Decision No. 02/2005/QD-BYT promulgating the Regulation on management of quality, hygiene and safety of bottled natural mineral water

DECISION No. 02/2005/QO-BYT OF JANUARY 7, 2005 PROMULGATING THE REGULATION ON MANAGEMENT OF QUALITY, HYGIENE AND SAFETY OF BOTTLED NATURAL MINERAL WATER THE MINISTER OF HEALTH Pursuant to the Government's Decree No. 49/ 2003/ND-CP of May 15, 2003 defining the functions, tasks, powers and organizalional structure of the Health Ministry; Pursuant to the December 24, 1999 Ordinance on Goods Ouafity; Pursuant to the Government's Decree No. 119/ 2004/ND--CP of Oc:tobor 21, 2004 prescribing tho State management over quality of products and goods; At the proposals of the director of the Food Safety and Hygiene Department, the director of thf! Legal Department and the director of the Science and Training Department of the Health Ministry, DECIDES: Article 1.N To promulgate tog0ther with this Decision the Regulation on management of quality, hygiene and safety of bottled natural mineral water. Article 2.- This Decision takes effect 15 days after its publication in the Official Gazette. Article 3.- The director of the Office, the chief inspector, the directors of the Science and Training Department and the Legal Department of the Health Ministry, the director of the Food Safety and Hygiene Department, the directors of the Health Services of the provinces or centrally-run cities and the heads of the units under the Hea\1h Ministry shall have to implement this Decision. For the Health Minister Vice Minister TRAN CHI LIEM THE REGULATION ON MANAGEMENT OF QUALITY, HYGIENE AND SAFETY OF BOTTLED NATURAL MINERAL WATER (Promulgated togc-dlwr with the floafth Minister's Decision No. 0212005/OD-B YT of.January 7, 2005) Chapter I GENERAL PROVISIONS Article 1.- Governing scope This Regulation governs the management of quality, hygi0n0 and safety of bottled natural mineral water used for refreshment purpose. Article 2.- Subjects of application This Regulation applies to Vietnamese as well as foreign organizations and individuals producing and trading in bottled natural mineral water in Vietnam. Article 3.- lnterpretatfon of terms In this Decision, the following terms are construed as follows: 1. Bottled natL1ral mineral water means water clearly distinguishable from other ordinary types of drinking water because: a/ !t has certain contents of a number of mineral sarts in their proportional correlations, with the presence of microelements or other components; b/ JI is exploited direclly from natural sources or drilled wells from underground water streams, which are preserved under the best conditions possible within the protection belts to prevent any pollution or any exotic elements which can affect tl10 physical and chemical quality of natural mineral water; c/ It remains unchanged in terms of composition and stable in terms of flow and ternr,erature in spite Clause 1 , Article 14 of this Regulation and after of all natural upheavafs; being bottled, contains a carbon dioxide (CO 2 ) content lower Hian that at sourcE~s. d/ It is exploited under conditions wl·lich ensure the initial cleanness in terms of microorganisms and chemical composition of typical components; e/ It is bottled at sources with stringent hygienic requirements and with the application of only technical solutions specified in Clause 1, Article 14 of this Regulation. 2. Bottling at source means the bottling of natural mineral water right at water sources or the conveyance thereof directly from sources to places for processing and bottling through a system of closed and continuous pipelines, ensuring stringent hygienic requirements throughout the course of exploitatfon and guaranteeing that composition and quality of natural mineral water remain unchanged as compared with ifs sources. 3. Bottled natural mineral water with natural gas means natural minerar water which, after the application of the technical solutions specified in Clause 1, Article 14 of this Regulation and after being added again with a gas volume from its very sources, still contains carbon dioxide (CO2) in a content similar to that at the water sources. 4. Bottled non-carbonated natural mineral wafer means natural mineral water which, after the application of the technical solutions specified in Clause 1 , Article 14 of this Regulation and after being bottled, contains no tree carbon dioxide (CO 2 ) content in excess of the necessary content to retain hydro carbonate salts dissolved in water. 5. Natural mineral water with little natural gas means natural mineral water which, after the application of the technical solutions specified in 6. Natural mineral water added with natural gas from sources means natural mineral water which, after the application of technical solutions specified in Clause 1, Article 14 of this Regulation and after being added with a gas volume from its very sources, contains a carbon dioxide (CO2) content higher than that at sources. 7. Bottled natural mineral water added with gas means natural minera( water obtained, after the application of technical solutions specified in Clause 1, Article 14 of this Regulation and after being added with food carbon dioxide (CO2). 8. Technical solutions mean treating solutions used in the process of producing bottled natural mineral water specified in Clause 1, Article 14 of this Regulation. Chapter II REGULATIONS ON PRODUCTION AND IMPORT OF BOTTLED NATURAL MINERAL WATER Article 4.- Production of bottled natural mineral water 1. Organizations and individuals shall be allowed to exploit natural mineral water only after being granted by the Environment and Science Ministry permits for exploitation of minerals (mineral water) according to law provisions on minerals. 2. Organizations and individuals shall be allowed to produce l)ottled natural mineral water only after being granted by the Health Ministry (the Food Hygiene and Safety Department) certificates of satisfaction of good hygiene and safety conditions. 3. Organizations and individuals producinn bottled natural mineral wator must notify the food quality, hygiene and safety standards to the Health Ministry (the Food Hygiene and Safety Department) according to law provisions before their products are circulated on the rnmket. 4. Organizations and individuals producing bottled natural mineral water shall only be allowed to treat and bottle natural mineral water at sources. A rticfe 5. ~ Import of bottled natural mineral waler a/ ~iroduction establishmnnts must be designed ancl built on U10 one-dimension principle in compatibility with the order or processes in production chains and shall be sectioned into separate areas, so as to avoid cross pollution botween pror:esses or areas. bl Total acreage and acreage structure between areas must be compatible with designed capacity of establishments, thus avoiding overload situation which r:an easily cause contamination and difficulties in rnaintenance, cleaning and inspection. cl The vicinities of areas under establishments' management must be ensured with a clean 1. Organizations and individuals importing environment; yards and passages within such bottled natural mineral water must fully observe the areas must be smoothly paved or asphalted to State quality inspection contents and procedures avoid dusts and stagnant water. as prescribed by the Health Ministry. 2. Organizations and individuals importing bottled natural mineral water must notify the food quality, hygiene and safety standards to the Health Ministry (the Food Hygiene and Safety Department) according to law provisions before their products are circulated on the market. Chapter fff REGULATIONS ON HYGIENIC CONDITIONS APPLICABLE TO ESTABLISHMENTS PRODUCING BOTTLED NATURAL MINERAL WATER Article 6.· Position, structure and designing 1. Position Establishments producing bottled natural mineral water must be built in isolation from areas which are likely to cause food pollution. 2. General structure 3. Designing al Wall and ceiling surface must be flat, bright and easy to be cleaned; the water-proof wall sections must be at least 2 meters high. bl House floors must be made of water-proof materials and easy for cleaning, and have a proper slope for water drainage. c/ Doors must be tight, made of water-proof materials and easy for cleaning. di The system to prevent the intrusion by harmful insects and animals must be made of stainless materials, easy for cleaning and installed to prevent to the utmost the intrusion by harmful insects and animals. e/ The ventilation system must be arranged so as to preclude condensed steam, dust, hot air and polluted gases; direction of the ventilation system must ensure that air must not be ventilated from conlf1minalerl areas to dean a,·eas. f/ The boWe-fi!!ing workshop must be closed and equippod with i,terilization system; equiprrnrnt in such system must be controlled so that they can always operate in good conditions. g/ Water source protection zone must be built so that ii can ward off dust and prevent tt1e intrusion by harmful insects and animals. h/ There must be an appropriate number of locker rooms; specifications of locker rooms' wails and floors must comply with the provisions of Points a and b, Clause 3 of this Article. Article 7.- Processing facilities, equipment and tools 1. Equipment and tools used in direct contact with natural mineral water must be those exclusively used for foodstuffs, made of stainless and non-corrosive materials, which do not emit nor are contaminated with toxic and hazardous substances and do not diffuse strange smells to products. 2. Equipment and tools used in the production process must be made of stainless materials, cause no contamination to products, be easy to clean and be regularly cleaned upon each production shift. 3. There must be special-use tools for collecting and storing garbage and waste. Article 8.-Water drainage system i. Water-draining ditches on floors must ensure good water drainage. Ditches must be made of impermeable materials and be of sizes suitable to the maximum flow of wastewater and have lids easy cleaning. 2. Pits for settling solid waste must be arranged in compatibility witl1 wastewater flow and drainage ditch networks. Pits must have lids and be easy for cleaning and sterilization. Pits must be arranged outside production areas. 3. Wastewater conduits outside production areas to wastewater tanks and treating quarters must have lids which are easy to be disassembled and cleaned. 4. Establishments producing bottled natural mineral water must carry out the treatrnent of waste according to law provisions on environment. Waste treating areas must be built inside protection fences of establishments to prevent the intrusion by animals. Article 9.- Sanitation reglme 1. Workshops, equipment, facilities and tools used in the production process must be periodically sanitized. 2. General sanitization of production establishments must be carried out at least once every six months. 3. Water pipes, beams, pillars and places where dirt usually accumulates must be regularly sanitized in order to minimize the grow! h of microorganisms. 4. Chemicals, insecticides and germicides used in establishments producing bottled natural mineral water must satisfy the current regulations. Article 10.- Water closet areas made of water-proof materials and with appropriate 1. Establishments producing bottled natural number and sizes of waler drainage holes. mineral water must have water closet areas isolated Wastewater-draining ditches must be structured for from production areas. 2. Water closets rnust be structured in a way that their cloors must not be dirncted towarc!s production areas 3. Each water closet must be furnished with a hand-washing sink where soap, hand towels or hand dry-blowers are available. 4. Water closets must be regularly cleaned. 5. The number of water closets must satisfy the labor sanitation standards promulgated together with the Health Minister's Decision No. 3733/2002/ QD-BYT of October 10, 2002. Article 11.- Water and steam 1. Water used in production processes must satisfy the drinking water hygiene standards promulgated together with the Health Minister's Decision No. 1329/2002/8 YT /QD of Ap ri I 18, 2002. 2. Water not up to the requirements prescribed in Clause 1 of this Article shall be used only for such purposes as freezing, fire fighting, supply to steam boilers and other purposes and must not be connected to water sources used for production and must be marked with specific signs in order to avoid misuse. Chapter JV RESPONSIBILITIES OF OWNERS OF ESTABLISHMENTS AND REGULATIONS APPLICABLE TO PERSONS DIRECTLY ENGAGED IN PRODUCTION Article 12.- Responsibilities of owners of establishments 1. To organize training courses on knowledge about food safety and hygiene for persons directly engaged in production. 2. To organize health-chocks at least once a year al medical establishments of district or higher level for persons directly engaged in production. 3. To conduct periodical assays of comprehensive quality of water sources and finished water product at least once every six months at recognized or designated assaying bodies. Article 13.- Regulations applicable to persons directly engaged in production 1. Persons who are infected with contagious diseases prescribed by the Health Ministry must not be engaged in production. 2. Persons directly engaged in production must satisfy all personal hygiene requirements while in production process and attend all training courses on knowledge about food safety and hygiene. 3. Persons directly engaged in production must satisfy the following requirements while in production process: a/ To wear specific outfits. Persons working in bottle-filling workshops must wear clean hats, gauze masks and disposable gloves or wash their hands with sterilizing soap; b/ To keep their fingernails short, clean and jewelry-free; cl To wash their hands with clean water and soap, then dry them with towels: Wh0n starling to work; •· After touching dirty surfaces; After toilet. d/ Not to eat, drink, tako chewin~HJUm, smoke, hawk or spit. Chapter V REGULATIONS ON PRODUCTION PROCESS AND TECHNICAL REGULATIONS ON BOTTLED NATURAL MINERAL WATER Article 14,- Technical solutions 1. Natural mineral water shal! only be allowed to be processed for bottling by using one or combined technical solutions as follows, prov(ded that such technical solutions do not .~hange contents of basic constituents of natural mineral water as compared with its sources: al Separation of unstable constituents as well as compounds containing iron, manganese, sulfur or arsenic by decanting and/or filtering, and in case of necessity, through quick treatment by method of prior aeration; b/ De-aeration or aeration of carbon dioxide (CO2); cl Sterilization by ultraviolet ray. contamination. The supervision and maintenanco rnust be fully recorded in writing. 2. Bottle fimng and capping equipment must /Jo kept in clean and hygienic conditions; they must be cleansed and sterilized as soon as the production starts, or at least once a week if the production is no n-i nte rrupted. 3. Bottles must be capped right after the filling process. 4. Bottle caps must be guaranteed airtight before ci rcu la tion. Article 16.~ Technical regulations 1. ~equirements regarding healfh safety-related norms of bottled natural mineral water are specified in Appendix i of this Regulation. 2. Requirements regarding microorganisms of bottled natural mineral water are specified in Appendix 2 of this Regulation. Chapter VI REGULATIONS ON LABELING, CONTAINING PACKAGES, PRESERVATION AND 2. It is strictly prohibited to carry natural mine rat TRANSPORT water tanks for bottling before it is bottled at sources. Article 17. - Labeling Article 15.- F-legulations on production process The labeling at bottled natural mineral water must comply with the Regulation on labeling of 1. Throughout the processes of bottle-filling anci domestically circulated goods, and export as well capping, attention must be paid so as lo avoid as import goods, which was promulgated together damaging bottles and to prevent foreign objects with the Prime Minister's Decision No. 178/"1999/ from falling into bottles. Filling and capping O0-TTg of August 30, 1999 and legal documents equipment must he supervised and reoularly guiding the said Regulation. Besides, the labeling maintained so as to ward off danger of product of bottled natural mineral water must coml)\y with the following regulations: 1. Product appellations a/ fJroduct appellations must bear the inscription of "Natural minoral water" bl ln addition to that, depending on each typo of natural mineral water, labels must be inscribed with the following appellations: " Natural mineral water with natural gas; Non-carbonated natural mineral water; Natural tr1inera! water with little natural gas; Natural mineral water added with gas from source; Natural mineral water added with gas. 2. Names of mineral water sources and areas where mineral sources exist must be clearly inscribed in product labels. 3. Chemical composition a/ Total dissolved solids (TDS), chemical constituents of bottled natural mineral water (sodium, calcium, potassium, magnesium, iodine, fluoride, HC03) and their contents, as well as technical solutions used ln the production of bottled natural mineral water must be inscribed in product labels. bl If bottled natural mineral water products contain more than 1 mg of fluoride per liter, product 5. Advcrtisemonts which may cause mis u n de rstandi ng of the nature, origin, co mpo si tion and characteristics of bottlec! natural minem\ water circulat0>d on the market are prot1ibited. A1ticle ·18.- Containing packages i. Packages used to contain natural mineral water must be of types exclusively used for food, tight( y dosed and of appropriate sizes, thus avoiding immitation and water pollution. 2. Bottle caps and plastic bottles of a capacity of under iO liters must not be reused. 3. Plastic cans ot a capacity of 10 liters or more and glass bottles may be reused. 4. All types of bottles and cans used for the first time or reused must be cleansed, sterilized and carefully rinsed before the bottle-filling process, except for those used for the first lime and manufactured with closed technology chains with sterilization. At bottle-cleansing areas, the sterilization, rinsing, cleaning processes must be supervised and supervision results rnust be recorded in writing. 5. After being rinsed, bottles must be )aid upside clown to avoid dust, and fore\gn objects from falling therein, except for cases where bottles are cleansed by automatic machines. labels must be inscribed with "containing fluoride." Article 19.~ Preservation If bottled natural mineral water products contain ·r. Bottled natural mineral water must be put into more than 2 rng of fluoride per liter, product labels hyglentc containers which can protect products must be inscribed with "product not used for under-- against clash and disproportion in the course of seven children." Ira nspo rtation. 4. \t is prohibited to inscribe in labels curative 2. Products must bo preserved at dry, airy and effects of products or other health-related effects. hygienic places. Article 20.~ Transportation water shall have to implement this Regulation. Bottled natural mineral watc~r rnust he Article 22.~ Tho Food Safety and Hygiene transported by means which do not affect the Department shall assume the prime responsibility quality, hygiene and safety of products. for, and coordinate with the functional departments of the HeaJfh Ministry and the concerned agencies Chapter VII in, guiding and directing the implementation of this Regulation, IMPLEMENTATION PROVISIONS Article 21.- Organizations and individuals that produce and/or trade in bottled natural minera! Appendix 1 For the Health Minister Vice Minister TRAN CHI LIEM REQUIREMENTS REGARDING HEALTH SAFETY-RELATED NORMS OF BOTTLED NATURAL MINERAL WATER Names of norms 1. Total dissolved solids, not exceeding 2. Antimony, mg/I, not exceeding 3. Arsenic, mg/I, calculated based on total arsenic, not exceeding 4. Barium, mg/I, not exceeding 5. Borate, mg/I calculated according to B, not exceeding 6. Cadmium, mg/I, not exceeding 7. Chromium, mg/J calculated based on total chromium, not exceeding 8. Copper, mg/I, not exceeding 9. Cyanide, mg/I, not exceeding 10. Lead, mg/\, not exceeding 1 L Manganese, mg/1 1 not oxceeding Level 1,500 0,005 0.01 0.7 5 0.003 0.05 0.07 O.Oi 0.5 ·······------ ---- ·- .. ·- ---------- .. -------- ·- ···-···------. --------------------- ----------- .. ,. --------., ~----· f"-12. Mercury, mg/I, 1101 excooding 1 :3. Nicl<ol, mg/l, not r,xcood'1ng 14. Nitra.te, mg/I calculated based on nitrate, not exceeding 1 b. Nitrite, mg/I calculated based on nitrite, not exceeding "16. Se\eniurn, mg/I, not exceeding 17. Multi-circle aromatic hydrocarbons 18. Plant protection drug residues 19. Mineral oils 20. Surfactants Notes: 0.001 0.02 50 0.02 0.01 (*): According to "drinking water hygiene standards" promulgated together w\1h Deds\on No. 1329/ 2002/BYT/QD. (**): Below the l\m\ts provided for in corresponding testing methods. Appendix 2 REQUIREMENTS REGARDING MICROORGANISMS FOR BOTTLED NATURAL MINE:RAL WATER FirsMime checks E.coli or coliform Total coliform Streptococci feacal Pseudomonas acruginosa Desulfited anaerobic bacterial spore Total coliform Streptococci feacal Desulfited anaerobic bacterial spore Pseudornonas aeruoinosa 1 x 250 ml 1 x 250 ml ·t x 250 ml 1 x 250 ml 1 x 50 ml Second-time checks n 4 4 4 4 Decision Not found in any samples If= 1 or= 2, second-time checks shat! be conducted If> 2, it is eliminated C m 0 0 0 0 M 2 2 2 2 Socond-tirno chucks shall bo conducted for the same capacity as that used for fimt-tirno cl'1ocki, n: Number 01 samples ta\,on horn t~,e noods lot for chocking under given sampling plan. c: Acceptable maximum number of samples or perrniHed maximum number of samples exceeding microorganism norm (m). If such number of samples is exceeded, the goods lot is considered failing. m: Maximum quality or maximum level of corresponding rnicrobes/g; values above such level may be either accepted or unaccepted. M: Quantity of accepted food in ttie volume of unaccepted food. This value, regardless of whether" it is larger than or equal to M in any sample, shall not l,o accepted for reason of bad effect on human health.