Decision No. 4196/1999/QD-BYT on the Issuance of the "Regulations on Quality and Food Safety Hygiene"

Pursuant to …;

Regarding the issuance of "Regulations on Quality and Food Safety Hygiene"

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THE MINISTER OF HEALTH

Based on the Law on Health Protection for the People dated June 30, 1989 and the Sanitation Regulations issued together with Decree No. 23/HĐBT dated January 24, 1991 of the Council of Ministers (now the Government);

Based on Decree No. 68/CP dated October 11, 1993 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Based on Decree No. 86/CP dated December 8, 1995 of the Government on the division of responsibilities for state management over product quality;

Pursuant to the proposal of the Director of the Preventive Medicine Department, the Inspector General of the Ministry of Health, and the Director of the Food Safety and Quality Management Department;

Pursuant to …;

Article 1. Issued together with this Decision is the "Regulations on Quality and Food Safety Hygiene."

Article 2. The Food Safety and Quality Management Department shall be responsible for directing, guiding, and inspecting the implementation of these Regulations.

Article 3. This Decision shall take effect fifteen days from the date of issuance.

Article 4. The Heads of the Office, Inspectorate, Preventive Medicine Department, Departments under the Ministry of Health, Food Safety and Quality Management Department, Heads of units under the Ministry, and Directors of Provincial Health Services directly under the Central Government shall be responsible for implementing this Decision.

REGULATIONS

On Quality and Food Safety Hygiene

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

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PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation.

These Regulations prescribe the quality and food safety hygiene during the production, processing, storage, transportation, and sale of food in Vietnam, including imported food.

Article 2. Scope of Application.

These Regulations apply to organizations and individuals engaged in food production and business within the territory of Vietnam, and organizations and individuals importing food for sale in the Vietnamese market.

Article 3. Definitions.

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

1. "Food"means food and drink for human consumption in fresh, raw, or processed form, including beverages, chewing, sucking substances, and materials used in food production and processing.

2. "Food Facility"includes factories, warehouses, equipment, infrastructure of food production, processing, trading facilities, food import facilities, catering service establishments, or other establishments with catering service departments.

3. "Street Food"refers to edible food and drinks, including fresh fruits and vegetables that can be consumed immediately, sold on streets or public places.

4. "Cleaning of Food"refers to the removal of dirt and residues from food.

5. "Food Processing"refers to the process of transforming raw food materials into finished food products.

6. "Irradiated Food"refers to food treated with radioactive substances for preservation and prevention of spoilage.

7. "Genetically Modified Food"refers to food produced from genetically modified raw materials without including food additives and processing aids.

8. "Counterfeit Food"refers to food circulating in the market that does not meet quality standards or registered brand specifications.

9. "Food Quality"refers to compliance with food safety and hygiene regulations and standards regarding composition, packaging, labeling, storage, and transportation of food.

10. "Food Safety and Hygiene"is the condition where food does not harm the health or life of consumers; it is not spoiled, deteriorated, or of poor quality; it does not contain chemical, biological, or physical contaminants beyond permissible limits; and it is not derived from diseased animals that could harm consumers.

11. "Food Regulations"are mandatory provisions on food quality and safety hygiene issued by competent authorities.

12. "Food Standards"are technical documents on food issued by competent authorities.

Chapter II

REQUIREMENTS FOR FOOD FACILITIES

Article 4. Location.

1. Food establishments must be located at least 50 meters away from areas contaminated with dust, toxic substances, smoke, waste zones, water accumulation areas, and other pollutants.

2. Internal roads within food establishments must be constructed to meet hygiene standards, equipped with good drainage systems and gutters.

Article 5. Design.

1. The food production and processing area must be designed according to a one-way flow from raw materials to final products to prevent contamination.

2. Warehouses, workshops, and equipment of food production and processing establishments must be designed to minimize animal intrusion.

3. Storage and preservation areas for food in business and retail establishments must be designed to suit the requirements of each type of food and to prevent insect and animal intrusion.

4. Bathrooms must not have direct access to the food production, processing, and business areas.

5. Separate waste and garbage removal doors must be designed.

Article 6. Structure.

1. Warehouses, workshops, and equipment must be arranged appropriately and conveniently during the food production and processing process to facilitate hygiene measures.

a) Ceiling: light-colored, waterproof, crack-free, resistant to mold and water accumulation, and contaminants.

b) Floor: light-colored, made of non-porous materials that are easy to clean, slip-resistant, non-toxic to food, easy to disinfect, and well-drained.

c) Walls and wall corners: smooth, light-colored, non-toxic to food, waterproof, easy to clean and disinfect.

d) Doorways: smooth, waterproof, preferably automatic opening and closing, and sealing. For canned food and pre-packaged processed food production establishments, there must be a place to soak boots in sterilizing water before entering and exiting.

e) Windows: protected by screens to prevent insect and animal intrusion. Screens must be easily cleaned regularly.

2. Ventilation system:

a) An appropriate ventilation system must be installed to remove condensation, hot air, polluted gases, odors, and dust.

b) The direction of the ventilation system must ensure that it does not blow contaminated air into clean areas.

c) There must be removable protective screens made of rust-proof materials for easy cleaning.

3. Waste containers and non-food items:

Waste containers must be sealed, have lids to prevent animal intrusion, and be cleaned regularly.

4. Lighting system:

a) Food establishments must always be adequately lit:

- Production areas must have a minimum light intensity of 200 lux.

- Areas requiring food inspection must have a minimum light intensity of 540 lux.

b) Lights in food establishment areas must be enclosed in protective boxes or screens and cleaned regularly.

5. Drainage and gutter systems must be sealed, well-drained, easily modified, and must not cause pollution to surrounding areas.

6. Adequate restroom facilities must be provided in convenient locations for all personnel within food establishments and must be equipped with sufficient sanitary facilities.

7. Animal housing areas (if present) must be located at the end of the prevailing wind direction and isolated separately from food production, processing, and business areas.

Article 7. Food Containers and Transportation Means.

1. Containers used for storing and processing food must be made from non-toxic materials that do not impart unusual flavors to food, do not absorb or leach into food, and are corrosion-resistant.

2. Food storage and processing containers must be smooth, crack-free, easy to clean, and surface-disinfected.

3. Transportation means must be suitable for the specific characteristics of food, easy to clean, and must be kept clean regularly to ensure food safety.

4. Transportation means used in food processing, production, business, and circulation must not contaminate, alter the smell, or change the quality of food.

Article 8. Sanitary Area.

1. There must be sufficient hand washing facilities at convenient locations within the food production and business area.

2. Hand washing areas in the production zone must provide clean water, soap, single-use towels, or hand dryers.

3. The sanitary area must have adequate lighting and ventilation systems to easily remove waste and ensure hygiene. Toilets must be constructed so that the main airflow does not blow from the toilet area to the food processing, storage, and display areas.

4. The sanitary area must be completely isolated from the food processing, storage, and display areas and must have signs indicating "Wash Hands After Using Toilet."

Article 9. Factory Hygiene.

1. Food must be processed, stored, and displayed in clean and hygienic places. Dirty substances and pollutants must be removed or reduced to levels that cannot harm human health.

2. Food processing areas and food display areas must be kept clean, free of grease accumulation and leftover foods, and cleaned daily.

3. Food storage areas for sale must be neatly arranged with separate zones for each type of food to prevent cross-contamination and must always be kept clean.

Article 10. Cleaning and Disinfecting Food Processing, Production, and Display Equipment.

1. Equipment and tools used in food processing, storage, and display must be cleaned before and immediately after use. Only cleaning agents and disinfectants approved by the Ministry of Health may be used for food containers.

2. Rinse multiple times with clean water to remove or reduce residual cleaning agents below permissible levels.

3. Water used for rinsing must comply with the regulations of the Ministry of Health.

4. Food processing and production equipment must be disinfected regularly.

5. Cleaning and disinfecting agents for food containers must be stored in clearly identifiable packaging with appropriate usage instructions based on technical characteristics. Cleaning agents must be kept away from food processing, storage, or display areas.

Chapter III

REQUIREMENTS FOR MANAGEMENT PERSONNEL AND DIRECT PRODUCTION AND FOOD BUSINESS STAFF

Article 11. Learning Sanitation and Food Safety Knowledge.

Food establishment owners are responsible for contacting local health authorities to organize training for workers directly involved in food production, processing, or sales regarding food safety and sanitation knowledge.

Article 12. Health of Producers.

1. All individuals directly involved in food production and processing must undergo a health examination prior to employment and regular health checks according to the regulations of the Ministry of Health.

2. Individuals suffering from infectious diseases listed by the Ministry of Health are not allowed to participate directly in food production or processing.

3. Health examinations must be conducted at healthcare facilities at district level or higher.

Article 13. Hygiene of Food Producers and Processors.

1. Individuals directly involved in food production or processing must wash their hands thoroughly with clean water and soap:

a) Before starting work

b) After handling raw materials.

c) After contact with dirty surfaces.

d) After using the toilet.

e) Before handling ready-to-eat food.

2. Food processors must adhere to the following requirements:

a) Wear designated clothing when processing or selling food. Additionally, in necessary cases, food producers and processors must wear hats, gloves, or clean masks.

b) Keep nails short, clean, and free of jewelry when handling ready-to-eat food.

c) Do not eat or drink in food production areas.

d) Do not spit or smoke in food processing areas.

Chapter IV

REQUIREMENTS FOR FOOD QUALITY AND SANITARY SAFETY

Article 14. Responsibility for Implementing Quality and Food Safety Requirements.

1. Food production and business establishments shall only produce, process, import, and sell food that meets quality standards and food safety requirements, ensuring safety for consumers.

2. Strictly prohibit the production, processing, importation, storage, or sale of counterfeit food.

Article 15. Water, Ice, and Steam.

1. There must be sufficient water supply for the entire production area.

2. Water used for food processing must be clean and free from other contaminants, meeting the drinking water and domestic use hygiene standards as prescribed by the Ministry of Health.

3. Production facilities must have adequate clean water with sufficient pressure to supply cleaning and food processing processes. Water storage equipment must be designed appropriately for hygienic storage and use.

4. Ice used for consumption must be produced from clean, hygienic water sources as prescribed by the Ministry of Health.

5. Ice used for consumption and food preservation must be stored and transported hygienically as prescribed by the Ministry of Health.

6. Steam used directly in food production or coming into contact with food must be hygienic, suitable for its intended purpose, and not harmful to human health.

7. Water used for steam production, cooling, firefighting, or other purposes must have separate pipelines and distinct colors for easy identification and must not be connected to the system supplying water for food production and processing.

Article 16. Food Additives.

1. Food additives outside the permitted list of the Ministry of Health must obtain written approval from the Ministry before importation or use.

2. Strictly prohibit the importation, processing, storage, use, advertising, or sale of food additives not on the permitted list of the Ministry of Health.

3. Strictly prohibit the production, importation, processing, storage, and sale of food containing food additives exceeding the safe limits set by the Ministry of Health.

Article 17. Supplements.

1. The use of new supplements must be approved in writing by the Ministry of Health.

2. Strictly prohibit the production, processing, importation, storage, and sale of food containing supplements at concentrations exceeding the safe limits as stipulated by current regulations.

Article 18. Genetically Modified Foods.

All genetically modified foods or ingredients using genetic technology must be labeled in Vietnamese as "produced using genetic technology."

Article 19. Residues of Plant Protection Chemicals and Veterinary Drugs.

Strictly prohibit the production, processing, importation, or sale of food containing plant protection chemicals or veterinary drugs exceeding permissible residue levels as prescribed by the Ministry of Health.

Article 20. Microorganisms and Their Toxins.

Strictly prohibit the production, processing, importation, or sale of food contaminated with microorganisms or their toxins exceeding safe limits as prescribed by the Ministry of Health.

Article 21. Irradiated Foods.

1. Irradiated foods must be produced and processed according to Codex Alimentarius standards and must be labeled in Vietnamese.

2. Strictly prohibit the production, processing, importation, or sale of irradiated foods not included in the list of permitted irradiated foods issued by the competent authority.

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

1. Street food must be displayed on stands at least 1 meter high.

2. Prepared food must be displayed in containers that ensure protection from dust, insects, animals, other sources of contamination, and must be kept separate from fresh or raw foods.

3. Hot prepared food must always be kept at a temperature not lower than 60°C, while cold prepared food must always be kept at a temperature not higher than 5°C during storage and sale.

4. Separate tools must be used to select, pick up, and serve prepared food.

Article 23. Measures to ensure food quality during production.

It is encouraged for food production and processing establishments to apply quality assurance systems for food safety according to HACCP, GMP, ISO, or equivalent food quality assurance systems.

Chapter V

REGULATIONS ON QUALITY AND FOOD SAFETY FOR PACKAGING, LABELING, AND ADVERTISING OF FOOD

Article 24. Food packaging.

1. The use of new packaging materials must be reviewed and permitted by the Ministry of Health.

2. Packaging materials for food production, processing, and packaging must ensure protection from dust, insects, and other sources of contamination.

3. It is strictly prohibited to package food with packaging materials that pose a risk of toxicity, harm, do not meet quality and safety standards, or cause food damage.

Article 25. Food labeling.

1. Food labeling must comply with the "Regulation on Labeling of Goods Circulating Domestically and Exported and Imported Goods" issued together with Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Government Prime Minister.

2. It is strictly prohibited to change food labels or alter the expiration date of circulating food products.

Article 26. Advertising.

Food advertising must be truthful and must be conducted in accordance 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 meet quality and hygiene safety requirements as stipulated by the Law.

2. Importers of food must be responsible for the quality and hygiene safety of imported food.

3. Food listed in the National Inspection List must have a certificate of quality and hygiene safety from the competent authority before importation and consumption in Vietnam.

4. Food not listed in the National Inspection List must still be inspected if there are signs indicating non-compliance with quality and hygiene safety requirements.

5. Imported food failing to meet quality and hygiene safety requirements must be recycled, destroyed, or re-exported according to the decision of the competent authority.

Article 28. Exported food.

1. Exported food must meet the quality and hygiene safety requirements of the importing country.

2. When requested by the purchasing country, the Ministry of Health will consider issuing certificates of quality and hygiene safety, and certificates of free circulation of domestic food products for items that have been registered by the Ministry of Health or provincial health departments under the central government.

Chapter VII

REGULATIONS ON FOOD POISONING, RECALLED FOOD, AND SAMPLE TESTING

Article 29. Retaining food samples, reporting food poisoning and foodborne illnesses.

1. Catering establishments serving meals to thirty or more people must retain food samples and be subject to local health authority supervision regarding food quality and safety. Food samples must be kept for at least twenty-four hours.

2. Individuals who discover or suspect food poisoning or foodborne illnesses must immediately report to the nearest health authorities.

3. Local health authorities must report cases of food poisoning or suspected foodborne illnesses to higher-level health authorities within twenty-four hours upon receiving notification.

4. Local health authorities must cooperate with the Food Safety and Quality Control Department to organize and direct investigations and handling of food poisoning incidents when notified.

5. Data related to foodborne illnesses must be collected, evaluated, and published by the Ministry of Health based on ensuring compliance with legal provisions concerning the protection of state secrets.

6. Individuals whose food causes poisoning or those who prepare, supply, or sell such food must be punished according to administrative violation laws and simultaneously pay all costs associated with investigating the cause and treating the poisoned individuals. If damage is caused to consumers, compensation must be provided according to legal provisions.

Article 30. Recall of Food.

1. Import enterprises, food production and processing establishments must maintain complete record books and be ready to provide them to competent authorities upon request.

2. Recalled food includes imported, produced, and circulated food products that do not meet quality standards and do not match registered documentation. The Food Safety Inspection Agency and other competent authorities are responsible for recalling these foods.

3. Recalled food must be stored in appropriate and separate locations.

4. Recalled food must be recycled or destroyed by food establishments in accordance with procedures prescribed by law.

5. If food establishments do not destroy recalled food themselves, local competent authorities will destroy it, and the food establishment must bear full responsibility for the costs of destruction or disposal of the food.

Article 31. Sample Testing.

1. The Ministry of Health designates agencies with the function of testing food samples collected.

2. The sample collection unit must deliver food samples to the testing agency as soon as possible. Samples must be clearly labeled in accordance with regulations and must ensure no physical, chemical, or microbiological changes from the time of sampling.

3. Sampling, sample retention, storage, and transportation methods must comply with current Vietnamese regulations.

4. The Food Safety and Quality Control Department, provincial/municipal Health Departments have the responsibility to inspect and supervise food establishments according to their level of authority and collect samples for inspection when there is suspicion of non-compliance with food quality and safety standards.

Chapter VIII

INSPECTION, AUDIT AND VIOLATION HANDLING

Article 32. Food Safety and Hygiene Inspection.

The Food Safety and Quality Control Department collaborates with the Ministry of Health's Inspectorate, relevant departments, and agencies to organize inspections and audits of food safety regulations implementation by organizations and individuals engaged in food production and trade nationwide.

Provincial/Municipal Health Departments are responsible for organizing inspections and audits of food safety regulations implementation by organizations and individuals engaged in food production and trade within their jurisdictions.

Article 33. Food Safety and Hygiene Inspection.

The State Sanitary Inspection for specialized health sectors shall be organized in accordance with the State Health Inspection Regulation issued pursuant to Decree No. 23/HĐBT dated January 24, 1991 of the Council of Ministers (now the Government), which is responsible for inspecting compliance with laws on food quality and safety hygiene, and has the authority to impose administrative penalties for violations related to food quality and safety hygiene in accordance with the Law on Administrative Penalties. The inspection of food quality and safety hygiene shall be carried out by inspection teams or inspectors.

Article 34. Handling Violations.

Organizations and individuals violating this regulation shall be subject to disciplinary action, administrative penalties, or criminal liability pursued, if causing damage, they must compensate according to the provisions of the law.