Regulation No. 585/MoH on Bottled Drinking Water

•LAO PEOPLE'S DEMOCRATIC REPUBUC Peace Independtnc:e Demoerac:y Unity Prosperity ........+........... Ministry ufHealth No58~IMOH Vientiane Capital, 12May 2006 Regulation on Bottled Drinking Water • Reference to: ~ 'Ihe FoodLaw No. 04/NA, datedMay 15th , 2004. ~ The Prime Minister Decree No. 020/PM, dated March J9th 1999 on the Organization and Function of the Ministry of Health. The submission of the Food and Drug Department, dated December 26,2005 The Minister of Health i!i5ued the regulation on Bottled Drinking Water as follows: Group I General Prineiples Artiele 1 Objeetives aDdoutputs 1 Objeetives: To detennine principles, rules, standard and measures for managing, controJling the safety of bottled drinking water for sale in order to protect consumers health. 9 2 Outputs To be as tools in managing, monitoring, controlling the production of bottleddrinking water and supporting, promotingthe business of bottled drinking water production in order to implement the principles, rules and required standards. Article 2 Scope This regulation applies to operators on production,distribution of bottled drinking water in the whole country. Article 3 Terms of meaning 1. Bottled drinking water means waters that are processed and sterilized, mayor may not add minerals or carbonated and is filled into containerswith sealingand labeling according to the correct principles of processing. 2. Mineral water means water that is obtained directly from natural source or added by mineral salts and has all characteristicsaccording to the mineral water standards that are officiaHyadopted. 3. Hardness of drinking water means the consequence of the solution of calcium and magnesium that are expressed by equivalent to the quantity ofcalcium carbonate. 4. Hazard Analysis Critical Control (HACCP) means the safety control system on drinking water by addressine the control measure for protectingof hazards and risks that can assume in advance and may occur in any specific points folJowing the processingchain. Group II Standard ofBottled drinking water Article 4 Muimum safety limits for speeiCIed Chemical Substances Bottleddrinking water addressed in this regulationmay contain the following chemical substances. but not more than the defined amount below: 10 (I). Arsenic (2). Barium (3). Boron (4). Cadmium (5). Chromium (6). Copper (7). Fluoride (8). Lead (9)-. Manganese (W). Mercury (lJ). Nitrate (12). Iron (13) Hardness (l4) pH 0.01-0.05 mg/l 0.7 mg/I 0.5 mg/I 0.003 mg/I 0.05 rng/I 2mgll 1.5 mgll 0.01-0.05 mg/l 0.5 mg/I 0.001 mg/I 50 mg/I 0.3 mg/I 100-300 mg/I 6.5·8.5 Article 5 Bacteriological requirements Bacteriological requirements is the required value on the safety of bottled drinking water that is processed, distributed, exported to consumers in the general society. E.Coli or thermo tolerant (Faecal) ooliforms shall not be detectable. To ensure the application of good Hygiene practice on the bottled drinking water. total coliforrns shall not exceed 2.2 MPN (Most Probably Number) in 100 ml, Article 6 Labeling requirement The determination of expression, terms of labels that fix to bottled drinking water shall comprise by terms as below: Name and signs of water product Registered number permitted by the Foodand Drug Department Name and address of the manufacturer, telephone number Net contents Composition calculated in percentage compared to total weigh by informing the quantity from maximum to minimum Production date, Batch/Lot number 11 Group III Tbe safety of drinking water Article 7 Water source for drinking water production Water using for producing of bottled drinking water shall come from source that is clean, not contaminated by chemical, microorganisms, physical constituents and emitting radioactivity, in quantities; thatmay he injurious to consumers health. Article.8 Handling water prior to processing Water using for producing of bottled drinking water shall be stored in good container and according the technical requirement in order to avoid other sources of contamination including the, water storage facility shall be suitable structure that are not mixed with other things, and prevents entry to unauthorized persons and pests. Article 9 Premises and facilities Premises and facilities on bottled drinking water shall be comply with the standard of the design and construction according to the regulations of concerned sectors and shall be applied in accordance with the defined principles of Safe Manufacturing Practices of the Ministry of Health. Article to Containers and packaging materials Containers using for bottled drinking water and packaging materials: are composed of~ hnttle'!', r~nt'\i ners, lid!' and seals that shall be clean, safety ensured, do not have reactions that hamper to the quality ofbottled drinking water, ArticJr 11 FUUug Bnd capping Filling and capping shall be enclosed, clean and safe that can protects against contamination. filling equipment should be protected from contaminationat all times. Sealing shall be in the good and strong form and not damageable 12 Anide U Establishment and production equipment maintenance and bygiene Establishment and production equipment maintenance and hygiene shall be carried out in accordance with the Good Hygiene Practice issued by Ministry of Health. Article 13 Food handlers training Personnel who arc working for manufacturing of Bottled Drinking Water shall be regularly and adequately trained on the production technique, the using of inspection tools, general hygiene practice and personnel hygiene. Article 14 Transportation and storage of bottled drinking water Bottled drinking WAter shall he stored in the dean mom and transported by an appropriate vehicle with ensuring against microorganism contamination from outside. Arttele 1~ Safety control by using the Hazard Analysts Critical Control Point System (HACCP) Government promotes the production of Bottled Drinking Water both in small and medium scale that apply the Hazard Analysis Critical Control Point (HACCP) System adopted by the Food and Drug Department. The Bottled Drinking Water in large scale factory must comply the Hazard Analysis Critical Control Point (HACCP) System. Group IV Management and Inspection Article 16 Management and Inspection Authorities The management and inspection authorities of Bottled Drinking Water are comprised of: at Central level: Ministry of Health at Provincial level : Provincial Health Authority, City. at District level: District Health office, Municipality 13 Location, role, right and duties has to apply in accordance with the part VI concerning Food Management and Inspection of the Food Law. Group V Prohibitions Anicle 17 Prohibttions 1. Prohibitto use the water sourcethat is contaminated with micro-organisms and chemicals in the excess ofrequirement. 2. Prohibitto distributecontaminated Bottled Drinking Water withmicro-organisms and chemicals in the excess of requirement. 3. Prohibit to distributecontaminated Bottled Drinking Water with the foreign matters such us nails, hairs, worm. etc ... 4. Sub standard and forbidden containersare prohibited. 5. Uncorrected, unclearproductslabels, no seals (for big container) or using labels and seals ofother factories are prohibited. 6. Advertising ofthe usefulness of BottledDrinking Water that is not permitted by Ministry of Health is strictlyprohibited. 7. Bottled Drinking Waterthat is not met with the standard in accordance with this regulation is prohibited to be produced, distributed, imported-exported. Group VI Rewards and sanctions Article 18 Rewards Individuals, juristic persons or organizations having good deeds in implementing this regulation shall be rewarded and appropriately privileged according to the Ministry of Health requirements such as: Certification of HACCP, Good Manufacturing Practice (GMP), Safety assurance system ofdrinking water and other certifications. 14 Article 19 Measure towards violators Individuals or organizations that violate this regulation shall be educated, warned, tined and punished according to the gravity of the violation as below: First violation: Educate, warn and record in the file. Second violation: Seize goods and fine 10% of the goods value according to market price, and record in the file. Third violation: Seize goods and fine twice of the goods values according to the market price, record in the -file orland collaborate and submit to the concerned sectors to temporary closed or permanently closed depending to the cases. Any violation of the first, second and third violation, if it affects seriously to health, economic or to the life of consumer shall be punished accordingly to the law. Group VI Final Provisions Article 20 Implementation The Food and Drug Department shall be responsible for the implementation and collaborate with other concerned sectors to perform effectively this regulation. Article 21 Effectiveness This regulation shall be enacted and effective as from the date of signature. This regulation shall be used to replace the regulation of bottled drinking water standard No. l52/FDA, dated 11 September 1992 and other regulations that are contradicted with this regulation. The Minister of Health H.E. Ponemek DARALOY ]5