Decree No. 67/2016/NĐ-CP on conditions for producing and trading food under the specialized management of the Ministry of Health

DECREE

REGULATING THE CONDITIONS FOR PRODUCTION AND BUSINESS OF FOODS UNDER THE SPECIAL MANAGEMENT OF THE MINISTRY OF HEALTH

The Government promulgates this Decree stipulating the conditions for production and business of foods under the special management of the Ministry of Health.

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organization of the Signed on July 1export,

Pursuant to the Investment Law dated November 26, 2014;

At the proposal of By the Minister of Health;

the Government detailing certain provisionsThe Government promulgates this Decree stipulating the conditions for production and business of foods under the special management of the Ministry of Health.CONDITIONS FOR PRODUCTION AND BUSINESS OF FOODSBELONGING TO THE FIELD OF SPECIAL MANAGEMENT OF THE MINISTRY OF HEALTH.This Decree stipulates the conditions for production and business of foods belonging to the field of special management of the Ministry of Health, including:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. General conditions for food production and business establishments.

2. Conditions for functional food and nutrient-fortified food production and business establishments.

3. Conditions for food additive and food processing aid production and business establishments.

4. Conditions for natural mineral water, bottled drinking water, and ready-to-use ice production and business establishments.

This Decree applies to agencies, organizations, and individuals in Vietnam; foreign organizations and individuals in Vietnam participating in the production and business of foods under the special management of the Ministry of Health (hereinafter referred to collectively as organizations and individuals).

Article 2. Applicability

GENERAL CONDITIONS FOR FOOD PRODUCTION AND BUSINESS ESTABLISHMENTS

Article 3. Principles of Legal Application

1. Organizations and individuals meeting the conditions prescribed in this Decree may produce and trade in food.

2. During the process of production and business, organizations and individuals engaged in food production and business must comply with laws and regulations on food safety.

Chapter II

FOOD PRODUCTION ESTABLISHMENTS

Article 4. Conditions for food production establishments include:

Section 1

FOOD PRODUCTION ESTABLISHMENTS

1. Location and environment:

a) Must have sufficient area to arrange food production zones, auxiliary zones, and facilitate food production, storage, and transportation activities;

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

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

d) Not affected by food safety from dust, toxic chemicals, and other pollution sources.

2. Design and construction of factory buildings:

a) Production factories and auxiliary zones must be designed and constructed with sufficient area to arrange food production line equipment and be consistent with the design function of the establishment;

b) The food production process must be arranged according to the principle of a one-way flow from raw materials to finished products;

c) Raw material warehouses, finished product warehouses, food pre-processing, processing, packaging areas, hygiene areas, protective clothing changing areas, and related auxiliary areas must be designed and constructed separately;

d) Internal roads must be designed and constructed to ensure sanitation; sewage drainage channels must be covered, ensuring sanitation and clearance;

đ) Waste collection and disposal sites must be designed and constructed outside the food production factory area and ensure sanitation.

3. Factory building structure:

a) Factories must have a solid structure suitable for the nature, scale, and food production technology process;

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;

d) Floors must be flat, smooth, well-drained, non-porous, and easy to clean.

4. Ventilation system:

a) Ensure ventilation for all areas of the establishment and be suitable for the type of food production; easy to maintain and clean.

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

5. Lighting system:

a) Ensure adequate lighting to meet production requirements, quality control, and product safety;

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

6. Water supply system:

a) Ensure sufficient clean water for food production and comply with national technical standards for drinking water quality;

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.

7. Steam and compressed air:

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

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:

a) Must have sufficient solid waste collection containers with lids. Containers for hazardous solid waste must be marked according to environmental protection laws. If there is no solid waste treatment system, there must be an economic contract for collection with organizations and individuals permitted to handle solid waste in the local area;

b) The wastewater treatment system must operate regularly and treated wastewater must meet environmental hygiene standards.

9. Toilet and protective clothing changing areas:

a) Toilets must be located separately from food production areas; toilet doors must not open directly into production areas;

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;

c) There must be rooms for changing protective work clothes before and after work.

10. During production, food ingredients and food packaging must meet the following requirements:

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

b) Food packaging must be secure and safe; must not leach or become contaminated affecting food quality and safety.

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

b) Food packaging must be secure, safe; not leach out and not be contaminated to affect the quality and safety of food.

Article 5. Conditions for equipment and tools

1. Equipment and tools that come into direct contact with food must be designed and manufactured to meet technological production requirements; ensure safety, not cause food contamination, easy to clean, disinfect, and maintain. Mobile production equipment must be durable, easy to move, assemble/disassemble, and clean.

2. Hand washing and disinfection facilities:

a) Must have sufficient hand washing, hand disinfection, boot, and shoe cleaning equipment before entering the food production area;

b) The food production workshop must have hand washing sinks for staff; the hand washing area must have soap or antiseptic water; disposable towels, paper towels, or hand drying machines must be provided.

3. Food production equipment and tools:

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

b) Must be made from non-toxic materials, resistant to wear, rust-free, do not release harmful substances, do not emit unusual odors, or alter food;

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

d) Must have sufficient sanitation procedures and operational procedures for production line equipment and facilities.

4. Prevention of pests and harmful animals:

a) Pest and harmful animal prevention equipment must be made from non-rusting materials, easily disassembled for cleaning, properly designed to prevent pest and harmful animal intrusion;

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 monitoring equipment for product quality and safety, capable of assessing basic quality and safety standards of food. If such monitoring equipment is unavailable, there must be an economic contract with another organization or individual authorized to test;

b) Measuring devices must ensure accuracy during use according to legal metrology regulations.

6. The use of cleaning agents and disinfectants must comply with the following requirements:

a) Only permitted cleaning and disinfecting chemicals may be used;

b) Must be stored in clearly labeled containers with usage instructions and not placed in food production areas.

Section 2

GENERAL CONDITIONS FOR FOOD BUSINESS ESTABLISHMENTS

FOOD BUSINESS

Article 6. Conditions for business establishments

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

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

3. Must not be affected by animals, pests, and other sources of contamination.

4. The structure of the business establishment must be appropriate for its nature and scale; constructed using sanitary and safe materials.

5. Walls and ceilings must be smooth, light-colored, made from durable, solid materials, free from leaks, cracks, mold, water stains, and dirt accumulation.

6. Sanitation areas must be separated from food business areas; toilet doors must not open directly into food storage areas.

7. Must have record-keeping systems or software to manage food throughout the business process.

Article 7. Conditions for equipment and tools

1. Must have sufficient equipment to serve business operations, store, and control food safety factors as required by manufacturers; must have sanitation procedures and maintenance schedules for the establishment.

2. Must have sufficient waste collection tools with lids that are regularly cleaned.

Chapter III

CONDITIONS FOR PRODUCTION AND BUSINESS UNITS OF FUNCTIONAL FOODS AND FOODS ENRICHED WITH MICRO-NUTRIENTS

CONDITIONS FOR PRODUCTION AND BUSINESS UNITS OF FOOD ADDITIVES AND FOOD PROCESSING AIDS

DIETARY SUPPLEMENTS

Article 8. Conditions for production units

1. Comply with the conditions prescribed in Articles 4 and 5 of this Decree.

2. Raw materials for producing food must meet the requirements set out in the corresponding national technical regulations, food safety regulations of competent authorities, and be within their shelf life.

3. Packaging containers must not contaminate harmful substances, affecting the food and consumer health.

Article 9. Conditions for business units

1. Comply with the conditions prescribed in Articles 6 and 7 of this Decree.

2. For import units, there must be a warehouse or storage area suitable for the preservation requirements of the manufacturer.

3. The sale of functional foods in retail drugstores must be arranged in a separate display area, with clear signage indicating the functional food section.

Chapter IV

CONDITIONS FOR PRODUCTION AND BUSINESS UNITS OF FOOD ADDITIVES AND FOOD PROCESSING AIDS

FOODS, PROCESSING AIDS FOR FOOD

Article 10. Conditions for production units

1. Comply with the conditions prescribed in Articles 4 and 5 of this Decree.

2. The use of raw materials and packaging containers in the production of food additives and food processing aids must meet the following requirements:

a) Raw materials used in production must comply with the requirements set out in the corresponding national technical regulations, food safety regulations of competent authorities, and must be within their shelf life;

b) Packaging containers must ensure safety, not contaminate harmful substances, affect the food, and not be contaminated by factors that affect consumer health.

3. Only food additives and food processing aids permitted for use in Vietnam may be produced.

Article 11. Conditions for business units

1. Comply with the conditions prescribed in Articles 6 and 7 of this Decree.

2. Publicly disclose the list of group names with product names or international product codes (if available), origin, and related information at the business unit, ensuring that the food additives and food processing aids sold have a clear origin, comply with corresponding national technical regulations, food safety regulations of competent authorities, and are within their shelf life.

3. The storage and display of food additives and food processing aids must be conducted in a dedicated area within the food business unit, with clear signage and labels for each product group. They shall not be displayed alongside chemicals for other purposes or non-food products in the same business unit.

4. Retail food additives must bear complete labeling according to the regulations for the smallest packaging unit that has been declared compliant with food safety standards or regulations.

5. Import units of food additives and food processing aids must have warehouses meeting the preservation requirements of the manufacturer.

Chapter V

CONDITIONS FOR PRODUCTION AND BUSINESS UNITS OF FUNCTIONAL FOODS AND FOODS ENRICHED WITH MICRO-NUTRIENTS

NATURAL MINERAL WATER, BOTTLED DRINKING WATER, INSTANT ICE

 ICE FOR IMMEDIATE USE

Article 12. Conditions for production units of bottled natural mineral water

1. Comply with the conditions prescribed in Articles 4 and 5 of this Decree. Must have a closed production line system.

2. The bottling area must be enclosed, separated from other areas, and equipped with an air sterilization system.

3. Factories, equipment, and tools used in the production process must be regularly cleaned and sterilized.

4. A cleaning and sterilization area for bottles and containers used to store the product must be arranged.

5. Equipment and tools that come into direct contact must be made of materials that do not cause contamination, suitable for production technology, easy to clean, sterilize, and maintain.

6. Sterilization and disinfection technologies must not affect the quality and safety of the product.

7. Product storage areas must be dry, well-ventilated, and hygienic; during transportation, they must be placed in sanitary containers that can withstand impact without deformation or breakage.

8. The use of packaging containers must meet the following requirements:

a) Plastic bottle caps and plastic bottles with a capacity of less than 10 liters cannot be reused; plastic bottles with a capacity of 10 liters or more and glass bottles can be reused;

b) New or reused bottles and containers must be thoroughly cleaned, disinfected, and rinsed before filling, except when new bottles are produced using a closed system with sterilization technology.

9. Natural mineral water sources must be protected from any contamination or external factors that could affect the quality and safety of the water.

10. Bottling must be carried out immediately at the source or through a closed pipeline system directly leading from the source to the treatment and bottling facility, ensuring strict hygiene regulations throughout the extraction process. Ensure that bottled natural mineral water meets the food safety standards and management requirements specified in the national technical regulations for natural mineral water and bottled drinking water.

11. Production units of natural mineral water must have a monitoring department responsible for bottle and container hygiene and water quality; they must have complete records of water source and finished product testing results as required by the national technical regulations for natural mineral water and bottled drinking water.

Article 13. Conditions for bottled drinking water production facilities

1. Comply with the conditions prescribed in Articles 4 and 5 of this Decree.

2. The bottling area must be enclosed, separated from other areas, and equipped with an air sterilization system.

3. A washing and sterilization area for bottles and containers must be arranged.

4. Packaging materials for bottled drinking water must comply with the provisions set forth in Clause 8, Article 12 of this Decree.

5. Sterilization and disinfection of products and packaging materials shall be carried out using specialized equipment employing ultraviolet light technology, ozone technology, or other technologies that do not affect product quality and safety.

6. The water source used in bottled drinking water production must ensure prevention of any contamination or foreign factors affecting water quality and comply with regulations on potable water quality; water sources exploited by the facility must be tested and ensured to meet quality standards at least once every twelve months.

7. Bottled drinking water production facilities must have a hygiene control department for bottles and containers, and water quality; they must maintain sufficient records of testing results from water source exploitation to finished products according to regulations for each batch of products.

Article 14. Conditions for ice production facilities for immediate use

1. Comply with the conditions prescribed in Articles 4 and 5 of this Decree.

2. The water source used in production must ensure prevention of any contamination or foreign factors affecting microbiological, physical, and chemical water quality and comply with national technical standards for potable water quality; water sources exploited, treated, and used by the facility must be tested and ensured to meet quality standards at least once every twelve months; there must be sufficient records of periodic and spot testing results.

3. The use of packaging materials for products must comply with national technical standards for ice for immediate use.

4. Ice production facilities for immediate use must have a hygiene and quality control department for finished ice products; each batch of products must be tested for food safety indicators according to regulations; there must be sufficient records of finished product testing results.

Article 15. Conditions for natural mineral water business, bottled drinking water, and ice for immediate use production facilities

Compliance with conditions stipulated in Articles 6 and 7 of this Decree.

Chapter VI

IMPLEMENTING PROVISIONS

Article 16. Effective Date

This Decree takes effect from July 1, 2016.

Article 17. Responsibility for Implementation

Ministers, heads of ministerial-level agencies, heads of government-affiliated agencies, Chairpersons of provincial and centrally-administered city People's Committees, and related organizations and individuals are responsible for implementing this Decree./.