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The Decree 67/2016/nd-Cp: Regulations Regarding The Conditions Of Production, The Food Business In The Field Of Management Of The Ministry Of Health

Original Language Title: Nghị định 67/2016/NĐ-CP: Quy định về điều kiện sản xuất, kinh doanh thực phẩm thuộc lĩnh vực quản lý chuyên ngành của Bộ Y tế

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The DECREE REGULATES the CONDITIONS of production, the FOOD BUSINESS in the FIELD of MANAGEMENT of the Ministry of health of the Government Organization Act base on June 19, 2015;
Pursuant to the law on investment on November 26, 2014;
According to the recommendation of the Minister of health;
The Government issued the decree to regulations regarding the conditions of production, the food business in the field of management of the Ministry of health.
Chapter I GENERAL PROVISIONS article 1. Scope of this Decree stipulates the conditions of production, the food business in the field of management of the Ministry of health include: 1. General conditions for production facilities, food business.
2. conditions for manufacturing facilities, food business functionality and enhanced food micro-nutrients.
3. The conditions for the production and trading of food additives, food processing support.
4. conditions for production facilities, sales of natural mineral water, bottled water, ice water use.
Article 2. The object of this Decree apply apply to agencies, organizations and individuals, Vietnam; organizations, foreign individuals in Vietnam to join the production, food business in the field of management of the Ministry of health (hereafter referred to collectively as organizations, individuals).
Article 3. Applicable principles of law 1. The Organization, individuals are eligible for the provisions of this Decree are produced, the food business.
2. In the process of production, business, organization, individual manufacturing, food business must comply with the provisions of the legislation on food safety.
Chapter II GENERAL CONDITIONS for PRODUCTION FACILITIES, FOOD BUSINESS Item 1. GENERAL CONDITIONS for FOOD PRODUCTION article 4. Conditions for the base 1. Location, environment: a) has sufficient area to layout the area of food production, the auxiliary area and convenient for production, storage and transportation of food;
b) production areas, food preservation is not flooded, condensation water;
c) unaffected by animals, insects, microorganisms that cause harm;
d) is not affected to safe food from areas of dust pollution, toxic chemicals and other pollution-causing sources.
2. The design of factory building: a) of factory production and ancillary areas must be designed to build enough area to layout of equipment, production lines for food and in accordance with the design features of the facility;
b) food production processes must be arranged according to the principles of a pm from raw materials to the final product;
c) warehouse area of raw materials, finished products warehouse; the area of preliminary processing, processing and packaging of food products; toilet area; the dressing area and related ancillary areas must be designed to build separate;
d) internal Roads must be designed to build hygienic assurance; waste drains must be sealed cover, ensure hygiene and publicity;
DD) Where concentrated waste, to design the building in the area of food production factory and guaranteed hygiene.
3. Workshop structure: a) workshops must have solid structure, in accordance with the nature, scale and process technology for production of food;
b) material in direct contact with food should have smooth surface, waterproof, non-stop toxic contamination out food, less eroded due to the cleaners, disinfect and easy cleaning, disinfection;
c) flat wall, brightly colored, not waterproof, not rift, not be clinging dirt and easy cleaning; the ceiling is flat, brightly colored, not dilapidated condemned, absorbent, rift, sticky clinging dirt and easy cleaning;
d) the floor is flat, smooth, good drainage, waterproof and easy to clean.
4. Ventilation system: a) ensure ventilation to the area of the base and fit the required types of food production; easy maintenance and cleaning.
b) wind direction of ventilation systems to ensure not to be blown from the area at risk of pollution to the area that requires the clean.
5. The lighting system: a) ensuring light to meet the requirements of production, quality control, product safety;
b) lighting bulbs must be safe by shielding, the grid to avoid rupture and secure debris falling into the food.
6. water supply system: a) ensure enough clean water for food production and in accordance with national technical regulation on water quality of eating;
b) ensure enough clean water to wash hands, utensils, equipment, toilets and sanitary compliance with national technical regulation on water quality in the production process.
7. Steam and compressed air: a) steam, compressed air used for food production to ensure clean, safe, non-polluting for food;
b) must have a private pipeline to the distinct colors, and not connected to the water system used for the production of foods with the water system used to produce steam, refrigeration, fire department, fire or used for other purposes.
8. waste disposal system: a) has enough solid waste collection tools with a lid. The tool contains dangerous solid waste must be symbols to differentiate according to the provisions of the law on the protection of the environment. If no system of solid waste must contract the economy picked up with the Organization, individuals are allowed to other solid waste disposal areas;
b) waste treatment systems must be operated regularly and the waste is processed according to the standards and regulations on environmental hygiene.
9. Toilet, dressing area labor protection: a) the toilet must be arranged separately with food production area; toilet doors are not opened in the production areas;
b) ventilation suitable layout, ensure not to be blown from the toilet to the manufacturing sector; sewer is easy and secure. There are hand washing instructions clean sheet;
c) room worker costume changes before and after work.
10. In the production process, the raw materials of food and food packaging must meet the following requirements: a) food ingredients, food additives and processing aid used in the manufacture of foods are derived, made clear and secure;
b) food packaging to ensure safe, certainly; not only infected with contaminated and affect the quality, safe food.
Article 5. Conditions for the equipment, instruments 1. Equipment, tools for direct contact with food must be designed in accordance with the requirements of production technology; ensure a safe, non-polluting food, easy to clean, disinfect, maintenance. Equipment, mobile production tools are durable, easy to move, removable and cleaning.
2. Means of washing and disinfection of hands: a) have adequate equipment for washing the hands, hand, shoes, boots, slippers before entering the area of food production;
b) food production must have sink for employees; where hand washing must have SOAP or antiseptic water; hand wipe paper towel, used once or hand dryer.
3. equipment, tools and food production: a) have sufficient and suitable to process raw materials, processing and packaging of food;
b) were built with non-toxic materials, wear, not rusty, not only infected with the toxic substance, does not cause strange odors or food changes;
c) ease of cleaning, maintenance; don't make food contamination by lubricants, metal debris;
d) have sufficient sanitation processes, operating procedures for facilities and equipment of the production line.
4. Prevention of insect and animal pests: a) equipment for the prevention of insect and animal pests must be made of stainless materials, easy to disassemble for cleaning, suitable design, guaranteed to prevent the entry of insect and animal pests;

b) do not use drugs, animals to kill rats, insects and animal pests in food production areas.
5. Equipment for measuring, monitoring tools: a) Has equipment, quality monitoring tools, safety products and reviews are basic norms of quality, safe food. If no device, quality monitoring tools, food safety must have economic contracts with the Organization, individuals are allowed to test;
b), equipment, means of measuring instruments to ensure accuracy during use under the provisions of the law on metrology.
6. The use of detergent and disinfectant must meet the following requirements: a) only use the cleansing, antiseptic chemicals are allowed to use;
b) Must be in recognizable packaging, there are manual and not to produce food.
Section 2. GENERAL CONDITIONS for FOOD BUSINESS ESTABLISHMENTS, article 6. Conditions for the base 1. There is enough area to layout the area sold food, the area contains, preserving and convenient to transport raw materials and food products.
2. Not flooded, water condensation.
3. Not affected by animals, insects and other pollution sources.
4. Textured base business fit with the nature, scale; built with materials that ensure sanitation, safe.
5. Wall, smooth ceilings, brightly colored, made of durable material, sure, not being dilapidated condemned, impervious to water, no cracking, standing water, Mossy and sticky clinging dirt.
6. toilet areas must be deployed to the area of the food business; toilet doors are not opened in the area of food preservation.
7. Have the system management software or books food throughout the business process.
Article 7. Conditions for the equipment, instruments 1. There is enough equipment for business, preserve and control food safety elements accordingly at the request of the manufacturer; There are rules about the process, hygienic regime with respect to the base.
2. Have enough tools for collecting waste, garbage, with a lid and clean regularly.
Chapter III CONDITIONS for MANUFACTURING FACILITIES, FOOD BUSINESS FUNCTIONALITY and ENHANCED FOOD MICRONUTRIENT article 8. Conditions for production facilities 1. Compliance with the conditions specified in article 4 and article 5 of this Decree.
2. Raw materials for food production must meet prescribed in the national technical regulation, food safety regulations of the competent bodies and longer shelf life.
3. The packaging must contain not only the harmful toxins, infections do not affect food and to the health of consumers.
Article 9. Conditions for business establishments 1. Compliance with the conditions specified in article 6 and article 7 of this Decree.
2. With regard to the importing facility must have shed or suitable private preservation area requires the preservation of the manufacturer.
3. functional food business in retail drug establishments must have sold private zone layout, and the sea areas named for functional food.
Chapter IV CONDITIONS for the PRODUCTION and trading of FOOD ADDITIVES, FOOD PROCESSING SUPPORT SUBSTANCES article 10. Conditions for production facilities 1. Compliance with the conditions specified in article 4 and article 5 of this Decree.
2. The use of raw materials and packaging used in the production contain a food additive, food processing support substances must meet the following requirements: a) the raw materials used in production must meet the technical standards specified in the respective countries, food safety regulations of the competent authority and must also use the term;
b) contains packaging must guarantee the sure, safe, not only infected with the toxic substance, does not affect the food, not the cause of pollution affect the health of consumers.
3. Only the production of food additives, food processing support substances have been used in Vietnam.
Article 11. Conditions for business establishments 1. Compliance with the conditions specified in article 6 and article 7 of this Decree.
2. Publicly listing the group name with the product name or with the international code of the product (if available), the origin and the related information in the base and must ensure the food additive, food processing support business at the base of origin, origin, meet the national technical regulation respectively , food safety regulations of the competent authorities, and the expiry date.
3. The preservation, presentation to sell food additives, substances to support food processing must be done in a separate area in the food business establishments and to have instruction area, full name for sea group products. No food additives sold, assist with processing chemicals for other purposes and not the food product in the same business.
4. retail food additives must complete labeling prescribed for the smallest packaging unit was announced conformity or appropriate regulations publication of food safety.
5. The basis of imported food additives, substances to support food processing preservation repository must be qualified according to the requirements for preservation of the manufacturer.
Chapter V CONDITIONS for PRODUCTION FACILITIES, sales of NATURAL MINERAL WATER, BOTTLED WATER, ICE WATER USE ASSOCIATED Thing 12. Conditions for the production of bottled natural mineral water 1. Compliance with the conditions specified in article 4 and article 5 of this Decree. Have the system closed manufacturing lines.
2. product filling area is enclosed, separate from other areas and are equipped with air sterilizing system.
3. Buildings, equipment and instruments used in the production process must be sanitized and sterilized frequently.
4. Is the layout area for washing and sterilization of bottles, jugs products.
5. equipment and instruments in direct contact must be made of material that does not cause pollution, in accordance with the requirements of production technology, ease of cleaning, disinfection, maintenance.
6. The use of sterilization, disinfection technology is not affecting the quality and safety of products.
7. Where preserved products must be dry, airy, ensuring sanitation; When shipping must be placed in the containers ensure sanitation, impact resistant, does not cause distortion or slamming.
8. The use of the packaging contained must ensure the following requirements: a) The type of bottle caps and plastic bottles contain natural mineral water has a lower capacity 10 litres are not used; plastic vase from 10 liter back up and the glass bottle can be reused;
b) bottle, the average first-time use or reuse must be cleaned, thoroughly before washing, sterilizing the pouring phase, unless the bottle, the average use was first produced in self-contained sterilizing technology.
9. natural mineral water Resources be guaranteed hygiene and avoid any contamination or foreign elements affecting the quality of water sources safe.
10. The bottle is made right in the water source or be led directly from source to place processed, bottled by a closed pipeline system, continuously, ensure strict hygiene regulations during the extraction process. Ensure the product bottled natural mineral water, in accordance with the rules of food safety norms and requirements management at the national technical regulation for natural mineral water and bottled drinking water.
11. The basis of the production of natural mineral water must have the supervision of toilet control bottle vase, water quality; There is enough stored profile test results of the water source and water product as defined in the national technical regulation for natural mineral water and bottled drinking water.

Article 13. Conditions for manufacturing bottled water 1. Compliance with the conditions specified in article 4 and article 5 of this Decree.
2. product filling area is enclosed, separate from other areas and are equipped with air sterilizing system.
3. Is the layout area for washing and sterilization of bottles, jugs products.
4. Packaging contain bottled water must comply with the provisions in paragraph 8 article 12 of this Decree.
5. The sterilization, disinfection, sterilization packaging products using dedicated equipment, using technology to create UV, ozone gas and technology or other technologies but do not affect the quality and safety of products.
6. Sources of water used in the production of bottled water be sure to prevent any contamination or foreign factors affecting water quality and in accordance with the regulations on the quality of the water to eat; the water source by the extraction facility must be checked and guaranteed consistent with rules of the quality for at least 12 months/times.
7. Production facilities must be bottled drinking water hygiene control parts, bottles of water quality; There is enough stored test results from water source to finished products in accordance with each batch of product.
Article 14. Conditions for ice production facilities use the Mainland 1. Compliance with the conditions specified in article 4 and article 5 of this Decree.
2. Sources of water used in production must ensure the room to avoid any contamination or foreign elements affecting the quality of Microbiology, physics, chemistry of clean water and in accordance with national technical regulation on water quality of eating; the water source by the extraction base, handle and use must be checked and guaranteed consistent with rules of the quality for at least 12 months/times; There is enough stored records and test results.
3. The use of product packaging packaging must ensure compliance with the provisions of the national technical regulation for ice users.
4. ice production facilities use the Mainland must have sanitary control Division, the quality of the finished water ice; the product is tested the food safety criteria as defined for each batch of products; There is enough stored profile test results of finished products.
Article 15. Conditions for business natural mineral water, bottled water, ice used sailings in compliance with the conditions specified in article 6 and article 7 of this Decree.
Chapter VI article 16 ENFORCEMENT TERMS. Effective enforcement of this Decree takes effect from July 1, 2016.
Article 17. Responsibility of Ministers, heads of ministerial agencies, heads of government agencies, the Chairman of people's Committee of the province, central cities and other organizations and individuals concerned is responsible for the implementation of this Decree.