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 14543 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 - 600 113

Email: sro@bis.org.in

Phone: 044 - 2254 2365

Fax: 044 - 2254 1087

1

PRODUCT MANUAL

ON

PACKAGED WATER

BUREAU OF INDIAN STANDARDS

2

2.0 AMENDMENT HISTORY SHEET

SL. NO.

AMENDMENT CLAUSE

REFERENCE DATE OF

ISSUE SIGNATURE

1

2

3

4

5

6

7

8

9

10

3

3.0. FOREWORD

3.1 BIS has published two Indian Standards on packaged water for drinking purpose,

namely, IS 13428 for Packaged Natural Mineral Water (PNMW) and IS 14543 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 2005. 3.3 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 2013-12-07 3.5 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 14543 and IS 13428 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;

� 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).

4

4.0 TABLE OF CONTENTS (To be completed after feedback)

ITEM CHAPTER Page No

5

SECTION-I 5.0 INTRODUCTION, SCOPE AND PRODUCT DESCRIPTION

5.1 INTRODUCTION 5.1.1 The Standard IS 14543 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. 5.1.2 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. 5.1.3 IS 13428 and 14543 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)

5.1.4 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.

6

5.2 SCOPE 5.2.1 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 13428 and IS 14543 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. 5.2.2 Explanatory notes have been incorporated wherever necessary to take care of

subjective interpretations. 5.2.3 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.. 5.2.4 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).

7

5.3 PRODUCT DESCRIPTION 5.3.1 Packaged Drinking Water 5.3.1.1 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.

5.3.1.2 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 5.3.1.1 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.

5.3.1.3 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.

8

5.3.1.4 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.

5.3.2 Packaged Natural Mineral Water 5.3.2.1 Packaged natural mineral water shall be water obtained directly from natural or

drilled sources from underground water-bearing strata. 5.3.2.2 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. 5.3.2.3 Packaged natural mineral water shall be packaged close to the point of emergence

of the source with particular hygienic precautions. 5.3.2.4 The transport of natural mineral water in bulk container is prohibited. 5.3.2.5 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.

9

5.3.3 Packaging 5.3.3.1 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 14543. 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. 5.3.3.2 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 Reusable plastic containers with capacity above 5 litres IS 15410: 2003

Plastic Bottles

One time use plastic containers with capacity upto and including 5 litres. IS 15410:2003

Cup/Tumbler 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 15609:2005

5.3.3.4 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 01 08 2003 and 01 10 2003.

10

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

5.3.3.5 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

14543:2004

PACKAGED DRINKING

WATER (OTHER THAN

PACKAGED NATURAL

MINERAL WATER)

Amendment 1, July 2004

Amendment 2, July 2005

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 2011

11

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

15609 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 Colour (first revision)

(Part 5) : 1983 Odour (first revision)

(Part 8) : 1984 Taste rating (first revision)

(Part 10) : 1984 Turbidity (first revision)

(Part II): 1983 pH value (first revision)

(Part 16) : 1984 Filterable residue (total dissolved solids) (first revision)

(Part 23) : 1986 Alkalinity (first revision)

(Part 24) : 1986 Sulphates (first revision)

(Part 26) : 1986 Chlorine, residual (first revision)

(Part 27) : 1986 Cyanide (first revision)

(Part 29) : 1986 Sulphide (first revision)

(Part 32) : 1988 Chloride (first revision)

(Part 34) : 1988 Nitrogen (first revision)

(Part 37) : 1988 Arsenic (first revision)

12

(Part 39) : 1991 Oil and grease

(Part 40) : 1991 Calcium

(Part 41) : 1992 Cadmium (first revision)

(Part 42) : 1992 Copper (first revision)

(Part 43) : 1992 Phenols (first revision)

(Part 45) : 1993 Sodium and potassium (first revision)

(Part 46) : 1994 Magnesium (first revision)

(Part 47) : 1994 Lead (first revision)

(Part 48) : 1994 Mercury (first revision)

(Part 49) : 1994 Zinc- (first revision)

(Part 53) : 2003 Iron (first revision)

(Part 55) :2003 Aluminium (first revision)

(Part 56) : 2003 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 Isolation, identification and enumeration of Escherichia coli (first revision)

(Part 2) : 1976 Isolation, identification and enumeration of Staphylococcus aureus and faecal streptococci (first revision)

(Part 3) : 1999 General guidance on methods for detection of Salmonella (second revision)

(Part 5) : 1976 Isolation, identification and enumeration of Vibrio cholera and Vibrio parahaemolyticus (first revision)

(Part 7) : 1999 General guidance on methods for isolation and identification of Shigella

13

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)

10142 : 1999 Polystyrene (crystal and high impact) for its safe use in contact with foodstuffs, pharmaceuticals and drinking water (first revision)

10146 : 1982 Polyethylene for its safe use in contact with foodstuffs, pharmaceuticals and drinking water

10151 : 1982 Polyvinyl chloride (PVC) and its copolymers for its safe use in contact with foodstuffs, pharmaceuticals and drinking water

10910 : 1984 Polypropylene and its Title copolymers for its safe use in contact with foodstuffs, pharmaceuticals and drinking water

12252 : 1987 Polyalkylene terrephthalates (PET and PBT) for their safe use in contact with foodstuffs, pharmaceuticals and drinking water

14194 Radionuclides in environmental samples—Methods of estimation

(Part 1) : 1994 Gross beta activity measurement

(Part 2) : 1994 Gross alpha activity measurement

14971 :2001 Polycarbonate resins for its safe use in contact with foodstuffs, pharmaceuticals and drinking water

15185 : 2002 Water quality —Detection and enumeration of Escherichia coli and coliform bacteria Membrane filtration method

15186 : 2002 Water quality —Detect oil and enumeration of intestinal enterococci— Membrane filtration method

15187 : 2002 Water quality — Detection of Salmonella species

15188 : 2002 Water quality—General guide to the enumeration of micro-organisms by culture

15302 : 2002 Determination of aluminium and barium in water by direct nitrous oxide-acetylene flame atomic absorption spectrometry

15303 : 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 IS14543:20004.

14

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 (www.bis.org.in). 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: 2012. 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.

15

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 One time use plastic containers with capacity upto and

including 5 litres. IS 15410:2003

Cup/Tumbler One time use plastic container in cup shape or tumbler

(glass shape) with a peel able seal 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 5.3.3 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.

16

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.

1. 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 (0.1 – 0.5 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.

17

10. TESTING - The raw water is tested once in three months. Finished water is tested as

per scheme of testing prescribed by BIS.

10.2 A TYPICAL PROCESS FLOW CHART

REMINERALISATION/

BLENDING

18

10.3 A TYPICAL CIP PROCESS (Sanitization and Sterilization is done daily before resuming production) 10.3.1 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 10-15 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. 10.3.2 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. 10.3.3 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.

19

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. 11.3 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)

SECTION-IV

CERTIFICATION CRITERIA

12.0 Identification of Critical Requirements of the Indian Standard A List of Critical Parameters for Packaged Drinking Water as per IS 14543 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

20

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.

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

21

The Marking fee fixed by Bureau of Indian Standards for Packaged Drinking Water (other than Packaged Natural Mineral Water) according to IS 14543 : 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 79400. b) For large scale industry: Rs 93400. 2) Rate of marking fee: (1 Unit - 1000 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: 28 11 2006 15.0 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

CONTAINER DESCRIPTION Guidelines

1 Jars

(PET/PC) Reusable plastic containers with capacity above 5

litres Each capacity to be tested

2 Plastic Bottles

One time use plastic containers with capacity upto and including 5 litres

Each capacity to be tested

3 Pouches Flexible Pouches made from plastic PE

Type 1: < 300 ml capacity – 65 microns minimum Type 2: > 300 ml capacity – 75 microns minimum

One capacity in each type

4 Cup/Tumbler One time use plastic container in cup shape or

tumbler (glass shape) with a peel able seal Each capacity to be tested

5 Glass Bottle Reusable containers made of glass material. Each capacity to be tested

Note: All packaging’s shall be in line with legal metrological requirements.

22

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 2.9.1 of OMPC is not applicable in such cases.

16.2 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 14543 : 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 5.3.3.2 for Guidelines for above classification)

The renewal endorsements shall indicate the permitted packaging’s. (Sample Endorsement enclosed).

17.0 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: 17.1. 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;

23

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

15410 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. 17.2. 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. 18.0 Sample size, including guidelines for drawal of separate samples when samples are required to be sent to different labs for testing 18.1. 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.

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

24

18.1.1. 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

1 18

2 9

5 4

10 2

20 2

24 2

� 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.

18.1.2. 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.

25

18.2. Sample of packaging material (containers) and Selection of laboratory for Independent Testing 18.2.1 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

26

18.2.2 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 15410 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 15410. 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.

18.3 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) 19.1. Masking of sample

� 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. 19.2. Test request 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 .

27

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. 20.0 Remnants

� Remnants of sample(s) may be scrapped.

This above advice may be mentioned in the test request itself.

21.0 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.

28

SECTION-V

22.0 INSPECTION, TESTING AND PACKING MATERIAL REQUIREMENTS

22.1 INSPECTION 22.1.1 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.

22.1.2 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.

22.1.3 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:

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 23.2.2 of this manual shall be referred;

29

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.

22.1.4 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.

22.2 USEFUL TIPS FOR INSPECTING PERSONNEL 22.2.1 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

30

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. 22.2.2 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.

31

22.2.3 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. 22.2.4 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. 22.2.5 For sample drawn for independent testing, requirement of Description, Odour & Taste should be tested and reported in

PIR, as these are subjective tests. 22.2.6 Shelf-Life (“Best Before”) Period should be clearly indicated on the test request. 22.2.7 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 210 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. 22.2.8 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. 22.2.9 Sample size for Testing of Packaged Drinking Water for Independent Testing

� Refer Cl 18.1 and 18.2 of this manual

32

22.2.10 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 15410 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 15410. 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 .

23.0 List of required Test Equipment / Facilities with requirement and frequency of Calibration

23.1 List of required Test Equipment / Facilities with requirement

� Please see Annex 1 of this manual for Test equipment list

23.2 Verification of Calibration of Test Equipment 23.2.1 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

33

accredited laboratory or from laboratory having traceability to national level. a) Analytical balance (electronic)/weight box (including fractional weights), b) Temperature indicators of all incubators, c) Pressure gauge of Autoclave, and d) Temperature indicator of Autoclave (optional)

� Other instruments, such as spectrophotometer, turbidity meter, pH meter are to be standardized as per the standard operating procedures supplied with respective instrument.

23.2.2 Quality Assurance Personnel

� There shall be minimum two Quality Assurance Personnel, one for carrying out chemical testing and the other for

microbiological testing.

� The personnel for chemical testing shall be minimum science graduate with chemistry as one of the subjects. Microbiologist shall be a science graduate with preferably Botany or Microbiology as a subject or a graduate in Food Technology/science or Dairy Technology/science or Agriculture. Both shall have necessary competence to carry out testing of the respective tests (chemical or microbiological).

� The IO shall witness all possible tests that can be conducted during the inspection. For those tests which are not possible

to be carried out during inspection, assessment of competence may be made through interview of the testing personnel,

demonstration of initiation of tests, equipment, interpretation of results etc., which shall be suitably recorded in IR.

Note: After STI amendments based on the feedback, the requirement of a chemist can be reviewed.

34

24.0 Status of Test Facilities in BIS Labs and OSLs with Testing Charges, and Approximate time required for testing by BIS labs / OSLs

� The list of BIS laboratories and laboratories recognized by BIS along with their testing charges, where sample of

packaged water and/or its container can be sent for independent testing, are available on BIS intranet/website. The

inspecting officer/agent shall collect latest status in respect of any laboratory before proceeding for inspection.

25.0 Grant of License / Operation of License for Packaged Drinking Water 25.1 Grant of License

� Based on Independent test reports only. 25.2 Operation of License 25.2.1 General This section provides guidelines for operation of licence based on IS 13428 or IS 14543 and the corresponding Scheme of Testing and Inspection. The operational guidelines as given under Operating Manual for Product Certification shall be followed

for those situations that are not specifically covered in this Manual. 25.2.2 Periodic (Surveillance) Inspection At least two surveillance inspections are required to be done in an operative year of a licence, as per the requirements of the

BIS (Certification) Regulations, 1988. The inspections shall be planned in a manner to evenly spread over during the period of a

licence’s validity. A surveillance inspection shall not be done after validity of a licence is over and decision is pending for its

renewal. The report of surveillance Inspection of a packaged water licensee shall be submitted as per the format given at Annex

6 along with Hygiene Checklist as given at Annex 8.

35

25.2.3 Sample from factory and market Sample of packaged water shall be drawn during surveillance inspection from the available stock or from production with

Standard Mark observed during such inspection (FS). Two FS shall be drawn and independently tested during an operative

period of a licence (drawing one sample during one inspection). Four market samples (MS) of packaged water shall also be

drawn during an operative year of the licence. Samples of containers and packaging materials are also required to be drawn for

testing by rotation pertaining to various containers as permitted in the licence as it is essential to monitor the quality of

container(s) being used for filling with packaged water. The details of samples that should be drawn in one operative year of a

licence are given in Table:

Sampling from Factory during surveillance inspection

Particulars of No. of Details of tests to be conducted

sample sample(s)

FS 2 During the operative period, at least one FS/MS shall be tested for all requirements including pesticide residues. Note: One FS shall be tested every two (2) years for parameters concerning radio-active residues. If FS could not be drawn for testing for Radioactive residues due to any reason then, MS shall be tested

for the same

Container 1 From the first periodic inspection

/surveillance visit (verification visit by

36

BIS in case of GOL under simplified

procedure) onwards, one sample of any

one type of container ( one size and

material) shall be tested once a year for all

requirements of relevant Indian Standard.

Sampling of container shall be done in a

manner so as to cover all type, sizes &

material on rotational basis during the

operation of the licence. Sample of

container shall be drawn at the same time

when a FS is being drawn.

Sampling from Market

Particulars of No. of Details of tests to be conducted

sample sample(s)

MS 4 All 4 MS shall be tested for all

requirements of the Indian Standard,

except for pesticides residues and

parameters concerning radio-active

residues. Also refer above table for FS

37

25.2.3 Hygienic Conditions Plant, process and personnel hygiene shall be assessed during every surveillance inspection as per Hygienic Practices at Annex

B of IS 14543:2004 or Annex B of IS 13428:2005 (Item 6 of this Manual). The filled up Checklist (Annex 8 of this Manual) also

shall be attached with Surveillance Inspection Report. 25.3 Operational Issues 25.3.1 Change of source of raw water or change in process

25.3.1.1 Packaged natural mineral water

In case of change of source of raw water by the licensee, documentary evidence shall be collected as stated under 5.3.2.5 of

this Manual and examined vis-à-vis the requirements of IS 13428 for constancy of source water quality. An inspection shall be

carried out to verify that the restrictions specified in the standard with respect to processing and disinfection are complied; to

verify plant machinery and to check hygienic conditions. A sample of packaged natural mineral water produced by using

changed source shall then be drawn for independent testing for its conformity to all requirements of the standard including

parameters concerning radio-active residues. CM/PF 305 shall be submitted by the licensee and countersigned by the

inspecting official after due verification of declarations made therein. Permission for use of Standard Mark shall be given on

receipt of test reports indicating conformity of the sample. 25.3.1.2 Packaged Drinking Water In case of change of source of raw water by the licensee, an inspection shall be carried out to verify the changes made in

processing of raw water, if any; to verify plant machinery and to check hygienic conditions. CM/PF 305 shall be prepared by the

licensee and countersigned by the inspecting official after due verification of details. A sample of packaged drinking water

produced by using changed source shall then be drawn for independent testing for its conformity to all requirements of the

standard including parameters concerning radio-active residues. Permission for use of Standard Mark shall be given on receipt

of test reports indicating conformity of the sample. Clause 18.1 (c) of this manual may also be referred.

38

25.3.1.3 Concurrent use of raw water from two different sources In case of concurrent use of raw water of two different types of sources (for example water being extracted through own bore-

well and also obtained from municipal source), the production from each source shall be assigned a different batch number and

separately tested as per STI for conformity of the product water, provided production lines are separate. Accordingly, records of

production and testing of packaged drinking water produced using both the sources shall be kept by the licensee. However,

when there is more than one source of raw water but processing plant is one, testing of packaged drinking water shall be done

after duly verifying the additional source(s) being introduced and appropriate record in CM/PF 305, if necessary shall be made.

Such testing shall include parameters concerning radio-active residues. 25.3.2 Change in the process In case of any addition, alteration and/or change in the production process without any change in raw water source (for

example, remineralization has been added after reverse osmosis in production of packaged drinking water or decantation has

been introduced as a process step in production of packaged natural mineral water), necessary verification of plant and

machinery shall be done with duly filling up of CM/PF 305. A sample is required to be drawn for independent testing for its

conformity to the relevant Indian Standard, except for parameters concerning radio-active residues, before permitting the same

to be marked. Testing of product water so produced by using different processes shall be carried out as per STI and records be

kept separately by the licensee.

Note 1: Testing for parameters concerning radio-active residues need not be done under above circumstances

provided the source of raw water remains the same.

Note 2: Any change in process may require fresh approval of label. Therefore licensee shall be advised to

prepare fresh label incorporating all marking details and obtain approval. 25.3.3 Shelf-life The shelf-life of packaged natural mineral water/packaged drinking water shall be minimum 30 days. If the manufacturer

intends to declare a longer shelf-life than minimum 30 days, study shall be conducted on each type of packing at least

once a year or whenever there is a change in the source of raw water/manufacturing/packing process, whichever is

39

earlier. The shelf-life period shall be declared on the labels suitably as “Best for consumption within ---- -days or -----months from the date of packing” based on the shelf life studies (but not less than 30 days). Subsequently,

for any change in the shelf life declared on the labels, the manufacturer shall inform BIS in advance along with shelf- life

study reports and submit fresh label for approval. Tests to be carried out for shelf life studies are requirements given in

Table 1 of IS 14543/IS13428 along with routine microbiological tests as per IS 14543/IS13428. 25.4 Stop Marking - Resumption of Marking

The procedure given in OMPC shall be followed.

� Also separate procedure for SOM / ROM is given in Amendment no-17, July 11 to OMPC 2004

25.5 Handling Complaints on Packaged Water 25.5.1 As the packaged water is meant for mass consumption and also related directly to the health and safety of the consumer,

it is quite likely that complaints may arise for the same. The product is not expensive. Therefore, as per the OMPC a

replacement can straight away be arranged to the complainant. However, the following aspects need to be addressed suitably. 25.5.2 Readressal to the complainant may be arranged either from the existing stock (if declared to be conforming) or from the

fresh production after resumption of marking is permitted to the licensee (in case Firm is under stop marking for any reason or

has been placed under stop marking due to complaint or any other reason). 25.5.3 If it is not possible to establish the complaint by visual examination, it would be necessary to send material under

complaint for independent testing. However, if the container has already been opened and the packaged water is not available in

originally packed condition, it shall not be sent for testing. Only unopened sealed container (packing with intact cap/closure/seal)

shall be sent for tests. Attempts may be made to procure material pertaining to the same lot/batch/manufacturing date from the

market, if available and sent for independent testing to establish the complaint. However, such sample purchased from the

market shall not have the status of complaint sample but would only be treated as a market sample and would be handled in the

manner in which any other market sample is handled.

40

25.5.4 The above procedure is to be followed in addition to the procedure of handling of complaints as given in the OMPC.

26.0 Details of Tests to be carried out in the Factory in case of: 26.1. Applicant Samples / Verification Samples /

� All possible daily tests and weekly tesst parameters may be carried out during preliminary inspection. � Inoculation / Evaluation of Ongoing microbiological tests may also be done. � Possible test on packing materials (specifically PE pouches) may also be done.

26.2 Surveillance (FACTORY) / Market Samples

� All possible daily tests and some weekly test parameters may be carried out during surveillance inspection. Inoculation / Evaluation of Ongoing microbiological tests may also be reported.

� Market Samples shall be tested for all requirements of the standard Note 1: One sample (FS/MS) shall be tested for all requirements of except RAR in an operative period. Other samples to be tested for all requirements except pesticide residue. Note 2: The RAR sample tested by the license once in two years is adequate and no independent sample to be drawn by BIS for RAR.

ANNEX – 1

LIST OF TEST FACILITIES

A- ORGANOLEPTIC AND PHYSICAL REQUIREMENTS

Sl. Tests Clause Ref. of Referred Test Equipment/Apparatus Chemicals/Reagents

No. IS 14543:2004 Method of Test

or & (6)

IS 13428:2005 Limit of

Detection

(1) (2) (3) (4) (5)

1. Colour 5.2, Sl No. i) IS 3025 (P 4):1983 Nessler cylinders,50 ml Potassium chloroplatinate

of Table 1 with Am. 1 Centrifuge or filter assembly, functional pore Cobaltous chloride, crystalline

i) Platinum cobalt

size 0.45µm Conc. Hydrochloric acid

Distilled water

(Visual comparison

method)

ii) Spectrophoto- Spectrophotometer,400-700 nm with 10 mm ● Conc. Sulphuric acid

absorption cell

metric method Filteration system consisting of filteration flask ● Sodium hydroxide

with side tubes

crucible holder

Micrometallic filter crucible, pore 40 µm

Calcined filter aid (Celite 505 or equivalent

Vacuum system

Refrigerator (recommended)

pH meter

Centrifuge

2. Odour 5.2, Sl No. ii) of IS 3025 (P 5):1983 Wide mouth glass stoppered bottles (approx. 1 lit. ● Odour free distilled water (or distilled water Table 1 capacity) and column of granulated activated carbon)

● Hydrochloric acid

3. Taste 5.2, Sl No. iii) IS 3025 (P 8):1984 Breaker (50 ml) Taste and Odour free water 2000 mg/l of Table 1 Water bath solution of sodium chloride Thermometer

4. Turbidity 5.2, Sl No. iv) IS 3025 (P 10): Sample tubes Distilled water of Table 1 1984 Turbidimeter Hexamethylene Tetramine Volumetric flasks (100 ml) Hydrazine sulphate Membrane filter with pore size not more than

0.45 µm 5. Total 5.2,Sl No. v) of IS 3025 (P 16): Filter:

dissolved Table 1 1983 with Am. 1 Filtering Assembly (suitable for type of filter solids selected) Drying oven (180 ± 2˚C) Desiccator Analytical balance (200 g capacity, l.c. 0.1 mg) Pipettes Evaporating dish Magnetic stirrer, recommended

pH 5.2,Sl No. vi) of IS 3025 (P 11): Table 1 1983

i) Electrometric

method

ii) Colorimetric

Method

pH meter – with glass and reference

electrode (saturated calomel) l.c 0.1 Magnetic stirrer with polytetrafluoro ethylene coated stirring bar Thermometer (l.c.

0.5°C) Beakers

Hard glass tubes

Standard pH Buffer solutions/tablets

(Minimum two different values) OR

Distilled water Borax (for Borax buffer)

Potassium dihydrogen phosphate, Sodium hydrogen phosphate and oven (for phosphate buffer) Potassium hydrogen tartarate (for Tartarate buffer) Potassium hydrogen phthalate (for Phthalate buffer) Potassium tetraoxalate dihydrate (for Calcium hydroxide buffer)

Calcium Carbonate Platinum dish, Muffle furnace, Hot Plate,

Fritted glass filter of medium porosity,

polyethylene bottle, Suction pump & fritted

glass funnel (for Tetra oxalate buffer)

Methyl orange, methyl red, bromothymol blue, phenolphthalein and alcohol (66%) (for universal indicator) Thymol blue indicator (acid range)

Bromophenol blue indicator Bromocresol green indicator

Methyl red indicator Bromocresol purple indicator

Bromothymol blue indicator

Phenol Red indicator Cresol Red indicator

Thymol Blue (alkali range) indicator

Thymolphthalein indicator Thymol violet indicator Different buffer solutions of known pH

B - CHEMICAL REQUIREMENTS

Sl. Tests Clause Ref. Referred Method of Test Equipment/Apparatus* Chemicals/Reagents

No. of Test

IS &

14543:2004 Limit of Detection

or

IS

13428:2005

(1) (2) (3) (4) (5) (6)

1. Barium 5.2, Sl. No i) i) Annex F of IS Filter paper and filtration assembly Ammonium Dichromate

of Table 2 13428:2005 Hot plate/gas burner Ammonium Acetate

Ammonium Hydroxide

Potassium Iodide

Sodium Thiosulphate(0.1N)

Hydrochloric Acid

Ammonium Chloride

Starch indicator

ii) IS 15302:2003

Atomic Absorption Spectrophotometer and Metal free water

Associated equipment (Burner, Readout Hydrochloric Acid

mechanism, lamp for Barium, Pressure

Nitric Acid

Reducing valves and vents)

Sulphuric Acid

Nitrous oxide burner head

Hydroflouric Acid

T-junction valve or other switching valve

Potassium Chloride

Air

Standard barium solution 100µg/ml

Acetylene Gas

(Barium chloride, oven, hydrochloric

Nitrous oxide gas

acid)

iii) IS 3025 (P 2) Induction Coupled Plasma-Atomic Emission

:2004

Spectrometer Nitric Acid

Sample Bottles Hydrogen Peroxide

Glasswares Sulphuric Acid

Acid Dispensers Hydrochloric acid

Membrane Filtration Equipment and Filters Ammonium Sulfate

(0.45µ) Stock Solution of Barium

Hot Plate

Argon Gas

2. Copper 5.2, Sl No. ii) i) IS 3025 (P 42): 1992

of Table 2 with Am 1

a) Neocuproine Method Spectrophotometer & 1cm cell Ammonium Hydroxide

Hot plate Chloroform, AR Grade

Detection range 0.05 to

Separating funnels (125 ml) Hydrochloric acid, Conc.

Conical flasks Hydroxylamine Hydrochloride

5.0mg/l Isopropyl Alcohol

Neocuproine

Double Distilled water

Nitric Acid, Conc.

Sulphuric Acid, Conc.

Hydrated Sodium Citrate

Stock copper (II) solution 200µg/ml

(Pure Copper Metal, hot plate)

Hydrogen Peroxide

b) Atomic Abso- rption Atomic Absorption Spectro- photometer Hydrochloric Acid, Conc.

Method (Direct) with Nitric Acid, Conc.

air-acetylene flame & Copper Hollow Dilute Sulphuric Acid

Cathode lamp Stock copper (II) solution – 1.0mg/ml

(Pure Copper metal & hot plate)

Detection range 0.02 to

5.0mg/l

c) Atomic Absorption

Method (Chelation

Extraction) Detection range 0.002

to 0.5 mg/l

d) Differential Pulse Anodic Stripping Voltametry Detection range 0.01

to 0.1mg/l

ii) IS 3025 (P

2) :2004

Atomic Absorption Spectrophotometer with air-acetyleneflame Copper Hollow Cathode Lamp Separating Funnel

Volumetric Flasks Distillation Assembly

Polarograph capable of Performing

differential pulse work Hanging Mercury Drop electrode

Platinum Counter Electrode Saturated Calomel Reference Electrode

Magnetic Stirrer Control unit with Stirring Bar Scrubber Assembly Whatman Filter Paper No.

40 Nitrogen Gas

Induction Coupled Plasma-Atomic

Emission Spectrometer Sample Bottles

Glasswares Acid Dispensers Membrane Filtration Equipment and Filters

(0.45µ) Hot Plate

Argon Gas

Hydrochloric Acid,

Conc. Nitric Acid, Conc. Pyrrolidine Dithiocarbamic acid

Methyl Isobutyl Ketone, AR

grade Carbon Disulphide Sodium Hydroxide

Distilled water Water Standard MIBK

Bromophenol Blue Ethanol or Isopropanol

Stock copper (II) solution – 1.0mg/ml

(Pure Copper metal & hot plate)

Hydrochloric Acid Conc.

(Spectro Grade) Nitric Acid-Conc. (Spectro

Grade) Sulphuric Acid Conc. Pure Copper Metal

Granular Zinc Mercury

Nitric Acid

Hydrogen Peroxide

Sulphuric Acid Hydrochloric acid

Ammonium Sulfate Stock Solution of Copper

3. Iron 5.2, Sl. No i) IS 3025 (P 53) :2003

iii) of Table 2 a) 1,10 Phenanthroline

Method

i) Detection range

0.075 to 0.5mg/l

ii)This requirement is

not applicable for

Packaged Natural

Mineral Water

b) Atomic Absorption

Method (DIRECT)

Detection range 0.1

to 10 mg/l

Spectrophotometer Std. volumetric glass wares Hot Plate Fuming Hood 0.45µ m Membrane Filter

with Filtration Assembly

Atomic Absorption Spectrophotometer

Air Acetylene Flame Iron Hollow Cathode Lamp or

Electrodeless discharge lamp for use at 248.3nm Volumetric Flasks

Amalgamated Zinc (Granular Zinc and Mercury)

Ammonium Meta

Vanadate Distilled water Hydrochloric Acid-Conc. (Containing

less than 0.00005% iron)

Hydroxylamine Hydrochloride

Ammonium Acetate Glacial Acetic Acid

Sodium Acetate 1,10 Phenanthroline Monohydrate Stock Iron Solution 1ml=200µg of Fe (Conc. Sulphuric Acid, Ferrous Ammonium Sulphate, Potasssium Permanganate) Std. Iron Solution (1.0 ml=1.0µg of

Iron) Di-isopropyl Ether Distilled water

Hydrochloric Acid,

Conc. Nitric Acid, Conc. Sulphuric Acid, Conc.

Calcium Chloride Solution (Calcium

Carbonate, Hydrochloric acid)

Stock Iron Solution (1.0 ml=100µg of

Fe) (Pure iron wire, Hydrochloric acid

Nitric Acid)

ii) IS 15303:2003 Metal free water

Electrothermal Atomic Atomic Absorption Spectrometer Hydrochloric Acid, Conc.

Nitric Acid, Conc.

Absorption Hollow Cathode lamp for Iron Matrix Modifier stock solutions

Spectrometric Method Graphite Furnace (Magnesium Nitrate, Nickel Nitrate,

Readout Mechanism Phosphoric Acid, Palladium Nitrate &

Sample Dispenser Citric Acid)

Minimum detection Vent for fumes Stock iron Solution – 100µg/ml (Iron

Cooling device wire)

limit 0.001mg/l Membrane Filter, 0.45µm Sodium hydroxide 10N

Chelating resin

iii) IS 3025 (P 2):2004 Induction Coupled Plasma-Atomic Emission Nitric Acid

Spectrometer Hydrogen Peroxide

Sample Bottles Sulphuric Acid

Glasswares Hydrochloric acid

Acid Dispensers Ammonium Sulfate

Membrane Filtration Equipment and Filters Stock Solution of Iron

(0.45µ)

Hot Plate

Argon Gas

4. Manganese 5.2, Sl. No. i) IS 3025:2006 Part 59 Nessler’s Tubes Sulphuric Acid

iv), Table 2 a) Periodate

Beakers Hydrogen Peroxide (30%)

Hot Plate Nitric Acid, Conc.

Colorimetric Method Volumetric flask Stabilized Distilled Water OR

Pipettes

Detection limit up

Distillation Assembly, OR

Conical Flasks

Distilled water,

to 0.2mg/l Burette

Potassium Permanganate and

Dil Sulphuric Acid

Phosphoric Acid (sp. Gr. 1.75)

Potassium Periodate

Std. Manganese Solution

(1ml=0.02 mg of

Mn) (Standard 0.1 N Potassium

Permanganate solution, saturated

solution of sulphur dioxide)

b) Formaldoxime

Fluoride Free Water

Spectrophotometer Potassium Peroxodisulphate or Sodium

Spectrometric Method

Peroxodisulphate

Glass Bottle EDTA Tetrasodium Salt, Solution, c(EDTA)

Detection limit Autoclave

Sodium Hydroxide

between 0.01mg/l to 5

Hydroxylammonium Chloride

mg/l Formaldehyde

Ammonia Solution

Ammonium Iron (II) Sulphate Hexahydrate

Solution

Sulphuric Acid, conc.

Manganese Monohydrate (for Standard Mn

Solution)

Induction Coupled Plasma-Atomic Emission Nitric Acid

Hydrogen Peroxide

Spectrometer

ii) IS 3025 (P 2):2004 Sample Bottles Sulphuric Acid

Glasswares Hydrochloric acid

Acid Dispensers Ammonium Sulfate

Membrane Filtration Equipment and Filters Stock Solution of Iron

(0.45µ)

Hot Plate

Argon Gas

5. Nitrate (as 5.2, Sl. No. IS 3025 (Part 34):1988 Reduction Column Distilled water

NO3) v) of Table 2 Colorimeter OR Nitrate free water

Spectrophotometer OR Cadmium granules (40 – 60 mesh)

i) Cadmium Reduction

Filter photometer Hydrochloric Acid (6N)

Glass wool Copper Sulphate Solution

Method 0.45 µ m pore diameter membrane filter Sulphanilamide

Refrigerator Conc. Hydrochloric Acid

N-(1-napthyl))-Ethylenediamine

Detection limit

maximum 0.1 mg/l

ii) Chromotropic

Acid Method Detection range 0.1

to 5.0mg/l iii) Devarda’s Alloy

Reduction Method Detection limit

minimum 2 mg/l

Spectrophotometer

Standard laboratory glasswares Distillation Assembly (Kjeldahl

Assembly)

Measuring Scoop

Spectrophotometer

dihydrochloride (NED) Dihydrochloride) Ammonium Chloride

Disodium Ethylene diamine tetra

acetate Ammonia Solution Copper sulphate Solution – 2%

Stock nitrate solution – 100µg/ml (Potassium Nitrate & Chloroform)

Chloroform

Stock nitrite solution - 100µg/ml

(Potassium Nitrite & Chloroform) Nitrite free water

Nitrate free water Stock Nitrate Solution - 100µg/ml

(Potassium Nitrate, Chloroform)

Standard Nitrate solution –

10.0µg/ml Sulphite Urea Reagent (Urea & Anhydrous sodium Sulphite)

Antimony reagent (Antimony

metal, Conc. Sulphuric acid)

Chromotropic Acid Reagent (Purified chromotropic Acid crystals, Conc. Sulphuric Acid)

Sulphuric Acid, Conc. Nitrate free

Ammonia Free Water Borate Buffer Solution (0.1N Sodium

Hydroxide, 0.025M Sodium Tetraborate) Sodium Hydroxide – 6 N Devarda’s Alloy – 20 mesh with less than

0.005 percent Nitrogen

Mixed indicator Solution (Methyl Red

indicator, Ethyl alcohol/Isopropyl alcohol,

Methylene Blue)

Indicating Boric Acid Solution

(Hydroboric Acid, mixed indicator

solution)

Std. Sulphuric Acid Titrant - 0.02 N

Nessler’s Reagent (Mercuric Iodide,

Potassium Iodine. Sodium Hydroxide)

Stock Ammonia Solution -1.22mg

ammonia/ ml (Anhydrous Ammonium

Chloride)

Standard Ammonia Solution

6. Nitrite 5.2, Sl. No. IS 3025(P 34) :1988 Spectrophotometer / Photometer Nitrite Free water (Distilled water,

vi) of Table OR Potassium Permanganate, Barium

2 Nessler’s cylinders method

Hydroxide/Calcium Hydroxide Conc.

Sulphuric Acid, Manganese Sulphate)

Nessler’s Tubes Sulphanilamide Reagent

0.45 µm Membrane Filter NED Dihydrochloride

Distillation Assembly (borosilicate) Hydrochloric Acid

Sodium Oxalate – 0.05 N.

Ferrous Ammonium Sulphate – 0.05N

(Ferrous Ammonium Sulphate, Conc.

Sulphuric Acid, Std. Dichromate solution)

Stock Nitrite Solution - 250µg of

nitrogen/ml (Sodium Nitrite, Chloroform,

Sodium Oxalate, Std., Potassium

Permanganate solution)

Intermediate Nitrite Solution – 50.0µg/ml

Standard Nitrite Solution – 0.500µg/ml

7. Flouride 5.2, Sl. No. Clause 23 of Nessler Tubes (100ml) Sodium Thiosulphate Solution (0.1 N)

vii) of Table IS 3025:1964 Distillation Apparatus Standard Sodium Fluoride Solution (1ml =

2 Refrigerator (Recommended) 0.01 mg F)

i) Zirconium alizarin Heating mantle Zirconium Oxychloride OR Zirconium

Method Oxynitrate

Alizarin Sodium Monosulphonate (Alizarin

S)

Detection range

Conc. Hydrochloric Acid

Conc. Sulphuric Acid

0.05 to 1.0 mg/l

Silver Sulphate

Perchloric Acid

Phenolphthalein Indicator

Sodium Hydroxide Solution

ii) Electro Chemical Millivolt Meter Sodium Hydroxide- 5 M

Probe Method Fluoride Ion – Selective Electrode Total Ionic Strength Adjustment Buffer

Reference Electrode – Either a calomel electrode,

(TISAB)-[Sodium Chloride, Glacial Acetic Acid,

Detection range Sodium Hydroxide, CDTA( trans -1,2-

filled with saturated Potassium Chloride (KCl) diaminocyclohexane – N,N,N’,N’ tetra acetic

0.2mg to 2.0 g/l Solution or a Silver / Silver Chloride Electrode acid)]

easuring Cells – 100ml(Polypropylene fitted Fluoride, Stock Solution, 1000mg/1 (Sodium

with thermostated jacket ) Fluoride )

Water Bath

agnatic Stirrer with a

polytetrafluoroethylene(PTFE)

Polyethylene Beaker Note :

pH meter Purity of the reagent – Unless specified

Standard Volumetric Glasswares otherwise, only pure chemicals & Fluoride free distilled water shall be used in tests.

Desiccator

Screw Capped Polyethylene Container

Plastic Bottle

8. Zinc 5.2, Sl. No. IS 3025 (P 49): 1994 Spectrophotometer (620 nm with 1cm cells) Sodium Hydroxide

viii) of Table with Am 1 Potassium Cyanide

2 Cyclohexanone

Distt. Water

i) Zincon Method

Zincon

Methanol

Sodium Ascorbate

Borate Buffer Solution (Sodium

Detection range 0.02 to

Hydroxide, Potassium Chloride, Boric

Acid)

5 mg/l Hydrochloric Acid, Conc.

Zinc Sulphate

ii) Atomic Absorption

Atomic Absorption Spectrophotometer with Hydrochloric Acid, Conc.

Air-Acetylene Flame

Method (Direct) Hollow Cathode Lamp Nitric Acid, conc.

Or Electrodeless discharge lamp Stock Zinc Solution – 1.0mg/ml (Zinc

Granules/Zinc Oxide)

Detection range 0.01 to

2.0mg/l

iii)Atomic Absorption Atomic Absorption Spectrophotometer with Hydrochloric Acid, Conc.

Method (Chelation – Air-Acetylene Flame Nitric Acid, Conc.

Extraction) Hollow Cathode Lamp Pyrrolidine Dithio Carbamic Acid -

Chloroform Reagent (Pyrrolidine,

Detection range 0.001 Chloroform, Carbon disulphide)

Sodium Hydroxide

to 0.2mg/l

Chloroform

Bromophenol Blue Indicator

(Bromophenol Blue, Ethanol or

Isopropanol)

Stock Zinc (II) Solution- 1.0 mg/ml (Zinc

Granules or Zinc Oxide, Nitric Acid)

iv) Differential Pulse Hydrochloric Acid, Conc.

Anodic Stripping Polarographic Instrumentation

Voltammetry Nitric Acid, Conc

(DPASV)Method Capable of Performing Differential Stock Zinc Solution -1.0mg/ml

Pulse Work Amalgamated Zinc (Granular Zinc, Conc.

Detection range 0.001 Hanging Mercury Drop Electrode Hydrochloric Acid, Mercury)

to 0.1mg/l Platinum Counter Electrode Purified Nitrogen (Ammonium Meta

Saturated Calomel Reference Vanadate, Scrubber, Amalgamated Zinc,

Electrode Nitrogen Gas)

Magnetic Stirrer

9. Silver 5.2, Sl. No. Annex J of IS Atomic Absorption Spectrophotometer Deionised Distilled Water (Ion Exchange

ix) of Table 2 13428:2005 with Oxidizing Air Acetylene Flame Column & Distilled Water)

Nitric Acid – Redistilled

Hydrochloric Acid – Redistilled

Silver Std. Solution (Silver Nitrate)

Lanthanum Chloride

Lanthanum Stock Solution (Lanthanum

Oxide, Hydrochloric Acid)

Ammonium Pyrrolidine Dithiocarbamate

solution)

Methyl isobutyl ketone

10. Aluminium 5.2, Sl. No. i) IS 3025(P 55): 2003

x) of Table 2 a) Eriochrome Cyanine

R Method

i) Detection range

0.02 to 0.3mg/l;

ii) This requirement is

not applicable for

Packaged Natural

Mineral Water

b) Atomic Absorption

Method (Direct)

Detection range 5 to

100mg/l

ii) IS 15302:2003 Direct

Nitrous Oxide –

Acetylene Flame

Atomic Absorption

Spectrometry

Detection limit 0.1mg/l

Spectrophotometer (535 nm with 1cm Cells) Sulphuric Acid – 0.02 N and 6 N pH Meter Ascorbic Acid Solution Standard Volumetric Glasswares Buffer Solution (Sodium Acetate & 1 N Acetic Acid) Acetic Acid Solution – 1:1 and 1 N Sodium Hydroxide Solution – 0.1 N and 1N Stock Eriochrome Cyanine R Dye Solution Stock Aluminium Solution – 500 µg/l (Aluminium Potassium Sulphate) Methyl Orange Indicator Solution Atomic Absorption Spectrophotometer with Hydrochloric Acid, Conc.

Nitrous Oxide – Acetylene Flame and Nitric Acid, Conc.

Hollow-Cathode Lamp

Potassium Chloride Solution

Standard Volumetric Glasswares

Stock Aluminium Solution - 500 µg/l

(Aluminium Potassium Sulphate)

Atomic Absorption Spectrometer Metal Free Meter

Burner

Hydrochloric Acid – 1 N

Read Out Mechanism

Nitric Acid, Conc.

Lamp (Hollow Cathode or EDL)

Sulphuric Acid

Pressure Reducing Valves

Hydrofluoric Acid – 1 N

Vent

Potassium Chloride

Nitrous Oxide Burner Head

Aluminium Nitrate

T-Junction Valve or Other Switching Valve Standard Aluminium Solution - 100 µg/l

Air (Compressor or Bottled Gas) (Aluminium Metal)

Acetylene, Standard Commercial Grade Nitrous Oxide Gas

11. Chloride 5.2, Sl. No IS 3025 (P32): 1988 .xi) of Table

2 i) Argentometric Method

ii) Mercuric

Nitrate Method

iii) Potentiometric

Method

Erlenmeyer Flask

(250ml) Burette

Erlenmeyer Flask (250 ml)

Microburette (5 ml with l.c.

0.01ml) Refrigerator pH meter

Glass and Silver- Silver Chloride

Electrodes Electronic Voltmeter Mechanical Stirrer

Potassium Chromate Indicator Solution

(Potassium Chromate, Silver Nitrate) Standard Silver Nitrate Solution – 0.01

N (silver nitrate, sodium chloride) Standard Sodium Chloride Solution – 0.01 N (Sodium Chloride) Aluminium Hydroxide Suspension (Aluminium Potassium Sulphate or Aluminium Ammonium Sulphate, Conc Ammonium Hydroxide) Phenolphthalein Indicator

Solution Sodium Hydroxide – 1N Sulphuric Acid – 1N Hydrogen Peroxide – 30%

Standard Sodium Chloride

Solution, 0.01N Nitric Acid, 0.1N Sodium Hydroxide, 0.1N

Indicator – Acidifier Reagent (S-Diphenyl- carbazone, Conc. Nitric Acid, Xylene Cyanol FF, Ethyl Alcohol or Isopropyl Alcohol) Standard Mercuric Nitrate Solution, 0.01N (Mercuric Nitrate, Conc. Nitric Acid, Sodium Bicarbonate, Std. Sodium Chloride Solution) Mixed Indicator Reagent

(Diphenylcarbazone, Bromo Phenol Blue,

Ethyl Alcohol or Isopropyl Alcohol) Standard Mercuric Nitrate Solution – 0.1N

Standard Sodium Chloride Solution (0.01N)

Nitric Acid-Conc

Standard Silver Nitrate Solution (0.01N)

Pretreatment Reagent (Sulphuric Acid,

Hydrogen Peroxide, Sodium Hydroxide –

1N)

iv) Automated Automated Analytical Equipment Stock Mercuric Thiocyanate Solution

Ferricyanide Method Filters (480nm) (Mercuric Thiocynate, Methanol)

Stock Ferric Nitrate Solution (Ferric

Nitrate, Conc. Nitric Acid)

Colour Reagent (Poly oxy Ethylene 23

Lauryl Ether)

Sodium Chloride

12 Selenium 5.2, Sl. No. i) IS 3025 (P56): 2003

xii) of Table

2

a)Spectrophotometric Spectrophotometer (480nm,light path of 1 Stock Selenium Solution – 1.0mg/ml

Method cm (Sodium Selenite, Hydrochloric Acid)

Volumetric Glasswares Hydrochloric Acid – 0.1N

(Diamino naphthalene Separating Funnel (250ml) Preferably Ammonium Hydroxide,1:1Cyclohexane

method) Flourocarbon Stopcock 2,3 – Diaminonaphthalene (DAN)

Water Bath – Thermostatically Controlled Hydroxylamine Hydrochloride

Detection limit pH Meter Sodium Salt of EDTA

minimum 0.01mg/l Centrifuge Amberlite XAD -8 or Equivalent Resin

Centrifuge Bottles with Flourocarbon Screw Hydrochloric Acid, Conc

Cap Potassium Hydroxide

b) Atomic Absorption Atomic Absorption Spectrometer ( 196.0

Nitric Acid

Spectrometric Method Sulphuric Acid

(Hydride Technique) nm) Fitted with Hydride System and Hollow Hydrochloric Acid

Cathode Lamp/Electrodeless Discharge Hydrogen Peroxide

Lamp

Sodium Hydroxide

Gas (Argon or Nitrogen)

Sodium Tetrahydro borate

Glasswares Decomposition Apparatus

Selenium Stock Solution (1mg/ml)

(Round Bottom Flask, Reflux Condenser,

(Selenium Dioxide)

Condensate Reservoir)

ii) IS 15303:2003

Atomic Absorption Spectrometer Metal Free Water

monochromator or filter and adjustable slit Hydrochloric Acid, Conc

Electrothermal Atomic Hollow Cathode Lamp or Electrodeless Nitric Acid, Conc

Absorption Discharge Lamp Matrix modifier Stock Solutions

Spectrometric Method Graphite Furnace (Magnesium Nitrate, Nickel Nitrate,

Photoelectric Detector Phosphoric Acid, Palladium Nitrate, Citric

Detection limit Readout Mechanism Acid)

minimum 0.002mg/l Sample Dispenser Stock Metal Solution – 1mg/ml (Sodium

Vent for Fumes Selenite)

Cooling Device Chelating Resin – 100 to 200 mesh

Membrane Filter Apparatus (0.45 µ m)

Argon Gas

13 Sulphate 5.2, Sl. No. IS 3025 (P24): 1986

xiii) of Table i)Gravimetric Method Steam Bath Methyl Red Indicator

2

Detection limit more

Drying Oven (thermostatically controlled) Hydrochloric Acid

Muffle Furnace Barium Chloride

than 10mg/l Desiccator Silver Nitrate

Analytical Balance (l.c.0.1mg) Nitric Acid

Filter Paper (Preferably Whatman No.42) Ion Exchange Resin (Amberlite IR-120 or

Silica or Porcelain Crucible (max pore size Equivalent)

of 5 microns)

Ion Exchange Column

Filter (0.45 µ m)

Platinum Dish

ii) Thorin Method White Porcelain Basin Ethyl Alcohol

Detection range 5 to

Burette Ammonium Hydroxide (Ammonia-Conc

Ion Exchange Column and Distilled Water)

150mg/l Filter – 0.45µm Hydrochloric Acid

Thorin (2,2 – Hydroxy – 3,6 – Disulpho –

1 – Naphthylazo Benzene Arsenic Acid)

Ion Exchange Resin (Amberlite

IR-120 or Equivalent)

Stock Sulphate Solution – 100 mg/l

(Anhydrous Sodium Sulphate)

iii)Turbidity Method Turbidity Meter or Spectrophotometer`(420 Barium Chloride – Standard Solution

Detection limit 1 to

nm) (Barium chloride in hydrochloric acid

Glass Apparatus ammonia)

40mg/l Hot Plate Barium Chloride

Refrigerator (recommended) Gelatin Powder

Filter – 0.45µm Glycerol

Hydrochloric Acid, Conc

Sodium Chloride

Ethyl or Isopropyl Alcohol

Anhydrous Sodium Sulphate

Stock sulphate solution – 100mg/l

14 Alkalinity 5.2, Sl. No. IS 3025 (P 23): 1986

xiv) of with Amendment 1& 2 pH Meter Distilled Water

Table 2 i) Indicator Method Burette Sulphuric Acid, Conc

Detection range 0.5 to

Magnetic Stirrer Assembly Sulphuric Acid, 0.02 N

Beaker Phenolphthalein Indicator

500mg/l Mixed Indicator Solution (Methyl Red,

Bromocresol Green, Ethyl or Isoprophyl

Alcohol)

ii)Potentiometric Potentiometer Standard Sulphuric Acid – 0.02N

Method Glasswares

Detection range 0.5 to

500mg/l

15 Calcium 5.2, Sl. No. i) IS 3025 (P40): 1991 xv) of Table with Amendment 1 2

a)EDTA Titrimetric

Method

b)Atomic Absorption

Spectrometric Method

Detection limit

maximum 50mg/l

c) Permanganate

Titration Method

Hot Plate

Glasswares Polyethylene Bottle

Atomic Absorption Spectrometer (422.7 nm )

with Air/Acetylene or Nitrous Oxide/Acetylene

Flame and Hollow Cathode Lamp (Calcium)

Beakers, Cover Glass, and Glass Rod

Filtration Set up (Gooch Crucible with Suction)

Hot plate

Sodium Hydroxide Solution –

1N Hydrochloric Acid – 0.1N Indicator Solution:Murexide (Ammonium

Purpurate) Indicator, Absolute Ethylene

Glycol Sodium Chloride OR

Patton and Reeder’s Indicator (Eriochrome Blue Black R, Sodium Sulphate/Potassium Sulphate)

Standard EDTA Solution – 0.01M

(Disodium Ethylene Diamine Tetra – Acetate, Standard Zinc Solution, (Or

Standard Calcium Solution) Buffer Solution,

Eriochrome Black T Indicator Solution

Stock Calcium Solution (Calcium

Carbonate, Hydrochloric Acid – 0.1N) Nitric Acid, Conc

Hydrochloric Acid – 1N and

0.1N Lanthanum Chloride Cesium Chloride Standard Calcium Solution Hydrochloric Acid – 1N

Methyl Red Indicator

Solution Ammonium

Oxalate Solution Urea Dilute Sulphuric Acid –

1N Sodium Oxalate Standard Potassium Permanganate

Solution (Potassium

permanganate, sodium oxalate)

ii)IS 3025(Part 2) ICP AES ( 315.887 nm) including - Nitric Acid

Inductively Coupled Hydrogen Peroxide

Plasma Atomic computer controlled a e s with background Sulphuric Acid

Emission Spectroscopy correction Hydrochloric Acid

(a e s) Ammonium Sulphate

radio frequency generator

Distilled Water

argon gas supply ( welding grade or better)

Calcium Stock solution ( 10 mg/l )

Detection limit Sample bottles

0.1 mg/l Glassware ( beakers, filter funnels,

volumetric flasks, pipettes)

acid dispensers

Membrane filtration equipment

filter of pore size 0.45 microns

16 Magnesium 5.2, Sl No. i) IS 3025 (P 46): 1994

xvi) of Table with Amendment 1 & 2 Vacuum Pump Methyl Red Indicator

2

Filter Flasks Hydrochloric Acid

a)Gravimetric Method

Filter Crucibles ( medium porosity, 30 ml) Ammonium Oxalate

Muffle Furnace Ammonium Hydroxide

Detection limit more

Nitric Acid, Conc

Diammonium Hydrogen Phosphate

than 1 mg/l Urea

b) Volumetric

Method (EDTA)

c)Atomic Absorption

Spectrophotometric

Method

Detection limit max

5 mg/l

-Hot plate -

Volumetric Flasks

-Glasswares Atomic Absorption Spectrophotometer ( 285.2 nm ) with Air-Acetylene Flame or Nitrous

Oxide-Acetylene Flame and Hollow

Cathode Lamp (Magnesium) Polyethylene Bottles

Indicator Solutions i) Patton and Reeder Reagent,

Sodium Chloride/Potassium Chloride ii)Murexide (Ammonium Purpurate),

Absolute Ethylene Glycol, Sodium Chloride iii)Eriochrome Black T Indicator (EBT

Indicator), Hydroxylamine

Hydrochloride, Ethanol/Methanol

Standard Zinc Solution – 0.01M

(Pure Zinc Dust/Granules –

99.9% Pure; Hydrochloric Acid) Buffer Solution (Ammonium Chloride,

Ammonia, Sodium Hydroxide-1N) Standard Ethylene Diamine Tetra

Acetic Acid (EDTA) Solution –

0.001M (Disodium Ethylene

Diamine Tetra Acetate Dihydrate,

Standard Zinc Solution) Triethanolamine Solution – 10% Potassium Cyanide

Hydroxlamine Hydrochloride

Hydrochloric Acid – 1N and 0.1N

Lanhanum Chloride (Lathanum Oxide, Hydrochloric Acid, Conc)

Cesium Chloride

Standard Magnesium Solution (1000mg/l) (Magnesium Oxide, Hydrochloric Acid)

ii) IS 3025(Part 2)

Inductively Coupled Nitric Acid

Plasma Atomic ICP AES (279.079nm) including -

Emission Spectroscopy Hydrogen Peroxide

computer controlled aes with background Sulphuric Acid

Detection limit correction Hydrochloric Acid

0.03 mg/l

radio frequency generator Ammonium Sulphate

argon gas supply ( welding grade or better) Distilled Water

Sample bottles Magnesium Stock solution ( 10 mg/l )

Glassware ( beakers, filter funnels,

volumetric flasks, pipettes)

acid dispensers

Membrane filtration equipment

17 Sodium 5.2, Sl No. i) IS 3025 (P45): 1993

xvii) of Table with Amendment 1

2 a)Flame Emission

Flame Photometer (Direct Reading OR Deionized Distilled Water

Photometric Method

Internal Standard Type) OR Atomic Stock Sodium Solution – 1mg/ml (Sodium

anyone of the Absorption Spectrophotometer (In Chloride)

following applicable

Flame Emission Mode) Standard Lithium Solution – 1mg/ml

Glasswares

detection range:(0 to

pH meter

1)mg/lit(1 to

Weighing balance

10)mg/lit (0 to

100)mg/lit

b)Atomic Absorption

Spectrometry Method Atomic Absorption Spectrophotometer

Sodium Chloride

Detection range 0.20 to with Air-Acetylene Flame and Hollow Potassium Chloride

4.0mg/l Cathode Lamp (Sodium) Stock Sodium Solution – 1mg/ml

Stock Potassium Solution – 1mg/ml

Glassware

c)Gravimetric Method

Beakers (20ml, Borosilicate) Zinc Uranyl Acetate Reagent (Glacial

Fritted Glass Crucible or Porous Porcelain

Crucibles Conc. Acetic Acid, Uranyl Acetate

Vacuum Pump or Aspirator Dihydrate, Zinc Acetate Dihydrate,

Sodium Chloride)

Filter paper Ethyl Alcohol Wash Solution (Ethyl

Pyrex bottle

Alcohol, Pure Sodium Zinc Uranyl

Acetate, Sodium Chloride, Acetic Acid,

Stirring rod

Diethyl Ether)

ii) IS 3025(Part

2):2004 Oven

Membrane filtration equipment and Nitric acid

filters(0.45µm)

Hydrogen peroxide

Inductively coupled plasma atomic emission

Sulphuric acid

spectrometer; Computer controlled AAS with

background correction, Radiofrequency Hydrochloric acid

Ammonium sulphate

Generator, Argon Gas supply(welding grade or

better) Sodium Stock solution

pH meter

PTFE container

PTFE sample bottles(250 ml or 500ml)

Acid dispensers, Variables

18 Residual 5.2, Sl No. IS 3025 (P 26): 1986

Free xviii) of Stabilized Neutral

Chlorine Table 2 Ortho-Toluidine Method

Detection range 0.005 Spectrophotometer ( wit h light pa t h Distilled Water – Chlorine Demand Free

to 0.01mg/l of 1c m c ell or longer f or ≤ (Distilled Water, Chlorine)

1 mg/ l)

This requirement is not

Magnetic Stirrer Assembly Neutral Ortho-Toluidine Reagent

applicable for PNMW Refrigerator (Recommended)

(Hydrochloric Acid – Conc, Mercuric

Chloride, Disodium Salt of EDTA –

pH meter Dehydrated, Ortho-Toluidine

Brown Glass Stoppered Bottles

Dihydrochloride Buffer Stabilizer

Reagent (Dipotassium Hydrogen

Phosphate, Potassium Dihydrogen

Phosphate, Di (2-Ethyl Hexyl)

Sulphosuccinate, Diethylene Glycol

Monobutyl ether

Potassium Iodide Solution (Potassium

Iodide

Sulphuric Acid Conc. Sodium Carbonate

Sodium Arsenite

Standard Chlorine Solution (Chlorine Gas

&

Distilled Water OR Hypochlorite

Solution) Sodium Thiosulphate Solution

– 0.025N)

20 Mineral Oil 5.2, Sl No IS 3025 (P 39): 1991

.xx) of Table with Amendment 1 Separating Funnel (1lit) with Teflon or Hydrochloric Acid

2 Partition Infra-Red

Equivalent Stopcock Hexane

Method Infra-Red Spectrophotometer – Double Sodium Sulphate, Anhydrous

Beam, Recording type Reference Oil (Iso-Octane, Hexadecane,

Cells – Infra-Red, Silica Benzene)

Filter Paper – Whatman No.40 or Trichlorotrifluoroethane

Detection limit 0.5 to Equivalent, 11cm Diameter

100 mg/l Analytical Balance

21 Anionic 5.2, Sl No. Annex K of pH Meter Sodium Chloride

Surface xxi) of Table IS 13428:2005

Spectrophotometer (650 nm) 10mm & Ethyl Acetate

Active 2 50mm cells Al2O3

Agents (as Gas Stripping Apparatus (1 lit Capacity) Chloroform

MBAS) Nitrogen Air (20 ltr/hr to 50 ltr/hr) Ethanol

Reflux Condenser

Methanol

Detection limit about

Fume hood Sulphuric Acid

0.05 mg/l

Water bath Ethanolic Sodium Hydroxide-0.1

mol/lit (Sodium Hydroxide, Ethanol)

Methylene Blue, Neutral Solution

Methylene Blue, Acidic Solution

Bufer Solution, pH 10 (Sodium

CHydrogen Carbonate, Anhydrous

Sodium Carbonate)

Phenolphthalein Indicator, Ethanol

Dodecyl Benzene Sulphonic Acid Methyl

Ester (Tetrapropylene Type), Stock

Standard Solution

22 Sulphide 5.2, Sl. No. IS 3025 (P 29): 1986 Zinc acetate solution – 2N

xxii) of Table i) Iodometric Method

Glass Fibre Filter Paper.

Sulphuric Acid, Conc.

2 Standard Iodine solution – 0.025 N

Detection limit above 1

Reaction Flask (1 lit capacity with 2 (Potassium Iodide, Iodine)

holestopper fitted with gas-diffusion Hydrochloric Acid, Conc.

mg/l tube. Standard Thiosulphate Solution - 0.025

Absorption flasks (250ml Capacity) (2 N (Sodium thiosulphate, Sodium

No’s) Hydroxide/Chloroform)

Nitrogen/Carbon dioxide gas cylinder Starch indicator solution (Starch, salicylic

Or Carbon dioxide gas generator acid, toluene)

Aluminium Chloride solution – 6N

Sodium hydroxide – 6N

ii) Methylene blue

method Spectrophotometer (664 nm) or

N, N-dimethyl-p-Phenylene Diamine

Detection limit upto 20

oxalate

filterphotometer (600 nm).

mg/l Matched test tubes Sulphuric Acid, Conc. & 1:1 solution

Droppers Ferric Chloride

Dark glass bottle. Diammonium Hydrogen Phosphate

Methylene Blue

Standard Sulphide Solution

Zinc acetate

23 Antimony 5.2 Sl. No. i) Annex G of

xxiii) of IS 13428:2005 Spectrophotometer (565 nm) Hydrochloric Acid – 6 N

Table 2 Spectrophoto-metric

Erlenmeyer Flask (125ml) Phosphoric Acid – 3N

Method Seperating Funnels (125 ml) with Teflon Rhodamine B

Stopcocks Antimony Standard Solution (100

Refrigerator µg/ml and 1 ug/ml (pure antimony,

Ice Bath sulphuric acid)

Test Tubes

Pipettes Benzene

Sulphuric Acid

Perchloric Acid

ii) IS 15303:2003 Atomic Absorption Spectrometer with Metal free Water

Hollow Cathode Lamp OR

Electrothermal

Hydrochloric Acid, Conc.

Electrodeless discharge lamp (EDL). Nitric Acid, Conc.

Atomic Absorption

Graphic Furnace Matrix Modifier Stock Solutions

Spectrometric Method

Readout Mechanism (Magnesium Nitrate, Nickel Nitrate,

Microlitre Pipettes-5 to 100 µl. OR Phosphoric Acid, Palladium Nitrate, Citric

Acid)

Automatic sampling device designed

Stock MetalSolution

for the specific instrument. Antimony Solutions (100 µg/m Sb)

Vent for Fumes

Iron-100µg Fe

Cooling Device

Selenam-1.00 mg Sb

Membrance Filter Apparatus Chelating Resin

(0.45µm) or smaller pore diameter Sodium hydroxide -10 N

membrane filters.

24 Borates 5.2, Sl. No. Annex H of IS Spectrometer (410 – 420nm) Azomethine – H, Sodium Salt xxiv) of 13428:2005 Lab Apparatus made of L + - Ascorbic Acid Table 2 Polypropylene/Polyethylene/Polytetrafluoro Buffer Solution (pH 5.9) [Ammonium Ethylene Acetate, Sulphuric Acid, Phosphoric Acid, Refrigerator Citric Acid, Disodium Ethylene diamine – Tetraacetic Acid Dihydrate] Borate Stock Solution - (1mg/ml) (Boric Acid) Boron Standard Solution - 10µg/ml Calcium Hydroxide

C - REQUIREMENTS FOR TOXIC SUBSTANCES

MERCURY 5.2, Sl. IS 3025 (P 48): 1994

1 No. i) with Amendment 1

of i) Cold Vapour

Table 3

Atomic Absorption

Spectrophotometry

Detection limit

0.0002 mg/l, Min

ii) Colorimetric

Dithizone Method

Detection limit

0.002 mg/l, Min

Atomic Absorption Spectrometer and Associated

Equipment (Cold Vapour Technique) Mercury Vapour Generation Assembly

Mercury Hollow Cathode Lamp Recorder/Printer/Display

Meter BOD bottle, 300 ml Water bath Equipment assembly as per Fig 1 Spectrophotometer

Separating Funnels (250 and 1000ml with PTFE stopcocks)

Glass wares Whatman Filter No. 42

Sulphuric acid, conc.

Nitric acid, Conc. Stannous chloride

Hydrochloric acid,

Conc. Sodium chloride Hydroxylamine sulphate

Potassium permanganate

Potassium persulphate

Mercuric chloride Mercury free distilled water

Redistilled or Deionised Distilled

Water (Mercury free) Mercuric chloride

Nitric acid, Conc. Potassium permanganate

Potassium persulphate Hydroxylamine hydrochloride Dithiozone solution, 6 µg/ml

Sulphuric acid – 0.25

N Potassium bromide Chloroform

Disodium hydrogen phosphate

Anhydrous potassium carbonate

Sodium sulphate, Anhydrous Hydrochloric acid (1:1)

Ammonium hydroxide

CADMIUM 5.2, Sl. IS 3025 (P 41): 1992 Atomic Absorption spectrophotometer Hydrochloric acid, Conc.

2 No. ii) with Air-Acetylene Flame Nitric acid, Conc.

of i) Atomic Absorption Cadmium Hollow Cathode Lamp or Nitric acid, dilute – 1:499

Table 3 Method (Direct) Multi Element Hollow Cathode Lamp Pure Cadmium Metal

Detection range

for Use at 228.8 nm

0.05 to 2mg/l

ii) Atomic Absorption Atomic Absorption spectrophotometer Hydrochloric acid, Conc.

Method (Chelation with Air-Acetylene Flame Hydrochloric acid – 1:49

and Extraction) Cadmium Hollow Cathode Lamp or Nitric acid, Conc.

Detection range Multi Element Hollow Cathode Lamp Nitric acid, dilute – 1:499

0.005 to 0.2mg/l for Use at 228.8 nm Pure Cadmium Metal

Separating funnel

Sodium hydroxide

pH meter

Methyl Isobutyl Ketone (MIBK)

pH paper

Bromophenol Blue

Ethanol or Isopropanol

Pyrrolidine dithiocarbamic acid

Carbon Disulphide

iii) Differential Pulse Polarograph – Capable of Differential Pulse Work

Hydrochloric Acid, Conc., spectrograde

Anodic Stripping Nitric Acid, Conc., spectrograde

Voltametry Hanging MercuryDrop Electrode

Nitric Acid, dil – 1:1

Platinum Counter Electrode

Hydroxylamine Hydrochloride

Detection range Saturated calomel Reference Electrode

L-Ascorbic Acid

Magnetic Stirrer Control Unit with Stirring Bar

0.0001 to 0.1mg/l Pure Cadmium Metal

Nitrogen Gas (Cylinder)

Granular Zinc

Scrubber assembly for nitrogen purification

Mercury

Voltametric Cell assembly

Ammonium Meta Vanadate

3 ARSENIC 5.2, Sl. IS 3025(P 37): 1988 Atomic absorption spectrometer equipped with gas Argon or Nitrogen and Hydrogen

No. iii)

of i) Atomic absorp tion flow meter for Argon or Nitrogen and Hydrogen Sodium borohydride

Table 3 method and with arsenic electrode less discharge lamp Sodium hydroxide

Detection limit

Atomizer Sodium Iodide

Reaction cell for producing arsenic hydride Sulphuric acid-18N & 2.5 N

0.001 mg/l Eye dropper or syringe Potassium persulphate

Refrigerator Nitric acid, conc

Perchloric acid, conc

Hydrochloric acid, conc

Arsenic trioxide

Arsenic pentaoxide

Dimethyl arsenic acid/cacodylic acid

Calcium chloride

ii) Silver diethyl Arsine generator & absorption assembly Hydrochoric acid , Conc

Potassium Iodide

dithiocarbamate (Fig 2 of IS 3025 Pt 37)

Stannous chloride, arsenic free

method Spectrophotometer, 535 nm with 1 cm cells

(Refree method) Lead acetate

Ephedrine

Detection limit

Pyridine

0.001 mg/l

Chloroform

Silver diethyl dithiocarbamate

Zinc – 20 to 30 mesh, arsenic free

Arsenic trioxide

Sodium hydroxide

iii) Mercuric bromide Arsine generator glass assembly (Fig 3 of IS Sulphuric acid (1:1)

stain method 3025 Nitric acid, conc

Detection limit

Pt 37) Roll cotton

Lead acetate

0.001mg /l

Arsenic papers

Mercuric bromide

Ethyl alcohol/isopropanol

Potassium iodide

Arsenic free stannous chloride

Zinc-20 to 30 Mesh, arsenic free

Arsenic trioxide

Sodium hydroxide

CYANIDE 5.2, Sl. IS 3025(P.27): 1986

4 No. iv) with

of Amendment 1

Table 3 i) Total cyanide after

Distillation apparatus consisting of boiling flask, Sodium hydroxide

1l, thistle tube, Allihn water cooled condenser, gas Lead carbonate-powdered

distillation method dispersion tube, needle valve, suction flask and Sulphamic acid

Detection limit

suction pump (Fig 1 of IS 3025 Pt 27) Magnesium chloride

Heating mantle Sulphuric acid, conc

minimum 0.02 mg/l Gas absorber Acetic acid, glacial

Ground glass ST joints Potassium cyanide

Spectrophotometer for use at 62 nm with 1-cm cell Silver nitrate

pH paper Chloramine - T

Thermometer – 0oC – 110

0C, l.c. 1

oC Pyridine

Pyrazolone

BIS – pyrazolone

Expanded – scale pH meter or specific Ion meter

Potassium cyanide

ii) Selective electrode Silver nitrate

Cyanide Ion selective electrode

Sodium hydroxide

method

Reference electrode, double junction Potassium nitrate

Detection range Magnetic mixer with TFE coated stirring Bar Potassium hydroxide

0.05 to 10 mg/l

5 LEAD 5.2, Sl. IS 3025(P 47): 1994

No. v) with Hydrochloric acid, conc

of Amendment 1 & 2 Atomic absorption spectrophotometer with air Nitric acid, conc.

Table 3 i) Atomic absorption acetylene flame (Lead nitrate

method (direct) Hollow cathode lamp OR Electrodeless Discharge Nitric acid, dil (1:499)

Detection range

lamp for use at 283.3 nm

1.0 to 10.0mg/l

ii) Atomic absorption

Hydrochloric acid, conc

Hydrochloric acid, dil (1:2)

method (chelation – Atomic absorption spectrophotometer with air

Hydrochloric acid, dil (1:49)

extraction) acetylene flame Nitric acid, conc.

Hollow cathode lamp OR Electrode less Discharge

Detection range

Pyrrolidine

lamp for use at 283.3 nm Chloroform

0.1 to 1.0 mg/l (with Separatory funnel

Carbon disulphide

graphite system 0.45µm membrane filter

Sodium hydroxide

0.001 mg/l)

Acid washed filter paper

Bromophenol blue

pH meter

Lead nitrate

iii) Differential pulse

anodic stripping

voltametry (DPASV) Polarograph capable of performing differential Lead nitrate

Detection range

pulse work Hydrochloric acid, conc.

Hanging mercury drop electrode Nitric acid, conc.

0.001 to 0.1mg/l Platinum counter electrode Nitric acid, dil (1:1)

Saturated calomel reference electrode Granular zinc

Magnetic stirrer control unit with stirring bar Mercury

Scrubber assembly for nitrogen purification Ammonium metavandate

Nitrogen gas (cylinder)

0.45µm membrane filter

iv) Dithizone method Spectrophotometer for use at 510 nm with 1-cm Lead free distilled water

Detection limit

cell Lead nitrate

0.1 mg/l

pH meter Nitric acid, 95% (w/w)

TEF beakers, 100 ml Nitric acid, dil 20% (w/w)

Separating funnels, 250 ml, 500 ml Nitric acid, dil (1:1)

Ammonium hydroxide Conc. (14 N)

Ammonium hydroxide, dil. 10% ( v/v)

Ammonium hydroxide, dil. 1% v/v)

Anhydrous Ammonium Citrate

Anhydrous Sodium Sulphite

Hydroxylamine hydrochloride

Potassium cyanide

Dithizone

Chloroform

Hydrochloric acid (1:1)

6 CHROMIUM

5.2, Sl. Annex J of IS Atomic absorption spectrophotometer with Deionised distilled water, Ammonia free

No. vi) 13428:2005 reducing Air – acetylene flame Nitric acid, redistilled – 1:1 (v/v)

of 0.45µm membrane filter Hydrochloric acid, redistilled – 1:1 (v/v)

Table 3 pH meter Chromium oxide

Centrifuge Lanthanum chloride

Lanthanum oxide , 99.9%, w/w

Ammonium pyrrolidine dithocarbamate

7 5.2, Sl. Annex L of IS Atomic absorption spectrophotometer with Nitric acid, conc. – 1.4 g/ml

No. vii) 13428:2005 nebulizer – burner having air- acetylene flame Pure nickel metal

NICKEL of Centrifuge Sodium hydroxide

Table 3 Nickel hollow cathode lamp/electrode less Hydrochloric acid, conc. – 1.19 g/ml

discharge lamp Methyl isobutyleketone (MIBK)

Separating funnel, 250-ml with PTFE taps Ammonium 1 – pyrrolidino

pH meter carbodithioate

Bromophenol blue

Ethanol

8 POLY 5.2, Sl. Annex M of Gas chromatograph with EC detector & coupled Silica gel, 60 – 100 mesh

CHLORINATED No. IS 13428:2005 with printer-plotter-cum- integrator N-hexane-redistilled

BIPHENYLE viii) of Glass chromatographic column, 300 mm long, 8 Potassium hydroxide pellets

(PCB) Table 3 mm ID with ground glass socket at the upper end Sodium hydroxide solution – 5N

and a stop cock at low end. Diethyl ether, chromatography grade

Kuderna-Danish type, evaporator Cotton wool, extracted with hexane and

Snyder columns diethyl ether

Syringe (5 µl) Acetic acid, glacial, redistilled

Heating oven Chromium trioxide, re-crystallized

Desiccator Apiezon L grease

Epikote Resin 1001 – 0.15 %

Chromosorb G (acid washed) DMCS

treated, 60 – 80 mesh

Silicone gum GE-S-SI – 1.3 %

POLYNUCLEAR 5.2, Sl.

9 AROMATIC i) High Performance High Performance Liquid Chromatograph Reagent Water

HYDROCARBON No. ix) Liquid (HPLC) complete with gradient pumping system, Sodium thiosulphate, granular

of Chromatography reverse phase column and detectors (UV and Cyclohexane

Table 3 (HPLC) Method fluorescence) Methanol

APHA Acetone,

6440

Gas Chromatograph (GC) complete with column

ii) Gas Methylene chloride

and flame ionization detector.

chromatographic

Pentane – Pesticide quality or

Separating funnel (2 l)

equivalent.

(GC) Method

Evaporative flask Acetonitrile – HPLC quality

Three Ball Synder column Sodium sulphate, granular, anhydrous

Kuderna- Danish Apparatus Silica Gel – 100/200 mesh

Water bath (60-65˚C) Stock standard solution Std. PAHs Solutions – (a) 100 µg/ml of naphthalene, acenaphthylene, fluorine, phneanthrene and anthracene. (b) 5µg/ml Benzo (k) fluoranthene

*Note: Besides listed Equipments/Apparatus/Chemicals, following accessories are essential part of a chemical lab:

i) General glass wares like Pipettes Burette, Conical flasks, Beakers, Measuring cylinders, Volumetric flasks, (of different volumes)

ii) Provision for distilled/double distilled water

iii) Fuming Hood and sink with tap in the lab

# The list does not cover the requirements of Pesticide Residues and Radio Active Residues as these requirements are got to be tested from

outside approved lab.

D - MICROBIOLOGICAL REQUIREMENTS

General microbiological lab equipments **

Hot air oven (capable of 180 ºC). Autoclave (capable of 15 psi/ 121 ºC) of suitable size as per need.

Weighing Balance with least count 0.01 g (least count 0.001 g, if Tergitol-7 agar medium or Crystal violet neutral red bile lactose (VRBL) agar is being prepared in house).

pH meter with least count 0.1 pH unit. Laminar air flow chamber OR inoculation room/cabinet fitted with U.V. tube light. Hot plate for media preparation. Membrane filtration assembly (including sterilized membrane filters of 47 mm to 50 mm diameter with 0.45 µm pore size, vacuum pump (for applying vacuum of about 70 kPa) and forceps with rounded tips).

Inoculation loop/needle. Bunsen burner with LPG cylinder.

Thermostatically controlled water

bath. Air conditioner (recommended) Refrigerator Colony counting equipment (recommended)

General glasswares including, petri dishes (made of glass or plastic), volumetric pipettes (of capacity 1 ml and 10 ml), flasks, test tubes, culture bottles, funnels, glass rod, measuring cylinders. Thermometer with least count 1

°C Filter Paper Cotton

Sl Parameter Clause Referred Method Test Equipment/Apparatus ** Chemicals/Media/Reagents **

No. Ref. of Test

(1) (2) (3) (4) (5) (6)

1 Escherichia 5.1.1 of IS i) Reference General microbiological lab equipments Distilled water

coli (or 14543 : method (as listed above) MacConkey broth medium – (Peptone, Sodium

thermotolerant 2004 taurocholate or Bile salts, Sodium chloride, Lactose,

bacteria) 6.1.1 of IS

IS 5887 (Part 1) : Incubator capable of maintaining 37 °C

Neutral red, Ethanol)

13428 : 1976 2005

@ Incubator capable of maintaining 44 °C (for test for growth with acid and gas

production in MacConkey broth)

@

Glass tubes open at both ends (for motility test)

@ Seitz filtration assembly (for sterilizing solution of urea for preparing medium for urease test)

Durham’s fermentation tubes (for

carbohydrate fermentation test)

@

Microscope and Glass slides (for Gram staining)

MacConkey agar medium – (MacConkey Broth, Agar)

Eosin methylene blue lactose agar medium –

(Peptone, Dipotassium hydrogen phosphate,

Agar, Lactose, Eosin Y, Methylene blue)

Tergitol-7 agar medium – (Proteose peptone, Yeast

extract, Lactose, Agar, Tergitol-7, Bromothymol blue)

@

Nutrient broth – (Peptone, Meat extract, Sodium chloride)

@ Nutrient agar – (Nutrient broth, Agar)

@

TSI medium for H2S test – (Meat extract, Yeast

extract, Peptone, Glucose, Lactose, Sucrose, Ferrous sulphate, Sodium chloride, Sodium thiosulphate, Agar, Phenol red)

@ Medium for urease test – (Peptone, Sodium

chloride, Agar, Potassium dihydrogen phosphate, Phenol red, Glucose, Urea)

@

Protease species as control for urease test (optional)

@ Medium for indole production – (Peptone, Sodium

chloride, Strain of bacterium known to produce indole)

@

Kovac’s reagent (for indole test) – (p-Dimethyl-

aminobenzaldehyde, Amyl alcohol or Iso-amyl alcohol,

Concentrated hydrochloric acid)

@ Medium for methyl red and Voges-Proskauer tests –

(Peptone, Dipotassium hydrogen phosphate, Glucose)

@

Methyl red, absolute ethanol (for methyl red test) @

α-naphthol, ethanol, potassium hydroxide (for Voges- Proskauer Reaction)

@ Simmon’s citrate agar – (Sodium chloride,

Magnesium sulphate, Ammonium dihydrogen phosphate, Dipotassium hydrogen phosphate, Sodium citrate, Agar, Bromothymol blue)

@ Peptone water medium (for carbohydrate

fermentation test) – (Peptone, Sodium chloride, Andrade’s indicator, Sugar)

@ Andrade’s indicator (for Peptone water medium

for carbohydrate fermentation tests) – (Sodium hydroxide, Acid fuschin)

@ Gram stain – (Methyl violet or Crystal violet, Iodine,

Potassium iodide; Neutral red, Acetic acid, Ethanol)

@

Lactose (for carbohydrate fermentation test)

ii) IS 15185 : General microbiological lab equipments Distilled water

2002 (as listed above)

Lactose TTC agar with sodium heptadecylsulphate – Water bath and/or incubator (Lactose, Peptone, Yeast extract, Meat extract, a) Standard Test thermostatically controlled (36 ± 2 °C and Bromothymol blue, Agar; 2,3,5 Triphenyltetrazolium 44.0 ± 0.5 °C chloride (TTC), Sodium heptadecylsulphate (Tergitol- 7))

Membrane filter of 0.2 µm pore size (for sterilizing TTC solution during preparation Tryptone soy agar (TSA) – (Tryptic digest of casein, of Lactose TTC agar) Soy peptone, Sodium chloride, Agar)

Tryptone broth – (Tryptic digest of casein, L- tryptophan, Sodium chloride)

Oxidase reagent – (Tetramethyl-p-phenylene diamine hydrochloride)

Kovac’s Reagent – (p-Dimethylaminobenzaldehyde, Amyl or butyl alcohol , Concentrated hydrochloric acid) b) Rapid test General microbiological lab equipments Distilled water

(Optional) (as listed above) Ultra violet lamp, wavelength 254 nm (low pressure mercury lamp) Tryptone soy agar (TSA) – (Tryptic digest of casein, Soy peptone, Sodium chloride, Agar)

Filter pads, with a diameter of at least 47 mm. Tryptone bile agar (TBA) – (Tryptone, Bile salts, Agar)

Water bath and/or incubator thermostatically controlled (36 ± 2 °C and Indole reagent – (p-Dimethylaminobenzaldehyde, 44.0 ± 0.5 °C Concentrated hydrochloric acid)

2 Coliform 5.1.2 of IS i) Reference General microbiological lab equipments Distilled water

Bacteria 14543 : method (as listed above)

2004 IS 5401 (Pt. 1) :

Crystal violet neutral red bile lactose (VRBL) agar –

6.1.2 of IS 2012 Incubator capable of operating at 30 ºC ± (Enzymatic digest of animal tissues, Yeast extract,

13428 : 1 ºC or 37 ºC ± 1 ºC Lactose, Sodium chloride, Bile salts, Neutral red,

Crystal violet, Agar)

2005

@ Test tubes of dimensions approximately

@ Brilliant green lactose bile broth – (Enzymatic digest

16 mm x 160 mm

of casein, Lactose, Dehydrated ox bile, Brilliant green)

@ Durham tubes of dimensions appropriate

for use with the test tubes

ii) IS 15185 : General microbiological lab equipments Distilled water

2002 (as listed above) Lactose TTC agar with sodium heptadecylsulphate –

(Lactose, Peptone, Yeast extract, Meat extract,

Bromothymol blue, Agar; 2,3,5 Triphenyltetrazolium

Water bath and/or incubator chloride (TTC), Sodium heptadecylsulphate (Tergitol-

Standard Test thermostatically controlled (36 ± 2 °C and 7))

44.0 ± 0.5 °C Tryptone soy agar (TSA) – (Tryptic digest of casein,

Soy peptone, Sodium chloride, Agar)

Membrane filter of 0.2 µm pore size (for

sterilizing TTC solution during preparation Tryptone broth – (Tryptic digest of casein, L-

of Lactose TTC agar) tryptophan, Sodium chloride)

Oxidase reagent – (Tetramethyl-p-phenylene diamine

hydrochloride)

Kovac’s Reagent – (p-Dimethylaminobenzaldehyde,

Amyl or butyl alcohol , Concentrated hydrochloric

acid)

Rapid test General microbiological lab equipments Distilled water

(Optional) (as listed above)

Tryptone soy agar (TSA) – (Tryptic digest of casein,

Ultra violet lamp, wavelength 254 nm (low Soy peptone, Sodium chloride, Agar)

pressure mercury lamp)

Tryptone bile agar (TBA) – (Tryptone, Bile salts,

Filter pads, with a diameter of at least 47 Agar)

mm.

Indole reagent – (p-Dimethylaminobenzaldehyde,

Water bath and/or incubator Concentrated hydrochloric acid)

thermostatically controlled (36 ± 2 °C and

44.0 ± 0.5 °C

3 Sulphite 5.1.4 of IS Annex C of IS General microbiological lab equipments Distilled water

reducing 14543 : 13428 : 2005 (as listed above)

anaerobes 2004 Screw cap bottles or vials and stoppers of Differential reinforced clostridial medium (DRCM) –

boron silicate glass of capacities 200, 100

6.1.4 of IS

and 25 ml (Peptone tryptic digest of meat , Meat extract, Yeast

13428 : Test tubes - 150 mm x 13 mm extract, Starch, Hydrated sodium acetate, Glucose, L-

cysteine-hydrochloride, Sodium hydroxide)

2005

Iron wire Sodium sulphite

Incubator (37 ºC ± 1 ºC) Iron (III) citrate

Anaerobic jar assembly (recommended)

4 Pseudomonas 5.1.5 of IS Annex D of IS General microbiological lab equipments Distilled water

aeruginosa 14543 : 13428 : 2005 (as listed above) Medium for determination of presumed Pseudomonas

2004

aeruginosa – (DL asparagine, L proline, Anhydrous

6.1.5 of IS Screw capped bottles dipotassium hydrogen phosphate, Magnesium sulphate

13428 : heptahydrate, Anhydrous potassium sulphate, Ethanol)

2005 Incubator (37 ± 1° C)

@ Confirmatory medium (Milk agar medium) – [Skim

milk powder, Bacteriological yeast extract, Peptone,

Sodium chloride, Agar hexadecyltrimethyl ammonium

UV cabinet fitted with UV lamp emitting bromide (centrimide)]

light of wavelength 360 ± 20 nm

Magnetic stirrer (recommended)

@ Clause D-10 (NOTE) of IS 13428 : 2005 specifies

confirmation of non-pigmented strains as a further step, if

required. Annex 2D of IS 13428 : 2005 specifies

Cellulose acetate or nitrate membrane of

biochemical characteristics to be tested for this purpose.

No specific apparatus, media and reagents have been

pore size 0.22 µm (for alternate

specified for the same. It is specified that commercially

sterilization of ethanol)

available identification kits may be used for this.

@ Incubator, capable of being maintained

at 42 ± 0.5° C

5 Aerobic 5.1.6 of IS IS 5402 : 2012 General microbiological lab equipments Distilled water

Microbial 14543 : (as listed above)

Count 2004 Plate count agar (PCA) – (Enzymatic digestion of

This Incubators 21 ºC ± 1 ºC and 37 ºC casein, Yeast extract, Glucose anhydrous, Agar)

requirement is

not applicable Colony counting equipment Overlay medium (if necessary) – Agar

for Packaged

Natural

Mineral Water

6 Yeast and 5.1.7 of IS IS 5403 : 1999 General microbiological lab equipments Distilled water

Mould 14543 : (as listed above)

2004 Yeast extract-dextrose-chloramphenicol-agar medium

6.1.6 of IS Incubator (25 ± 1 ºC) – (Yeast extract, Dextrose, Chloramphenicol or

13428 : Oxytetracycline hydrochloride, Agar)

2005

** NOTES Note 1 – The list does not cover the following requirements, as these parameters are got to be tested from outside approved lab:

i) Faecal streptococci and Staphylococcus aureus.

ii) Salmonella and Shigella.

iii) Vibrio cholera and V. parahaemolyticus. Note 2 – General Microbiological Lab Equipments as listed are common for various microbiological tests. Other additional equipments required for

specific test methods are indicated against each parameter. Note 3 – For preparation of culture media and reagents ingredients of uniform quality and chemicals of analytical reagent grade should be used.

Alternatively, commercially available media and reagents may be used provided their composition comply with those given in Indian Standards. Note 4 – Disposable glassware may be accepted as an alternative to re-usable glassware. Note 5 – All efforts have been made to compile the list as per the respective standards exhaustively covering all the required test equipments, apparatus and

chemicals. However, in case any omission or incorrectness is noticed while referring, the same may be conveyed to CMD immediately for suitable actions.

@

The marked equipments/ chemicals and media are required for confirmatory tests of respective microorganisms. The confirmatory test may be

dispensed with/omitted, provided the licensee undertakes to start corrective actions based on presumptive presence of microorganisms.

E - REQUIREMENTS FOR BOTTLES/CONTAINERS FOR PACKAGED WATER

Sl. Clause No. Specified Test Facility Range and Accuracy/ Method of Test/ No. of IS Requirement Requirement Least Count ( If and Remarks (If any)

15410:2003 as Applicable) 1 4.1 Material --- ---- Raw Material

conformity to ISs is indicated 2 4.2 Design, Shape Visual -----

4.2.1 and Dimensions 3 4.3 Manufacture,

Workmanship, 4.3.1 Finish and ----- To adhere GMP 4.3.2 Appearance Visual ----- -- 4 4.4 Capacity Weighing Balance Suitable range with , Cl 5 of IS 2798

LC 0.1 g for Balance or or Measuring Cylinder 1 ml for Cylinder 5 4.5 Wall Thickness Micrometer Suitable Range with Cl 4.5 of IS 2798

LC 0.02 mm 6 4.6.2 Transparency Transparency/ Haze Meter Range upto 100 %, Annex A of

LC 1% IS 15410 7 4.6.3 Leakage Test Vibration Leakage Tester as per Cl. 6.2.1 of - Cl 6 of IS 2798

IS 2798 Reservoir Air Pressure Leakage Tester 8 4.6.4 Drop Test Drop Tester with height of 0.5 m Cl 8 of IS 2798 9 4.6.5 Migration Test Oven/Water Bath Capable of IS 9845

Hot Plate maintaining Analytical Balance 40+2° C SS Evaporating Dish Dessicator Glass Beaker, pyrex, 1000 ml Pouch Sealing Machine 10 4.6.6 Water Potability Conditioning Chamber Capable of Annex B of

Test maintaining 38+2° C IS 15410

F- REQUIREMENTS FOR POLYETHYLENE FLEXIBLE POUCHES FOR PACKAGED WATER Sl. Clause Specified Test Facility Range and Accuracy/ Method of Test/ Remarks (If any)

No. No. Requirement Requirement Least Count ( If and

as Applicable)

Clause 6.1 Requirements for Films

1 6.1.1 Description Visual -----------------

2 6.1.2 Film Form Visual -----------------

3 6.1.3 Winding of Film Visual -----------------

4 6.1.4 Odour Olfactory -----------------

5 6.1.5 Thickness Dead Weight Dial Suitable Range with A-2 of IS 2508

(65± 5µ/ 75± 5µ) Micrometer LC 1 µ

6 6.1.6 Width (in mm) Scale Suitable Range,

LC 1 mm

7 6.1.7 Overall Migration Oven/Water Bath Capable of IS 9845

Hot Plate maintaining 40 + 2

o C

Analytical Balance

SS Evaporating Dish

Dessicator

Glass Beaker, pyrex, 1000 ml

Pouch Sealing Machine

8 6.1.8 Tensile Strength Tensile Testing Machine of LC 0.01 kN A-4 of IS 9845

suitable range

9. 6.1.9 Elongation at Tensile Testing Machine of LC 0.01 kN A-4 of IS 9845

break suitable range

10. 6.1.10 Dart Impact Dart Impact Tester with Drop Set of weights A-6 of IS 9845

Resistance Height of 66 cm (Min. Impact failure

load : 2.20 N)

Clause 7 Requirements for Pouches

11. 7.1 Vibration Vibration Table Table conforming to Annex D of

Leakage Test Temp. - Ambient or

IS 7028 (Pt 2) IS 15609

27 + 2

0 C in Frequency of

case of dispute vibration 2 Hz

12. 7.2 Water Potability Oven/Heating Arrangement Capable of Annex E of

Test Pouch Sealing Machine

maintaining 38 + 2

o C IS 15609

13. 7.3 Stack Load Test Flat Wooden Plank Set of weights for Annex F of

Temp. - Ambient or 20 N to 200 N IS 15609

27 + 2

0 C in

case of dispute

14. 7.4 Drop Test Arrangement for flat drop ----------- Annex G of

from 1.2 m height IS 15609

15. 7.5 Ink Adhesion Test Pressure Sensitive Tapes or 25 mm wide tape Annex H of

for Printed Pouch Cello- Tape Arrangement for

IS 15609

pulling tape at 10

mm/s at about 90 o

16. 7.6 Product Paper Tissue -------------- Annex J of

Resistance Test IS 15609

for Printed Pouch

Clause 8 Construction

17. 8 Construction Visual -----------------

Chemicals List FOR PDW - TEST

REQUIREMENTS

SL.NO PARTICULARS QUANTITY MAKE REMARK

1 Aluminium Potassium Sulphate

2 Ammonium Acetate

3 Ammonium Chloride

4 Ammonium Dichromate

5 Ammonium Ferrous Sulphate ( Ferrous

Ammonium Sulphate )6 Ammonium Nitrate

7 Ammonium Sulphate

8 Ascorbic Acid

9 Acetic Acid Glacial

10 Ammonia Solution

11 Acetone - E (Ethanol)

12 Acetone M (Methanol)

13 Barium Chloride

14 Boric Acid

15 Buffer Tables (4.00, 7.00 & 9.2)

16 Bromocresol Green Power

17 Cobaltus Chloride

18 Calcium Carbonate

19 Calcium Chloride

20 Calcium Hydroxide

21 Charcoal Activated crystals

22 Cirtic acid

23 Copper metal powder

24 Cupric sulphate

25 chloroform AR

26 Cyclohexanone

27 Di ammonium Hydrogen Orthophosphate

28 Dodecyl Benzene Sulphonic Esther

29 Devardas Alloy

30 Di Iso Propyl Ether

31 E.D.T.A. DI Sodium Salt AR

32 Erithrome Black-T

33 Erichrome Cyanine R Dye

34 Ethyl Acetate

35 Ferric Chloride

36 Ferric Citrate (Iron Citrate)

37 Glycerol (Glycerin)

38 Gelatin Power

39 Hexamine (Hexamethylene tetra amine)

40 Hydrazine Sulphate

41 Hydroxylamine Hydrochloride

42 Hydrochloric Acid

43 Hydrogen Peroxide

44 Magnesium Sulphate

45 Mercury lodide

46 Methyl Orange

47 Methyl Red

48 Methyl Blue

49 NED Dihydrochloride

50 N-N-Dimethyline Diamine P-Oxalate

51 Neocuproine

52 Nitric Acid

53 Ortho Phosphoric Acid

54 Patton & Reeder's

55 Phenolphthalein

56 Pottassium Periodate

57 Pottassium Chloride

58 Potassium Chloroplatinate

59 Potassium Chromate

60 Potassium Hydrogen Sulphate

61 Potassium Iodide

62 Potassium Nitrate

63 Potassium Permanganate

64 Potassium Sulphate

65 1,10 Pehnathroline

66 Propan-2-ol (Iso Propyl Alcohol)

67 Silver Nitrate

68 Sodium Ascorbate

69 Sodium Tetra Borate

70 Sodium Acetatee

71 Sodium Carbonate

72 Sodium Chloride

73 Tri Sodium Citrate

74 Sodium Hydrogen Carbonate

75 Sodium Hydroxide

76 Sodium Nitrite

77 Sodium Oxalate

78 Sodium Sulphate

79 Sodium Sulphite

80 Sodium Thio Sulphate

81 Starch

82 Sulphanilamine

83 Sulphuric Acid

84 Sulphurdioxide

85 Trithanolamine

86 Urea

87 Zine Metal

88 Zine Sulphate

89 Zincon

90 Asparagine Proline Broth

91 Chlorophenical Yeast Extract Agar

92 Differential Reinforced Clostridial Broth

93 Kovac's Indole Regent

94 Milk Agar

95 Oxidase Reagent

96 Plate Count Agar

97 Tergitaol - 7 Agar

98 TTc Solution (Himedia)

99 Tryptone Broth

100 Tryptophan Broth

101 TryptoneSoy Agar

102 Gram Staining Kid

103 Sodium Sulphide

104 Manganese Sulphate

105 Paraffin Oil

Glassware

list for SL.NO. PARTICULAR Quantity No's

1 Aluminium Foil

2 Bunsen Burner

3 Burette Glass 50 ml

4 Burette Stand with Clamp

5 Beaker Glass 100 ml

6 Beaker Glass 250 ml

7 Beaker Glass 500 ml

8 Beaker PVC 250 ml

9 Beaker PVC 500 ml

10 Cover Glass

11 Cotton absorbent/non Absorbent

12 Centrifuge Table Model 4 Tube

13 Conical Flask Glass 100 ml

14 Conical Flask Glass 250 ml

15 Conical Flask Glass 500 ml

16 Conical Flask PVC 250 ml

17 Desicator 2 liter capacity with inner plate

18 Dropper

19 Durham's Tubes

20 Distillation Apparatus 1 liter capacity

21 Distillation Apparatus Stand

22 Evaporating Dish Glass 250 ml

23 Evaporating Dish Glass 125 ml

24 Enamel Tray

25 Filter assembly Glass

26 Filter Funnel S.S. 250 ml

27 Filter paper

28 Filter Paper Whatman 40 (125 mm)

29 Filter paper Membrane (0.45 micron)

30 Filter paper Membrane (0.22 micron)

31 Funnel Glass 25 ml

32 Funnel Glass 50 ml

33 Funnel Glass 100 ml

34 Funnel PVC 100 ml

35 Gas stripping apparatus with stand, flow meter &

air unit36 Gibbs Apparatus (250 ml)

37 Glass Rod

38 Glass bits

39 Iodine Flask Glass 250 ml

40 Iodine Flask Glass 100 ml

41 Inoculation Loop with Wire

42 Iron wire 1 meter

43 Kjeldal assembly 1 L capacity

44 Kjeldal assembly stand

45 Measuring cylinder Glass 10 ml

46 Measuring cyliner Glass 25 ml

47 Measuring cyliner Glass 50 ml

48 Measuring cylinder Glass 100 ml

49 Nessler Tube Stand PVC 100 ml

50 Nessler Tube Stand PVC 50 ml

51 Nessler Cylinder 100 ml

52 Nessler Cyliner 50 ml

53 Petridish's Glass

54 Petridish Container S.S

55 Pestle & Mortat

56 Pipette Gradual 1 ml

57 Pipette Gradual 2 ml

58 Pipette Gradual 5 ml

59 Pipette Gradual 10 ml

60 Pipette Gradual 0.1 ml

61 Pipette Volumetric 50 ml

62 Pipette Volumetric 20 ml

63 Pipette Volumetric 10 ml

64 Pipette Rock PVC

65 Pipette Container S.S

66 Procelain tiles

67 pH paper 1 Box

68 Reagent Bottle N/M Glass 500 ml

69 Reagent Bottle N/M Glass 250 ml

70 Reagent Bottle N/M Glass 100 ml

71 Reagent Bottle N/M Glass 50 ml

72 Reagent Bottle PVC 500 ml

73 Reagent Bottle PVC 100 ml

74 Reagent Bottle Amber 500 ml

75 Reagent Bottle Amber 250 ml

76 Reagent Bottle Amber 100 ml

77 Rubber Bulb (For pipette Out)

78 Rubber Tube 10 mm special

79 Separating Funnel 250 ml

80 Separating Funnel 125 ml

81 Separting Funnel Stand

82 Silica Crucible 50 ml

83 Slides

84 Spatula S.S

85 Standard Flask Glass 500 ml

86 Standard Flask Glass 250 ml

87 Standard Flask Glass 100 ml

88 Standard Flask Glass 50 ml

89 Standard Flask PVC 100 ml

90 Standard Flask PVC 250 ml

91 Screw Cap (Culture) Bottle 125 ml (wide mouth)

92 Screw Cap (Culture) Bottle 60 ml

93 Screw Cap (Culture) Bottle 30ml

94 Test Tube 10 ml

95 Test Tube 20 ml

96 Test Tube stand PVC

97 Tissue Paper

98 Tripart Stand

99 Tongs

100 Test-tube Holder

101 Thermo Meter 50 C (0.5 C least count)

102 Thermo Meter 110 C

103 Thermo Meter 350 C

104 Watch Glass 3"

105 Watch Glass 4"

106 Watch Glass 5"

107 Wash Bottles 500 ml

108 Wash Brush

109 Wide mouth Glass Stoppard Bottle 250 ml

110 Wide mouth Glass Stoppard Bottle 1000 ml

111 Wire gaze

112 Corban column

CHECK-LIST FOR APPLICATION TO BE SUBMITTED BY APPLICANT TO BIS WHILE APPLYING FOR BIS LICENCE UNDER PRODUCT CERTIFICATION SCHEME OF

BIS The following check-list is required to be submitted with all the applications for grant of BIS licence under the Product Certification Scheme of BIS. Please tick (√) in the relevant box. Name of Firm : Place: Product Applied : Whether applied under: Simplified Procedure or Normal Procedure Note: Refer BIS website or details of “Simplified Procedure” and “Normal Procedure” for grant of licence.

No. Check-point Requirement Observations Page No.

General Is the application form completely filled?

1. Name & Address

Is the name and address of applicant (manufacturing unit applying for licence) same in the application as given in the attached document of Central/State Government

2. Status of Applicant (Manufacturing Unit)

a. Has it been indicated whether the applicant is a large scale or small scale unit?

b. In case the applicant is a small scale unit, does the applicant hold valid Registration Certificate from the Local / State authority or from a Chartered Accountant, and is the certificate attached.

c. Has it been indicated whether the applicant is a Public Sector or a Private Sector company?

3. IS No. & Varieties

a. Has applicant recorded the applicable Indian Standard with correct title of the Standard?

b. Where applicable, has applicant mentioned designation, grade, type, variety, size, etc., of the product for which the BIS licence is sought?

5. History a. Where applicable, has the applicant provided information regarding earlier BIS licence(s) held by them and / or cancelled in the past?

b. Where applicable, has the applicant provided information regarding BIS licences currently held by them?

6. Signature a. Is the application signed by the CEO of the applicant?

b. In case the application is signed by a person other than the CEO, is the application signed by the authorized signatory of the applicant and his authorization is attached by the authorized signatory?

7. Machinery a. Does applicant possess requisite manufacturing infrastructure to manufacture the product as per the Indian Standard?

b. Is installed capacity of production indicated in the application?

c. Does applicant have all machineries installed as per manufacturing process at the applicant’s manufacturing premises?

d. If answer to ‘c’ above is no, does the applicant outsource any of its manufacturing processes and possesses valid agreement(s) with other manufacturing units for the outsourced processes and traceability of material, thus produced, etc.?

e. If answer to ‘d’ above is yes, does the applicant has any control over such outsourced activity? Are these outsourced process will ensure testing the quality of final product for all requirements at the applicant's manufacturing premises?

8. Test Equipment & Calibration

a. Does applicant possesses requisite test facilities in-house as per the relevant Indian Standard at its factory address?

b. Are valid calibration certificates for relevant test equipment attached are complete and valid at least 3 months after the date of recording?

c. If reply to ‘a’ above is no, does applicant have arrangement with a BIS recognized outside lab for testing of the requirements for which it does not possess test facilities in-house? Is the consent letter as attached by applicant in this regard in order?

Note: Relaxation in in-house test facilities may be allowed on submission of proper justification for requirements which are obligatory to get tested and for which frequency of testing, as prescribed in the relevant scheme of testing and inspection (STI), is, normally, one month or more.

9. QC personnel Does the applicant employ qualified & experienced Quality Control (QC) personnel on permanent basis and possess documentary evidence to establish the same? Are the copies of the qualification certificates and appointment letters of the QC personnel are in order.

10. Raw Materials and Components

Where ever requirements for raw materials/ components used in the manufacturing of the product are specified in the standard, do test reports/suppliers’ test certificates, as submitted by the applicant show that these requirements are met as per the standard?

11. Plant Layout Does copy of the plant (applicant manufacturing premises) layout clearly indicates locations of manufacturing machinery, laboratory, office, workshop, amenities, storage area, etc.?

13. Test Report(s) a. Is the attached test report of in-house or from independent laboratory cover all requirements of the Indian Standard and is passing in such requirements?

b. In case the application is filed under “simplified Procedure” is the test report(s), in original, as submitted a) from BIS or its recognized laboratories? b) the test report is not older than one month from the date of submission of application, c) covers all the requirements of the standard, and d) passes in all such requirements

14

Undertakings 1. In case application is under simplified procedure, an undertaking shall be obtained from the applicant on his letter-head that the licence if granted against his application shall be put under Stop Marking by BIS if the verification sample(s) (any sample including the long duration test samples) drawn during visit of the BIS

officer prior to grant of licence fail to conform to the requirements of relevant Indian Standards. The licensee shall take necessary corrective actions and inform the same to BIS along with fresh samples (of rating/size/variety which facilitates verification of corrective actions on the reported failures) manufactured after taking the corrective actions. The resumption of marking in such cases shall be allowed only on the basis of independent satisfactory Test Reports of the fresh samples offered (including long duration tests where failures were in long duration tests). In case the fresh sample drawn by BIS for independent testing fails, or the licensee does not inform corrective actions taken and does not offer improved samples within 1 month of the date of Stop Marking, the licence shall be processed for cancellation and no further chance would be given to the licensee

2. Undertaking for following statutory rules of the country (Copy enclosed at annexure 2)

15

Annex A

LIST OF DOCUMENTS TO BE ATTACHED WITH APPLICATION

No. Title of Document Page

1 Check-list (Please see above) 2 In case the application is filed under “simplified Procedure”, the test report(s) in original from BIS

or its recognized laboratories for all the requirements of the product and, where applicable, of raw material(s)/ component(s)

3 Document of Central/State Government (e.g. Registration Certificate, Memorandum of Articles, etc) authenticating the address and purpose of the establishment of the manufacturing unit for which the application is made for grant of licence.

4 In case the applicant applies as SSI unit, copy of valid Registration Certificate from the Local / State authority or from a Chartered Accountant?

5 In case the application is signed by the authorized signatory of the applicant, authorization letter from CEO in the name of the authorized signatory.

6 Process Flow-chart covering all processes of manufacture (from raw material to finished product stage), including details of in-process controls at each stage, even for those stages which have been outsourced?

7 Complete list of manufacturing machinery, clearly indicating the name of the machinery, the details of the process for which it is used, its capacity and quantity in Annex A-1.

8 In case some of the manufacturing processes are outsourced, provide details of such processes and the controls exercised by you before receipt of such material/components, etc. Also attach an authenticated copy of the agreement.

9 Complete list of testing facilities, clearly indicating the name of the equipment, the test for which it is used (mention clause No. of the Indian Standard), range / least count / accuracy of the test equipment, calibration status and quantity in Annex A-2. Note: Model lists of testing facilities for some of the Indian Standards already covered under product certification are available on the BIS website and may be referred. However, for other Indian Standards, you are advised to study the relevant Indian Standard(s) and / or contact the concerned Branch Office of BIS for guidance.

10 Copies of calibration certificates of testing equipment valid at least till 3 months of acceptance of application

11 Where applicable, ‘consent letter’ from BIS recognized laboratory (for requirements which have got to be and / or are proposed to be got tested from outside lab for which the applicant does not have in-house test facilities).

12 Plant Layout clearly indicating location of manufacturing machinery, lab, office, workshop, amenities, storage area, etc., available in the factory premises, with the application?

13 Appointment letter of QC personnel indicating names, experience, qualifications, date of appointment and also attach a copy each of the qualification certificates

14 Copy each of the test reports/suppliers’ test certificates for each of the raw materials / components.

15 Copy of in-house or independent test report for the product covering all requirements as per the relevant Indian Standard

16 In case application is under simplified procedure, an undertaking from the applicant on his letter-head (see Annex A-3) that the licence if granted to him shall be put under Stop Marking by BIS if the verification sample(s) drawn during verification visit of the BIS officer prior to grant of licence fail to conform to the Indian Standard. In case the licensee does not take corrective actions, informs BIS and offers two improved lots to BIS for inspection and testing within one month of the date of Stop Marking, the licence shall be processed for cancellation and no further chance would be given to the licensee

CMPF 305 ANNEX A-1

(Sl. No. 7 on the List of Documents)

DECLARATION REGARDING MANUFACTURING MACHINERY

1. Applicant name:____________________________________ 2. Application No. ____________________________________

3. Name/Address _____________________________________

Date Machinery Make Capacity Number Remarks

I hereby declare that the machinery of which details are given overleaf is owned by me and are actually installed in the premises*. I also declare that in case of grant of licence , I will send prior intimation to BIS whenever any machinery is taken out of the premises of the firm due to any reason Sig. of Firm’s Representative _______________ Name:__________________________________ Designation:_____________________________ Date _______________

I have checked and found that machinery of which details are given overleaf was available during my inspection. Sig. of BIS I.O. _______________________ Name _______________________ Designation _______________________ Date of verification _________________

CM/PF 306

ANNEX A-2 (Sl. No. 9 on the List of Documents)

DECLARATION REGARDING TEST EQUPMENT

No entry to be crossed

1. Application No. ____________ 2. Licence No. ______________ 3. Name /Address __________________ Sl. No. & Date

Test Equipment/Chemicals and Identification Numbers (Where applicable)

Least Count & Range (Where applicable)

Valid Calibration (Where required) Yes/No

Tests Used in with Clause Reference

Remarks (Indicate number of Equipment)

I hereby declare that the test equipments of which details are given overleaf are owned by me and are actually installed in the premises. I also declare that in case of grant of licence, I will send intimation to BIS whenever any equipment is taken out of the premises of the firm due to any reason. Signature of firm’s Representative_____________ Name:_________________________ Designation________________________ Date:__________________________

I have checked and found that the test equipment of which details are given overleaf were available during my inspection. Sig. of BIS I.O. _____________________ Name:_________________________ Designation:________________________ Date of verification _________________

ANNEX A-3 (Sl. No. 16 on the List of Documents)

UNDERTAKING BY APPLICANT APPLYING UNDER SIMPLIFIED PROCEDURE

(To be submitted on the letter head by CEO/Authorized Signatory to concerned Head of the

Branch office along with the Application and other documents) The Director and Head BIS ____________ Dear sir I, -----------------( name of person), ----------------------( designation) have applied for a licence to you for use of BIS standard mark on --------------------(name of product) being manufactured at our factory at ------------( give address). I give an undertaking that the licence if granted against his application shall be put under Stop Marking by BIS if the verification sample(s) drawn during verification visit of the BIS officer prior to grant of licence fail to conform to the Indian Standard. In such a case, I shall take necessary corrective actions and inform the same to BIS within 15 days along with offering fresh lot of products manufactured after taking corrective actions, from which samples (of rating/size/variety which facilitates verification of corrective actions on the reported failures) shall be drawn by BIS for independent testing . I agree that the resumption of marking in such cases shall be allowed only on the basis of independent satisfactory Test Reports of the fresh samples offered (including long duration tests where failures were in long duration tests). In case the fresh sample drawn by BIS for independent testing fails, or the licensee does not inform corrective actions taken and does not offer improved samples within 15 days of the date of Stop Marking, the licence shall be processed for cancellation without any further chance to me Date:

(Name)

(Designation)

(Seal)

Annex B

ADDITIONAL REQUIREMENTS FOR APPLICANTS UNDER

FOREIGN MANUFACTURERS’ CERTIFICATION SCHEME OF BIS

Sl. No.

Check-point Requirement Yes Not Applicable

15. Application Fee Has applicant paid requisite application fee of Rs. 1000/-, in equivalent US$ (Rs. 1000/- plus 12.36% tax for applicants from SAARC countries)?

16. Signature Is the application countersigned by the applicant’s Authorized Indian Representative?

17. Nomination a. Has ‘Nomination Form’ of ‘authorized Indian representative (AIR)’ in the prescribed format on the firm’s letter-head, duly signed by the authorized signatory of the applicant and the AIR or the authorized person of the company of the AIR, been submitted with the application?

b. Is the authorization to the signing authority to sign the ‘Nomination Form’ on behalf of the Indian Co. also submitted?

c. Is address of the AIR in the ‘Nomination Form’ complete and evidence of nationality, address proof, contact details like phone / fax numbers and e-mail address of the AIR submitted?

d. In case AIR is an Indian company, have copies of registration certificate and/or Memorandum of Articles along with authorization letter from top management of the Indian company in the name of a person acting as the AIR also been submitted with the application?

e. Has copy of Agreement between applicant and the Indian company / individual, nominated as the AIR, also been submitted?

f. Are copies of valid RBI clearance certificate for Indian Office / Branch of the applicant or any other relevant document for establishment of its Office / Branch in India provided?

18. Language Are English translations of all the documents, which are in languages other than English, also available?

19. Preliminary Inspection / Visit Charges

Does the applicant undertake to bear inspection charges for all the inspections to be carried out by BIS at its premises before the grant of licence, including the arrangements and costs incidental thereto for travel and stay, visa, insurance, etc.?

20. Translation Facility

Does the applicant undertake to arrange, if required, services of translator (for translation in English) during the visits of BIS officers to its factory?

21. Agreement Does the applicant agree to sign a legally binding agreement with BIS in the prescribed format?

22. Indemnity Bond Does the applicant agree to submit an Indemnity Bond to BIS in the prescribed format?

23. Performance Bank Guarantee

Does the applicant agree to furnish a Performance Bank Guarantee to BIS of US $ 10000/- (from a bank having its branch in India) in the prescribed format on the letter-head of the bank?

ANNEX 1

CHECK LIST FOR SCRUTINY OF APPLICATION

PACKAGED DRINKING WATER (IS 14543) & PACKAGED NATURAL MINERAL WATER (IS 13428)

Firm : Normal / Simplified Place :

A. CHECKPOINTS Complies (Yes/No)

1 Application is submitted with the required Fees

2 Complete Office address & Manufacturing address are given 3 Manufacturing address in various documents is same

4 Composition of Top Management is indicated and tallying with other

documents submitted with application (such as at 1, 6 etc.)

5 Copy of Partnership Deeds, List of Director etc., as applicable 6 Copy of Registration of the firm (if applicable)

7 Documentary evidence submitted for status as Small Scale etc

8 Type, Material and Capacity is clearly indicated 9 Brand Name Declaration

a) CM/PF 307 is submitted

b) Copies of agreements with Brand owners are submitted (wherever

applicable) 10 Plant Machinery declaration is submitted on CM/PF 305

11 Test Equipment

a) Declaration submitted on CM/PF 306 (covering equipment, glassware,

chemicals and media)

b) Least Count, Range and quantity of equipment are as per ISS

c) Calibration reports of required equipment are submitted

d) Consent letter from approved OSL is submitted for testing of

requirements for which in-house facilities are not available

12 Personnel for Chemical & Microbiological Test

a) Whether copies of appointment letters submitted b) Whether qualification of personnel are in order

c) Whether copies of qualification certificates submitted

13 Raw Water-Permissible source of raw water is used

14 Details regarding procurement/manufacturing facilities for packing

materials are submitted

15 Details of Manufacturing Process with Treatment for Disinfection and

Process Flow Chart are submitted

16 Factory Layout Plan indicating locations of important facilities (source water, processing stages, disinfection, packing, storing, testing etc) is

submitted

17 Location and Route Map to factory is submitted

18 Production Figures for previous/current periods (as applicable)

19 Installed Capacity is clearly indicated

20 Acceptance of STI is submitted/ indicated

21 Acceptance to pay Marking Fees is submitted/indicated

22 Hygienic Conditions – whether copies of reports submitted for

a) compliance to Annex B

b) medical examination of concerned staff c) Pest Control Treatment (if got done from outside source

23 Declaration submitted for Shelf-Life of product packed in all

containers 24 Details of previous application/licence provided, as applicable

25 Whether request made for blocking of Licence No. If so, whether Indemnity

Bond submitted B CHECKPOINTS SPECIFIC TO NORMAL PROCEDURE Complies(Yes/No)

1 Whether date for preliminary inspection is proposed

2 Whether details of samples being offered for inspection (water and

packaging materials) are indicated C CHECKPOINTS SPECIFIC TO SIMPLIFIED PROCEDURE Complies(Yes/No

1 Whether Self-Evaluation Report submitted

2 Original Test Report for Water & Containers

a) Whether the reports submitted are from approved Labs

b) Whether the reports are not older than 30 days

3 Whether undertaking for compliance to Labeling Prohibition

submitted

4 Whether undertaking submitted for stoppage of marking in case of

failure of verification sample in independent testing Any other details/comments

Recommendations of Dealing Officer

Sign. Dealing Officer Name Date

Decision of Group Leader

ACCEPTANCE OF SCHEME OF TESTING AND INSPECTION

This is with reference to your letter No------------------dated --------------------

We hereby agree that after a licence is granted to us for 'Packaged Drinking Water (other than

Packaged Natural Mineral Water) - Specification' as per IS 14543 : 2004 we shall follow the scheme of

Testing and Inspection (Doc: STI/14543/7:AUG 2011

) strictly and maintain all records properly

Place: Signature

Name

Date Designation

Seal

ACCEPTANCE OF RATE OF MARKING FEE This is with reference to your letter No .----------------- dated --------------- We hereby agree to pay marking fee to Bureau of Indian Standards after grant of licence to use the Standard Mark on Packaged Drinking Water (other than Packaged Natural Mineral Water) - Specification according to IS 14543 : 2004at the following rates and in the manner stipulated as under:) i) Rate of marking fee: Unit- 1000 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 ii) The marking fee is payable as follows: a) Minimum marking fee Rs. 79400 (for small scale industry) and Rs (for large Rs 93400 scale industry) for one operative year payable in advance which will be carried over to next renewal(s). b)Actual marking fee for the first nine months of the operative period calculated on the unit rate on the production marked or the minimum fee whichever is higher shall be payable at Delhi/New Delhi at the time of the first renewal of the licence. For subsequent renewals, the actual marking fee for 12 months period consisting of last three months of previous operative year and the first nine months of the current operative year or the minimum fee whichever is higher, shall be payable. c)Service tax @12.36% as applicable shall also be paid.

Place: Name

Date: Designation

Seal

ACCEPTANCE OF RATE OF MARKING FEE This is with reference to your letter No .----------------- dated --------------- We hereby agree to pay marking fee to Bureau of Indian Standards after grant of licence to use the Standard Mark on Packaged Drinking Water (other than Packaged Natural Mineral Water) - Specification according to IS 14543 : 2004at the following rates and in the manner stipulated as under:) i) Rate of marking fee: Unit- 1000 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 ii) The marking fee is payable as follows: a) Minimum marking fee Rs. 79400 (for small scale industry) and Rs (for large Rs 93400 scale industry) for one operative year payable in advance which will be carried over to next renewal(s). b)Actual marking fee for the first nine months of the operative period calculated on the unit rate on the production marked or the minimum fee whichever is higher shall be payable at Delhi/New Delhi at the time of the first renewal of the licence. For subsequent renewals, the actual marking fee for 12 months period consisting of last three months of previous operative year and the first nine months of the current operative year or the minimum fee whichever is higher, shall be payable. c)Service tax @12.36% as applicable shall also be paid.

Place: Name

Date: Designation

Seal

CM/PF 201 Sept 1995

ANNEX 2

(Clause Ref. 4.3.1)

BUREAU OF INDIAN STANDARDS REPORT OF PRELIMINARY INSPECTION

Application No. CM/A- IR No : IS Date of writing : Product Type/ Size/Grade/Variety 1. GENERAL INFORMATION a) Applicant’s Name

b) Address: i) Factory

ii) Office:

c) Date of inspection

d) Situation of factory

e) Telephone/Fax i) Factory

ii) Office

2. Management Staff 3. Person(s) contacted 4. BIS Licences, if any, held by the applicant ________________________________________________________________________ REMARKS OF THE REVIEWING OFFICER (ON IRS, TRS , GENERAL ETC) _____________________________________________________________________________

CM/PF 201 Sept 1995

5. RAWMATERIALS

a) Raw Materials Used:

Sl. No. Raw Material Name of With or Test How Supplier Without Certificate Received BIS Certi- of the Batches/ fication Supplier Lots Mark Nature of

Package ____________________________________________________________________________ b) Arrangement for testing

as received c) Details of sampling d) Methods of disposal of

sub-standard raw materials e) Record of tests with proforma

of records 6. MANUFACTURE a) Type/ Size/Grade/Variety being

manufactured at the time of inspection

b) Description of the process from raw

material to finished product stage

ready for dispatch (Also enclose

Layout plan of the factory)

CM/PF 201 Sept 1995

c) Intermediate points where control is exercised

d) Details of records maintained

and control used e) Method(s) of disposal of sub-standard products f) Units of production g) Production per day or per shift h) Details of manufacturing machinery

(See proforma PF 305 Annexed) i) Technical comments on the manufacturing

capabilities and inprocess controls

7. PACKING AND MARKING a) Nature of packing

b) Quantity per package

c) Marking on article

d) Method of marking (printing,

stenciling, embossing etc)

e) Form of label(s), if any f) Batch or Code numbering

for identification g) In what manner marking differs

from the provisions in the Indian Standard Specification

(4)

CM/PF 201 Sept 1995

8. LABORATORY AND INSPECTION

a) Details of Staff:

Sl. No. Name of Qualification Experience Person

____________________________________________________________________________

b) Competency of

testing personnel

c) Equipment and other

facilities for complete

specification testing. Test equipment/chemicals

not available

d) Accuracy of instruments and

arrangements for calibration

e) Records maintained in

laboratory for routine tests:

Sl. No. Requirement/Characteristic Value ____________________________________________________________________________

f) Stage of processing where

laboratory reports are made

available

g) Sampling and testing of

end products

(5)

CM/PF 201 Sept 1995

9. SAMPLE

a) Source of drawl: stock/production

b) Size of lot from which sampled

c) Type/ Size/Grade/Variety of the sample

d) Details of the counter sample left with the firm

e) Manner of packing, labeling, coding and sealing

f) How sealed ? Give impression of the seal used

g) Laboratory to which dispatched

h) Test results on a sample tested in the factory:

Requirements Value Value Remarks Tested Obtained Recorded

By Firm

i) Any further information

regarding sample drawn

j) Information regarding sample of

other type/grade/variety applied for

k) Comment in the testing capabilities

CM/PF 201 Sept 1995

10. OTHER INFORMATIONS

a) Main buyers and selling price

b) Storage facilities

c) Hygienic conditions (in case of food

products, give complete note as

per relevant hygienic code)

d) Discussion with the firm on:

e) STI and marking fee rate

i) The manner of putting

the Standard Mark

ii) Manner of manufacture

and dispatches without

Standard Mark in case of

stoppage of marking

11. INSPECTION/TESTING CHARGES Collected/Not Collected

12. CONCLUSIONS, RECOMMENDATIONS

AND POINTS FOR ACTION

Signature:

No. of Encl.: Inspected by:

(Name)

Designation:

Station: Date:

ANNEX 3 (Clause Ref. 4.3.2)

VERIFICATION REPORT BY BIS INSPECTING OFFICER

(The Inspecting Officer(s) shall give technical comments on manufacturing capability, in

process controls, competency of testing personnel and testing capability. Any discrepancy

observed during verification at factory shall be conveyed formally through D/V Report)

1. Application No. :

2. Applicant :

3. Address :

4. Date of Visit :

5. IS No. :

6. Product : 7. Person(s) Contacted:

8. VERIFICATIONS

S.No Aspect Verification Observation * . a Manufacturing Applicant’s declaration on PF 305 be verified Complete or

Facilities for completeness and correctness and Incomplete

countersigned b Manufacturing Applicant’s declaration regarding process, Conforming or Non

process filling and packing be verified for correctness conforming including filling and countersigned and packing c Testing Applicant’s declaration on PF 306 be verified Complete or

Facilities for completeness and correctness and Incomplete

countersigned d Requirements Copy of consent letter from OSL including Available and

for which each requirement and frequency specified in complete or not Testing facilities STI, be obtained and enclosed with this available/incomplete are not available report e Factory Testing Sample be got tested in factory and test report Sample Pass or Fail

be submitted in format Annex-3A d Competence of Competence be assessed for Microbiological Q.C competent or

Q.C. personnel and Chemical testing through factory testing, Not competent

interview etc.

f Hygienic Assessment be made as per Annex B of the Satisfactory or Conditions Indian standard and reported using Annex 4 Needs improvement of this manual duly countersigned by IO and

applicant’s Hygiene Incharge . * In case the observations are not satisfactory for any of the aspects and for which actions are

required to be taken by the applicant, details be given in D/V Report. 9. SAMPLES FOR INDEPENDENT TESTING

a) Details of samples drawn for independent testing be given in the Annex-3 B.

Whether left with the applicant for dispatch to Lab or brought to office?

10. ACCEPTANCES & DECLARATIONS BY THE APPLICANT

S.No. Subject Whether already Whether

submitted obtained now Yes No Yes * N.A. a Acceptance of STI

b Acceptance of Marking Fee c Brand Name Declaration with Copies

of Agreement, if applicable d Undertaking for stoppage of marking

if verification sample fails in

independent testing * Documents which are obtained during verification visit be Annexed with the report, duly marked.

11. ANY OTHER POINT/COMMENT (Give details of verification of other actions taken by applicant

on advise rendered by BIS based on scrutiny of application or otherwise asked for, if any) 12. RECOMMENDATIONS

13. POINTS FOR ACTIONS (Give details of all actions required to be taken by the

applicant as per deficiencies indicated on the D/V Report)

Signature Name Designation Date

Group Leader

ANNEX 3A

FACTORY TESTING REPORT P D water/ P NM Water

Manufacturing Date

Batch No. (if applicable)

Type of Container from which sample drawn Quantity in stock pertaining to above Batch/Mfg. Date

IS Requirement Specified Value Observed Value S.No. clause

Ref.

Result : Pass for the requirements tested or Fail in the requirement(s) …… (strike out whichever is not applicable)

Signature

Name

Designation Chemist Microbiologist

Representing (BIS) Firm:

ANNEX 3B

SAMPLES FOR INDEPENDENT TESTING 1. Sampling of P D Water or PNM Water a) Source of drawl (Stock/production) b) Size of lot (quantity) from which sample is drawn with details of type/material/Capacity c) Batch No. (if applicable) and Mfg. Date of Water d) Declared shelf-life e) Quantity drawn (indicate no. of packing & capacity) f) Code assigned to the sample (Give separate codes for samples sent to different Labs.,

such as for chemical & radiological) g) Manner of packing, labeling and sealing h) Tests to be carried out and name of the Lab. where sample is to be tested (Chemical,

Physical, Microbiological, Radiological) 2. Sampling of Packaging Material for Water a) Type, Material and Capacity of container(s) b) IS No. and Standard c) Size(s) of lot(s) from which sample(s) drawn d) Quantity drawn (indicate no. of packing & capacity) e) Declared parameters (Width of PE Film, Wall Thickness of plastic container) e) Code assigned to the sample f) Manner of packing, labeling and sealing g) Tests to be carried out and name of the Lab. where sample is to be tested 3. Details of counter samples left with the firm:

ANNEX 4

(Clause 4.3.4 and 4.3.6) CHECKLIST FOR GOOD HYGIENE PRACTICES AND FOOD SAFETY SYSTEMS FOR PACKAGED NATURAL MINERAL WATER PROCESSING UNITS AS PER CLAUSE 5 OF IS 13428:2005 OR CHECKLIST FOR GOOD HYGIENE PRACTICES AND FOOD SAFETY SYSTEMS FOR PACKAGED DRINKING WATER PROCESSING UNITS AS PER CLAUSE 4, ANNEX C OF IS 14543:2004 (TO BE VERIFIED BY IO DURING PRELIMINARY/VERIFICATION VISIT)

Sl. Requirements Answers Remarks (briefly No. Satisf- Unsatis describe how required

actory factory is met or not )

A Building, Facilities and Locations

i) Is the facility located in an area free from

objectionable odour, smoke, dust or other contaminants and not subject to flooding? ii) Are the areas immediately surrounding the

buildings, roads, parking places, suitably

paved, grassed and kept clean? iii) Is adequate facility for drainage of

surroundings available and designed to handle

peak load? iv) 1s the facility used for processing water free

from domestic animals? v) Are the facility surroundings free from refuse,

waste materials, rubbish, over grown weeds and grasses? vi) Are there adequate facilities for the disposal

of effluents and wastes? vii) Are the buildings and facilities of sound

construction and maintained in good repair? viii) Are the buildings and facilities designed and

maintained to prevent entrance and harboring

of pests and entry of contaminants? ix) Are building and facilities designed to

facilitate hygienic operations? B. Plant and Physical Facilities i) Is adequate lighting provided at working

station, hand washing area, and storage areas?

ii) Is the lighting intensity adequate:1) 540 lux in

all inspection area, and 2) 220 lux in work

areas and walls

iii) Are light fixtures safety types and protected to

prevent contamination in the event of breakage

in the processing and packing area?

iv) 1s adequate ventilation provided in processing areas to minimize odours, noxious fumes and condensates? v) Are barrier traps provided at drains to prevent

the entry of rodents from the drains into the facility? vi) Is effective screening provided against entry

of birds, animals, insects, rodents, etc vii) Are doors, hatches and other openings to the

building constructed in such a way to render opening pest proof? NOTE — Installation of one or more of the following, which effectively prevents pest entry, will meet this requirement: a) Doors self closing type, b) Have air curtains, and c) Have strip curtains. viii) Are floors, walls, ceilings, windows and doors

so designed and constructed as to prevent accumulation of dust, dirt and render them washable? ix) Is product in process and storage area

adequately protected from any leakage from external surfaces and other sources of contamination? x) Are immediate surroundings of extraction or

collection protected from entry of unauthorized persons? C Raw Water Processing i) In case of extraction /collection for processing

are the sources free from contaminations/ impurities? ii) Are water storage tanks, pipe lines utilized for

handling water constructed and so designed as to facilitate cleaning and inspection? iii) Are inspections of containers/ carriers/

pipelines of raw water supply performed for

the material of construction and cleanliness?

iv) Are possible chances of contamination from incoming water assessed? v) Are water storage tanks effectively cleaned to

prevent entry of pests and potential

contaminator?

vi) Are the storage tanks periodically cleaned and

records maintained? vii) Are the processed water contact surfaces

regularly cleaned and sanitized? viii) Are all equipment and utensils so designed

and constructed as to prevent hygiene hazards

and allow easy cleaning and sanitation? D Post-Processing Handling i) Are cleaning operations of bottles/containers

so done as to preclude contamination of product and product contact services with residues? ii) Has absence of residual cleaning chemicals

been ensured? iii) Is preventive maintenance in place for all

processing machinery and equipment? iii) Are the primary packing material and

containers of food grade conforming to

relevant Indian Standards? iv) Are packing and sealing, where required,

monitored? v) Are containers visually/electronically

inspected for their soundness? vi) Are physical hazards prevented from entering

into processed water?

vii) Are glassware excluded from production

area? E Packaging Material and Finished Goods

Storage i) Are the primary packing material and

containers of food grade conforming to

relevant Indian Standards? ii) Are packaging material inspected to ensure

their suitability? iii) Are the packing materials especially primary

packing material properly stored and properly

handled to preclude contamination?

iv) Are packaging material purchased, stored and

handled in sanitary manner?

F Finished Product Storage and Distribution i) Is first-in-first out (FIFO) of stored product

maintained? ii) 1s storage properly sanitized and disinfected

periodically?

iii) Are stores protected from pest infestations?

iv) Are coding and tracking clear and in place?

v) Are the instructions clear and in place? vi) Are hold release procedure in place and

product identified? vii) Are the records maintained for batch number,

date and volume of production? viii) Are transport containers/vehicles maintained

in clean condition? G Customer Handling of Products i) Are the storage instructions provided on

containers? ii) Is the shelf life period (best before) mentioned

on containers in accordance with PFA

requirements? iii) Are instructions provided for handling

defective/ damaged products? H Sanitary Facilities and Control i) Are toilet provided in sufficient numbers and

are they provided with: 1) Doors of self closing type? 2) Opening directly into processing areas? 3) Hand washing signs provided in appropriate language? 4) Proper lighting and ventilation? 5)Proper maintenance to keep in clean and

tidy manner? ii) Are hand washing facilities provided

adequately and conveniently to wash hands,

foot, elbow with sensor operated taps?

iii) Are germicidal soaps / soap solution and hand

drying facility provided? iv) Are notice/instructions prominently pasted in

toilet directing employees to wash their hands on entry and re-entry into the food handling

areas? v) Are the refuse receptacles, self closing type,

maintained in a manner to protect from J Personnel Hygiene and Habits i) Is any individual assigned to supervise overall

sanitation of plant and personnel? ii) Is there any person responsible for day-to-day

monitoring of health and hygiene?

iii) Have the employees in processing, packing

and maintenance been medically examined?

iv) Are the personnel with infectious diseases,

skin infection and open lesion or any other source of microbial contamination excluded

from working in process/packing areas?

v) Are personnel hygiene practices regularly

maintained and monitored? 1) Clean outer garments — protective clothing? 2) Personal cleanliness — finger nails? 3) Head cover— hair restraints, caps, head bands, beard cover 4) No tobacco in any form— smoking, chewing 5) No eating at work stations vi) Are protective clothing stored on the premises

and not allowed to be used for outside wear vii) Are there clear legible notices defining limits

of no smoking areas such as “NO SMOKING

BEYOND THIS POINT” displayed?

viii) Are personnel imparted regular training or

hygienic food handling, processing food and personal hygiene? ix) Are unsecured jewellery and other objects,

such as, wrist watches, cufflinks, ear rings, glass bangles, stick BINDIS removed at

work?

CONCLUSION: OVERALL ASSESSMENT OF HYGIENIC CONDITIONS -

SATISFACTORY / NOT SATISFACTORY

NAME OF UNIT Signature ………………….

…. CM/A.............. Name ..…………… Designation …………………..

Date…………………

….

CM/PF /PDW

AUG 2009

ANNEX 7

(Clause 5.2)

BUREAU OF INDIAN STANDARDS REPORT OF PERIODIC INSPECTION (. .. . . . . . . . . . . . inspection since the grant of licence/Renewal)

CM/L - IR No.. . . .

Valid upto: Date of writing IR . . . . . . .

1. a) Licensee

b)IS 14543:2004 Packaged Drinking Water (Other Than Packaged Natural Mineral

Water)/ IS 13428:2005 Packaged Natural Mineral Water

Type, Material & Capacity of containers covered under licence

c) Other license(s) held CM/L . . . . .. . . . . IS Product 4 Special inspection charges, if applicable, with details of realization

3. Date(s) of inspection

4. Person(s) contacted

5. Change in Management, if any

6. Previous inspection

a) Date(s) b) Conducted by c) Conclusion and Recommendations

d) Details of last 2 factory samples Sl. No. Date of drawl Mode & Date Status of sample Pass/Fail

of sample of dispatch (whether report recd.) (if applicable) ----------------------------------------------------------------------------------------------------------------

1. 2. --------------------------------------------------------------------------------------------------------------- 7. ACTION ON ADVICE RENDERED IN PREVIOUS INSPECTION OR OTHERWISE ASKED FOR WHILE GRANTING LICENCE /RENEWAL OF THE LICENCE _______ REMARKS OF THE REVIEWING OFFICER ON PERFORMANCE OF LICENSEE KEEPING IN VIEW THE PAST PERFORMANCE (ON IRS, TRS , GENERAL ETC)

SIGNATURE & DATE

62

(2)

CM/L - …………… 8. Source of Raw Water

a) Own Bore well/Municipality/Other Source Supply (specify) b) Whether source changed from declared earlier c) If yes, compliance to STI d) Whether records of testing maintained as per STI

9. Packaging Material (Jar/Bottle/Cup/Glass/ Caps/Closures/Pouch-Give details in each case)

a) Details of Receipt

Container Name of the Supplier Whether BIS Whether recd.with Whether tested Certified test certificate in-house

Type Material Capacity

b) Whether packing is done in approved container(s)? If not, give details

c) Whether records being maintained in accordance with STI

10. PRODUCTION DETAILS

a) Whether Water being produced/packed at the time of inspection

b) Whether any change in the process of manufacturing & disinfection from that declared

earlier? If yes, give details (Disinfection of natural mineral water is not permitted)

c) Production Controls (Satisfactory/Unsatisfactory)

e) Production & supply since last periodic inspection (enclose details for

completed month)

i) Quantity produced ii) Quantity marked iii) Quantity unmarked and manner of disposal iv) Reason for not marking v) Parties supplied to (Give complete address):

63

(3) CM/L -………………

11. Storing, Packing and marking of BIS certified material a) Material held in stock

b) Packing and marking on packages

c) At what stage marking is done

(After or before test results are known)

d) Any change in the marking procedure from approved one

e) Compliance to Labeling Prohibitions 12. TESTING ARRANGEMENTS & TESTING a) Details of change(s) in Testing Personnel,

if any since previous inspection

b) Competence of new Testing Personnel

c) Are the frequencies of tests and

records testing being maintained

satisfactorily vis-à-vis the STI

d) Variation in factory test result Enclose Report in Annexure – 7A

e) Details of testing got done from Enclose Report in Annexure - 7B outside laboratory

f) Details of failure reported, if any and

corrective actions taken for the same

g) Are all required instruments available

and in working order? If No, give details

h) Change/addition in testing facilities/arrangement

i) Details of calibration of Balance, Thermometers& pressure gauge 13 Testing in factory Description of the sample (Type, Material, Capacity of containers and B.No./Mfg.Date): Sl.No.Requirements Tested Value Obtained Value Recorded Remark

64

(4) CM/L………………….

14. Samples for Independent Tests a) From where sampled (Stock/production line)?

b) Details of sample (Batch/Lot No., Date of Mfg.

Shelf-Life and Type, Material and Capacity c) Test record of the batch from which sample is drawn Report in Annexure - 7A d) Give details of packing, labeling, coding, sealing of the sample e) Mode of dispatch and laboratory to which sample will be tested f) Details of the counter sample left with the firm 15. HYGIENIC CONDITIONS

a) Availability of responsible/designated hygiene control incharge

b) Overall compliance to Annex B of IS 13428/IS 14543 Satisfactory/Unsatisfactory as verified as per the check-list attached

16. CONCLUSION AND RECOMMENDATIONS

a) Assessment of performance since last inspection Satisfactory /Unsatisfactory

b) If operated unsatisfactorily, give reasons (Also

indicate whether the discrepancies were

conveyed to the licensee through D/V Report, if so enclose copy)

c) Any discussion with the firm for difficulties, in production, testing, operation of Scheme and

actions proposed, if any for the difficulties observed

d) Recommendation for action to be taken f) Any other observation/comments for

better appraisal of the report

Signature: No. of Encl.: Inspected by:

(Name) Designation:

Station: Date:

65

CM/L …………….

ANEXURE – 7A ASSESSMENT OF COMPLIANCE TO IS 13428 FOR PNMW/IS 14543 FOR PDW

Sl. REQUIREMENT LIMIT VARIATIONS BATCH DRAWN No. PDW PNMW FROM FOR IT

RECORDS FOUR HOURLY 1. Description To comply

2. Colour 2 Max 2 Max 3. Odour Agreeable Agreeable

4. Taste Agreeable Agreeable 5. Turbidity 2 NTU, 2 NTU,

Max Max 6. pH 6.5 to 8.5 6.5 to 8.5 EACH CONTROL UNIT 1. Total Dissolved Solids 500 mg/l, 150–700

Max mg/l, Max 2. Chlorides 200 mg/l, 200 mg/l,

Max Max 3. Sulphate 200 mg/l, 200 mg/l,

Max Max 4. Alkalinity 200 mg/l, 75–400

Max mg/l 5. Residual Free Chlorine 0.2 --

6. Escherichia coli Absent Absent 7. Coliform bacteria Absent Absent 8. Sulphite reducing Absent Absent

anaerobes 9. Pseudomonas Absent Absent

aeruginosa 10. Aerobic Microbial a) 20/ ml, --

Count Max at

370C &

b) 100/ml, Max at 20-

220C

11. Yeast & Mould Count Absent Absent

ONCE IN A WEEK 1. Barium 1 mg/l, 1 mg/l,

Max Max 2. Copper 0.05 mg/l, 1 mg/l,

Max Max 3. Iron 0.1 mg/l, 0.1 mg/l,

Max Max

66

4. Manganese 0.1 mg/l, 2.0 mg/l,

Max Max 5. Nitrate 45 mg/l, 50 mg/l,

Max Max 6. Nitrite 0.02 mg/l, 0.02 mg/l,

max Max 7. Zinc 5 mg/l, 5 mg/l,

Max Max 8. Aluminium 0.03 mg/l, 0.03 mg/l,

Max Max 9. Calcium 75 mg/l, 100 mg/l,

Max Max 10. Magnesium 30 mg/l, 50 mg/l,

Max Max 11. Anionic Surf. Act. 0.2 mg/l, Not

Agents Max detectable 12 Sulphide 0.05mg/l 0.05mg/l

Max Max

67

CM/L……………….. ANNEX - 7B

DETAILS OF TESTING GOT DONE FROM OUTSIDE LABORATORY (PROGRESS SINCE LAST PERIODIC INSPECTION)

Sl.No YEAR MONTHLY, 3 MONTHLY, 6 MONTHLY, YEARLY,

B.NO./TR NO. B.NO./TR NO. B.NO./TR NO. B.NO./TR NO. MONTH (RESULT/SENT) (RESULT/SENT) (RESULT/ SENT) (RESULT/SENT)

1 JAN

2 FEB

3 MAR

4 APR

5 MAY 6 JUN 7 JUL

8 AUG 9 SEP

10 OCT 11 NOV

12 DEC

TWO YEARLY TEST:

ANNEX 8

(Clause 5.2)

HYGIENE CHECK LIST ( VERIFICATION DURING PERIODIC INSPECTION/ SURVEILLANCE VISIT OF

PACKAGED DRINKING WATER / PACKAGED NATURAL MINERAL WATER AT BIS LICENCED UNIT)

CM/L- DATE OF VISIT: NAME OF THE UNIT:

Particulars Requirements Observ Remarks, if any

ation Extraction/Collection The source of extraction is well Yes/No

protected from Contamination and unauthorized access Raw Water Storage Storage tank for raw water is clean Yes/No

and cleaning schedule is being

followed. Processing Area - Processing area is clean and Yes/No

adequately closed. - Adequate ventilation and lighting Yes/No facilities available and working - Wire mesh/glass provided on Yes/No windows - Walls and ceiling are well painted Yes/No and clean. - Flooring is smooth, sloped, clean Yes/No and free from cervices. - Freedom from insects, rodent and Yes/No birds, animals etc. - Fly-catchers provided. Yes/No - Not being used for storage Yes/No purposes. - Drains are clean and well covered. Yes/No - Doors are self closing/close fitting Yes/No

type with air-curtains Hygienic Facilities - No over flow/ dripping from Yes/No

processing vessels. - Cleaning schedule of equipment is Yes/No adequate and is being followed. - Proper disinfection of containers Yes/No and caps is being ensured. - Washing and disinfection of reusable jars is being done Yes/No adequately and absence of

OVERALL ASSESSMENT OF HYGIENIC CONDITIONS: SATIS./NOT SATIS.

Signature of I.O._______________ Name:________________________ Date:___________________

residual cleaning chemicals ensured. - Changing facilities are clean and Yes/No not being used as store. - Toilets are clean and away from Yes/No processing area. - Protective clothing being used by Yes/No workers coming in contact with the product. - Medical examination of workers is Yes/No being done periodically and affected personnel are not allowed to work. - Adequate hand washing facilities are available and notices to this Yes/No effect are displayed. - Personnel are being trained in food handling, processing and Yes/No personal hygienic. Raw Material - The raw material including bottles, Yes/No

caps, etc. are properly stored and free from probable contamination. - TC of R/M is available Yes/No

consignment wise. Finished Product - Finished product pipeline and Yes/No

storage tank is of inert material and is clean and free from corrosion. - Cleaning schedule being followed Yes/No and supervised by identified personnel. - Inspection screen is provided and Yes/No is well lit. Storage of finished - The packed material is stored Yes/No

product adequately under hygienic conditions, free from chances of contamination.

ANNEX 6

(Clause 4.10)

CHECK LIST FOR RED FORM OF PACKAGED DRINKING WATER (IS 14543) and NATURAL MINERAL WATER (IS 13428)

ITEM CHECK POINT DOCUMENT REMARKS

No. (Tick)

Address Same address given in 1 Verify in application. Plot Purchase/ Rent

Application Form, PIR, RF and 1 (a) etc. agreement or lease agreement etc.

Other Documents

Authorized Person Authority Letter (In case 2

application and other

documents are signed by person

other than Proprietor/Partner/

Director of the applicant)

Status of Unit Manufacturing status is clearly 3 SSI Certificate/Chartered Accountant/

stated as large/small scale in Certificate from any other agency.

order to give concession in

marking fee.

STI Acceptance of STI is for the 4 Should not be signed on blank proforma

latest version

Marking fee Acceptance of applicable 5 Should not be signed on blank proforma

Marking Fee with complete

details

Brand Name(s) Proforma CM/PF 307 6 Enclose copies as applicable, for each brand

Agreement with Brand Owner, 6 (a)

if applicable 6 (b) etc.

Test Reports Reports for Water cover all the 7 Reports of all samples to be attached, i.e.,

requirements for 7 (a) including those of failures, if any.

7(b)

Physical/ Chemical Tests 7 (c) etc. Pass/Fail to be clearly mentioned on each test

Microbiological Test report by Dealing officer for samples drawn

Pesticides Residues by BIS for test reports verified by him/her

Radio Active Residues Code numbers and details of samples in TR

Packaging material report for and IR tally.

the relevant type, material and

capacity Test reports under Simplified should not be

older than 30 days

Approval of Approval of Competent 8(a)

Testing Authority for change of lab, if

applicable

Factory Testing in Permission of Competent 8 (b) Factory test report should be as per CL

lieu of I/T Authority proforma,

Manufacturing Plant machinery declaration 9 CM/PF 305 should be countersigned by IO on

Facilities including details for source and all pages.

storage of raw water

Testing Testing facilities including 10 CM/PF 306 should be countersigned by IO on

Facilities details of test method adopted all pages.

by the firm, wherever options

available

Consent Letter Firm’s request for permitting 11 (a) Permission should to be granted only for

for testing in testing at OSL, Consent from 11 (b) requirements having frequencies of test as

Outside Lab OSL for testing on behalf of 11 ( c) monthly & above

applicant,

Permission by the CA

Calibration of As a minimum, following Copies of calibration certificates to clearly

Instruments instruments shall be got indicate the validity status and traceability

calibrated: 12 (a)

Analytical Balance 12 (b) etc.

All Incubators

Quality Appointment letters of testing 13 (a) Testing personnel should be employed as full-

Control personnel time.

Personnel Qualification certificates of Verification of competence should be clearly

testing personnel recorded by IO.

Preliminary Preliminary Inspection Report 14(a) Report to clearly indicate availability of

Inspection infrastructure for manufacturing & testing of

Report Raw Material receipt details 14(b) product as declared by the applicant.

(for Old Procedure) Declarations made by the applicant on the

Manufacturing Process – 14( c) prescribed proforma should be verified and

indicating complete process, countersigned by the IO.

treatment fordisinfection (for

each type of packing, if 14(d) Discrepancies, if observed during the

different) Preliminary Inspection, should have been

Process Flow Diagram 14(e) conveyed through D/V report and also

attached with the preliminary inspection

Layout Plan of Factory – report

clearly indicating locations of

raw water source & storage,

process equipment, plant 14(f)

machinery, Packing & Storage

Area, Change Room, Toilet etc. 14(g)

Report of testing of raw water 14(h)

Firm’s own testing of processed

water indicating conformity to

ISS 14 (i)

Reports of plastic containers 14 (j)

submitted by firm, as applicable

Any other document such as :

Test Results of samples tested

in factory (if not reported in

PIR)

Sample Labels, if available

Contact Report Visits other than Preliminary 15(a)

Inspection 15 (b) etc.

Verification Visit Report of verification 16 (a) Annex III or Annex IV to be used by IO. All

under Simplified Factory testing Report 16 (b) the declarations made by the applicants shall

Procedure be verified and countersigned.

Hygienic Complete assessment as per 17(a) Assessment report should be countersigned by

Conditions Annex B 17(b) IO.

Medical Examination of 17( c)

employees

Pest Control treatment (as

applicable)

Declarations by the Undertaking to intimate BIS 18

firm regarding shifting of Plant

Machinery/Test Equipment 19

Ownership

of

Plant

Machinery/Test Equipment

(if not covered under Doc. No. 20

9 & 10)

Affidavit on Stamp paper for 21

material offered for inspection

(for sample drawn from stock) 22

Indemnity Bond (for Blocking

of CM/L-No.)

Undertaking regarding

cancellation of licence in case

verification sample fails

Any Other Other documents, as relevant to 23 onwards

Documents the

Application

Red Form Should be complete in all Clear recommendations for scope w.r.t Type,

respect Material & Capacity of containers

Recommendations of Dealing Officer :

Dealing Officer

Date : Head :

GUIDELINES FOR ASSESSMENT OF INFRASTRUCTURE IN PACKAGED DRINKING

WATER UNIT WITH EXPLANATORY NOTE (BASED ON IS 14543:2004)

REQUIREMENT OF INDIAN STANDARD

EXPLANATORY NOTES FOR GUIDANCE

B-1 FIELD OF APPLICATION The hygienic practices cover the appropriate

general techniques for collecting drinking water, its treatment, bottling, packaging,

storage, transport, distribution and sale for direct consumption, so as to guarantee a

safe healthy and whole some product.

B-2 HYGIENE PRESCRIPTIONS FOR COLLECTION OF DRINKING WATER

B-2.1 Extraction or Collection In the case of extraction or collection of

water intended for packaging from ground water sources, it should be ensured that it is

safe from pollution, whether caused by natural occurrence or actions or neglect or

ill-will.

It may be ensured that the ground water source is reasonably away from any polluting source like drain/ sewer/ septic tank.

Ground water source (whether owned/ shared)

shall be under the direct control and supervision

of the manufacturer. Clear declaration from the

manufacturer for ensuring that the ground water

source is safe from pollution either by natural

occurrence or because of action/ neglect/ ill-will

shall be taken.

B-2.2 If water to be processed for packing is obtained from any other potable source it

should be protected from being contaminated.

B-2.3 The firms using waters from drinking

water systems intended for packaging

should ensure that it meets the requirements

of the standard.

B-2.4 Materials The pipes, pumps or other possible devices

coming into contact with water and used for its collection should be made of such

material that they do not change the quality

of water.

The material should preferably be of stainless steel. However, GI or plastic material may also

be used. In case of plastic materials, it should be supported with certificate for its food-grade

quality. Rubber pipe shall not be permitted.

� Pipelines shall be ensured to be made of

SS or superior material or any other

food grade material with food grade certificate.

B-3 PROTECTIVE MEASURES

B-3.1 All possible precautions should be The surrounding of the source water outlet taken within the protected perimeter to should be completely covered with pucca

avoid any pollution of, or external influence construction to avoid contamination due to

on, the quality of the ground or surface ingress of external causes. If it is atground

water. Preventive measures should be taken level then it should be covered with a boundary

for disposal of liquid, solid or gaseous waste

wall upto an adequate

height.

that could pollute the ground or surface

water. Drinking water resources should not

be in the path of potential source of

underground contamination.

B-3.2 Protection of the Area of Origin

The immediate surroundings of the Outlets of bore well/ well heads should be extraction or collection area should be covered and locked.

protected by limiting access to authorized Units should prevent entries of individuals,

persons only. Wellheads and spring pests and other sources of extraneous matter to

outflows should be protected by a suitable the immediate surroundings of source of water.

structure to prevent entry by unauthorized

individuals, pests and other sources of

extraneous matter.

B-4 TRANSPORT OF DRINKING WATER

B-4.1 Means of Transport, Piping and Water from the source to processing unit may

Reservoirs

be transported through

pipes.

Any vehicle, piping or reservoir used in the Piping used should preferably be of SS. processing of water from its source to the However, food grade plastics or GI may also be

bottling facilities, should be made of inert permitted. Rubber pipe should not be permitted.

material such as ceramic and stainless steel

Reservoir should

preferably be of SS. In case

which prevent any deterioration, be it by of plastic reservoir, inside layer should be of water, handling, servicing or by food grade plastic (certificate may be

disinfection; it should allow easy cleaning. collected). Cemented (underground/

overground) reservoir should be properly tiled

from

inside. B-4.2 Maintenance of Vehicles and The design of reservoir should be such as to Reservoirs enable easy cleaning or disinfection and it

Any vehicle or reservoir should be properly should be properly maintained throughout the cleaned and, if necessary, disinfected and operation of licence.

kept in good repair so as not to present any

danger of contamination to drinking water

and of deterioration of its quality.

B-5 ESTABLISHMENT FOR PROCESSING OF DRINKING WATER – DESIGN AND

FACILITIES

B-5.1 Location The unit should not be in low lying area toEstablishments should be located in areas avoid collection of dust, contaminant, rain and

which are free from objectionable odours, flood water.

smoke, dust or other contaminants and are Factories in open area/ field should have its

not subject to flooding. proper boundaries with controlled access.

B-5.2 Roadways and Areas Used by Areas in front of main entry to the unit and Wheeled Traffic immediate surroundings should be paved

Such roadways and areas serving the (pucca) or properly grassed to prevent dust

establishment which are within its contamination due to vehicular traffic.

boundaries or in its immediate vicinity

should have a hard paved surface suitable

for wheeled traffic. There should be

adequate drainage and provision should be

made for protection of the extraction area.

B-5.3 Buildings and Facilities

B-5.3.1 Type of construction Buildings should be sound pucca construction, Buildings and facilities should be of sound preferably plastered and properly painted/ white

construction and maintained in good repair. washed. Internal partitions made of plastic may

be accepted.

B-5.3.2 Disposition of Holding Facilities The manufacturing area should not be permitted Rooms for recreation, for storing or for general residence or recreation purposes.

packaging of water and areas for cleaning of In case of any duty quarters for workers/

containers to be reused should be apart from residential area, the same should be reasonably

the bottling areas to prevent the end away from the plant and clearly demarcated and

products from being contaminated. Raw maintained.

materials and packaging materials and any Area for cleaning of reusable containers,

other materials which come into contact packaging material and storage of finished

with drinking water should be stored apart water should be separate from processing/

from other material. filling area. All types of packaging materials

should be stored in a separate room/ area.

B-5.3.3 Adequate working space should be Sufficient space should be available for easy

Provided to allow for satisfactory movement in different operations of

performance of all operations. manufacturing.

B-5.3.4 The design should be such as to

permit easy and adequate cleaning and to

facilitate proper supervision of hygiene for

drinking water.

B-5.3.5 The buildings and facilities should There should not be any other activity except be designed to provide separation by production and packing of water. In case

partition, location or other effective means similar products like cold drink/ beverages/ between those operations which may cause soda are also manufactured in the same

cross-contamination. premises, these activities should be clearly and entirely separated from water manufacturing

and packing facilities. However, for such food

items manufacturing, use of processed water

through a separate pipe line and separate plant

and machinery may be permitted.

There should be proper separation between

different processing activities like blowing of

bottles/ storage of containers: cleaning of reusable containers: raw water storage tank:

filtration (ROs/Micron) disinfection and filling. Exhaust of laboratory should not open in

processing/ filling area.

B-5.3.6 Buildings and facilities should be As far as possible the flow of air should be from designed to facilitate hygienic operations by filling room to the outer area and not the other means of a regulated flow in the process way round.

from the arrival of the drinking water at the

premises to the finished product, and should

provide for appropriate conditions for the

process and the product.

B-5.3.7 Drinking Water Handling, Storing and Bottling Areas

B-5.3.7.1 Floors The flooring should be smooth, without any Where appropriate, should be of water- cracks/ broken surfaces. Joints shall be

proof, non-absorbent, washable, non-slip properly filled and smooth. The slope of the

and non-toxic materials, without crevices, flooring in processing and filling area should be

and should be easy to clean and disinfect. such as to avoid any stagnation of water. The

Where appropriate, floors should have inside drains, if kept open, should be properly

sufficient slope for liquids to drain to tiled for easy and effective cleaning. Drains

trapped outlet. should always be in clean condition and

provided with traps to prevent the entries of

rats/ pests.

B-5.3.7.2 Walls In case of cemented walls, tiles upto height of Where appropriate, should be of water about 5 to 8 feet from floor level should be

proof, non-absorbent, washable and non- provided. Wall made of smooth

toxic materials and should be light coloured.

material or painted with plastic emulsion

paint may also be accepted. Walls made of smooth plastic emulsion paint may also be

provided

Up to a height appropriate for the operation

they should be smooth and without crevices,

and should be easy to clean and disinfect.

Where appropriate, angles between walls,

between walls and floors and between walls

and ceilings should be sealed and smoothen

to facilitate cleaning.

B-5.3.7.3 Ceilings Ceiling should preferably be pucca cemented Should be so designed, constructed and and smooth. However, factories with tin/

finished as to prevent the accumulation of aluminum/ asbestos shed should have proper

dirt and minimize, condensation, mould smooth false ceiling made of non absorbent

growth and flaking, and should be easy to material (like plastic). Wood or similar

clean. material should not be used as it may attract

fungal/ mould growth. False ceiling to be

provided in filling room and lab.

B-5.3.7.4 Windows Open windows should not be permitted. Windows and other openings should be so Windows shall be provided with net screens

constructed as to avoid accumulation of dirt which are easily cleanable and moveable.

and those which open should be fitted with Fittings shall be so intact as to prevent entry of

screens. Screens should be easily movable mosquitoes/ flies.

and cleaning and kept in good repair.

Internal window sills should be sloped to

prevent use as shelves.

B-5.3.7.5 Doors Each door should have door closure. Air Should have smooth, non-absorbent curtains should preferably be provided at

surfaces and, where appropriate, be self- different entries including all inlets and outlets

closing and close fitting type. of filling room. The surface of doors should be

of non absorbent material.

B-5.3.7.6 Stairs, lift cages and auxiliary All stairs, lifts, chutes and ladders should be of structures sound construction and properly painted.

Platforms, ladders, chutes, should be so

situated and constructed as not to cause

contamination to drinking water. Chutes

should be constructed with provision of

inspection and cleaning hatches.

B-5.3.7.7 Piping Different colour coding should be provided so Piping for drinking water lines should be as to easily distinguish between different pipe

independent of non-potable water. lines. The pipe line meant for potable water

should preferably be green in colour. The

entire pipe line for production water including

joints after RO shall be made of stainless steel.

The joints should preferably be of dairy fitting

type. Pipelines shall be ensured to be made of SS

or superior material or any other food grade

material with food grade certificate.

B-5.3.8 In drinking water handling areas all In case false ceiling is provided, care should be overhead structures and fittings should be taken to periodically clean the same and it

installed in such a manner as to avoid should be ensured that ceiling is perfect

contamination directly or indirectly of (without any breakage/ seepage) at all times.

drinking water and raw materials by

condensation and drip and should not

hamper cleaning operations. They should

be insulated where appropriate and be so

designed and finished as to prevent the

accumulation of dirt and to minimize

condensation, mould growth and flaking.

They should be easy to clean.

B-5.3.9 Living quarters, toilets and areas

where animals are kept should be

completely separated and should not open

directly on to drinking water handling areas.

B-5.3.10 Where appropriate, Entry to different water processing area should establishments should be so designed that be controlled in such a way that only the

access can be controlled. authorized persons have the access. B-5.3.11 The use of material which cannot Wood in any form should not be used in be adequately cleaned and disinfected, such processing and filling area.

as, wood, should be avoided unless its use

would not be a source of contamination. B-5.3.12 Canalization, Drainage Lines The drainage line of plant should have proper Canalization and drainage and used water slope and should be made of material which

lines should be built and maintained in such facilitate easy cleaning. There should not be a manner as not to present any risk any stagnation of water/ effluent.

whatsoever of polluting the underground The main drainage line of the plant should be of water source. . sound structure, fully covered and should open

outside the plant only, away from underground

water source.

B-5.3.13 Fuel Storage Area

Any storage area for the storing of fuels,

such as, coal or hydrocarbons should be

designed, protected, controlled and

maintained in such a manner as not to

present a risk of pollution during the storage

and manipulation of these fuels.

B-5.4 Hygienic Facilities

B-5.4.1 Water Supply

B-5.4.1.1 Ample supply of potable water Conformity of raw water is for guidance only. under adequate pressure and of suitable It should be ensured that the source of raw temperature should be available with water (potable) remains uniform. The use of

adequate facilities for its storage, where raw water from different sources shall not be necessary, and distribution with adequate done unless permitted (see Section 5 of the

protection against contamination. The manual). However in case of change of source, potable water should conform to IS 10500. provisions of STI shall be followed.

In order to monitor the uniform supply of raw

water, testing of the same should be carried out

as per the frequency prescribed in STI and

records be maintained.

B-5.4.1.2 Potable water, non-potable water See Explanatory notes against Cl. B-5.3.7.7

for steam production or for refrigeration or

for any other use should be carried in

separate lines with no cross connection

between them and without any chance of

back siphonage. It would be desirable that

these lines be identified by different

colours. B-5.4.2 Effluent and Waste Disposal Pipe line carrying the effluent and waste should Establishments should have an efficient preferably be of red in colour.

effluent and waste disposal system which

should at all times be maintained in good

order and repair. All effluent lines

(including sewer system) should be large

enough to carry the full loads and should be

so constructed as to avoid contamination of

potable water supplies.

B-5.4.3 Changing Facilities and Toilets Entrance to the production unit should preferably be through change room.

Adequate, suitable and conveniently located

.(Changing room may be located at entrance of

the firm preferably)

changing facilities and toilets should be

It is desirable that the Change room has hand

washing

provided in all establishments. Toilets facilities (with hot and cold water) wash basin,

should be so designed as to ensure hygienic

foot cleaning and drying facilities.

(Optional). However, wash basin

with hot and cold or mixed water and

foot wash at entrance of the firm is

mandatory

Protective

removal of waste matter. These areas clothing, footwear and head gear should be should be well lighted, ventilated and changed inside the change room only. The

should not open directly on to drinking protective clothings should be taken out as andwater handling areas. Hand washing when workers go out of the production hall, so

facilities with warm or hot and cold water, a as to prevent any contamination of the same. suitable hand-cleaning preparation, and with Toilets should be provided for workers and

suitable hygienic means of drying hands, should always be kept clean. These should beshould be provided adjacent to toilets and in properly separated from water handling areas.

such a position that the employee will have Toilets should be made of pucca structured to use them when returning to the preferably tiled with proper doors and water

processing area. Where hot and cold water facilities. Hand and foot washing facilities are available mixing taps should be should be provided adjacent to toilets.

provided. Where paper towels are used, a Notices giving instructions for hand and foot

sufficient number of dispensers and washing after using toilets (in local languages) receptacles should be provided near each should be pasted at proper places.

washing facility. Care should be taken that

these receptacles for used paper towels are

regularly emptied. Taps of a non-hand

operatable type are desirable. Notices

should be posted directing personnel to

wash their hands after using the toilets.

B-5.4.4 Hand Washing Facilities in See explanatory notes against Cl. No. B-5.4.3 Processing Area

Adequate and conveniently located facilities

for hand washing and drying should be

provided wherever the process demands.

Where appropriate facilities for hand

disinfection should also be provided.

Warm or hot and cold water should be

available and taps for mixing the two should

be provided. There should be suitable

hygienic means of drying hands. Where

paper towels are used, a sufficient number

of dispensers and receptacles should be

provided adjacent to each washing facility.

Taps of a non-hand operatable type are

desirable. The facilities should be furnished

with properly trapped waste pipes leading to

drains.

B-5.4.5 Disinfection Facilities Disinfection of pipe lines and process Where appropriate, adequate facilities for equipments should preferably be done before

cleaning and disinfection of equipment commencement of production.

should be provided. These facilities should

be constructed of corrosion resistant

materials, capable of being easily cleaned,

and should be fitted with suitable means of

supplying hot and cold water in sufficient

quantities.

B-5.4.6 Lighting Intensity of light is given only for guidance. Adequate lighting should be provided However the IO should judge the adequacy of

throughout the establishment. Where light intensity required for carrying out various

appropriate, the lighting should not alter activities.

colours and the intensity should not be less Suspended light bulbs and fixtures should be

than: protected by providing suitable covers.

540 lux (50 foot candles) at all inspection

points,

220 lux (20 foot candles) in work rooms,

and

110 lux (10 foot candles) in other areas.

Suspended light bulbs and fixtures in any

stage of production should be of a safer type

and protected to prevent contamination of

drinking water in case of breakage.

B-5.4.7 Ventilation Exhaust openings should be covered with Adequate ventilation should be provided to wiremesh or with suitable flaps. Air curtains

prevent excessive heat, steam condensation should be fitted in such a way that air should

and dust and to remove contaminated air. not flow towards water filling room/ area.

The direction of the air flow should never

be from a dirty area to a clean area.

Ventilation openings should be provided

with a screen or other protecting enclosure

of non-corrodible material. Screens should

be easily removable for cleaning.

B-5.4.8 Facilities for Storage of Waste Facilities for storage of waste and inedible and Inedible Material material should be outside the processing plant Facilities should be provided for the storage and finished product storage area.

of waste and inedible material prior to

removal from the establishment. These

facilities should be designed to prevent

access to waste or inedible material by pests

and to avoid contamination of drinking

water; equipment, buildings or roadways on

the premises.

B-5.5 Equipments and Utensils

B-5.5.1 Materials

All equipment and utensils used in drinking

water handling areas and which may contact

the drinking water should be made of

material which does not transmit toxic

substances, odour or taste, is non-absorbent,

is resistant to corrosion and is capable of

withstanding repeated cleaning and

disinfection. Surfaces should be smooth

and free from pits and crevices. The use of

wood and other materials which cannot be

adequately cleaned and disinfected should

be avoided except when their use would not

be a source of contamination.

B-5.5.2. Hygienic Design, Construction and Installation

B-5.5.2.1 All equipment and utensils should

be so designed and constructed as to prevent

hazards and permit easy and thorough

cleaning and disinfection.

B-6 ESTABLISHMENT

B-6.1 Maintenance

The buildings, equipments, utensils and all

other physical facilities of the

establishment, including drains, should be

maintained in good repair and in an orderly

condition.

B-6.2 Cleaning and Disinfection

B-6.2.1 To prevent contamination of All equipments and utensils should be cleaned drinking water, all equipment and utensils and preferably disinfected, every day before

should be cleaned as frequently as necessary commencement of production.

and disinfected whenever circumstances

demand.

B-6.2.2 Adequate precautions should be See explanatory note as given in B-5.4.5

taken to prevent drinking water from being

contaminated during cleaning or

disinfection of rooms, equipment or

utensils, by wash water and detergents or by

disinfectants and their solutions.

Detergents and disinfectants should be

suitable for the purpose intended. Any

residues of these agents on a surface which

with may come in contact with drinking

water should be removed by thorough

rinsing with water, before the area or

equipment is again used for handling

drinking water.

B-6.2.3 Either immediately after cessation

of work for the day or at such other times as

may be appropriate, floors, including drains,

auxiliary structures and walls of water

handling areas should be thoroughly

cleaned.

B-6.2.4 Changing facilities and toilets Changing facilities like aprons, headgears, should be kept clean at all times mask etc. should be available in sufficient

numbers to meet daily and contingency

requirement.

B-6.2.5 Roadways and yards in the The area surrounding the unit may be grassed to immediate vicinity of and serving the prevent entry of dirt and dust in the plant.

premises should be kept clean.

Construction of wall / fencing of adequate height is required when theimmediate

surrounding is not in the control of the unit.

B-6.3 Hygiene Control Programme

A permanent cleaning and disinfection The hygiene control programme should cover should be drawn up for establishment to all aspects.

ensure that all areas are appropriately An elaborate hygiene control plan should be

cleaned and that critical areas, equipment drawn for monitoring the hygienic conditions of and material are designated for special the plant and personnel. The plan should

attention. An individual, who should invariably include the following:

preferably be a permanent member of the Hygiene requirement

staff of the establishment and whose duties Frequency

should be independent of production, should Name of the person directly responsible for

be appointed to be responsible for the supervision

cleanliness of the establishment. He should The above plan should be monitored by a

have a thorough understanding of the designated person who has thorough

significance of contamination and the understanding of significance of contaminants

hazards involved. All cleaning personnel and hazards.

should be well-trained in cleaning The hygiene control schedule should be

techniques. properly displayed at different points like

processing/ filling/ storage.

B-6.4 Storage and Disposal of Waste

Waste material should be handled in such a See explanatory notes as given in Cl. B-5.4.2 manner as to avoid contamination of

drinking water. Care should be taken to

prevent access to waste by pests. Waste

should be removed from the water handling

and other working areas as often as

necessary and at least daily. Immediately

after disposal of the waste, receptacles used

for storage and any equipment which has

come into contact with the waste should be

cleaned and disinfected. The waste storage

area should also be cleaned and disinfected.

B-6.5 Exclusion of Animals

Animals that are uncontrolled or that could No animal should be allowed inside the plant be a hazard to health should be excluded area. If any stray intrusion of pest like lizard,

from establishments. flies are found, immediate action shall be taken to remove them and further necessary

preventive measures shall be taken.

B-6.6 Pest Control

B-6.6.1 There should be an effective and Pest control measures should preferably be got continuous programme for the control of done through professional agencies with clear

pests. Establishments and surrounding area indication of validity period, through a

should be regularly examined for evidence certificate for the same. Fly catchers should be

of infestation. provided in processing/ filling area.

B-6.6.2 If pests gain entrance to the Pesticides designated safe for use in food establishment, eradication measures should industry should only be used under direct

be instituted. Control measures involving supervision of trained personnel.

treatment with chemical, physical or

biological agents should only be undertaken

by or under direct supervision of personnel

who have a thorough understanding of the

potential hazards to health resulting from

the use of these agents, including those

hazards which may arise from residues

retained in the drinking water. B-6.6.3 Pesticides should only be used if See explanatory note as given in Cl. B—6.6.2 other precautionary measures cannot be

used effectively. Before pesticides are

applied, care should be taken to safeguard

drinking water, equipment and utensils from

contamination. After application,

contaminated equipment and utensils should

be thoroughly cleaned to remove residues

prior to be used again.

B-6.7 Storage of Hazardous Substances B-6.7.1 Pesticides or other substances

which may present a hazard to health should

be suitably labeled with a warning about

their toxicity and use. They should be stored

in locked rooms or cabinets, and dispersed

and handled only by authorized and

properly trained personnel or by persons

under strict supervision of trained

personnel. Extreme care should be taken to

avoid contamination. B-6.7.2 Except when necessary for hygienic

or processing purposes, no substance which

could contaminate drinking water should be

used or stored in drinking water handling

areas.

B-6.8 Personal Effects and Clothing Personal effects and clothing should not be Protective clothing should not be permitted to deposited in drinking water handling areas. be taken out beyond change room. Separate

cabinets for storage of personal belongings

should preferably be provided.

B-7 Personnel; Hygiene and Health Requirements. B-7.1 Hygiene Training

Managers of establishments should arrange

for adequate and continuing training of all

water handlers in hygienic handling of

water and in personal hygiene so that they

understand the precautions necessary to

prevent contamination of drinking water.

B-7.2 Medical Examination

Persons who come into contact with Medical examination of all workers, testing drinking water in the course of their work personnel and supervisors should be got done at

should have a medical examination prior to least once in a year or as and when required. In

employment, if the official agency having case any new worker joins, his fitness with

jurisdiction acting on medical advice, respect to freedom from communicable diseases

considers that this is necessary, whether should be first medically examined before

because of epidemiological considerations permitting work in water processing area.

or the medical history of the prospective

water handler. Medical examination of

water handlers should be periodically

carried out and when clinically or

epidemiologically indicated.

B-7.3 Communicable Diseases

The management should take care to ensure Medical examination report should clearly that no person, whether known or suspected indicate that the workers are free from any

to be suffering from, or to be a carrier of a communicable diseases.

disease likely to be transmitted or afflicted

with infected wounds, skin infections, sores

or diarrhea, is permitted to work in any

drinking water handling area in any capacity

in which there is any likelihood of such a

person directly or indirectly contaminating

drinking water with pathogenic micro-

organisms. Any person so affected should

immediately report to the management. B-7.4 Injuries Any person who has a cut or wound should Availability of first aid box should be ensured. not continue to handle drinking water or

contact surfaces until the injury is

completely protected with a waterproof

covering which is firmly secured and which

is conspicuous in colour. Adequate first-aid

facilities should be provided for this

purpose.

B-7.5 Washing of Hands

Every person, while on duty in a drinking Foot operated or photo sensitive taps may water handling area, should wash the hands preferably be used.

frequently and thoroughly with a suitable

hand cleaning preparation under running

warm water. Hands should always be

washed before commencing work,

immediately after using the toilet, after

handling contaminated material and

whenever necessary. After handling any

material which might be capable of

transmitting disease, hands should be

washed and disinfected immediately.

Notices requiring hand-washing should be

displayed. There should be adequate

supervision to ensure compliance with this

requirement.

B-7.6 Personal Cleanliness

Every person engaged in a drinking water Wearing of protective clothing should be handling area should maintain a high degree ensured when the plant is in operation.

of personal cleanliness while on duty and

should, at all times while so engaged, wear

suitable protective clothing including head

covering and footwear, all of which should

be cleanable, unless designed to be disposed

off and should be maintained in a clean

condition consistent with the nature of the

work in which the person is engaged.

Aprons and similar items should not be

washed on the floor. When drinking water is

manipulated by hand, any jewellery that

cannot be adequately disinfected should be

removed from the hands. Personnel should

not wear any insecure jewellery when

engaged in handling drinking water.

B-7.7 Personal Behaviour Any behavior which could result in Proper notices in this regard should be contamination of drinking water, such as displayed in local languages at appropriate eating, use of tobacco, chewing (for places.

example, gum, sticks, betel nuts, etc.) or

unhygienic practices, such as, spitting,

should be prohibited in drinking water

handling areas.

B-7.8 Visitors

Precautions should be taken to prevent General visitors should be prohibited for visitors as far as possible from visiting the entering into processing area.

drinking water handling areas. If

unavoidable, the visitors should observe the

provisions of B-6.8 and B-7.3

B-7.9 Supervision

Responsible for ensuring compliance by all Hygiene supervisor should be other than the personnel with the requirements of B-6.1 to one responsible for production. However, the B-6.8 and the responsibility should be overall supervision for requirements of B-6.1 to

specifically allocated to competent B-6.8 may be done by a senior person

supervisory personnel. irrespective of actual work area.

B-8 ESTABLISHMENT: HYGIENIC PROCESSING REQUIREMENTS

B-8.1 Raw material Requirements

To guarantee a good and stable quality of See explanatory note given in Cl. B-5.4.1.1 drinking water, the quality criteria should be

monitored regularly.

B-8.2 Should there be a perceptible lacking

in meeting the requirements, necessary

corrective measures are immediately to be

taken.

B-8.3 Treatment

The treatment may include decantation, IO should specifically report the type of filtration, combination filtration (for processes adopted by the firm for production

example, membrane filters, depth filters, and disinfection..

cartridge filters, activated carbon), Any subsequent change in the process should

demineralization, reverse osmosis, aeration, be positively informed to BIS for action (see

and disinfection. Section 5 of Manual)

B-8.3.1 Processing should be supervised by

technically competent personnel.

B-8.3.2 All steps in the production process, The water processed in a day should be filled/

including packaging, should be performed packed on the same day. The left out processed without unnecessary delay and under water should be either drained or reprocessed

conditions which will prevent the possibility (on the subsequent day).

of contamination, deterioration, or the

growth of pathogenic and spoilage micro-

organisms.

B-8.3.3 Rough treatment of containers Reusable containers where transparency or should be avoided to prevent the possibility shape is impaired because of repeated use,

of contamination of the processed product. should be rejected.

B-8.3.4 Treatment are necessary controls

and should be such as to protect against

contamination or development of a public

health hazard and against deterioration

within the limits of good commercial

practice.

B-8.4 Packaging Material and Containers

B-8.4.1 All packaging materials should be Separate stores should be available for stored in a clean and hygienic manner. The packaging material, finished products and other

material should be appropriate for the items. Containers/ bottles received or blown by

product to be packed and for the expected the firm should preferably be stored in a closed

conditions of storage and should not mouth polybag/ caps to avoid any

transmit to the product objectionable contamination.

substances beyond the limits specified. The

packaging material should be sound and

should provide appropriate protection from

contamination. Only packaging material

required for immediate use should be kept

in the packing or filling area.

B-8.4.2 Product containers should not have The reusable containers and caps should be been used for any purpose that may lead to cleaned, disinfected, washed and jet rinsed contamination of the product. In case of (with processed water) before filling.

new containers if there is a possibility that Various options are available for disinfection they have been contaminated, they should like use of chlorinated water (using

be cleaned and disinfected. When hypochlorite), food grade detergents like chemicals are used for these purposes, the Ranocide etc. However, use of disinfectants

container should be rinsed. Containers (one or a combination) should be left to the should be well drained after rinsing. Used discretion of the manufacturer. Due care should

and, when necessary; unused containers be taken that no residue of disinfectant is left in should be inspected immediately before the pipeline/ container.

filling.

B-8.5 Filling and Sealing of Containers B-8.5.1 Packaging should be done under Filling room should be regularly disinfected. conditions that preclude the introduction of For this purpose, various options may be

contaminants in the product. assessed such as use of UV light, filling under sterile positive pressure etc. However, selection

of disinfectant should be left at the discretion of

manufacturer.

Air conditioner may also be provided in the

filling room, if required in view of ventilation/

environmental conditions of the area.

B-8.5.2 The methods, equipment and To ensure tight and impervious sealing, the material used for sealing should guarantee a shrinkable sleeve may be used on caps and the

tight and impervious sealing and should not container may be held upside down to check for

damage the containers nor deteriorate the any leakage. The above method is suggestive.

physical, chemical, microbiological and However, any other suitable method may be

organoleptic qualities of drinking water. used.

The container should be visually inspected for

any suspended particle etc. against an

illuminated screen.

B-8.6 Packaging of Containers

The packaging of containers should protect The reusable containers may preferably be the latter from contamination and damage Wrapped /covered in a plastic (polyethylene) and allow appropriate handling and storing. film/ bag to avoid any damage/

transparency to the container

B-8.7 Lot Identification

Each container shall be permanently marked The date of manufacturing should be clearly with code to identify the producing factory indicated on the container itself, in one straight

and the lot. A lot is quantity of drinking line instead of any other combination which

water produced under identical conditions, may not be consumer friendly.

all packages of which should bear a lot Writing of batch No. in place of manufacturing

number that identifies the production during date should not be practiced unless it is declared

a particular time, interval and usually from a that batch number and manufacturing date are

particular ‘processing line’ or other the same.

processing unit.

B-8.8 Processing and Production Records

Permanent, legible and dated records of Batch wise records of production and dispatch pertinent processing and production details for each type of container should be maintained should be kept concerning each lot. These separately.

records should be retained for a period that

exceeds the shelf life of the product or

longer if required. Records should also be

kept of the initial distribution by lot.

B-8.9 Product Durability

Product durability shall be declared on the Product durability should not be less than one container as per 7.1 (g). It shall be based on month. Each type of container should be

in-house shelf life study and proper checks subjected for durability assessment and based

and records be maintained for the on the study conducted by the manufacturer, the

conformity of the declared product shelf life should be declared. Records of the

durability. same should be maintained and may be verified

by IO.

Decision about the type of study should be left

with the manufacturer. Durability study should be reassessed by the

licensee at least once in a year for each type of

container.

B-8.10 Storage and Transport of the End-Product The end-product should be stored and The finished product should not be stored under transported under such conditions as will direct sun light.

preclude contamination with and/or Manufacturer should invariably exercise to proliferation of micro-organisms and protect inspect the end product available in distribution

against deterioration of the product or chain to ensure its compliance to the damage to the container. During storage, specification. This may be done either directly

periodic inspection of the end-product or through proper arrangements with their should take place to ensure that only dealer/ distributor.

drinking water which is fit for human Manufacturer should provide proper training to consumption is dispatched and that the end- the distributor/ marketer for its proper storage

product specifications are complied with. and distribution. Manufacturer is liable for the

product quality till it reaches the consumer.

DOC:STI/14543/7 August 2011

SCHEME OF TESTING AND INSPECTION

FOR CERTIFICATION OF PACKAGED DRINKING WATER

(OTHER THAN PACKAGED NATURAL MINERAL WATER)

ACCORDING TO IS 14543:2004 (Incorporating Amendment No. 1 to 7)

1.0 Laboratory - A laboratory shall be maintained which shall be suitably equipped and

staffed to carry out the different tests in accordance with the methods given in the Indian standards.

2.0 Test Records - All records of analysis and tests shall be kept in suitable forms

approved by the Bureau of Indian Standards (BIS).

2.1 Copies of any records that may be required by BIS shall be made available at any time

on request.

3.0 Quality Control - It is recommended that, as far as possible, Statistical Quality Control

(SQC) methods may be used for controlling the quality of the product as envisaged in this Scheme [See IS 397(Part 1), IS 397 (Part 2), and IS 397 (Part 3)].

3.1 All instruments/equipments are required to be brought under calibration control, as per

frequency to be decided depending upon the usage.

3.2 In addition, effort should be made to gradually introduce a Quality Management

System in accordance with IS/ISO 9001 or Food Safety Management System as per IS/ISO 22000.

4. Standards Marks - The Standard Mark, as given in Column (1) of the First Schedule

of the Licence shall be clearly marked legibly and indelibly on the label of the bottle/container or on the pouch as the case may be, provided always that the material on which this Mark is applied

conforms to every requirement of the specification. The dimension of standard mark shall be in accordance with preferred specified design.

5. Packing -The Packaged Drinking Water shall be packed as per clause 3.2, clause 6 and

Annex B of IS 14543:2004. The pouches and bottles/containers shall be supplied in secondary packaging as agreed to between the purchaser and the supplier.

6. Marking - In addition to the Standard Mark as per clause 7.3 of IS 14543 the

following information shall be given legibly & indelibly on each bottle/container or its label or directly printed on the pouch/bottle/container.

a) Name of the product (i.e. Packaged Drinking Water)

b) Name and full address of the processor (i.e. manufacturer); c) Brand Name, if any;

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DOC:STI/14543/7 August 2011

d) Batch or Code Number/Control Unit No.; e) Date of processing/packing; f) Treatment of disinfection, if any; g) Best for consumption upto (date/month/year in capital letters); OR Best for consumption

within days or months from the date of packing; h) Net quantity; i) Direction for storage; and j) Any other marking required under the Standards of Weights and Measures (Packaged

Commodities) Rules, 1977 and the Prevention of Food Adulteration Act, 1954 and Rules framed thereunder.

k) Recycling symbol as per IS 14535

6.1

6.2

6.3

Each secondary packing of pouches shall be marked with the following:

a) Indication of the source of manufacture of pouch; b) Number of pouches of 200/250/300/500 ml.; and c) Brand name, if any

Each secondary packing of bottles/containers shall be marked with the following:

a) Nominal capacity; and b) Batch No. or Code No.

Labelling Prohibitions -The label on the bottles/containers, pouches and/or the

secondary packaging shall not contain claims which are prohibited as per clause 7.2 of IS 14543:2004.

7. Levels of Control -The tests as indicated in Table 1 and at the levels of control

specified therein, shall be carried out on the whole production of the factory covered by this Scheme

and appropriate records maintained in accordance with clause 2 of this Scheme. Entire production which conforms to the Indian Standard and covered by the licence shall be marked with Certification Mark of the Bureau.

7.1 Control Unit - For the purpose of this Scheme, the quantity of packaged drinking

water treated/processed from same raw water source and filled/packed in one day shall constitute a Control Unit.

7.1.1 On the basis of tests and analysis results, the decision regarding conformity or otherwise

of a Control Unit to the given requirements shall be made.

7.2 In respect of all other clauses of the Standard (other than those mentioned under Levels of

Control - Table 1 of this Scheme) the factory shall maintain appropriate controls and checks to ensure that their product conforms to the requirements of the standard.

7.3 The material shall be held for 48 hours before dispatch so as to ensure that it conforms

to all the requirementos applicable for "Each Control Unit" except for the tests of Aerobic Microbial

Count at 20 C to 22oC and Yeast & Mould which shall be reviewed for conformity

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DOC:STI/14543/7 August 2011

on availability of their reports on completion of their test durations i.e., 3 days and 5 days respectively.

7.4 Microbiological Requirements - As and when a failure is noticed in any of the

microbiological requirements in a control unit during in-process quality control, the control unit shall not be dispatched. Also the previous control units available in stock shall be released into the

market only after rechecking. The manufacturer should reject or re-process the entire previous defective stock including the control unit found failing.

7.4.1 The licensee shall take immediate corrective actions, which would involve complete

investigation of the reasons for contamination and non-conformity. The manufacturer should re-start

marking and despatch only after the completion of satisfactory corrective actions and availability of

satisfactory results of all microbiological tests as applicable for each control unit, for next five

consecutive control units. The original frequency of despatch after 48 hours shall be restored, if all the

five control units are found conforming to the microbiological requirements. The manufacturer shall

keep complete records of such instances for review by BIS.

8. Source Water - The source water used in production of Packaged Drinking Water may

be initially tested for Colour, Odour, Taste, Turbidity, pH, Total Dissolved Solids,

Microbiological & Chemical requirements including Toxic Elements & Pesticides Residues and

Radioactive Residues. Subsequently, its quality may be regularly assessed at least once in three months through in-house testing for Colour, Odour, Taste, Turbidity, pH, Total Dissolved Solids and

Microbiological requirements. In addition, any other requirements as considered necessary for process

control, are to be tested where the incidence of their presence in higher levels has been detected during the previous tests.

8.1 Whenever, the quality of processed water is found to be not meeting the requirements

of Table 2, Table 3 & Clause 5.3 of IS 14543, the source water shall be checked again for such parameters in which failure is observed for deciding upon the necessary controls to be exercised for conformance of quality of processed water to IS 14543.

8.2 In case non-conformity is observed for radioactive residues, the source of raw water

shall be abandoned and water shall be recalled immediately.

8.3 As and when there is change in source water, it shall be intimated to BIS. The raw water

collected from the new source shall be tested in accordance with Clause 8 as above and the processed

water produced from such source water shall be tested for conformity to IS 14543. The reports of source water and the product water produced from the new source shall be submitted to BIS for approval before commissioning for regular production and marking.

8.4 The source water shall be treated as per clause 3.2 of IS 14543:2004. In case the licensee

carries out remineralization as part of its treatment process, the ingredients used shall conform to food grade/pharma grade quality.

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8.5 The means adopted for disinfection of the product water shall be declared and shall be

done in accordance with Clause 3.2 of IS 14543.

8.6 Plastic Bottles/Containers - The plastic container used for packing the material shall

conform to IS 15410:2003. The conformity assessment shall be carried in accordance with the levels of controls as given under Table 2.

8.6.1 In addition, the top lid for glasses/cups shall be of suitable peelable structure in

accordance with Clause 4.2.1 of IS 15410:2003.

8.7 Pouches-The polyethylene film and pouches shall conform to IS 15609. The

conformity assessment shall be carried in accordance with the levels of controls as given under Table 3.

8.8 Reused Containers - Licensee shall ensure use of only such jars for packing the

product water whose transparency continues to meet the requirements as per IS 15410 even after its

repeated use. Jars which get soiled, de-shaped and/or mutilated during the course of use and refilling shall not be used.

8.9 Water to be used for the purpose of cleaning etc., IS 4251:1967 may be followed as

Good Manufacturing practices.

9. Hygienic Condition - The source water shall be collected, processed, handled, stored,

packed and marketed in accordance with the hygienic practices given under Annex B of IS

14543:2004. Other clauses shall also be complied in day to day production and quality control activities. Schedule for each activity for this purpose shall be displayed prominently in the factory

premises and records of compliance shall be maintained for scrutiny by the Bureau. The hygienic

conditions shall also be maintained at the site of water source. A check list for good hygienic practices

and food safety system for packaged drinking water processing units is given in Annex C of IS 14543:2004.

10. Rejection - A separate record providing the detailed information regarding the rejected

control units and mode of their disposal shall be maintained. Such material shall in no case be stored together with that conforming to the specification.

11. Samples - The licensee shall supply, free of charge, the sample(s) required in

accordance with Bureau of Indian Standards (Certification) Regulations, 1988 (as subsequently amended) from its factory or godowns. The BIS shall pay for the samples taken by it from the open market.

12. Replacement - Whenever a complaint is received soon after the goods with Standard

Mark have been purchased and used, and if there is adequate evidence that the goods have not been misused,

defective goods are replaced free of cost by the licensee, in case the complaint is proved to be genuine and

the warranty period (where applicable) has not expired. The final

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DOC:STI/14543/7 August 2011

authority to judge conformity of the product to the Indian Standard shall be with BIS. The firm should have own complaint investigation system as per IS/ISO 10002.

12.1 In the event of any damages caused by the goods bearing the standard mark, or claim

being filed by the consumer against BIS Standard Mark and not "conforming to" the relevant Indian

Standards, entire liability arising out of such non conforming products shall be of licensee and BIS shall not in any way be responsible in such cases.

12. Stop Marking - The marking of the product shall be stopped under intimation to the

Bureau if, at any time, there is some difficulty in maintaining the conformity of the product to the specification, or the testing equipment goes out of order. The marking may be resumed as soon as the

defects are removed under intimation to BIS. The marking of the product shall be stopped immediately if

directed to do so by BIS for any reason. The marking may then be resumed only after permission is

given by the BIS. The information regarding resumption of markings shall also be sent to the Bureau.

14. Production data - The licensee shall send to BIS, as per the enclosed proforma, a

statement of the quantity produced, marked and exported by him and the trade value thereof during the half year ending 30 June and 31 December. This statement is required to be forwarded to BIS on or before the 31st day of July and January for the proceeding half-year.

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DOC:STI/14543/7 August 2011

IS 14543:2004 PACKAGED DRINKING WATER

(OTHER THAN PACKAGED NATURAL MINERAL WATER) TABLE 1 LEVELS OF CONTROL

Para 7 of the Scheme of Testing and Inspection)

TEST DETAILS LEVELS OF CONTROL

Cl. Requirement Test Method No. of Frequency REMARKS

Clause Reference Sample

5.1 Microbiological Requirement

5.1.1 Escherichia coli -- IS 5887 (Part-1)* or IS 15185 One Each control unit

5.1.2 Coliform Bacteria -- IS 5401 (Part-1)* or IS 15185 One Each control unit

5.1.3 Faecal streptococci and Staphylococus aureus -- IS 5887 (Part-2)* or IS 15186 One Once in month+

5.1.4 Sulphite Reducing anaerobes -- Annex C of IS 13428 One Each control unit

5.1.5 Pseudomonas aeruginosa -- Annex D of IS 13428 One Each control unit

5.1.6 Aerobic Microbial Count -- IS 5402 One Each control unit

5.1.7 Yeast & Mould count -- IS 5403 One Each control unit

5.1.8 Salmonella and Shigella -- IS 15187 & IS 5587 (Part-7) One Once in month+

5.1.9 Vibrio cholera and V parahaemolyticus -- IS 5887 (Part-5) One Once in month+

Note:- The requirements indicated with + shall be got tested from outside approved laboratory

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Table 1 (continued)

TEST DETAILS LEVELS OF CONTROL

Clause Requirement Test Method No. of Frequency REMARKS

Clause Reference Sample 5.2 Description 5. 2 IS 14543 One Each Control Unit 5.2 and Table 1 i) Colour - IS 3025 (Part 4) One Every four hours See Note 2

-do- ii) Odour - IS 3025 (Part 5) One -do- -do- -do- iii) Taste - IS 3025 (Part 8) One -do- -do- -do- iv) Turbidity - IS 3025 (Part 10) One -do- -do- -do- v) Total dissolved solids - IS 3025 (Part 16) One Each Control Unit See Note 3 -do- vi) pH - IS 3025 (Part 11) One Every four hours See Note 2

5.2. and Table 2 i) Barium (as Ba) - Annex F of IS One Once in a week See Note 4 13428* or IS 15302 or IS 3025 (Part 2)

-do- ii) Copper (as Cu) - IS 3025 (Part 42)* or IS One -do- -do- 3025 (Part 2)

-do- iii) Iron (as Fe) - IS 3025(Part 53)* or IS One -do- -do- 15303 or IS 3025 (Part 2)

-do- iv) Manganese (as Mn) - IS 3025 (Part 59)* or IS One -do- -do- 3025 (Part 2)

-do- v) Nitrate (as NO3) - IS 3025 (Part 34) One -do- -do- -do- vi) Nitrite (as NO2) - IS 3025 (Part 34) One -do- -do- -do- vii) Fluoride (as F) - IS 3025 (Part 60) One Once in six months See Note 6 -do- viii) Zinc (as Zn) - IS 3025 (Part 49)* or IS One Once in a week See Note 4

3025 (Part 2) -do- ix) Silver (as Ag) - Annex J of IS 13428 One -Once in six -Once in a month for

months licensees using silver -See Note 6 also in any form.

-See Note 5 also -do- x) Aluminium (as Al) - IS 3025 (Part 55) or One Once in a week See Note 4

IS 15302* 5.2 & Table 2 xi) Chloride (as Cl) - IS 3025 (Part 32) One Each control unit

-do- xii) Selenium((as Se) - IS 3025 (Part 56) or One Once in six months See Note 6 IS 15303*

-do- xiii) Sulphate ( as SO4) - IS 3025 (Part 24) One Each control unit -do- xiv) Alkalinity as (HCO3 ) - IS 3025 (Part 23) One Each control unit -do- xv) Calcium (as Ca) - IS 3025 (Part 40)* or IS One Once in a week See Note 4

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TEST DETAILS LEVELS OF CONTROL

Clause Requirement Test Method No. of Frequency REMARKS

Clause Reference Sample 3025(Part 2)

-do- xvi) Magnesium (as Mg) - IS 3025 (Part 46)* or IS One Once in a week See Note 4 3025 (Part 2)

-do- xvii) Sodium (as Na) - IS 3025 (Part 45)* or IS One Once in six months See Note 6 3025(Part 2)

-do- Xviii ) Residual free chlorine - IS 3025 (Part 26) One Each control unit -do- xix) Phenolic compounds (as C6 H5 OH) 6 IS 3025 (Part 43) One Once in a month See Note 5 -do- xx) Mineral Oil 6 IS 3025 (Part 39) One Once in a month - See Note 5 also

-May be tested preferably fro m outside approved lab

-do- xxi) Anionic surface active agents (as MBAS) - Annex K of IS 13428 One Once in a week See Note 4 -do- xxii) Sulphide (as H2 S) - IS 3025 (Part 29) One Once in a week See Note 4 -do- xxiii) Antimony (as Sb) - Annex G of IS 13428* One Once in a month See Note 5

or IS 15303 -do- xxiv) Borate (as B) - Annex H of IS 13428* or One -do- See Note 5

IS 3025 (Part 2) 5.2 & Table 3 i) Mercury (as Hg) - IS 3025 (Part 48) one Once in six months See Note 6

-do- ii) Cadmium (as Cd) - IS 3025 (Part 41) one -do- -do-

iii) Arsenic (as As) - IS 3025 (Part 37) one -do- -do-

-do- iv) Cyanide (as CN) 2 IS 3025 (Part 27) one -do- -do-

-do- v) Lead (as Pb) - IS 3025 (Part 47) one -do- -do-

-do- vi) Chromium (as Cr) - Annex J IS 13428* or IS one -do- -do- 3025 (Part 2)

-do- vii) Nickel (as Ni) - Annex L IS 13428 one -do- -do-

-do- viii)Polychlorinated - Annex M of IS one -do- -do- bi-phenyle (PCB) 13428

-do- ix) Poly-nuclear aromatic - APHA 6440 one -do- -do- hydrocarbons

5.2. & Table 4 i) Alpha emitters - IS 14194 (Part 2) one Once in two years

ii) Beta emitters - IS 14194 (Part 1) one -do-

5..3 Pesticide residues Annex D of one See Note 1 below.

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TEST DETAILS LEVELS OF CONTROL

Clause Requirement Test Method No. of Frequency REMARKS

Clause Reference Sample

i) Individually

ii) Total

5.3.1 IS 14543***

-do- -do-

Initially once in six months for •st operative period. Thereafter once in a year.

-do-

In case of dispute the method indicated by * shall be the reference method.

*** Shall be got tested from recognized laboratory using internationally established test method as specified in Annex D of IS 14543

Note 1 Operative period for the purpose of testing pesticide residues shall begin from 1 September 2005. For existing licensees, in case no failure is

observed during the first operative period (sample tested every 6 months) the frequency of such test may be reduced to one year. In case any failure is observed, the frequency shall be increased to once in three months. The original frequency of once in 6 months may be restored only if two consecutive samples pass. Note 2 In case of failure in any requirement like colour, odour, taste, turbidity and pH, the frequency to be increased from every four hours to every hour for one month. Thereafter frequency of every 4 hours may be restored if all the samples during the month are found passing.

Note 3 In case of failure in total dissolved solid, the frequency to be increased from each control unit to every four hours for one month. Thereafter

frequency of each control unit may be restored if all the samples during the month are found passing.

Note 4 In case of failure in any requirement like Barium, Copper, Iron, Manganese, Nitrate, Nitrite, Zinc, Aluminium, Calcium, Sulphide, Magnesium, Anionic

Surface Active Agent, the frequency to be increased from once in a week to each control unit for one month. Thereafter frequency of once in a week may be restored if all the samples during the month are found passing.

Note 5 In case of failure in any requirement like Phenolic Compounds, Mineral Oil, Antimony, Borate, Silver, (licensee using silver in any form) the

frequency to be increased from once in a month to each control unit for one month. Thereafter frequency of once in a month may be restored if all the samples during the month are found passing.

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Note 6 In case of failure in any requirement like Fluoride, Sodium, Selenium, Mercury, Cadmium, Arsenic, Cyanide, Lead, Chromium, Nickel, PCB, PAH, Silver, the frequency to be increased from once in 6 months to once in 3 months for 6 months. Thereafter frequency of once in a month may be restored only if both the samples tested at each quarter are found passing.

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FORM 1

REPORT FOR FOUR HOURLY TESTINGS

Date of Batch Quantity packed in each type of Total Time of Colour Odour Taste Turbidity pH Remarks Production Number/control packing quantity production

unit number packed in kl

Type of Capacity Quantity Every Every Every Every Every packing of pack four hour four hour four hour four hour F our hour

FORM 2

REPORT FOR DAILY/ EACH CONTROL UNIT TESTING

Date of Batch Description Chloride Sulphate Alkalinity T DS Residual E.coli Coliform Sulphite Pseudomonas Aerobic microbial count Yeast & Remarks Production Number/ free Bacteria reducing Aeruginosa Mould

control chlorine anaerobes uni t 20-220C 3 7 0C number

• 2 3 4 • 6 7 8 9 10 11 12 13 14 15 16

FORM 3

REPORT FOR WEEKLY & MONTHLY TESTING

Date Batch/ Barium Copper Iron M angan- Nitrate Nitrite Zinc Aluminium Calcium Sulphide Magnesium Anionic Antimony Borate Phenolic Remarks control ese surface Com pounds unit no. active

agent • 2 3 4 • 6 7 8 9 10 11 12 13 14 15 16 17 18

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FORM 4

FORMAT FOR TESTING FROM OUTSIDE LABORATORY

Month & Year Batch No./DOM Type of packing Dates on which Lab to which Test report Results Remarks

sample sent sample sent number & date

A) REPORT FOR MONTHLY TEST

1. Faecal streptococci and S. Aureus, Salmonella and Shigella, V. cholera and V. parahaemolyticus

2. Mineral Oil, Phenolic Compound, Antimony, Borate

B) REPORT FOR SIX MONTHLY TEST

1. Mercury, Cadmium, Arsenic, Cyanide, Lead, Chromium, Nickel, Fluoride, Selenium, Sodium, PCB, PAH

2. Silver (as applicable)

3. Pesticide Residues

C) REPORT FOR TWO YEARLY TEST

1. Radio Active Residues (Alpha and Beta Emitters)

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FORM 5

SOURCE WATER TESTING (3 MONTHLY TESTS)

Month Source of In-house testing Outside testing (if done) Record of in-house Results Remarks

& Year water (if done) testing/outside TR

Name of sample TR No. lab sent on & Date

FORM 6

RECORD FOR PLASTIC CONTAINERS USED FOR PACKING WATER

Date of Type of Name of Quantity Whether Suppliers TC Details of outside Results Remarks

receipt packing supplier received ISI number & testing/ suppliers TC material marked date

Name of Date of Overall Colour Remaining

lab spending migration migration parameters samples as per IS

15410

FORM 7

RECORDS FOR SHELF LIFE ASSESSMENT (SEPARATE FOR EACH TYPE OF CONTAINER BEING USED)

Date on which Batch Type of Declared shelf Periodicity of Date of Requirements Results Remarks

sample kept No./DOM packing whose life testing (like Testing Tested sample kept Monthly)

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FORM 8

A) FORMAT FOR PE FILM

Date of Name of Quantity Details of Description Film Winding Odour Thickness Width Overall Tensile Elongation at Dart Impact Results Remark Receipt Supplier Received Test Form of Film Migration Strength Break Resistance of Rolls (No. of Certificate

Rolls) from supplier / O S Lab. With date

(1) (2) (3) (4) (5) (6) (7) (7) (8) (9) (10) (11) (12) (13) (14) (15)

B) FORMAT FOR POUCH TESTING

Date of Time of Total quantity Drop Test Vibration Leakage Stack Load Ink Adhesion of Product Resistance of Water Results Remarks Pouch production produced Test Test Printed Pouches Printed Pouches Potability Producti Test on Machine No.

• 2 3 4 Etc.

(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11)

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Table 2 Guidelines on ensuring conformity of containers used for Packaged Drinking Water

Type of Parameters Options for mode of conformity Frequency to be followed by licensee container a) Plastic Jars i) Overall migration and colour i) 'ISI' marked Each consignment of specific size/ material of jars

migration as per Clause 6 of IS ii) Test certificate of conformity by the manufacturer of received by the licensee 14543: 2004 & jars ii) Conformity to IS 15410: 2003 iii) In-house Test Reports of licensee, if facilities exist All consignments of plastic material (raw/moulded) and

iv) Outside laboratory Test Report of the samples got of the same chemical composition shall be treated as tested by licensee one consignment as verified from the test certificate of v) Combination of the above. original manufacturer.

b) Plastic i) Overall migration and colour i) 'ISI' marked a) In case bottles, glasses/ cups are received from Bottles, Glass/ migration as per Clause 6 of IS ii) Test certificate of conformity by the manufacturer of outside source options as given at i) to v) as given in c ups 14543:2004 & plastic bottles, glasses/ cups Column 3 may be followed for any one consignment

ii) Conformity to IS 15410:2003 iii) In-house Test Reports of licensee, if facilities exist received during a period of every three months for each iv) Outside laboratory Test Report of the samples got capacity, shape and material b) In case bottles, glasses/ tested by licensee cups are manufactured from preforms in licensee's own v) Combination of the above. premises, licensee to ensure conformity of containers

through in-house or outside lab testing or combination thereof, for each type/ capacity/ shape/ material once in a period of three months.

c) Plastic cap i) Overall migration and colour i) Declaration/ certificate w.r.t. food grade quality, as Once in a year for each type/ shape/ size/ material of (closures) of migration as per Clause 6 of IS permitted under IS 14543 closure received from each manufacturer. containers 14543:2004 & ii) Test certificate from manufacturer for overall

ii) Conformity to IS 15410:2003 migration and colour migration. d) Foil (for i) Overall migration and colour Declaration/ certificate w.r.t. food grade quality of the Once in a year for each type of material received from sealing of migration as per Clause 6 of IS material used for the plastic film. each manufacturer. plastic cups/ 14543:2004 & glasses) ii) Conformity to

IS 15410:2003

Note: Licensee to keep records for all types of containers and closures received along with the corresponding test certificate/ reports and to be verified by BIS during periodic inspections for adequacy of the system being followed by licensee to control quality of packaging material received, accepted, rejected and method of disposal.

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Table 3

Levels of control for Polyethylene Flexible Pouches for the packing of Natural Mineral Water and Packaged Drinking Water as per IS 15609:2005

Test details Levels of Control

Clause Requirement Test Method No. of Lot size Remarks

Clause Reference Samples

• Material • IS 15609: 2005 One Each consignment i) Test certificate of conformity by the of Polyethylene film manufacturer of film OR

ii) Outside laboratory Test Report of the samples got tested by licensee

iii) Combination of the above.

6.1 Requirement for Polyethylene Film

6.1.1 Description 6.1.1 IS 15609:2005 One Each roll of All rolls to be checked before using the polyethylene same for making pouches. All such rolls film which do not conform to the

requirement shall be rejected

6.1.2 Film Form 6.1.2 -do- -do- -do- -do-

6.1.3 Winding of film 6.1.3 -do- -do- -do- -do-

6.1.4 Odour 6.1.4 -do- -do- -do- -do-

6.1.5 Thickness 6.1.5 -do- -do- -do- -do-

6.1.6 Width 6.1.6 -do- -do- -do- -do-

6.1.7 Overall Migration 6.1.7 -do- -do- Each consignment i) Test certificate of conformity by the from one source manufacturer of film OR

ii) In house test report, if facility exist with the licensee OR

iii) Outside approved laboratory test report of the sample got tested by licensee OR

iv) Combination of the above If the sample does not conform to the requirement, the consignment shall be

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Test details Levels of Control

Clause Requirement Test Method No. of Lot size Remarks

Clause Reference Samples

rejected

6.1.8 Tensile strength 6.1.8 -do- -do- -do- -do-

6.1.9 Elongation of break 6.1.9 -do- -do- -do- -do-

6.1.10 Dart impact resistance 6.1.10 -do- -do- -do- -do-

7 Requirement for Flexible Pouches

7.1 Vibration leakage Annex D IS 15609:2005 -do- One day production If the sample does not confirm to the test requirement the licensee shall follow

the criteria for acceptance and retesting as per clause D-5 of IS 15609:2005. If it does not confirm then the same day production shall be rejected.

7.2 Water Potability Test Annex E -do- -do- Once in two months Sample of each size shall be tested by rotation so that all the sizes shall be tested in one operative period.

7.3 Stack load Test Annex F -do- -do- One day production If the sample does not confirm to the requirement the same day production shall be rejected.

7.4 Drop test Annex G -do- -do- Every hour for each If the sample does not confirm to the machine requirement, the licensee shall follow

the criteria for acceptance and retesting as per clause G-3 of IS 15609:2005. If it does not confirm then the same day production shall be rejected.

7.5 Ink Adhesion of Printed Annex H IS 15609:2005 -do- One day production If the sample does not confirm to the Pouches requirement the same day production

shall be rejected.

7.6 Product resistance of Annex J -do- One -do- -do- printed Pouches

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