Circular No. 16/2012/TT-BYT stipulates food safety conditions for food production and business establishments, food utensils, packaging materials, and containers under the management of the Ministry of Health.

CIRCULAR

Provisions on food safety conditions for food production and business establishments, food packaging materials and containers under the management of the Ministry of Health.

Food safety conditions for functional food production and business establishments, nutrient-enriched food production and business establishments, food additive production and business establishments, food processing aid production and business establishments; natural mineral water, bottled drinking water; food packaging materials and containers; small-scale food production and business establishments under the management of the Ministry of Health (hereinafter referred to as the establishment).

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Pursuant to the Food Safety Law 2010;

Based on Decree No. 38/2012/NĐ-CP dated April 25, 2012, issued by the Government, detailing certain provisions of the Food Safety Law;

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

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

The Minister of Health shall issue a Circular stipulating food safety conditions for food production and business establishments under the management of the Ministry of Health.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates food safety conditions for functional food production and business establishments, nutrient-enriched food production and business establishments, food additive production and business establishments, food processing aid production and business establishments; natural mineral water, bottled drinking water; food packaging materials and containers; small-scale food production and business establishments under the management of the Ministry of Health (hereinafter referred to as the establishment).

Article 2. Interpretation of Terms

In this Circular, the terms are understood as follows:

1. Small-scale production and business establishments A household or individual food production and business establishment with or without a food business registration certificate.

2. Special storage conditions for food Temperature control refers to the use of equipment to adjust and maintain temperature requirements, humidity, and other factors during product storage to ensure food quality and safety.

Chapter II

FOOD SAFETY CONDITIONS FOR FUNCTIONAL FOOD PRODUCTION AND BUSINESS ESTABLISHMENTS, NUTRIENT-ENRICHED FOOD PRODUCTION AND BUSINESS ESTABLISHMENTS, FOOD ADDITIVE PRODUCTION AND BUSINESS ESTABLISHMENTS, FOOD PROCESSING AID PRODUCTION AND BUSINESS ESTABLISHMENTS

Article 3. Food safety conditions for production establishments

1. For physical facilities, equipment, tools, and persons directly involved in producing functional foods, nutrient-enriched foods, food additives, and food processing aids, they must comply with the requirements set forth in Articles 1, 2, 3, and 4 of Circular No. 15/2012/TT-BYT dated September 12, 2012, issued by the Ministry of Health, concerning general food safety conditions for food production and business establishments.

2. For food raw materials, food additives, food processing aids, and food packaging materials:

a) Raw materials used to produce functional foods, nutrient-enriched foods, food additives, and food processing aids at the establishment must be safe according to relevant national technical standards, food safety regulations of competent authorities, and must still be within their shelf life.

b) Initial raw materials used to produce nutrient-enriched foods must be safe and retain their inherent properties. Raw materials forming the food must not interact to create harmful products to human health. Only vitamin and mineral fortification into food at levels that do not harm consumer health and listed by the Ministry of Health may be produced and processed.

c) Food additives, food processing aids, and food preservatives used in food production must have clear origins and be permitted for use according to the regulations of the Ministry of Health and must be safe according to the regulations.

d) Food packaging materials must be secure, safe, free from toxic substance leaching, not affecting food quality and safety, and not contaminated by agents harmful to consumer health.

Article 4. Food safety conditions for business establishments

1. For physical facilities, equipment, tools, and persons directly engaged in selling functional foods, nutrient-enriched foods, food additives, and food processing aids, they must comply with the requirements stipulated in Articles 5, 6, 7, and 8 of Circular No. 15/2012/TT-BYT dated September 12, 2012, issued by the Ministry of Health, concerning general conditions to ensure food safety for food production and trading establishments.

2. Raw materials, functional food products, nutrient-enriched food products, food additives, and food processing aids sold at the establishment must comply with national technical standards, food safety regulations of competent authorities, and must be within their shelf life; there must be records, contracts, invoices, and other documents kept to trace the origin of the traded food products.

3. Clean water sources for cleaning equipment, tools, and sanitation at the establishment must be quality-checked and sanitized at least once a year.

Article 5. Food safety conditions in food storage

1. Physical facility and equipment conditions for storing raw food materials, food additives, food processing aids, food preservatives, and food: Must comply with the requirements stipulated in Article 4 of Circular No. 15/2012/TT-BYT dated September 12, 2012, issued by the Ministry of Health, concerning general conditions to ensure food safety for food production and trading establishments.

2. Conditions for persons directly handling food: Must comply with the requirements stipulated in Clauses 1, 2, and 3 of Article 7 of Circular No. 15/2012/TT-BYT dated September 12, 2012, issued by the Ministry of Health, concerning general conditions to ensure food safety for food production and trading establishments.

Article 6. Food safety conditions during food transportation

1. Food containers must be isolated from the surrounding environment to prevent dust and insect intrusion; they must be suitable for transport dimensions.

2. Specialized transportation equipment and containers that come into direct contact with food during transportation must be made of materials that do not contaminate food or its packaging, and are easy to clean.

3. There must be sufficient equipment to control temperature, humidity, ventilation, and other factors affecting food safety according to technical requirements for each type of food as specified by the manufacturer throughout the transportation process.

4. There must be internal regulations specifying food safety assurance procedures during food transportation; maintaining and controlling storage conditions according to requirements throughout the transportation process for each type of food product; for food requiring special storage conditions, specific handover procedures must be established between the receiver and the transporter.

5. Equipment and tools must be cleaned and sanitized before, during, and after food transportation; food must not be transported alongside hazardous goods or items that could cause cross-contamination affecting food quality and safety.

6. For persons directly handling food during transportation: Must comply with the requirements stipulated in Clauses 1, 2, and 3 of Article 7 of Circular No. 15/2012/TT-BYT dated September 12, 2012, issued by the Ministry of Health, concerning general conditions to ensure food safety for food production and trading establishments.

Chapter III

Article 7. Food Safety Conditions for Natural Mineral Water Bottling Production Facilities

Article 7. Natural mineral water bottling production facilities

1. For physical infrastructure, equipment, tools, and persons directly involved in the production of bottled natural mineral water: Comply with the requirements stipulated in Articles 1, 2, 3, and 4 of Circular No. 15/2012/TT-BYT dated September 12, 2012, issued by the Ministry of Health, concerning general conditions to ensure food safety for food production and business establishments.

2. Areas for bottle washing, production areas (filtration, sterilization, filling, bottling, labeling, printing expiration dates on product packaging), and storage areas for bottled natural mineral water must be designed and constructed according to the principle of unidirectional flow, consistent with the sequence of production stages, ensuring separation and preventing cross-contamination between processes or areas.

3. The production facility must be built solidly, with flat, light-colored walls and ceilings that are easy to clean; non-porous wall sections (such as glazed tiles, glass, acrylic...) must be at least two meters high; floors must be flat, well-drained, and easy to sanitize.

4. The filling area for natural mineral water must be enclosed, separated from other areas, and equipped with an air disinfection system; regular maintenance schedules for equipment must be established to ensure continuous good operation.

5. Factories, equipment, and tools used during the production process must be cleaned regularly; the entire facility must undergo thorough cleaning at least once per quarter.

6. There must be a closed production line system; equipment and tools that come into direct contact with the product must be made of materials that do not cause contamination, suitable for production technology requirements, easy to clean, sterilize, and maintain.

7. Sterilization and disinfection of bottled natural mineral water products and packaging containers must be performed using specialized equipment employing ultraviolet light technology and other sterilization and disinfection methods without affecting product quality or safety.

8. Storage areas for bottled natural mineral water must be dry, well-ventilated, and hygienic; during transportation, they must be placed in sanitary containers that prevent impact, deformation, or breakage.

9. Packaging containers for natural mineral water must be food-grade packaging, sealed, and of appropriate size to avoid contamination of the water.

a) Bottle caps and plastic bottles containing natural mineral water with a capacity under 10 liters may not be reused; plastic containers with a capacity of 10 liters or more and glass bottles may be reused.

b) All types of bottles and containers, whether new or reused, must be thoroughly cleaned, disinfected, and rinsed before the bottling process, except when new containers are produced using a closed system with built-in disinfection.

c) After cleaning, bottles and containers must be inverted to prevent dust or foreign objects from falling inside, except when washed by automatic machines; prior to filling, they must be rinsed again with the bottled water source.

d) For paper packaging, the inner surface must be coated with safe, waterproof material to ensure product safety.

10. The extraction of natural mineral water must be within the protected zone to prevent any contamination or external factors from affecting the quality of the natural mineral water.

11. Bottling must be carried out immediately at the water source or through a closed pipeline system directly from the source to the processing and bottling site, ensuring strict hygiene regulations throughout the extraction process. Ensure that bottled natural mineral water meets food safety standards and management requirements set forth in National Technical Regulation (QCVN) No. 6-1:2010/BYT for natural mineral water and bottled drinking water.

12. Natural mineral water production facilities must have a monitoring department responsible for bottle and container hygiene and water quality; they must maintain records of water source and finished product testing results as required by National Technical Regulation No. 6-1:2010/BYT for natural mineral water and bottled drinking water.

Article 8. Bottled Water Production Facility

1. For physical facilities, equipment, tools, and persons directly involved in bottled water production: Comply with the requirements stipulated in Clauses 1, 2, 3, 4, 5, 6, 7, and 9 of Article 7 of this Circular.

2. Sterilize and disinfect bottled drinking water products, and disinfect packaging using specialized equipment utilizing ultraviolet light technology, ozone technology, and other technologies that do not affect product quality and safety.

3. The water source used in bottled water production must ensure prevention of any contamination or external factors affecting the microbiological, physical, and chemical quality of clean water, and comply with the National Technical Regulation (QCVN) on Clean Water No. 02:2009/BYT.

4. Bottled water production facilities must have a department for bottle hygiene control and water quality; maintain sufficient records of testing results from water extraction to finished products according to the National Technical Regulation (QCVN) on Drinking Water Quality No. 01:2009/BYT.

Article 9. Natural Mineral Water Business Facilities, Bottled Water Production Facilities

Comply with the provisions stipulated in Clauses 1, 2, 3, 4, 5, 12, and 13 of Article 5, Clause 1 of Article 6, Clauses 1, 2, and 3 of Article 7 of Circular No. 15/2012/TT-BYT dated September 12, 2012, issued by the Ministry of Health regarding general conditions ensuring food safety for food production and business establishments.

Chapter IV

FOOD SAFETY REQUIREMENTS FOR PRODUCTION AND BUSINESS ESTABLISHMENTS OF FOOD CONTAINERS AND PACKAGING MATERIALS

UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH

Article 10. Requirements for Production Establishments

1. For physical facilities, equipment, tools, and persons directly involved in the production of food containers and packaging materials under the management of the Ministry of Health: Comply with the requirements stipulated in Clauses 1, 2, 3, 4, and 8 of Article 1, Clauses 1, 3, and 6 of Article 2, Clauses 1 and 3 of Article 3, and Clauses 1, 2, and 3 of Article 4 of Circular No. 15/2012/TT-BYT dated September 12, 2012, issued by the Ministry of Health regarding general conditions ensuring food safety for food production and business establishments.

2. Food containers and packaging materials must be produced from safe raw materials, ensuring they do not leach harmful substances or strange tastes into food, affecting food quality and safety.

3. Food containers and packaging materials must be secure, safe, and meet corresponding technical standards.

4. Additives used in the production of food containers and packaging materials must have clear origins and sources, ensuring they do not leach harmful substances affecting the quality and safety of food contained within them.

Article 11. Requirements for Business Establishments

Comply with the provisions stipulated in Clauses 1, 2, 3, 4, 5, 12, and 13 of Article 5, Clause 1 of Article 6, Clauses 1, 2, and 3 of Article 7 of Circular No. 15/2012/TT-BYT dated September 12, 2012, issued by the Ministry of Health regarding general conditions ensuring food safety for food production and business establishments.

Chapter V

FOOD SAFETY REQUIREMENTS FOR PRODUCTION AND BUSINESS ESTABLISHMENTS

OF SMALL SCALE FOOD BUSINESSES

Article 12. Regarding Locations, Physical Facilities, Raw Materials, and Food

1. Small-scale food production and business establishments must maintain a safe distance from hazardous sources and pollution sources, without affecting product safety.

2. The establishment must have sufficient clean water for food production in compliance with National Technical Regulation (QCVN) No. 01:2009/BYT; and sufficient clean water for food business operations in compliance with National Technical Regulation (QCVN) No. 02:2009/BYT.

3. The establishment must maintain regular sanitation procedures and conditions ensuring food safety at the facility.

4. Raw materials for production, food additives, food processing aids, tools, and packaging materials at food production facilities must have clear origins and sources, and ensure food safety as required.

5. The establishment must maintain books, contracts, invoices, and other documents to record information related to the purchase and sale of raw materials, food additives, food processing aids, tools, and packaging materials for production, and food for business operations at the facility, ensuring traceability of their origins.

Article 13. Equipment, Utensils, and Persons Directly Involved in Food Production and Business

1. The establishment must have sufficient equipment suitable for food production and business; such equipment must be made from non-harmful materials that do not cause pollution to food; they must be easy to maintain and clean.

2. The establishment must have sufficient equipment and utensils for collecting and treating waste in accordance with the provisions of the law on environmental protection.

3. Persons directly involved in food production and business shall comply with the requirements stipulated in Clauses 1 and 3 of Article 7 of Circular No. 15/2012/TT-BYT dated September 12, 2012, issued by the Ministry of Health, concerning general conditions ensuring food safety for food production and business establishments.

Chapter VI

INSPECTION OF FOOD PRODUCTION AND BUSINESS ESTABLISHMENTS UNDER THE MANAGEMENT OF THE MINISTRY OF HEALTH

Article 14. Periodic Inspection

1. Not more than twice a year for establishments that have been granted a Certificate of Food Safety Conditions, and those holding both certificates of GMP, HACCP, ISO 22000, and equivalent certificates issued by authorized agencies.

2. Not more than three times a year for establishments that have been granted a Certificate of Food Safety Conditions by authorized state agencies.

3. Not more than four times a year for establishments that are not required to obtain a Certificate of Food Safety Conditions.

Article 15. Surprise Inspection

State agencies shall conduct spot inspections if there are violations related to food safety, food safety incidents, or special inspection campaigns directed by higher-level authorities.

Chapter VII

IMPLEMENTING PROVISIONS

Article 16. Effective Date

1. This Circular takes effect from December 5, 2012.

2. Repeal Decision No. 39/2005/QĐ-BYT dated November 28, 2005, of the Minister of Health promulgating regulations on general hygiene conditions for food production establishments, Decision No. 01/2005/QĐ-BYT dated January 7, 2005, of the Ministry of Health promulgating regulations on hygiene and safety conditions for food production and processing of beverages, and Decision No. 02/2005/QĐ-BYT dated January 7, 2005, of the Ministry of Health promulgating regulations on the management of quality and hygiene safety of bottled natural mineral water from the date this Circular takes effect.

Article 17. Implementation Organization

1. The National Food Safety Authority is responsible for guiding the implementation of this Circular nationwide.

2. Provincial Departments of Health and Provincial Food Safety Supervision Centers are responsible for guiding and implementing this Circular within their jurisdiction.