Thông tư 16/2012/TT-BYT quy định điều kiện an toàn thực phẩm đối với cơ sở sản xuất, kinh doanh thực phẩm thuộc phạm vi quản lý của Bộ Y tế

CIRCULAR

ON THE FOOD SAFETY CONDITIONS APPLICABLE TO ESTABLISHMENTS THAT PRODUCE AND TRADE FOOD, INSTRUMENTS AND MATERIALS FOR WRAPPING AND STORING FOOD UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH

Pursuant to the Law of Food safety 2010;

Pursuant to the Government's Decree No. 38/2012/NĐ-CP dated  April 25^th 2012 detailing a number of articles of the Law of Food safety;

Pursuant to the Government's Decree No. 63/2012/NĐ-CP dated August 31^st 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Department of Food safety;

The Minister of Health promulgates a Circular on the food safety conditions applicable to establishments that produce and trade food under the management of the Ministry of Health.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular provides the food safety conditions applicable to establishments that produce or trade functional foods, vitamin-enriched foods, food additives, food processing supplements, mineral water, bottled water; instruments and materials for wrapping and storing food; the small establishments that produce or trade food under the management of the Ministry of Health (hereinafter referred to as establishments).

Article 2. Interpretation of terms

The terms in this Circular are construed as follows:

1. Small establishments that produce and trade food are the establishments that produce and trade food in the household scale with or without Certificates of food trading registration.

2. The special conditions of food preservation is the use of devices to adjust and maintain the appropriate temperature, humidity, and other factors during the food preservation to ensure the food safety and quality.

Chapter II

FOOD SAFETY CONDITIONS APPLICABLE TO ESTABLISHMENTS THAT PRODUCE AND TRADE FUNCTIONAL FOODS, MICRONUTRIENT-ENRICHED FOODS, FOOD ADDITIVES, AND FOOD PROCESSING SUPPLEMENTS,

Article 3. The safety conditions applicable to producing establishments

1. The facilities, equipment, instruments and people directly producing functional foods, micronutrient-enriched foods, food additives, and food processing supplements, must comply with Article 1, 2, 3, and 4 of the Circular No. 15/2012/TT-BYT dated September 12^th 2012 of the Ministry of Health on the general conditions for ensuring food safety applicable to establishments that produce and trade food.

2. For food ingredients, food additives, food processing supplements and food packages:

a) The ingredients used in the production of functional foods, micronutrient-enriched foods, food additives, and food processing supplements, must ensure the safety as prescribed in the corresponding National Technical Regulations and the provisions on food safety issued by competent agencies, and must be unexpired;

b) The initial ingredients of micronutrient-enriched foods must be safe and retain their intrinsic properties. The food ingredients must not react with each other to create products that harm human life and health. Only produce and process foods that provide micronutrients being vitamins, and minerals, with an amount that does not harm the consumers’ health, and must be in the list of the Ministry of Health;

c) Food additives, food processing supplements, and food preservatives used in the products of food must have clear origin and be in the list of permissible substances made by the Ministry of Health, and ensure the safety as prescribed;

d) The food packages must be sturdy and safe without being contaminated by toxicants, without affecting the food safety and quality, without being contaminated by the agents that affect the consumers’ health.

Article 4. The food safety conditions applicable to trading establishments

1. The facilities, equipment, instruments and people directly trading functional foods, micronutrient-enriched foods, food additives, and food processing supplements, must comply with Article 1, 2, 3, and 4 of the Circular No. 15/2012/TT-BYT dated September 12^th 2012 of the Ministry of Health on the general conditions for ensuring food safety applicable to establishments that produce and trade food.

2. The ingredients, functional foods, micronutrient-enriched foods, food additives, and food processing supplements being traded must comply with the National Technical Regulations and the provisions on food safety issued by competent agencies, and must be unexpired. The books, contracts, invoices, and documents related to the sale must be kept in order to trace the origin of the food being traded.

3. The clean water source for cleaning equipment must undergo quality and hygiene inspection at least once a year.

Article 5. The food safety conditions applicable to food preservation

1. The facilities and equipment for preserving food ingredients, food additives, food processing supplements, food preservatives, and foods must comply with Article 4 of the Circular No. 15/2012/TT-BYT dated September 12^th 2012 of the Ministry of Health on the general conditions for ensuring food safety applicable to establishments that produce and trade food.

2. The conditions for to people in direct contact with food: comply with Clause 1, 2, and 3 Article 7 of the Circular No. 15/2012/TT-BYT dated September 12^th 2012 of the Ministry of Health on the general conditions for ensuring food safety applicable to establishments that produce and trade food.

Article 6. The food safety conditions applicable to the transport of food

1. The instruments for storing food must be separated from the surroundings, avoid the intrusion of dirt and insects; and must be appropriate for the transported amount.

2. The specialized means of transport and the instruments in direct contact with food during the transport must be made of materials that do not contaminate food or the food wrappings, and be cleanable.

3. The temperature, humidity, ventilation, and other factors that affect the food safety must be controlled, according to technical requirements for the preservation of each kind of food at the request of the producer, throughout the transport.

4. There must be regulations on the conditions for ensuring the food safety during the transport; maintain and control the preservation conditions on demand throughout the transport depending on each kind of foods; there must be a specific procedures for delivering and receiving foods under special preservation.

5. The instruments must be cleaned before, during, and after the transport of food; food must not be transported together with toxic goods that may cause cross-contamination and affect the food safety and quality.

6. The people in direct contact with food during the transport of food must comply with Clause 1, 2, and 3 Article 7 of the Circular No. 15/2012/TT-BYT dated September 12^th 2012 of the Ministry of Health on the general conditions for ensuring food safety applicable to establishments that produce and trade food.

Chapter III

THE SAFETY CONDITIONS APPLICABLE TO ESTABLISHMENTS THAT PRODUCE AND TRADE MINERAL WATER AND BOTTLED WATER

Article 7. Establishments that produce bottled mineral water

1. The facilities, equipment, instruments and people directly producing bottled mineral water must comply with Article 1, 2, 3, and 4 of the Circular No. 15/2012/TT-BYT dated September 12th 2012 of the Ministry of Health on the general conditions for ensuring food safety applicable to establishments that produce and trade food.

2. The area where the bottles and jar are rinsed and cleaned, the area of production (filtering, sterilizing, extracting, bottling, labeling, printing expiry date), the area of preserving bottled mineral water must be designed and built according to the one-way rule that suit the other of the stages of the production line, avoid the cross-contamination among the stages or with other areas.

3. The producing establishments must be solidly built. The surfaces of walls and ceiling must be flat, bright, and cleanable. The wall must be impermeable (paved with ceramic tile, glass, plastic, etc.) and at least 2-meter tall, cleanable, and easy to drain.

4. The extraction area must be closed and separated from other areas, and has a system of air sterilization; a regime for regularly controlling the equipment in order to ensure procedures they are always working.

5. The workshop, equipment, and instruments used in the production must be regularly cleaned; the establishment must be cleaned at least once per quarter.

6. Having a closed production line; the equipment and instruments in direct contact must be must be made of materials that do not cause contamination, suit the requirements of production technologies, are easy to be cleaned, sterilized, and maintained.

7. The bottled mineral water and the packages thereof must be sterilized using ultraviolet rays and other sterilization technologies that do not affect their quality and safety.

8. The area for preserving bottled mineral water must be dry, airy, and hygienic; the products must be put in hygienic reservoir that are not impacted, deformed, or broken.

9. The packages of mineral water must be the packages especially used for food, must be closed and in appropriate size to avoid contaminating the water.

a) The caps and plastic bottles of mineral water of which the volume is smaller than 10 liters must not be reused; the plastic bottles with a capacity of 10 liters or more, and glass bottles, may be reused;

b) Every kind of bottles being used for the first time or reused must be cleaned, sterilized, and carefully rinsed before the bottling stage, except for the bottles being used for the first time that are produced using closed technologies with sterilization;

c) The bottles must be put upside down after being cleaned to avoid dirt and contaminant falling inside, except for the bottled being cleaned automatically; the bottles must be rinsed using the exact same kind of water being bottled before the bottling stage;

d) The inside of paper packages must be coated with safe and impermeable materials to ensure the safety.

10. The sources of mineral water being extracted must lie within the protection perimeter to avoid any foreign contamination that affect the chemical and physical properties of mineral water.

11. The water must be bottled at the sources, or the water must be taken to the bottling location in a closed and continuous pipeline that ensure the strict hygienic provision during the entire extraction. The bottled mineral water must satisfy the provisions on food safety and the management requirements in the National Technical Regulation on mineral water and bottled water No. 6-1:2010/BYT.

12. The establishment that produces bottled mineral water must have a department specialized in supervising and controlling the hygiene of bottles and the quality of water; must have the documents on the test results of the water sources and the finished products as prescribed in the National Technical Regulation on mineral water and bottled water No. 6-1:2010/BYT.

Article 8. Establishments that produce bottled water

1. The facilities, equipment, instruments and people directly producing bottled water must comply with Clause 1, 2, 3, 4, 5, 6, 7 and 9 7 of this Circular.

2. The bottled water must be sterilized using ultraviolet rays, ozone gas, and other technologies that do not affect the product quality and safety.

3. The sources of mineral water being use for producing bottled water must be protected from any foreign contamination that affect the microbiological, chemical and physical properties of mineral water, and must comply with the National Technical Regulation on clean water No. 02:2009/BYT.

4. The establishment that produces bottled water must have a department specialized in controlling the hygiene of bottles and the quality of water; must have the documents on the test results of the water sources and the finished products as prescribed in the National Technical Regulation on potable water No. 01:2009/BYT.

Article 9. Establishments that trade mineral water and bottled water

Must comply with Clause 1, 2, 3, 4, 5, 12 and 13 Article 5, Clause 1 Article 6, and Clause 1, 2 and 3 Article 7 the Circular No. 15/2012/TT-BYT dated September 12^th 2012 of the Ministry of Health on the general conditions for ensuring food safety applicable to establishments that produce and trade food.

Chapter IV

THE FOOD SAFETY CONDITIONS APPLICABLE TO ESTABLISHMENTS THAT PRODUCE AND TRADE INSTRUMENTS AND MATERIALS FOR WRAPPING AND STORING FOOD UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH

Article 10. The requirements applicable to producing establishments

1. The facilities, equipment, instruments and people directly producing instruments and materials for wrapping and storing food under the management of the Ministry of Health must comply with Clause 1, 2, 3, 4 and 8 Article 1, Clause 1, 3 and 6 Article 2, Clause 1 and 3 Article 3, Clause 1, 2 and 3 are 4 of the Circular No. 15/2012/TT-BYT dated September 12th 2012 of the Ministry of Health on the general conditions for ensuring food safety applicable to establishments that produce and trade food.

2. The instruments and materials for wrapping and storing food must be made of safe materials without being contaminated by toxicants and unusual smells or tastes that affect the food safety and quality.

3. The instruments and materials for wrapping and storing food must be sturdy and safe, ensure the corresponding technical regulations.

4. The additives used in the production of instruments and materials for wrapping and storing food must have clear origins, not be contaminated by toxicants that affect the safety and quality of the food contained therein.

Article 11. The requirements applicable to trading establishments

Must comply with Clause 1, 2, 3, 4, 5, 12 and 13 Article 5, Clause 1 Article 6, and Clause 1, 2 and 3 Article 7 the Circular No. 15/2012/TT-BYT dated September 12th 2012 of the Ministry of Health on the general conditions for ensuring food safety applicable to establishments that produce and trade food.

Chapter V

THE FOOD SAFETY CONDITIONS APPLICABLE TO SMALL ESTABLISHMENTS THAT PRODUCE AND TRADE FOOD

Article 12. The location, facilities, ingredients, and food

1. The small establishments that produce and trade food must be safely separated from sources of toxicants and pollutants, and must not affect the product safety.

2. The establishment must have enough clean water for producing food in accordance with the National Technical Regulation No. 01:2009/BYT; and enough clean water serving the trading of food in accordance with the National Technical Regulation No. 02:2009/BYT.

3. The establishment must maintain the regular process of hygiene and the conditions for ensuring food safety therein.

4. The ingredients, food additives, food processing supplements, instruments and materials for wrapping and storing food in the food-producing establishment must have clear origins and ensure the food safety as prescribed.

5. The books, contracts, invoices, and documents about the information related to the sale and purchase must be sufficient in order to trace the origins of the ingredients, food additives, food processing supplements, instruments and materials for wrapping and storing food used for producing or trading food.

Article 13. The equipment, instruments, and people that directly produce or trade food

1. The establishment must have adequate equipment to produce or trade food; the equipment must be made of non-toxic materials that do not contaminate food, and must be easy for maintaining and cleaning.

2. The establishment must have adequate equipment and instruments for collecting and treating waste in accordance with law provisions on environment protection.

3. The people that directly produce or trade food must comply with Clause 1 and 3 Article 7 of the Circular No. 15/2012/TT-BYT dated September 12th 2012 of the Ministry of Health on the general conditions for ensuring food safety applicable to establishments that produce and trade food.

Chapter VI

THE INSPECTION OF ESTABLISHMENTS THAT PRODUCE AND TRADE FOOD UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH

Article 14. Periodic inspection

1. No more than twice a year, applicable to establishments that have been issued with the Certificate of food safety, and the certificates of GMP, HACCP, ISO 22000, or the equivalent, by competent agencies.

2. No more than three times a year, applicable to establishments that have been issued with the Certificate of food safety by competent agencies.

3. No more than four times a year, applicable to establishments exempted from applying for the Certificate of food safety.

Article 15. Irregular inspection

State agencies shall carry out irregular inspection if there are any violations of food safety and relevant food safety incidents. The intensive inspection shall be directed by superior agencies.

Chapter VII

IMPLEMENTATION PROVISIONS

Article 16. Effect

1. This Circular takes effect on December 05^th 2012.

2. The Decision No. 39/2005/QĐ-BYT dated November 28^th 2005 of the Minister of Health, on the promulgation of the Regulation on the general hygiene conditions applicable to establishments that produce food, the Decision No. 01/2005/QĐ-BYT dated January 07^th 2005 of the Ministry of Health on the promulgation of the Regulation on food safety and hygiene conditions applicable to the establishments that produce soft drink, the Decision No. 02/2005/QĐ-BYT dated January 07^th 2005 of the Ministry of Health on the promulgation of the Regulation on the control of quality, hygiene, and safety of bottled mineral water are annulled as from the day this Circular takes effect.

Article 17. Implementation organization

1. The Department of Food safety must guide the implementation of this Circular nationwide.

2. Services of Health, and provincial Sub-department of Food safety must guide and implement this Circular locally.