BUREAU OF INDIAN STANDARDS CNBO(FCT) · 2018-12-10 · BUREAU OF INDIAN STANDARDS CNBO(FCT) Our...

BUREAU OF INDIAN STANDARDSCNBO(FCT)

Our Ref: CNBO(FCT)/IS 14543/Policy 10/12/2014

Subject: Revision of STI for Packaged Drinking Water consequent to revision of IS 14543

1. The ‘F’ Draft for revision of IS 14543:2004 was circulated by CMD-II(Legal) to all ROs, BOs andSBOs on 14-8-2014 and as informed by CMD-II(legal) it is under printing and could be notifiedany time. The significant changes finalized for incorporation in the proposed revision include:

a) Incorporation of all existing seven amendments.b) Revision of definition of Packaged Drinking Water to broaden its scope.c) Revision of limits of pH, Barium, Cadmium, and Arsenic.d) Marking on water, not meant for human consumption has been prescribed.e) Locational requirements of a Packaged Drinking Water processor have been modified in

Clause B-5.1 of the ‘F’ draft.

2. In addition to ensuing revision of ISS, comments received from the following on frequency of certaintests for packaged drinking water and packaging material have also been forwarded by CMD-II(Legal) to CNBO(FCT):

a) M/s President, Greater Chennai Water manufacturers’ Association, Chennai.b) M/s Sur Enamel & Stamping Works Pvt Ltd. Kolkata.c) Jamshedpur SBO and Coimbatore BO of BIS.

3. As per BIS/DGO(404)/ 2014 of 30 July 2014 the responsibility for revision of STI for IS 14543 has

been entrusted to the CNBO(FCT). The current STI (Doc: STI/14543/7) for IS 14543 was issued inAugust 2011 and calls for a thorough review of its various provisions, in view of the above inputs.

4. A draft revised STI/14543 has been prepared taking into consideration revised draft of IS 14543 andcomments on STI received from stakeholders as mentioned at S. No. 2 above.

5. A copy of the draft revised STI/14543 is enclosed as Annex A (The additions are indicated inred colour (underlined) and deletions are indicated by strikethrough)

6. The recommendations of CNBO(FCT) on the comments received from various stakeholders isenclosed as Annex B for reference.

7. All ROs /BOs/ SBOs are requested to give their comments on the draft revised STI in theformat enclosed as Annex D within two weeks i.e. latest by 25 th December 2014 by emaildirectly to CNBO(FCT) on email id.: [email protected].

8. Specific feedback is sought on the proposal of CNBO(FCT) given in Annex C regarding frequencyof testing of parameters under Table 2 of IS 14543 ‘General parameters concerning substancesundesirable in excessive amounts’.

9. The draft revised STI/14543 will be finalized taking into consideration the comments received.

10. This is issued with the approval of Competent Authority.

(Chinmay Dwivedi) Scientist C- CNBO(FCT)

Circulated to all ROs, BOs, SBOs

Copy to: Sc. G & DDGSSc. F & H(CNBO(FCT)CMD-II (Legal) FAD

DOC: Draft revised STI/14543December 2014

ANNEX ADRAFT SCHEME OF TESTING AND INSPECTION

FOR CERTIFICATION OF PACKAGED DRINKING WATER (OTHER THAN PACKAGED NATURAL MINERAL WATER)

ACCORDING TO IS 14543:2004 14543:2014(Incorporating Amendment No. 1 to 7)

1.0 Laboratory - A laboratory shall be maintained which shall be suitably equipped and staffedto 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 approvedby the Bureau of Indian Standards (BIS).

2.1 Copies of any records that may be required by BIS shall be made available at any timeon 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 thisScheme [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 perfrequency to be decided depending upon the usage. However, the following test equipmentsshall be calibrated at least once a year:

a) Analytical balance (electronic)/weight box (including fractional weights),b) Temperature indicators of all incubators,c) Pressure gauge of Autoclave, andd) Temperature indicator of Autoclave (optional)

3.2 In addition, effort should be made to gradually introduce a Quality Management Systemin 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 theLicence shall be clearly marked legibly and indelibly on the label of the bottle/container or onthe pouch as the case may be, provided always that the material on which this Mark is appliedconforms to every requirement of the specification. The dimension of standard mark shall be inaccordance with preferred specified design.

5. Packing – The Packaged Drinking Water shall be packed as per clause 5.1.2 3.2, clause 6 andAnnex B of IS 14543:2014 14543:2004. The pouches and bottles/containers shall be supplied insecondary 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 followinginformation shall be given legibly & indelibly on each bottle/container or its label or directlyprinted 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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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; j) Keep the container away from direct sunlight; andk) 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. Any other information required under the Legal Metrology (Packaged Commodities) Rules, 2011 and the Food Safety and Standards (Packaging and Labelling) Regulations, 2011.

l) Recycling symbol as per IS 14535.

6.1 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

6.2 Each secondary packing of bottles/containers shall be marked with the following: a) Nominal capacity; and b) Batch No. or Code No.

6.3 Labelling Prohibitions -The label on the bottles/containers, pouches and/or thesecondary packaging shall not contain claims which are prohibited as per clause 7.2 of IS14543:2014 14543:2004.

6.5 Water not meant for human consumption shall be marked as per clause 8 of IS14543:2014.

7. Levels of Control -The tests as indicated in Table 1 and at the levels of control specifiedtherein, shall be carried out on the whole production of the factory covered by this Scheme andappropriate records maintained in accordance with clause 2 of this Scheme. Entire productionwhich conforms to the Indian Standard and covered by the licence shall be marked withCertification Mark of the Bureau.

7.1 Control Unit - For the purpose of this Scheme, the quantity of packaged drinking watertreated/processed from same raw water source and filled/packed in one day shall constitute aControl Unit.

7.1.1 On the basis of tests and analysis results, the decision regarding conformity or otherwise ofa 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 ofControl – Table 1 of this Scheme) the factory shall maintain appropriate controls and checks toensure 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 toall the requirements applicable for “Each Control Unit” except for the tests of Aerobic MicrobialCount at 20oC to 22oC and Yeast & Mould which shall be reviewed for conformity

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on availability of their reports on completion of their test durations i.e., 3 days and 5 daysrespectively.

7.4 Microbiological Requirements - As and when a failure is noticed in any of themicrobiological requirements in a control unit during in-process quality control, the control unitshall not be dispatched. Also the previous control units available in stock shall be released intothe market only after rechecking. The manufacturer should reject or re-process the entireprevious defective stock including the control unit found failing.

7.4.1 The licensee shall take immediate corrective actions, which would involve completeinvestigation of the reasons for contamination and non-conformity. The manufacturer should re-start marking and despatch only after the completion of satisfactory corrective actions andavailability 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 berestored, 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 beinitially tested for Colour, Odour, Taste, Turbidity, pH, Total Dissolved Solids, Microbiological& Chemical requirements including Toxic Elements & Pesticides Residues and RadioactiveResidues. Subsequently, its quality may be regularly assessed at least once in three monthsthrough in-house testing for Colour, Odour, Taste, Turbidity, pH, Total Dissolved Solids andMicrobiological requirements. In addition, any other requirements as considered necessary forprocess control, are to be tested where the incidence of their presence in higher levels has beendetected during the previous tests.

8.1 Whenever, the quality of processed water is found to be not meeting the requirements ofTable 2, Table 3 & Clause 5.4 5.3 of IS 14543, the source water shall be checked again for suchparameters in which failure is observed for deciding upon the necessary controls to be exercisedfor conformance of quality of processed water to IS 14543.

8.2 In case non-conformity is observed for radioactive residues, the source of raw watershall 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 watercollected from the new source shall be tested in accordance with Clause 8 as above and theprocessed 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 besubmitted to BIS for approval before commissioning for regular production and marking.

8.4 The source water shall be treated as per clause 5.1.1 3.2 of IS 14543:2014 14543:2004. Incase the licensee carries out remineralization as part of its treatment process, the ingredientsused shall conform to food grade/pharma grade quality.

8.5 The means adopted for disinfection of the product water shall be declared and shall bedone in accordance with Clause 5.1.1 3.2 of IS 14543.

8.6 Plastic Bottles/Containers - The plastic container used for packing the material shallconform to IS 15410:2003. The conformity assessment shall be carried in accordance with thelevels 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 accordancewith Clause 4.2.1 of IS 15410:2003.

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8.7 Pouches – The polyethylene film and pouches shall conform to IS 15609. Theconformity assessment shall be carried in accordance with the levels of controls as given underTable 3.

8.8 Reused Containers – Licensee shall ensure use of only such jars for packing the productwater whose transparency continues to meet the requirements as per IS 15410 even after itsrepeated use. Jars for reuse shall be cleaned with prescribed agents and properly rinsed,before use, to remove foreign matter both from inside and outside. Jars which get soiled, de-shaped and/or mutilated during the course of use and refilling shall not be used.

8.9 Whenever fresh jars/bottles/containers are purchased, the traceability of the date ofmanufacture of the jars shall be ensured in the test certificate being received for eachconsignment.

8.10 Water to be used for the purpose of cleaning etc., may conform to IS 4251:1967 as GoodManufacturing 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 IS14543:2014 14543:2004. Other clauses shall also be complied in day to day production andquality control activities. Schedule for each activity for this purpose shall be displayedprominently in the factory premises and records of compliance shall be maintained for scrutinyby the Bureau. The hygienic conditions shall also be maintained at the site of water source. Acheck list for good hygienic practices and food safety system for packaged drinking waterprocessing units is given in Annex C of IS 14543:2014 14543:2004.

10. Rejection - A separate record providing the detailed information regarding the rejectedcontrol units and mode of their disposal shall be maintained. Such material shall in no case bestored together with that conforming to the specification.

11. Samples - The licensee shall supply, free of charge, the sample(s) required in accordancewith 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 StandardMark have been purchased and used, and if there is adequate evidence that the goods have notbeen misused, defective goods are replaced free of cost by the licensee, in case the complaint isproved to be genuine and the warranty period (where applicable) has not expired. The finalauthority to judge conformity of the product to the Indian Standard shall be with BIS. The firmshould 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 beingfiled by the consumer against BIS Standard Mark and not “conforming to” the relevant IndianStandards, entire liability arising out of such non conforming products shall be of licensee andBIS 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 Bureauif, at any time, there is some difficulty in maintaining the conformity of the product to thespecification, or the testing equipment goes out of order. The marking may be resumed as soonas the defects are removed under intimation to BIS. The marking of the product shall be stopped

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immediately if directed to do so by BIS for any reason. The marking may then be resumed onlyafter permission is given by the BIS. The information regarding resumption of markings shallalso be sent to the Bureau.

14. Production data – The licensee shall send to BIS, as per the enclosed proforma, a statementof the quantity produced, marked and exported by him and the trade value thereof during the halfyear ending 30 June and 31 December. This statement is required to be forwarded to BIS on orbefore the 31st day of July and January for the proceeding half-year.

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IS 14543:2014 14543:2004PACKAGED 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

REMARKSCl. Requirement Test Method No. of

FrequencyClause Reference Sample5.2 5.1 Microbiological Requirement5.2.1 5.1.1 Escherichia coli (or thermotolerant bacteria) -- IS 5887 (Part-1)* or IS 15185 One Each control unit5.2.25.1.2 Coliform Bacteria -- IS 5401 (Part-1)* or IS 15185 One Each control unit5.2.35.1.3 Faecal streptococci and Staphylococus aureus -- IS 5887 (Part-2)* or IS 15186 One Once in month+5.2.3 Staphylococus aureus -- IS 5887 (Part-2) One Once in month+5.2.45.1.4 Sulphite Reducing anaerobes -- Annex C of IS 13428 One Each control unit5.2.55.1.5 Pseudomonas aeruginosa -- Annex D of IS 13428 One Each control unit5.2.65.1.6 Aerobic Microbial Count -- IS 5402 One Each control unit5.2.75.1.7 Yeast & Mould count -- IS 5403 One Each control unit5.2.85.1.8 Salmonella and Shigella --

IS 15187 and IS 5587 (Part-7) respectively One Once in month+

5.2.95.1.9 Vibrio cholera and V parahaemolyticus -- IS 5887 (Part-5) One Once in month+

The requirements indicated with ‘+’ shall be got tested from outside approved laboratory.In case of dispute, the method indicated by ‘*’ shall be the reference method.

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Table 1 (continued)TEST DETAILS LEVELS OF CONTROL REMARKS

Clause Requirement Test Method No. ofSample

FrequencyClause Reference

5.3 5.2 Description 5.3 5.2 IS 14543 One Each Control Unit5.3 5.2 and Table 1

i) Colour - IS 3025 (Part 4) One Every four hours See Note 1

-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 14)/IS 3025 (Part 16)* One Each Control Unit See Note 2-do- vi) pH - IS 3025 (Part 11) One Every four hours See Note 1

5.3 5.2 and Table 2 i) Barium (as Ba) - Annex F of IS13428* or IS 15302 or IS3025 (Part 2)

One Once in a month Once in a week

See Note 4

-do- ii) Copper (as Cu) - IS 3025 (Part 42)* or IS3025 (Part 2)

One -do- -do-

-do- iii) Iron (as Fe) - IS 3025(Part 53)* or IS15303 or IS 3025 (Part 2)

One -do- -do-

-do- iv) Manganese (as Mn) - IS 3025 (Part 59)* or IS3025 (Part 2)

One -do- -do-

-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 5-do- viii) Zinc (as Zn) - IS 3025 (Part 49)* or IS

3025 (Part 2)One Once in a month

Once in a week See Note 4

-do- ix) Silver (as Ag) - Annex J of IS 13428 One -Once in six Months for licensees not using silver in any form

-See Note 5 also

-Once in a month forlicensees using silver in any form.

-See Note 4 also

-do- x) Aluminium (as Al) - IS 3025 (Part 55) orIS 15302* One Once in a month Once in a week

See Note 4


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REMARKSClause Requirement

Test Method No.of

Sample FrequencyClause Reference5.3 5.2 and Table 2 xi) Chloride (as Cl) - IS 3025 (Part 32) One Each control unit See Note 2

-do- xii) Selenium (as Se) - IS 3025 (Part 56) orIS 15303*

One Once in six months See Note 5

-do- xiii) Sulphate ( as SO4) - IS 3025 (Part 24) One Each control unit See Note 2-do- xiv) Alkalinity as (HCO3 ) - IS 3025 (Part 23) One Each control unit-do- xv) Calcium (as Ca) - IS 3025 (Part 40)* or IS

3025(Part 2)One Once in a week See Note 3

-do- xvi) Magnesium (as Mg) - IS 3025 (Part 46)* or IS3025 (Part 2)

One Once in a week See Note 3

-do- xvii) Sodium (as Na) - IS 3025 (Part 45)* or IS3025(Part 2)

One Once in six months See Note 5

-do- xviii ) Residual free chlorine - IS 3025 (Part 26) One Each control unit See Note 2-do- xix) Phenolic compounds (as C6 H5 OH) 6 IS 3025 (Part 43) One Once in a month See Note 4-do- xx) Mineral Oil 6 IS 3025 (Part 39) One Once in a month - See Note 4 also

- May be tested preferably Fromoutside approved lab

-do- xxi) Anionic surface active agents (as MBAS) - Annex K of IS 13428* or IS15303

One Once in a month Once in a week

See Note 4

-do- xxii) Sulphide (as H2 S) - IS 3025 (Part 29) One Once in a month Once in a week

See Note 4

-do- xxiii) Antimony (as Sb) - Annex G of IS 13428*or IS 15303

One Once in a month See Note 4

-do- xxiv) Borate (as B) - Annex H of IS 13428* orIS 3025 (Part 2)

One -do- See Note 4

5.3 5.2 & Table 3

i) Mercury (as Hg) - IS 3025 (Part 48) one Once in six months See Note 5

-do- ii) Cadmium (as Cd) - IS 3025 (Part 41) one -do- -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-


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REMARKSClause Requirement

Test Method No.of

Sample FrequencyClause Reference5.3 5.2 &

Table 3v) Lead (as Pb) - IS 3025 (Part 37) IS

3025 (Part 47)one Once in six months See Note 5

-do- vi) Chromium (as Cr) - Annex J IS 13428* or IS3025 (Part 2)

one -do- -do-

-do- vii) Nickel (as Ni) - Annex L IS 13428 one -do- -do--do- viii)Polychlorinated bi-phenyle (PCB) - Annex M of IS

13428one -do- -do-

-do- ix) Poly-nuclear aromatic hydrocarbons - APHA 6440 one -do- -do-5.3 5.2. & Table

4i) Alpha emitters - IS 14194 (Part 2) one Once in two years

ii) Beta emitters - IS 14194 (Part 1) one -do-

5.4 5.3 Pesticide residuesi) Individually 5.4.1

5.3.1Annex D of IS 14543*** One Initially once in six

months for1st operativeperiod. Thereafteronce in ayear.

See Note 6 below.

ii) Total -do- -do- -do- -do- -do- In case of dispute the method indicated by * shall be the reference method.Approved international standard test methods from organizations like ISO/ APHA/ ASTM/ AOAC/EPA/EN may also be followed for requirements under clause 5.3 Table 2 and clause 5.3 Table 3. In case of dispute, methods given at column 4 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 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 2 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 controlunit may be restored if all the samples during the month are found passing.

Note 3 In case of failure in any requirement like Barium, Copper, Iron, Manganese, Nitrate, Nitrite, Zinc, Aluminium, Calcium, Sulphide, Magnesium, Anionic Surface ActiveAgent, 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 samplesduring the month are found passing.

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Note 4 In case of failure in any requirement like Barium, Copper, Iron, Manganese, Nitrate, Nitrite, Zinc, Aluminium, Sulphide, Anionic Surface Active Agent, PhenolicCompounds, Mineral Oil, Antimony, Borate, Silver (licensee using silver in any form) the frequency to be increased from once in a month to once a week each control unitfor one month. Thereafter frequency of once in a month may be restored if all the samples during the month are found passing.

Note 5 In case of failure in any requirement like Fluoride, Sodium, Selenium, Mercury, Cadmium, Arsenic, Cyanide, Lead, Chromium, Nickel, PCB, PAH, Silver (licensee notusing silver in any form), 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 restoredonly if both the samples tested at each quarter are found passing.

Note 6 Operative period for the purpose of testing pesticide residues shall begin from 1 September 2005. For existing licensees, Pesticide residues shall be tested i nitiallyonce in six months for first operative period. In case no failure is observed during the first operative period (sample tested every 6 months) the frequency of such testmay 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 berestored only if two consecutive samples pass.

FORM 1

REPORT FOR FOUR HOURLY TESTINGS

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Date ofProduction

BatchNumber/controlunit number

Quantity packed in each type ofpacking

Totalquantitypacked in kl

Time ofproduction

Colour Odour Taste Turbidity pH Remarks

Type ofpacking

Capacityof pack

Quantity Everyfour hour

Everyfour hour

Everyfour hour

Everyfour hour

EveryFour hour

FORM 2

REPORT FOR DAILY/ EACH CONTROL UNIT TESTING

Date ofProduction

BatchNumber/controlunitnumber

Description Chloride Sulphate Alkalinity TDS Residualfreechlorine

E.coli ColiformBacteria

Sulphitereducinganaerobes

PseudomonasAeruginosa

Aerobic microbial count Yeast &Mould

Remark

20-220C 370C ±10C

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

FORM 3

REPORT FOR WEEKLY & MONTHLY TESTING

Date Batch/controlunit no.

Weekly Monthly Remarks

Calcium Magnesium Barium Copper Iron Mangan-ese

Nitrate Nitrite Zinc Aluminium Sulphide Anionicsurfaceactiveagent

Antimony Borate PhenolicCompounds

1 2 3 4 5 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 whichsample sent

Lab to whichsample sent

Test reportnumber & date

Results Remarks

A) REPORT FOR MONTHLY TEST

1. Faecal streptococci and S. Aureus, Salmonella and Shigella, V. cholera and V. parahaemolyticus

2. Barium, Copper, Iron, Manganese, Nitrate, Nitrite, Zinc, Aluminium, Sulphide, Anionic Surface Active Agent, Phenolic Compounds, MineralOil, Antimony, Borate, Silver (licencee using silver in any form)

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& Year

Source ofwater

In-house testing(if done)

Outside testing (if done) Record of in-housetesting/outside TR

Results Remarks

Name oflab

samplesent on

TR No.& Date

FORM 6

RECORD FOR PLASTIC CONTAINERS USED FOR PACKING WATER

Date ofreceipt

Type ofpackingmaterial

Name ofsupplier

Quantityreceived

WhetherISImarked

Suppliers TCnumber &date

Details of outsidetesting/ suppliers TC

Results Remarks

Name oflab

Date ofspendingsamples

Overallmigration

Colourmigration

RemainingParametersas per IS15410

FORM 7

RECORDS FOR SHELF LIFE ASSESSMENT (SEPARATE FOR EACH TYPE OF CONTAINER BEING USED)

Date on whichsample kept

BatchNo./DOM

Type ofpacking whosesample kept

Declared shelflife

Periodicity oftesting (likeMonthly)

Date ofTesting

RequirementsTested

Results Remarks

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FORM 8

A) FORMAT FOR PE FILM

Date ofReceiptof Rolls

Name ofSupplier

QuantityReceived(No. ofRolls)

Details ofTestCertificatefrom supplier/ O S Lab.With date

Description FilmForm

Windingof Film

Odour Thickness Width OverallMigration

TensileStrength

Elongation atBreak

Dart ImpactResistance

Results Remark

(1) (2) (3) (4) (5) (6) (7) (7) (8) (9) (10) (11) (12) (13) (14) (15)

B) FORMAT FOR POUCH TESTING

Date ofPouchProductiOn

Time ofproduction

Total quantityproduced

Drop Test Vibration Leakage Test

Stack LoadTest

Ink Adhesion ofPrinted Pouches

Product Resistance ofPrinted Pouches

WaterPotabilityTest

Results Remarks

Machine No.

1 2 3 4 Etc.

(1) (2) (3) (4) (5) (5) (6) (7) (8) (9) (10)

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Table 2Guidelines on ensuring conformity of containers used for Packaged Drinking Water

Type ofcontainer

Parameters Options for mode of conformity Frequency to be followed by licensee

a) Plastic Jars i) Overall migration and colourmigration as per Clause 6 of IS14543:2014 14543: 2004 &ii) Conformity to IS 15410: 2003

i) ‘ISI’ markedii) Test certificate of conformity by the manufacturer ofJarsiii) In-house Test Reports of licensee, if facilities existiv) Outside laboratory Test Report of the samples gottested by licenseev) Combination of the above.

Each consignment of specific size/ material of jarsreceived by the licensee All consignments of plastic material (raw/moulded) and of the same chemical composition shall be treated as one consignment as verified from the test certificate of original manufacturer.Whenever fresh jars are purchased, the traceability of thedate of manufacture of the jars shall be ensured in the testcertificate being received for each consignment.

b) PlasticBottles, Glass/cups

i) Overall migration and colourmigration as per Clause 6 of IS14543:2014 14543: 2004 &ii) Conformity to IS 15410:2003

i) ‘ISI’ markedii) Test certificate of conformity by the manufacturer ofplastic bottles, glasses/ cupsiii) In-house Test Reports of licensee, if facilities existiv) Outside laboratory Test Report of the samples gottested by licenseev) Combination of the above.

a) In case bottles, glasses/ cups are received fromoutside source options as given at i) to v) as given inColumn 3 may be followed for any one consignmentreceived during a period of every three months for eachcapacity, shape and material b) In case bottles, glasses/cups are manufactured from preforms in licensee’s ownpremises, licensee to ensure conformity of containersthrough in-house or outside lab testing or combinationthereof, for each type/ capacity/ shape/ material once ina period of three months.

c) Plastic cap(closures) ofcontainers

i) Overall migration and colourmigration as per Clause 6 of IS14543:2014 14543: 2004 &ii) Conformity to IS 15410:2003

i) Declaration/ certificate w.r.t. food grade quality, aspermitted under IS 14543ii) Test certificate from manufacturer for overallmigration and colour migration.

Once in a year for each type/ shape/ size/ material ofclosure received from each manufacturer.

d) Foil (forsealing ofplastic cups/glasses)

i) Overall migration and colourmigration as per Clause 6 of IS14543:2014 14543: 2004 &ii) Conformity toIS 15410:2003

Declaration/ certificate w.r.t. food grade quality of thematerial used for the plastic film.

Once in a year for each type of material received fromeach manufacturer.

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 periodicinspections for adequacy of the system being followed by licensee to control quality of packaging material received, accepted, rejected and method of disposal.

20


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 ControlClause Requirement Test Method No. of

SamplesLot size Remarks

Clause Reference5 Material 5 IS 15609: 2005 One Each consignment

of Polyethylene filmi) Test certificate of conformity by the

manufacturer of film ORii) Outside laboratory Test Report of

the samples got tested by licenseeiii) Combination of the above.

6.1 Requirement for Polyethylene Film6.1.1 Description 6.1.1 IS 15609:2005 One Each roll of

polyethylenefilm

All rolls to be checked before using thesame for making pouches. All such rollswhich donot 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

from one sourcei) Test certificate of conformity by the

manufacturer of film ORii) In house test report, if facility exist

with the licensee ORiii) Outside approved laboratory test

report of the sample got tested bylicensee ORiv) Combination of the aboveIf the sample does not conform to therequirement, the consignment shall be rejected

21


22


Test details Levels of ControlClause Requirement Test Method No. of

SamplesLot size Remarks

Clause Reference6.1.8 Tensile strength 6.1.8 IS 15609:2005 One -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 Pouches7.1 Vibration leakage

testAnnex D IS 15609:2005 -do- One day production If the sample does not confirm to the

requirement the licensee shall followthe criteria for acceptance and retestingas per clause D-5 of IS 15609:2005. If itdoes not confirm then the same dayproduction shall be rejected.

7.2 Water Potability Test Annex E -do- -do- Once in two months Sample of each size shall be tested byrotation so that all the sizes shall betested in one operative period.

7.3 Stack load Test Annex F -do- -do- One day production If the sample does not confirm to therequirement the same day productionshall be rejected.

7.4 Drop test Annex G -do- -do- Every hour for eachmachine

If the sample does not confirm to therequirement, the licensee shall followthe criteria for acceptance and retestingas per clause G-3 of IS 15609:2005. If itdoes not confirm then the same dayproduction shall be rejected.

7.5 Ink Adhesion of PrintedPouches

Annex H IS 15609:2005 -do- One day production If the sample does not confirm to therequirement the same day productionshall be rejected.

7.6 Product resistance ofprinted Pouches

Annex J -do- One -do- -do-

23


24

COMMENTS ON STI/14543/7/Aug 2011

ANNEX B

CNBO(FCT) RECOMMENDATIONS ON COMMENTS ON STI/IS 14543/7/Aug 2011 AS FORWARDE BY CMD-II (Legal)

I. COMMENTS FROM BNBO LICENSEES ALONG WITH OBSERVATIONS OF CMD-II

SlNo

TestParameter/Comments

Details CMD Comments RECOMMENDATIONS OFCNBO(FCT) WITH RESPECT TO

REVISION OF STI1 Micro-

Biological AMC There is no need of testing AMC at 20 degree

centigrade for 72 hours as we get the results ofAMC within 48 hours incubated at 37 degreecentigrade

Aerobic microbial count test not present in IS13428 for natural mineral water. PDW is alsobottled water. Can please delete AMC testing forPDW.

AMC at 37 and 20˚C tests differentmicroorganisms. Those which growat 37˚C are different from those thatgrow at 20˚C.

Aerobic Microbial Count reflectstotal microbial load that require air togrow. The test is not prescribed forPNMW because as per definition it isa totally different productcharacterized by its originalMicrobial purity (Refer definition inIS 13452). Hence AMC limit donotapply to PNMW. AMC cannot bedeleted from STI for IS 14543.

Comment does not pertain to STI.

2 Total DissolvedSolids

Lower limits of TDS are not given in STI, butmany of us maintaining TDS around 10 and above.But the water of the lower TDS is equal to distilledwater which is harmful to human body if consumedcontinuously. We are receiving some complaintfrom customer asking for low TDS water becausesome manufacturers maintain low, due to this,customers confused regarding the TDS parameter,In this regard, why can’t you give minimum andmaximum limits for TDS as that of pH value? i.e.,our request is to fix minimum 50-ppm for PDW,

There are many advanced methods to detect TDSof PDW. Electric method is one such methodgiving accurate values. Why can’t you permit us touse electric method instead of gravimetric method,which takes long duration to get the results.

Upper limit of TDS is prescribed, itis upto water processors to keep TDSas low as they want to delight theircustomer. There appear to be no meritin the proposal.

The ensuing revision of IS 14543permits use of Electrical conductivitybased methods for TDS.


25


Anyhow, the limit for TDS is upto 500 PPM. Allof us are using advanced technology i.e., ReverseOsmosis to process water and maintainingmaximum TDS levels is upto 100 only. So, pleaseallow to test the TDS with electric method i.e., withTDS meter available in the market.

3 Frequency of petbottle 200 to2000 ML(ContainerTesting)

As per STI the frequency of testing bottles andcontainers from 200 ml to 2000 ml is once in 3months. Our request is to change this Frequencyfrom 3 months to 1 year because we are gettingpreform from same manufacturer and using samepreform for blowing and using the same bottleswithout any changes. Request consider this.

Same preform or bottle source can usePET resin of different grades or fromdifferent sources, which is difficult tomake out on visual examination. Therehas to be some sort of monitoring bywater processors on PET quality.Prescribed frequency is minimum. Therecannot be any end to relaxing testfrequency.

Agreed to comments of CMD

4 Non ISI Units We are happy to receive your publication andadvertisements on PDW, as per your statement paperpublication on 2.4.2014 regarding non ISI PDW,manufacturer or seller, stating that If any Non ISI Unitsor seller would be seen operating it should be informedto BIS”. We have give on 9.4.2014 the list on non ISIPDW manufacturer and let us know the actions takenon date.

The BO may please effectively take upthe issue with Food Safety Commissionerof the State and apprise the outcome tothe commentator.


5 AreaRequirement forPDW Plant

For package drinking water industry there is no specificdeclaration in IS 14543 about the total area required torun the PDW industry. Please fix the minimum arearequired to get BIS license for PDW industry.

There is no point in prescribing spacerequirement. The requirements underHygienic conditions are very clear and donot need any elaboration. It only requirescommon-sense and careful reading of therequirements.


6 Change ofFrequency ofWeekly Test

Our request is to change frequency of weekly testing tomonthly and to be tested in BIS approved outsidelaboratory. All of us are using advanced technologyi.e., Reverse Osmosis to process water and maintainingmaximum TDS levels is up to 100 only and as per oursurvey no sample has been failed in weekly parametertill date. As the TDS is below 100 we are getting allweekly results always within the limits.

Raw water composition is fairly uniformfor ground water except for seasonalchanges. However surface water (fromlakes, rivers etc) composition isinfluenced by human activity which arebeyond control. Compositional analysis istherefore required. The existing frequencyfor these tests may be reviewed asdemanded on grounds of:

See CNBO(FCT) recommendations atAnnex C

26


We are facing difficulties in testing of weeklyparameters in in-house laboratory for eg.,

For testing of Zinc, Potassium Cyanide isrequired which is highly poisonous and it isvery difficult to safeguard the cyanide, if anyspillage occurs, unexpectedly it may causeserious casualty to the QC and otherpersonnel’s handling the water also it affectsthe product water. Hence, our request is tochange the frequency of weekly testing tomonthly testing.

For testing of Anionic Surface Active agentthe apparatus using is gas stripping apparatus,which is very delicate, frequently damagingand time consuming. Hence, our request is tochange the frequency of weekly testing tomonthly testing.

Extent of variation in raw watercomposition.

The risk posed by use of KCN. Proportion of failure in the

requirements.

7 Frequency ofProduct Storage

As of now, as per STI of IS 14543 the product PDW tobe stored for 48 hours after packing before dispatch.Our request is to withdraw the condition of storage for48 hours frequency at least for 20 ltrs. Jars. Anyhow, ifnon-conformity occurs the product can be recalledfrom the market as of now.

Jars have a limited shelf life (1-4 weeks)and on distribution they are quicklyconsumed. Recall of jars is difficultbecause holding time of jars indistribution is very low. Hence, requestfor waiving of 48 hour Holding time forjars in factory is therefore lacks merit.

Agreed to comments of CMD

8 All Packedwaters to comeunder BISpurview

There are some manufacturers across India are packingtheir processed water through RO and labeling them asRO Water, Ayurvedic Water, Tonic Water, EnergyWater etc., and these products are meant for Drinkingpurpose only and packed as per IS standards 15410.

Our request is to bring all kinds of waters for drinkingpurpose by whatsoever name it is called or sold, andany water processed and packed to come under thepurview of BIS certification. Please look into thismatter seriously and safeguard all BIS Licensees.

These items have been brought under thescope of certification through revision ofproduct Definition in ensuing revision ofthe ISS. However, amendment todefinition of PDW in FSSAI Regulationsis required for which FAD was requestedby CMD-II. A letter for the purpose maybe sent to Chairman, FSSAI may be sentunder signature of DG BIS.


9 Action AgainstIllegal PDWManufacturers

There are innumerable number of illegal packageddrinking water industries in Karnataka especially inBengalooru are operating their business without BIS

Enforcement is everyone’s responsibility.Association of water industry has a roleequal to enforcing agencies. I-Care


27


Certification, as per BIS Act 1986 if PDW is soldwithout the usage of BIS mark then the offence underSection 14 read with Section 33 of the BIS Act standsattracted. Delhi High Court, Delhi Divisional Benchand Karnataka High Court uphold the same. Pleaserefer page nos. 71,72,73,74 and 75 of Karnataka HighCourt Orders (enclosed). Hence, we request you totake immediate action against these manufacturers.Advertisement copy of BIS published in KannadaDaily PRAJAVANI on 2.4.2014 is also enclosed.

Officers at SRO /BNBO may organisespecific enforcement action for waterindustry.

10 Guidelines touse other typesof containers byCommunityWaterManufacturers

As per IS 15410 pet jars are meant only to packpackaged drinking water but, some private companies,Government organizations and NGOs are using 20 ltr.Pet jars for filling and selling their treated water whichis confusing by general public regarding authenticity ofISI marked product.

Our request is to give some guidelines to theseorganizations not to use pet jars to pack their product.

Similar packaging may confuse aconsumer, but agencies named in the parado not label or mark or claim the waterbeing supplied by them in PET Jars asPackaged Drinking Water. Hence noguidelines on use of PET Jars may berequired. PET Jar is a container andanyone can use it as a container, butwithout making any false claim about itscontents.


II. COMMENTS from M/s Sur Enamel & Stamping Works Pvt Ltd Kolkata (ERO Licensees)

Sl No TestParameter/Comments

Details RECOMMENDATIONS OF CNBO(FCT) WITHRESPECT TO REVISION OF STI

1 Microbiology The microorganisms of each type as (per STI of IS 14543) are testedregularly at the plant level for each Control Unit and also by BIS onfactory and Market samples. So test for pathogens as given underClause 5.1.3, 5.1.8 & 5.1.9 frequency of testing be fixed Once inThree Month from OSL instead of once in month.

May not be agreed as these are pathogenic microorganismsand (except Staphylococcus aureus) are of faecal origin andcause severe gastrointestinal diseases with acute and alsochronic health effects. The present frequency of testing, i.e.once a month from OSL, may be retained particularly sincesample failures in indicators of faecal contamination likefaecal streptococci and sulphite reducing anaerobes arefairly common during independent testing.

2 Radio-activeResidues andPesticideResidues

Frequency of testing of Radio-Active Residues may be changed toOnce in Four Year instead of Once in Two Year and for PesticideResidues Once in Two Year instead of Once in a Year, as no failurehave been observed in these parameters since operation of

May not be agreed.

Water sources can contain radionuclides of natural as wellas artificial origin which may enter into raw water source as

28


Certification Scheme (almost 10 years). a result of regular or incidental discharges. For prolongedexposures, as is the case for ingestion of drinking watercontaining radionuclides over extended periods of time,evidence of an increased cancer risk in humans is available.As per WHO, it is assumed that there is a linear relationshipbetween exposure and risk, with no threshold value belowwhich there is no risk.

All pesticides are also highly toxic in nature and maycontaminate drinking water source through incidentaldischarges from agricultural activities or public healthactivities.

As such the present frequency of testing (once in two yearfor radioactive residues and once in a year for pesticideresidues) is appropriate in view of no failures beingobserved in these parameters and any decrease in frequencycannot be justified and would not be appropriate in view ofhighly carcinogenic/toxic nature of these contaminants.

3 PackagingMaterials

Frequency of testing for Packaging materials be fixed Once in a Yearfor each type/capacity/shape/material as no failure observed for thelast 5 years. It is also to be noted that initially this parameter was notincorporated in STI at the beginning of the operation of CertificationScheme. For your information nothing is sued except air duringblowing of PET bottles, in this context manufacturer's "TestCertificate" can be accepted.

Same preform or bottle source can use PET resin ofdifferent grades or from different sources, which is difficultto make out on visual examination. There has to be somesort of monitoring by water processors on PET quality.Prescribed frequency is minimum. There cannot be any endto relaxing test frequency.

4 Frequency ofchemical testing

a) As per the method of testing of Zinc (as Zn) (Clause 5.2 & Table2 (viii)), Potassium Cyanide and Chiorohexanone are not required forPackaged Drinking Water testing as it does not contain interferingmetallic ions in high quantity which requires for masking as perIS3025 (Part 49):1994 as per Zincon Method. Therefore Zn to betested in-house without Potassium Cyanide and Chiorohexanone. IfKCN is used then the project will come under Red Category ofPollution Control Board and will be a hazardous one.

b) No significant variation observed at plant level for testing ofBarium (as Ba), Zinc (as Zn), Copper (as Cu), Sulphide (as H2S),Manganese (as Mn), Aluminium (as Al) and Anionic Surface ActiveReagents (Clause 5.2 & Table 2) and also results are well below the

a) See CNBO(FCT) recommendations at Annex C

b) See CNBO(FCT) recommendations at Annex C

29


permissible limit. It is also be noted, that source of Raw water andalso the Process of PDW for a particular manufacturer is notchanging, so once both the raw water and finished Packaged DrinkingWater are tested and found to contain above parameters (Zn, Ba, Cu,Mn, Al, Sulphide, Anionic Surface Active Reagents) withinpermissible limit, until and unless there is change in raw water andthe processing system, there is no question of testing in once in aweek, so our suggestion is Licensee be allowed to test in OSL, Oncein Six Months or during Change of Seasons for Raw Water.

From the enclosed analysis report (Table-1), it is evident that rawwater itself contain less than permissible limit so the finished waterwill never have those items above limit.

c) Same for the Heavy Metals (Clause 5.2 & Table 3), as nosignificant change/variation observed in these parameters, it may befixed from once in Six Months to once in a Year, or if any Raw Watercontain any of the parameters more than the permissible limit, thatparameter only may be tested at present frequency.

c) In view of highly acutley toxic/carcinogenic nature ofheavy metals specified in Table 3, the present frequency oftesting is appropriate and any decrease in frequency cannotbe justified and would not be appropriate .

5 Residual FreeChlorine

Change of testing method for Residual Free Chlorine (Clause 5.2 &Table 2 (xviii)), or Licensee may be allowed to test in OSL Once in aMonth.

May not be agreed. See CNBO(FCT) recommendations atAnnex C

6 Assessment ofHygienicConditions

Objective assessment of Hygienic Condition of a Plant is beingcarried out by BIS Personnel during Preliminary Inspection andfollowed by subsequent visit during operative period of Licience. Itwidely varies from person to person. For example- Installation ofRoom-Ozonater in the Filling Room, Wooden Door/Windows/ othersin the Lab-rooms, etc. A clear directives/suggestions should be givenunder the STI, categorically to avoid such ambiguities. The SITshould be given to the applicant at the time of application.


7 Drawl of MarketSamples

There is every possibility of drawing "Spurious Sample of PDW"from the market, over which the manufacturers have no control. So,while drawing sample from the market, manufacturers shouldaccompany with BIS person to verify the originality/genuineness ofthe sample.


8 Sampling forindependenttesting

In the event of drawing Factory samples, two Counter Samples bedrawn. In event of failure of original sample, option be given toLicensee to send one counter sample to a OSL of his choice/ otherBIS approved laboratory for conformation of results.


30


9 OSL All major cities should have a Testing Laboratory approved by BIS tominimize testing time and cost of testing, incidentallyKolkata/Eastem India don't have any.


10 Spurious waterbottles

More vigilance is required from the BIS ends, particularly in railwaystations and Hospital areas to stop sealing of spurious water bottles,and 20Lt. jars without any, label of manufacturer.


11 Copy of testreports ofMS/FS

Copy of the Test Reports of the sample drawn from theFactory/Market by BIS personnel, should be given to the Licenseeeither passed or failed as we pay for it and it will be a reference.


12 COMMENTSON ANNUALMARKINGFEES

Minimum Marking Fees of around Rs.80,000/- per year seems to beexorbitantly high particularly for the new units for whom it takesmore than two years to attain a substantial sell-volume to compensatethe fees. So, we earnestly request you to reduce the amount straightway to Rs.50,000/- or give a concessional rate for the first three yearsparticularly SSI and tiny units. Give special thought for the units inRural/Backward areas specially arsenic Sc fluoride affected areas.


13 STOPMARKING:

In many cases Licensee are unable to understand the reason for StopMarking and corrective action to be taken for resumption of Marking.BIS should give under STI, the situations which will lead to StopMarking. Generally BIS gives time of 15 days from the date of issueof Letter for reply, number of times delay has happened both fromBIS as well as Manufacturer end, resulting Stop Marking. 15 daystime should be calculated not from the issuing date, but from the dateof receiving of BIS Letter by the Licensee.

During any inspection of BIS Officials, whether . surprised orinformed, if any discrepancies are found, a DV Report is issued andStop Marking is imposed. BIS officials during their secondVerification/Special visit (after taking all corrective action againstearlier DV report) again issues fresh DV report on some newdiscrepancies and as such resumption of marking cannot be done. BISofficials should check each & every aspect during their. first visit andduring the second verification visit they will only verify compliancesof the earlier DV report.

Stop Marking and Resumption of Marking procedureprocedures are a part of OMPC which is available on BISwebsite. Inclusion of situations which will lead to StopMarking with corrective actions as suggested by licensees inSTI may lead to situations where revised STI to be issuedwhenever OMPC is amended.

14 COMMENTS Testing of Aerobic Microbial Count (AMC): Comment does not pertain to STI.

31


ONSTANDARDS:

Aerobic Microbial Count (AMC) is only a Process Control parameterrather than a Safety parameter. Failure in AMC does not indicate thatwater is unsafe for drinking. The limit of AMC at 22°C and 37°C asmentioned under 1S14543:2004 should only be specified under the ISas Recommendatory not as an Obligatory Parameter.

Testing of Yeast and Mould:Neither WHO guideline on Drinking water nor any other Standards(National IS 10500 & International) recommend testing of Yeast &Mould in Drinking water as well as Bottled water, as presence ofYeast& Mould have any significant towards aesthetic as well assafety value of Packaged Drinking Water.

Please also note that during Regional Review Meeting of Licensees ofPDW at Kolkata on 24th March, 2010, one of the Scientist during hisdeliberation have categorically stated that it is virtually impossible tomanufacture PDW at our temperate and humid condition tomaintaining the above parameters as per STI. Another Scientistduring his Power Point presentation of comments, have alsocategorically said that "It is only God can guarantee the production of100% free from AMC/Yeast & Mould". So, we request that AMCshould only be specified under the IS as Recommendatory not as anObligatory Parameter and Yeast & Mould needs to be removed fromIS 14543 and also 1S13428.

III. COMMENTS FROM JSBO

SlNo


Details RECOMMENDATIONS OFCNBO(FCT) WITH RESPECT TO

REVISION OF STI1 Zinc testing in

PDWThis is in reference to requirement of Zinc in IS 14543:2004 .The requirement for Zinc is 5mg/1 max as per Si no viii) of Table 2.The test method IS 3025 (Part 49) prescribes fourmethods for detection of Zinc i.e.


32


Zincon MethodAAS (Direct),AAS (Chelation)DPSAV method.

As per Amendment No 7 to IS 14543, IS 3025 Part 2 is also referred to be a valid test methodfor testing of Zinc. However, the same is a very costly instrumental method requiring ICP(costing approx. 30 Lakhs).

• The later 4 methods are instrumental methods which require costly and sophisticatedequipment's which P.D.W manufactures being small scale industry cannot afford to purchase.BIS labs and OSLs are testing the requirement of Zinc through AAS /ICP method.

• The Zincon method is a wet chemical analysis method but as per clause 5.4.3. of IS3025 (Part 49) , it requires Potassium Cyanide solution to mask the interference of the metalions. Potassium cyanide is a deadly poison handling of which is extremely dangerous anddisposal of used potassium cyanide with other chemicals is problematic in itself.

• As per STI of IS 14543:2004, Zinc is to be tested once in a week in the factory itself.Keeping a dangerous chemical like potassium cyanide in factory manufacturing P.D.W may notbe recommended. Moreover purchase of the same and keeping also requires variousgovernment permissions.

• Since already Mineral Oil, Phenolic Compound, Antimony, Borate are allowed to betested Monthly from OSL as per STI of P.D.W., it is proposed that Zinc testing frequency maybe changed to once in a month with permission to get the same tested from OSL.

CMD may consider the same.

IV. COMMENTS FROM GREATER CHENNAI PACKAGED DRINKING WATER MANUFACTURERS’ ASSOCIATION

SlNo


Details RECOMMENDATIONS OFCNBO(FCT) WITH RESPECT TO

REVISION OF STI1 Failures under

Table 2a) Failures under table-2 as per our internal data from our members are not frequent. We aresure the finding will be similar from Bureau of Indian Standards also. Thus, there is a strongcase to shift the following parameters to a monthly frequency:

Barium, Copper, Iron, Manganese, Fluoride, Zinc, Silver, Aluminium, Chloride, Selenium,


33


Calcium, Magnesium, Sodium, Phenolic compounds, Mineral oil, Sulphide, Antimony, Borate

b) In addition, licensees may be permitted to get these parameters tested in outside laboratory

c) We request that the following parameters of table-2 may be brought to a weekly frequency.but tested in-house:

Nitrate, Nitrite, Alkalinity

d) ASAA: Licensees may please be permitted to follow the break-through tests asrecommended by their respective detergent suppliers instead of the test method as currentlyprovided.

e) Residual Free Chlorine: Residual chlorine may be done as per current frequency.

2 Residual ozone Where ozone is employed in the final sanitation of product water, residual ozone level must beestimated and recorded. Suggested frequency: Hourly. Suggested test method: IS:3025 - Part-36or commercially available DPD tablets.

Comment does not pertain to STI

Sl.No.

Clause No.

Characteristics Existingfrequency

Proposed by thefirm

RECOMMENDATIONS OF CNBO(FCT)

1 5.1.3. Faecal streptococci andStaphylococcus aureus

Once in a month Once in threemonths

May not be agreed as faecal streptococci is an indicator of faecalcontamination and staphylococcus aureus is an pathogenicmicroorganism. Also failures in these parameters are fairly commonduring independent testing

2 5.1.8 Salmonella and shigella -do- -do- May not be agreed as these are pathogenic microorganisms of faecalorigin and cause severe gastrointestinal diseases with acute and alsochronic health effects. The present frequency of testing, i.e. once a monthfrom OSL, may be retained particularly since sample failures inindicators of faecal contamination like faecal streptococci and sulphitereducing anaerobes are fairly common during independent testing.

34


3 5.1.9 Vibrio Cholera andV.Parahaemolyticus

-do- -do- May not be agreed as these are pathogenic microorganisms of faecalorigin and cause severe gastrointestinal diseases with acute and alsochronic health effects. The present frequency of testing, i.e. once a monthfrom OSL, may be retained particularly since sample failures inindicators of faecal contamination like faecal streptococci and sulphitereducing anaerobes are fairly common during independent testing.

4 5.2 Radio active residues Once in two years

Once in four years

May not be agreed.

Water sources can contain radionuclides of natural as well as artificialorigin which may enter into raw water source as a result of regular orincidental discharges. For prolonged exposures, as is the case foringestion of drinking water containing radionuclides over extendedperiods of time, evidence of an increased cancer risk in humans isavailable. As per WHO, it is assumed that there is a linear relationshipbetween exposure and risk, with no threshold value below which there isno risk.

All pesticides are also highly toxic in nature and may contaminatedrinking water source through incidental discharges from agriculturalactivities or public health activities.

As such the present frequency of testing (once in two year for radioactiveresidues and once in a year for pesticide residues) is appropriate in view ofno failures being observed in these parameters and any decrease infrequency cannot be justified and would not be appropriate in view ofhighly carcinogenic/toxic nature of these contaminants.

5 5.3 Pesticide residues Once in a year(once in sixmonths for firstoperative period)

Once in two years

6 8.6 & Table 2

Packaging Material Plastic jars

Each consignment

Once in a year

Same preform or bottle source can use PET resin of different grades or from different sources, which is difficult to make out on visual examination. There has to be some sort of monitoring by water processors on PET quality. Prescribed frequency is minimum. There cannot be any end to relaxing test frequency.

Plastic bottles,glass/cups

One consignment,every threemonths

Once in a year

Same preform or bottle source can use PET resin of different grades or from different sources, which is difficult to make out on visual examination. There has to be some sort of monitoring by water processors on PET quality. Prescribed frequency is minimum. There cannot be any end to relaxing test frequency.

Plastic cap (closures) Once in a year Once in a year

--

35


Foil for sealingofplastic cups/glass

-do- -do- --

7 5.2 Table 2

Barium Copper Zinc Aluminium Manganese Anionic surfac active agent Sulphide

Once in a week Once in six months

See CNBO(FCT) recommendations at Annex C

8 5.2 Table 2

Residual freechlorine

Each control unit Once in a month

May not be agreed. See CNBO(FCT) recommendations at Annex C

9 5.2 Table 3

Heavy metals Once in sixmonths

Once in a year

In view of highly acutley toxic/carcinogenic nature of heavy metals specified in Table 3, the present frequency of testing is appropriate and any decrease in frequency cannot be justified and would not be appropriate .

V. COMMENTS FROM CBBO LICENSEES

36


37

SlNo

Comment Details RECOMMENDATIONS OF CNBO(FCT) WITH RESPECTTO REVISION OF STI

1 The New Sample Failure Procedure has affect on our members financially &administratively, so please change the new procedure to the old procedure forsample failures.


2 When there's a sample failure in any of the parameters, all the tests are done for allthe parameters which is not required. Hence it will be good & sufficient enough ifonly the failed parameter is tested again.


3 Practically in the long run we have seen that most of our samples fail in yeast &mould and aerobic microbial plate count and hence result in stop marking. As weare aware of the fact that Yeast is considered to be a harmless bacteria used in manyof our food products, it can be considered as an uncritical parameter.


4 The Specified value for Yeast & Mould testing count to be allowed up to 5 in100 mlsample product water.


5 The Specified Value for Aerobic microbial plate count to be increased. Comment does not pertain to STI

6 The thickness of pet bottle containers to have a deviation of 5% in its minimumdeclared value and no specified value for the maximum parameter in thickness.


7 Due to mishandling of 20 litres pet jars during transportation and delivery, these jarsbeing Poly Pet Jars get easily scratched and damaged on the outer surface thoughthe inner side of it is clean and good. Also practically it is seen that the water staysgood with no change in its quality standards. Hence we humbly request for theminimum Transparency limit for 201it Pet Jars to be 70%.


8 When there is RO method of processing where membrane pore size is only 0.0001microns, 98% of the salts are filtered. In our Packaged Drinking Water plants it hasbeen observed over a decade that there is a very, very negligible amount of thesesalts in the product water and hence the Specified Value for TDS can also bereduced from 500 to 300ppm.

Considerably we suggest the following: a) To change the periodicity of Chloride,Sulphate and Alkalinity testing from Daily to Weekly Testing. b) To change theperiodicity of Barium, Copper, Manganese, Nitrite, Zinc, Aluminum, Sulphide andAnionic Surfactant Agents from Weekly to Monthly Testing. c) To change theperiodicity of Antimony, Borate, Phenolic compounds and Mineral Oil fromMonthly to Three Monthly Testing. d) To change the periodicity of Fluoride,Selenium, Sodium, Silver, Mercury, Cadmium, Arsenic, Cyanide, Lead, Chromium,Nickel, Poly Chlorinated Biphenyl (PCB), Polynuclear Aromatic Hydrocarbons(PAH) from Six Monthly Testing to Yearly Testing.

See CNBO(FCT) recommendations at Annex C

9 In the current situation a lot of our companies are facing the problem in samplefailures due to a lot of malpractices happening in our Products. To avoid this all themanufacturers should print CML NO & Company name on 20 lit Cans & Caps. Weare very much interested to adopt this method in order to avoid these malpracticessuch as other brand filling, misuses, etc.

Licensees are free to use such practices to avoid misuse of theirbrand and licence.

Annex C

ANNEX C

RECOMMENDATIONS OF CNBO(FCT) REGARDING FREQUENCY OF TESTING OF PARAMETERS UNDER Cl 5.3, Table 2 of Finalizeddraft IS 14543 : 2014 ‘General Parameters Concerning Substances Undesirable in Excessive Amounts’

The frequency of testing for parameters under Table 2 of IS 14543 : 2004 ‘General Parameters Concerning Substances Undesirable in Excessive Amounts’as specified in STI/14543/7 August 2011 is as given below:

PARAMETERS FREQUENCY REMARKS

Phenolic Compounds, Mineral Oil, Antimony and Borate Once in a Month --

Fluoride, Silver*, Selenium and Sodium Once in Six Months *Once in a week forlicensees using silver inany form.

Chloride, Sulphate, Alkalinity, Residual Free Chlorine Each Control Unit --

Barium, Copper, Iron, Manganese, Nitrate, Nitrite, Zinc, Aluminium, Sulphide, AnionicSurface Active Agent, Calcium and Magnesium

Once in a Week. --

As per CMMS data for CNBO(FCT), out of 10473 licensee samples (FS/MS/INC) drawn for Packaged Drinking Water till date, 1113 samples have failedin one or more requirements of IS 14543. Out of approximately 2316 licensee samples drawn for chemical testing, approximately 137 samples have failedout of which only 19 have failed in the parameters where frequency of testing is once a week. This is represented in tables below:

Licensee Samples drawn (FS/MS/INC) forPDW

Samples failed Samples failing in chemical parameterswhere frequency of testing is ‘Once a Week’

10473 1113 19

Approximate no. of Licensee Samples Samples failed Samples failing in chemical parameters

38

Annex C

drawn for chemical testing where frequency of testing is ‘Once a Week’

2316 approx. 137 approx. 19

Parameter No of failures observed

Nitrite 8

Aluminium 7

Nitrate 3

Manganese 1

Barium, Copper, Iron, Zinc, Sulphide, Anionic Surface Active Agent,Calcium and Magnesium

0

Therefore, out of licensee samples drawn for chemical testing approximately 0.82 % only have failed in chemical parameters where frequency oftesting is ‘Once a Week’. Further, no failures have been observed in these parameters at the end of licensee during verification of test recordsduring periodic/surveillance inspections.

In view of above, in the light of comments from licensees and experience at CNBO(FCT), the following is recommended:

‘For requirements specified under Table-2 of IS 14543:2014, calcium, magnesium, residual free chlorine, chloride, sulphate andalkalinity may be deemed acceptable for the purpose of indicating on going levels of operational efficiency of processing in apackaged drinking water manufacturing plant for which existing frequency may be retained.

For Barium, Copper, Iron, Manganese, Nitrate, Nitrite, Zinc, Aluminium, Sulphide, Anionic Surface Active Agent frequencyof testing may be decreased to ‘Once in a Month.

Further, as per Cl. 4.13, Annexure 16 of OMPC 2004, licensees may be permitted to carry out these tests in a BIS recognizedOSL.’

This also addresses the issue raised by BNBO licensees, ERO Licensees and JSBO regarding in-house testing of Zinc which requires Potassium Cyanidewhich is a deadly poison and extremely dangerous to handle and dispose.

The above proposal is in line with the earlier proposals of CNBO(FCT) given along with the revised draft Packaged Water Manual.

39

FORMAT FOR COMMENTS

ANNEX DComments on Draft STI/14543/December 2014

BO- _________

Sl. No.

Relevant Cl. No. of draft revised STI/14543/Dec 2014

Existing Text

Proposed Modification

Justification

40

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