Decision No. 02/2005/QD-BYT on issuing the "Regulations on the Management of Quality and Sanitation Safety of Bottled Natural Mineral Water"

DECISION OF THE MINISTER OF HEALTH

Regarding the issuance of the "Regulations on the Management of Quality and Sanitation Safety of Bottled Natural Mineral Water" bottled natural mineral water"

 

THE MINISTER OF HEALTH

On the basis of Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government on the Provision of Functions, Tasks, Authorities, and Organizational Structure of the Ministry of Health;

WHEREAS the Quality Goods Ordinance dated December 24, 1999;

Pursuant to Decree No. 179/2004/NĐ-CP dated October 21, 2004 of the Government on the management of state quality control of products and goods;

At the proposal of the Director of the Food Safety Agency, the Head of the Legal Department, and the Head of the Science and Training Department of the Ministry of Health,

DECISION:

Article 1. Issued together with this Decision are the "Regulations on the Management of Quality and Sanitation Safety of Bottled Natural Mineral Water".

Article 2. The Standard Measurement Quality Control Department shall be responsible for organizing and guiding the implementation of the Regulations adopted herein.

Article 3. The Officials: the Director of the Office, the Inspector General, Heads of Departments of Science and Training, Legal Affairs - Ministry of Health; Director of the Food Safety Agency, Directors of Provincial Health Services under central cities and Heads of units directly under the Ministry of Health shall be responsible for implementing this Decision./.

REGULATIONS

On the management of quality and sanitation safety of bottled natural mineral water

(Issued together with Decision No. 02/2005/QĐ-BYT dated January 7, 2005)

of the Minister of Health)

PART I

GENERAL PROVISIONS

Article 1. Scope of application

These regulations govern the management of quality and sanitation safety for bottled natural mineral water intended for consumption.

Article 2. Scope of application

These regulations apply to organizations and individuals, both domestic and foreign, producing and trading bottled natural mineral water in Vietnam.

Article 3. Explanation of terms

In this Regulation, the following terms shall be understood as follows:

1. Bottled natural mineral water is distinguished from other drinking waters by:

a) Having a certain concentration of specific minerals with a proportional ratio among them and the presence of trace elements or other components;

b) Being extracted directly from natural sources or drilled from underground aquifers, preserved in the best possible condition within a protected zone to prevent any contamination or external factors affecting the physical and chemical quality of the natural mineral water;

c) Not changing its composition, maintaining a stable flow rate and temperature despite natural fluctuations;

d) Being extracted under conditions that ensure its initial purity regarding microorganisms and the chemical structure of characteristic components;

đ) Being bottled at the source with strict sanitary requirements and only permitted to use technical solutions as specified in Clause 1, Article 14 of these Regulations.

2. Bottling at the source refers to bottling natural mineral water immediately at the water source or through a closed pipeline system directly from the source to the processing and bottling facility while strictly adhering to sanitary regulations throughout the extraction process, ensuring that the composition and quality of the natural mineral water remain unchanged compared to the source water.

3. Bottled natural mineral water with natural carbonation is natural mineral water processed using the technical solutions specified in Clause 1, Article 14 of these Regulations and then recharged with carbon dioxide (CO2) from the original water source, retaining the CO2 content as it was at the source after bottling.₂) as at the source of the water.

4. Bottled natural mineral water without carbonation is natural mineral water processed using the technical solutions specified in Clause 1, Article 14 of these Regulations and then bottled without free CO2 exceeding the necessary amount to keep the soluble bicarbonates in solution.₂) freely exceed the necessary amount to maintain dissolved hydrogen carbonate salts in the water. 

5. Naturally low-carbonated bottled natural mineral water is natural mineral water processed using the technical solutions specified in Clause 1, Article 14 of these Regulations and then bottled with a lower CO2 content than at the source.₂) lower than the water at the source. 

6. Bottled natural mineral water with natural carbonation added from the source is natural mineral water processed using the technical solutions specified in Clause 1, Article 14 of these Regulations and then recharged with CO2 from the original water source, resulting in a higher CO2 content after bottling than at the source.₂) after bottling is higher than the water at the source .

7. Bottled natural mineral water with added carbonation is natural mineral water processed using the technical solutions specified in Clause 1, Article 14 of these Regulations and then charged with food-grade CO2.₂) food. 

8. Technical solutions refer to the treatment methods used during the production of bottled natural mineral water as specified in Clause 1, Article 14 of these Regulations.

Chapter II

REGULATIONS ON THE PRODUCTION AND IMPORT OF

BOTTLED NATURAL MINERAL WATER

Article 4. Production of bottled natural mineral water

1. Organizations and individuals may only extract natural mineral water after obtaining a Mining License from the Ministry of Natural Resources and Environment in accordance with the laws on mineral resources.

2. Organizations and individuals may only produce bottled natural mineral water after obtaining a Certificate of Hygiene Conditions for Food Production from the Ministry of Health (Food Safety Agency).

3. Organizations and individuals producing bottled natural mineral water must declare their food hygiene and safety standards to the Ministry of Health (Food Safety Agency) in accordance with the law before the product can be marketed.

4. Organizations and individuals producing bottled natural mineral water are only allowed to treat and bottle natural mineral water at the source.

Article 5. Import of bottled natural mineral water

1. Organizations and individuals importing bottled natural mineral water must comply fully with the national inspection procedures for quality as stipulated by the Ministry of Health.

2. Organizations and individuals importing bottled natural mineral water must declare their food hygiene and safety standards to the Ministry of Health (Food Safety Agency) in accordance with the law before the product can be marketed.

Chapter III

REGULATIONS ON SANITARY REQUIREMENTS FOR

BOTTLED NATURAL MINERAL WATER PRODUCTION FACILITIES

Article 6. Location, structure, and design

1. Position

The production facility for bottled natural mineral water must be located away from areas that pose a risk of food contamination.

2. General structure

a) The production facility must be designed and constructed according to a unidirectional principle consistent with the sequence of production stages in the manufacturing line and divided into separate zones to prevent cross-contamination between processes or areas.

b) The total area and the structure of the areas between zones must be consistent with the designed capacity of the facility to avoid overloading that easily causes pollution and difficulties in maintenance, cleaning, and inspection.

c) Adjacent areas within the management scope of the facility must ensure clean environmental hygiene; playgrounds and paths within the area must be paved or covered with asphalt to prevent dust and water accumulation.

3. Design

a) Wall and ceiling surfaces must be flat, light-colored, and easy to clean; non-waterproof wall sections must be at least 2 meters high.

b) Floors must be made of waterproof materials that are easy to clean and have appropriate slopes for good drainage.

c) Doors must be tight-fitting and made of waterproof materials that are easy to clean.

d) Insect and pest prevention systems must be made of rust-resistant materials that are easy to clean and installed to minimize insect and pest intrusion.

đ) Ventilation systems must be arranged to eliminate condensation, dust, hot air, and pollutants; the direction of ventilation must ensure that air does not blow from contaminated areas to clean areas.

e) Filling workshops must be sealed and equipped with sterilization systems; there must be a system to monitor these devices to ensure they operate in optimal condition.

g) Water protection zones must be constructed to prevent dust, insect, and pest intrusion.

h) Changing rooms must have an appropriate number; walls and floors of changing rooms must comply with the provisions of points a and b of Clause 3 of this Article.

Article 7. Equipment and processing tools

1. Equipment and tools that come into direct contact with natural mineral water must be food-grade, made from materials that do not rust, corrode, leach harmful substances, or emit unusual odors into products.

2. Equipment and tools used during production must be made of rust-proof materials that do not contaminate products, are easy to clean, and must be cleaned regularly according to production shifts.

3. There must be dedicated equipment for collecting and storing waste.

Article 8. Drainage System

1. Floor drainage channels must ensure effective water flow. Channels must be made of waterproof materials, sized appropriately for maximum wastewater flow, with waterproof covers having suitable numbers and sizes of drainage holes. Drainage channels must have structures that are easy to clean.

2. Sedimentation tanks for solid waste must be arranged according to wastewater flow rates and drainage channel networks. Tanks must have covers and be easy to clean and disinfect. Tanks must be located outside the production area.

3. External wastewater conduits leading from the production area to storage tanks and wastewater treatment areas must have tightly sealed covers that are easy to remove and clean.

4. Natural mineral water bottling production facilities must comply with environmental laws regarding waste treatment. Waste treatment areas must be built within the facility's protective fence to prevent animal intrusion.

Article 9. Sanitation Practices

1. Production workshops, equipment, and tools used during production must be cleaned regularly.

2. The entire facility must undergo thorough cleaning at least once every six months.

3. Pipes, beams, columns, and places where dirt often accumulates must be cleaned frequently to minimize microbial growth.

4. Chemicals and pest control agents used in natural mineral water bottling facilities must meet current regulations.

Article 10. Sanitary Facilities

1. Natural mineral water bottling facilities must have separate sanitary areas from the production area.

2. Sanitary areas must be structured so that their doors do not directly open into the production area.

3. Each sanitary area must have hand-washing stations equipped with soap, paper towels, or hand-dryers.

4. Sanitary areas must be cleaned regularly.

5. The number of toilets must comply with the Labor Hygiene Standards issued along with Decision No. 3733/2002/QĐ-BYT dated October 10, 2002, by the Minister of Health.

Article 11. Water and Steam

1. Water used in production processes must comply with the Drinking Water Sanitation Standards issued with Decision No. 1329/2002/BYT-QĐ dated April 18, 2002, by the Minister of Health.

2. Water that does not meet the requirements set out in Clause 1 of this Article may only be used for purposes such as cooling, firefighting, supplying steam boilers, and other purposes not connected to production water sources and must be marked separately to prevent misuse.

Chapter IV

RESPONSIBILITIES OF THE FACILITY OWNER AND REGULATIONS

FOR PERSONS DIRECTLY INVOLVED IN PRODUCTION

Article 12. Responsibilities of the entity causing the incident

1. Organize training sessions on food safety knowledge for persons directly involved in production.

2. Organize regular health check-ups at district-level or higher healthcare facilities at least once a year for persons directly involved in production.

3. Conduct regular comprehensive quality testing of source water and finished product water at recognized or designated testing agencies at least once every six months.

Article 13. Regulations for Persons Directly Involved in Production

1. Persons suffering from infectious diseases as defined by the Ministry of Health are not allowed to participate in production.

2. Persons directly involved in production must strictly adhere to personal hygiene requirements during production and attend all scheduled food safety training sessions.

3. Persons directly involved in production must comply with the following requirements during production:

a) Wear specific work attire. Individuals working in filling workshops must wear clean hats, masks, and disposable gloves or wash hands with antibacterial soap.

b) Keep nails short and clean, and do not wear jewelry.

c) Wash hands thoroughly with clean water and soap, then dry them:

- At the start of work;

- After touching dirty surfaces;

- After using the restroom.

d) Do not eat, chew gum, smoke, or spit.

Chapter V

REGULATIONS FOR THE PRODUCTION PROCESS AND TECHNICAL REQUIREMENTS

FOR NATURAL MINERAL WATER IN BOTTLES

Article 14. Technical Solutions

1. Natural mineral water is only permitted to be processed for bottling by using one or a combination of the following technical solutions if such solutions do not change the basic component content of natural mineral water compared to its source:

a) Separating unstable components as well as iron, manganese, sulphur, or arsenic compounds through decantation and/or filtration, and in case of necessity, rapid treatment by air injection may be applied;

b) Removing or charging carbon dioxide gas (CO2);₂);

c) Sterilizing with ultraviolet rays.

2. It is strictly prohibited to transport natural mineral water in containers for bottling before bottling at the source.

Article 15. Production process regulations

1. During the filling and capping process, care must be taken to avoid damaging bottles and prevent foreign objects from falling inside. Equipment must be regularly monitored and maintained to prevent risks of product contamination. The monitoring and maintenance process must be fully recorded.

2. Filling and capping equipment must be kept clean and hygienic; it must be cleaned and sterilized at the start of production, and if production is continuous, at least once per week.

3. Bottles must be capped immediately after the filling process.

4. Bottle caps must ensure sealing before circulation.

Article 16. Technical requirements

1. Requirements related to health safety for bottled natural mineral water are specified in Appendix 1 of this Regulation.

2. Microbiological requirements for bottled natural mineral water are specified in Appendix 2 of this Regulation.

Chapter VI

LABELING, CONTAINERS, STORAGE AND TRANSPORTATION REGULATIONS

STORAGE AND TRANSPORTATION

Article 17. Labeling

Labels for bottled natural mineral water must comply with the Product Labeling Regulations for Domestic Circulation and Exported and Imported Goods issued together with Decision No. 178/1999/QĐ-TTg dated August 30, 1999 of the Prime Minister, and other guiding legal documents implementing the above regulation. In addition, labeling of bottled natural mineral water must comply with the following provisions:

1. Product name

a) The product name must include the phrase "Natural Mineral Water".

b) Additionally, depending on the type of natural mineral water, labels must be marked with the following names:

- Naturally carbonated natural mineral water;

- Non-carbonated natural mineral water;

- Low naturally carbonated natural mineral water;

- Natural mineral water supplemented with carbonation from the source;

- Natural mineral water supplemented with carbonation.

2. The name of the mineral water source and the area where the source is located must be clearly marked on the product label.

3. Chemical composition

a) Total dissolved solids (TDS), chemical components of bottled natural mineral water (sodium, calcium, potassium, magnesium, iodine, fluoride, HCO3-) and their concentrations, and the technical solutions used in the production process of bottled natural mineral water must be marked on the product label.₃b) If bottled natural mineral water contains more than 1 mg/L fluoride, it must be marked on the product label as "contains fluoride".

If bottled natural mineral water contains more than 2 mg/L fluoride, it must be marked on the product label as "Product not suitable for children under 7 years old".

It is forbidden to label the product with claims about therapeutic effects or other health-related effects.

4. It is forbidden to advertise causing misunderstanding about the nature, origin, composition, and characteristics of bottled natural mineral water when circulating in the market.

5. Packaging

Article 18. 1. Packaging used to contain natural mineral water must be food-grade packaging, sealed properly, and have appropriate sizes to prevent counterfeiting and contamination.

2. Bottle caps and plastic bottles with a capacity of less than 10 liters must not be reused.

3. Plastic containers with a capacity of 10 liters or more and glass bottles may be reused.

4. All types of bottles and containers, whether new or reused, must be thoroughly cleaned, sterilized, and rinsed before the filling process; except for new containers produced with closed-loop technology that includes sterilization. Monitoring of the sterilization and rinsing processes must be conducted in the bottle washing area, and the results must be recorded.

5. After thorough rinsing, bottles must be inverted to prevent dust and foreign objects from falling inside, except when bottles are washed by automatic machines.

Storage

Article 19. 1. Bottled natural mineral water must be placed in containers that ensure hygiene, avoiding impact and displacement during transportation.

2. Products must be stored in dry, well-ventilated areas that ensure hygiene.

Transportation

Article 20. Bottled natural mineral water must be transported by means that do not affect the quality, hygiene, and safety of the product.

Organizations and individuals producing and trading bottled natural mineral water are responsible for implementing this Regulation.

Chapter VII

IMPLEMENTING PROVISIONS

Article 21. The Food Safety Authority shall take the lead, coordinating with relevant Departments and Agencies under the Ministry of Health and related agencies to guide and direct the implementation of this Regulation./.

Article 22. The Department of Food Safety shall take the lead, coordinating with relevant Departments and Agencies under the Ministry of Health and related agencies to guide and direct the implementation of this Regulation./.