Thông tư 15/2012/TT-BYT quy định điều kiện chung bảo đảm an toàn thực phẩm đối với cơ sở sản xuất, kinh doanh thực phẩm do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

PROVIDING ON GENERAL CONDITIONS TO ENSURE FOOD SAFETY FOR FOOD PRODUCTION AND BUSINESS FACILITIES

Pursuant to the 2010 Law of Food safety;

Pursuant to the Government’s Decree No.38/2012/ND-CP, of April 25, 2012 detailing a number of articles of the Law of Food safety;

Pursuant to the Government’s Decree No.188/2007/ND-CP, of December 27, 2007 defining the functions, tasks, powers and organizational structure of the Ministry of Public Health;

At the proposal of Director of the food safety and hygiene Department;

The Minister of Public Health promulgates Circular providing on general conditions to ensure food safety for food production and business facilities.

Chapter I

GENERAL CONDITIONS TO ENSURE FOOD SAFETY FOR FOOD PRODUCTION FACILITIES

Article 1. Requirement for facility

1. Place, environment:

a) Having sufficient area to arrange zones of production lines and be convenient for food transportation;

b) Production zones not be flooded, stagnant;

c) Not being affected by animals, insects, harmful microorganisms;

d) Food safety not being affected from areas polluted by dust, toxic chemicals and other source causing pollution.

2. Design and arrangement of workshops:

a) Area of workshops, zones must be suitable to the designed production performance of facility;

b) Arrangement of food production process under one-direction principle from the input raw materials to the final product;

c) Areas of raw materials storehouse, finished products storehouse; areas of production, preliminary treatment, processing; areas of product package; restrooms; protective clothing dressing rooms and relevant auxiliary areas must be designed separately. The raw materials, finished foods, materials of food package, waste must be separated;

d) Internal road must be constructed to ensure hygiene standard; sewer to discharge sewage must be covered closely and cleaned, freed obstruction regularly;

e) Place of collecting and handling waste must be outside areas of food production.

3. Structure of workshops:

a) Workshops must have firm structure, be suitable to nature, scale and food production technology process;

b) Materials contacting directly with food must ensure create a surface which is smooth, impermeable, not release harmful substances to food, be eroded not much by detergents, disinfectants and easy to wipe clean, sterilize;

c) Ceiling is flat, bright color, not leaked, water-permeable, not cracked, not adhered by dirty substances and easy to clean;

d) Floor is flat, smooth, load supporting, not to cause slipperiness, good drainage, impermeable, not stagnant and easy to clean;

dd) Doors, windows are made of reliable material which is smooth, little water-permeable, closed, flat, convenient to clean, ensured to avoid from penetration of insects, pets.

e) Stairs, landing steps and shelves are made of durable materials which are not slippery, easy to clean and laid at suitable position.

4. Air ventilation system:

a) Being suitable to characteristic of food production, ensure ventilation for areas of facility, satisfy standards on industrial exhaust, easy to maintain and clean;

b) Direction of air ventilation system must ensure breeze not blowing from dirty areas to clean areas.

5. Lighting system:

a) Lighting system must ensure according to provisions for production, control of product safety quality;

b) Lamps for lighting must be shielded safely by box or gird in order to prevent from being broken and ensure fragments not dropping down food.

6. Water supply system:

a) Having sufficient water for food production and in conformity with National technical regulation (QCVN) on quality of edible and drinkable water No.01:2009/BYT;

b) Having sufficient water for sanitary of equipments, tools, and sanitary of facility and in conformity with National technical regulation (QCVN) on quality of living water No.02:2009/BYT;

c) The above water source must be inspected quality, hygiene at least of per 6 month duration as prescribed.

7. Steam and compressed air:

a) Steam and compressed air used for food production must ensure clean, safe, not to cause pollution for food;

b) Water used for production of steam, for chilling, fire prevention and fighting or for other purposes must have separate pipe, separate color in order to distinct and not to connect with water system used for food production.

8. Waste treatment system:

a) Having sufficient tools to collect waste; tools are made of materials which not be corrupted much, ensure be closed, with lids and locked in necessary cases. Tools containing hazardous waste must be designed specially, easy to distinct, when necessary can lock to prevent from pollution;

b) Waste treatment system must be operated regularly and satisfy standards of waste treatment as prescribed by law on environment protection.

9. Restrooms, protective-clothing dressing rooms

a) Restrooms must be laid separately with areas of food production; gate of restrooms are not open through production zones; must have at least of 01 (one) restroom for 25 persons;

b) Air ventilation system is laid suitably, ensure not blowing from restrooms to production zones, the drainage system must be easy to eliminate waste and ensure hygiene. Having instruction board “Washing hands after going to the toilet” at an apparent position in restrooms;

c) Having rooms to dress or undress protective clothing before and after working.

10. Food raw materials and food wrapping:

a) Food raw materials, food additives, processing supports, presevatige agents used in food production must have clear origin, permitted to use as prescribed.

b) Food wrapping must ensure reliable and safety; not release toxic substances, not affect quality and food safety; not be polluted by agents effecting health of consumers as prescribed.

Article 2. Requirement for equipments, tools

1. Equipments, tools contacting directly with food must be designed, manufactured for assurance of safety; be mde of materials not causing pollution for food; be suitable to requirement of production technology, easy to clean, sterilize, maintain. For mobile production equipments and tools, they must be durable, easy to move, assembly and disassembly and clean.

2. Devices to wash and sterilize hands:

a) Having sufficient equipments to wash hands, sterilize hands, boots, shoes, sandals before entering food production zones;

b) Places to wash hands must supply sufficient clean water, antiseptic water, towels or paper towels or hand dryers;

c) Food production workshops must have sinks with quantity at least of 01 (one) sink for 50 workers.

3. Equipments, tools for food production:

a) Being sufficient and suitable in order to treat raw materials, process and pack food;

b) Being made of materials which are not harmful, little abrasion, not be rusted, not to release toxic substances into food, not to cause strange smell or food changes;

c) Being easy to clean, maintain; not to contaminate food due to lubricant, metal debrids;

d) Devices, equipment of production lines must have hygiene process, operation process.

4. Preventing from harmful insects and animals:

a) Equipment preventing from harmful insects and animals must be made of rustless materials, easy to disassembly to clean, designed suitably, ensure preventing effectively from harmful insects and animals;

b) Not to use drugs, animals in order to destroy rats, insects and harmful animals in food production zones.

5. Equipment, tools for supervision, measurement:

a) To have sufficient equipment, tools to suppervise quality, safety of products and must assess major product safety quality norms of food;

b) Equipment, tools for supervision ensure accuracy and be maintaines, tested periodically as prescribed.

6. Detergents, disinfectants:

a) Using just chemicals for cleaning, disinfection as prescribed by the Ministry of Public Health;

b) Must be contained in recognizable wrappings, having guidance for use and not to put in the food production place.

Article 3. Requirement for person directly producing food

1. Owner of facility and persons who directly producing food must be trained and granted certification of training knowdleges on food safety as prescribed.

2. Owner of facility and persons directly producing food must be examined health and granted cetificate of good health as prescribed of the Ministry of Public Health; for areas having diarrhea epidemic as announced by the Ministry of Public Health, persons directly producing food must be performed stool culture in order to detect pathogens causing intestinal diseases (cholera, dysentery, bacillus and typhoid) and must have negative stool culture result; the health examination and testing are performed by medicine facilities of district level or equal or higher level.

3. Persons getting illness or diseases in list of contagious illness or diseases to which employees are not permitted to directly contact in the course of food production and processing prescribed by the Ministry of Public Health shall not permitted to directly take part in the course of food production.

4. Persons directly producing food must dress separate protective clothing, wear specialized-use hat, gloves, mark.

5. Persons directly producing food must obey provisions on practice for hygiene assurance: Keeping fingernails short and clean and not to wear rings, wrist-watches. Non smoking, spitting in the food production zones.

Article 4. Requirement for food preservation in food production

1. Raw materials, wrappings, finished food must be preserved in containing zones, separate storehouses, with an area that is enough large to preserve food; designed in conformity with requirement on preservation, delivery of each type of food and food raw materials; building materials contacting with food ensure safty.

2. The food storehouse must ensure reliable, safety, ventilation, east to clean and prevent from penetration and habitation of insects, harmful animals.

3. The containing zones, storehouses to preserve food must have sufficient name board; internal rules, process, hygiene mode; for raw materials, finished food with requirement of special preservation must have register book monitoring temperature, humidity and other conditions.

4. Having sufficient brackets, shelves made of reliable and sanitary materials; ensure enough light and shielded safely. Raw materials, food products must be packed and preserved at position with distance from floor of not less than 20cm, distance from wall of not less than 30cm and distance from ceiling of not less than 50cm.

5. Having specialized-use equipment to adjust temperature, humidity, air ventilation and elements effecting food safety; specialized-use equipment must be suitable and ensure it is able to monitor and control mode of preservation with respect to each type of food at the request of producers; equipment is easy to maintain and clean.

6. Having sufficient other equipment, tools to supervise temperature, humidity and elements effecting food safety during the course of food production.

7. Food raw materials, food additives, processing supports, presevatige agents and food products must be contained, preservated in according to provisions on product preservation of producer and requirement of food type on temperature, humidity, light and elements effecting food safety.

8. Ice water used in food preservation must be produced from clean water sources in according to National technical regulation (QCVN) on clean water No.02:2009/BYT.

Chapter II

GENERAL CONDITIONS TO ENSURE FOOD SAFETY FOR FOOD BUSINESS FACILITIES

Article 5. Requirement for facility

1. Having sufficient area to arrange zones of food showing and sale, zones of containing, preservation and being convenient to transport materials, food products.

2. Not being flooded, stagnant.

3. Not being affected by animals, insects, and harmful microorganisms;

4. Food safety not being affected from areas polluted by dust, toxic chemicals and other source causing pollution.

5. Design of zones for food business, sanitation, dressing and undressing protective clothing and auxiliary zones must be separate, suitable to requirement of business food.

6. Structure of houses of zones are solid, suitable to nature, scale of food business; being built by materials which are suitable and assurance of hygiene, prevented from harmful microorganisms, destruction, penetration and habitation of insects, animals.

7. Floor is falt, smooth; with hard surface, load supporting, abrasion-proof, and good drainage, not cause slipperiness, not stagnant and easy to clean.

8. Ceiling is flat, bright color, made of solid materials, not leaked, water-permeable, not cracked, no moss, mold, not stagnant, not adhered by dirty substances and easy to clean;

9. Doors, windows are smooth, flat, convenient to clean; necessary places must have protection grid to avoid from penetration of insects, harmful animals.

10. Light source, light intensity must ensure comply with provision; lamps should be shielded safely.

11. The air ventilation system is suitable to requirement of food precervation, ensure ventilation in zones.

12. Having sufficient tools to collect waste; tools are made of materials which not be corrupted much, ensure be closed, with lids and be cleaned regularly.

13. The sanitation zones of facility must be arranged to separate with food business zones; gates of restrooms are not open through the food preservation zones; at least, it must have 01 (one) restroom for 25 persons; having sufficient clean water in conformity with National technical regulation (QCVN) on clean water No.02:2009/BYT, having tools, soap, detergents for sanitation and washing hands; having instruction board “Washing hands after going to the toilet” at an apparent position.

14. Having sufficient clean water for sanitary of equipments, tools, and sanitary of facility and in conformity with National technical regulation (QCVN) on quality of living water No.02:2009/BYT;

15. The business food must have clear origin, not been expired.

Article 6. Requirement for equipments, tools

1. Having sufficient equipments for business operation, preservation which are suitable to requirement of each type of food (shelves, cupboard displaying product, equipment to control temperature, humidity, air ventilation in zones of containing, diaplayig and sale, preserving food); having regulation on process, hygiene mode for facility.

2. Having sufficient equipment to control temperature, humidity, air ventilation and elements effecting food safety at the technical request of each type of food product during the course of food business operation.

3. Equipments of insect and harmful animal prevention and fighting are not rusted, easy to disassembly to maintain and clean, designs ensure effective operation in insect and harmful animal prevention and fighting; not to use drugs, animals in order to destroy rats, insects in food business and preservation zones.

4. Equipment, tools for product quality and safety supervision, measurement must ensure accuracy and be maintaines, tested periodically as prescribed.

Article 7. Requirement for person directly performing food business

1. Owner of facility and persons directly performing food business must be trained and granted certificate of training knowdleges on food safety as prescribed.

2. Owner of facility and managers contacting directly with food and persons directly performing food business must be examined health and granted cetificate of good health as prescribed by the Ministry of Public Health. The health examination is performed by medicine facilities of district level or equal or higher level.

3. Persons getting illness or diseases in list of contagious illness or diseases to which employees are not permitted to directly contact in the course of food business operation prescribed by the Ministry of Public Health shall not permitted to directly take part in the course of food business operation.

4. Persons, who directly operating food business, must wear separate protective clothing; not smoke, spit in the food business zones.

Article 8. Requirement for food preservation in food business operation

The food preservation in food business operation facilities must comply with requirements specified in clause 1, 2, 3, 4, 5, 7, 8 Article 4 of this Circular.

Chapter III

IMPLEMENTATION PROVISIONS

Article 9. Effect

1. This Circular takes effect from November 01, 2012.

2. To annul the Decision No.39/2005/QD-BYT, of November 28, 2005 of the Minister of Public Health on promulgating together with Regulation on hygiene conditions for food production facilities from the effective day of this Circular.

Article 10. Organization of implementation

On the basic of guides in this Circular, the ministries managing branches, sectors shall promulgate specific provisions on food safety conditions for food production and business facilities in their assigned management sectors.

During the course of implementation, any problems should be reported to the Ministry of Health for consideration and settlement.