Decision No. 4282/2004/QD-BYT on hygiene and safety conditions for milk production and processing facilities and dairy products issued by the Minister of Health.

Pursuant to …;

REGARDING THE ISSUE OF "REGULATIONS ON SANITARY AND SAFETY CONDITIONS FOR MILK PRODUCTION AND PROCESSING FACILITIES AND MILK PRODUCTS"

THE MINISTER OF HEALTH

Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 on the functions, tasks, powers, and organizational structure of the Ministry of Health;
Pursuant to Decree No. 86/CP dated December 8, 1995 of the Government assigning responsibilities for state management over product quality;
Considering the proposal of the Director of the Legal Department and the Director of the Food Safety and Control Department - Ministry of Health,

Pursuant to …;

Article 1. The Ministry of Health hereby promulgates with this Decision the "Regulations on Sanitary and Safety Conditions for Milk Production and Processing Facilities and Milk Products".

Article 2. The Standard Measurement Quality Control Department shall be responsible for organizing and guiding the implementation of the Regulations adopted herein.

Article 3. The officials: Head of the Office, Chief Inspector, Heads of Departments: Legal Affairs, Science and Training; Director of the Food Safety and Control Department - Ministry of Health, Directors of Health Services of provinces and centrally governed cities, Heads of units under the Ministry of Health, Heads of health services of sectors are responsible for implementing this Decision.

REGULATIONS

REGULATIONS ON SANITARY AND SAFETY CONDITIONS FOR MILK PRODUCTION AND PROCESSING FACILITIES AND MILK PRODUCTS

(Promulgated together with Decision No. 4282/2004/QĐ-BYT dated December 1, 2004 of the Minister of Health)

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

These regulations stipulate sanitary and food safety conditions for milk production and processing facilities and milk products.

Article 2. Applicability

These regulations apply to organizations, households, and individuals within and outside Vietnam engaged in milk production and processing facilities and milk products in Vietnam.

Article 3. Explanation of Terms

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

1. Milk products are products processed from animal milk that may be supplemented with nutrients, food additives, flavorings, or other vitamins to meet human consumption needs.

2. Milk production and processing facilities and milk products (hereinafter referred to as the facility) include: factory buildings; warehouses; equipment and machinery; infrastructure of the production and processing facility.

Chapter II

Conditions for milk production and processing facilities and milk products

Article 4. Location, environment, structure, and design

1. Location, environment

a) The facility must be constructed in places that avoid pollution from the surrounding environment, at least 50 meters away from national highways, livestock pens, poultry houses, hospitals, and other polluted areas measured by the flight path of birds.

b) If the facility has been built in a location that does not comply with the provisions of point a, Clause 1 of this Article, it must have measures to mitigate pollution and other harmful effects caused by natural and environmental factors to the greatest extent possible.

c) For facilities with internal traffic roads, such internal traffic roads must be constructed to minimize dust pollution as much as possible.

d) Within the premises of the facility, cleanliness, dryness, and prevention of the development of harmful organisms must be ensured.

đ) The wastewater drainage system of the facility must be sealed, without water accumulation, convenient for regular cleaning, and must not cut across water supply lines serving food processing.

2. Structure:

a) The facility must be designed and constructed according to the principle of unidirectional flow consistent with the sequence of production stages in the production line and divided into separate zones to ensure cross-contamination between stages or areas is avoided.

b) The total area and the structure of the areas between zones must be consistent with the designed capacity of the facility to avoid overloading that easily causes pollution and difficulties in maintenance, cleaning, and inspection.

3. Factory building design:

a) Wall and ceiling surfaces must be flat, light-colored, easy to clean. The part of the wall surface made of non-porous material must be at least 2 meters high.

b) Floors must be made of light-colored, non-porous, non-slippery, crack-free materials that are easy to clean.

c) Doors must be made of non-porous materials, with a design that is easy to clean and ensures tightness.

d) The system to prevent the intrusion of harmful organisms must be made of rust-resistant, easy-to-clean materials and installed to prevent the maximum intrusion of harmful organisms into the factory area.

đ) The ventilation system must be arranged to remove condensation, dust, hot air, and contaminated air. The direction of the ventilation system must not blow from contaminated areas to clean areas.

e) Lighting systems must always meet the requirements: production areas must have a light intensity of at least 200 lux, inspection areas must reach a light intensity of at least 540 lux. Lights in the milk production and processing facility and milk product areas must have protective boxes or grids.

g) Changing rooms must have an appropriate number. Walls and floors of changing rooms must comply with the provisions of point a, b, Clause 3 of this Article.

h) Milk production and processing facilities and milk products must have a disinfection area for shoes and boots before entering the processing area.

Article 5. Equipment, Utensils for Processing and Means of Transport

1. Equipment and utensils that come into direct contact with food must be made from non-corrosive, non-rusting materials that do not release harmful substances, do not emit unusual odors, and do not alter the quality of food. Such equipment and utensils must have designs that facilitate cleaning.

2. Pipes must bear markings or symbols indicating the contents inside, be easy to disassemble for cleaning, especially at elbow joints.

3. Fixed equipment must be arranged to facilitate cleaning underneath and around it.

4. Means of transporting food must be made from non-corrosive, easily cleanable materials and must ensure they do not contaminate food.

Article 6. Sanitation Regime for Equipment and Factories

1. Factories, equipment, and utensils used during production and processing must be thoroughly cleaned before and after each shift to ensure no contaminants remain.

2. Internal traffic routes must be swept regularly. The facility must have dedicated tools for collecting and storing waste. Solid waste must be collected daily, concentrated in separate areas, isolated from processing and finished product storage areas, and disposed of according to relevant legal regulations.

3. Structures such as light covers, protective grilles, water pipes, beams, columns, and places where contaminants can accumulate must be cleaned frequently to minimize microbial contamination in the production area.

4. Equipment and containers for milk processing must be thoroughly cleaned using detergents approved by the Ministry of Health for circulation.

5. Milk production and dairy product facilities must undergo comprehensive cleaning and disinfection at least once per month.

Article 7. Sanitary Facilities

1. The facility must have sanitary facilities completely isolated from the processing and finished product storage areas. Sanitary facilities must be constructed so that prevailing winds do not blow from the toilet area to the production and processing areas.

2. The facility must ensure the number of toilets meets the Labor Hygiene Standards issued along with Decision No. 3733/2002/QD-BYT dated October 10, 2002, of the Minister of Health.

3. Sanitary facilities must have good lighting, ventilation, and drainage systems. There must be sufficient water supply. Toilet doors must not directly open into processing areas. Sanitary facilities must have hand-washing stations equipped with soap and disposable towels or hand-drying devices, and must display the sign "Wash Hands After Using Toilet" in a visible location.

Article 8. Storage for Milk and Dairy Products

1. Storage for milk and dairy products must be located in positions that facilitate easy entry and exit of products.

2. Storage must ensure that the characteristics, quality, and aroma of milk and dairy products are not altered and that they are not contaminated by harmful chemicals or microorganisms affecting consumer health.

3. In storage, each type of product must be placed in positions where temperature distribution is uniform across all types of products. Raw materials, semi-finished products, and finished products must be stored separately to minimize microbial contamination.

4. Raw milk, semi-finished products, and dairy products must be stored at appropriate temperatures suitable for each type of food.

5. Packed products must be placed at least 20 cm above the floor, 30 cm away from walls, and 50 cm below the ceiling.

Chapter III

RESPONSIBILITIES OF THE FACILITY OWNER AND PERSONS DIRECTLY INVOLVED IN PRODUCTION AND PROCESSING

Article 9. Responsibilities of the Facility Owner

The facility owner shall be responsible for:

1. Organizing training sessions on food safety knowledge for those directly involved in production and processing.

2. Conducting regular health examinations for those directly involved in production and processing in accordance with the regulations of the Ministry of Health.

3. Maintaining record books to fully document issues related to the quality and hygiene safety of milk and dairy products, and being ready to provide them to competent authorities upon request.

4. Gradually applying advanced quality management systems such as Good Hygienic Practices (GHP), Good Manufacturing Practices (GMP), and Hazard Analysis and Critical Control Points (HACCP) systems.

Article 10. Responsibilities of Those Directly Involved in Production and Processing

Those directly involved in production and processing shall be responsible for:

1. Not participating directly in the production and processing of milk and dairy products when suffering from infectious diseases as specified by the Ministry of Health.

2. Washing hands thoroughly with clean water and soap, then drying them when:

a) Starting work;

b) After contact with dirty surfaces;

c) Before contact with milk and dairy products;

d) After using the toilet.

3. Fulfilling the following requirements:

a) Wearing specialized attire: protective clothing, hats, masks, gloves, boots, and head coverings during the production and processing of milk and dairy products;

b) Keeping nails short and clean, not wearing jewelry or watches while processing;

c) Not eating, chewing gum, spitting, or smoking cigarettes or pipes in the production and processing area.

Chapter IV

OTHER REQUIREMENTS

Article 11. Water and Steam

1. The facility must ensure there is sufficient clean water for use in food processing, ice production, and steam that comes into direct contact with food, in compliance with the Drinking Water Sanitation Standards issued together with Decision No. 1329/2002/QD-BYT dated April 18, 2002, of the Minister of Health.

2. Water pipelines for cooling, firefighting, temperature control, and sanitation must have distinct markings and must not be connected to the source of water used directly for the production and processing of milk and dairy products.

Article 12. Packaging and Labeling

1. The facility must ensure that packaging materials directly contacting milk and dairy products comply with current regulations of the Ministry of Health. Materials used for packaging milk and dairy products must be sanitary and safe, and must not contaminate products with harmful substances.

2. Product labeling must comply with the Regulations on Domestic Goods Labeling and Export and Import Goods Labeling issued together with Decision No. 178/1999/QĐ-TTg dated August 30, 1999, of the Prime Minister, and other relevant laws.

Article 13. Use and Storage of Food Additives and Other Chemicals

1. Only food additives listed in the approved list may be used at appropriate quantities for each type of product as stipulated by the Ministry of Health. During use, food additives must be stored according to the manufacturer's requirements.

2. Supporting substances used in the processing and other chemicals must be known in origin, clearly labeled, and stored and used in accordance with legal regulations.

3. The use of cleaning and disinfectant agents for sanitizing equipment and devices that come into direct contact with food must follow the instructions on the label.

4. Rodenticides, insecticides, bactericides, and other potentially toxic chemicals must be stored and used in accordance with legal regulations.

Article 14. Reporting of Milk Poisoning and Milk Products Poisoning Incidents

1. The head of the facility where milk poisoning incidents occur must report to the nearest health authority, take measures to mitigate the poisoning and its consequences according to the requirements of the health authority.

2. Facilities related to the poisoning incident must be responsible for recalling and retaining the batch of products involved to serve the investigation and verification work.

3. The facility producing the food causing the poisoning must bear all costs for examining and treating patients poisoned and investigating the cause of the poisoning.

4. Data related to diseases caused by milk and milk products must be collected, evaluated, and published by the authorized health authority in accordance with the law.

Article 15. Circulation and Recall of Milk and Milk Products

1. Milk production and processing facilities may only circulate products that meet quality standards as announced. When there is a food safety incident involving their products, they must immediately inform the authorized health authority and consumers and take timely measures to address the issue.

2. Specialized food safety inspection agencies and authorized authorities have the responsibility to require facilities to recall milk and milk products that do not meet quality standards and do not match the quality announcement files of the facilities.

3. Recalled milk and milk products must be stored separately and can only be recalled, recycled, or destroyed in accordance with the law.

Article 16. Specific Requirements for Milk and Milk Products

1. Raw milk used in the production and processing of milk and milk products must come from healthy animals without disease and must have a quarantine certificate issued by the authorized veterinary authority.

2. Raw milk must be tested for hygiene and safety indicators before processing. Fresh raw milk when purchased must be stored at a temperature below 5°C. Before processing, raw milk must undergo measures to minimize the risk of microbial contamination.

3. In the butter manufacturing process, the water content in butter must not exceed 18% (typically between 8% and 15%) to minimize the risk of microbial contamination during cooling. Water used in the washing process must be clean and sterile to limit pathogenic microbial contamination.

4. In the fermented milk manufacturing process, if food additives are used to create a sour taste in the product, only those additives listed in the Ministry of Health's permitted list may be used.

5. In the powdered milk manufacturing process, equipment and utensils used for powdered milk production must be made of non-hygroscopic materials. The spray nozzle and air filter parts of the drying equipment must be regularly inspected to minimize contamination due to residues of cleaning and disinfecting agents.

6. In the ultra-high temperature sterilization process for milk, products must be sterilized at high temperatures to minimize the risk of microbial contamination. Packaging processes for heat-treated products must be conducted in separate areas and ensure hygiene. These processes must be monitored and recorded in detail.

7. In the milk packaging process, the filling and sealing processes must ensure hygiene to minimize the risk of product contamination.

8. In the production of powdered milk for children under 12 months old, the addition of vitamins and minerals during processing must comply with legal regulations.