Quyết định 4196/1999/QD-BYT

DECISION

ON PROMULGATING "PROVISIONS ON QUALITY, HYGIENE AND FOOD SAFETY"

MINISTER OF HEALTH

Pursuant to the Law on Protection of People's Health dated 06/30/1989 and Charter of Sanitation issued together with Decree No.23 - HDBT dated 24/01/1991 of the Council of Ministers (now the Government);

Pursuant to Decree No.68/CP dated 11/10/1993 of the Government on functions, tasks, powers and organizational apparatus of the Ministry of Health;

Pursuant to Decree No.68/CP dated 11/10/1993 of the Government on functions, tasks, powers and organizational apparatus of the Ministry of Health;

Pursuant to Decree No.86/CP dated 08/12/1995 of Government on the assignment of responsibilities of State management over goods quality;

At the proposal of the General Director of Department of Preventive Medicine, Chief Inspector - Ministry of Health, General Director of Department for Management of quality, hygiene and food safety,

DECIDES

Article 1. Issuing together with the Decision is the “Provisions on quality, hygiene, and food safety”.

Article 2. Management Department of Quality, Hygiene, and Food Safety is responsible for directing, guiding, and inspecting the implementation of this Regulation.

Article 3. This Decision takes effect 15 days after the signing date.

Article 4. Mr. and Ms: Chief Office, Chief Inspector, General Director of Department of Preventive Medicine, General Director of Department of the Ministry of Health, General Director of Department of Management of quality, hygiene and food safety, the heads of the units directly under Ministry and Director of the Department of Health of provinces/cities under the Central Government are responsible for the implementation of this Decision.

PROVISIONS

ON QUALITY, HYGIENE AND SAFETY OF FOODS

(Issuing together with the Decision No.4196/1999/QD-BYT dated December 29, 1999 of Minister of Health)

Chapter I

GENERAL PROVISIONS

Article 1. Scope of governing.

This Regulation provides for quality, hygiene, and food safety in the production, processing, storage, transportation, trading of food in Vietnam, including imported food.

Article 2. Subjects of governing.

This Regulation applies to organizations and individuals producing, trading food in the territory of Vietnam, organizations, and individuals that import food to sell in the Vietnam market.

Article 3. Interpretation of terms.

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

1. "Food" means food and drink of the people in fresh, raw or subject to preliminary treatment, processed including beverages, chewing, sucking and substances used in manufacturing, processing of food.

 2. "Food establishment" includes workshops, warehouses, equipment and infrastructure of the facilities of production, processing and sales of food, import of food and food service facilities or other facilities with food service department.

3. "Street food" is food, beverages, including vegetables, fresh fruit that may be eaten immediately sold on the streets or public places.

4. "Food cleaning" is the removal of dirt, residues in food.

5. "The food processing" means the processing of food from raw materials to finished food.

6. "Irradiation food" is the food used radioactive substances in order to preserve and prevent deterioration of food.

7. "Food used gene technology" means the food made from food materials which have been modified by application of genetic technology and not including food additives and processing aids.

8. "Fake food" means the foods circulated on the market not guaranteeing the quality or trademark as registered.

9. "Food quality" is consistent with the regulations on hygiene and food safety and the standards on the components, packaging, labeling, storage, and transportation of food.

10. "Hygiene and food safety" means the food that is not harmful to health or life of users; not being ruined, degenerated, reduced quality or low quality; not containing physical or biologic, chemical agents exceeding the permissible limitation; not being the products of diseased animals that can be harmful to users.

11. "Regulations on food" is the provision applying mandatory for quality, hygiene, and food safety issued by the competent authority.

12. "Food standard" is the technical documents on food issued by the competent authority.

Chapter II

REQUIREMENTS FOR THE FOOD ESTABLISHMENTS

Article 4. Location.

1. Food establishments must locate away from areas of dust contamination, toxic substances, smoke, waste areas, place of the stagnant water and other contaminants at least 50m.

2. Internal roads in the food establishments must be constructed to ensure hygiene standards, with well sewers, drains.

Article 5. Design.

1. The area of production, processing of food must be designed according to the rule of one way from raw material to finished product to avoid contamination.

2. Storage, factory and equipment of the establishments of production, processing of food must be designed to limit the entry of animals.

3. Place containing and storing food of the establishments of trading, selling food designed in accordance with the requirements of each type of food and prevention of the entry of insects and animals.

4. Toilets must not be opened directly to the sectors of manufacturing, processing, trading food.

5. Doors taking waste, garbage must be designed separately.

Article 6. Structure.

1. Warehouse, workshops, and equipment are located conveniently and easily in the process of manufacturing, processing food to facilitate the application of measures to handle sanitary.

a) Ceiling: bright color, waterproof, no cracks, prevention of mold and stagnant water and dirt.

b) Floors: bright color; made of materials that are waterproof, washable, non-slip, non-toxic for food, easy to clean, sterile and well drained.

c) Walls and wall angle: flat, bright, non-toxic for food, waterproof, easily easy to clean, sterile.

d) Doors: smooth, waterproof, it is better to automatically open and closed. For the establishments producing canned food, packed, processed food, the in-front entrance must be designed the location for placing antiseptic water to soak boots before entering and exiting.

e) Window: a safety net to avoid the intrusion of insects and animals. The net must facilitate for regular cleaning.

2. Ventilation system:

a) Ventilation system must be proper to eliminate condensation, heat, polluted air, strange smells, and dust.

b) The direction of the ventilation system must be ensured not being blown the wind from contaminated areas to clean areas.

c) With protection mesh made of easy-to-disassemble; rustless materials for cleaning.

3. Containers of waste and inedible items:

Waste containers must be sealed with lids to avoid the entry of animals and be cleaned regularly.

4. Lighting system:

a) The food establishments must always be fully illuminated:

- The place of producing must have the light intensity of not less than 200 lux.

- The place of checking food must reach the light intensity of not less than 540 lux.

 b) Lights in the areas of food establishments must have a safety net or box and be cleaned regularly.

5. Sewage, ditches systems must be tight, well-drained, easily renovated, non-pollution of the surrounding area.

6. The full toilets system which are located in the convenient locations for everyone in the food establishment and all the equipment to ensure hygiene.

7. Area of breeding pet (if any) is arranged at the end of the main wind direction and separate isolation with the area of producing, processing, and trading food.

Article 7. Containers of food and means of transportation.

1. The instrument used for containing and processing food must be made from nontoxic materials without causing strange odor compared to the taste of initial food, not being absorption, not being contamination into food, non-corrosive .

2. The instrument used for containing and processing food must be smooth, without cracks, easy to clean and disinfected its surfaces.

3. The means of transportation must conform to the particular nature of food, easy to clean and should be kept clean regularly to ensure food safety.

4. The means of transportation used in the processing, production, business, and circulation of food is not polluted, changed odor or deteriorated food

Article 8. Toilet area.

1. Having sufficient hand washing facilities in convenient locations in the sector of manufacturing and processing, trading food.

2. Hand wash place in the production area must be provided adequate clean water, soap, hand towels of one time use or hand dryer.

3. Toilet area must have the systems of lighting and ventilation, easy drainage, waste disposal and hygiene assurance. Toilets should be constructed so that the main wind direction does not blow from the restroom area to the area for processing, storage, and sale of food.

4. Toilet area must be completely separated from the area of processing, storage, selling of the food and having guidline "Wash your hands after leaving the toilet”.

Article 9. Sanitation of facilities.

1. Food is processed, stored, displayed for sale in the clean and hygienic places. The dirt, contaminants must be eliminated or reduced to the levels not likely to cause hazards to human health.

2. The place where food is processed; sold must be clean and not depositing grease and outstanding foods are washed; cleaned daily.

3. The place where food is stored for sale must be neatly arranged, with each separate area for each type of food to avoid cross contamination and always kept clean.

Article 10. Making clean and disinfect equipment, tools of processing, production and sale of food.

1. The equipment and tools used in the processing, storage and sale of food must be cleaned before and after use. Only use detergents for food containers and disinfectant permitted by the Health Ministry.

2. Rinsing with clean water several times to remove or reduce the residual detergent to below the permitted level.

3. Water used for washing must be ensured according to provisions of the Ministry of Health.

4. Equipment, tools of processing and production of food must be disinfected regularly.

5. The substance used for cleaning and sterilizing food containers must be placed in easily identifiable packages and manuals in accordance with specifications. The detergents must be placed separate from the area of processing, storage, or sale of food.

Chapter III

REQUIREMENTS FOR EXECUTIVES, PERSONS WHO DIRECTLY PRODUCE AND TRADE FOOD

Article 11. Learning knowledge of hygiene and food safety.

Owners of the food establishments shall have to contact local health agencies for organizing the workers directly participate in the production, processing, or selling food to study the knowledge of hygiene and food safety.

Article 12. Health of producers.

1. Persons who directly participate in producing and processing food must be examined health before the recruitment and periodic re-examination in accordance with the provisions of the Ministry of Health.

2. Those who are suffering from infectious diseases by the list provided by the Ministry of Health are not directly participated in the production or processing of food.

3. The medical examination must be conducted in the medical institutions from district level upwards.

Article 13. Hygiene of those who manufacture and process food.

1. The persons who directly produce or process food must wash their hands with water, with soap:

a) When starting to work.

b) After processing the raw materials.

c) After touching dirty surfaces.

d) After the toilet is complete.

e) Before contacting with ready to eat food.

2. The persons who process food must comply with the following requirements:

a) Wearing specific outfits when preparing or selling food. In addition, in the necessary cases, the persons who produce, process food must wear hats and gloves or clean masks.

b) Keeping the nails short, clean and not wearing jewelry when contacting directly with instant food.

c) Not to eat in the food manufacturing sector.

d) Not to spit, smoke in the area for processing.

Chapter IV

REQUIREMENTS FOR THE QUALITY, HYGIENE, AND FOOD SAFETY

Article 14. Responsibility for implementing the requirements of quality, hygiene, and food safety.

1. The establishments manufacturing, selling food is produced, processed, imported, traded only the foods reaching the standards of quality, hygiene, and food safety, safety for the users.

2. Strictly prohibit the manufacture, processing, importation, storage, or sale of fake food.

Article 15. Water, ice, and steam.

1. Having enough water to distribute for the entire manufacturing sector.

2. Water used for food processing must be clean and not containing other contaminants, ensuring hygiene and safety standards for drinking water and living water in accordance with provisions of the Ministry of Health.

3. Manufacturing establishments must have sufficient clean water, enough pressure to provide for the cleaning, food processing. Water storage equipment must be designed properly to store and use hygienically.

4. Ice used for food must be produced from clean water, sanitary according to the Health Ministry’s provisions.

5. Ice used for food and food preservation must be preserved and transported under sanitary regulations of the Ministry of Health.

6. Steam used directly to produce food or contact with food must be hygienic, suitable to the using purpose and not causing harm to human health.

7. Water used for steam production, refrigeration, fire protection or used for other purposes must have separate pipes, be painted its own distinctive colors, and not connected to the water system used for production and processing of food.

Article 16. Food additives.

1. Food additives that are not included in the permissible list of the Ministry of Health before being imported or brought into use must be permitted in writing by the Ministry of Health.

2. Strictly prohibit the import, processing, storage, use, advertisement, or selling of food additives that are not included in the list permitted by the Health Ministry.

3. Strictly prohibit the manufacture, importation, processing, storage, and sale of food containing food additives in excess of permissible safe limits of the Ministry of Health.

Article 17. Supplements.

1. The use of new additional substances must be permitted in writing by the Health Ministry.

2. Strictly prohibit the manufacture, importation, processing, storage, and sale of food containing the supplements at the contents exceeding permissible safe limits by current regulations.

Article 18. Food using genetic technology.

All food using genetic technology or materials using genetic technology must be labeled in Vietnamese "With use of genetic technology."

Article 19. Residues of plant protection medicine and veterinary medicine

Strictly prohibit the manufacture, processing, importation and sale of foods containing plant protection medicine or veterinary medicine exceeding permitted residues under the provisions of the Health Ministry.

Article 20. Microorganisms and Microorganisms’ toxins.

Strictly prohibit the manufacture, processing, importation, or sale of foods contaminated with microorganisms or their toxins exceeding the safety limits as prescribed by the Ministry of Health

Article 21. Irradiated Food.

1. Irradiated food must be produced, processed by the CODEX standards and must be labeled in Vietnamese.

2. Strictly prohibit the manufacture, processing, importation, or sale of irradiated foods out of the list of food permitted for irradiation issued by the competent authority.

Article 22. Requirements on hygiene and safety for street food.

1. Street food must be put on the high shelf of not less than 1m.

2. Processed foods must be marketed in the tools ensuring to avoid dust, insects, animals and other pollution sources and must be placed separate from the draw food or preliminarily processed.

3. Hot processed food must be kept at a temperature of not lower than 60°C, processed food for cold eating must be kept at a temperature of not more than 5°C during the storage and sale of food.

4. It must have its own tools to pick the prepared food.

Article 23. Application of measures to ensure food quality during production.

To encourage the establishments of production, processing of food applying the system of assurance of quality, hygiene, and food safety under HACCP, GMP, ISO or other equivalent food quality assurance systems.

Chapter V

PROVISIONS ON THE QUALITY, HYGIENE, AND FOOD SAFETY FOR PACKAGING, LABELLING AND ADVERTISING OF FOOD

Article 24. Food packaging.

1. The use of new packaging materials must be appraised and licensed by the Ministry of Health.

2. The food packaging materials produced, processed, packaged must ensure the prevention of dust, insects, and other pollution sources.

3. Strictly prohibit the foods packaging by the packages which are likely to cause toxic, harmful, not guaranteeing the quality and safety or causing ruin to food.

Article 25. Food labeling.

1. The labeling of food must comply with the "Regulation on labeling of domestically circulated goods and exports and imports" issued together with the Decision No.178/1999/QD – TTg dated 30/8/1999 of the Prime Minister.

2. Strictly prohibit the self-change of food labels, change of the expiry of the food circulated.

Article 26. Advertising.

Advertising of food must be true and must comply with the provisions of the law on advertising.

Chapter VI

IMPORTED AND EXPORTED FOOD

Article 27. Requirements for imported food.

1. Food imported into Vietnam must ensure the quality, hygiene, and safety as prescribed by law.

2. Food importing establishments shall be responsible for the quality, hygiene, and safety of imported food.

3. Imported food on the list required for state inspection must have a certificate of quality, hygiene, and food safety of the competent authorities before they are imported and sold in Vietnam.

4. Imported food which is not on the list required for state inspection must still check if detected signs of failure to ensure the quality, hygiene, and safety.

5. Imported food which is unsatisfactory in quality, hygiene, and safety must be recycled, cancelled or re-exported under decisions of the competent authorities.

Article 28. Exported food.

1. Exported food must be ensured quality and hygiene and food safety as required by the importing country.

2. Upon request by the purchasing country, the Ministry of Health will consider to grant a certificate of quality, hygiene and food safety and certificate of food products circulated freely in the country for the food items which were issued the registration number by the Ministry of Health or the Health Departments of provinces and cities under central authority.

Chapter VII

REGULATION ON FOOD POISONING, RECALLED FOOD AND SAMPLE TESTING

Article 29. Saving of food sample, reports of poisonings and diseases caused by contaminated food.

1. The establishments, units that organize the meals for from 30 people or more must save food samples and under the supervision of local health agencies on quality, hygiene, and food safety. The food samples must be kept for at least 24 hours.

2. The persons who detect or suspect poisoning and diseases caused by contaminated food shall be responsible for notifying immediately the nearest health agencies.

3. The local health agencies must report the cases of food poisoning or suspected signs of diseases caused by contaminated food to high level health authorities for the period of not exceeding 24 hours after receiving the notice.

4. The local health agencies coordinate with the Management Department of quality, hygiene and food safety to organize and direct the investigation and handling of food poisoning cases as being notified.

5. The data relating to diseases caused by contaminated food must be collected and evaluated and announced by the Ministry of Health on the basis of ensuring the implementation of the provisions of the law on protection of state secrets.

6. People with food or processing, supplying, and selling food causing poisoning must be sanctioned in accordance with the law regulations on handling of administrative violations and must pay the costs for the investigations to find the causes and costs for therapy of the poisoned persons. If it causes damage to the consumers, they must pay compensation in accordance with the law regulations.

Article 30. Withdrawn food.

1. The importing enterprises, establishments manufacturing, processing food must have the book system to keep track and record in full and ready to provide for the competent authorities upon request.

2. Withdrawn foods are the foods imported, manufactured, or marketed without quality assurance and improper registration records. Inspection of hygiene and food safety and the competent authorities are responsible for revoking these foods.

3. Foods which were withdrawn must be kept in appropriate and separate places.

4. Foods which were withdrawn must be recycled or canceled by the orders provided by the law.

5. If the food establishments do not make self-destruction of food, the local competent authorities shall destroy and the food establishments are responsible for paying all costs for disposal or processing of food.

Article 31. Sample testing.

1. The Ministry of Health designates the function agencies to test food samples collected.

2. The unit collecting samples must hand over the food samples to the samples testing agency as soon as possible. Samples must be labeled in full and clearly as prescribed and make sure that there is not any change in the physics, chemical, micro-organism compared to the time of sampling.

3. Methods of sampling, storage, preservation, and transportation of samples must conform to current regulations of Vietnam.

4. Management Department of quality, hygiene and food safety, the Departments of Health of provinces and cities under the Central Government is responsible for inspecting, monitoring the food establishments by decentralization and sampling for inspection if it is in doubt of not guaranteeing quality, hygiene and food safety.

Chapter VIII

EXAMINATION, INSPECTION AND HANDLING OF VIOLATIONS

Article 32. Examination of hygiene and food safety.

The Management Department of quality, hygiene and food safety coordinates with inspectors of the Ministry of Health, the Departments and relevant agencies to examine and inspect the implementation of the provisions on hygiene and safety of food for organizations and individuals producing and trading food in the country.

The Departments of Health of provinces or cities under central authority are responsible for organizing the examination and inspection of the implementation of the provisions on hygiene and safety of food for organizations and individuals producing and trading food in the country.

Article 33. Inspection of hygiene and food safety.

The State inspectorate of specialized-hygiene health that are held under the State Inspectorate Charter of Health issued by the Decree No.23/HDBT dated 24/01/1991 of the Council of Ministers (now the Government) is responsible for inspecting the observance of the law on quality, hygiene and food safety, entitled to sanction administrative violations of quality, hygiene and food safety in accordance with the law regulations on handling of administrative violation. The inspection of quality, hygiene, and food safety is performed by inspection teams or inspectors.

Article 34. Handling of violations.

Organizations and individuals violating this regulation, depending on the nature and seriousness of their violations, shall be disciplined administratively or examined for penal liability, if causing damage, pay compensation in accordance with law regulations.