Circular No. 15/2012/TT-BYT stipulates general conditions to ensure food safety for food production and business establishments.

CIRCULAR

Provisions on general conditions ensuring food safety for food production and business establishments

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Pursuant to the Food Safety Law 2010;

Pursuant to Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing some provisions of the Food Safety Law;

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

At the proposal of the Director of the Food Safety and Hygiene Administration;

The Minister of Health shall issue a Circular stipulating general conditions ensuring food safety for food production and business establishments.

PART I

GENERAL CONDITIONS ENSURING FOOD SAFETY FOR FOOD PRODUCTION ESTABLISHMENTS

Article 1. Requirements for the establishment

b) Food production and storage zones must not be flooded or waterlogged;

a) Having sufficient area to arrange production line areas and facilitate food transportation;

b) Production areas not being flooded or waterlogged;

2. Design and construction of factory buildings:

d) Not being affected by food safety issues from dust, hazardous chemical areas, and other pollution sources.

2. Design and layout of factory buildings:

a) Factory building area and zones must be appropriate for the designed production functions of the establishment;

b) Layout of food production processes according to the principle of unidirectional flow from raw materials to final products;

c) Zones for raw material storage, finished product storage, production, preliminary processing, processing, product packaging, sanitation, protective clothing changing, and related auxiliary areas must be designed separately. Raw materials, finished products, food packaging materials, and waste must be handled separately;

d) Internal roads must meet hygiene standards; drainage channels must be covered and cleaned regularly;

đ) Waste collection and treatment areas must be outside the food production area.

b) Materials directly contacting food must have a smooth surface, non-porous, non-leaching harmful substances into food, resistant to wear caused by cleaning and disinfecting agents, and easy to clean and disinfect;

c) Walls must be flat, light-colored, non-porous, free from cracks, free from dirt adhesion, and easy to clean; ceilings must be flat, light-colored, free from leaks, cracks, dirt adhesion, and easy to clean;

b) Materials directly contacting food must ensure smooth surfaces, non-porous, free from harmful substance leaching into food, resistant to cleaning and disinfecting agents, easy to clean and disinfect;

c) Flat, light-colored ceilings without leaks, cracks, dirt accumulation, and easy to clean;

d) Flat, smooth floors capable of bearing weight, non-slippery, good drainage, non-porous, and easy to clean;

đ) Doors and windows made of sturdy, smooth, non-porous, leak-proof materials, convenient for cleaning, and preventing insect and animal intrusion;

e) Stairs, steps, and shelves made of durable, non-slip, easy-to-clean materials and positioned appropriately.

b) The direction of the ventilation system's airflow must ensure that it does not blow from contaminated areas to clean areas.

a) Suitable for food production characteristics, ensuring ventilation for all areas of the establishment, meeting industrial exhaust standards, easy maintenance and cleaning;

b) Ventilation system direction must ensure air does not blow from contaminated areas to clean areas.

b) Light bulbs must be safely shielded by boxes or grids to prevent breakage and ensure that fragments do not fall into food.

a) Lighting system must comply with regulations for production and quality control of safe products;

b) Light bulbs must be safely shielded by boxes or grids to prevent breakage and ensure fragments do not fall into food.

b) Ensure sufficient clean water for hand washing, equipment and facility cleaning, and establishment sanitation during production, complying with national technical standards for potable water quality.

a) Adequate water for food production complying with National Technical Regulations (QCVN) on drinking water quality number 01:2009/BYT;

b) Adequate water for equipment and facility cleaning and establishment sanitation complying with National Technical Regulations (QCVN) on potable water quality number 02:2009/BYT;

c) Water sources must be tested for quality and hygiene at least every six months as prescribed.

b) Separate pipelines and colors must be provided for easy identification and the production water system must not be connected to the steam, cooling, fire protection, or other purpose systems.

8. Wastewater treatment system:

b) Water used for steam generation, cooling, fire prevention, firefighting, or other purposes must have separate pipelines and colors for easy identification and must not be connected to the water system for food production.

8. Wastewater and waste management systems:

a) Adequate waste collection tools that are durable, sealed, with lids, and locks when necessary. Hazardous waste containers must be specially designed, easily identifiable, and lockable to prevent contamination;

b) Wastewater treatment systems must operate regularly and meet environmental protection standards.

b) Ventilation must be properly arranged to ensure that air does not blow from toilets to production areas; sewage discharge must be easy and sanitary. There must be a guide for proper hand washing;

a) Separate toilet facilities from food production areas; toilet doors must not open directly into production areas; at least one toilet must be provided for every twenty-five people;

b) Ventilation systems must be properly arranged to prevent air from toilets blowing into production areas; drainage systems must easily remove waste and maintain hygiene. A "Wash Hands After Using Toilet" sign must be placed in visible locations in toilet areas;

a) Food ingredients, food additives, and food processing aids used in food production must have clear origins and be safe;

10. Food ingredients and food packaging:

a) Food ingredients, food additives, processing aids, preservatives used in food production must have clear origins, be permitted for use according to regulations;

b) Food packaging must be secure and safe; free from harmful substance leaching, not affecting food quality and safety; not contaminated by factors affecting consumer health as prescribed.

Article 2. Requirements for equipment and tools

1. Equipment and tools that come into direct contact with food must be designed and manufactured to ensure safety; made from materials that do not cause contamination of food; suitable for production technology requirements, easy to clean, disinfect, and maintain. For mobile production equipment, it must be durable, easy to move, disassemble, and clean.

2. Hand washing and disinfection facilities:

a) Must have sufficient hand washing facilities, hand disinfection facilities, boots, shoes, and slippers before entering the food production area;

b) Hand washing facilities must provide clean water, antiseptic water, disposable towels or paper towels, or hand dryers.

c) Food production workshops must have hand washing basins, with a minimum of one basin for every fifty workers.

3. Food production equipment and tools:

a) Must be adequate and suitable for processing raw materials, preparing, and packaging food;

b) Made from non-toxic materials that are resistant to wear, corrosion, and do not release harmful substances into food, do not produce unusual odors, or alter food.

c) Easy to clean and maintain; do not contaminate food due to lubricating oil or metal fragments;

d) Production line equipment must have cleaning procedures and operating procedures.

4. Prevention of pests and harmful animals:

a) Insect and pest control equipment must be made from rust-resistant materials, easily disassembled for cleaning, designed appropriately, and effectively prevent insects and pests.

b) Chemicals, animals shall not be used to eliminate rodents, pests, and harmful animals within the food production area.

5. Monitoring and measuring equipment:

a) Must have sufficient quality monitoring equipment and tools to assess the main quality and safety indicators of food products.

b) Monitoring equipment must be accurate and regularly maintained and calibrated according to regulations.

6. Cleaning agents and disinfectants:

a) Only chemicals for cleaning and disinfection approved by the Ministry of Health may be used;

b) They must be stored in clearly labeled containers with usage instructions and must not be kept in food production areas.

Article 3. Requirements for persons directly involved in food production

1. The owner of the facility and persons directly involved in food production must undergo training and obtain a certificate confirming their knowledge of food safety according to regulations.

2. The owner of the facility and persons directly involved in food production must undergo health examinations and obtain certificates confirming their fitness for work according to the regulations of the Ministry of Health; in regions where diarrheal diseases are currently circulating as announced by the Ministry of Health, persons directly involved in food production must undergo stool cultures to detect pathogens causing intestinal infections (cholera, bacillary dysentery, and typhoid fever) and must have negative culture results; health checks and tests must be conducted by healthcare facilities at district level or higher.

3. Persons suffering from infectious diseases listed in the catalog of infectious diseases that workers are prohibited from coming into direct contact with during food production and processing, as specified by the Ministry of Health, shall not participate directly in food production.

4. Persons directly involved in food production must wear dedicated protective clothing, hats, gloves, and masks.

5. Persons directly involved in food production must comply with hygiene practices: keep nails short and clean, and do not wear rings or watches. Smoking and spitting are prohibited in food production areas.

Article 4. Requirements for food storage during food production

1. Raw materials, packaging, and finished food products must be stored in designated storage areas and warehouses with sufficient space for food storage; designed to meet storage and handling requirements for each type of food and raw material; construction materials in contact with food must be safe.

2. Food warehouses must be sturdy, secure, well-ventilated, easy to clean, and capable of preventing insect and pest entry and habitation.

3. Storage areas and warehouses for food must have nameplates, internal rules, cleaning procedures, and for raw materials and finished food products requiring special storage conditions, temperature, humidity, and other condition records must be kept.

4. There must be sufficient shelves and racks made of sturdy, hygienic materials; ensuring adequate lighting and safe coverage. Raw materials and food products must be packaged and stored at least 20 cm above the floor, 30 cm away from walls, and 50 cm below the ceiling.

5. Specialized equipment to adjust temperature, humidity, ventilation, and other factors affecting food safety must be available; such equipment must be appropriate and able to monitor and control storage conditions for each type of food according to manufacturer requirements; equipment must be easy to maintain and clean.

6. Sufficient monitoring equipment for temperature, humidity, and other factors affecting food safety throughout the food production process must be available.

7. Raw materials, food additives, processing aids, preservatives, and food products must be stored according to the manufacturer's product storage guidelines and the temperature, humidity, light, and other factors affecting food safety requirements for each type of food.

8. Ice used for food preservation must be produced from clean water according to National Technical Regulation (QCVN) on Clean Water No. 02:2009/BYT.

Chapter II

Article 5. General Conditions for Ensuring Food Safety for Food Business Establishments

Article 5. Requirements for the establishment

1. Must have sufficient area to arrange food display areas, storage areas, preservation areas, and facilitate the transportation of raw materials and food products.

2. Must not be prone to flooding or water accumulation.

3. Not be affected by animals, insects, harmful microorganisms.

4. Not be affected by food safety from dust-contaminated areas, toxic chemicals, and other pollution sources.

5. Design of food business areas, sanitation, protective clothing changing areas, and auxiliary areas must be separate and meet food business requirements.

6. The structure of buildings in various areas must be sturdy, suitable for the nature and scale of food business operations; constructed with appropriate materials to ensure hygiene, prevent harmful microorganisms, insects, and destructive animals from entering and residing.

7. The floor must be flat and smooth; have a hard surface capable of bearing weight and wear; have good drainage, not slippery, and free from water accumulation and easy to clean.

8. The ceiling must be flat and light-colored, made of durable and solid material, not leaking, water-permeable, cracked, moldy, water-dripping, or dirty.

9. Doors and windows must be smooth and flat, facilitating cleaning; where necessary, there must be insect-proof and animal-proof screens.

10. Lighting sources and intensity must comply with regulations; light bulbs must be safely shielded.

11. Ventilation systems must be suitable for food preservation requirements, ensuring air circulation in all areas.

12. Must have sufficient waste collection equipment; these tools must be made of durable material, sealed with lids, and regularly cleaned.

13. Sanitation areas must be separated from food business areas; toilet doors must not open directly into food storage areas; at least one toilet must be provided for every twenty-five people; there must be sufficient clean water meeting National Technical Regulations (QCVN) on clean water number 02:2009/BYT, cleaning supplies, soap, and detergents for hand washing and cleaning; a sign reading "Wash Hands After Using Toilet" must be placed in a visible location.

14. There must be sufficient clean water for cleaning equipment, utensils, and the establishment, meeting National Technical Regulations (QCVN) on potable water quality number 02:2009/BYT.

15. Food sold must have clear origin and expiration date.

Article 6. Requirements for Equipment and Utensils

1. Adequate equipment to serve business and storage needs, suitable for each type of food (shelves, product displays, temperature and humidity control equipment, ventilation in storage, display, and preservation areas); there must be procedures and hygiene regimes established for the establishment.

2. Adequate equipment to monitor temperature, humidity, ventilation, and other factors affecting food safety throughout the food business process according to technical requirements for each type of food product.

3. Insect and pest prevention equipment must not rust, be easily disassembled for maintenance and cleaning, designed to effectively prevent insects and pests; chemical pesticides, rodenticides, and insecticides must not be used in food business and storage areas.

4. Monitoring and measuring equipment for product quality and safety must be accurate and regularly maintained and calibrated as required.

Article 7. Requirements for persons directly engaged in food business

1. The owner of the establishment and persons directly engaged in food business must be trained and issued with a Certificate of Food Safety Knowledge Training in accordance with the regulations.

2. The owner or manager who has direct contact with food and persons directly engaged in food business must undergo a health examination and be issued with a Certificate of Adequate Health Status in accordance with the regulations of the Ministry of Health. Health examinations shall be conducted by healthcare facilities at district level and above.

3. Persons suffering from diseases or conditions listed in the catalogue of infectious diseases that workers are not permitted to have direct contact with during food business operations, as specified by the Ministry of Health, shall not be allowed to participate directly in food business operations.

4. Persons directly engaged in food business must wear specific protective clothing; they are prohibited from smoking or spitting in the food business area.

Article 8. Requirements for food storage in food business

Food storage in food business establishments must comply with the requirements stipulated in Clauses 1, 2, 3, 4, 5, 7, and 8 of Article 4 of this Circular.

Chapter III

IMPLEMENTING PROVISIONS

Article 9. Effective Date

1. This Circular takes effect from November 1, 2012.

2. The Decision No. 39/2005/QĐ-BYT dated November 28, 2005 of the Minister of Health on the issuance of regulations concerning hygiene conditions for food production establishments shall be abolished from the date this Circular takes effect.

Article 10. Implementation Organization

Based on the guidelines set out in this Circular, relevant ministries responsible for managing sectors and fields shall issue specific regulations on food safety conditions for food production and business establishments within their assigned areas of management.

During implementation, if there are any difficulties, they should be promptly reported to the Ministry of Health for consideration and resolution./.