrial property objects that are currently protected (if any or required when the dossier-receiving agency detects violation signs).

2. For imported food, a publicization dossier consists of:

a/ Documents specified at Point a, Clause 1 of this Article;

b/ The card of the result of the test of major quality components and food hygiene and safety criteria, issued by the manufacturer that has a good manufacturing practice certificate or by a competent testing agency of the country of origin; if such card is not available, the testing result card of a designated examining agency or an accredited testing laboratory in Vietnam is required;

c/ The product label and the draft contents of additional labels (affixed with the importing enterprise's stamp);

d/ The certificate of free sale or health certificate issued by a competent State agency of the country of origin to food additives and processing supports.

3. For products being functional food, food complemented with micronutrients, supplementary food containing new biological active ingredients, their publicization dossiers must include, apart from the product criteria documents, a certificate of free sale or health certificate; the results of research and clinical tests or publicized scientific documents on the effects and safety of the products, the results of the tests of food quality, hygiene and safety, issued by the accredited laboratories or competent Vietnamese examining agencies designated by the Vietnamese Health Ministry or by the manufacturers that have GMP (good manufacturing practice) certificates or HACCP (Hazard Analysis and Critical Control Point) certificates. Where the tests cannot be performed by such agencies, the results of the tests performed by competent agencies or accredited laboratories of the country of origin or a third country shall be used.

Article 19.- Procedures for receiving publicization dossiers

The Health Ministry and competent health agencies decentralized by the Health Ministry (provincial/municipal Health Services) shall receive and check the dossiers according to law provisions. Within 15 days as from the date of receiving dossiers, these agencies shall have to examine them and, if the enterprises have publicized product standards in accordance with current regulations, give certifications in the product standard publicization certificates then hand to the enterprises 1 original dossier set (affixed with the stamp of the Health Ministry or a competent health agency).

To notify and guide the enterprises to complete their standard publicization dossiers if finding that the contents of such dossiers do not strictly comply with the law provisions on food hygiene and safety.

Article 20.- Responsibility for certifying the product standard publicization

1. The Health Ministry shall certify the product standard publicization by enterprises (producing and importing enterprises, foreign enterprises' representatives) with regard to the following products: bottled natural mineral water, cigarettes, functional food, food complemented with micronutrients, supplementary food and imported products being food additives, processing supports, materials or heat-treated products.

2. The provincial/municipal Health Services shall certify the product standard publicization by enterprises which have production establishments based in the localities with regard to products other than those prescribed in Clause 1 of this Article.

Chapter III

STATE MANAGEMENT RESPONSIBILITIES FOR FOOD HYGIENE AND SAFETY AND RESPONSIBILITIES IN THE PREVENTION AND OVERCOMING OF FOOD POISONING AND FOOD-BORNE DISEASES

Section 1. STATE MANAGEMENT RESPONSIBILITIES FOR FOOD HYGIENE AND SAFETY

Article 21.- The Health Ministry

1. To formulate and promulgate according to its competence or submit to the Government for promulgation legal documents, strategies and policies on food hygiene and safety; coordinate with the concerned ministries and branches in formulating, promulgating and certifying food which satisfies or complies with the hygiene and safety standards applicable to domestically consumed food;

2. To assume the prime responsibility for, and coordinate with the concerned ministries and branches in, performing the State management over food hygiene and safety with regard to food circulated on the market and imported food; organize the control of micro-organism pollution and chemical surpluses in food (including food additives as well);

3. To assume the prime responsibility for, and coordinate with the concerned ministries and branches in, examining and inspecting food hygiene and safety;

4. To assume the prime responsibility for, and coordinate with the concerned ministries and branches in, organizing scientific and technological researches, professional training and international cooperation in the domain of food hygiene and safety; organize the information work, propagation and dissemination of food hygiene and safety knowledge and legislation.

Article 22.- The Agriculture and Rural Development Ministry

1. To perform the State management over food hygiene and safety according to its assigned functions and tasks with regard to food products throughout the production process from rearing, cultivation, exploitation, gathering, harvest, production, processing, slaughtering, preservation and transport till the time agricultural food products are put into circulation on the domestic market or exported; to manage the veterinary hygiene of imported food of animal origin;

2. To assume the prime responsibility for, and coordinate with the Health Ministry in, formulating and promulgating documents guiding the management of food hygiene and safety prescribed in Clause 1 of this Article.

Article 23.- The Fisheries Ministry

1. To perform the State management over food hygiene and safety with regard to aquatic products for domestic consumption throughout the production process from rearing, catching, processing, preservation and transport till the time the products are put into circulation on the market;

2. To perform the food hygiene and safety management over aquatic food products which are exported or temporarily imported for re-export;

3. To assume the prime responsibility for, and coordinate with the Health Ministry in, formulating and promulgating documents guiding the management of food hygiene and safety prescribed in Clauses 1 and 2 of this Article.

Article 24.- The Industry Ministry

1. To perform the State management over food hygiene and safety with regard to food products throughout the production process at the establishments under its management according to its assigned functions and tasks till the time food products are put into circulation on the domestic market or exported;

2. To assume the prime responsibility for, and coordinate with the Health Ministry as well as concerned ministries and branches in, formulating and promulgating documents guiding the management of food hygiene and safety prescribed in Clause 1 of this Article.

Article 25.- The Trade Ministry

1. To coordinate with the Health Ministry and the concerned ministries and branches in performing the State management over food circulated on the market according to its assigned functions and tasks;

2. To coordinate with the concerned ministries and branches in examining and inspecting hygiene and safety of food circulated on the market and imported food;

3. To assume the prime responsibility for, and coordinate with the concerned ministries and branches in, formulating and promulgating legal documents on conditions for the food- and drink-catering service business, the fresh and raw and processed food service business; to inspect the observance of these legal documents.

Article 26.- The Science and Technology Ministry

1. To assume the prime responsibility for, and coordinate with the Health Ministry as well as concerned ministries and branches in, formulating Vietnamese standards for food, the process for recognition and certification of qualified food production and trading establishments.

2. To assume the prime responsibility for, and coordinate with the Health Ministry as well as concerned ministries and branches in, formulating the process of State examination of food quality.

Article 27.- The Culture and Information Ministry

To coordinate with the Health Ministry as well as other concerned ministries and branches in, propagating and disseminating food hygiene and safety knowledge and legislation; to provide for food advertising activities.

Article 28.- The Finance Ministry

1. To assume the prime responsibility for, and coordinate with the Health Ministry in, guiding the collection and payment of charges and fees for food hygiene and safety;

2. To coordinate with the Health Ministry and the specialized management ministries in examining imported food according to the provisions of customs legislation and this Decree.

Article 29.- The People's Committees at all levels

1. To coordinate with the competent agencies prescribed in Articles 21, 22, 23, 24, 25, 26, 27 and 28 in performing the State management over food hygiene and safety in the localities throughout the production process from rearing or cultivation, gathering, harvest, exploitation, slaughtering, processing, preservation, transport till the time the food is delivered to consumers; to manage hygiene and safety of food on sale in streets, markets, tourist resorts and festivals.

2. To direct the propagation and education about, guide the implementation of legal documents on, food hygiene and safety. To organize the examination and inspection of the observance of law provisions on food hygiene and safety in the localities.

3. To direct the local Services, Departments and branches to build areas for production and processing of safe farm produce and food; to build models of community participation in the management and supervision of the assurance of food hygiene and safety in the localities.

Section 2. RESPONSIBILITIES IN THE PREVENTION AND OVERCOMING OF FOOD POISONING AND FOOD-BORNE DISEASES

Article 30.- The People's Committees at all levels

1. The People's Committees at all levels shall have to manage and direct activities to ensure hygiene and safety for food circulated in the localities;

2. When a food poisoning or food-borne disease occurs, to direct the timely investigation, overcoming and remedy of consequences. Where they are unable to deal with the situation, the People's Committees of lower levels must report it to the immediate superior People's Committees and the competent State agencies in charge of food hygiene and safety for coordination in thoroughly settling and remedying the consequences caused by food poisoning or food-borne diseases in their localities.

Article 31.- The Agriculture and Rural Development Ministry, the Fisheries Ministry

1. The Agriculture and Rural Development Ministry and the Fisheries Ministry shall have to manage and direct the good manufacturing practice in order to ensure hygiene and safety for agricultural and aquatic products before they are marketed.

2. When food poisoning occurs, they shall have to coordinate with the People's Committees at all levels, the Health Ministry as well as the concerned ministries and branches in overcoming and settling consequences.

Article 32.- The Industry Ministry

1. The Industry Ministry and the concerned branches shall have to manage and direct the food production and processing in plants and factories so that food products must ensure hygiene and safety when marketed.

2. When food poisoning occurs, it shall have to coordinate with the People's Committees at all levels, the Health Ministry as well as the concerned ministries and branches in overcoming and settling consequences.

Article 33.- The Health Ministry

1. The Health Ministry shall have to promulgate branch standards and regulations on food hygiene and safety; to examine and inspect the observance of such branch standards and regulations; and at the same time to conduct investigations to identify the causal establishments, causal meals, causal food and the origin of food poisoning as well as organize the urgent treatment and treatment of poisoned people.

2. Upon the occurrence of food poisoning, it shall have to coordinate with the concerned ministries, branches and People's Committees at different levels in overcoming and handling the consequences.

Article 34.- Food-producing and/or trading organizations, households and individuals

Food-producing and/or trading organizations, households and individuals shall have to observe the food hygiene and safety regulations and requirements, must store food samples according to regulations. When food poisoning or food-borne diseases occur due to the food produced and/or traded by their establishments, they must immediately report them to the local health agencies and administrations for taking timely remedial measures. Depending on the seriousness of violation, they shall be administratively sanctioned or examined for penal liability and, if causing damage, have to pay compensation therefor according to law provisions.

Article 35.- Other concerned agencies and organizations

The concerned ministries and branches, the mass media, socio-political organizations, social organizations and socio-professional organizations shall have to join in organizing the communication of, education and raising of awareness about, and good practice of, food hygiene and safety, take initiative in preventing food poisoning and food-borne diseases, and coordinate with the health sector in overcoming the consequences of food poisoning when it occurs.

Article 36.- Action to be taken when food poisoning occurs

1. When food poisoning occurs, it must be promptly reported to the nearest medical establishment and local People's Committee. If it is a case of massive food poisoning affecting many people or causing deaths or occurring in two or more provinces and/or centrally-run cities, any individuals or organizations that are the first to detect the case must promptly report it to the concerned provincial/municipal Health Services for taking measures to deal with the case and overcome its consequences, and at the same time report it to the Health Ministry.

2. The Health Ministry shall prescribe the regime of reporting on food poisoning and food-borne diseases.

Chapter IV

EXAMINATION AND INSPECTION OF FOOD HYGIENE AND SAFETY

Section 1. EXAMINATION OF FOOD HYGIENE AND SAFETY

Article 37.- Examining competence

Within the scope of their respective functions, tasks and powers, the State management agencies in charge of food hygiene and safety prescribed in Articles 21, 22, 23, 24, 25, 26, 27, 28 and 29 of this Decree shall have to conduct regular and irregular examinations of the observance of law provisions on food hygiene and safety.

Article 38.- Examination contents

To examine the food hygiene and safety conditions prescribed in Section 1, Chapter II of this Decree, food hygiene and safety criteria and law provisions on food labeling and advertisement.

Article 39.- Responsibilities of examined units

1. To appoint competent persons to work with the examination teams;

2. To supply information, documents and reports fully and promptly as requested by the persons assigned with the examination task and be responsible before law for such information, documents and reports;

3. To strictly comply with the examination-related requests, recommendations, decisions and conclusions.

Article 40.- Examination minutes

1. When terminating an examination, the examining agency must make an examination minutes. Each examination minutes must be made in 2 copies, one to be filed at the examining agency and one to be filed at the examined unit;

2. An examination minutes must fully contain the signatures of the examination team's representative and the examined unit's representative.

a/ Where the examined unit disagrees with the conclusions of the examination team, it may reserve its opinion in the minutes, clearly stating the reasons for its disagreement with the conclusions made in the minutes;

b/ If the examined unit refuses to sign the examination minutes, the examination teams shall clearly write: "the examined unit's representative refuses to sign the minutes." This minutes shall be legally valid if it fully contains the signatures of all members of the examination team.

3. Where through examination, the examining agency detects violation acts committed by the examined unit, it shall make a minutes of the violations and transfer it to the competent agency for handling according to law provisions.

Section 2. INSPECTION OF FOOD HYGIENE AND SAFETY

Article 41.- Organization and operation of the specialized food hygiene and safety inspectorate

The health inspectorate shall perform the function of specialized inspection of food hygiene and safety in the whole country. The organization and operation of the specialized food hygiene and safety inspectorate shall comply with the provisions of Articles 46, 47, 48 and 49 of the Ordinance on Food Hygiene and Safety, the State Inspectorate's regulations on health and other relevant law provisions.

Article 42.- Responsibilities for food hygiene and safety inspection

1. The Health Ministry shall assume the prime responsibility for, and coordinate with the Trade Ministry, the Finance Ministry and the concerned ministries and branches in, inspecting hygiene and safety of food circulated on the market and imported food. The Fisheries Ministry, the Agriculture and Rural Development Ministry and the Industry Ministry shall have to assume the prime responsibility for, and coordinate with the Health Ministry and the concerned ministries and branches in, inspecting hygiene and safety of food in the production process, which is assigned to them for management. When detecting that organizations, households and individuals show signs of violation of food hygiene and safety regulations, the Health Ministry's inspectorate shall assume the prime responsibility for, and coordinate with the inspectorates of the concerned ministries and branches in, inspecting the stages of the production process of such food.

2. The People's Committees at all levels shall inspect food hygiene and safety within the scope of their decentralized tasks and powers in the localities.

Chapter V

IMPLEMENTATION PROVISIONS

Article 43.- Implementation effect

This Decree takes effect 15 days after its publication in the Official Gazette. All previous regulations contrary to this Decree are hereby annulled.

Article 44.- Implementation guidance responsibility

To assign the Health Ministry to assume the prime responsibility for, and coordinate with the concerned ministries and agencies in, detailing the implementation of this Decree.

Article 45.- Implementation responsibility

The ministers, the heads of the ministerial-level agencies, the heads of the Government-attached agencies, the presidents of the People's Committees of the provinces and centrally-run cities shall have to implement this Decree.