PM/ IS 14625/2

April 2023

उत्पाद मानुयल
प्लास्टिक की दध
ू पपलाने की बोतलें
IS 14625:2015 के अनस
ु ार

Product Manual for

PLASTICS FEEDING BOTTLES
ACCORDING TO IS 14625:2015
भारतीय मानक ब्यूरो (अनुरूपता मूलयाांकन) पिननयम 2018 की टकीम-I के तहत यह उत्पाद मानुयल प्रमाणीकरणके प्रचलन
मे रीनत और पारदर्शिता के सुसांगता सुननस्चचत करने के र्लए सभी क्षेत्रीय/शाखा कायािलयों एिां लाइसेन्स धाररयों द्िारा सांदभि
सामग्री के रूप मे उपयोग ककया जाएगा। बीआईएस लाइसेन्स/प्रमाण पत्र प्राप्त करने के इच्छुक भािी आिेदकों द्िारा भी इस
दटतािेज़ का उपयोग ककया जा सकता है ।

This Product Manual shall be used as reference material by all Regional/Branch Offices & licensees
to ensure coherence 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 licence/
certificate.

1. उत्पाद :
Product IS 14625 :2015
शीर्ष क : प्लास्टिक की दध
ू पिलाने की बोतलें
Title Plastics Feeding Bottles
संशोधन सख्ं या : 04
No. of Amendments
2. नमुनाकरण ददशा दनदेश
Sampling Guidelines:
a) For material used for plastics feeding bottles excluding teats,
each consignment to be accompanied with test certificates as per
Cl. 4.1 and 4.2

कच्चा माल b) In case the applicant uses/intends to use ISI Marked teats as
a) : per IS 3565, the manufacturer may submit a consent letter from
Raw material
the BIS licensed manufacturer, that he has agreed to supply ISI
Marked teats to the applicant firm. In that case test reports from
third party labs need not be submitted. The letter from BIS
licensed manufacturer shall not be older than 90 days on the date
of submission of application.
 PM/ IS 14625/2
April 2023

However, if the teats are not ISI-marked, each consignment of

teats, to be accompanied with test certificates conforming to IS
3565 or third-party lab test report conforming to IS 3565.

c)For printing inks, each consignment to be accompanied with

declaration/undertaking from the supplier in compliance to IS
15495.
समूदिकरण ददशा दनदेश : कृ पया Annex-A देखें
b)
Grouping guidelines Please see Annex – A
c) नमनू ेका पररमाण :
Sample Size 60 bottles
3. परीक्षण उपकरणो की सचू ी : कृ पया Annex-B देखें
List of Test Equipment Please see Annex – B
दनरीक्षण व परीक्षण स्कीम कृ पया Annex-C देखें
4. Scheme of Inspection and : Please see Annex – C
Testing
5. एक ददन में संभादवत परीक्षण
Possible tests in a day:
a) Wall thickness (Cl. 5.1.3)
b) Capacity (Cl. 5.1.4)
c) Transparency (Cl. 5.3.2)
d) Leakage Test (Cl. 5.3.3)
e) Drop Test (Cl. 5.3.4)
f) Compressive Deformation Resistance (Cl. 5.3.6)
6. लाइसेन्स का कायषक्षेत्र / Scope of the Licence:
IS 14625: 2015 के अनुसार मानक मुिर का उपयोग करने के दलए लाइसेन्स दनम्नदलदित कायषक्षेत्रके दलए प्रदान दकया जाता िै
Licence is granted to use Standard Mark as per IS 14625: 2015 with the following scope:
उत्पाद का नाम प्लादस्िक की दूध दपलाने की बोतलें
Name of the product Plastics Feeding Bottles
Material Polypropyelene (PP) / Polyethersulfone (PES) / any other olefin-
based polymer/ co-polymer or any other raw material
(as per Annex –A of IS 14625:2015)

BUREAU OF INDIAN STANDARDS

Manak Bhawan, 9, Bahadur Shah Zafar Marg,
New Delhi – 110002
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April 2023

ANNEX A
TO THE PRODUCT MANUAL FOR
PLASTICS FEEDING BOTTLES AS PER IS 14625:2015
GROUPING GUIDELINES

1. The manufacturer shall declare the type of material of Plastics Feeding Bottles which they intend to cover
in the scope of licence as per provisions of Cl. 4.1 of IS 14625:2015. The sample of each type to be drawn
and shall be subjected to testing for considering grant of licence/inclusion of that type.
2. The manufacturer shall submit the drawing of all the sizes of Plastic Feeding Bottles and declare the
minimum wall thickness for sizes to be included in the scope of licence.
3. Sample (of requisite quantity) of plastic feeding bottles made from each type of material (PP/PES any other
olefin-based polymer/ co-polymer or any other raw material as per Annex –A of IS 14625:2015), shall be
drawn and subjected to testing for considering grant of licence/inclusion of that type of material.

4. It shall be ensured that the firm is having all the necessary manufacturing and testing facilities for the types
to be included in the licence.

5. In case it is also intended to cover ECO-Mark, the sample(s) shall conform to the additional requirements
for ECO-Mark as given in Annex-G of IS 14625:2015.

6. During the operation of licence, BO shall ensure that all the types of Plastics Feeding Bottles covered in the
scope of license are drawn for independent testing on rotation basis over a period of time.
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April 2023

ANNEX – B
TO THE PRODUCT MANUAL FOR
PLASTICS FEEDING BOTTLES AS PER IS 14625:2015
List of test equipment
Sr.
Tests used in with Clause Reference Test equipment
No.
Water(grade 1), Acid (hydrochloric acid or sulfuric acid),
Acetone, 4-(1,1,3,3-Tetramethylbutyl)phenol, 4-(1,1,3,3-
Tetramethylbutyl)phenol monoethoxylate, 4-(1,1,3,3-
Tetramethylbutyl)phenol diethoxylate, 4-(3,6-Dimethyl-3-
heptyl)phenol, 4-(3,6-Dimethyl-3-heptyl) phenol
monoethoxylate, 4-(3,6-Dimethyl-3-heptyl) phenol
diethoxylate, Bisphenol-A, 2,2,2-Trifluoro-N-methyl-N-
(trimethylsilyl)acetamide (MSTFA), Solid-phase material, on
styrene-divinylbenzene polymer basis, Sand(e.g. sea sand,
1. Bisphenol A (BPA) (Cl. 4.4) acid washed and calcinated for analysis, particle size 0.1 mm
to 0.3 mm), Nitrogen(N2), Sodium thiosulfate
pentahydrate(Na2 S2O3 ⋅ 5H2O)
Narrow-neck flat bottomed glass bottles, Solid-phase
extraction cartridges, of inert non-leaching plastic, Vacuum or
pressure assembly, ne-mark volumetric flasks, Quartz wool,
Pear-shaped flask, Evaporation assembly, Vials, brown glass
with PTFE-lined septa, capacity e.g. 1.5 ml, according to the
autosampler. Stainless steel cocks, with stainless steel cone.
Gas chromatograph
Micrometer/screw gauge, fitted with ball point tips or dial
caliper gauge fitted with spherical anvils giving an accuracy
2. Wall Thickness (Cl. 5.1.3) of measurement of 0.02 mm

Cutting Tools
3. Capacity (Cl. 5.1.4) Beakers and Measuring Cylinders
Sodium Bicarbonate, Conc. Sulphuric Acid, Analytical
4. Permanency of Pigment [Cl. [Link] a)]
Balance and Glass ware
Apparatus/Reagents for Migration of elements
• Water bath, able to maintain the temperature of the test
mixture at 37 ± 2 oC and having the means to agitate
the test mixture.
Migration of Certain Elements (Cl. • pH meter, with an accuracy of ±0.2 pH units
5.
5.2.1) • Membrane filter, with a pore size of 0.45 μm
• Centrifuge, capable of centrifuging at 5 000 ± 500 rpm.
• Analytical Balance
• Hydrochloric acid and other chemicals and laboratory
reagents
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April 2023

Apparatus/Reagents for determination of quantity of

migrated elements

Inductively coupled plasma optical emission

Spectrophotometer (ICP-OES) along with necessary
laboratory apparatus and reagents as per IS 3025 (Part 2):2019
OR,
Atomic Absorption Spectrophotometer and associated
apparatus and reagents as per IS 15303 (Antimony and
Selenium), IS 3025 (Part 37) – (Arsenic), IS 3025 (Part 48) –
Mercury, IS 3025 (Part 41)- (Cadmium), IS 3025 (Part 47) –
(Lead), and IS 1699 – (Barium)
Circulating Air Oven capable of housing at least 15 containers
and providing temperature of at least 60±1°C, Conditioning
Environmental Stress-Crack Resistance chamber capable of conditioning at least 15 containers at a
6.
(Cl. 5.3.1) temperature of 27±2°C and 65±5% RH, Any environmental
stress cracking reagent, Heat sealing equipment, closures,
Plastic bags, rubber band/seal/tape etc
Integration ball type light transmittance measurement
7. Transparency (Cl. 5.3.2)
apparatus as per Annex C or Apparatus as per ASTM 1003
8. Leakage Test (Cl 5.3.3) Blotting paper, Closures
9. Drop Test (Cl 5.3.4) Flat horizontal surface of steel or smooth concrete
10. Ageing Resistance (Cl. 5.3.5) Boiling water and ice water arrangement
Compressive Deformation Resistance Compression Jig with 2 kgf load Room Thermometer with LC
11.
(Cl.5.3.6) 1°C
Simulant: Distilled water (to simulate the product)
Product Resistance of Printed
12. Arrangement to heat the samples to 40±2°C , thermometer
Containers (Cl 5.3.7)
Cold Water/Hard tissue paper
Simulants: n-heptane and distilled water, Oven/water bath/
pressure cooker/autoclave, Electric hot plate with temperature
control regulator, Water Bath/Electrical Oven with digital
13. Migration Test (Cl.5.3.8) Temp controller (0-150 °C, LC 0.1 °C), Stainless steel
evaporating dish of 100 ml capacity, stainless steel tongs(SS
pins), Dessicators, Analytical Balance (LC 0.1 mg), Pyrex
Beakers and other laboratory glassware and reagents
Water, complying with grade 1, Nitric acid, Hydrogen
peroxide, Sulfuric acid, Hydrochloric acid, Ammonium
sulfate, Element stock solutions of Ba, Co, Cu, Fe, Li, Mn, Sb,
14. Specific Migration (Cl. 5.3.9) Radiofrequency generator, Mass-flow controller, Nebulizer,
Ultrasonic nebulizer, Inductively coupled plasma optical
emission spectrometer, Argon gas supply, General labware,
Storage bottles, Acid dispensers, Filtration equipment,
The above list is indicative only and may not be treated as exhaustive
 PM/ IS 14625/2
April 2023

ANNEX- C
TO THE PRODUCT MANUAL FOR
PLASTICS FEEDING BOTTLES AS PER IS 14625:2015
Scheme of Inspection And Testing

1. LABORATORY - A laboratory shall be maintained which shall be suitably equipped (as per the
requirement given in column 2 of Table 1) and staffed, where different tests given in the specification shall
be carried out in accordance with the methods given in the specification.

1.1 The manufacturer shall prepare and implement a calibration plan for the test equipments.

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

3. PACKING AND MARKING- The Standard Mark as given in the schedule of the licence shall be
incorporated legibly and indelibly on each plastics feeding bottle and its packaging along with the other
marking details as required by the standard, provided always that the material so marked conforms to each
requirement of the specification. Packing and Marking shall be done as per the provisions of the Indian
Standard.

3.1 The information as mentioned under clause 7.2.1 of IS 14625:2015 shall be legibly and indelibly marked
on each package. In addition, the following shall be incorporated on each bottle and each package:
a) BIS License Number CM/L—and
b) BIS website details i.e. ― “ For details of BIS certification please visit [Link]”. *
*In case of space constraints, (b) may be marked only on the package

4. CONTROL UNIT – For the purpose of this scheme, plastic feeding bottles of same nominal capacity and
of same material manufactured from the same consignment of raw material in a day/shift (if production is in
more than one shift in a day) shall constitute one control unit.

5. LEVELS OF CONTROL - The tests as indicated in column 1 of Table 1and the levels of control in
column 3 of Table 1, shall be carried out on the whole production of the factory which is covered by this plan
and appropriate records maintained in accordance with paragraph 2 above.

5.1 All the production which conforms to the Indian Standards and covered by the licence should be marked
with Standard Mark.

6. REJECTIONS – 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.
 PM/ IS 14625/2
April 2023

TABLE 1 (Levels of Control)

(Para 5 of Scheme of Inspection and Testing)

(1) (2) (3)

Test Details Test equipment Levels of Control
Test Method requirement
R: required (or)
Cl. Requirement S: Sub- No. of Sample Frequency Remarks
Clause Reference contracting
permitted
4.3 and Bisphenol A (BPA) ISO 18857-2 or S One Once in every
4.4 EN 13130-13 six months or
whenever there
is change in raw
material,
whichever is
earlier
5 REQUIREMENTS
5.1 Physical Requirements See Note 3
5.1.1 Description 5.1.1 -do- R Firm to have adequate in-process controls to check
compliance of this parameter as per the Indian Standard.
However, appropriate records shall be maintained by the
manufacturer for evidence of conformity
5.1.2 Manufacture, Workmanship, 5.1.2 -do- R Firm to have adequate in-process controls to check
Finish and Appearance compliance of this parameter as per the Indian Standard.
However, appropriate records shall be maintained by the
manufacturer for evidence of conformity
5.1.3 Wall Thickness 4.5 IS 2798 R One Each hour
1% of bottles in each Each consignment
consignment
[Link] Brimful Capacity [Link] IS 14625 R One Each hour
1% of bottles in each Each consignment
consignment
[Link] Capacity Scale [Link] IS 14625 R One Each hour
1% of bottles in each Each consignment
 PM/ IS 14625/2
April 2023

consignment
[Link] Permanencyof Annex B IS 14625 R Three Every seventh For bottles with
pigment control unit printed scale/
graduations
5.2 Chemical Requirements
5.2.1 Migration of 5.2.1 IS 14625
Certain Elements
i) Arsenic IS 3025 (Part 37 S One Every 3
/IS 3025 (Part 2) months
ii) Chromium IS 3025 (Part 52 S -do- -do-
IS 3025 (Part 2)
iii) Mercury IS 3025 (Part 48 S -do- -do-
IS 3025 (Part 2)
iv) Cadmium IS 3025 (Part 4 S -do- -do-
IS 3025 (Part 2)
v) Lead IS 3025 (Part 4 S -do- -do-
IS 3025 (Part 2)
vi) Barium IS 1699/ S -do- -do-
IS 3025 (Part 2)
vii) Selenium IS 15303/ S -do- -do-
IS 3025 (Part 56
IS 3025 (Part 2)
5.3 Performance Requirements
5.3.1 EnvironmentalStress-Crack Method 1 IS 8747 S Five Every 7th
Resistance control unit
5.3.2 Transparency Annex C IS 14625 S Three Once in two
months for each
type of material
(PP/PES etc.)or
for each
consignment
whichever is
earlier
5.3.3 Leakage Test 5.3.3 -do- R Ten Each control
unit
5.3.4 Drop Test Annex D -do- R Three Each control
unit
5.3.5 Ageing Resistance 5.3.5 -do- R Three Every third
 PM/ IS 14625/2
April 2023

control unit
5.3.6 CompressiveDeformation Annex E -do- R -do- -do-
Resistance
5.3.7 Product Resistance of 14 IS 2798 R -do- -do-
Printed Containers
5.3.8 Migration Test IS 9845 S One Every thirdcontrol
unit with nheptane
as stimulants
One Once in a
fortnight with
distilledwater as
stimulant.
Determination of Specific
5.3.9 5.3.9 IS 14625
Migration
i) Barium IS 3025 (Part 2) S One Every 3
months
ii) Cobalt IS 3025 (Part 2) S -do- -do-

iii) Copper IS 3025 (Part 2) S -do- -do-

iv) Iron IS 3025 (Part 2) S -do- -do-

v) Lithium IS 3025 (Part 2) S -do- -do-

vi) Manganese IS 3025 (Part 2) S -do- -do-

vii) Zinc IS 3025 (Part 2) S -do- -do-

viii) Antimony IS 3025 (Part 2) S -do- -do-

Phthalic Acid, bis (2- -do- -do-

ix) ISO 18856 S
ethylexyl) ester (DEHP)
 PM/ IS 14625/2
April 2023

Note 1: Whether test equipment is required or sub-contracting is permitted in column 2 shall be decided by the Bureau and shall be mandatory. Sub-
contracting is permitted to a laboratory recognized by the Bureau or Government laboratories empaneled by the Bureau.
Note 2: Levels of control given in column 3 are only recommendatory in nature. The manufacturer may define the control unit/batch/lot and submit his
own levels of control in column 3 with proper justification for approval by BO Head.
Note-3: Physical requirements shall be checked either hourly or consignment wise or control unit wise against a drawing incorporating material,
design, wall thickness, shape and capacity for each capacity which shall be prepared & endorsed by both purchaser and manufacturer.