Nghị định 67/2016/ND-CP

DECREE

ON REQUIREMENTS FOR FOOD MANUFACTURING AND TRADING UNDER SPECIALIZED MANAGEMENT OF THE MINISTRY OF HEALTH

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

Pursuant to the Law on investment dated November 26, 2014;

At the request of the Minister of Health;

The Government promulgates a Decree on requirements for food manufacturing and trading under specialized management of the Ministry of Health.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

The Government deals with requirements for food manufacturing and trading under specialized management of the Ministry of Health, including:

1. General requirements pertaining to food manufacturing and trading facilities.

2. Requirements pertaining to manufacturing and trading facilities of functional food and micronutrient-fortified.

3. Requirements pertaining to manufacturing and trading facilities of food additives and food processing aids.

4. Requirements pertaining to manufacturing and trading facilities of bottled mineral water, bottled drinking water, and edible ice.

Article 2. Regulated entities

This Decree applies to Vietnamese agencies, organizations, and individuals; foreign organizations and individuals in Vietnam engaging in food manufacturing and trading under specialized management of the Ministry of Health (hereinafter referred to as entities).

Article 3.Rules for law application

1. Entities satisfying requirements as prescribed in this Decree are eligible for food manufacturing and trading.

2. During the business process, food manufacturing and trading facilities must comply with law on food safety.

Chapter II

GENERAL REQUIREMENTS PERTAINING TO FOOD MANUFACTURING AND TRADING FACILITIES

Section 1. GENERAL REQUIREMENTS PERTAINING TO FOOD MANUFACTURING FACILITIES

Article 4. Requirements pertaining to facilities

1. Location and environment:

a) Sufficient space for such placement of food production area and auxiliary areas is provided to facilitate the food production, storage and transportation;

b) No standing water or pooled water is present in the manufacturing and storage areas;

c) Pests and other contaminants are prevented from affecting the facility;

d) Food safety is protected from not polluted by dust, harmful chemicals and other sources of pollution.

2. Construction design of factories:

a) Manufacturing factories and auxiliary facilities must be designed and built so as to they are sufficient to arrange zones of food manufacturing lines and suitable to the designed manufacturing performance of the facility;

b) The food manufacturing process shall be designed to provide an operational flow through pattern and follow a sequence from raw materials to finished product;

c) The following areas shall be designed to be situated separately: raw materials storage, finished products storage; preparation, processing and packaging area; restrooms; protective clothing change rooms and relevant auxiliary areas.

d) Internal roads shall be constructed and maintained to ensure hygiene standard; sewage drainage must be covered closely, cleaned and free of obstruction regularly;

dd) The accumulation area of garbage and waste materials shall be constructed outside the production area to ensure the hygiene standards.

3. Structure of factories:

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

b) The surface of materials in direct contact with food shall be smooth, impervious to water, not release harmful substances into the food, not be eroded not much by detergents, disinfectants and easily cleanable and sterilized;

c) Walls shall be flat, in bright color, impervious to water, not cracked, not adhered by dirty substances and easily cleanable; ceilings shall be flat, in bright color, not leaked, impervious to water, not cracked, not adhered by dirty substance and easily cleanable;

d) Floors shall be flat, smooth, good drainage, impervious and easily cleanable.

4. Air ventilation system:

a) Ventilation for the facilities shall be ensured that satisfy the type of food production; easily maintainable and cleanable.

b) Direction of air ventilation system must be ensured in a manner of not blowing from the areas posing risks of contaminating food to areas where non-contamination requirements must be satisfied.

5. Lighting system:

a) Adequate lighting for production, control of product quality and safety is provided;

b) Lamps shall be covered safely by boxes or grids in the manner to prevent from being broken and broken fragments not dropping down food.

6. Water supply system:

a) Sufficient clean water is provided for food production and in accordance with national technical regulation on quality of edible and drinkable water;

b) Sufficient clean water is provided for hand washing, sanitary of equipment, utensils and facilities in accordance with national technical regulation on quality of domestic water in production process.

7. Steam and compressed air:

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

b) Water used for food production shall be run in different pipes with different color from the pipeline system for the purposes of production of steam, chilling, fire prevention and fighting or for other purposes.

8. Waste treatment system:

a) Sufficient solid waste containers with covers are provided. The containers of dangerous solid waste shall bear symbols for identification purposes as prescribed in law on environment protection. If it fails to establish a treatment system of solid waste, it must conclude an agreement with an organization or individual that is licensed to provide a solid waste treatment in the administrative division;

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

9. Restrooms, protective-clothing change rooms:

a) Restrooms must be laid separately with areas of food production; and restrooms‘ doors do not open into the food production areas;

b) The air ventilation is constructed in a manner that air flow does not blow from the restrooms to the food production areas; the drainage system works well and maintains the sanitary condition. There are hand wash signs that instruct employees on the proper procedures for washing their hands;

c) There are rooms to change protective clothing before and after working.

10. During the manufacturing process, food raw materials and food packaging materials are required to meet the following requirements:

a) Food raw materials, food additives, food processing aids used in food production must have clear origin and safe;

b) Food packaging materials must be reliable and safe; the chemical contaminants from the food packaging materials do not migrate into food and those materials are not contaminated that affect to food safety and quality.

Article 5. Requirement for equipment and utensils

1. Equipment and utensils in direct contact with food must be manufactured in a such manner as to satisfy production technology requirements, be safe and not to pose a product contamination issue, and easily assessable for cleaning, sterilization and maintenance. For mobile production equipments and utensils, they must be durable, easily movable, assemble and cleanable.

2. Hand wash and sterilization stations:

a) Provide sufficient stations for hand washing, sterilization of hands, boots, footwear before entering into the food production areas;

b) Food production factories must have hand wash sinks for employees; the hand wash stations must have sanitizing soap or disinfectants; and disposable towels and paper towels or hand dryers.

3. Equipment and utensils for food production:

a) There are sufficient and suitable equipment and utensils for the purposes of raw materials treatment, food processing and packaging;

b) The material of equipment and utensils must be non-toxic, corrosion-resistant, non-rusty; not to release toxic substances into food, not to cause strange smell or food changes;

c) The equipment and utensils must be easily cleanable and maintainable; and lubricants and metal debrids thereof do not contaminate food;

d) There are sufficient sanitary and operational procedures for equipment and utensils of the production lines.

4. Pest control:

a) Pest control devices must be made of materials that are non-rusty and easily disassembled for the purpose of cleaning, and be designed in a manner to prevent the pest infestation;

b) No drug or animal is used to destroy rats and pests in the food production areas.

5. Monitoring and measuring instruments:

a) Having instruments used for the purposes of monitoring and measuring food quality and safety to ensure that the food satisfies the basic criteria for food safety and quality. If the facility has no monitoring and measuring instruments of food safety and quality, it must conclude an agreement with an organization or individual that is licensed to do such kind of test;

b) Measuring instruments and devices must be accurate during its operation in accordance with law on measurement.

6. The usage of detergents and antiseptics must satisfy the following requirements:

a) Only permitted detergents and antiseptics are used;

b) Detergents and antiseptics must be contained in recognizable packages with guidance for use and not be put in the food production areas.

Section 2. GENERAL REQUIREMENTS PERTAINING TO FOOD TRADING FACILITIES

Article 6. Requirements pertaining to facilities

1. Sufficient space for such placement of food selling area and food storage is provided to facilitate the raw materials and food transportation.

2. No standing water or pooled water is present.

3. Pests and other contaminants are prevented from affecting the facility.

4. The trading facility is constructed with the structure in conformity with its nature and scale; with the materials that ensure the safe and sanitary condition.

5. Walls and ceilings are smooth, in bright color, made of solid materials, not leaked, impervious to water, not cracked, free from mosses and standing water and dirty substances.

6. Restrooms must be laid separately with areas of food production; restrooms‘ doors do not open into the food production area and food storage area.

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

Article 7. Requirement pertaining to equipment and utensils

1. Sufficient equipment for the purposes of trading, storage and monitoring of food safety criteria is provided as recommended by the manufacturer; and regulations on procedures for sanitary maintenance in the facility must be established.

2. Sufficient waste containers with covers which are cleaned regularly must be provided.

Chapter III

REQUIREMENTS PERTAINING TO FUNCTIONAL FOOD AND MICRONUTRIENT-FORTIFIED FACILITIES

Article 8. Requirements pertaining to manufacturing facilities

1. They comply with Article 4 and Article 5 of this Decree.

2. The raw materials for food production must satisfy requirements prescribed in corresponding national technical regulation, regulations on food safety promulgated by competent authorities and those materials have not passed their expiration dates.

3. Chemical contaminants of packaging materials do not migrate into the food that cause negative affects to consumers’ health.

Article 9. Requirements pertaining to trading facilities

1. They comply with Article 6 and Article 7 of this Decree.

2. Warehouses or separate storage areas are required for an importer that satisfy the storage requirements recommended by the manufacturers.

3. The trading of functional foods in a drug retail facility must be provided with a separate selling area with instructions and name tags of functional foods.

Chapter IV

REQUIREMENTS PERTAINING TO FOOD ADDITIVES AND FOOD PROCESSING AIDS FACILITIES

Article 10. Requirements pertaining to manufacturing facilities

1. They comply with Article 4 and Article 5 of this Decree.

2. Raw materials and packages used in production of food additives and food processing aids must satisfy the following requirements:

a) Raw materials for food production must satisfy requirements prescribed in corresponding national technical regulation, regulations on food safety promulgated by competent authorities and those materials have not passed their expiration dates;

b) Food packages must be reliable and safe; the chemical contaminants of packaging materials do not migrate into the food; and those materials are not contaminated that affect consumers’ health.

3. Only food additives and food processing aids that are permitted in Vietnam are produced.

Article 11. Requirements pertaining to trading facilities

1. They comply with Article 6 and Article 7 of this Decree.

2. Lists of groups and groups of products in conjunction with international codes of products (if any), origins and relevant information must be published at the trading facilities and all food additives and food processing aids traded at the facilities must have origin in accordance with corresponding national technical regulation and regulations on food safety promulgated by competent authorities, and those products have not passed their expiration dates.

3. The storage and sale of food additives and food processing aids in a trading facility must be provided with a separate area with instructions and name tags of product groups. Food additives and food processing aids are not put up for sale together with chemicals used for other purposes and non-food products in the same trading facility.

4. food additives for retail sale must be labeled sufficiently in accordance with the smallest packaging unit which the declaration of conformity or conformity with food safety is made.

5. Each importer of food additives and food processing aids must have storage facilities that satisfy the storage requirements recommended by the manufacturers.

Chapter V

REQUIREMENTS PERTAINING TO BOTTLED MINERAL WATER, BOTTLED DRINKING WATER, AND EDIBLE ICE FACILITIES

Article 12. Requirements pertaining to manufacturing facilities of bottled mineral water

1. They comply with Article 4 and Article 5 of this Decree. A system of closed production line is provided.

2. Filling product areas must be closed, separate from other areas and equipped with air sterilization system.

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

4. An area must be provided for the purpose of washing and sterilizing bottles.

5. Equipment and devices in direct contact must be made of materials that do not contaminate the products to satisfy production technology requirements, and easily assessable for cleaning, sterilization and maintenance.

6. The application of sterilization shall not cause negative effects on the products’ quality and safety.

7. The storage facilities must be dry, spacious, and meet sanitary condition; during the transportation, the products must be placed in containers that meet sanitary condition, be shockproof, protect products from deformation or crack .

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

a) Plastic caps and mineral water bottles of under 10 liters are disposable; glass caps and plastic water bottles of 10 liters or more are reusable;

b) Every bottle or jar which is used initially or reused must be cleaned, sterilized, and rinsed carefully before the bottling process, except for the bottle or jar that is produced in the sterilized and closed technology process and used for the first time.

9. The source of mineral water must be protected from any contaminants and alien factors that affect the quality and safety of the source of mineral water.

10. The bottling lines are operated originally from the source of water to the processing location, and made by a system of closed and continuous pipelines which meet the sanitary condition during the extraction process. All products of bottled mineral water must comply with regulations on food safety criteria and management requirements prescribed in national technical regulation applicable to both mineral water and bottled water.

11. The mineral water manufacturing facility must establish a department in charge of inspection and supervision of the sanitary condition of bottles and water quality; keep sufficient records of test results of water resource and water finished products as prescribed in National technical regulation applicable to both mineral water and bottled water.

Article 13. Requirements pertaining to manufacturing facilities of bottled drinking water

1. They comply with Article 4 and Article 5 of this Decree.

2. Filling product areas must be closed, separate from other areas and equipped with air sterilization system.

3. An area must be provided for the purpose of washing and sterilizing bottles.

4. Packages containing bottled drinking water must comply with Clause 8 Article 12 of this Decree.

5. Products shall be sterilized and disinfected, and packages shall be disinfected by specialized equipment using UV-emitting technology, ozone technology or other technologies provided that quality and safety of products are ensured.

6. The source of water used in production of bottled drinking water must be protected from any contaminants and alien factors that affect the quality of the source of water and in accordance with regulations on quality of edible and drinkable water; any water resource extracted by the facility must be inspected in accordance with regulations on quality at least every 12 months.

7. The bottled drinking water manufacturing facility must establish a department in charge of the sanitary condition of bottles and water quality; keep sufficient records of test results of water resources to finished products in terms of every batch.

Article 14. Requirements pertaining to edible ice manufacturing facilities

1. They comply with Article 4 and Article 5 of this Decree.

2. The source of water used in production of bottled drinking water must be protected from any contaminants and alien factors that affect the biological, physical, and chemical quality of clean water and in accordance with National technical regulation on quality of edible and drinkable water; any water resource extracted, processed and used by the facility must be inspected in accordance with regulations on quality at least every 12 months; and the facility must keep sufficient records of results of regular and irregular tests.

3. The usage of product packages must comply with National technical regulation applicable to edible ice.

4. The edible ice manufacturing facility must establish a department in charge of the sanitary condition and quality of ice products; it must also have each batch of products tested to ensure that food safety criteria are satisfied, and keep sufficient records of test results of finished products.

Article 15. Requirements pertaining to bottled mineral water, drinking water, and edible ice facilities

They comply with Article 6 and Article 7 of this Decree.

Chapter VI

IMPLEMENTATION

Article 16. Effect

This Decree comes into force from July 1, 2016.

Article 17. Implementation

Ministers, Heads of ministerial-level agencies, Heads of Governmental agencies, the Presidents of the People’s Committees of central-affiliated cities and provinces and relevant organizations or individuals shall implement this Decree./.