BUREAU OF INDIAN STANDARDS (Southern Regional Office) This has reference to CMD-I s circular CMD-1/31 dated 11 Nov 2013 on the above subject.

Transcription

1 BUREAU OF INDIAN STANDARDS (Southern Regional Office) Our Ref: 60/CM 1 23 Dec 2013 Subject: Preparation & Review of Product Manuals for Product Certification This has reference to CMD-I s circular CMD-1/31 dated 11 Nov 2013 on the above subject. In this connection, the draft Product Manual in respect of IS allotted to SRO has been prepared. The same is attached herewith for hosting on the BIS Intranet for inviting suggestions and comments for a period of 15 days. The comments may be sent to SRO/ CNBO(FCT). (E. Devendar) Sc.G & DDGS Encl: a/a HITSD BIS HQ Bureau of Indian Standards Southern Regional Office IV Cross Road, C.I.T. Campus Tharamani, Chennai sro@bis.org.in Phone: Fax:

2 PRODUCT MANUAL ON PACKAGED WATER BUREAU OF INDIAN STANDARDS 1

3 2.0 AMENDMENT HISTORY SHEET SL. NO. AMENDMENT CLAUSE REFERENCE DATE OF ISSUE SIGNATURE

4 3.0. FOREWORD 3.1 BIS has published two Indian Standards on packaged water for drinking purpose, namely, IS for Packaged Natural Mineral Water (PNMW) and IS for Packaged Drinking Water (Other Than Packaged Natural Mineral Water) (PDW). Both the products were brought under mandatory BIS certification effective from 29 March 2001 through two gazette notifications issued by Ministry of Health and Family Welfare, namely GSR No. 759 for Packaged Natural Mineral Water (PNMW) and GSR No. 760 for Packaged Drinking Water (PDW) as amendments to Prevention of Food Adulteration Rules. Presently, these products under mandatory BIS certification are covered under FSSAI regulation. 3.2 In the early stages of certification of PDW, different situations were handled differently by ROs/BOs. This had necessitated issuance of several guidelines for creating uniformity in certification of PDW throughout the country. Further, a need was felt to compile all these guidelines into a manual. Thus, the Manual for PDW was brought out in the year Revision of the Manual has been taken up to suitably incorporate the changes that had taken place since 2005 in the certification of PDW and also in the general policies of product certification. A specific sub-section for guidelines related to PNMW such as for constancy of source water and criteria for decision seasonal variations etc introduced. 3.4 This effort is to enhance the practicality of the manual and align its architecture in with the guidelines issued by CMD in Nov Packaged Drinking Water (Other Than Packaged Natural Mineral Water) (PDW) Packaged Natural Mineral Water (PNMW) are basically packaged water for drinking purpose. Therefore, title of this MANUAL is MANUAL FOR PACKAGED WATER. 3.6 Salient changes in this version of the Manual are as follows: updation of the manual with respect to various amendments to IS and IS and guidelines issued from time to time; incorporation of guidelines under simplified procedure for GOL and inclusion; updation of the list of test equipment as per revised test methods wherever applicable; 3 This Manual is intended only for internal use by BIS officers and inspection personnel working on behalf of BIS. However, others can draw benefit from the Manual to improve their activities related to certification of PDW and PNMW. Note: An addendum suggesting possible changes to the STI and Test Methods is added for enabling comments from all. Suggestions for any improvement in this Draft Manual may be sent to CNBO (FCT).

5 4.0 TABLE OF CONTENTS (To be completed after feedback) ITEM CHAPTER Page No 4

6 SECTION-I 5.0 INTRODUCTION, SCOPE AND PRODUCT DESCRIPTION 5.1 INTRODUCTION The Standard IS provides sufficient freedom to the manufacturer to adopt any process for converting raw water into packaged water for drinking purposes. Therefore, the required manufacturing machinery for the purpose is neither specified in the respective Indian Standard nor in this Manual. Illustrative examples have been given of typical manufacturing process with process flow diagram, cleaning and disinfection (CIP) of plant and machinery, pipelines as well as of containers in Section 3 at 10.1, 10.2 & 10.3 of this manual However, there are restrictions with regard to processing of PNMW as specified in IS 13428, such as the source water shall not be subjected to process steps, such as reverse osmosis, demineralization or disinfection before packaging IS and prescribe a large number of requirements to be tested as per the methods of tests given in the various cross-referred standards. Further, many requirements have options for selection of test method to be followed. This has made the task of the inspecting official difficult and time consuming for complete assessment of adequacy of the test facilities. This Manual provides a ready reference for the inspecting official to check facilities for each of the requirements against the method given under the relevant Indian Standard and the method chosen by the firm (Annex 1). (The consolidated list of chemicals has also been included to enable easy verification of Test equipments/chemicals during visit Annexure 1A) All efforts have been made to incorporate details as per the latest versions of the standards. However, as the standards are dynamic and subject to amendments and revisions, users are encouraged to check the latest versions of the respective methods of test subsequent to issuance of this issue of the Manual, before using the information contained herein. 5

7 5.2 SCOPE This Manual of Packaged Water provides guidelines for various aspects related to certification of Packaged Natural Mineral Water and Packaged Drinking Water (Other Than Packaged Natural Mineral Water) according to IS and IS respectively along with the respective STIs. The provisions of these Indian Standards, STIs, as also the various guidelines issued from time to time for certification of packaged water have been kept in view while preparing this Manual Explanatory notes have been incorporated wherever necessary to take care of subjective interpretations Specific proforma and checklists are available for submission of application, its verification, in line with the guidelines issued by CMD, reports of preliminary, periodic and verification inspections so as to facilitate uniform reporting by all concerned, covering all essential parameters required to be reported as per the relevant ISS, STI. Other proforma for checking plant, process and personnel hygiene; processing of application; preparation of red form for grant of licence; test equipment details etc are also available In case of any deviation, the requirements of the Indian Standards and the corresponding STIs shall prevail. *No changes has been made w.r.t PNMW since no licensee for PNMW in CNBO (FCT). 6

8 5.3 PRODUCT DESCRIPTION Packaged Drinking Water Packaged drinking water means water derived from surface water or underground water or sea water which may be subjected to specified treatments, namely, decantation, filtration, combination of filtrations, aeration, filtration with membrane filter, depth filter, cartridge filter, activated carbon filtration, demineralization, remineralization, reverse osmosis and packed after disinfecting the water to a level that shall not lead to any harmful contamination in the drinking water by means of chemical agents or physical methods to reduce the number of microorganisms to a level beyond scientifically accepted level for food safety or its suitability: Provided that sea water, before being subjected to the above treatments, shall be subjected to desalination and related processes. It shall be filled in sealed containers of various compositions, forms and capacities that is suitable for direct consumption without further treatment The water used for production of drinking water is water derived from any source of surface water or underground water or sea water received on regular basis. Supplies of such water through pipelines, tankers would be acceptable provided the source remains the same. Note 1: It is the responsibility of the manufacturer to ensure that the source of raw water remains the same. An undertaking in this regard shall be obtained from the manufacturer. Note 2: Raw water supplies received through tankers, river, lake, pond etc. is acceptable, provided treatment of such water is done as mentioned in as above Note 3: In case of change of raw water source, the manufacturer shall carry out tests for table-3 and radioactive residue test on the finished product As indicated above, in the manufacturing of the packaged drinking water, remineralization may also be done. This process involves addition of ingredients. In case remineralization is carried out by any manufacturer, ingredients used for the purpose shall be of food grade/pharmaceutical grade quality. Note: With respect to the conformity of ingredients used for remineralization to food grade/pharmaceutical grade, original manufacturer s declaration through labels or certificate/test certificate from a BIS approved laboratory as per relevant Indian Standard or IP/NFP/USP/BP requirements, in this respect will be accepted. 7

9 Processed water may be disinfected by means of chemical agents and/or physical methods to control the micro-organisms to a level that does not compromise food safety or suitability for consumption. Various means adopted for disinfection include ozonation, ultraviolet treatment, silver ionization, etc. and/or combination thereof Packaged Natural Mineral Water Packaged natural mineral water shall be water obtained directly from natural or drilled sources from underground water-bearing strata Packaged natural mineral water is collected under conditions which guarantee the original microbiological purity and chemical composition of essential components and subjected to permitted treatments which include separation from unstable constituents, such as compounds containing iron, manganese, sulphur or arsenic, by decantation and/or simple filtration, if necessary, accelerated by previous aeration. No disinfection process is permitted. Note: Only simple filtrations through filters of pore size not finer than 0.5 microns which do not change the composition of the source water are permitted. Processes like reverse osmosis, activated carbon bed filtration etc. are not permitted Packaged natural mineral water shall be packaged close to the point of emergence of the source with particular hygienic precautions The transport of natural mineral water in bulk container is prohibited Natural mineral water shall have the constancy of its composition and the stability of its discharge and temperature, due account being taken of the cycles of minor natural fluctuations. Evidences for constancy of water composition at source on account of cycles of minor natural fluctuations during different seasons in a year shall comprise of the following: a) Test report (from any BIS approved OSL) of all the major seasons covering major physical-chemical parameters; b) Record of temperature at discharge point/ point of emergence (by manufacturer); c) The reports of all the seasons shall be reasonably comparable and conforming to IS 13428; and d) Report from the Hydro geologist covering genesis of natural mineral water; period of its residence in the ground; chemical, physical and radiological qualities; and the risk of pollution. 8

10 5.3.3 Packaging The packaged water shall be packed in clean, hygienic, colourless, transparent, tamperproof and sealed containers of various types/sizes/ made from plastic materials as permitted in IS Containers with features like Cool Jugs, Jugs with built-in taps, Jars with threaded (reusable) caps without seal etc. shall not be permitted. Single-use disposable/collapsible jars are also not permitted There are many terminologies presently adopted by the industry and consumer for describing the different packaging containers of packaged water. For the purpose of uniformity in describing the various types of containers, descriptions as given in Table 1 have been derived. In case of change in material (i.e., PET/PC) it shall be treated as separate type (ex. PET Jar, PC Jar). Table 1: Description of Containers for Packaged Water CONTAINER DESCRIPTION Conforming to IS Jars Plastic Bottles Cup/Tumbler Reusable plastic containers with capacity above 5 litres IS 15410: 2003 One time use plastic containers with capacity upto and including 5 litres. IS 15410:2003 One time use plastic container in cup shape or tumbler IS 15410:2003 (glass shape) with a peelable seal Glass Bottle Reusable containers made of glass material. N.A. Pouches Flexible Pouches made from plastic films. IS 15609: The standards prescribe use of colourless and transparent containers. Therefore tinted containers are not permitted. Note 1: Use of HDPE containers had been discontinued after 31 July 2003, as communicated by CMD-II vide note dated and

11 Note 2: Details of packing/shelf life and related certificates shall be submitted. Manufacturer/supplier shall be obtained that the containers have been manufactured from virgin food grade material S No Type of packing Food grade certificate Wall thickness declaration Supplier test certificate(if blown outside) Shelf life declaration Cup/tumbler/pouch shall be filled with drinking water/natural mineral water followed by heat sealing of cup/tumbler with peel off seal through automatic process. Manual filling and sealing shall not be allowed so as to maintain hygiene and sanitation. Manual loading of packaging material (cup/tumbler) may be accepted. 6.0 Latest Indian Standard Number with Product Title and Number of Amendments IS No. PRODUCT TITLE No. OF AMENDMENTS Amendment 1, July 2004 Amendment 2, July :2004 PACKAGED DRINKING WATER (OTHER THAN PACKAGED NATURAL MINERAL WATER) Amendment 3, December 2005 Amendment 4, August 2007 Amendment 5, December2008 Amendment 6, June 2010 Amendment 7, May 2011 IS 13428:2005 PACKAGED NATURAL MINERAL WATER Amendment 1, Dec 2005 Amendment 2, Nov 2006 Amendment 3, June 2010 Amendment 4, May

12 7.0 List of referred Indian Standards for raw materials / components and test methods 7.1 Referred Indian Standards for raw materials IS No. Title 10500: 1991 Drinking water (first revision) 15410: 2003 Containers for packaging of natural mineral water and packaged drinking water PE Pouches 7.2 Referred Indian Standards for test methods IS No. Title 3025 : 1964 Methods of sampling and test (physical and chemical) for water used in Industry 3025 Methods of sampling and test (physical and chemical) for water and waste water (Part 4) : 1983 (Part 5) : 1983 (Part 8) : 1984 (Part 10) : 1984 (Part II): 1983 (Part 16) : 1984 (Part 23) : 1986 (Part 24) : 1986 (Part 26) : 1986 (Part 27) : 1986 (Part 29) : 1986 (Part 32) : 1988 (Part 34) : 1988 (Part 37) : 1988 Colour (first revision) Odour (first revision) Taste rating (first revision) Turbidity (first revision) ph value (first revision) Filterable residue (total dissolved solids) (first revision) Alkalinity (first revision) Sulphates (first revision) Chlorine, residual (first revision) Cyanide (first revision) Sulphide (first revision) Chloride (first revision) Nitrogen (first revision) Arsenic (first revision) 11

13 (Part 39) : 1991 (Part 40) : 1991 (Part 41) : 1992 (Part 42) : 1992 (Part 43) : 1992 (Part 45) : 1993 (Part 46) : 1994 (Part 47) : 1994 (Part 48) : 1994 (Part 49) : 1994 (Part 53) : 2003 (Part 55) :2003 (Part 56) : 2003 Oil and grease Calcium Cadmium (first revision) Copper (first revision) Phenols (first revision) Sodium and potassium (first revision) Magnesium (first revision) Lead (first revision) Mercury (first revision) Zinc- (first revision) Iron (first revision) Aluminium (first revision) Selenium (first revision) 4905 : 1968 Methods for random sampling 5401(Part 1) : General Microbiology guidance for enumeration of coliform: 5402 : 2002 Microbiology General guidance for enumeration of Colony micro-organisms count technique at 30 C (first revision) 5403 : 1999 Method for yeast and mould count in foodstuffs and animal feed (first revision) 5887 Methods for detection of bacteria responsible for food poisoning (Part 1) : 1976 (Part 2) : 1976 (Part 3) : 1999 (Part 5) : 1976 (Part 7) : 1999 Isolation, identification and enumeration of Escherichia coli (first revision) Isolation, identification and enumeration of Staphylococcus aureus and faecal streptococci (first revision) General guidance on methods for detection of Salmonella (second revision) Isolation, identification and enumeration of Vibrio cholera and Vibrio parahaemolyticus (first revision) General guidance on methods for isolation and identification of Shigella 12

14 9845 : 1998 Determination of overall migration of constituents of plastic materials and articles intended to come in contact with foodstuffs Method of analysis (second revision) : 1999 Polystyrene (crystal and high impact) for its safe use in contact with foodstuffs, pharmaceuticals and drinking water (first revision) : 1982 Polyethylene for its safe use in contact with foodstuffs, pharmaceuticals and drinking water : 1982 Polyvinyl chloride (PVC) and its copolymers for its safe use in contact with foodstuffs, pharmaceuticals and drinking water : 1984 Polypropylene and its Title copolymers for its safe use in contact with foodstuffs, pharmaceuticals and drinking water : 1987 Polyalkylene terrephthalates (PET and PBT) for their safe use in contact with foodstuffs, pharmaceuticals and drinking water Radionuclides in environmental samples Methods of estimation (Part 1) : 1994 (Part 2) : 1994 Gross beta activity measurement Gross alpha activity measurement :2001 Polycarbonate resins for its safe use in contact with foodstuffs, pharmaceuticals and drinking water : 2002 Water quality Detection and enumeration of Escherichia coli and coliform bacteria Membrane filtration method : 2002 Water quality Detect oil and enumeration of intestinal enterococci Membrane filtration method : 2002 Water quality Detection of Salmonella species : 2002 Water quality General guide to the enumeration of micro-organisms by culture : 2002 Determination of aluminium and barium in water by direct nitrous oxideacetylene flame atomic absorption spectrometry : 2002 Determination of antimony, iron and selenium in water by electro thermal atomic absorption spectrometry Note: Accurate and quick test methods wherever available may be used. In case of dispute the referral test methods shall be as given in IS14543:

15 8.0 Check-list for submission and recording of application for grant of licence See Annexure 3 for check list for submission of application 8.1 Recording of Application The receiving, recording of an application and its processing for grant of licence (GOL) of the application shall as the guidelines issued by CMD in Oct 2013 and the visit carried out as per the time norms given in the CMD guidelines.. ) for both the normal procedure and the simplified procedure. Application for grant of licence for packaged water shall be accompanied by the list of documents given in BIS Web site ( An application under simplified procedure shall be accompanied with original test reports of PDW/PNMW as per relevant specifications and on entire range of containers, their materials, caps and closures for which GOL has been requested. An application with its enclosures shall be scrutinized as per the check-list given in Annex 3. Recording of application is done at the BO counter once the application complies with the check list at Annexure 3. SECTION-II RAW MATERIALS / COMPONENTS 9.0 List of important raw materials/packaging materials including those which are required to conform to the relevant Indian standards. 9.1 Raw Water Raw water used for processing packaged drinking water shall be tested for all requirements as per IS 10500: However conformity to the standard need not be insisted since the raw water undergoes further processing to meet the requirements of packaged drinking water as per ISS. 14

16 9.2 Packaging materials Container type Description of containers Conforming to IS Jars Reusable plastic containers with capacity above 5 litres IS 15410: 2003 Plastic Bottles Cup/Tumbler One time use plastic containers with capacity upto and including 5 litres. One time use plastic container in cup shape or tumbler (glass shape) with a peel able seal IS 15410:2003 IS 15410:2003 Glass Bottle Reusable containers made of glass material. N.A. Pouches Flexible Pouches made from plastic films. IS 15609:2005 Note: Please refer of this manual for more details 9.3 Additives for remineralisation In case remineralization is carried out by any manufacturer, ingredients used for the purpose shall be of food grade/pharmaceutical grade quality. Note: With respect to the conformity of ingredients used for remineralization to food grade/pharmaceutical grade, original manufacturer s declaration through labels or certificate/test certificate from a BIS approved laboratory as per relevant Indian Standard or IP/NFP/USP/BP requirements, in this respect will be accepted. Processed water may be disinfected by means of chemical agents and/or physical methods to control the micro-organisms to a level that does not compromise food safety or suitability for consumption. Various means adopted for disinfection include ozonation, ultraviolet treatment, silver ionization, etc. and/or combination thereof. 15

17 SECTION-III Manufacturing process and in process quality controls 10.1 Description of Manufacturing Process (es) A TYPICAL MANUFACTURING PROCESS Steps are involved in the manufacturing process for packaged drinking water: Raw Water Raw Water Storage Tank Raw Water Feed Pump dosing system 1 & 2 Pressure Sand Filter Activated Carbon Filter Micron Cartridge Filter High Pressure Pump Reverse Osmosis Ozone generator and re circulation Finished Water Storage U.V System Filling and Packing Visual Examination Storage for testing Forwarding DOSING SYSTEM 1 & 2 - The water is drawn from Bore Well or any source and collected in storage tank. It then goes to dosing system through raw water feed pump with use of antiscalant for softening the water. 2. PRESSURE SAND FILTER - From softener, the water is transferred to pressure sand filter for removing the impurities. 3. ACTIVATED CARBON FILTER - The water is then passed through activated carbon filter to remove organic impurities. 4. MICRON CARTRIDGE FILTER (MCF) - Water is then passed through a micron filter or a series of such filters ( u) for removal of fine particles. 5. DEMINERALISATION BY REVERSE OSMOSIS SYSTEM (R.O.) - Water from MCF goes to R.O. System through High Pressure Pump. R.O. removes 90-95% of dissolved solids. The finished water is passed into Storage Tank through SS/ inert pipe line. 6. OZONE GENERATOR WITH RE-CIRCUALTION - Finished water from R.O. system is stored in S.S storage tank. The tank is provided with a Man Hole so that the tank can be cleaned. This tank is used as ozone circulation tank. The ozone is passed to this tank for disinfection. 7. U.V. SYSTEM - Water from S.S. tank is passed through MCF to U.V. disinfection system, where the bacteria are inactivated. 8. FILLING AND PACKING - Water is then filled in cleaned and rinsed containers. 9. VISUAL EXAMINATION - Containers are visually inspected for any leakage and suspended matter against illuminated screen.

18 10. TESTING - The raw water is tested once in three months. Finished water is tested as per scheme of testing prescribed by BIS A TYPICAL PROCESS FLOW CHART REMINERALISATION/ BLENDING 17

19 10.3 A TYPICAL CIP PROCESS (Sanitization and Sterilization is done daily before resuming production) SANITIZATION 1. Take sufficient quantity of soft water in CIP tank. 2. Add required quantity Sodium Hypochlorite solution in CIP tank containing soft water. 3. Now start CIP pump. 4. Let the chlorine solution go into tank through CIP line. 5. Solution will go from top through CIP volume which distributes solution in entire tank. 6. Check the available chlorine. 7. Chlorine (free) should be PPM. 8. If percentage of chlorine is less then add more Sodium Hypochlorite solution till required strength of chlorine is achieved in water. 9. Start feed pump and pass solution through sand filter, (bypassing carbon filter since it removes chlorine), all micron filters, Ozone contact column etc. and filling machine. 10. Hold this solution at least for 30 minutes which can be extended to overnight. 11. Drain out the solution from the whole system. 12. Take fresh water and remove the chlorine of storage tank. 13. After removing chlorine traces from storage tank, fill with fresh bore well water. 14. Remove the chlorine traces from each points upto filling machine by flushing with fresh water. 15. Check for residual chlorine. 16. Do final washing with product water STERLIZATION 1. Produce soft water by softener 2. Generate steam by boiler using soft water. 3. Supply steam in storage tanks, bore well line and pipe lines upto filling machine. 4. Continue the steam supply in tanks till attains required temperature. 5. Continue the steam supply to filling machine till steam comes out from all rinsing and filling nozzle of machines. 6. Stop steam supply and disconnect the hose pipe. 7. Rinse the whole system with product water TYPICAL CLEANING AND WASHING SYSTEM OF RE-USABLE JARS The process of cleaning and washing of re-usable jars is as follows:- 1. Check the jars for crack, contamination and foul odours. Reject jars not fit for re-use. 2. Wash the outside of jars thoroughly with detergent solution and normal water. 3. After outer cleaning, wash jars internally with food grade detergents (like iodine based) and then thoroughly wash till free of last traces of detergent. 4. Send clean jars to filling station. 5. Rinse jars internally with product water, before final filling at filling station. 18

20 11.0 INFRASTRUCTURE FOR PRODUCTION AND GOVERNMENT CLEARANCES/APPROVAL 11.1 The Firm shall have necessary manufacturing facilities with legal power connection and satisfactory process controls. The applicant shall provide an undertaking that all statutory clearances shall be obtained by them (refer check list for applicant at Annexure-3) 11.2 Assessment of Hygienic Conditions The assessment of hygienic conditions with explanatory notes has been given at Annexure-8 for the inspecting personnel. Note: Inspecting personnel shall clearly report in his IR regarding whether hygienic condition is satisfactory / unsatisfactory / needs improvement. Unsatisfactory and areas for improvement shall be reflected in the D/V report along with clause number. For the purpose of assessment of the reporting the areas which need improvement shall be treated as advisory Storage space Adequate storage facility is to be made available by the firm for raw water, finished product and packaging materials. PDW stock to be stored inside the firm s premises for 2 days keeping in view the installed capacity/packing capability per day. (SPECIFIC FEEDBACK WITH A HYPOTHETICAL FORMULA FOR STORAGE SPACE REQUIREMENTS IS REQUESTED TO ENABLE UNIFORMITY OF ASSESSMENT) CERTIFICATION CRITERIA SECTION-IV 12.0 Identification of Critical Requirements of the Indian Standard A List of Critical Parameters for Packaged Drinking Water as per IS was mentioned in the CENTRAL MARKS DEPARTMENT I Circular CMD-I/5:2 dt. 21 February 2005 is given below: Sl. No. Requirement 1 E. Coli 2 Coliform 3 Faecal Streptococci & Staphylococcus aureus 4 Sulphite Reducing anaerobes 19

21 5 Pseudomonas aeruginosa 6 Yeast and mould 7 Salmonella & Shigella 8 Vibrio Cholera & V. parahaemolyticus 9 Fluoride 10 Selenium 11 Phenolic Compounds 12 Mineral Oil 13 Antimony 14 Mercury 15 Cadmium 16 Arsenic 17 Cyanide 18 Lead 19 Chromium 20 Nickel 21 PCB 22 Polynuclear Aromatic Hydrocarbon 23 Alpha emitters 24 Beta emitters 25 Pesticide Residues 13.0 Scheme of Testing and Inspection IS14543:2004 Acceptance of existing scheme of testing and inspection (STI) shall be obtained from the applicant during the inspection visit, if the same has not been received earlier. Please see Annexure- 4 for Proforma of Acceptance of Scheme of Testing and Inspection Suggestions for changes in STI: In the light of experience at MDC-1, for requirements under Table-II, frequency of testing to be reduced to monthly except for calcium, magnesium, residual free chlorine, chloride, sulphate and alkalinity. Other tests can be tested once in a month in recognized OSL. (SPECIFIC FEEDBACK IS REQUESTED TO ENABLE TAKING UP THE MATTER SEPARATELY WITH THE CA) PL NOTE This platform is being used for this generating suggestion and the same will not be part of the manual 14.0 Marking Fee Rate Acceptance of existing rate of marking fee shall be obtained from the applicant during the inspection visit, if the same has not been received earlier. 20

22 The Marking fee fixed by Bureau of Indian Standards for Packaged Drinking Water (other than Packaged Natural Mineral Water) according to IS : 2004 is at the following rates and in the manner stipulated as under: 1) Minimum marking fee for one operative year payable in advance which will be Carried over to next renewal(s): a) For small scale industry: Rs b) For large scale industry: Rs ) Rate of marking fee: (1 Unit LITRE) Rs 20 per unit for the Ist 6000 Units Rs 15 per unit for the next 4000 Units Rs 10 per unit for the remaining Units Note 1: Service tax as applicable shall also be paid. Note 2: Refer Annexure-5 for Performa of Acceptance of Marking Fee. Effective Date: Grouping guidelines There are many terminologies presently adopted by the industry and consumer for describing the different packaging containers of packaged water. For the purpose of uniformity in describing the various types of containers, descriptions as given in Table below have been derived. In case of change in material (i.e., PET/PC) it shall be treated as separate type (ex. PET Jar, PC Jar) S No 1 CONTAINER DESCRIPTION Guidelines Jars (PET/PC) Reusable plastic containers with capacity above 5 litres Each capacity to be tested 2 Plastic Bottles 3 Pouches 4 Cup/Tumbler One time use plastic containers with capacity upto and including 5 litres Flexible Pouches made from plastic PE Type 1: < 300 ml capacity 65 microns minimum Type 2: > 300 ml capacity 75 microns minimum One time use plastic container in cup shape or tumbler (glass shape) with a peel able seal 5 Glass Bottle Reusable containers made of glass material. Each capacity to be tested One capacity in each type Each capacity to be tested Each capacity to be tested Note: All packaging s shall be in line with legal metrological requirements. 21

23 16.0 GOL / Guidelines for writing Scope of Licence 16.1 Processing for Grant of Licence The Red Form shall be put up as per the check-list given in Annex 7 with all attached documents serially page-numbered. In case of GOL under normal procedure, if the product water is conforming and failure(s) of Container samples are reported, grant of licence shall be processed for the product water as per IS 14543/IS 13428, as the case may be along with the remaining container(s) which have been reported as passing. Note 1 under of OMPC is not applicable in such cases Guidelines for writing Scope of Licence Licence shall be granted with scope specifying the type(s), material(s) of container(s) and volumes permitted to be used for packing the product. Licence shall not be granted with open scope. A container shall be included in the licence subject to availability of proof of conformity to the relevant Indian Standard for each of such container(s). The grant of licence letter and the Licence Document shall clearly indicate the following: a) Packaged Drinking Water as per IS : 2004 b) Type of each container (Jar, Bottle, Cup/Tumbler, Pouch); c) Material of construction of each container (PC/PET/PP/PS/PE/Glass);and d) Size/Capacity of the container. (see Clause for Guidelines for above classification) The renewal endorsements shall indicate the permitted packaging s. (Sample Endorsement enclosed) Guidelines for Inclusion of new Varieties There are many instances when licensees request for permitting use of additional types of packaging materials/filling capacities, although basically the packaged water may remain the same (i.e., other than those related to remineralization). These may be considered based on the following: Under Normal Procedure a) Packing/filling/cleaning and disinfection (in case of reusable containers) arrangements related to proposed inclusion such as required infrastructure, filling facilities, flow process and intermediate checks etc., are verified and recorded on CM/PF-305; b) Associated hygienic conditions are verified, if applicable; c) Raw water shall not be tested; 22

24 d) Sample for shelf-life test shall not be drawn. Only declaration in this regard shall be obtained; and e) Sampling of container for independent testing should be done as follows: Irrespective of whether, the test certificate of containers with respect to conformity to IS or 15609, as applicable, is available or not, sample of each type/ size/volume/ material shall be drawn for complete testing. Endorsement to the licence shall be issued for including the particular type of container in the licence after sample of such container is found conforming to the standard Under Simplified Procedure For inclusion under the simplified procedure, in case the licensee submits the complete test report of containers from OSL along with modified process flow chart if any, additional infrastructure facilities if required, intermediate checks etc., inclusion as per the simplified procedure shall be permitted without any further testing. The variety so included may be drawn for independent testing during subsequent visits on rotational basis, so as to cover the entire range and the changes intimated shall be verified during the subsequent visit. The licensee shall submit an undertaking that in case of failure of sample in independent testing, he shall abide by the instructions of BIS for stop marking/withdrawal of permission to use the particular type of container/cancellation of licence, as the case may be. Note: CMD circular- Inclusion of same type (say 500ml PET Bottle) in the scope of license (1L, 2L, 300ml PET Bottle already available) without Yellow form Sample size, including guidelines for drawal of separate samples when samples are required to be sent to different labs for testing Packaged Water (Packaged Drinking Water and/or Packaged Natural Mineral Water) a) One sample of packaged water shall be drawn and sent for complete testing for all requirements of the relevant Indian Standard. b) In case the applicant is adopting more than one type of processes/sources of raw water, separate samples shall be drawn for each process/source. c) In the event of more than one bore well /open well located in the same premises, they shall be considered as a single source for the purpose of drawing of sample of PACKAGED DRINKING WATER as well as for exercising quality control, provided there is only one processing line. 23 d) Samples shall be drawn in sealed containers only, which shall not be leaking. During sampling, the container of packaged water sample shall never be opened for any purpose as the water will get contaminated

25 For all parameters other than radio active residues - A sample containing approximately 18 litres of packaged water (PDW/PNMW) is adequate, if packed in 2 litres or smaller containers but in case the samples are available in large size packages, minimum two such packages are required as microbiological laboratory needs separate sample for ensuring aseptic handling. For example: Capacity of bottle/jar in litres Numbers to be drawn Pouches: 2 bags of 100 pouches each and 15 meter PE Film. A sample of 4 bags shall be drawn in case each bag contains 50/60 pouches For Parameters concerning Radio-active Residue In addition to the above, sample shall also be drawn for testing parameters concerning radio active residues. A sample of 10 litres is adequate. Note: If a fresh application has been submitted after closure of earlier application or expiry/cancellation of earlier licence and the closure of application/licence was for reasons other than failure in radioactive residues, fresh sample of water need not be drawn for testing of radioactive residues, if evidence is available that the source of raw water remained the same as that in earlier application/licence, provided that radioactive residue TR of the sample drawn by BIS during verification visit passes and is not older than two years. The earlier test reports of sample drawn by BIS (not older than two years) shall be accepted within a period of two years. 24

26 18.2. Sample of packaging material (containers) and Selection of laboratory for Independent Testing Sample of packaging material (containers) 1) PET Bottles Upto 2 litres 18 Empty (with caps) + 12 filled 5 litres 12 Empty (with caps) + 9 filled 2) PET Jars 10 litres & above 6 Empty (with caps) + 3 filled 3) PE Pouches 4 bags of 50/100 pouches each + 15 meter film used for making the pouches. 4) Cup/Glass along with peel able seal: 25 Empty + 25 filled + lids (25) Note 1: The pouches shall be made in the presence of BIS officer, during inspection, and may be printed with only details like batch number, date of manufacturing, best before date, capacity, using ink to be used by the manufacturer for marking on the pouches. This will facilitate testing of pouches for ink adhesion test and product resistance test. This is being allowed as manufacturer can not get the pouch film rolls printed with all other details such as Standard Mark etc. before the GOL. Note 2: As there is presently no Indian Standard for glass bottle/tumbler, such containers need not be tested. However, if any manufacturer intends to use such container, it shall be included in the licence. Note 3 Samples shall not be drawn for independent testing for the following: a) Product Durability Assessment (shelf life study), and b) Raw Water Requirements Note 4: For GOL under normal procedure all packaging material sample to be drawn. Under simplified procedure any one packaging material may be drawn during Preliminary Inspection. Note 5: For closed applications in view of PDW failures the applicant when reapplies in accordance with the norms of OMPC the conforming reports with respect to packing materials of the earlier application can be considered if there is no change in raw material/supplier 25

27 Guidelines for Reused Containers Licensees are required to ensure use of only such jars whose transparency continues to meet the minimum requirements of 85% as per IS even after its repeated use. BO may draw sample of reusable container for ascertaining continued suitability over a period of time by getting the same tested for transparency requirement. Every market sample of processed water filled in reusable jar shall be got tested for transparency requirement also as per IS Jars which get deshaped and mutilated during the course of use shall not be permitted. Licensees may be advised in this regard strictly. Further action may be taken as per OMPC Selection of laboratory for independent testing: Samples shall be tested either at a BIS laboratory or BIS recognized laboratory.list of recognized laboratories is given on BIS website. Selection of laboratory for independent testing shall be as per provisions of OMPC 19.0 Manner of Sealing of Sample(s) Masking of sample Test request Effort shall be made, as far as possible, to send samples without the manufacturer s identification and/or markings. Any label and/or manufacturer's identification from the bottles/jars shall be removed or defaced. Test request shall clearly indicate the following: a) Date of processing/packing; b) Best Before Date; c) Quantity (in litre or milli-liter), d) Type, material and capacity of container e) Declared wall thickness of container(s)/width of film of pouch. 26

28 Note: Samples should be labelled suitably giving all sample particulars as given in the test request and sample code along with signature of the inspecting officer. Samples should be sealed with sealing wax using the BIS Brass Seal. Proper care may be taken to ensure that clear impression of all details of the seal used is available on the sample. Sealed Samples should be packed suitably to avoid damage to seal and containers during transit. For containers above 5 litres capacity sample code and sample details may also be written with indelible marker on the body of the container. Small size container samples may be packed in cartons and the unit may then be sealed to avoid damage to the samples Remnants Remnants of sample(s) may be scrapped. This above advice may be mentioned in the test request itself Procedure to be followed for destroying / deshaping / recycling the product that does not meet the quality parameters during regular production Any lot of Packaged Drinking Water processed which does not meet the requirements of IS 14543:2004 or which has crossed the period of shelf life may be drained off/ reprocessed. Proper CIP to be followed. 27

29 SECTION-V 22.0 INSPECTION, TESTING AND PACKING MATERIAL REQUIREMENTS 22.1 INSPECTION The format for Preliminary Inspection Report specific to PDW/PNMW shall be as Given at Annex 6, in case of application received under normal procedure The verification by BIS Inspecting Officer shall be reported in the format specific to PDW/PNMW and as given at Annex 6, in case of application received under Simplified procedure Aspects to be inspected During preliminary inspection/verification visit, for assessing capabilities of the applicant organization, with respect to manufacturing and testing facilities; competence of Quality Assurance Personnel and hygienic conditions, following shall be verified: 28 a) Correctness of documents and declarations submitted with the application and self evaluation report (in case of application under simplified procedure); b) Availability of all manufacturing facilities including filling and/or packaging machinery; c) Process capability, starting with collection of raw water to packaged water including intermediate checks; d) Filling and packing capabilities for all capacities and types of containers used in packaging of water; e) Availability of required testing facilities, as per the relevant ISS. List of test equipment / chemicals required for testing of packaged water is given at Annex 1. f) For testing certain requirements, as specified in the STI, the applicant may avail the provision of STI for getting some tests done from outside BIS recognized laboratories (OSL), if in-house facilities are not available. The applicant shall furnish an undertaking that they shall get samples tested as per the frequency of STI at any BIS recognized laboratory (test requirements which are to be conducted once in a month or beyond shall only be permitted to be tested at OSL); g) Competence of Quality Assurance Personnel. There shall be at least two (2) Quality Assurance Personnel, one of whom shall be a Chemist, the other a Microbiologist. For further details, Cl of this manual shall be referred;

30 h) Compliance to Hygienic Practices as per Annex B of IS 13428:2005 or Annex B of IS 14543:2004 (Annexure 8); i) Availability of adequate storage facility for raw water, finished product and packaging materials, keeping in view the installed capacity of the firm for packaging in 24 hours and storage capacity of finished product for 48 hours; j) The correctness of plant layout with respect to following: Source of raw water and raw water storage facility pipeline, storage tanks etc; Plant for the manufacture of PDW and/or PNMW, as the case may be (with various process stages); Filling/packing/loading/ unloading areas; Storages for packaging material and finished product ; Entry/exit with indications of double door/door closures/air curtains, wherever provided; Laboratory; Actual boundary/perimeter of the establishment; Change room, toilet(s), whether the premises also used for residential/other purposes, with identified locations. Note: A typical manufacturing process; process flow chart; CIP process for plant and machinery and pipelines; and cleaning process for reusable jars are given at 10.1, 10.2, 10.3 of this manual Hygiene Practices Hygienic practices in the plant shall be verified as per Annex B of IS 13428:2005 or Annex B of IS 14543:2004 (Annex 8 of this manual). Explanatory notes provided at the end for guidance only USEFUL TIPS FOR INSPECTING PERSONNEL To verify the actual factory layout. The layout should clearly indicate the different locations preferably including the following: a) Bore well or entry point for the source of raw water, pipeline etc. b) Raw water storage facility c) Plant for the manufacture of the product (with various stages) d) Filling/packing areas, change room, toilet(s), loading/unloading points e) Entry/exit with indications of double door/door closures/air curtains wherever provided 29

31 f) Stores for packaging material and finished product g) Laboratory h) Actual boundary/perimeter of the establishment i) If the premises are also used for residential quarters/other purposes, then specific mention of the same be made with identified locations As product is under mandatory certification, it is unlikely to be in production during PI. It is therefore essential to get some production & filling/packing done during the visit and then make comments on the firm s capability for the same. 30

32 It should be clearly reported in the PIR as to whether the filling/packaging adopted are manually operated or automatic. It may be noted that the plastic cups, tumbler, pouch are required to be filled only through automatic machine Sample be got tested in factory for some requirements possible to be tested, with purpose of verifying manufacturing capability (process controls), competence of the QC personnel and working conditions of test equipment For sample drawn for independent testing, requirement of Description, Odour & Taste should be tested and reported in PIR, as these are subjective tests Shelf-Life ( Best Before ) Period should be clearly indicated on the test request STI requires holding material till such time the test results for Each Control Unit are known. However in case of microbiological parameters each batch of Packaged drinking water is required to be held for 48 hours so as to ensure that it conforms to all the microbiological parameters applicable for each control unit except for the tests of aerobic microbial count at 21 0 C and yeast and mould, which shall be reviewed for conformity on availability of their test reports after 72 hours and 5 days respectively. Therefore it is important to assess the firm s installed production capacity as well as capability to store the product. Accordingly both the production capacity and storage facility need to be reported Hygienic conditions need to be assessed as per every clause of Annex B of ISS. Declarations made by the firm with respect to medical examination, Pest Control, Hygiene Schedule, Supervisor designated for Hygiene maintenance, Overall Supervision, Criteria devised for assessing product durability etc. be verified and reported.all aspects related to reusable containers, availability of arrangements for washing, cleaning (outer surface), disinfection and rinsing be also verified and reported Sample size for Testing of Packaged Drinking Water for Independent Testing Refer Cl 18.1 and 18.2 of this manual 31

33 Guidelines for Reused Containers Licensees are required to ensure use of only such jars whose transparency continues to meet the minimum requirements of 85% as per IS even after its repeated use. BO may draw sample of reusable container for ascertaining continued suitability over a period of time by getting the same tested for transparency requirement. Every market sample of processed water filled in reusable jar shall be got tested for transparency requirement also as per IS Jars which get deshaped and mutilated during the course of use shall not be permitted. Licensees may be advised in this regard strictly. Further action may be taken as per OMPC 22.3 Packing Material requirement (to be available in factory at all times) for Packing / Dispatch of Samples The following packing materials may be made available at all times All containers covered/applied for, cardboard, Plain cartons/boxes, sealing wax, thread, White gadda cloth, candles, match boxes, Cello tape and permanent Marker pens with indelible ink List of required Test Equipment / Facilities with requirement and frequency of Calibration 23.1 List of required Test Equipment / Facilities with requirement 32 Please see Annex 1 of this manual for Test equipment list 23.2 Verification of Calibration of Test Equipment Records of calibration of test equipment need to be maintained by the applicant. Although the test equipment will depend upon the selection of test method by the applicant from the options available in the respective Indian Standard, calibration of following test equipment is considered necessary at least once a year. The calibration certificates shall be from NABL