100% found this document useful (1 vote)
3K views61 pages

PM 14543 July 2024 Approved

Latest amendment
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
100% found this document useful (1 vote)
3K views61 pages

PM 14543 July 2024 Approved

Latest amendment
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 61

PM/14543/6

July 2024

www.bis.gov.in

उ"पाद मै(यअ
ु ल
पैकेजबंद पेय जल (पैकेजबंद 2ाकृ4तक 6म4नरल जल के अलावा ) - :व6शि=ट

IS 14543:2024 के अनस
ु ार

PRODUCT MANUAL FOR


Packaged Drinking Water (other than Packaged Natural Mineral Water) — Specification
ACCORDING TO IS 14543:2024

:व6भ(न उ"पादA के 6लए भारतीय मानक Dयूरो) अनुGपता मूHयांकन (:व4नयम, 2018 कI योजना -I के तहत 2माणन के
संचालन मM एकGपता और पारद6शOता के 6लए इस उ"पाद मैनअ
ु ल का उपयोग सभी RेSीय / शाखा कायाOलयA और
लाइसMसधाVरयA Wवारा संदभO सामXी के Gप मM Yकया जाएगा। द[तावेज़ का उपयोग बीआईएस 2माणन 2ा_त करने के
इ`छुक संभा:वत आवेदकA Wवारा भी Yकया जा सकता है I

This Product Manual shall be used as reference material by all Regional/Branch Offices &
licensees to ensure uniformity of practice and transparency in operation of certification under
Scheme-I of Bureau of Indian Standards (Conformity Assessment) Regulations,2018 for various
products. The document may also be used by prospective applicants desirous of obtaining BIS
certification.

1. : IS 14543:2024
मानक संbया
IS No.
शीषOक : Packaged Drinking Water (other than Packaged Natural
Mineral Water) — Specification
Title
: NIL
संशोधनA कI संbया
No. of amendments
2.
उ"पाद :व6श=ट dदशा4नदe श:
Product Specific Guidelines:

लाइसMस 2दान करने और Please refer Annex-A


a) :
लाइसMस के दायरे मM बदलाव के
6लए आवेदनA पर कारO वाई के
6लए dदशा4नदe श
Guidelines for
processing applications
for grant of licence and
change in scope of
licence

b) 4नगरानी के 6लए dदशा4नदe श : Please refer Annex-B

Guidelines for
surveillance
c) अनपु ालन न होने कI ि[थ4त Please refer Annex-C
मM 4नलंबन और 4नलंबन रWद
करने सdहत कारO वाई के 6लए
dदशा4नदe श
Guidelines for action in
case of non-conformity
including suspension
and revocation of
suspension
3. परgRण उपकरणA कI सूची : Please refer to Annex-D
List of Test Equipment
Please refer to Annex-E
4. 4नरgRण और परgRण कI [कIम :
Scheme of Inspection
and Testing
5. !वशेष ि'थ)तय, के .लए
Please refer to Annex-F
:
1दशा)नद5 श
Guidelines for Special
Situations
Please refer ANNEX –G (It shall be verified, filled up, duly
6. [व`छता जांच सच ू ी : signed and uploaded as an attachment along with the
Hygiene Checklist Factory Test report. Hygiene assessment shall be
done during all inspections (Preliminary inspection,
Surveillance inspection, Verification inspection)
7.
लाइसMस का दायरा /Scope of the Licence:
Licence is granted to use Standard Mark as per IS 14543:2024 with the following
scope:
Name of the product Packaged Drinking Water (other than Packaged Natural
Mineral Water)
Varieties (Packaging) Mention material (PE/PET/PVC/Glass etc.), type of
containers (bottles, jars etc.) and capacity in ml or litres
(500 ml/1 litre/20 litres etc.)

e.g. PET Bottles of 500 ml, 1 litre and 1.5 litre capacity
and/or PET jars of 20 litres capacity
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN,9, BAHADUR SHAH ZAFAR MARG,
NEW DELHI-110002
ANNEX-A

Product Specific Guidelines for processing applications


for grant of licence and change in scope of licence

A-1. Application for grant of licence

i. Domestic manufacturers of PDW shall apply for grant of licence for his unit online through
the Manakonline system as per the provided application format i.e. as per Form V as
specified in Scheme I of Schedule II of BIS (Conformity Assessment Regulations), 2018.
(Presently foreign applications under FMCS are being processed on offline mode).

ii. Applications will only be accepted under Option 1 (Normal procedure), i.e. after receipt
of the application and ensuring completeness of the application, a visit will be paid by BIS
to the factory of the applicant for assessment of the manufacturing infrastructure,
production process, quality control and testing capabilities, assessment of hygiene
conditions and sample will be drawn for testing in third party laboratory.

A-2 Preliminary Inspection

A-2.1 During preliminary inspection, the documents/aspects as mentioned in general GoL


guidelines shall be verified and the observations recorded in the Preliminary Inspection Report in
the format circulated by CMD.

A-2.2 The actual factory layout shall be verified against the layout submitted with application. 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),
e) Entry/exit with indications of double door/door closures/Air curtains wherever provided
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.

A-2.3 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 as ‘Trial Batch’ during the visit
and then make comments on the firm’s capability for the same.

A-2.4 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, bottles are
required to be filled only through automatic machine. However, jars maybe filled manually also.

A-2.5. In addition, the following product specific aspects shall also be verified and observations
recorded in the Preliminary Inspection Report or in an Annexure to that report:
i. Availability of all manufacturing facilities including filling and/or packaging
machinery for the varieties applied for to be verified and observations
recorded;
ii. Compliance to hygienic practices as per Annex B of IS 14543, to be verified and
observations to be recorded as per Hygiene Checklist (as per Annex-G).

iii. As per Cl 5.1.1 of IS 14543, Water shall be derived from surface water or civic
water supply or underground water or sea water or any other consistent source of
water. Source of Water shall be identified and observations reported in the
Preliminary Inspection report (e.g. Civic Water supply or Borewell water)

iv. As per Cl 5.1.1 of IS 14543, source water shall be subjected to specified treatments,
namely, decantation, distillation, filtration, combination of filtration, aerations,
filtration with membrane filter, sand filters, 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 effect in the drinking water by
means of chemical agents or physical methods to reduce the number of micro-
organisms to a level below 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. Nature of
treatments/disinfection processes, Process description and observations
thereon to be reported (This may be mentioned in the process flowchart
submitted.)

v. In case the manufacturer conducts remineralization as part of treatment


process, the ingredients shall be of food/pharma grade quality. The test
certificate indicating the individual ingredients and the respective compositions of
each mineral/ingredient in the product shall be submitted by the applicant at the
time of application. If remineralization is part of treatment process, DO has to
record the same to reflect in RF at the time of recommendation.

vi. Availability of required testing facilities, as per the ISS and SIT shall be verified and
recorded. The test equipment should have valid calibration on the day of the visit.
Calibration should be done from NABL accredited laboratory or any other
laboratory provided traceability to NPL is established through the calibration
certificates. Calibration of Analytical Balance, temperature indicators and
pressure gauge of autoclave (internal/in-house or from an outside lab.) is
considered necessary at least once a year. Indicative List of test equipment and
chemicals required for testing of packaged water is given at Annex D for guidance.
Status of test equipment calibration observed from calibration certificates
should be verified and recorded
vii. Testing person(s) shall be science/engineering graduate from disciplines such as
chemistry/chemical engineering/ microbiology/ biotechnology/ biochemistry/ food
technology/ botany and other biological/ life sciences. Engineering graduates from
disciplines such as chemical engineering may also be engaged as testing persons.
Availability of testing person(s), his/her competence, qualifications and
experience shall be verified and reported. One testing personnel may be allowed
in case he/she is found competent for both chemical and microbiological testing and
if so, this shall be duly recorded in Inspection Report.
A-3 Factory testing

A-3.1 One sample of the product shall be tested in the factory during the preliminary
inspection for preferably following requirements: Description, Colour, Odour, Taste,
Turbidity, Total Dissolved Solids (TDS) by gravimetric method as per IS 3025(Part-16),
pH, Chloride, Alkalinity, and Residual Free Chlorine.

A-3.2 In case any non-conformity is observed during factory testing, no sample shall be
drawn for independent testing in third party lab. (Please refer Annex C for guidelines to
be followed in case of non-conformity).

A-4 Sample for Independent Testing

A-4.1 If the sample passes in factory testing, sample of packaged drinking water shall be
drawn and sent for complete testing for all requirements of the Indian Standard. The
following details should be mentioned in the test request (generated through
Manakonline):

i. Date of manufacture/packing and batch number;

ii. Expiry/Use by;

iii. Quantity (number of containers and total quantity of packaged water in litre or milliliter),

iv. Type, material and capacity of containers

v. Declared wall thickness of container(s) for Top, Middle and Bottom / width of film of
pouch

A-4.2 In case of foreign manufacturers, test request through Manakonline - LIMS is not
applicable, till applicants/licencees under FMCS are brought on online mode, integrated
with Manakonline - LIMS.

A-4.3 However, in case the manufacturer intends to cover more than one variety of
packaging in the scope of licence, he need not offer samples of each variety of packaging
during the factory visit (preliminary inspection) for testing in third party lab. However, it shall
be ensured that the manufacturing facilities for manufacturing other packing sizes (if
applicable) like moulding machines, etc. are available. He may offer sample of the product
in at least one variety of packaging, along with either:

a. Conforming tests reports issued by BIS recognized labs (through LIMS only) for the
other varieties of packaging/containers intended to be covered in the scope of the
licence. These test reports issued through LIMS, shall not be older than 90 days on
the date of submission of application.

Note: In case an application is received for more than one variety of container and the
variety of the container drawn during preliminary inspection, does not conform to the
requirements of the Indian Standard, however the product (Packaged Drinking water)
is found conforming to all the requirements of the Indian Standard, then the application
may be processed for Grant of Licence for all those varieties of container packaging,
whose conforming test report has been submitted with the application. Under such
circumstances, the variety of container, which has not been found conforming to the
requirements of relevant Indian Standard, shall be excluded from the scope. Further
there may be a situation when applicant has applied for one variety only and the
container is found failing but the product (PDW) is passing. Under such circumstances,
only the improved sample of the container as offered by the manufacturer, maybe
tested for conformity to the requirements of the relevant Indian Standard for processing
the application.
OR

b. In case the applicant uses/intends to use ISI Marked Plastic Containers as per IS 15410
or ISI Marked polyethylene flexible pouches as per IS 15609 or ISI marked aluminum
cans as per IS 18285:2023, the manufacturer may submit a consent letter from the BIS
licensed manufacturer of the container, that he has agreed to supply ISI Marked
containers for the required varieties (to be explicitly mentioned in the letter) to the
applicant firm. In that case test reports from third party labs need not be submitted for
those varieties. The letter from BIS licensed manufacturers shall not be older than 90
days on the date of submission of application. The test certificates of the containers
issued as per relevant Indian Standard(s) by the BIS licensed manufacturer is required
to be submitted at the time of submission of application / before inspection, for
examination by BIS.

OR
c. In case the applicant intends to use Paper based multilayer laminated/extruded
composite cartons for packaging as per IS 17753, the case shall be sent by BO to
CMD-2 with complete information and recommendation. CMD-2 shall review all such
cases and decide on approval and communicate to BO till further guidelines in this
matter are issued.

A-4.4 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. (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.)

A-4.5 The sample quantity to be sent to the third-party lab for testing is as follows:

(i) Packaged Drinking Water

a) For all parameters other than radioactive residues - A sample containing


approximately 18 litres of packaged water (PDW) in two parts is adequate, if packed in
1 liter or smaller containers but in case the samples are available in large size
packages (eg. 20 L jars), minimum two such packages are required as microbiological
laboratory needs separate sample for ensuring aseptic handling. For example:

Capacity of the container (cup/bottle/jar) in litres Number of containers to be drawn

1 18
2 9
5 4
10 2
20 2
25 2

For Pouches: 2 bags/cartons each containing total of atleast 100 pouches + Film.

b) For Parameters concerning Radio-active Residue

In addition to the above, sample shall also be drawn for testing parameters
concerning radioactive residues. A sample of 10 litres is adequate.
(ii) Sample of packaging material (containers)::

Capacity of the container Number of containers (including caps) to be drawn


(cup/bottle/jar/can) in ml/L
200ml 30(empty with caps) + 9(filled)+40 caps
250ml 27 (empty with caps) + 9 (filled) + 40 (caps)
500ml 24 (empty with caps) + 9 (filled) +40 caps
1 liter 21 (empty with caps) + 9 (filled) + 40 caps
2 litre 18 Empty (with caps) + 8 (filled) + 40caps
5 litre and above 7 Empty (with caps) + 8 (filled) + 25 caps

Pouches: 1 bag of 50 filled pouches + 18 meter film+ 10 Nos. of Preformed pouches of


dimension 125 mm X 200 mm.

Cup/Glass along with peelable seal: 37 (Empty) + 15 (filled) + 18 meter film of


peelable seal + 8 preformed pouches of 125 mm x 200 mm of peelable seal.

Aluminium cans: equivalent quantity as above.

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, Expiry/Use by,
capacity, using ink to be used by the manufacturer for marking on the pouches. This will
facilitate testing of pouches for ink adhesion test. This is being allowed as manufacturer
cannot get the pouch film rollsprinted with all other details such as Standard Mark etc.
before the GOL.

Note 2: IS 11984 has been indicated as a reference Indian Standard for glass
bottles/tumbler, however such containers need not be tested. However, if any
manufacturer intends to use such container, it shall be included in the licence. The
separate processing line for filling the glass bottles may be verified by BIS during the next
surveillance visit and necessary steps in the process for ensuring sterility of bottles may
be adopted like steam sterilizing, hot water rinsing, UV sterilization (except in case of
PNMW) or combination thereof. In case of lug caps containing plastic lining, food grade
certificate or OSL report for migration testing may be accepted.

Note 3: 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.

Note 4: The manufacturer’s declaration with respect to the minimum wall thickness
(Top/Middle/Bottom) of the container and shelf life of product, shall be obtained and the
same to be mentioned in the test request.

A-5 Change in Scope of Licence

A-5.1 For the purpose of certification of PDW, change in scope of licence pertains only to
addition/deletion of the varieties of packaging covered in the scope of the licence.

A-5.2In case a licensee intends to add new varieties of packaging in scope of licence,
he shall submit an application in the Form – XIV along with requisite fee and relevant
documents.

A-5.3 In addition, he shall submit conforming third-party lab test report(s) of samples of
each variety of the packaging (i.e. each material (PET/PE etc.), form or type
(cup/bottle/jar/can) and capacity in ml or litres) intended to be added to the scope of
licence.
A-5.4 In addition to these guidelines, Guidelines for Grant of Licence (GoL) and Change
in Scope of Licence (CSoL) as per the conformity assessment Scheme – I of Schedule –
II of BIS (Conformity Assessment) Regulations, 2018 issued by CMD-1 shall be followed.

ANNEX B
Guidelines for Surveillance

Surveillance consists of two activities in case of Packaged water certification i.e.


surveillance visits at factory premises (which includes testing of sample drawn from
factory) and drawl of samples from the market for third party lab testing. Product Specific
guidelines for these are as follows:

B-1. Factory Surveillance

B-1.1 During factory surveillance visit, the compliance to the requirements of the SIT and
ISS shall be verified and the observations recorded in the inspection report.

B-1.2 However, in addition, the following product specific aspects shall also be verified
and observations recorded in the Report of Periodic Inspection or in an Annexure to that
report:

vi. Any change in manufacturing facilities including filling and/or packaging machinery for
the varieties applied for to be verified and observations recorded;

vii. Compliance to hygienic practices as per Annex B of IS 14543 to be verified and


observations to be recorded as per Hygiene Checklist at Annex-G of this product
manual.

viii. Any change in Source of Water shall be checked for and reported. Any observations
including non- compliance to IS requirements to be reported (e.g. No change in source
of water OR change in source of water from borewell to civic water supply, in
compliance with IS)

ix. Any change in nature of treatments/disinfection processes to be verified and


observations including compliance thereon to be reported (This may be mentioned in
the process flowchart submitted.)

x. In case the manufacturer conducts remineralization as part of treatment process,


any change in the ingredients shall be checked for and reported. Further, the
ingredients shall be of food/pharma grade quality. The test certificate indicating the
individual ingredients and the respective compositions of each mineral/ingredient in the
product shall be obtained from the manufacturer and enclosed with the report. The
licensee shall not modify the process without obtaining the consent of BIS. For
obtaining consent, they shall submit process flow chart indicating the change in process
and declare the addition of machineries if any. Necessary verification of process and
machinery shall be done during the next surveillance visit.
xi. As applicable, availability of required testing facilities, as per the ISS and SIT should
be verified and recorded. Any change in the test facilities should be checked for and
reported. The test equipment should have valid calibration on the day of the visit.
Calibration should be done from NABL accredited laboratory or any other laboratory
provided traceability to NPL is established through the calibration certificates.
Calibration of Analytical Balance, temperature indicators, pressure gauge of autoclave
and spectrophotometer (internal/in-house or from outside lab.) is considered necessary
at least once a year. Indicative List of test equipment and chemicals required for testing
of packaged water is given at Annex D for guidance. Status of test equipment
calibration observed from calibration certificates should be reported.

xii. Any change in testing person(s) should be checked for and reported along with
comments on the competence, qualifications and experience.

xiii. Compliance to requirements of SIT shall be verified and observations reported.

B-2 Factory testing

B-2.1 One sample of the product shall be tested in the factory during the preliminary
inspection for preferably following requirements: Description, Colour, Odour, Taste,
Turbidity, pH, Chloride, Alkalinity, and Residual Free Chlorine.

B-2.2 In case any non-conformity is observed during factory testing, no sample shall be
drawn for independent testing in third party lab. (Please refer Annex C for actions to be
taken in case of non- conformity)

B.3 Sample for Independent Testing

B-3.1 If the sample passes in factory testing, sample of packaged drinking water shall be
drawn and sent for testing for all requirements of the Indian Standard IS 14543:2024
except the parameters concerning radioactive residues. However, out of all the
samples drawn for factory/market surveillance in a year, only one sample may be got
tested for pesticide residues, which is required to be clearly indicated on the test requests
generated by BOs/outsourced agencies. But, if a sample fails in the requirement of
Pesticide Residues, then the next 3 consecutive samples (factory/market) of that licence
shall be tested for all tests including Pesticide Residues(except Radioactive residues), till
the 3 consecutive samples are found conforming to all requirements tested including
pesticide residues.

The following details should be mentioned in the test request (generated


through Manakonline):

i. Date of manufacture or packaging and batch number;

ii. Expiry/Use by or Best Before Days/Months from the date of Packaging/Manufacture;

iii. Quantity (number of containers and total quantity of packaged water in litre or milliliter),

iv. Type, material and capacity of containers

v. Declared wall thickness of container(s)/width of film of pouch


vi. ‘All tests/All Chemical tests/All Possible tests, except Pesticide Residues and
Radioactive Residues’ (where pesticide residue is not required to
be tested) And All tests/All Chemical tests/All Possible tests, including Pesticide
Residues, but excluding Radioactive Residues (where pesticide residue is
required to be tested).

B-3.2 In case the applicant is adopting more than one type of processes/sources of raw
water, samples shall be drawn for each process/source by rotation during factory
surveillance.( 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.)

B-3.3 The sample quantity to be sent to the third-party lab for testing is as follows:

i) Packaged Drinking Water

For all parameters other than radioactive residues - A sample containing


approximately 18 litres of packaged water (PDW/PNMW) in two parts is adequate, if
packed in 1 liter 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.

B-4 Market Surveillance

B-4.1 While obtaining samples of packaged drinking water from the market, it should be
ensured that the samples being drawn are bearing genuine ISI mark. This may be done
by checking the licence number printed on the label. In case it is found that the ISI mark
is spurious, the sample shall not be drawn for testing and further investigation/suitable
action should be initiated.

B-4.2 For sending the market sample to the lab for testing, the following details should be
mentioned in the test request (generated through Manakonline):

i. ‘Date of manufacture or packaging’ and ‘Expiry/Use by;


ii. Best before date (optional);
iii. Quantity (number of containers and total quantity of packaged water in litre or milliliter),
iv. Type, material and capacity of containers

B-4.3 Separate samples of containers need not be drawn during market surveillance for
testing. The possible tests on containers (including transparency) will be carried out on the
containers of the samples of packaged water drawn for testing requirements as per IS
14543 excluding PR and RAR. This shall be mentioned on the test request.

B-4.4 The sample quantity to be sent to the third-party lab for testing is as follows:

i) Packaged Water

For all parameters other than radioactive residues – A sample containing


approximately 18 litres of packaged water (PDW/PNMW) in two parts is adequate, if
packed in 1 liter 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 the container Number of containers to be drawn
(cup/bottle/jar) in litres
1 18
2 9
5 4
10 2
20 2
25 2

For Pouches: 2 bags of 100 pouches each + Film. A sample of 4 bags shall be
drawn in case each bag contains 50/60 pouches.
ANNEX C

Guidelines for actions in case of non-conformity including suspension and revocation of


suspension of licence

C-1.1 Guidelines for dealing with non-conformity of product(s) observed during operation
of Licence including product recall, suspension and revocation of suspension under
Scheme - I of Schedule - II of BIS (Conformity Assessment) Regulations, 2018 issued by
CMD-1 shall apply in case of packaged water. In addition, the following product specific
guidelines will apply. Wherever the general and product-specific guidelines are in conflict,
the product specific guidelines will take precedence.

C-1.2 Non Conformity of Samples

Non-conformity of containers/packaging material shall not be treated at par with non-


conformity of drinking water, since the criticality of the former is lower. Accordingly, non-
conformity in case of drinking water and containers/packaging material shall be treated
separately as follows:

C-1.2.1 Non-conformity of drinking water (IS 14543)

Suspension is normally considered in the event of consecutive non-conformity of samples


of other products. However, in case of packaged drinking water suspension shall be
imposed on first non-conformity itself if the non-conformity of drinking water is in respect
of parameters concerning radioactive residues or pesticide residue or toxicity.

In all other respects, the prevalent Guidelines for dealing with non-conformity of product(s)
observed during operation of Licence including product recall, suspension and revocation
of suspension under Scheme - I of Schedule - II of BIS (Conformity Assessment)
Regulations, 2018 as applicable for all products, shall apply.

C-1.2.2 Non-conformity of container or packaging material (IS 15410 etc)

i. Suspension is normally considered in the event of first consecutive non-conformity of samples


of other products. However, for containers/packaging of packaged drinking water, non-
conformity is to be considered as consecutive only when the same variety of containers (i.e.
the same material, type/form and capacity) is found to be non-conforming consecutively.

ii. Suspension shall not be considered in the first instance of consecutive non conformity in case
of containers/packaging. The non- conformity shall be communicated to the licensee through
email/speed post/IT software with a copy of the test report (as per template given in SUS/ROS
guidelines). The licensee shall be advised to take corrective action and submit reply with
supporting evidence, as applicable, within 30 days (one month) of the date of communication
and offer improved samples for testing.

iii. Suspension may be considered in case licensee fails to submit appropriate corrective actions
and/or offer improved samples for testing within the timeline specified. When the corrective
actions as mentioned above, are received within 30 days (one month), the DO shall put up the
case to the Head BO for nominating an officer for verification of the corrective actions preferably
within 90 days through a surveillance inspection.
iv. Since factory testing of containers during surveillance visit may not be feasible in most
cases as most manufacturers are procuring containers from outside and do not have in-
house testing facilities, the corrective action shall be verified from documents etc as far
as possible and improved sample of container shall be drawn for testing for all
requirements of the standard (i.e. IS 15410) in third party lab during surveillance visit

v. Suspension shall be considered in case of second consecutive non-conformity of


same variety of container i.e. the same material, type/form and capacity) and actions
as per SUS/ROS guidelines shall be taken.

vi. Revocation of suspension shall be done as per the general Guidelines for Suspension
(SUS) and Revocation of Suspension (ROS) of Licence.

vii. In all other respects, the prevalent Guidelines for dealing with non-conformity of
product(s) observed during operation of Licence including product recall, suspension and
revocation of suspension under Scheme - I of Schedule - II of BIS (Conformity
Assessment) Regulations, 2018as applicable for all products, shall apply.

C-2 Unsatisfactory performance

C-2.1 In case the following situations are observed, it shall be treated as major modification in
process without prior evaluation of the Bureau and shall attract suspension on the first
instance itself:

i) Change of source of raw water without evaluation of the Bureau other than the one
outside the licensed premises not evaluated by BIS (However, 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.)

ii) Modification in the process with or without any change in raw water source, without
prior evaluation of BIS. (Any addition or deletion of processing machinery eg. Tanks/RO/Filling
machine, etc for capacity enhancement or otherwise, which does not change the overall
manufacturing process, will not constitute as modification in the process. A declaration
regarding the same may be taken during surveillance in Form-I.)

iii) In all other respects, the prevalent Guidelines for dealing with unsatisfactory
performance (other than matters related to non-conformity of the product) during operation of
Licence including suspension and revocation of suspension under Scheme - I of Schedule -
II of BIS (Conformity Assessment) Regulations, 2018 as applicable for all products, shall
apply.
ANNEX D
LIST OF TEST EQUIPMENTS
(INDICATIVE LIST, FOR GUIDANCE ONLY)
TABLE 1 - ORGANOLEPTIC AND PHYSICAL PARAMETERS

Sl. Tests Used In With Test Equipment/Chemical


No. Clause Reference
1 Colour a) Platinum cobalt (visual comparison method)

Nessler Tubes — Matched, 50 ml capacity, tall


Form, pH Meter, Filter and Filter Assembly and reagents as
per IS 3025 (Part 4)

b) Spectrophotometric — Single wavelength method

Spectrophotometer — capable of operating between 450 and


465 nm with lowest count for adjustable wavelength of 1 nm,
pH Meter, Filter and Filter Assembly and reagents as per IS
3025 (Part 4)

c) Spectrophotometric — Multi wavelength method.

Spectrophotometer — Capable of measuring


the transmittance/absorbance at a narrow (10 nm or
less) spectral band, and an effective operating range
from 400 to 700 nm, along with absorption cell of a
minimum of 10 mm path length, pH Meter, Filter and Filter
Assembly and reagents as per IS 3025 (Part 4)
2 Odour Wide-mouth glass-stoppered bottles of about one litre
capacity, hydrochloric acid, odour-free distilled water as per
IS 3025 (Part 5)
3 Taste 50 ml beaker, water-bath with temperature controller capable
of being maintained at a temperature of 15 °C (not to exceed
27 °C), Glass bottles with glass or polytetrafluroethylene
lined closures, Taste and odour-free water, 2 000 mg/l
solution of sodium chloride prepared with taste and odour-
free water as reference sample
4 Turbidity Sample Tubes, and Nephelometer and reagents as per IS
3025 (Part 10)
5 Total Dissolved Solids Dishes of 90 mm diameter with 100 ml capacity
made of porcelain / platinum / high silica, Wide-Bore Pippets
Class B glass, mechanical or electronic, Hot Plate/Block to
Maintain <100°C Temperature, Desiccator — Provided with
a colour indicating desiccant, Analytical Balance of 200g
capacity and capable of weighing to 0.1 mg, Magnetic Stirrer
— With teflon coating stirring bars, Glass Fibre Filter Disc —
(Whatman GF/C or equivalent) 22 mm to 125 mm dia, ≤ 2
μm nominal pore size without organic binder, Oven — With
thermostatic control for maintaining temperature up to 180
°C ± 2°C, Filtering Apparatus, Gooch Crucible — 25 ml to 40
ml capacity, and Suction Flask as per IS 3025 (Part 16)
6 pH pH meter, Sampling bottle, sealable, flat-bottomed, made of
polyethylene or glass, Temperature measurement device,
capable of measurement with a total uncertainty not greater
than 0.5 °C, Thermometer with a 0.5 °C scale, Temperature
sensor, separate or integrated into the pH electrode, Glass
electrode and reference electrode, Stirrer or agitator and
reagents as per IS 3025 (Part 11)

TABLE 2 – GENERAL PARAMETERS CONCERNING SUBSTANCES UNDESIRABLE IN


EXCESSIVE AMOUNTS

Sl. Tests Used In WithClause Test Equipment/Chemical


No. Reference
1 Determination of Barium, Copper, Inductively coupled plasma optical emission
Iron, Manganese, Zinc, Silver, spectrometer , Radiofrequency generator, Mass-flow
Aluminium, Selenium, Calcium, controller, Nebulizer (or ultrasonic nebulizer if
Magnesium, Manganese, Sodium, required), Argon gas supply, containers of appropriate
Antimony and Borates by material (perfluoroalkoxy (PFA), hexafluoroethene
Inductively Coupled Plasma Optical propene (FEP) or quartz container is recommended),
Emission Spectrometry ( ICP-OES labware and reagents as per IS 3025 (Part 2)
) as per IS 3025 (Part 2)
2 Determination of Barium, Copper, Mass spectrometer, Nebulizer with variable speed
Iron, Manganese, Zinc, Silver, peristaltic pump, Argon gas supply, containers of
Aluminium, Selenium, Calcium, appropriate material (perfluoroalkoxy (PFA),
Magnesium, Manganese, Sodium, hexafluoroethene propene (FEP) or quartz container
Antimony and Borates by is recommended), labware and reagents as per IS
Inductively Coupled Plasma Mass 3025 (Part 65)
Spectrometry ( ICP-MS ) as per IS
3025 (Part 65)
3 Determination of Nitrate, Nitrite, Ion chromatography system consisting of Eluent
Fluoride, Chloride, Sulphate, by reservoir, and a degassing unit, Metal-free HPLC
Liquid Chromatography of Ions as pump, Sample injection system, Conductivity detector
per IS 3025 (Part 75), (CD), Ultraviolet (UV) detector, e.g. a
spectrophotometer, Recording device (e.g. a
computer with software for data acquisition and
evaluation), Precolumns, if necessary and reagents
as per IS 3025 (Part 75)
4 Determination of Barium content as Analytical Balance, Hot plate, filter paper, Ammonium
per Annex G of IS 13428 Dichromate Solution, Ammonium Acetate Solution,
Dilute Ammonium Acetate Wash Solution, Potassium
Iodide Solution, Standard Sodium Thiosulphate
Solution, Hydrochloric Acid and other labware,
reagents as per Annex G of IS 13428
5 Determination of copper content as a) Neocuproine Method
per IS 3025 (Part 42)
Spectrophotometer for use at 457 nm with 1 cm cell,
pH meter, Neocuproine, ammonium hydroxide,
chloroform, hydrochloric acid, hydroxylamine
hydrochloride, Isopropyl Alcohol, sodium citrate, nitric
acid and sulphuric acid, pure copper, labware and
reagents as per IS 3025 (Part 42)
b) Atomic Absorption Method (Direct)

Atomic Absorption Spectrophotometer -


with air-acetylene flame, Copper Hollow Cathode
Lamp - for use at 324·7 nm, labware and reagents as
per 3025 (Part 42)

c) Atomic Absorption (Chelation extraction)

Atomic Absorption Spectrophotometer -


with air-acetylene flame, Copper Hollow Cathode
Lamp - for use at 324·7 nm, labware and reagents as
per 3025 (Part 42)

6 Determination of Manganese as a) Direct air-acetylene flame atomic absorption


per IS 3025 (Part 59) spectrometry (AAS) method

Atomic Absorption Spectrometer and Associated


Equipment, labware and reagents as per IS 3025
(Part 59)

b) Per sulphate method

Colorimetric Equipment i.e. Spectrophotometer — for


use at 525 nm, providing a light path of 1 cm or
longer or Filter photometer — providing a light path of
1 cm or longer and equipped with a green filter
having maximum transmittance near 525 nm with
labware and reagents as per IS 3025 (Part 59)
7 Determination of Nitrate as per IS a) Cadmium reduction method, and its advanced
3025 (Part 34/Sec 1) methods;

Reduction column, Colorimetric Equipment i.e.


Spectrophotometer — or use near 543 nm with a light
path of 1 cm or longer or Filter photometer — provided
with a yellow green filter having maximum
transmittance near 540 nm and a light path of 1 cm or
longer with labware and reagents as per IS 3025 (Part
34/Sec 1)

b) Ultraviolet Spectrophotometric screening


method;

Spectrophotometer for use at 220 nm and 275 nm with


matched silica cells of 1 cm or longer light path with
labware and reagents as per IS 3025 (Part 34/Sec 1)

c) Nitrate electrode method;

pH/mv/ISE meter which is capable of measuring 0.1


mv resolution, Nitrate electrode with a double junction
electrode or a combined electrode with suitable
reference solution (ammonium sulphate) as per
manufactures instructions for storage and usage,
Magnetic stirrer with teflon bars for constant stirring,
labware and reagents as per IS 3025 (Part 34/Sec 1)
8 Determination of Nitrite as per IS Spectrophotometer or Photometer for use at 543 nm
3025 (Part 34/Sec 1) in case of spectrophotometer having a green filter
and having maximum absorbance near 540 nm,
Nessler Tubes — matched, 50 ml capacity, labware
and reagents as per IS 3025 (Part 34/Sec 1)
9 Determination of Fluoride using i) Ion-selective electrode, SPANDS methods as per IS
3025 (Part 60/Sec 1)
i) Ion-selective electrode, or
SPANDS methods as per IS 3025 For preliminary distillation step:
(Part 60/Sec 1) Distillation Apparatus, Quartz Hemispherical Heating
Mantle for full voltage operation, Soft Glass Beads,
OR Magnetic Stirrer, with stirring bar coated with
Tetrafluoroethylene (TFE), labware and reagents as
ii) Method using flow injection per IS 3025 (Part 60/Sec 1)
analysis (FIA) and spectrometric
detection after off-line Distillation as For Ion Selective electrode method:
per IS 3025 (Part 60/Sec 2) Expanded Scale or Digital pH Meter or Ion
Selective Meter, Sleeve Type Reference Electrode,
OR Timer, Magnetic Stirrer, stirring bar coated with TFE,
Fluoride electrode, Magnetic Stirrer with labware and
iii) Method using Continuous Flow reagents as per as per IS 3025 (Part 60/Sec 1)
Analysis (CFA) with Automated In-
line Distillation as per IS 3025 (Part
60/Sec 3) For SPADNS Method:
Colorimetric Equipment: Spectrophotometer — For
use at a wavelength of 570 nm providing a light path
of atleast 1 cm, or Filter Photometer — Providing a 1
cm light path and equipped with a greenish yellow filter
having a maximum transmittance at 550 nm to 580 nm
with labware and reagents as per 3025 (Part 60/Sec
1).

ii) Method using flow injection analysis


(FIA) and spectrometric detection after off-line
Distillation as per IS 3025 (Part 60/Sec 2):

Flow injection analysis system, Low pulsation pump,


Sample introduction system, Reaction manifold,
consisting of fluorocarbon polymer tubes, such as
polytetrafluoroethylene (PTFE) with the internal
diameter of 0.5 mm to 0.8 mm, plastics joints of
chemically inert and small dead volume and a
thermostat which is capable of heating at 70 °C,
Detection system.
using a spectrometric detector with flow cell, which is
capable of measuring at a wavelength of 620 nm ± 5
nm, Recording system, which is capable of recording
signals from the detector, Distillation apparatus,
labware and reagents as per IS 3025 (Part 60/Sec 2)

iii) Method using Continuous Flow


Analysis (CFA) with Automated In-line Distillation as
per IS 3025 (Part 60/Sec 3)
Continuous flow analysis system with following
components: Low pulsation-pump, Sample
introduction system, Distiller, composed of a
distillation unit and a heater which is capable of
heating at 145 °C, Reaction manifold, composed of
chemically inert tubes with the internal diameter of
about 0.5 mm to 2 mm, and glass or plastic parts with
a small dead volume, Detection system using a
spectrophotometric detector with flow cell which is
capable of measuring at a wavelength of 620 nm ± 5
nm, Recording system, which is capable of recording
signals from the detector, labware and reagents as per
IS 3025 (Part 60/Sec 3)

10 Determination of Zinc as per IS Zincon method:


3025 (Part 49)
Spectrophotometer - for use at 620 nm
with 1 cm cells with labware and reagents as per IS
3025 (Part 49)

Atomic Absorption Method (Direct) and Atomic


Absorption method (Chelation-Extraction):

Atomic Absorption Spectrophotometer with


Air-Acetylene Flame, Multi-element hollow-cathode
lamps or electrode less discharge lamps for use at
213.8 nm, labware and reagents as per IS 3025 (Part
49)

11 Determination of Silver

As per IS 3025 (Part 79) a) Extraction/air-acetylene flame method

Atomic Absorption Spectrometer and


Associated Equipment, , labware and reagents as per
IS 3025 (Part 79)

c) Electrothermal atomic absorption


spectrometric method

Atomic Absorption Spectrophotometer with


background correction capability, Graphite Furnace,
Readout, Membrane Filter Apparatus, all glass
filtering device and membrane filters having a pore
diameter
of 0.45 μm or smaller, Cooling Water Supply, tap
water at 1 l/min to 4 l/min to cool and use a
recirculating cooling device, Sample Dispensers,
pipets of microliter capacity (5 μl to 100 μl) or an
automatic sampling device which is designed for the
particular instrument, Source Lamps, a hollow -
cathode lamp or an
electrode discharge lamp, Vent, labware and
reagents as per IS 3025 (Part 79)
12 Determination of Aluminium as per a) Eriochrome cyanine R method
IS 3025 (Part 55)
Spectrophotometer — for use at 5.35 nm with
1 cm cells, pH meter, labware and reagents as per IS
3025 (Part 55)

b) Atomic Absorption Method

Atomic Absorption Spectrophotometer — with


nitrous oxide-acetylene flame, hollow-cathode lamp
or electrodeless discharge lamp for use at 309.3 nm,
labware and reagents as per IS 3025 (Part 55)
13 Determination of Chloride as per IS a) Argentometric Method
3025 (Part 32)
Erlenmeyer Flask 250 ml, Burette 50 ml, labware and
reagents as per IS 3025 (Part 32)

b) Mercuric Nitrate Method

Erlenmeyer Flask 250 ml, Microburette 5 ml with 0.01


ml graduation intervals, labware and reagents as per
IS 3025 (Part 32)

c) Potentiometric Method

Glass and silver-silver chloride electrodes, Electronic


voltmeter, Mechanical stirrer, labware and reagents
as per IS 3025 (Part 32)

d) Automated Ferricyanide Method

Automated analytical equipment as per Fig. 1 of IS


3025 (Part 32), Filters – 480 nm, labware and
reagents as per IS 3025 (Part 32)
14 Determination of Selenium as per a) Atomic absorption spectrometric method
IS 3025 (Part 56) (Hydride technique).

Atomic Absorption Spectrometer — Fitted


with a hydride system and a suitable radiation
source for the determination of selenium, for
example, electrodeless discharge lamp or a hollow
cathode lamp and preferably, a background
correction facility, gas supply with Argon or Nitrogen,
labware and reagents as per IS 3025 (Part 56)
15 Determination of Sulphate

As per IS 3025 (Part 24/Sec 1) a) Gravimetric method

Steam Bath,
Drying Oven, equipped with thermostatic control,
Muffle Furnace, with heat indicator,
Desiccator,
Analytical Balance, with least count of 0.1 mg, Filter
Paper, acid washed, ash-less hard finish filter paper
sufficiently retentive for fine precipitates (preferably
Whatman No. 42/equivalent),
Crucible, porous bottom silica or porcelain
crucible with a maximum pore size of 5 microns,
Ion-Exchange Column,
Labware and reagents as per IS 3025 (Part 24/Sec 1)

b) Turbidity method

Magnetic Stirrer,
Photometer (preferably a Nephelometer or if not
available, a spectrophotometer, for use at 420 nm with
light path of up to 5 cm),
Stopwatch, to be used if magnetic stirrer is not
equipped with an accurate timer,
Measuring Spoon, capacity from 0.2 ml to 0.3 ml,
Labware and reagents as per IS 3025 (Part 24/Sec 1)

As per IS 3025 (Part 24/Sec 2) Continuous-flow analysis (CFA) system consisting of:
Sampler or other device, for reproducible sample
introduction,
Reagent containers,
Low pulse pump, with chemical resistant pump tubes,
Inlet connector, made of glass, or chemical resistant
material, with reproducible air-, sample- and reagent
segmentation, Photometer, with flow cell, optical path
length, e.g. 10 mm, wavelength range 450 nm to 470
nm,
Data acquisition and display unit, such as a PC,
recorder, printer or plotter,
Graduated flasks, nominal capacity 100 ml and 1 000
ml,
Graduated pipettes, nominal capacity 1 ml, 2 ml, 3
ml, 4 ml, 5 ml, 6 ml, 7 ml, 8 ml, 9 ml, 10 ml and 50 ml,
Cation exchange column,
Labware and reagents as per IS 3025 (Part 24/Sec 2)
16 Determination of Alkalinity as per IS pH Meter
3025 (Part 23) Burette, 50 ml capacity.
Pipets, 10 ml capacity.
Beaker, 100 ml.
Volumetric flask, 100, 200 ml.
Magnetic Stirrer Assembly
Labware and reagents as per IS 3025 (Part 23)
17 Determination of Calcium as per IS a) EDTA titrimetric method
3025 (Part 40)
Hot plate, titration assembly, labware and reagents
as per IS 3025 (Part 40)

b) Atomic absorption spectrometric method

Atomic absorption spectrometer set up and


equipped with an appropriate burner for air/
acetylene flame or nitrous oxide/acetylene flame and
a hollow cathode lamp for calcium with a wavelength
of 422·7 nm.
labware and reagents as per IS 3025 (Part 40)
c) Permanganate titration method

Beakers with Glass Rod - 400 ml capacity


and cover glass
Filtration Set Up - A coarse filter paper or a small filter
paper supported in a Gooch crucible with suction.
18 Determination of Magnesium as per a) Volumetric method using EDTA
IS 3025 (Part 46)
Analytical grade Volumetric Glassware
Labware and reagents as per IS 3025 (Part 46)

b) Atomic absorption spectrophotometric


method

Atomic absorption spectrophotometer set up and


equipped with an appropriate burner for
air-acetylene flame or nitrous oxide-acetylene flame
and a hollow cathode lamp for magnesium with
wavelength of 285.2 nm,
Labware and reagents as per IS 3025 (Part 46)

19 Determination of Sodium as per IS a) Flame emission photometric method using


3025 (Part 45) either a flame photometer or an atomic
absorption spectrophotometer in the
flame emission mode

Flame Photometer either direct-reading or internal


standard type or an atomic absorption
spectrophotometer in the flame emission mode,
Labware and reagents as per IS 3025 (Part 45)

b) Atomic absorption spectrometric method


using an atomic absorption spectrophoto-
meter in flame absorption mode

Atomic absorption spectrophotometer in the


absorption mode, set up and operated according to
the manufacturer's instructions, equipped with an
appropriate burner for air-acetylene flame and hollow
cathode lamps for sodium and potassium
determinations,
Labware and reagents as per IS 3025 (Part 45)

c) Gravimetric method for determination of


sodium

Beakers - 20-ml borosilicate.


Fritted Glass Crucible - 30-ml borosilicate
of medium porosilicate of medium porosity: or
porous porcelain crucibles.
Vacuum pump or aspirator, with manifold
and individual petcocks,
Labware and reagents as per IS 3025 (Part 45)
20 Determination of Residual Free a) Titrimetric Method using DPD
Chlorine as per IS 3025 (Part 26)
Ordinary laboratory apparatus
Microburette, measuring up to 5 ml and graduated in
divisions of 0.02 ml.
anhydrous disodium hydrogen phosphate, Potassium
dihydrogen phosphate (KH2PO4) and other reagents
as per IS 3025 (Part 26)

b) Colorimetric Method using DPD for routine control

Usual laboratory apparatus and, in particular,


photometric or colorimetric equipment respectively,
comprising one of the following:

- Comparator, equipped with a scale of permanent


glass or plastics colour standards specially set up for
the DPD technique and suitable for concentrations
from 0.000 4 mmol/l to 0.07 mmol/l (that is 0.03 mg/l
to 5 mg/l) of chlorine.

- Spectrometer, a photometer, colorimeter or


spectrophotometer, with a selector for wavelength
variation, suitable for use at 510 ± 20 nm or 550 ± 20
nm and equipped with rectangular or cylindrical cells
with an optical path length of 10 mm or greater.

Chlorine-demand free glassware, obtained by


filling with sodium hypochlorite solution
then, after 1 h, rinsing copiously with water

Other Labware and reagents as per IS 3025 (Part 26)


21 Determination of Phenolic a) 4-Aminoantipyrine method with chloroform
Compounds as per IS 3025 (Part extraction.
43/Sec 1)
Spectrophotometer, for use at 460 nm and
equipped with 1 to 10 cm cells.
Filter Funnels, Buchner type with fritted disc.
Filter Paper, alternative to Buchner type funnel,
use Whatman No. 40 filter paper and anhydrous
sodium sulphate for filtration of chloroform phase.
H Meter
Separating Funnel, 1 000 ml capacity with ground
glass stoppers and TFE stop cock
Labware and reagents as per IS 3025 (Part 43/Sec 1)

22 Determination of Mineral Oil as per a) Partition infra-red method


IS 3025 (Part 39)
Separating Funnel — 2 litre capacity with Teflon or
equivalent stopcock.
Infra-Red Spectrophotometer
Cells — Infra-red, silica/quartz (1 or 5 cm path
length; for lower range, 5 cm path length will be
appropriate).
Filter Paper — Whatman No. 40 or equivalent,11 cm
diameter.
100 ml glass centrifuge tubes at 2 400 rpm or more.
Centrifuge Tube — 100 ml glass (optional).
Labware and Reagents as per IS 3025 (Part 39)

23 Determination of Anionic surface Ordinary laboratory equipment and the following:


active agents (as MBAS) as per IS pH-meter with suitable electrodes made from glass.
3025 (Part 68) UV-VIS Spectrometer capable of measurement at
650 nm, equipped with quartz cuvettes of optional
path lengths 10 mm and 50 mm.
Gas-stripping Apparatus
Labware and Reagents as per IS 3025 (Part 68)

24 Determination of Sulphide (as H2S) a) Titrimetric iodine method or methylene blue


as per IS 3025 (Part 29) method
Matched Test Tubes, with an outer diameter (OD) of
approximately 15 mm and 125 mm long Droppers,
delivering the methylene blue solution (20 drops/ml).
Spectrophotometer, suitable for use at a wavelength
of 664 mm with cells providing the light paths of 1 cm
and 1
mm or other path lengths or filter
photometer, having a filter that provides a
maximum transmittance near 660 nm.
Methylene blue solution I and II
Labware and Reagents as per IS 3025 (Part 29)

b) Iodometric method
Glass Bottles with Stoppers
Sodium Hydroxide Solution, 6N
Aluminium Chloride Solution
Hydrochloric Acid (HCl), 6 N
Standard Iodine Solution, 0.025 N
Standard Sodium Thio-Sulphate
Solution, 0.025 N
Starch Solution
Labware and Reagents as per IS 3025 (Part 29)

25 Determination of Antimony

As per Annex H of IS 13428 Suitable Spectrophotometer


Erlenmeyer Flask
Hydrochloric Acid Solution — 6 N
Dilute Phosphoric Acid — 3 N
Rhodamine B Solution — 0.02 percent (in
distilled water)
Antimony Standard Solutions
Labware and reagents as per Annex H of IS 13428
As per IS 15303 Atomic absorption spectrometer
Source Lamps
Graphite Furnace
Readout
Sample Dispensers
Vent
Cooling Water Supply
Membrane Filter Apparatus
Metal-Free Water
Labware and reagents as per IS 15303
26 Determination of Borates as per Ordinary laboratory apparatus made of
Annex J of IS 13428 polypropylene, polyethylene or
polytetrafluoroethylene, where applicable.

Spectrometer, for use in the wavelength range


of 410 nm to 420 nm, with cells of an optical path
length between 10 mm and 50 mm.

Labware and reagents as per Annex J of IS 13428


27 Determination of Bromates as per Ion chromatographic system, complying with the
IS 3025 (Part 67) quality requirements of clause 8 of IS 3025 (Part 67),
i.e. resolution. In general, it shall consist of the
following components
a) eluent reservoirs, and a degassing unit for two
eluents;
b) pump, suitable for step gradient technique;
c) sample delivery device (e.g. sample pump)
including a sample injection system incorporating a
sample loop of
appropriate volume (e.g. 0,05 ml to 2 ml) or
autosampler device;
d) column-switching valves (e.g. 6-port-valve)
including a device for timing and controlling valves
and pump;
e) concentrator column (may be required for low
concentrations);
f) separator column with the specified separating
performance (see clause 8);
g) conductivity detector with an anion suppressor
device assembly;
h) UV detector (e.g. spectrophotometer: 190 nm to
400 nm);
i) recording device (e.g. recorder, integrator with
printer, PC with software for data acquisition and
evaluation).
j) Labware and reagents as per IS 3025 (Part 67)
k) Cartridges.
-cation exchanger in the Ag-form (cartridge);
-cation exchanger in the Ba-form (cartridge);
-cation exchanger in the H-form (cartridge);
-optional: metal clean-up column for on-line use;
-cartridges with non-polar phases to be used for
sample preparation (e.g. polyvinylpyrrolidone).

TABLE 3 - PARAMETERS CONCERNING TOXIC SUBSTANCE

Sl. Tests Used In WithClause Test Equipment/Chemical


No. Reference
1 Determination of Cadmium, Inductively coupled plasma optical emission
Arsenic, Lead, Chromium, and spectrometer , Radiofrequency generator, Mass-flow
Nickel, by Inductively Coupled controller, Nebulizer (or ultrasonic nebulizer if required),
Plasma Optical Emission Argon gas supply, containers of appropriate material
Spectrometry ( ICP-OES ) as per IS (perfluoroalkoxy (PFA), hexafluoroethene propene (FEP)
3025 (Part 2) or quartz container is recommended), labware and
reagents as per IS 3025 (Part 2)
2 Determination of Mercury, Mass spectrometer, Nebulizer with variable speed
Cadmium, Arsenic, Lead, peristaltic pump, Argon gas supply, containers of
Chromium, Nickel and Uranium by appropriate material (perfluoroalkoxy (PFA),
Inductively Coupled Plasma Mass hexafluoroethene propene (FEP) or quartz container is
Spectrometry ( ICP-MS ) as per IS recommended), labware and reagents as per IS 3025
3025 (Part 65) (Part 65)
3 Mercury (as Hg) as per IS 3025
(Part 48

Cold Vapour Atomic Absorption Atomic Absorption Spectrometer and


Spectrometry 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
Labware and Reagents as per IS 3025 (Part 48)
4 Cadmium as per IS 3025 (Part 41) a) Direct air-acetylene flame method
Atomic absorption spectrometer and associated
equipment.
Cadmium hollow-cathode lamp or multi-element hollow-
cathode lamp for use at 228.8 nm.
Burner head as recommended by the
manufacturer.
Labware and Reagents as per IS 3025 (Part 41)
b) Extraction/air-acetylene flame method
Atomic absorption spectrometer and associated
equipment.
Burner head as recommended by the
manufacturer.
Labware and Reagents as per IS 3025 (Part 41)

c) Differential pulse anodic stripping


voltammetry
Polarographic instrumentation capable of performing
differential pulse work
Hanging Mercury Drop Electrode
PIatinum Counter Electrode
Saturated Calomel Reference Electrode (SCE)
Magnetic Stirrer Control Unit, Stirring bar
Labware and Reagents as per IS 3025 (Part 41)
5 Arsenic as per IS 3025 (Part 37)
a) Atomic absorption method

Atomic absorption spectrometer


equipped with gas flow meter for
Argon or Nitrogen and Hydrogen and
with arsenic electrodeless discharge
lamp
Atomizer
Reaction Cell for producing Arsenic Hydride
Eye Dropper or Syringe
Refrigerator
Labware and Reagents as per IS 3025 (Part 37)
b) Silver diethyl dithiocarbamate method

Arsine Generator and Absorption Tube


Photometric Equipment that consists of:
(a) Spectrophotometer, for use at 520 nm with 1 cm
cells,
(b) Filter photometer with a green filter with
a maximum transmittance in the range of
500-540 nm, and
(c) Cells for spectrophotometer or filter photometer
having a path length of 1 cm.
Labware and Reagents as per IS 3025 (Part 37)
6 Cyanide

As per IS 3025 (Part 27/Sec 1) Total Cyanide After Distillation (Preliminary step)

Boiling Flask — 1 litre, with inlet tube and


provision for water-cooled condensers.
Heating Mantle
Gas Absorber — With gas dispersion tube
equipped with medium-porosity fritted outlet.
Ground Glass ST Joints — TFE sleeved or
with an appropriate lubricant for the boiling flask and
condenser.
Neoprene stopper and plastic threaded joints
may also be used.

As per IS 3025 (Part 27/Sec 2) Usual laboratory apparatus and in particular the
following.
Flow injection analysis system for gas diffusion
method.
Autosampler, or other device allowing a reproducible
introduction of the sample
Reagent reservoirs.
Low pulsation pump, with specific chemically inert
pump tubes, for flow rates as shown in Figure A.1 as
an example.
UV-lamp, with:
— an emission maximum >310 nm to 400 nm;
— a power of 8 W to12 W;
— a digestion coil of FEP or PTFE, internal diameter
0,8 mm, length 5 000 mm, tube wall thickness at
maximum 1 mm (e.g. 351 nm UV lamp with PTFE coil).
Thermoreactor 1: digestion coil of FEP with 0,8 mm × 3
600 mm, tube wall thickness at maximum 1.5 mm with a
temperature of 85 °C for total cyanide and 40 °C for free
cyanide Gas diffusion cell, with hydrophobic
semipermeable membrane made from polypropylene or
PTFE, for example, typical thickness 90 μm to 200 μm,
pore size 0,1 μm to 1 μm.
Manifold with highly reproducible dosing of sample and
reagents, with appropriate transport systems and
connection assemblies of chemically inert polymer.
Photometric detector, with flow cell, wavelength 600 nm
± 10 nm.
Recording unit (e.g. strip chart recorder, integrator,
printer and plotter or a computer data system).
Thermoreactor 2, 65 °C, length 3 000 mm, internal
diameter 0,8 mm (see Figure A.1).
Lead acetate test paper, commercially available.
Membrane filter assembly, with membrane filters having
a pore size of 0,45 μm.
pH measuring device.
Labware and Reagents as per IS 3025 (Part 37/Sec 2)
As per IS 3025 (Part 27/Sec 3) Usual laboratory apparatus and in particular the
following:

Continuous flow analysis system for distillation method.


Autosampler, or other device capable of introducing
sample reproducibility.
Reagent reservoirs.
Low pulsation pump, having specific chemically inert
pump tubes,
UV lamp, with:
— UV-B lamp (312 nm to 400 nm);
— a power of 8 W to 12 W;
— a digestion coil of borosilicate glass, quartz glass or
polytetrafluorethylene (PTFE).
In-line distillation device, adjustable to a temperature of
125 °C ± 1 °C with a distillation coil of glass or polymer
material, length of coil e.g. 80 cm, internal diameter e.g.
1,5 mm.
Manifold, capable of highly reproducible dosing of gas
bubbles, sample and reagents, and having appropriate
transport systems and connection assemblies of
chemically inert glass, polymer or metal.
Heating bath, for colorimetric reaction, adjustable to a
temperature of 37 °C ± 1 °C with a coil volume to allow a
sample retention period of approximately 4 min.
Photometric detector, with a flow cell, and having a
wavelength range 600 nm ± 10 nm.
Recording unit (e.g. strip chart recorder, integrator,
printer and plotter or a computer data system)

OR

Continuous flow analysis system for gas diffusion


method.
Autosampler, or other device capable of introducing
sample reproducibly
Reagent reservoirs.
Low pulsation pump, having specific chemically inert
pump tubes.
UV lamp
Gas diffusion cell, having a hydrophobic semipermeable
membrane made from polypropylene or PTFE,
Heating bath for gas diffusion temperature stabilization,
adjustable to a temperature between 30 °C to 40 °C
(with a tolerance of ± 1 °C) with a coil capacity of
typically 2 ml
Manifold, capable of highly reproducible dosing of gas
bubbles, sample and reagents, and having appropriate
transport systems and connection assemblies made of
chemically inert glass, polymer or metal.
Heating bath for colorimetric reaction adjustable to a
temperature of 37 °C ± 1 °C with a spiral dimension to
allow a sample retention period of approximately 4 min.
Photometric detector, with flow cell, and having a
wavelength range of 600 nm ± 10 nm.
Use an appropriate optical pathlength to achieve a
minimum absorbance (absolute value) of 0,01 per 1 cm
pathlength for a 10 μg/l cyanide solution.
Recording unit (e.g. strip chart recorder, integrator,
printer and plotter or a computer data system).
Lead acetate test paper, commercially available.
Membrane filter assembly, with membrane filters having
a pore size of 0.45 μm.
pH measuring device.

7 Lead as per IS 3025 (Part 47) Differential Pulse Anodic Stripping Voltammetry (DPAV);

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 for nitrogen
purification
•Nitrogen gas (cylinder)
•0.45µm membrane filter

Dithizone method

Spectrophotometer for use at 510 nm


with 1-cm cell
pH meter
TEF beakers, 100 ml
Separating funnels, 250 ml, 500 ml
8 Chromium as per Annex K of IS
13428 Atomic Absorption Spectrophotometer of wavelength
328.1, Oxidizing air-acetylene flame, and optimum range
0.1 to 20 (as per table 8 of Annex K of IS 13428),
labware and reagents as per Annex K of IS 13428
9 Nickel as per Annex L of IS 13428 Atomic absorption spectrometer fitted with hollow
cathode lamps for appropriate metals or electrodeless
discharge lamps, and with a suitable device for allowing
for the correction of the nonspecific absorbance and with
a nebulizer-burner with an acetylene-air flame.
Labware and reagents as per Annex L of IS 13428
10 Polychlorinated biphenyl (PCB) as Glass Chromatographic Column —
per Annex M of IS 13428 300 mm long, 8 mm 1D with a ground-glass socket at
the upper end and a stopcock at the lower end.
Gas Chromatograph Equipped with electron capture
detector and coupled with printer-plotter-cum-integrator
as per M-2.2
Electron Capture Detector
Kuderna-Danish Type, Evaporator —
with interchangeable 10 ml graduated collection tubes
Snyder Columns — two-bubble micro-columns, with
ground glass cones to fit the Kuderna-Danish type, 10
ml collection tubes.
Syringe — 5μl capacity
Labware and reagents as per Annex M of IS 13428
11 Polynuclear aromatic hydrocarbons High Performance Liquid
as per APHA 6440 Chromatograph (HPLC) complete with gradient pumping
system, reverse phase column and detectors (UV and
fluorescence)
Gas Chromatograph (GC) complete
with column and flame ionization detector.
Separating funnel (2 l)
Evaporative flask
Three Ball Synder column
Kuderna- Danish Apparatus
Water bath (60-65˚C)
Labware and Reagents as per APHA 6440
12 Uranium as per IS 14194 (Part LED Uranium Fluorimeter
3/Sec 1) Micro-Pipettes — (5 ml, 0.5 ml, 100 μl, 50 μl) with
disposable tips.
Analytical Weighting Balance
pH Meter
TDS Meter
Suprasil Quartz Cuvette with Teflon Cap
Lint Free Wipers
Uranium Standard Solution (100 ppm or
Higher)
Sodium Pyrophosphate — purity more than 99 percent.
Phosphoric Acid — purity more than 90 percent
Labware and Reagents as per IS 14194 (Part 3/Sec 1)
Note 1: Approved and validated international test methods from ISO/APHA/ASTM/AOAC/EPA/EN
may also be followed and test equipment/chemicals as per those standard referred in such cases

Note 2: The list does not cover the requirements of Pesticide Residues and Radio Active Residues
since these tests are normally subcontracted.

TABLE 4 – MICROBIOLOGICAL PARAMETERS

Sl. Tests Used In WithClause Test Equipment/Chemical


No. Reference
1 General microbiological lab Hot air oven (capable of 160 to 180 ºC).
equipment 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 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 Class II Biosafety
Cabinets shall be used for product testing and
reference culture in microbiology laboratories.
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 glass wares 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, at least four times
smaller than the range of required maximum
permissible tolerance shall be used)
Filter paper
Cotton
Ready-to-use microbiological culture plates may also
be used against the medias, as mentioned in the table
below
2 Escherichia coli — (or • General microbiological lab equipments (as
thermotolerant bacteria) listed above)
• Incubator capable of maintaining (36+2)0C
Or • Equipment, for membrane filtration

Coliform • Membrane filters


• Disinfected forceps, for handling of
as per IS 15185 membrane filters.
• @Incubator capable of maintaining 44°C
Microscope and Glass slides (for Gramstaining)

• Distilled water

• Chromogenic Coliform Agar (Enzymatic digest


of casein 1.0g, Yeast Extract
2.0g, Sodium chloride 5.0g,
• Sodium dihydrogen phosphate x 2H2O 2.2g,
• Disodium Hydrogen Phosphate 2.7g,
• Sodium pyruvate 1.0g,
• Sorbitol 1.0g,
• Tryptophane 1.0g, 6-chloro 3 indoxyl Beta D
Galactopyranoside 0.2g, 5- Bromo 4-Chloro
3Indoxyl Beta D Glucuronic Acid 0.1g,
• Iso propyl Beta D
thiogalactopyranoside (IPTG) 0.1g,
• Bacteriological Agar 9-18g
• Water 1000ml
• pH 6.8±0.2 at 25°C.
• Oxidase reagent:
• Labware and reagents as per IS 15185
3 Coliform as per IS 5401 (Part 1) General microbiological lab equipments
(as listed above)
Incubator capable of operating at 37 ºC ±
1 ºC
• Petri dishes, made of glass or plastic, of
diameter 90 mm to 100 mm
• Total-delivery pipettes, having nominal
capacities of 1ml
• Water bath, or similar apparatus, capable
of operating at 44 to 47°C
• Colony-counting equipment, consisting of
an illuminated base and a mechanical or electronic
digital counter
• Test tubes of dimensions approximately
16 mm x 160 mm
• Durham tubes of dimensions appropriate
for use with the test tubes
• Bottles or flasks, for boiling and storage
of culture media
Labware and reagents as per IS 5401 (Part 1)

4 Sulphite reducing anaerobes as General microbiological lab equipments


per Annex C of IS 13428 (as listed above)
Sample quantity : 50 ml
• Screw cap bottles or vials and stoppers of
boron silicate glass of capacities 100 ml
• Water bath capable at 75 ± 5 °C.
Iron wire
• Incubator (37 ºC ± 1 ºC)
• Appropriate method to hermetically seal
the vial or anaerobic systems
• Anaerobic jar assembly (recommended)
• Culture media and reagents as per Annex C of IS
13428
clostridial medium (DRCM) –
Double strength and Single
Strength (if necessary)
(Peptone tryptic digest of meat
, Meat extract, Yeast extract,
Starch, Hydrated sodium
acetate, Glucose, L- cysteine-
hydrochloride, Sodium
hydroxide)
Sodium sulphite
Iron (III) citrate
Iron (III) citrate
5 Pseudomonas Aeruginosa As General microbiological lab equipments
per Annex D of IS 13428 (as listed above)
Screw capped bottles
• Incubator (37 ± 1° C)
• @Incubator, capable of being maintained
at 42 ± 0.5° C
@Incubator 4° C
• UV cabinet fitted with UV lamp emitting
light of wavelength 360 ± 20 nm
• Cellulose acetate or nitrate membrane of
pore size 0.22 µm (for alternate
sterilization of ethanol)
@ Incubator, capable of being maintained
at 42 ± 0.5° C
6 Aerobic Microbial Count as per IS • General microbiological lab equipments (as
5402 (Part 1) listed above)
• Incubators 21 ºC ± 1 ºC and 37 ºC+10C
• Colony counting equipment
• Distilled water
• Plate count agar (PCA) – (Enzymatic digestion
of casein, Yeast extract, Glucose anhydrous,
Agar)
• Overlay medium (if necessary) – Agar
7 Yeast and Mould as per IS 16069 • General microbiological lab equipments (as
(Part 1) listed above)
• Incubator (25 ± 1 ºC)
• Distilled water
• Yeast extract-dextrose- chloramphenicol-agar
medium – (Yeast extract, Dextrose,
Chloramphenicol or Oxytetracycline
hydrochloride, Agar)

Note 1: Test equipment/chemicals for Faecal Streptococci and Staphylococcus aureus, Salmonella
and Shigella Vibrio cholera and V. parahaemolyticus are not indicated here since these tests are
normally subcontracted.

Note 2: Test equipment/chemicals for testing of containers are not indicated here since these tests
are normally subcontracted or done by the supplier of containers
ANNEX C

SCHEME OF INSPECTION AND


TESTING

1.0 LABORATORY -A laboratory shall be maintained which shall be suitably equipped and
staffed with competent testing person(s) to carry out the different tests in accordance with the
methods given in the Indian standards. Testing person(s) shall be science/engineering graduate
from disciplines such as chemistry/chemical engineering/ microbiology/ biotechnology/
biochemistry/ food technology/ botany and other biological/ life sciences. Engineering graduates
from disciplines such as chemical engineering may also be engaged as testing persons.
1.1. The manufacturer shall prepare and implement a calibration plan for the test equipment.

2. TEST RECORDS –The manufacturer shall maintain test records for the tests carried out to
establish conformity.

3.0 LABELLING AND MARKING - The Standard Mark, as given in the 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 specified design.

3.1 PACKING – The Packaged Drinking Water shall be packed as per clause 6 of IS 14543:2024.
The pouches and bottles/containers may be supplied in secondary packaging as agreed to
between the purchaser and the supplier.

3.2 MARKING – In addition to the Standard Mark as per clause 7. 3 of IS 14543:2024 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 in capital letters (that is, packaged drinking water);
b) Name and address of the processor;
c) Brand name, if any;
d) Batch or code number;
e) Date of manufacture or packaging and
f) ‘Expiry/use by;
g) Treatment of disinfection, if any;
h) Best before date (optional);
i) Net quantity;
j) Direction for storage;
k) Keep away from direct sunlight; and
l) Any other information required under the Legal Metrology (Packaged Commodities)
Rules, 2011 and the Food Safety and Standards (Labelling and Display) Regulations, 2020.

3.2.1 Minimum height of the BIS Standard Mark on different pack sizes of Packaged Drinking
Water shall be as under:

S. No. Size of Container Min height of BIS Standard Mark*


1 Pouch/Cups/bottle (250 ml 5mm
capacity & below)
2 Bottles upto500ml capacity & below 7.5mm
(but greater than 250 ml capacity)
3 Bottles more than 500ml capacity 10mm
4 All re-useable Jars 15mm
(* other dimensions of the BIS Standard Mark shall be in appropriate proportions as
per BIS guidelines).
3.3 Each secondary packing of pouches/bottles/containers shall be marked with the following, except
where such secondary packing is transparent and the markings on the
pouches/bottles/containers are legible through the secondary packing:
i. Indication of the source of manufacture i.e. manufacturer’s name and address;
ii. Number of pouches/bottles/containers
iii. Brand name, if any
iv. Nominal capacity;
v. Batch No. or Code No.

Note: In case a manufacturer with same brand name is holding BIS licences at multiple premises
(units) under same ownership and opts for marking multiple licence numbers on the unified label,
the same may be considered, provided the identification and traceability of the product, is established
as envisaged.

3.4 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
IS14543:2024.

3.5 Shelf life: Declared shelf life for Packaged Drinking Water in all type of packing materials
shall not be less than 30 days. (also see Table 1)

3.6 Brand names: The labels conforming to the marking details as mentioned in clause 7 of
IS 14543 along with the brand names are to be submitted to by licensees to BIS for information
only, which will only be noted by BIS for records. The compliance of such labels to the
requirement of clause 7 shall be ensured by licensees. However, in case non-compliance to
Clause 7 is observed by BIS and communicated in writing to licensee, licensee shall make
necessary rectification and resubmit the label for confirmation to concerned BIS Branch Office
within 15 days. Decision of BIS regarding whether labeling is complying or not with clause 7 of IS
14543 shall be final.

4.0 LEVELS OF CONTROL –For packaged drinking water, 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.

NOTE: The provisions of BIS Central Marks Department-1’s circular no. CMD-I/2:4:1 dated 19
January 2024 as regards levels of control and subcontracting of testing shall not apply in case of
Packaged Drinking Water. https://www.services.bis.gov.in/tmp/Circular_UZnP_2024-01-19.pdf

5.0 CONTROL UNIT - For the purpose of this Scheme, the quantity of packaged drinking water
treated/processed from each processing line and filled/packed in one day shall constitute a
Control Unit.

5.1 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.

5.2 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.

5.3 Records of the batch wise consumption of the added minerals, if applicable, are to be
maintained along with the invoices and test certificates for the same.

6.0 Microbiological Requirements - If any failure is noticed in any of the microbiological


requirements, control units available in the stock shall be rechecked and released into the market
only after conformity is ensured.
6.1 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 dispatch 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 2 consecutive control units.
7.0 SOURCE WATER - The source water used in production of Packaged Drinking Water shall
be initially tested for Organoleptic and physical parameters (Table 1), Chemical requirements
(Table 2), and all microbiological requirements possible to be tested in house. 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.

7.1 Whenever, the quality of processed water is found to be not meeting the requirements of IS
14543 for the tested parameters, 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.

7.2 In case non-conformity is observed for radioactive residues, the source of raw water shall be
abandoned and water shall be recalled immediately.

7.3 As and when there is change in source water or addition of new source of raw water, it shall
be intimated to BIS. The raw water collected from the new source shall be tested in accordance
with Clause 7 as above and the processed water produced from such source water shall be
tested for conformity to IS 14543 from BIS recognized outside lab. 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.

7.4 The source water shall be treated as per clause 5.1 of IS 14543:2024. In case the licensee
carries out remineralization as part of its treatment process, the ingredients used shall conform
to food grade/pharma grade quality. The test certificate of these ingredients shall be submitted
to BIS.

7.5 The means adopted for disinfection of the product water shall be declared and shall be done
in accordance with clause 5.1.1 of IS 14543:2024.

8.0 Plastic Jars/Bottles/Containers - The plastic containers used for packing the material shall
conform to IS 15410. The conformity assessment shall be carried in accordance with the levels
of controls as given under Table 2.

8.1 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.

8.2 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.

8.3 Glass Bottles - IS 11984 has been specified as a reference Indian Standard for glass bottles.
However, if any manufacturer intends to use glass bottles for packaging, it shall be included in
the licence. The separate processing line for filling the glass bottles may be verified by BIS
during the next inspection and necessary steps in the process for ensuring sterility of bottles
may be adopted like steam sterilizing, hot water rinsing, UV sterilization or combination thereof.
In case of lug caps containing plastic lining, food grade certificate or OSL test report for
migration testing may be accepted.
8.4 Paper based multilayer laminated/extruded composite cartons and aluminum cans -
Paper based multilayer laminated/extruded composite cartons shall conform to IS 17753. The
conformity assessment may be carried in accordance with the levels of controls as given under
Table 4. (Cases where the applicant intends to use Paper based multilayer laminated/extruded
composite cartons for packaging as per IS 17753, the case shall be sent by BO to CMD-2 with
complete information and recommendation. CMD-2 shall review all such cases and decide on
approval and communicate to BO till further guidelines in this matter are issued).

8.5 Aluminum cans shall conform to IS 18285. The conformity assessment may be carried in
accordance with the levels of controls as given under Table 5.

9 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. Water to be used for the purpose of cleaning etc. IS 4251:1967
may be followed as Good Manufacturing practices.

10.0 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
14543:2024. 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
H of this product manual.

11.0 REJECTION - Disposal of non-conforming product shall be done in such a way so as to


ensure that there is no violation of provisions of BIS Act, 2016. 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.
TABLE 1

LEVELS OF CONTROL

TEST DETAILS Test LEVELS OF


equipment CONTROL REMARKS
Clause Requirement Test Method requirement No. of Frequency
Clause Reference R: required (or)S: Sample
Sub-
contracting
permitted
5.2 Microbiological Requirement
5.2.1 Escherichia coli -- IS 15185 R One Each
control unit
IS 5401 R
5.2.2 Coliform Bacteria -- (Part-1) One Each
or IS 15185 control unit
5.2.3 Faecal Streptococci -- IS 5887 S One Once in
and Staphylococcus (Part-2) month
aureus or IS 15186
5.2.4 Sulphite Reducing -- Annex C of R One Each
Anaerobes IS control unit
13428
5.2.5 Pseudomonas -- Annex D of R One Each
aeruginosa IS control unit
13428 or
ISO 16266-
2
5.2.6 Aerobic Microbial -- IS 5402 R One Each
Count Part 1 control unit
5.2.7 Yeast &Mould -- IS 16069 R One Each
(Part 1) control unit
5.2.8 Salmonella and -- IS 15187 & S One Once in
Shigella IS month
5887 (Part-
7),
respectively
5.2.9 Vibrio cholera and V. -- IS 5887 S One Once in
parahaemolyticus (Part-5/Sec month
1)
TABLE 1 (continued)
TEST DETAILS Test LEVELS OF CONTROL
Clause Requirement Test Method equipment No. of Frequency REMARKS
Clause Reference requirement Sample
R: required
(or)S: Sub-
contracting
permitted
5.3 Description 5.3 IS 14543 R One Each Control
Unit
5.3 and i) Colour - IS 3025 (Part R One Each Control
Table 1 4) Unit
-do- ii) Odour - IS 3025 (Part R One Each Control
5) Unit
-do- iii) Taste - IS 3025 (Part R One Each Control
8) Unit
-do- iv) Turbidity - IS 3025 (Part R One Each Control
10) Unit
-do- v) Total - IS 3025 (Part R One Each Control
Dissolved Solids 16) Unit
-do- vi) pH - IS 3025 (Part R Manufacturer shall put in place
11) adequate inspections and in
process controls to ensure
conformity of this requirement
as per the standard
5.3 and i) Barium (as - Annex G of IS S One Once in a
Table 2 Ba) 13428 or IS month
15302 or
IS 3025 (Part
2) or IS 3025
(Part 65)
-do- ii) Copper - IS 3025 (Part S One Once in a
(as Cu) 42) or month
IS 3025 (Part
2) or IS 3025
(Part 65)
-do- iii) Iron (as - IS 3025(Part S One Once in a
Fe) 53) or month
IS 15303 or
IS 3025 (Part
2) or IS 3025
(Part 65)
-do- iv) - IS 3025 (Part S One Once in a
Manganes 59) or IS month
e (as Mn) 3025 (Part 2)
or IS 3025
(Part 65)
-do- v) Nitrate (as - IS 3025 (Part R One Once in a week
NO3) 34/Sec 1) or IS
3025 (Part 75)
-do- vi) Nitrite (as - IS 3025 (Part R One Once in a week
NO2) 34/Sec 1) or IS
3025 (Part 75)
-do- vii) Fluoride - IS 3025 (Part S One Once in six
(as F) 60/Sec 1) or IS months
3025 (Part
60/Sec 2) or IS
3025 (Part 75)
-do- viii) Zinc (as - IS 3025 (Part S One Once in a
Zn) 49) or IS month
3025 (Part 2)
-do- ix) Silver (as - Annex K of IS S One -Once in six
Ag) 13428 or IS months
3025 (Part 2)
or IS 3025 -Once in a
(Part 65) or IS month for
3025 (Part 79) licensees
using silver in
any form.

-do- x) Aluminium - IS R One Once in a week


(as Al) 3025 (Part 2)
or IS 3025
(Part 55) or
IS 15302 or IS
3025 (Part 65)
-do- xi) Chloride - IS 3025 (Part R One Each control
(as Cl) 32) or IS 3025 unit
(Part 75)
-do- xii) Selenium - IS S One Once in six
(as Se) 3025 (Part 2) months
or IS 3025
(Part 56) or IS
15303 or IS
3025 (Part 65)
-do- xiii) Sulphate - IS 3025 (Part R One Each control
(as SO4) 24/Sec 1) or unit
IS 3025 (Part
24/Sec 2) or IS
3025 (Part 75)
-do- xiv) Alkalinity - IS 3025 (Part R One Each control
(as HCO3) 23) unit
5.3 and xv) Calcium - IS 3025 (Part R One Once in a week
Table 2 (as Ca) 40) or IS
3025 (Part 2)
or IS 3025
(Part 65)
-do- xvi) Magnesiu - IS 3025 (Part R One Once in a week
m (as Mg) 46) or
IS 3025 (Part
2) or IS 3025
(Part 65)
-do- xvii) Sodium (as - IS 3025 (Part S One Once in six
Na) 45) or IS months
3025(Part 2)
or IS 3025
(Part 65)
-do- xviii) Residual - IS 3025 (Part R One Each control
Free Chlorine 26) unit
-do- xix) Phenolic 6 IS 3025 (Part S One Once in a
compound 43/Sec 1) month
s
(asC6H5OH)
-do- xx) Mineral Oil 6 IS 3025 (Part S One Once in a
39) month
-do- xxi) Anionic - IS 3025 (Part S One Once in a
surface- 68) or IS 3025 month
active agents (Part 78)
(as MBAS)
-do- xxii) Sulphide (as - IS 3025 (Part R One Once in a week
H2S) 29)
-do- xxiii) Antimony (as - Annex H of IS S One Once in a
Sb) 13428 or IS month
3025 (Part 2)
or
3025 (Part 65)
-do- xxiv) Borates (as - Annex J of IS S One Once in a
B) 13428 or month
IS 3025 (Part
2) or IS 3025
(Part 65)
-do- xxv) Bromates (as - IS 3025 (Part S One Once in six
BrO3) 67) months
PARAMETERS CONCERNING TOXIC SUBSTANCES

5.3 & i) Mercury - IS 3025 (Part S one Once in six


Table 3 (as Hg) 48) or IS 3025 months
(Part 65)
-do- ii) Cadmium - IS 3025 (Part S one Once in six
(as Cd) 2) or IS 3025 months
(Part 41) or IS
3025 (Part 65)
-do- iii) Arsenic (as - IS 3025 (Part S one Once in six
As) 2) or IS 3025 months
(Part 37) or IS
3025 (Part 65)
-do- iv) Cyanide 2 IS 3025 (Part S one Once in six
(as CN) 27/Sec 1) or months
IS 3025 (Part
27/Sec 2) or
IS 3025 (Part
27/Sec 3)
-do- v) Lead (as - IS 3025 (Part S one Once in six
Pb) 2) or IS 3025 months
(Part 47) or IS
3025 (Part 65)
-do- vi) Chromium - Annex K of IS S one Once in six
(as Cr) 13428 or IS one months
3025 (Part 2) Once in six
or IS 3025 months
(Part 65)
-do- vii) Nickel (as - Annex L of IS S one Once in six
Ni) 13428 or IS months
3025 (Part 2)
or IS 3025
(Part 65)
-do- viii) Polychlorin - Annex M of IS S one Once in six
ated 13428 months
biphenyl (PCB) one
-do- ix) Polynuclea - APHA 6440 S one Once in six
r aromatic months
hydrocarbo
ns -=--
-do- x) Uranium IS 3025(Part S one Once in six
65) or months
IS 14194
(Part 3)
PARAMETERS CONCERNING RADIOACTIVE RESIDUES

TEST DETAILS Test LEVELS OF REMARKS


CONTROL
Clause Requirement Test Method equipment No. of Frequency
requirement Sample
R: required
Clause Reference
(or)S: Sub-
contracting
permitted
5.3 & i) Alpha emitters - IS 14194 (Part S one Once in
Table 4 2) five
years
-do- ii) Beta emitters - IS 14194 (Part S one -do-
1)
PESTICIDE RESIDUES
5.4 Pesticide Residues 5.4 Annex D of IS
14543
i) Pesticide residues considered 5.4.1 IS 14543** S One Once in a
individually year
ii) Total pesticide residue -do- -do- -do- -do-
- Shelf Life Assessment B 8.9 Annex B of IS R Once in six months
14543 each type
of container shall
be tested for
shelf life
assessment
FORM 1
REPORT FOR FOUR HOURLY PH TESTING

Batch
Date of
Number pH Remarks
Production / unit
number
1 2 3 4

FORM 2
REPORT FOR DAILY/ EACH CONTROL UNIT TESTING

Date Batc Colo Od Tas Turbid T Chlori Sulph


E. Colifo
Alkalin Resid Co rm Sulphite Pseu Aerobi Ye Rema
of h/ ur our ual do ast
te ity D de ate ity li reducing c rks
Produc contr Free anaero mon microb &
tion ol S chlori as Mo
unit ne bes ial uld
count
no. aerugi
n
osa
20- 37
22 de
de g
gC C
1 2 3 4 5 6 7 8 9 10 11 1 13 14 15 16 17 18
2

FORM 3
REPORT FOR WEEKLY & MONTHLY TESTING

Dat Bat Bari Cop Ir Manga Nitr Nitr Alumi Calci Sulp Magne Anti Bor Pheno Min Zi Anio Rem
e of ch/ um per on nese
ate ite nium
um
hide
sium mony ate lic eral n nic arks
Prod co Comp Oil c Surf
uct ntr
ion ol ounds ace-
unit Activ
no. e
Agen
ts
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1 18 19
7
4
FORM 4

FORMAT FOR TESTING FROM BIS RECOGNIZED OUTSIDE LABORATORY

Month & Batch Type of Dates on Lab to which Test report Results Remarks
Year No./DOM packing which
sample sent sample sent number &
date

1. REPORT FOR MONTHLYTEST

i. Faecal streptococci and S. aureus, Salmonella and Shigella, Vibrio cholera and Vibrio
parahaemolyticus

ii. Mineral Oil, Zinc, Anionic Surface-Active Agents, Phenolic Compounds, Antimony, Borates,

iii. Barium, Copper, Iron, Manganese (If done from BIS recognized outside laboratory)

2. REPORT FOR SIX MONTHLYTEST

i. Mercury, Cadmium, Arsenic, Cyanide, Lead, Chromium, Nickel, Fluoride, Selenium, Sodium, PCB,
PAH, Bromates, Uranium

ii. Silver (as applicable)

iii. Pesticide Residues

3. REPORT FOR FIVE YEARLY TEST

i. Radio Active Residues (Alpha and Beta Emitters)


FORM 5

SOURCE WATER TESTING (3 MONTHLY TESTS)

Month Source of In-house Outside testing (if done) Record of in- Results Remarks
testing house
& Year water testing/outside
TR
Name of sample TR No.
lab sent on & Date

FORM 6

RECORD FOR PLASTIC CONTAINERS USED FOR PACKING WATER

Date Type of Name Quantity Whether Details of Results Remarks


of of outside
receipt packing supplier received ISI testing
material marked
Name Date of Overall Colour Remaining
of
lab sending 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 Batch Type of Declared Periodicity Date of Requirements Results Remarks


which shelf of
sample No./DOM packing life testing Testing Tested
kept whose
sample
kept
FORM 8

FORMAT FOR PE FILM

Date Name Quanti Detai Descrip Film Windi Odo Thickn Widt Overa Tensil Elongati Dart Res Rema
of of ty ls of tio ng ur es h ll e on ult rk
Recei Suppli Recei Test n For of s Migrat Streng n at Impact s
pt er ve repor m Film io th Break
t
of d from n Resistan
OS ce
Rolls (No. of Lab.
With
Rolls) date

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

FORM 9

FORMAT FOR POUCH TESTING

Date of Time of Total Drop Test Stack Ink Product Water Results Remarks
quantity Load Adhesion of Resistance of
Pouch production produced Test Printed Printed Potability
Pouches Pouches
Production Test

Machine No.

1 2 3 4 Etc.

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


container licensee
a) Plastic i) Overall i) ‘ISI’ marked, OR Once in six months, sample from one
migration and consignment
Jars colour
migration ii) In-house Test Reports of of plastic jars of each size/material
as per licensee, if procured from a
Clause 6
of
IS 14543 facilities exist; OR single source (i.e. supplier) shall be
& tested as per
iii) BIS recognized outside laboratory the modes of conformity given in
Test column 3 (Not
ii) Conformity Report of the samples (not older required if material is ISI marked)
to IS15410 than
6months from the date of
purchase);
OR
iv) Combination of the above.

b) Plastic i) Overall i) ‘ISI’ marked OR Once in six months, sample from one
Bottles, migration and consignment
Glass/ colour
cups migration of plastic bottles/glasses/cups of
as per each
Clause 6
of
IS 14543& type/shape/capacity/material procured
from a single
ii) Conformity source (i.e. supplier) shall be tested
to IS15410 as per the
modes of conformity given in column
3 (Not
ii) In-house Reports of required if material is ISI marked)
Test licensee, if
facilities exist OR
iii) BIS recognized outside laboratory
Test
Report of the samples (not older
than
6months from the date of
purchase)

c) Plastic Overall migration i) Declaration/ Once in six months, sample from one
cap and colour certificate consignment
(closures) migration as per w.r.t of plastic caps/closures of each
of Clause 6 of IS foodgrade quality, as permitted size/material
containers 14543 under procured from a single source (i.e.
IS 14543, AND supplier) shall
ii) In house tes be tested as per the modes of
t report of conformity given in
licensee, if column 3 (Not required if material is
iii) facilities exist OR ISI marked)
BIS recognized outside
laboratory test
report of samples (not older
than
6months from the date of
purchase)

Note : Licensee to keep records of receipt for all types of containers and closures received, along with the
corresponding test certificate in case of ISI marked consignment or test reports of samples tested in-house
or got tested as per the specified frequency at BIS recognized laboratory, 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.
TABLE 3
Levels of control for Polyethylene Flexible Pouches for
the packing of Packaged Drinking Water as per IS 15609
TEST DETAILS Test LEVELS OF CONTROL
equipment
Clause requirement
Requirement Test Method R: No. of Lot size Remarks (Modes
required of Conformity
(or)S: etc.)
Clause Reference Sub-contracting Samples
permitted
5 Material 5 IS 15609 S One Each i) ISI Marked, OR
consignment
of
Polyethylene ii) BIS recognized
film outside laboratory
Test
Report of the
samples, OR
iii) Test certificate
issued by PE resin
supplier.
6.1 Requirement for Polyethylene Film
6.1.1 Description 6.1.1 IS 15609 R One Each roll of All rolls to be
checked before
using the
polyethylene same for making
film pouches. All such
rolls
which do not
conform to the
requirement
shall be rejected
6.1.2 Film Form 6.1.2 -do- R -do- -do- -do-
6.1.3 Winding of 6.1.3 -do- R -do- -do- -do-
film
6.1.4 Odour 6.1.4 -do- R -do- -do- -do-
6.1.5 Thickness 6.1.5 -do- R -do- -do- -do-
6.1.6 Width 6.1.6 -do- R -do- -do- -do-
S One i) ISI Marked, OR
consignment ii) In house test
from each report, if facility
source (i.e. exist
supplier) with the licensee
initially and OR
6.1.7 Overall 6.1.7 -do- -do- subsequently iii) Outside
Migration once every approved
six months laboratory test
for each report of the
source (i.e. sample
supplier) If the sample does
not conform to the
requirement, the
consignment shall
be rejected.
Table 3 contd…

TEST DETAILS Test LEVELS OF CONTROL


Requirement Test Method equipment No. of Lot size Remarks
Clause Clause Reference requirement Samples
R:
required
(or)S:
Sub-
contracting
permitted
6.1.8 Tensile 6.1.8 -do- S -do- -do- -do-
strength
6.1.9 Elongation of 6.1.9 -do- S -do- -do- -do-
break
6.1.10 Dart impact 6.1.10 -do- S -do- -do- -do-
resistance
7 Requirement for Flexible Pouches
7.2 Water Annex -do- S -do- Once in Sample of
Potability E two each size
Test months shall be
tested by
rotation
so that all the
sizes
shall be
tested in one
operative
period.
7.3 Stack load Annex -do- R -do- One day If the sample
Test F production does not
conform to
the
requirement
the same day
production
shall be
rejected.
7.4 Drop test Annex -do- R -do- Every If the sample
G hour for does not
each conform to
machine the
requirement,
the licensee
shall follow
the criteria
for
acceptance
and
retesting as
per clause
G-3 of IS
15609:2005.
If it still does
not conform
then the
same
day
production
shall be
rejected.

7.5 Ink Adhesion Annex IS 15609 R -do- One day If the sample
of H production does not
Printed conform to
Pouches the
requirement
the same
day
production
shall be
rejected. All
rolls to be
checked
before using
the same for
making
pouches. All
such rolls
which do
not conform
to the
requirement
shall be
rejected.
Product R
7.6 resistance of Annex -do- One -do- -do-
printed J
Pouches
Handling of R Manufacturer shall ensure
polyethylene Annex IS 14543 that guidelines for handling
flexible film E of polyethylene flexible film
meant for meant for packing of
packing packaged drinking water in
of packaged pouches as per Annex E of
drinking IS 14543:2024 are followed
water in
pouches
TABLE 4
Levels of control for Paperbased Multilayer Laminated/Extruded Composite Cartons (Aseptic
and Non-Aseptic) For Processed Liquid Food Products and Beverages as per IS 17753

TEST DETAILS Test LEVELS OF CONTROL


equipment
requirement
Requirement Test Method R: No. of Lot size Remarks
require (Modes of
d (or)S: Conformity
Claus Reference Sub- etc.)
contracting Sample
e permitted s
Material, 4.1 IS 17753 S One Each i) Test
Cl. 4.1 consignme Reports
nt of paper from BIS
based
multilayer recognize
composite d outside
sheet laborator
y, OR
ii) Test
certificate
issued by
supplier
Paper --- IS 16983/IS 1776/ S One Each i) BIS
Board, Cl. IS 12999 consignme recognized
4.1.1 nt outside
laboratory Test
Report of the
samples, OR
ii) Test
certificate
issued by
supplier
Polyethylen --- IS 2508/IS S One Each i) Test
e, Cl. 4.1.2 14500 consignme Reports
/ IS nt from BIS
10146 recognize
/ IS d outside
16738 laborator
y, OR
ii) Test
certificate
issued by
supplier
Aluminium 4.3 of IS 8970 and Table S One Each i) BIS
Foil, Cl. 4.1.3 IS 1 of IS 17753 consignme recognized
IS nt outside
8970 laboratory Test
Report of the
samples, OR
ii) Test
certificate
issued by
supplier
Caps, --- IS 10910 S One
Each i) ISI Marked,
Cl. consignme OR
4.1.4 nt ii) BIS
recognized
outside
laboratory
Test Report of
the samples,
OR
iii) Test
certificate
issued by
supplier
Printing IS 15495 S One Each i) BIS
Inks, Cl. consignme recognized
4.1.6 nt outside
laboratory Test
Report of the
samples, OR
ii) Test
certificate
issued by
supplier
Requirement for Paper Based Multilayer Laminated/Extruded Composite Sheets
Description, 5.1 IS 17753 R One Every hour
Cl. 5.1

Overall ---- IS 9845 R -do- Once in a -do-


Migration, Cl. fortnight
5.2.1
Specific ---- IS 9845 and IS R -do- Every -do-
Migration Test, 3025(Part-2)/ IS month
Cl. 5.2.2 5158(A-4)/ IS
9873(Part-6)

Vibration Annex- IS 17753 R -do- Every 24 -do-


Leakage B hours
Test,
Cl. 5.2.3
Storage --- IS 8639 R -do- Every -do-
Test, Cl. month
5.2.4
Water Annex- IS 17753/ISO R -do- Once in a -do-
Vapour C of IS 2528(for WVTR) fortnight
Transmission 17753 And
Rate ISO 15105-2(for
(WVTR) and OTR)
Oxygen
Transmission
Rate (OTR), Cl.
5.2.5

Print Resistance Annex- IS 17753 R -do- Every 24 -do-


Test, Cl. 5.2.6 D hours
Ink Adhesion Annex- IS 17753 R -do- Every 24 -do-
Test Cl. E hours
5.2.7

TABLE 5
Levels of control for Aluminium Cans for Packaged Natural Mineral Water and Packaged
Drinking Water as per IS 18285

TEST DETAILS Test LEVELS OF


equipment CONTROL
Requirement Test Method requirement Lot size Remarks (Modes of Conformity
R: required No. of etc.)
(or)S:
Clause Reference Sub- Samples
contracting
permitted
Material, Cl. 5.1 IS 504 S One Each
5.1 (Part 1 to consignment
12) and of
IS 504 paper based i) Test Reports from BIS
(Part 13 to multilayer recognized outside laboratory, OR
16) composite
sheet
ii) Test certificate issued by
supplier.
Temper, Cl. --- IS S One Each Test Reports from BIS recognized
5.2 16983/IS consignment outside laboratory, OR
1776/ IS Test certificate issued by supplier
12999
Mechanical --- IS 18285 S One Each Test Reports from BIS recognized
properties of consignment outside laboratory, OR
the alloys for Test certificate issued by supplier
the body and
closure,
Cl. 5.3
Can body, 6.1.1 IS 18285 By visual
Cl. 6.1.1
Can Ends Cl. 6.1.2 IS 18285 S One Each Test Reports from BIS recognized
6.1.2 consignment outside laboratory, OR
Test certificate issued by supplier
Internal 6.2 IS 18285 By visual
finish
Cl. 6.2
External 6.3 IS 18285 S One Each Test Reports from BIS recognized
Coating Cl. consignment outside laboratory, OR
6.3 Test certificate issued by supplier

Shape and Table IS 18285 S One Each Test Reports from BIS recognized
Dimension 3 consignment outside laboratory, OR
Wall Test certificate issued by supplier
thickness
Cl. 6.4.1
Shape and Table IS 18285 S One Each Test Reports from BIS recognized
nominal 4 consignment outside laboratory, OR
dimension of Test certificate issued by supplier
closure
components
Cl. 6.4.2
Top Load 7.1.1 IS 18285 S One Each i) Test Reports from BIS
/ Axial consignment recognized outside
Load / laboratory, OR
Column ii) Test certificate issued by supplier
Strength
Cl. 7.1.1
Enamel 7.1.2 IS 18285 S One Each i) Test Reports from BIS
Rater consignment recognized outside
Criteria Cl. laboratory, OR
7.1.2 ii) Test certificate issued by supplier
Air --- IS 2471 S One Each i) Test Reports from BIS
Pressure consignment recognized outside
Test Cl. laboratory, OR
7.1.3 ii) Test certificate issued by supplier
Slip Angle Annex- IS 18285 S One Each i) Test Reports from BIS
Test / Wall B consignment recognized outside
Mobility Test laboratory, OR
Cl. 7.1.4 ii) Test certificate issued by supplier
Testing 7.2 IS 18285 S One Each i) Test Reports from BIS
of Ends consignment recognized outside
Cl. 7.2 laboratory, OR
ii) Test certificate issued by supplier
Overall --- IS 9845 S One Each i) Test Reports from BIS
Migration consignment recognized outside
Limit laboratory, OR
Cl. 7.3.1 ii) Test certificate issued by supplier
Specific --- IS 9845 S One Each i) Test Reports from BIS
Migration consignment recognized outside
Limit laboratory, OR
Cl. 7.3.2 ii) Test certificate issued by supplier
Water --- IS S One Each i) Test Reports from BIS
Potability 2500(Part- consignment recognized outside
Test Cl. 7.4 1) laboratory, OR
ii) Test certificate issued by supplier
Annex F

Guidelines for Special Situations

F-1 Change of source of raw water or change in process

As and when there is change in source water or addition of new source of raw water, it shall be
intimated to BIS. The raw water collected from the new source shall be tested in accordance with
Clause 7 of SIT and the processed water produced from such source water shall be tested for
conformity to IS 14543 from BIS recognized outside lab. 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.

In case the manufacturer conducts remineralization as part of treatment process, any


change in the ingredients shall be declared by the manufacturer. Further, the ingredients
shall be of food/pharma grade quality. The test certificate indicating the individual ingredients
and the respective compositions of each mineral/ingredient in the product shall be obtained from
the manufacturer

F-2 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 SIT 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, the raw water collected from the new source shall be tested in accordance with Clause 7
of SIT and the processed water produced from such source water shall be tested for conformityto
IS 14543 from BIS recognized outside lab. 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.

F-3 Modification in the process

F-3.1 In case of any addition, alteration and/or change in the production process without any
change in raw water source, the processed water produced from such changed process shall be
tested for conformity to IS 14543 from BIS recognized outside lab. The reports of the product
water produced from the changed process shall be submitted to BIS for approval before
commissioning for regular production and marking.

F-3.2 Testing of product water so produced by using different processes shall be carried out as
per SIT 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 change of label. Therefore licensee may beadvised to
prepare fresh label incorporating all marking details.
F-4 Shelf-life

F-4.1 Declared shelf life for Packaged Drinking Water in all type of packing materials shall
not be less than 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 whenever there is a change in the source
of raw water/manufacturing/packing process, whichever is earlier. The shelf-life shall be declared on
the labels as per 7.1 (g) of IS 14543. It shall be based on in-house shelf life study for which proper
records be maintained conforming to declared shelf life.

F-4.2 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 along with routine
microbiological tests as per IS 14543.

F-5 Label/marking approvals

F-5.1There is a practice that applicants/licensees submit labels to BIS for approval. Wherever any
applicant/licensee submits labels to BIS for approval, it shall be informed to them that the labels
conforming to the marking details as mentioned in clause 7 of IS 14543 along with the brand names
are tobe submitted to by licensees to BIS for information only, which will only be noted by BIS for
records.

F-5.2 The compliance of such labels to the requirement of clause 7 shall be ensured by licensees.
However, in case non-compliance to Clause 7 is observed by BIS and communicated in writing
(providedbrand name/trademark is not registered) to licensee, licensee shall make necessary
rectification and resubmit the label for confirmation to concerned BIS Branch Office within 15 days.
Decision of BIS regarding whether labeling is complying or not with clause 7 of IS 14543 shall be
final.

F-5.3 However, in case the brand name/trademark submitted by the firm is a registered brand
name/trademark, no objection to its use shall be raised even if the brand name/trademark is found
to be in non-compliance to Clause 7. However, in such a case, the Head BO concerned shall
communicate the details of such cases to CMD-2 for taking up with the concerned authorities.
Annex G

CHECKLIST FOR GOOD HYGIENE PRACTICES AND FOOD SAFETY SYSTEMS FOR
PACKAGED DRINKING WATER PROCESSING UNITS

SI No. Requirements Answers Remark


s
(1) (2) Adequat Not
e Adequa
te (4)
(3) (5)
i) Building, Facilities and Locations

a) Is the facility location area free from objectionable


odour, smoke, dust or other contaminants and not
subject to flooding?
b) Are the areas immediately surrounding the
buildings, roads, packing places, suitably paved,
grassed and kept clean?
c) Is adequate facility for drainage of surroundings
available and is designed to handle peak load?
d) Is the facility used for processing water, free from
Domestic animals?
e) Is the facility surroundings free from refuse, waste
materials, rubbish, overgrown weeds and
grasses?
f) Are there adequate facilities for the disposal of
effluents and wastes?
g) Are the buildings and facilities of sound
construction and maintained in good repair?
h) Are the buildings and facilities designed and
maintained to prevent entrance and harboring of pests
and entry of contaminants?
i) Are building and facilities designed to facilitate
Hygienic operations?

ii) Plant and Physical Facilities

a) Is adequate lighting provided at working station, hand


washing area, and storage areas? (as per B-5.4.6)
b) Are light fixtures safety type and protected to prevent
contamination in the event of breakage in the
processing and packing area?
c) Are the processing areas well-ventilated, to minimize
odours , noxious fumes and condensates?
d) Are the barriers/traps provided at drains to prevent
the entry of rodents from the drains into the facility?
e) Is effective screening provided against entry of
birds, animals, insects, rodents, etc
f) Are doors, hatches and other openings to the
building constructed to render opening pest proof?
g) Are floors, walls, ceilings, windows and doors so
designed and constructed as to render them
washable?
h) Is product in process and storage area adequately
protected from any leakage from external surfaces
and other sources of contamination?
i) Are immediate surroundings of extraction or collection
protected from entry of unauthorized persons?
iii) Raw Water Processing
a) In case of extraction/collection for processing are the O
sources free from contaminations/ impurities?
b) Are water storage tanks, pipe lines utilized for
handling water constructed and so designed as to
facilitate cleaning and inspection?
c) Are inspections of containers/carriers/pipe lines of
raw water supply performed for the material of
construction and cleanliness?
d) Are possible chances of contamination from
incoming water assessed?
e) Are water storage tanks regularly cleaned and records
maintained to prevent entry of pests and potential
contaminator?
f) Are the processed water contact surfaces regularly
cleaned and sanitized and records maintained?

iv) Post-processing Handling

a) Are cleaning operation of bottles/containers so


done as to preclude contamination of product and
product contact services with residues?
b) Has absence of residual cleaning chemicals been
ensured?
c) Is preventive maintenance in place for all processing
machinery and equipment?
d) Are the primary packing materials and containers of
food grade conforming to relevant Indian
Standards?
e) Are packing and sealing, where required, monitored?
f) Are physical hazards prevented from entering into
processed water?
g) Are glassware excluded from production area?

v) Packaging Material and Finished Goods Storage

a) Are the primary packing materials and containers of


food grade conforming to relevant Indian
Standards?
b) Are the packaging materials inspected to ensure their
suitability?
c) Are the packing materials especially primary packing
material properly stored and properly handled to
preclude contamination?
d) Are the packaging materials purchased, stored
and handled in sanitary manner?

vi) Finished Product Storage and Distribution

a) Is first-in-first out (FIFO) of stored product maintained?


b) Is storage properly sanitized and disinfected periodically?
c) Are stores protected from pest infestations?
d) Are coding and tracking clear and in place?
e) Are the instruction clear and in place?
f) Are hold/release procedure in place and product
identified?
g) Are the records maintained for batch number, date of
and volume of production? O
h) Are transport containers/vehicles maintained in clean
condition?

vii) Customer Handling of Products

a) Are the storage instructions provided on containers?


b) Is the shelf life period/best before mentioned on
containers ?
c) Are instructions provided for handling defective/damaged
products?

viii) Sanitary Facilities and Control

a) Are toilets provided in sufficient numbers and


are they provided with:
1) Doors of self-closing type?
2) Do not open 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?
b) Are hand washing facilities provided adequately
and conveniently to wash hands, foot, elbow or
sensor operated taps?
c) Are germicidal soaps/soap solution and hand
drying facility provided?
d) Are notice/ instructions prominently pasted in toilet
directing employees to wash their hands on entry
and re-entry into the packaged drinking water
handling areas?
e) Are the refuse receptacles self closing type
maintained in a manner to protect from
contaminations?

ix) Personnel Hygiene and Habits

a) Is any individual assigned to supervise overall


sanitation of plant and personnel?
b) Is there any person responsible for day-to-day
monitoring of health and hygiene?
c) Are the medical records of the employees in
processing, packing and maintenance been
periodically maintained?
d) 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?
e) Are the following 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?
f) Are protective clothing stored on the premises and O
not allowed to be used for outside wear?
g) Are there clear legible notices defining limits of no
smoking areas such as ‘NO SMOKING BEYOND THIS
POINT’ displayed?
h) Have the personnel been imparted training or
hygienic food handling, processing food and personal
hygiene?

CONCLUSION: OVERALL ASSESSMENT OF HYGIENIC CONDITIONS – SATISFACTORY/ NOT


SATISFACTORY

You might also like

pFad - Phonifier reborn

Pfad - The Proxy pFad of © 2024 Garber Painting. All rights reserved.

Note: This service is not intended for secure transactions such as banking, social media, email, or purchasing. Use at your own risk. We assume no liability whatsoever for broken pages.


Alternative Proxies:

Alternative Proxy

pFad Proxy

pFad v3 Proxy

pFad v4 Proxy