Decree No. 67/2016/ND-CP dated July 01, 2016 of the Government on conditions for food production and trading under the specialized management of the Ministry of Health

DECREE

On conditions for food production and
trading under the specialized management of
the Ministry of Health[1]

Pursuant to the June 19, 2015 Law on Organization of the Government;

Pursuant to the November 26, 2014 Law on Investment;

At the proposal of the Minister of Health;

The Government promulgates this Decree on conditions for food production and trading under the specialized management of the Ministry of Health.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Decree prescribes conditions for food production and trading under the specialized management of the Ministry of Health, including:

1. General conditions on food production and trading establishments.

2. Conditions on functional food or micronutrient-fortified food production and trading establishments.

3. Conditions on food additives or processing aids production and trading establishments.

4. Conditions on bottled natural mineral water and bottled drinking water and edible ice production and trading establishments.

Article 2. Subjects of application

This Decree applies to Vietnamese agencies, organizations and individuals and foreign organizations and individuals in Vietnam engaged in food production and trading under the specialized management of the Ministry of Health (below referred collectively to as organizations and individuals).

Article 3. Principle of law application

1. Organizations and individuals fully satisfying the conditions specified in this Decree may engage in food production and trading.

2. In the process of production and trading, food producers and traders must comply with the food safety law.

Chapter II

GENERAL CONDITIONS ON FOOD PRODUCTION AND TRADING ESTABLISHMENTS

Section 1

GENERAL CONDITIONS ON FOOD PRODUCTION ESTABLISHMENTS

Article 4. Conditions on establishments

1. Site and environment:

a/ Having sufficient space for food production areas and auxiliary areas convenient for food production, preservation and transportation;

b/ There is no water logging and stagnation in production and preservation areas;

c/ Not being affected by harmful animals, insects and microorganisms;

d/ Not being affected by dust, harmful chemicals and other sources of pollution on food safety.

2. Workshop layout and design:

a/ Workshops and auxiliary areas must be designed and built to be large enough to accommodate equipment of food production lines and suitable to the establishment’s design capacity;

b/ Food production processes must follow the one-way rule from input materials to finished products;

c/ Material warehouses, finished-product warehouses; food preliminary processing, processing and package areas; toilets; protective clothing dressing rooms and relevant auxiliary areas must be designed and built separately;

d/ Internal roads must be designed and built to ensure sanitation; drains must be tightly covered and ensure sanitation and complete drainage;

dd/ Waste collection and disposal sites must be designed and built outside  food production areas and ensure sanitation.

3. Workshop structure:

a/ Workshops must be firmly built suitable to the nature, scale and process of food production technology;

b/ Materials in direct contact with food must be smooth and flat, waterproof, easily cleaned and sterilized, resistant to corrosion from detergents and disinfectants, and must not produce toxic substances into food.

c/ Walls must be flat, light-colored, waterproof, crack-free, not be covered with dirt, and be easily cleaned; ceilings must be flat, light-colored, waterproof, leak- and crack-free, and not be covered with dirt, and be easily cleaned;

d/ Floors must be smooth and flat, waterproof, easily cleaned and ensure complete drainage.

4. Ventilation system:

a/ Ensuring air circulation in areas of the establishment suitable to the type of food production; being easy to maintain and clean.

b/ Ensuring that the air of the ventilation system does not blow from areas at risk of contamination to areas with non-contamination requirements.

5. Lighting system:

a/ Guaranteeing sufficient light for food production and product quality and safety control;

b/ Light bulbs must be protected by boxes or grids so as to avoid being broken and broken pieces falling onto food.

6. Water supply system:

a/ Ensuring sufficient clean water for food production and conformable with the national technical regulation on domestic water quality;

b/ Ensuring sufficient clean water for washing hands and cleansing equipment, tools and cleaning the establishment during the production process in conformity with the national technical regulation on domestic-use water quality.

7. Steam and compressed air:

a/ Steam and compressed air used for food production must be clean, safe, and avoid contamination of food;

b/ There must be separate pipes with a different color for easy identification and the water system for food production must not be connected with the water systems for steam production, cooling, fire prevention and fighting or other purposes.

8. Waste disposal system:

a/ Having sufficient solid waste containers with lids. Containers of hazardous solid waste must have peculiar signs under the environmental protection law. In case a hazardous solid waste disposal system is not available, there must be an economic contract signed with an organization or individual licensed to dispose of solid waste in the locality;

b/ The waste disposal system must operate continuously to dispose waste up to the prescribed environmental sanitation standards.

9. Toilets, protective-clothing dressing rooms:

a/ Toilets must be separated from food production areas; toilet doors must not be opened into food production areas;

b/ Ventilation must be arranged in a way that the air does not blow from toilets to food production areas; drainage must be easy and ensure sanitary conditions. There must be boards of hand washing guidelines;

c/ There must be rooms for changing protective clothing before and after working.

10. In the production process, food materials and food packages must satisfy the following conditions:

a/ Food materials, food additives and processing aids used for food production must have a clear origin and be safe;

b/ Food packages must be firm and safe; must neither produce toxic substances into food nor affect food quality and safety.

Article 5. Conditions on equipment and tools

1. Equipment and tools in direct contact with food must be designed and manufactured suitable to production technology; prevent contamination of food, and be easily cleaned, sterilized and maintained. Mobile production equipments and tools must be durable, easily moved, installed and cleaned.

2. Devices for hand washing and disinfection:

a/ Having sufficient devices for washing hands and disinfecting hands and footwear before entering food production areas;

b/ Having hand washing sinks for employees in workshops; providing soaps or disinfectant liquids; and disposable towels and paper tissues or hand dryers at hand washing places.

3. Equipment and tools for food production:

a/ Have sufficient equipment and tools suitable for handling and processing materials and packaging food;

b/ Being made of non-toxic, corrosion-resistant and stainless materials; and neither produce toxic substances or strange odor into food nor modify food;

c/ Being easily cleaned and maintained; and preventing contamination of food with lubricants and metal bits;

d/ Having cleaning and operational processes for equipment and tools of production lines.

4. Prevention and extermination of harmful insects and animals:

a/ Devices for prevention and extermination of harmful insects and animals must be made of stainless materials, be detachable for cleaning, and be designed in a way that prevents intrusion of harmful insects and animals;

b/ Poisons or animals must not to be used to kill rats and harmful insects and animals in food production areas.

5. Monitoring and measuring instruments and tools:

a/ Having instruments and tools to monitor food quality and safety and assess basic food safety and quality parameters. In case food safety and quality monitoring instruments and tools are not available, there must be an economic contract with an organization or individual licensed to perform tests;

b/ When being in use, measuring instruments and tools must ensure precise measurements under the measurement law.

6. The use of detergents and disinfectants must satisfy the following requirements:

a/ To use only detergents and disinfectants permitted for use;

b/ To be contained in easily identifiable packages with use instructions and placed outside food production areas.

Section 2

GENERAL CONDITIONS ON FOOD TRADING ESTABLISHMENTS

Article 6. Conditions on establishments

1. Having sufficient space for food display and sale, storage and preservation areas convenient for transportation of food materials and products.

2. There is no water logging and stagnation;

3. Not being affected by animals, insects and other sources of pollution;

4. Having a structure suitable to the establishment’s nature and size and made of safe and sanitary materials.

5. Walls and ceilings must be smooth and flat, light-colored, be made of durable, firm and waterproof materials, and free of crack, leak, moss, stagnant water and dirt;

6. Toilets must be separated from food trading areas; toilet doors must not be opened into food preservation areas.

7. A system of food management records or software must be maintained throughout the trading process.

Article 7. Conditions on equipment and tools

1. Having sufficient equipment for food trading and preservation and control of food safety elements according to manufacturers’ requirements; having cleaning processes and regulations.

2. Having sufficient waste and garbage containers with lids which are regularly cleaned.

Chapter III

CONDITIONS ON FUNCTIONAL FOOD AND MICRONUTRIENT-FORTIFIED PRODUCTION AND TRADING ESTABLISHMENTS

Article 8. Conditions on establishments

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

2.  Food materials must conform with relevant national technical regulations and food safety regulations of competent agencies, and be unexpired;

3. Packages and containers must neither produce toxic substances into nor affect food and consumer health.

Article 9. Conditions on trading establishments

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

2. Importers must have warehouses or separate preservation areas as instructed by manufacturers.

3. For the trading of functional foods in a retail drug establishment, there must be a separate display area with instructions and name tags of functional food.

Chapter IV

CONDITIONS ON FOOD ADDITIVES AND PROCESSING AIDS PRODUCTION AND TRADING ESTABLISHMENTS

Article 10. Conditions on production establishments

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

2. Materials, packages and containers used in the production of food additives and processing aids must satisfy the following requirements:

a/ Materials must conform with relevant national technical regulations and food safety regulations of competent agencies, and remain unexpired;

b/ Packages and containers must be firm and safe, neither produce toxic substances into nor affect food, and not be contaminated with elements harmful to consumer health.

3. Producing only food additives and processing aids already permitted for use in Vietnam.

Article 11. Conditions on trading establishments

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

2. Publicly displaying lists of names of product categories together with names of products or international codes of products (if any) and their origins and relevant information at the establishment and ensuring that food additives and processing aids traded at the establishment have a clear origin and comply with relevant national technical regulations and food safety regulations of competent agencies, and remain unexpired;

3. The preservation and display of food additives and processing aids in a trading establishment must be organized in a separate area in the establishment, and there must be area instructions and name tags of product categories. Food additives and processing aids must not be displayed for sale together with chemicals used for other purposes and non-food products in an establishment.

4. Food additives for retail must be labeled sufficiently under regulations on the smallest packaging unit which has been announced to conform with food safety standards or regulations.

5. Importers of food additives and processing aids must have a preservation warehouse that satisfy all conditions as required by manufacturers.

Chapter V

CONDITIONS ON BOTTLED MINERAL WATER, BOTTLED DRINKING WATER OR EDIBLE ICE PRODUCTION AND TRADING ESTABLISHMENTS

Article 12. Conditions on bottled mineral water establishments

1. Satisfying the conditions prescribed in Articles 4 and 5 of this Decree. Having closed production lines.

2. Bottling workshops must be closed, separated from other workshops and equipped with an air sterilization system.

3. Workshops, equipment and tools used in the production process must be regularly cleansed and sterilized.

4. Having areas for washing and sterilizing bottles and cans.

5. Equipment and tools in direct contact with products must be made of materials which do not cause contamination and are suitable to production technologies and easily cleaned, sterilized and maintained.

6. The application of pasteurizing and sterilizing technologies must not affect product quality and safety.

7. Product preservation areas must be dry, airy and clean. During transportation, products must be put into sanitary containers which can stand impact so as not to be deformed and broken.

8. The use of packages must satisfy the following requirements:

a/ Bottle caps and plastic bottles of a capacity of under 10 liters must not be reused; plastic cans of a capacity of 10 liters or more and glass bottles may be reused;

b/ New or reused bottles and cans must be cleansed, sterilized and carefully rinsed before being filled with water, except for brand-new ones which are manufactured in a closed process with sterilizing technology.

9. Natural mineral water sources must be kept free from any contaminants or external elements that may affect their quality and safety.

10. Water must be bottled at source or may be conveyed directly from source to a processing and bottling workshop via a closed and continuous pipeline system, ensuring strict compliance with sanitation rules during the exploitation process. Bottled natural mineral water products must conform with food safety criteria and management requirements under the national technical regulation on bottled natural mineral water and drinking water.

11. A natural mineral water production establishment must have a section to supervise and control bottle sanitation and water quality; and must keep sufficient records of test results of water sources and water products according to the national technical regulation on bottled natural mineral water and drinking water.

Article 13. Conditions on bottled drinking water establishments

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

2. Bottling workshops must be closed, separated from other workshops and equipped with an air sterilization system.

3. Having areas for washing and sterilizing bottles and cans.

4. Drinking water packages must comply with Clause 8, Article 12 of this Decree.

5. Products must be sterilized or pasteurized and their packages and containers must be pasteurized by special-use equipment using ultraviolet- light or ozone technologies or other technologies which do not affect product quality and safety.

6. Water sources used for bottling drinking water must be kept free from any contaminants or external elements that may affect water quality and conform with the regulation on domestic water quality. Exploited water sources must undergo quality inspection at least once 12 months.

7. A bottled drinking water production establishment must have a section to supervise and control sanitation of bottles and cans and quality of water; and must keep sufficient records of test results of water sources and water products for every lot of products.

Article 14. Conditions on edible ice production establishments

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

2. Water sources used for production must be kept free from any contaminants or external elements that may affect the biological, physical or chemical qualities of clean water, and must conform with the national technical regulation on domestic water quality; water sources exploited, treated and used must undergo quality inspection at least once 12 months; an edible ice production establishment must keep sufficient records of regular and irregular test results.

3. The use of packages must comply with the national technical regulation on edible ice.

4. A bottled drinking water production establishment must have a section to supervise and control sanitation and quality of edible ice; every lot of products must be tested according to food safety parameters under regulations; and must keep sufficient records of test results of finished products.

Article 15. Conditions on bottled mineral water, bottled drinking water or edible ice trading establishments

Satisfying the conditions prescribed in Articles 6 and 7 of this Decree.

Chapter VI

IMPLEMENTATION PROVISIONS

Article 16. Effect

This Decree takes effect on July 1, 2016.

Article 17. Implementation responsibility

Ministers, heads of ministerial-level agencies, heads of government-attached agencies, chairpersons of provincial-level People’s Committees and related organizations and individuals shall implement this Decree.-

On behalf of the Government
Prime Minister
NGUYEN XUAN PHUC