PM 14543 July 2024 Approved
PM 14543 July 2024 Approved
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
: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:
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
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-2.2 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-2.4 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.)
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-4.1 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):
iii. Quantity (number of containers and total quantity of packaged water in litre or milliliter),
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:
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.
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)::
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-5.1 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
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;
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)
xii. Any change in testing person(s) should be checked for and reported along with
comments on the competence, qualifications and experience.
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-3.1 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.
iii. Quantity (number of containers and total quantity of packaged water in litre or milliliter),
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:
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):
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 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
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.
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.
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
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-2.1 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
11 Determination of Silver
c) Potentiometric 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) 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 IS 3025 (Part 27/Sec 1) Total Cyanide After Distillation (Preliminary step)
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:
OR
7 Lead as per IS 3025 (Part 47) Differential Pulse Anodic Stripping Voltammetry (DPAV);
Dithizone method
Note 2: The list does not cover the requirements of Pesticide Residues and Radio Active Residues
since these tests are normally subcontracted.
• Distilled water
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
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:
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.
3.5 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.
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.
LEVELS OF CONTROL
Batch
Date of
Number pH Remarks
Production / unit
number
1 2 3 4
FORM 2
REPORT FOR DAILY/ EACH CONTROL UNIT TESTING
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
Month & Batch Type of Dates on Lab to which Test report Results Remarks
Year No./DOM packing which
sample sent sample sent number &
date
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)
i. Mercury, Cadmium, Arsenic, Cyanide, Lead, Chromium, Nickel, Fluoride, Selenium, Sodium, PCB,
PAH, Bromates, Uranium
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
FORM 7
RECORDS FOR SHELF LIFE ASSESSMENT (SEPARATE FOR EACH TYPE OF CONTAINER BEING
USED)
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
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
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…
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
TABLE 5
Levels of control for Aluminium Cans for Packaged Natural Mineral Water and Packaged
Drinking Water as per IS 18285
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
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 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-3.1 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-5.1There 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