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BSEN 14350:2020
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BS EN 14350:2020
English Version
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14350:2020 E
worldwide for CEN national Members.
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BS EN 14350:2020
EN 14350:2020 (E)
Contents
European foreword 5
Introduction...
1 Scope...
2 Normative references •••••• ••••••• •••••••• •••••• 8
3 Terms and definitions •••••••• •••••• •••••••• ••••••• 9
4 Description 11
Test equipment and tolerances
5 ..19
5.1 Small parts cylinder
5.2 Indentor
5.3 Fixture for security/retention test 21
5.4 Probes for holes (finger traps) test 21
5.5 Templates A and B
5.6 Tolerances
6 Construction and mechanical properties - General and sample preparation 23
6.1 Sample preparation for construction and mechanical properties 23
6.2 General •••••••• •••••• ••••••••• •••••••• •••••• 23
6.3 Pre-treatment (see B.4)
6.4 Boiling (see B.5)
6.5 Conditioning 23
7 Construction and mechanical requirements and tests. ••••••• ••••••• 23
7.1 Order of testing for construction and mechanical properties 23
7.2 Decoration, inscription and decals (see B.6) 25
7.3 Visual and tactile examination 25
7.4 Small parts ••••••• •••••••• ••••••• •••••• ..25
7.5 Additional requirements for sealing discs (see B.7) 25
7.6 Requirements and tests for containers •••••••• •••••• •••••• ..25
7.7 Requirements and tests for drinking accessories 28
7.8 Protective covers (see B.ll) •••••• •••••• •••••••• .31
7.9 Handles and clips (see B.13) •••••• •••••• •••••••• .32
7.10 Finger traps
7.11 Protruding parts
7.12 Cords or loops
8 Chemical requirements and test methods 36
8.1 General •••••••• •••••••• •••••• ••••••• •••••••• 36
8.2 Preparation of samples for chemical tests 36
8.3 Requirements by component and material.
8.4 Volatile compounds content of silicone components intended to be put in the mouth
or in contact with food (see B.14) ••••••• •••••••• •••••••• ....40
8.5 N-nitrosamines and N-nitrosatable substances release 41
8.6 Migration of certain elements (see B.16 and B.21) 41
8.7 2-mercaptobenzothiazole (MBT), antioxidant and formaldehyde release (see B.19,
B.20, B.24) 43
8.8 Colour fastness (see B.15) ••••••• •••••••• ••••••• ..44
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Apparatus
C.l 73
C.2 Procedure 73
C.3 Column 74
C.4 Detection 74
C.5 Standards •••••••• •••••••• •••••• ** * 74
C.6 Preparation of standard solutions of MBT and antioxidants •••••••• •••••••••• 75
/
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BSEN 14350:2020
EN 14350:2020 (E)
European foreword
This document (EN 14350:2020] has been prepared by Technical Committee CEN/TC 252 '"Child care
articles", the secretariat of which is held by AFNOR.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2020, and conflicting national standards
shall be withdrawn at the latest by June 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
The main changes compared to the previous edition are listed below:
— The standard has been completely renewed and a new structure was given. The former two parts
were joined together into one standard. A whole series of new aspects had to be considered,
following changes in the market and the regulatory background.
— Clause 3: Completely restructured and partly described in more detail. Definitions for completely
new parts were added.
— Clause 7: The whole clause has been divided into several sub-paragraphs for individual
components of drinking equipment and the associated tests to improve the clarity of the sequence.
Several paragraphs for new items and their tests were added.
— Clause 8: This clause was completely restructured and subdivided. The requirements and test
conditions have been set with the consideration of the likely chemical exposure: food contact,
mouthing or ingestion. Chemical requirements and test methods were set for materials (like
rubber, silicon, TPE, metal, glass) and exposures (mouthing and swallowing] which are recently not
covered by harmonised legislations. Requirements for substances (e.g. Phthalates and BPA]
covered by harmonised regulation (like REACH, (EU] 10/2011 or its amendments] have not been
included.
— Annex A: This normative annex with translations of warnings into 24 languages is completely new.
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EN 14350:2020 (E)
— Annex E: This informative annex on good practice for visibility and legibility is completely new.
This document has been prepared under a mandate M/264 given to CEN by the European Commission
and the European Free Trade Association. The standard is developed in support of the EU
Directive 2001/95/EC (GPSD).
According to the CEN-CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
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BSEN 14350:2020
EN 14350:2020 (E)
Introduction
This document harmonises minimum safety requirements and test methods for children's drinking
equipment. Some of the provisions have been taken from other existing national and European
Standards and for these provisions the Technical Committee has relied on previous validation.
A significant choking hazard can arise if the component parts of drinking equipment become separated
during use. This hazard is addressed in this document by the inclusion of a security test. However, as
the fixing of such products to the container is user-dependent, the risk of an accident cannot be
completely eliminated. This document sets out labelling requirements stating that parents or carers
should not leave children unattended whilst being fed with a product containing a feeding teat or using
a container made of glass and that children should not be allowed to use feeding teats as a soother.
The Technical Committee considered the possibility of standardizing both sizes of feeding teats and
ranges of flow rates. However, it was decided that the many combinations of container systems
precluded being standardized. It is recommended that all container and drinking accessory
combinations are matched components. Providing meaningful flow rate information is difficult because
of several factors including hole diameter, teat thickness, hole shape/type of feed, and also how
individual infants suck the teat. Accordingly, it was decided not to include a test for flow rate but to
recommend that manufacturers provide information on flow rate and hole size that is appropriate to
their particular product.
This document sets chemical requirements and test methods for materials (like rubber, silicon, TPE etc)
and exposures (mouthing and swallowing) not covered by harmonised legislations. Where this
document sets migration limits for substances also covered by legislation, the requirements of this
document with stated test conditions must be regarded as additional.
Materials and chemical risks included in the standard (Table 3) do not present a definitive list but the
considered opinion of the Technical Committee based on current knowledge of likely risks.
All food contact materials and articles are regulated by Regulation (EC) No 1935/2004 [1], Regulation
(EC) No 2023/2006 [39] and relevant implementation measures, at European or national level.
All plastics components of drinking equipment intended to come into contact with food are specifically
regulated by the Regulation (EU) 10/2011 [2] on plastic materials and articles intended to come into
contact with food and its amendments.
Therefore, for example the Bisphenol A - requirement has not been included in this document. [40]
Phthalates in childcare articles are restricted by Annex XVII of the REACH Regulation [3] and have not
been included in this document.
Latex protein allergy risk has not been included in this document. There is no published information
that sensitization is caused by feeding teats and there is an extremely low incidence of latex protein
allergy among young children and babies. Nevertheless, provision for packaging information for feeding
teats made from natural rubber latex has been included in this document.
It is recommended that manufacturers and suppliers operate to EN ISO 9001 standard for quality
management systems [4]. It is also recommended that laboratories operate to EN ISO/IEC 17025,
General requirements for the competence of testing and calibration laboratories [5].
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1 Scope
This document specifies safety requirements relating to the materials, construction, performance,
packaging and product information for drinking equipment intended for children of 0 to 48 months (see
B.2) of age:
— Re-usable containers and re-usable drinking accessories;
This document does not include requirements for the cleanliness of ready to use and single use
products.
This document does not apply to products designed for specialist clinical medical applications, e.g.
those relating to cleft lip palates.
This document does not apply to drinking equipment made from ceramics.
This document does not apply to bags intended for storage only.
This document does not apply to drinking equipment which is supplied with fluids or food when
purchased and to feeding accessories fixed to it.
This document is not applicable to soothers. Safety requirements and test methods for soothers are
specified in EN 1400 [6].
This document is not applicable for cutlery and other feeding utensils. Safety requirements and test
methods for Cutlery and other feeding equipment are specified in EN 14372 [7].
For drinking equipment excluded from the scope, consider the applicable requirements of this
document whenever possible.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 71-3, Safety of toys - Part 3: Migration of certain elements
EN 12868, Child use and care articles - Method for determining the release of N-nitrosamines and N-
nitrosatable substances from elastomer or rubber teats and soothers
EN ISO 3696, Water for analytical laboratory use - Specification and test methods (ISO 3696)
I EC 60454-2, Pressure-sensitive adhesive tapes for electrical purposes, Part 2: Methods of test
ISO 188:2011, Rubber, vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
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3.1
matched components
components which are intended to be used together whilst feeding a child
Note 1 to entry: Their dimensions are matched to fit together and fulfil the relevant safety requirements.
3.2
drinking accessory
device fitted to a container which permits a child to obtain fluid from it
3.2.1
feeding teat
elastic drinking accessory other than a straw
Note 1 to entry: there is no accepted scientific definition for the word “elastic". The Technical Committee intended
to describe by ' elastic'1 products made of silicone rubber, latex rubber, etc.
3.2.2
drinking spout
non-elastic drinking accessory other than a straw
3.2.3
push-pull valve
drinking accessory equipped with a valve designed to be manually operated by a push-pull, twist or
similar action
3.2.4
straw
drinking accessory consisting of a cylindrical hollow tube which is in contact with the mouth and
through which fluid is sucked
3.2.5
protruding part
drinking accessory when assembled for its intended use on a container
3.3
container
feeding bottle, drinking cup or feeding bag
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3.3.1
feeding bottle
container which is capable of holding fluid incorporating a graduated scale suitable for visual
measurement and is intended for feeding a child through a suitable drinking accessory
3.3.2
drinking cup
container other than a feeding bottle or feeding bag capable of holding a fluid intended for feeding a
child
Note 1 to entry: Drinking cups are also known as "beakers" in the English language
3.3.3
feeding bag
bag capable of holding fluid and designed to be used with drinking accessories
3.3.4
feeding bag holder
support for a feeding bag
3.4
locking ring
component used to secure a drinking accessory to a container
3.5
sealing disc
component used to create a seal between the container and the locking ring
3.6
protective cover
component to cover a drinking accessory
3.6.1
detachable protective cover
cover or parts of it intended to be detached when drinking or for cleaning
Note 1 to entry: After being detached they can be reassembled in the original state.
3.6.2
permanent protective cover
cover or parts of it intended to stay attached to the product during use/drinking
Note 1 to entry: It can only be detached by using a tool or force and is not intended to be reassembled afterwards.
3.7
handle
component designed to assist the handling of a container during drinking
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3.8
dip
component designed to assist the attachment of a container onto garments
3.9
cord or loop
flexible component designed to assist the handling of a container
3.10
graduations
markings which indicate the volume of fluid within the container, numbered or unnumbered
3.11
single-use product
product intended to be disposed of after first use
3.12
re-usable product
product intended to be used again after first use
3.13
ready to use product
product intended to be used without the need to clean before first use
3.14
outer packaging
any packaging used for storage of the product by a retailer, not including the packaging intended for the
consumer
4 Description
Figures 1 to 10 illustrate typical examples of different items of drinking equipment and their design
features.
Key
1 mouthpiece
2 feeding hole/holes
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1 2
Key
1 feeding spout including a locking ring
2 spout
3 straw
4 drinking accessory with mouthpiece in form of a spoon
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1 3
Key
1 protective cover 5 feeding bottle
2 locking ring 6 feeding bag
3 feeding teat 7 graduations
4 sealing disc 8 feeding bag holder
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Key
1 drinking cup
2 drinking accessory
3 handle
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EN 14350:2020 (E)
a)
b)
Key
a closed position
b open position
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a)
b)
Key
a detachable protective cover in form of a cap
b permanent protective cover in form of a protective cap for straw
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5.2 Indentor
The indentor is made from Hl3 high chrome tool steel or equivalent and hardened to a minimum of 50
Rockwell C and shall have dimensions as shown in Figure 12. All dimensions with a tolerance are
machined as ISO 1302 [8] to ^Rao.4 .The larger diameter of the indentor has not been specified, as it
hould be of a size to fit into the equipment for applying the necessary force specified in the test
methods.
Dimensions in millimetres
Key
Encircled is the tip of the indentor with the cutting blade.
a this face is flat and has dimensions of (3,0 x 0,20) mm
Figure 12 — Indentor
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ft
Key
A direction of tensile force
I
II
5.4 Probes for holes (finger traps) test
+0
-0
Key
1 tip radius equalling half the probe diameter
2 scribed line
3 diameter of probe 1: 5,5 % ! mm, diameter of probe 2:12 q0'1 mm
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04
+1
m
r*-
73 ±2
Mechanical tests are often described in terms of the application of forces. Masses can however be used.
One kg mass may be used for 10 N force.
Unless otherwise specified, the test forces may be applied by any suitable device which does not affect
the results.
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Parts made of vulcanised rubber (not silicone parts) taken directly from the manufacturer prior to
being shipped to a retailer, shall be artificially aged for (7 days) ± 2 h in an oven with forced air
circulation by means of a fan and a ventilation of three to ten changes per hour (as described as Method
B in ISO 188:2011) at a temperature of (70 ± 2) °C.
6.4 Boiling (see B.5)
All samples, excluding single-use products, shall be disassembled and immersed in boiling water, to the
requirements of EN ISO 3696, Grade 3, for (10 ± 1) min without touching the walls of the container and
removed. Afterwards allow the samples to cool to room temperature. Then after a maximum of 2 h after
boiling place in the conditioning room (see 6.5).
After boiling, there shall be no damage which causes the failure of any subsequent tests, or impairs the
assembly for the intended use and no graduation shall have been removed when assessed by visual
inspection.
6.5 Conditioning
All samples shall be conditioned for at least 40 h before the tests, at a temperature (23 ± 2) °C, and
relative humidity (50 ± 5) %. Samples shall remain in the conditioning atmosphere until the test is
carried out. The tests may be carried out in a non-conditioned room.
The tests for construction and mechanical properties shall be carried out in the order given in Table 1,
after treatments according to Clause 6.
New samples, preferably from the same batch, shall be used for each test (i.e. samples used in one test
shall not be used in another test) unless otherwise stated.
When tensile tests are applied, clamps or other devices shall hold the components securely during the
test without causing damage which results in a test failure. Any failure due to such damage shall be
disregarded. If after a number of attempts using different methods secure holding is not possible due to
material weakness, the product fails.
NOTE If secure holding of the component causes problems, advice of the manufacturer should be considered.
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7.6 Containers
7.6.1 Volume labelling
7.6.2 Volumetric accuracy
7.6.3 Print adhesion of graduations (for re
usable products)
7.6.4 Thermal shock (for re-usable products )
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EN 14350:2020 (E)
All areas of drinking equipment may be decorated or inscribed by techniques which do not apply
materials to their surface, e.g. by laser engraving. The manufacturer has to make sure that possible
contamination, e.g. from laser engraving combustion products, does not impair product safety.
Areas with intended food contact may only be printed or inmold labelled, if this printed or inmold
labelled area is completely covered by a functional barrier according to EU/10/2011 [2].
Areas of drinking accessories (3.2) that are intended or foreseeable to be mouthed shall not be printed,
also not when covered by a functional barrier including inmold labelling.
A drinking cup (3.3.2) which provides a drinking rim and is also intended to be used without a drinking
accessory (3.2) or a similar product where the child's mouth can contact the outside of the cup shall not
be printed and / or inmold labelled on the area extending to 20 mm measured from the drinking rim.
Areas of drinking equipment that are not intended to contact food and/or to be mouthed may be
decorated or inscribed with techniques which apply colorant such as printing with printing inks.
Adhesive decals and labels intended to stay on the product during use are not allowed on any part of
drinking equipment. Decorations shall not be attached to any part of drinking equipment by glue.
7.3 Visual and tactile examination
All components of drinking equipment when assembled for use shall be free from any accessible sharp
points or edges and free of flash and burrs, which could cause injuries, and shall be assessed by visual
and tactile examination. In case of doubt apply test for sharp point and sharp edge according to
EN 71-1.
7.4 Small parts
All parts which are designed to be removed (e.g. for cleaning), or become separated after the tensile or
other mechanical tests shall not fit entirely within the small parts cylinder (see Figure 11) in any
orientation and without compression.
7.5 Additional requirements for sealing discs (see B.7)
The minimum diameter of a sealing disc shall be 35 mm.
7.6 Requirements and tests for containers
7.6.1 Volumetric labelling requirements (see B.8)
If containers are marked with graduations these shall include the nominated maximum capacity. The
volumes shall be given in millilitres and the letters "ml" or "mL" shall appear at least once. Additional
units for measurement can be used if applicable.
Drinking cups, feeding bags or holders for feeding bags may be marked with graduations. Feeding bags
with graduations shall not be used to prepare formula milk (see 10.3.3).
All feeding bottles shall be marked with graduations. The lowest numbered graduation shall not be
more than 60 ml and the highest graduation, numbered or unnumbered, shall be the nominal capacity
of the bottle. There shall be numbered or unnumbered graduations every 30ml starting from 60 ml. The
gap between numbered graduations shall not exceed 60 ml.
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EN 14350:2020 (E)
When tested in accordance with 7.6.2.2 the volumetric accuracy of all graduations, unnumbered and
numbered, on feeding bottles or if present on feeding cups shall be as follows:
— all graduations > 100 ml: ± 5 %;
For feeding bags and holders for feeding bags that have graduations their volumetric accuracy shall be
within ±15 % as measured according to 7.6.2.2 with the product set up by the method given in the
instructions for use.
7.6.2.2 Volumetric accuracy test procedure
Fill the container with distilled or preboiled water at (20 ± 5) °C to each of the numbered and
unnumbered graduations (where present).
Check the mass of the water using a balance, with an accuracy of ± 0,1 g.
Ensure that the base of the meniscus of the water is level with the middle of the graduation.
7.6.3 Print adhesion of graduations (see B.10)
7.6.3.1 Requirement
All containers with printed graduations intended for repeated use shall be tested. After being tested in
accordance to 7.6.3.3 all graduations required under 7.6.1, numbered and unnumbered, shall be
readable (see Figure 17).
7.6.3.2 Equipment
Adhesive tape with an adhesion strength of (10 ± 1) N per 25mm width when tested in accordance with
IEC 60454-2.
7.6.3.2.2 Eraser
Carry out the test on the whole area of the container where the graduations are printed. Containers
which do not have numbered graduations shall not be tested.
Place the adhesive tape (7.6.3.2.1) over the printed graduations and smooth by hand in every direction.
To ensure a good contact rub the surface of the adhesive tape with the eraser (7.6.3.2.2), except for a
(10 ± 2) mm length at one end of the tape. Leave for (5 ± 1) min. Then remove the tape by grasping the
free end and pulling it off steadily in 0,5 s to 1,0 s, depending on the length of the tape at an angle of
(60 ± 10)° as shown in Figure 16.
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Key
A container
B adhesive tape
C printed graduations
D direction of adhesive tape removal
After removing the tape, the readability of the tested volumetric graduations is checked visually. The
product passes if all graduations required under 7.6.1 are readable. For examples see Figure 17.
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80 4 80 4 — 80-
40 - 40 - 40 - 40 —
A B c D E
Key
A pass, print same as new
B pass, graduations still legible
C fail, gap between numbered graduations (40 to 120) is too large
D fail, graduation for 90 ml is not legible anymore
E fail, graduations are not legible
7.6.4.1 Requirement
When tested in accordance with 7.6.4.2 no part of any re-usable container shall crack or break.
7.6.4.2 Test procedure
Immerse the sample completely in boiling water for (lO^jmin. Take the sample out from the hot
water. Empty the sample and immediately immerse the sample completely in water atj5 ° | °C for
7.7.1.1 Principle
This test measures the tear resistance after the drinking accessory has been punctured. The tear
resistance test is in two parts:
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— making the puncture (see 7.7.1.3] - If the drinking accessory does not puncture it fulfils the
requirements of 7.7.1.2 and the subsequent tensile test is not required.
7.7.1.2 Requirements
When tested in accordance with 7.7.1.4, no drinking accessories which can be punctured during 7.7.1.3
shall break, tear or separate. Straws are excluded from the puncturing according to 7.7.1.3 and shall be
submitted un-punctured to the tensile test according to 7.7.I.4.
7.7.1.3 Making the puncture
Attach the indentor vertically with its tip directed downwards to the moveable part of the universal
tensile machine. Mount a cutting board of at least 10 mm thickness and (70 ± 5] Shore D hardness
horizontally below. Place the drinking accessory on the cutting board and adjust the height of the
indentor to loosely clamp the accessory but allowing for its positioning. Adjust so that the puncture will
occur at the most onerous position that is accessible to the teeth of a child when using the drinking
accessory, but still allowing to securely clamp the punctured part in the subsequent tensile test so that
the clamps do not touch the puncture.
NOTE 70 Shore D Hardness is equivalent to 97 IRHDs.
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EN 14350:2020 (E)
Feeding teats shall be adjusted so that the the indentor (see Figure 18) is centred over, and at right
angles to, the major axis of the teat, in the region of the waist or neck of the teat i.e. 15 mm to 20 mm
from the tip of the mouthpiece. The major axis of the teat shall be oriented perpendicularly to the
cutting blade of the indentor.
Other drinking accessories shall be tested accordingly. In the case of a drinking accessory not having a
circular cross-section, the indentor shall be placed over the flattened surfaces of the neck of the
drinking accessory
At a cross head speed of (10 ± 5) mm/min apply a force of (200 ± 10) N for (1 ± 0,5] s. If the indentor
punctures the component, test in accordance with 7.7.1.4.
Before use, the cutting blade of the indentor shall be inspected visually for any damage such as burrs
and chips. Only undamaged indentors shall be used as otherwise the results of the test will be affected.
7.7.1.4 Testing the punctured product and straws with a tensile test
Suitable fixing devices shall be used to hold the opposite ends of the component securely on either side
of the puncture, along the major axis.
Apply a force of (5 + 2) N along the major axis to align the specimen before increasing the force to
(90 ± 5) N at a crosshead speed of (200 ± 10) mm/min. Maintain for (10 ± 0,5) s.
7.7.2 Push-pull valve (see B.12)
The push-pull valve is opened and closed for 1 000 cycles to simulate its lifespan. This cycle test
(7.7.2.3) is followed by a tensile strength test (7.7.2.4), on the same sample.
Push - pull - valves may employ also other open and close - mechanisms such as twist action or spring-
loaded. Although, a test procedure for these alternatives has not been specified the requirement given
in 7.7.2.2 applies. The general principle of the test has also to be followed, that is open and close for 1
000 cycles, followed by a standard tensile test.
7.7.2.2 Requirements
For push - pull mechanisms the opening force shall not exceed 45 N. (see B.12). Push - Pull valves with
other mechanisms shall be opened and closed according to the instructions given in the product
information. During the cycle test the push-pull valve shall open and close. During either the cycle test
or the tensile strength test no part shall break, tear or separate to form small parts.
7.7.2.3 Cycle test procedure
Open and close the valve for 1000 times, using a suitable test machine or manually. To facilitate the test
procedure aqueous solution of wetting agent shall be used.
NOTE 2 % (V/V] of solution of polyoxyethylene (20] sorbitan mono-oleate was found to be suitable as
wetting agent.
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After the cycle test, parts to be tested shall be held securely by clamps or by such other means as might
be required depending on the design of the push-pull valve. The tensile force shall be applied to one
component of the push-pull valve whilst another part is held. A preload of (5 ± 2] N shall be applied to
align the specimen and the force shall be increased to (90 ± 5] N at a crosshead speed of (100± 5)
mm/min and maintained at that load for (10 ± 0,5] s. Inspect the push valve for breaks, tears or
separation.
Detachable protective covers shall be tested for small parts according to 7.4.
7.8.2 Size of permanent protective cover
Permanent protective covers, while attached to the product, shall in no direction protrude through
template A and B (see Figure 15] by their own weight. Permanent protective covers on straws are
excluded from this test (see Figure 20).
7.8.3 Security of permanent protective cover
7.8.3.1 Principle
The purpose is to test the security of a permanent protective cover by means of a tensile strength test,
which is followed by the small parts test in the case of detached parts.
7.8.3.2 Requirement
A permanently attached protective cover shall be tested according to 7.8.3.3. No part shall break during
the test. Any part that detaches or is released during the test, shall be tested for small parts according to
7.4.
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Parts to be tested shall be held securely by clamps or by such other means as might be required
depending on the design of the permanent protective cover. The tensile force shall be applied to one
component of the permanent protective cover whilst the other part is held, see Figure 20. A preload of
(5 ± 2) N shall be applied to align the specimen and the force shall be increased to (90 ± 5) N at a
crosshead speed of (100 ±5) mm/min and maintained at that load for (10 ±0,5) s. Inspect the
permanent protective cover for breaks, tears or separation.
The tensile force is applied in the most onerous positions. This indicates that more than one position
has to be assessed. For each test a new sample shall be used.
When tested in accordance with 7.9.2 and visually inspected, no part of the handle or clip when
assembled on the container shall break, tear or separate. If the handle or clip is detachable and is
detached from the container, without breaking, tearing or separating, during the test then this shall not
be deemed as a failure.
7.9.2 Test procedure
The handle (s) or clip shall be held securely by clamps or by such other means as might be required
depending on the design of the handle or clip so that the force on the handle or clip is at right angles to
the container and in the most severe configuration and position (some examples are shown in
Figure 21). A preload of (5 ± 2) N shall be applied to align the specimen and then the force shall be
increased to (90 ±5) N at a crosshead speed of (100 ± 5) mm/min and maintained at that level for
(10 ± 0,5) s.
Some examples of suitable tests are shown in Figure 21.
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Key
Arrows show the direction of force
To avoid entrapment of fingers in any part of drinking equipment, all accessible holes more than 10 mm
deep shall not have an opening width between 5,5 mm and 12 mm, when tested in accordance with
7.10.2.
This requirement only applies to components made of materials with a Shore A hardness of more than
60.
7.10.2 Test procedure
Only accessible holes shall be tested when the drinking components are in their assembled state. If
movable parts are involved test all configurations representing the intended use for possible
entrapments.
Using the 5,5 mm probe [Figure 14] measure the penetration of any accessible hole. If the unhindered
penetration is more than 10 mm, repeat using the 12 mm diameter probe (Figure 14).
The test is passed if ei ther both or none of the 2 probes penetrate to a depth of > 10 mm.
The test is failed if only one of the probes penetrates to a depth >10 mm and the hardness of the
material housing the hole is more than 60 Shore A.
7.11 Protruding parts
7.11.1 Maximum length
7.11.1.1 Requirement
The length of any protruding part (see 3.2.5) emerging from the container shall not be greater than
100 mm when fixed in the normal position of use and tested according to 7.11.1.2.
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Assemble the product with each possible configuration which can be used to feed the child. When the
protruding part is a straw that can move up and down, perform the test when the base of the straw
touches the internal base of the container.
Measure the length of the protruding part along the major axis using a suitable measuring device with
an accuracy of 0,1 mm. The measurement is taken from the surrounding, flat surface of the protruding
part, e.g. screw ring of a teat, up to the top end of the protruding part.
7.11.2 Flexibility
7.11.2.1 Principle
A force is applied to the end of the protruding part using a steel plate and the point at which the
protruding part bends is measured. Assemble the product with each possible configuration which can
be used to feed the child. When the protruding part is a straw that can move up and down, perform the
test when the base of the straw touches the internal base of the container.
7.11.2.2 Requirement
When tested in accordance with 7.11.2.3 the protruding part shall collapse to less than 40mm.
7.11.2.3 Test procedure
Assemble the protruding part with its matched components) including the container. Clamp the
container in a suitable device.
Apply a force of (10 ± 1) N at a crosshead speed of (10 ± 2) mm/min to a 100 mm x 100 mm polished
steel plate positioned at right angles to the major axis of the protruding part (see Figure 22). The end of
the protruding part can be moved a maximum of 5° off the major axis at the start of the test.
Measure the length from the locking ring to where the protruding part bends, using a suitable
measuring device with an accuracy of 0,1 mm. If no locking ring exists measure the length from where
the protrusion emerges from the container to where the protruding part bends.
Dimensions in millimetres
Key
A direction of force
B steel plate
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7.11.3.1 Principle
The purpose is to test the security of a drinking accessory, when assembled as intended to be used
which is why the test has to be done only on feeding teats. Non - elastic drinking accessories will
normally not break or separate even at higher forces than required under 7.11.3.3.
When tested in accordance with 7.11.3.3, any individual part of the product (excluding a straw) that
constitutes a protrusion and that passes through templates A or B (see Figure 15) or protrudes from the
base of the templates shall meet the requirements of 7.11.3.2.
7.11.3.2 Requirement
When tested in accordance with 7.11.3.3 no part of a feeding teat shall break, tear or separate from the
container.
7.11.3.3 Test procedure
Orientate the component to be tested in a position which would most likely permit the entry of the
component through the slot in the test template. Check if it passes through the slot or whether any part
protrudes beyond the base of the template, using only the mass of the component.
Assemble the component(s) to the container. Where a locking ring is provided, tighten it to a torque of
(1,75 ± 0,25) Nm.
Secure the container at an angle of 45 degrees to the major axis (see Figure 13).
Using a suitable clamping device, hold (10 ± 2) mm of the sides of the feeding teat in line with the major
axis.
Apply a pre-load of (5 ± 2) N at 45 degrees to the major axis of the feeding teat to ensure alignment,
then increase the force to (60 ± 5) N in the same direction, at a crosshead speed of (200 ± 5) mm/min.
Maintain for (10 ± 0,5) s.
7.12 Cords or loops
7.12.1 Principle
When tested according to 7.12.3 the maximum length of a single cord shall not exceed 220 mm. If there
is a loop it shall have a maximum circumference of 360 mm. If the loop opens when pulled with 90 N,
the single cords shall each not exceed a length of 220 mm. Parts of the product which extend the
circumference of the loop shall be included in the measurement of the loop.
7.12.3 Test procedure
A tensile force of (25 ± 2) N shall be applied in such a way that the longest length is achieved. After
(60 ± 2) s measure the length whilst the force is still applied. All configurations shall be measured, in
order to determine the longest length. A loop shall also be measured under a tension of (25 ± 2) N and
the single length of one side is multiplied by two in order to calculate the circumference.
Integrity of the loop shall be assessed by using a force of (90 ± 2) N. Use a suitable clamping device or
other means fixing the clamped part of the loop securely. The points to apply the force are the two
points where the loop ends and begins and the middle of the loop, which shall be determined by using
the method to determine the longest length. Apply the force once in the most onerous way. If unclear,
try several approaches. A preload of (5 ± 2) N shall be applied to align the specimen and the force shall
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EN 14350:2020 (E)
be increased to (90 ± 5) N at a crosshead speed of (100 ± 5] mm/min and maintained at that load for
(10 ± 0,5] s. After release, check the loop for its integrity.
8.1 General
Drinking equipment shall be subjected to the sample preparation as specified in 8.2 and shall meet the
requirements as specified in 8.3.
Materials not included in Table 3 but used in a component of the drinking equipment shall be assessed
to ensure there are no chemicals that present a risk to health whether or not specified in this document.
8.2 Preparation of samples for chemical tests
8.2.1 General
The sample preparation described in 8.2.2 shall apply to all tests excepting N-nitrosamines and N-
nitrosatable substances release, see 8.5.
Samples and test portions shall only be handled with suitable (for example, non-rubber) gloves to avoid
contamination and stored in securely fastened containers free from potential contaminants and
protected from light.
8.2.2 Boiling
All samples, excluding single-use products (3.11) and ready to use products (3.13), shall be immersed in
boiling water, to the requirements of EN ISO 3696, Grade 3, for (10 ± 1) min without touching the walls
of the container. The samples shall be removed and kept in a closed container, for example a desiccator
to reduce the risk of contamination.
8.3 Requirements by component and material
8.3.1 Requirements for food contact materials
The components in Table 2 are intended to be in contact with food. All food contact materials and
articles are regulated by European Regulation (EC) 1935/2004 [1] and relevant implementation
measures, for example, European Regulation (EU) number 10/2011 for plastic materials and articles
intended to come into contact with food [2J.
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Definition
Component
Clause
3.2 Drinking accessory
3.2.1 Feeding teat
3.2.2 Drinking spout
3.2.3 Push pull valve
3.2.4 Straw
3.3 Container
3.3.1 Feeding bottle
3.3.2 Drinking cup
3.3.3 Feeding bag
3.5 Sealing disc
3.6 Protective covers
8.3.2 Other requirements
Materials used in the manufacture of components of drinking equipment shall be subjected to the tests
marked with an x in Table 3. This list is not exhaustive but includes the most common combinations of
component, materials of construction and test methods.
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Table 3 — Other requirements and tests to be carried out on components and materials
Requirement Clause 8.4.1 8.5 8.6.1 8.7.1 8.7.1 8.7.1 8.8.2 8.9.1 8.10.1
8.11.1
Test Clause 8.4.2 8.5 8.6.2 8.7.2 8.7.2 8.7.2 8.8.3 8.9.2 8.10.2
8.11.2
Primary aromatic
Definition Clause
Colour fastness
Formaldehyde
N-nitrosatable
MBT release
Component
substances
and metal
elements
Volatiles
Material
amines
3.2.1 to 3.2.4 Drinking accessories plastic X X
TPE X X X X X
silicone rubber X X X X X
rubber X X X X X X X
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silicone rubber X X X X
metal X
decorations X X
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EN 14350:2020 (E)
Requirement Clause 8.4.1 8.5 8.6.1 8.7.1 8.7.1 8.7.1 8.8.2 8.9.1 8.10.1
8.11.1
Test Clause 8.4.2 8.5 8.6.2 8.7.2 8.7.2 8.7.2 8.8.3 8.9.2 8.10.2
8.11.2
Primary aromatic
Definition Clause
Colour fastness
Formaldehyde
N-nitrosatable
MBT release
Component
substances
and metal
elements
Volatiles
Material
amines
3.3.3 Feeding bag plastic X X
silicone rubber X X X X
TPE X X X X
TPE X X X X
3.8
TPE X X X
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EN 14350:2020 (E)
8.4 Volatile compounds content of silicone components intended to be put in the mouth
or in contact with food (see B.14)
8.4.1 Requirement
Silicone rubber components intended to be put in the mouth or to be in contact with food shall be tested
according to 8.4.2, and the results calculated in accordance with 8.4.2.3.
The volatile compounds content shall not exceed 0,5 % (m/m).
Different silicone rubber components shall be tested as separate samples. Each sample shall be tested
as a minimum in duplicate.
8.4.2 Determination of volatile compounds content
8.4.2.1 Apparatus
The oven shall have forced internal air circulation (fan ON) set to low speed and fresh air ventilation
(Opened) set to minimum or closed.
NOTE Some ovens enable 40 % fresh air ventilation with the ventilation flap set to minimum or even "'closed”
position, while other ovens have dampers where the minimum position is fully closed.
8.4.2.1.3 Desiccator containing fresh anhydrous calcium chloride or fresh self indicating silica gel
8.4.2.2 Method
Silicone rubber components shall be disassembled from other components. If this requires cutting from
other components then this shall be performed by a single cut as close to the other component as
possible, without further cutting of the silicone rubber components.
Preboil the silicone rubber components according to 8.2.2.
Collect as many items of the same part (e.g. spout, teat) of the sample as required to achieve a minimum
weight of 10 g.
Preheat the watch glass (8.4.2.1.4) in the oven (8.4.2.1.2) at (100 ± 5) °C for (60 ± 5) min. Remove from
the oven and cool in a desiccator (8.4.2.1.3) for (60 ± 5) min. After cooling, weigh the watch glass and
record as Weight A.
Cut the collected silicone rubber components in pieces of approximately 2 cm x 1 cm. Place the silicone
rubber pieces onto the watch glass, ensuring that they do not overlap. Use up all the pieces from the
collected silicone rubber components.
Place the watch glass with the silicone rubber pieces in the oven at (100 ±5) °C for (60 ± 5) min.
Remove from the oven and cool in a desiccator for (60 ± 5) min. After cooling, weigh the watch glass
with the silicone rubber pieces and record as Weight B.
Place the watch glass with the silicone rubber pieces in the oven at (200 ± 5) °C for 4 h ± 5 min. Remove
from the oven and cool in a desiccator for 2 h ± 5 min. After cooling, weigh the watch glass with the
silicone rubber pieces and record as Weight C.
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Where
A is the weight of the watch glass after the drying step (g);
B is the weight of the watch glass and the sample after the drying step (g);
C is the weight of the watch glass and the sample after the heating step to 200 °C (g).
The difference between the lowest and highest determination shall be less than 0,1 %, otherwise the
test shall be repeated.
The average of the multiple determinations shall be taken as the result. Any volatile compounds content
result above the limit specified in 8.4.1 shall be subjected to an analytical tolerance of 0,3 %.
Examples of applying the analytical tolerance are shown in Table 4.
Table 4 — Volatile compounds content - Examples for applying the analytical tolerance to
analytical results
Analytical result (%) Analytical tolerance Calculated analytical Complies with 8.4.1?
(%) result (%)
0,40 Not required 0,40 Yes
0,55 0,3 0,25 Yes
0,80 0,3 0,50 Yes
1,00 0,3 0,70 No
The analytical tolerance is required to take into account the inherent variability in measurement shown
by interlaboratory trials (see B.14).
The test report (see 11) shall show both the analytical and the calculated analytical results.
8.5 /V-nitrosamines and /V-nitrosatable substances release
Feeding teats made of rubber and other elastomers are regulated by Commission Directive 93/11/EEC
[10] and shall be tested according to EN 12868.
Drinking accessories made of rubber and other elastomers shall be tested according to EN 12868 using
the sample preparation procedures for elastomer and rubber teats given in that standard.
8.6 Migration of certain elements (see B.16 and B.21)
8.6.1 Requirement
When tested in accordance with 8.6.2 the migration of elements from all materials shall not exceed any
of the limits given in Table 5.
Components manufactured from the same material may be tested as a composite sample or as
individual colours. However, if any composite result is greater than any of the limits set in Table 5
divided by the number of components then any of the different colours shall be retested individually.
Decorations shall be scraped off the part of the material on which they are printed. If scraping off is not
possible or the scraped off weight from one sample is less than 10 mg, the test for decorations as
specified in EN 71-3 can be omitted.
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Antimony, Sb 120
Arsenic, As 10
Barium, Ba 4 000
Boron, B 3 200
Cadmium, Cd 3,6
Chromium Cr VI 0,002 «
Cobalt, Co 28
Copper, Cu 1 660
Lead, Pb 5,0
Manganese, Mn 600
Mercury, Hg 20
Nickel, Ni 56
Selenium, Se 100
Strontium, Sr 12 000
Tin, Sn 40 000
Zinc, Zn 10 000
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When components of drinking equipment are tested in accordance with 8.7.2, the migration of 2-
mercaptobenzothiazole shall not exceed the limit given in Table 6.
Table 6 — MBT release limit (see B.22)
Compound CAS number Limit•
mg/kg
2-mercaptobenzothiazole (MBT) 149-30-4 8 mg/kg
a Limits are expressed as amount of substance migrating from one kg of rubber
When components of drinking equipment are tested in accordance with 8.7.2 the migration of the
following antioxidants shall not exceed the limits given in Table 7.
Table 7 — Antioxidant release limits (see B.19)
Chemical name CAS Limitsa
number mg/1
2,6-bis(l,l-dimethylethyl)-4-methyl-phenol (BHT) 128-37-0 0,42
2,2’-methylenebis(4-ethyI-6-tert-butylphenol) (Cyanox 425) 88-24-4 0,08>>
2,2r-inethylenebis(6-(l,l-diinethylethyl)-4-inethyl-phenol) 119-47-1
(Antioxidant 2246)
Butylated reaction product of p-cresol and dicyclopentadiene 68610-51-5 0,34
(Wingstay L)
2,4-bis(octylthiomethyl)-6-methylphenol (Irganoxl520) 110553-27-0
2,4-bis(dodecylthiomethyl)-6-methylphenol (Irganox 1726) 110675-26-8 0,34 <=
a Limits are expressed as amount of substance per litre of migrate.
b This limit is the SML(t) for the sum of Cyanox 425 and Antioxidant 2246.
c This limit is the SML(t) for the sum of Irganox 1520 and Irganox 1726
When components of drinking equipment are tested in accordance with 8.7.2 the migration of
formaldehyde shall not exceed the limit given in Table 8.
Table 8 — Formaldehyde migration (see B.20)
Compound CAS number Limita
mg/1
Formaldehyde 50-00-0 0,5
a Limits are expressed as amount of substance per litre of migrate.
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8.7.2 Determination
8.7.2.1 Principles
MBT, its metal-salts, the antioxidants listed in Table 7 and formaldehyde are quantitatively determined
following migration into an aqueous food simulant (3 % acetic acid]
8.7.2.2 Procedure
Take one elastomeric drinking accessory, cut into two pieces along the major axis and weigh. No further
cutting shall be undertaken.
Place the pieces into the extraction bottle, add (150 + 1) ml 3 % acetic acid. Immerse the elastomeric
parts into the simulant to be completely covered by the fluid. The migration conditions shall be
(24 ± 0,5] h at (40 ± 2] °C.
For silicone containers to be tested for formaldehyde release, fill the container with 150 ml 3 % acetic
acid or if too small to maximum capacity and obtain the migrate as described above.
One part of the migrate (100 ml] is used for MBT and antioxidants determination. A suitable method of
determination for MBT and antioxidants is described in Annex C. The other part of the migrate (50 ml]
is used for determination of formaldehyde as specified in EN 71-11:2005 Clauses 5.5.3.1 to 5.5.3.6 [11].
8.8 Colour fastness (see B.15]
8.8.1 Principle
Filter paper is attached to the tested surfaces, soaked with the test liquids (3 % acetic acid, coconut fat]
and conditioned. The colour of the filter paper is then compared to a blank.
8.8.2 Requirement
Components which have been coloured or printed shall not release any colourant showing a visible
difference when compared to the blank in the filter paper test described in 8.8.3.
8.8.3 Determination of colour fastness
8.8.3.1 General
This test follows the principles given in "Priifung von eingefarbten Bedarfsgegenstanden aus
Kunststoffen und anderen Polymeren auf Farblassigkeit" [12]
8.8.3.2 Apparatus and Materials
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8.8.3.3 Reagents
Coconut fat has the advantage to be colourless. If it is solid at room temperature, it needs to be warmed
to liquify before the test, e.g. to 50 °C. Alternatively, rectified olive oil according to Table 2 in "JRC
Scientific and Technical Report "Suitability of new sources of olive oil intended to be used as simulant D
in migration testing" [13] can be used.
8.8.3.4 Procedure
Place strips of filter paper (8.8.3.2.2) of appropriate size (10 to 15 cm2] onto those areas of the product
to be tested. Fix the strips to the product by colourless adhesive tape (8.8.3.2.3]. Saturate the filter
paper strips on the product with acetic acid (3 %] (8.8.3.3.1) and immediately wrap the test sample in
polyethylene foil (8.8.3.2.4). In parallel, prepare the blank by wrapping a strip of filter paper moistened
with excess 3 % acetic acid in polyethylene foil (8.8.3.2.4).
If necessary to achieve close contact between the filter paper and the tested surface, wrap in aluminium
foil and compress the foil around the sample.
Place both the sample and the blank in the oven (8.8.3.2.1) maintaining a temperature of (50 ± 2) °C.
After (5 ± 0,1) h remove from the oven. Remove the filter paper strips from the foil and visually
compare with the blank under daylight or adequate illumination. The requirement shall be fulfilled also
when the filter paper is dried.
Perform the same test with another sample using warm, liquid coconut fat (8.8.3.3.2) as test liquid.
8.9 Migration of primary aromatic amines (see B.23)
8.9.1 Requirement
Primary aromatic amines shall not be released into food or food simulant. Compliance shall be
established using test methods that can confirm the absence of migration above a limit of detection of
0,01 mg/kg, which applies to the sum of primary aromatic amines released.
8.9.2 Method for the determination of the migration of primary aromatic amines
The migration shall be carried out for (24 ± 0,5) h in 3 % acetic acid at (40 ± 2) °C. The migration ratio
shall correspond to the surface to volume ratio under foreseeable conditions of use.
Analytical methods suitable for determination of primary aromatic amines migrated out under above
conditions are described in "JRC Technical guidelines on testing the migration of primary aromatic
amines from polyamide kitchenware and of formaldehyde from melamine kitchenware" [14].
8.10 Migration of lead and cadmium from glass (see B.17)
8.10.1 Requirement
When glass components in contact with food are tested according to 8.10.2 the migration of lead and
cadmium shall not exceed 10 pg lead and 3 pg cadmium per litre simulant (see B.17).
8.10.2 Determination of lead and cadmium
The determination shall be carried out according to analytical method described in EN ISO 17294-2
[15]. The glass container shall be filled with the 4% acetic acid aqueous solution to the indicated
maximum capacity. The migration shall be carried out for (24 ± 0,5) h at (22 ± 2) °C.
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When metal components in contact with food are tested according to 8.11.2 the migration of elements
shall not exceed the limits given in "EDQM Metals and Alloys used in food contact materials and articles”
[16],
8.11.2 Determination of elements
The determination shall be carried out according to "EDQM Metals and Alloys used in food contact
materials and articles" [16],
The migration shall be carried out for (24 ± 0,5) h in 5g/L citric acid at (40 ± 2) °C. The migration ratio
shall correspond to the surface to volume ratio under foreseeable conditions of use.
9 Consumer packaging
The package as received by the consumer shall include clear, legible instructions for the use and
hygienic care of the drinking equipment (see Annex E).
These instructions shall be given as described in Clause 10.4 and may be included on a separate leaflet
placed inside the packaging or in/on the product.
Feeding teats and drinking accessories shall be sold in clean condition.
NOTE Consumer packaging should be designed and manufactured to avoid contamination of the product
under the foreseeable conditions of transport and storage. Manufacturers when designing consumer packaging
should consider environmental issues, such as disposal instructions and recycling.
10 Product information
10.1 General
The text shall be printed in the official main language of the country of retail sale. If additional
languages are included, they shall be easy to distinguish, e.g. by separate presentation.
Product information for sales by mail order, either via catalogue or from the Internet shall be in the
language of the catalogue or Internet page. However, an additional choice of languages may be offered.
NOTE The manufacturer or distributor when considering languages for both retail and Internet sales should
not only pay attention to the official main language, but also to significant minority languages, which may be one
of the official languages.
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— warnings and instructions for use given in 10.3 and 10.4 or if these are included within the
packaging, an indication that this is the case;
— for products made from natural rubber latex: "Produced from natural rubber latex";
— for products containing straws: "Straws are not suitable for a child under 6 months";
— for single-use products: "This is a single use product and shall be disposed of after first use";
— for drinking accessories sold separately, an indication of the containers for which they are suitable
shall be provided.
For feeding teats it is recommended that additional information on flow rate, hole size or type of feed
should be given.
NOTE 1 Examples for visibility at the point of sale are: on the packaging, on a leaflet placed inside the product
but which is visible at the point of sale; printed on the side of the product, on the Internet page, when sold on line
or in the mail order catalogue.
10.3 Warnings
10.3.1 General
Translations of these warnings into other languages shall use those given in Annex A (normative).
All warnings shall be kept together and distinguished from other text. Individual warnings shall be
easily distinguishable from one another, e. g. by bullet points or by using a new line.
It is recommended that the supplier of drinking equipment include informative literature to explain the
reasons and background for the warnings. Examples of possible phrases are:
— Accidents have occurred when babies have been left alone with drinking equipment due to the baby
falling or if the product has disassembled.
— Tooth decay in young children can occur even when non-sweetened fluids are used. This can occur
if the baby is allowed to use the bottle/cup for long periods through the day and particularly
through the night, when saliva flow is reduced or if it is used as a soother.
For glass bottles permanently covered with other material to make it more resitant to breakage, e.g.
silicone, there has to be an additional warning on the bottle to make the adult aware of possible but not
obvious breakage. Shards or splinters of glass can be in the bottle without being discovered and
therefore swallowed by children.
The following heading shall be used for the warnings section:
For your child's safety and health
WARNING!
10.3.2 Warnings for all drinking equipment
For all drinking equipment the following warnings shall be provided in the form and order given:
— Continuous and prolonged sucking of fluids will cause tooth decay.
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— Never attach to cords, ribbons, laces or loose parts of clothing. The child can be strangled.
The following additional warnings shall be provided if applicable in the form given.
For products with feeding teats:
— Never use feeding teats as a soother.
Information on the safe use of drinking equipment and the following instructions shall be provided as
applicable on the packaging or in a leaflet. Alternative wording is permitted. Further instructions may
also be provided.
10.4.2 Re-usable products (3.12)
— Before first use, disassemble and clean the product and then place the components in boiling water
for 5 min. This is to ensure hygiene.
— Where applicable methods of cleaning food from non-visible surfaces. Instructions shall ensure that
all parts including areas which may not be visible but where food has passed through are
thoroughly washed and flushed with clean water to remove any food residues.
— Where applicable, unsuitable common methods of heating, cleaning (including where applicable
unsuitable common cleaning agents), storage and use which might damage the product.
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inspect the feeding teat before each use and pull the feeding teat in all directions. Throw away at
the first signs of damage or weakness.
Do not leave a feeding teat in direct sunlight or heat, or leave in disinfectant ("sterilising solution")
for longer than recommended, as this may weaken the teat
— information that it is a single use product which shall be disposed of after first use;
— if applicable, information on unsuitable common methods for heating and storage which might
damage the product.
— Do not use if there are signs of damage or weakness to either the primary packaging or the product.
If a ready to use product is not intended to be re-used the instructions for single use products (10.4.3)
shall also be provided.
If a ready to use product is intended to be re-used this should be clearly stated and the instructions for
re-usable products (10.4.2) shall also be provided.
10.4.5 Feeding bags and holders for feeding bags (see 3.3.3 and 3.3.4)
— information that if more accurate measurement of breast milk is required then a feeding bottle
complying with EN 14350 or a more accurate measuring device shall be used.
Take extra care when microwave heating; localized over heating can occur. Always mix the heated food
and check the temperature before feeding.
10.5 Supply chain information for products that contain vulcanised rubber
10.5.1 Requirements
The following information shall be provided on any outer packaging (see 3.14) used for storage of
products that contain vulcanised rubber (this does not include the packaging intended for consumers).
This information in the form of text given in 10.5.2, in the local language, and/or the symbol given in
10.5.3, Figure 23 shall be visible on the outside of the packaging at least once.
10.5.2 Text
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10.5.3 Symbol
NOTE The symbol shown in Figure 23 is taken from ISO 7000:2014, symbol number 0624.
11 Test report
Each test report shall include at least the following information:
a) title (e.g. "Test Report");
c) information on the scope of accreditation of third party laboratories and where applicable the
subcontractor(s) and identifying the relevant test clauses;
d) unique identification of the test report (such as the serial number), and on each page an
identification in order to ensure that the page is recognized as a part of the test report, and a clear
identification of the end of the test report;
f) reference to this document (EN 14350) and the date of its publication;
g) description and unambiguous identification of the item(s) tested and of the condition in which they
were received by the laboratory (e. g. consumer packaging, undamaged or in bulk);
h) date of receipt of the test item(s) and the date(s) of performance of the test(s);
i) test results with, where appropriate, the units of measurement and relevant clauses;
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l) name(s), function^] and signature(s) or equivalent identification of person(s) authorizing the test
report;
m) If the product fails any requirement then a photograph of the product shall be included with the
test report, to assist identification of the failed product.
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Annex A
(normative)
Warnings
The translations shown in Table A.l shall be used for the relevant country of retail sale for the warnings
given in Clause 10.3 in the form given.
Translation into languages not listed shall be made and the national standardization body be informed.
Table A.l — Translation of warning phrases
English For your child's safety and health
WARNING!
Always use this product with adult supervision.
Never use feeding teats as a soother.
Continuous and prolonged sucking of fluids will cause tooth decay.
Always check food temperature before feeding.
Glass bottles may break.
Keep components not in use out of the reach of children.
Throw away at the first signs of damage or weakness.
Single-use only.
Due to strangulation hazards do not extend cords or loops.
Never attach to cords, ribbons, laces or loose parts of clothing. The child can be strangled.
For use with Breast Milk only. Not to be used for mixing formula milk.
Bulgarian 3a 6e3onacHocTTa h 3/ipaBeTo Ha BauieTo /jeTe
BHHMAHHE!
BwHarw u3nojT3BanTe to3m npo^yKT no/t Ha/j3op Ha B,b3pacTHW.
H wk ora ne w3noji3BawTe bwSepoun 3a xpaiieiie i<aTo 6w6epoH-3ajrbraJiKa.
HenpeicbCHaTOTO w upo^JiTKHTejiHO CMyKaHe Ha TeuHOCTK me /joBe/je 40 Kapwec.
BwHarw npouepMuaMTe TeMnepaTypaTa Ha xpaHaTa npe/jw xpaHeHe.
CrbK/ieHM byTWJiKH Moxee /ja ce cnyiiOT.
CiixpaimBanTe KOMnoHeuTHTe, kohto i-ie ce w3noji3BaT, H3B'bH obcera ua zjeqa.
M3XBijp^eTe npw mbpBHTe npw3Haqw Ha yBpew/tane hjth /jec|)eKT.
CaMO 3a e/jHOKpaTHa ynoTpeba.
riopa/tw onacHOCTWTe OTy/jyuiauaHe He y^'bJixcaBawTe uiHypoue wjim npMMKW.
HwKora He npnKpermuTe k'bm lUHypose, naimejiKw, ^aHTe/iw wjih cbo6o/jhh hbcth ot
,qpexn. ^CTeTo Mox<e 4a Sime y/tymeHo.
3a ynoTpefia caMo c K’bpMa. /la He ce w3noji3Ba 3a npwroTBBue na cyxo mjthko.
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Greek Tia rqv aocpdAsia Kai ttjv uysia tov naiSiov aaq
IIPOEIAOnOIHSH!
To ITpOlOV (WTO TipETlEL Vtt XpT|OLpOTTOLELTCtl TUXVTO pE T1]V EllipAElpl] EVT|AlKCL
Mr| xpiioipuTTOLEiTE tu; 0i]Aeq TafopaToq cot; lurriAa.
Svvex^ Kai TTapaTEiapEvo iriTTiAicrpa pocpipidTinv 0a TTpoKaAecrEi T£pr|66va.
EAeyxete ^avra Ti] 0£ppoKpacria tt]<; Tpocpi]<; TTpiv to Taicrpa.
Ta yvaALva pnipnEpo ev<5exetol va anacrouv.
<J>uAaaaETE Ta E^apvqpaTa ttou Sev xPTQLP0Tr0L°^VTLXL paicpia ano TiaiSid.
FlETa^TE to Tipoidv pe Ta Trpayra oripaSLa <p0opd<; f| aSuvapiaq.
Flpoiov piaqxP^hS'
Aoya) KivSuvou OTpayyaAiopov pi]v ttpoektelvete Ta KopSovia i] tu; 0i]Aieg.
Mi] chjvSeete to Tipoiov ps ax0LVK^ kopSeAec;, KopSovia i] Aura pspi] vipacrpaToc;. To naiSt
EV^EXETat va OTpayyaALOTEi.
Tia XPPQ11 povov pE prjTpiKO yaAa. Mi] to xPT]oipoitoieite yia va avaKQTEipETE yaAa as
QKOvrp
Hungarian A gyermeke biztonsaga es egeszsege erdekeben
FIGYELEM!
Mindig felnott feliigyelete mellett hasznalja ezt a termeket.
Soha ne hasznalja az etetogumit cumikent.
A folyadekok folyamatos es hosszu ideig tarto szfvasa fogszuvasodast okoz.
Etetes elott mindig ellendrizze az etel homersekletet.
Az iiveg cumisiiveg torekeny.
A hasznalaton kivuli alkatreszeket tartsa tavol a gyermekektoL
Ha az anyag gyengiilesenek vagy seriilesenek elso jelet eszleli azonnal dobja el
Csak egyszeri hasznalatra
Fulladas veszely elkeriilese erdekeben, ne hosszabbftsa meg a zsinorokat vagy hurkokat.
Soha ne rogzftse zsinorokhoz, szalagokhoz vagy konnyen elmozduld ruhadarabokhoz. A
gyermek megfulladhat
Csak anyatejhez hasznalhato. Nem hasznalhato tapszer keveresehez
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Annex B
(informative)
Rationales
B.l Introduction
This informative annex has been included with the purpose of providing the rationales for the inclusion
of some of the requirements given in this document
This document has been prepared using the latest information available to the Technical Committee as
of May 2019.
The purpose of a rationale is to provide the underlying principles for a description or reasoning for
requirements and tests to aid the application of the standard to an article. Also to provide additional
information that aids understanding of the reasons why requirements have been made and any
limitations or precautions that needs to be kept in mind when applying the standard to products.
B.2 General
Drinking equipment is used by a wide age range: newborns, neonates (0 to 4 weeks of life), infants,
toddlers and young children. Historically, accidents are rare and it is the intention of the Technical
Committee to continue to minimize any risks in the future. The prime purpose of this document is to
reduce the risk of accidents occurring in the future. It is stressed that this document cannot eliminate all
possible risks to babies and young children using drinking equipment and that parental or guardian
supervision is important. It is essential that all warnings and instructions specified in this document are
given clearly by the manufacturer, to allow the carer to ensure that drinking equipment is used
correctly and safely.
Since the products covered by this document are supposed to be used under adult supervision, a
possibility of damage due to dropping is not deemed a risk. The carer can intervene and prevent the
child from being injured.
Glass is known to be a fragile material and therefore a warning has been included in this document. If
glass bottles are covered by some other material, e.g. silicone, the breakage might not be recognised and
therefore the user is in danger. Manufacturers have to be aware of this and give proper notice to the
adults.
The Technical Committee considered the issue of shelf life / expiry date for a long time. It decided to not
include shelflife / expiry date in the standard because:
Non suitable storage and inappropriate use can damage a product - much before reaching expiry date.
Therefore giving a shelflife / expiry date could mislead the consumer that any product must be fit for
use while within the shelf life, which could encourage the consumer to ignore warnings and not follow
the safety instructions.
B.3 Preparation of samples for construction and mechanical tests (see 6.1)
The rationale for specifying that all samples should be at least 3 days post-production is to allow factors
such as humidity and shrinkage of materials to stabilize. When submitting a sample to a laboratory the
manufacturer will declare the date of manufacture which will be included in the Test Report. All
samples taken from the market can be assumed to be more than 3 days post-production.
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B.8 Volumetric labelling and accuracy requirements (see 7.6.1. and 7.6.2)
The Technical Committee believes it is essential following discussions with various authorities and the
World Health Organization (WHO), for feeding bottles to have accurate graduations. This is to assist the
carer in correctly making up formula milk, and also to allow the carer to quantify the volume of fluid
consumed by the child.
The graduations required for feeding bottles represent the volumes and measurements found in the
instructions on most common retail packaging for formula milk. The Technical Committee conducted
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market research in several member states of the EU and found the given volumes to be representative.
The safety objective is to enable the carer to mix the formula milk accurately.
Drinking cups are used by older children where these requirements are not essential. However, if
graduations are given on drinking cups then accuracy requirements apply (see 7.6.2.1).
The volumetric accuracy requirements (see 7.6.2.1) and tests (7.6.2.2) are the same as given in
EN 14350-1:2004. They were the result of an extensive market survey and a round robin series of tests
and still represent what is currently technically feasible.
Accuracy of graduations on feeding bags currently on the market does not appear to be reproducible as
it is for bottles. Formula milk requires accurate graduations to ensure correct mixing while breast milk
does not. After a market assessment of feeding bags an accuracy requirement of 15 % was found to be
technically feasible. Therefore, feeding bags are not suitable for mixing formula milk.
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Permanent protective covers stay connected to the drinking equipment also when in use, see 3.2. If
disassembly does not occur at less than 90N then no hazard exists. A series of tests concluded that
either the forces required to remove these covers from drinking equipment were greater than 90 N or
those parts which disassembled at less than 90N did not constitute small parts. Therefore, a test for
Small Parts was added to the requirements - see 7.8.1.
Templates A and B were added to the requirements to test for any hazard that may be created by any
protrusions - see 7.8.2.
The Technical Committee is not aware of any serious accidents with protective covers despite being
very common in the marketplace.
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Certain elements may be present and be released from the raw materials used in the manufacture of
drinking equipment such as inks, pigments, fillers, anti-oxidants etc. or through inadvertent
contamination during the production process.
TD! values have been taken from the sources given in Table B.l.
B.16.2 Calculation of migration limits
Using a defined method such as EN 71-3 which simulates the effect of ingestion, a maximum migration
limit can be calculated based on the weight of sample ingested. Using the allocated percentage of the
TDI (see B.16.5), the weight of a child (see B.16.3), and the amount of material that may be
bitten/scraped off a drinking equipment and ingested (see B.l6.4), the migration limit in terms of mg
element/kg material, can be expressed in the following formula:
Migration limit [mg/kg] = {(T x A x W) v B} x 1000 (Table B.l)
where:
T is the TDI in micrograms per kilogram body weight per day;
A is the allocation of TDI as a decimal;
W is the weight of the child (kg);
B is the amount of material that can be bitten/scraped off a teat or a drinking accessory (mg);
1 000 is the multiplication factor.
For example, using the TDI value shown in Table B.l, the migration limit for antimony (Sb) can be
calculated as follows:
Migration limit (Sb) = {(6 x 0,1 x 5) - 25} x 1000 = 120 mg /kg
B.16.3 Weight of a child
This document covers drinking equipment for children from birth to 48 months of age. Accordingly,
body weights in this age range vary significantly. Many Experts agree that the age when the '"average"
baby has grown teeth which are capable of scraping-off material from drinking equipment is 6 months,
corresponding to a body weight of more than Skg.Therefore the Technical Committee has decided to
use a body weight of 5kg (lowest foreseeable weight of a baby with teeth) for calculating the migration
limits for certain elements shown in Table B.l
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There are no definitive studies providing information on the amounts of material that may be ingested
when using drinking equipment. Examination of used drinking equipment has shown that while the
most likely source of ingested material is from scraping off, resulting amounts are quite small. Larger
quantities may be ingested if parts are bitten off from teats or soft drinking accessories when the child
is left unattended. In the seldom cases when this was observed, missing particles had dimensions up to
3 mm and weights up to 25 mg. In the absence of any other data, and until other evidence to the
contrary becomes available, the value of 25 mg has been taken.
B.16.5 Allocation ofTDI
Following from the RIVM/SIR Advisory Report 320003001 [19], it is not acceptable that the (daily)
systemic exposure from drinking equipment alone would fill up the TDI. Background exposure through
the environment and through food, drinking water and other products designed for children should be
taken into account in order to prevent a total exposure that exceeds the TDI.
The Technical Committee decided to generally use a 10% allocation of TDI where applicable in the
standard. It is also noted that the 2010 SCHER report [20] recommends 10 % allocation for all chemical
elements.
However, Directive 2009/48/EC on the Safety of Toys [21] states (in Recital 22) that “Limit values for
arsenic, cadmium, chromium VI, lead, mercury and organic tin, which are particularly toxic, and which
should therefore not be intentionally used in those parts of toys that are accessible to children, should
be set at levels that are half of those considered safe according to the criteria of the relevant Scientific
Committee". Therefore, a 5 % allocation has been set for arsenic, cadmium, lead, and mercury.
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Table B.l — TDI Values for certain elements and calculated migration limits
TDI Migration
Allocation of
Element Symbol (pg/kg body Sources of TDI limits
TDI
weight] (mg/kg)
Aluminium Al 300 0,10 [22] 6000
Antimony Sb 6 0,10 [19] 120
Arsenic As 1 0,05 [19] 10
Barium Ba 200 0,10 [25] 4 000
Boron B 160 0,10 [19] 3 200
Cadmium Cd 0,36 0,05 [26] 3,6
Chromium III Cr 5 0,10 [19] 100
Chromium VI Cr 0,0002 0,05 [27] 0,002
Cobalt Co 1,4 0,10 [19] 28
Copper Cu 83 0,10 [19] 1 660
Lead Pb 0,5 0,05 [23], [24] 5,0
Manganese Mn 30 0,10 [19] 600
Mercury Hg 2 0,05 [19] 20
Nickel Ni 2,8 0,10 [28] 56
Selenium Se 5 0,10 [19] 100
Strontium Sr 600 0,10 [19] 12 000
Tin Sn 2 000 0,10 [19] 40 000
Organic tin 0,25 0,05 [19] 2,5
Zinc Zn 500 0,10 [19] 10 000
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To ensure the safety and suitable quality of food contact materials and articles made from metals and
alloys, the Council of Europe has adopted Resolution CM/Res(2013)9 and a Technical Guide presenting
this resolution and practical guidelines for its implementation was published [16]. Chemical elements
occurring in metallic food contact articles are stated in the current edition of the Technical Guide and
specific release limits (SRLs] have been set for each relevant element. Methods for migration and
detection are also given. They have been adopted by the Technical Committee for food contact drinking
equipment made from metals.
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Table B.2 — TDI values for antioxidants and calculated migration limits
Migration
TDI
Allocation Sources Limit
Antioxidant CAS No. ing/kgbody of TDI [%] ofTDI (mg/1)
weight/day
mg/1
2,6-Di-t-butyl-4-methylphenol 128-37-
0,25 10 [29] 0,42
BUT 0
2,2'-methylenebis(4-ethyl-6-
tert-butylphenol] 88-24-4
Cyanox 425
0,025 20 [30] 0,08’
2,2'-methylene bis(4-inethyl-
119-47-
6-tertbutylphenol]
1
Antioxidant 2246 or A22M46
2,4-bis(octylthiomethyl)-6-
methylphenol 110553-
27-0
Irganox 1520
0,10 ‘ 20 [31] 0,34
2,4-bis(dodecylthiomethyl)-
6- methyiphenol 110675-
26-8
a This migration limit is the sum of Cyanox 425 (2J2'-methylenebis(4-ethyl-6-tert-butylphenol) and Antioxidant
2246 (2,2'-methylene bis(4-methyl-6-tertbutylphenol)].
b There is no published TDI for Wingstay L, only a SML. The TDI given here is back calculated, taking the same
ratio as for Irganox 1520 [2,4-bis(octylthiomethyI)-6-methylphenoI] and Irganox 1726
[2,4-bis(dodecylthiomethyl)-6-methylphenol], for which both a TDI and SML are published.
c The TDI is for the sum of Irganox 1520 (2,4-bis(octylthiomethyl]-6- methylphenol] and Irganox 1726
(2,4-bis(dodecylthiomethyl]-6-methylphenol)
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Annex C
(informative)
C.l Apparatus
C.1.1 Flask, (approx. 250 ml with flat base)
C-l-2 Glass rods
C.l.3 HPLC, UV /DAD detector
C.1.4 HPLC-column,
C.1.5 Reagents
C.l.5.1 Water (distilled or deionised)
C.1.5.2 Methanol (HPLC grade)
C.1.5.3 Ammonium acetate (Analytical grade)
C.l.5.4 Acetic acid (3 %)
C.l.5.5 Formic acid (HPLC grade) - For concentration step according to C.2.a)
C.l.5.6 Dichloromethane (Residue analysis grade) - For concentration step according to C.2.b)
C.l.5.7 Sodium sulphate anhydrous - For concentration step according to C.2.b)
C.2 Procedure
100 ml of the migrate obtained from 8.7.2 is subjected to a concentration step. Options for
concentration step:
a) SPE column with reverse phase, using methanol and water for conditioning and methanol with
formic acid content for elution. The extract is evaporated carefully to dryness under Nz in an
evaporation step. The residue is then re-dissolved in 0,5 ml methanol and analysed with HPLC.
Concentration with SPE column - reverse phase C18, for example ISOLUTE C18(EC) 500 mg/10 ml as
follows:
— Conditioning: 4 ml methanol;
— The pH of the migrate should be set to pH of 2 (by using Hydrochloric acid) before loading;
or
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b) Fluid-fluid extraction in dichloromethane. Shake the aqueous migration liquid with two 50 ml
aliquots of dichloromethane. The combined organic phases are dried over anhydrous Sodium
sulphate and evaporated carefully to dryness. The residue is then re-dissolved in 0,5 ml of
methanol and analysed with HPLC.
C.3 Column
A Spherisorb S5C8, 4,6 pm diameter, length 25 cm. column has been found to be suitable.
The following operating conditions are suitable for this column:
— Mobile phase (Eluent A): Ammonium acetate buffer 0,005M, pH 5,8 ± 0,01
Depending on the type of equipment used, establish the appropriate operating conditions and adjust
the gradient of the eluent if a different column to that described above is used.
C.4 Detection
MBT: UV 320 nm, Diode array spectrum from 240 nm to 360 nm.
Antioxidants: UV 280 nm, Diode array spectrum from 240 nm to 360 nm
C.5 Standards
The standards shown in Table C.2 have been found to be suitable
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Key
MBT: approximately 10,5 min (max absorbance 320 nm);
Antioxidant BHT: approximately 17,3 min (max absorbance 280 nm);
Antioxidant 2246: approximately 18,5 min (max absorbance 280 nm);
Cyanox 425: approximately 19,4 min (max absorbance 280 nm);
Wingstay L: approximately 20,0 min (max absorbance 280 nm);
Irganox 1520: approximately 21,7 min (max absorbance 280 nm);
Irganox 1726: approximately 23,9 min (max absorbance 280 nm)
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Annex D
(informative)
A-Deviations
A-deviation: National deviation due to regulations, the alteration of which is for the time being outside
of the competence of the CEN/CENELEC member.
This European Standard does not fall under any Directive of the EC.
In the relevant CEN/CENELEC countries these A-deviations are valid instead of the provisions of the
European Standard until they have been removed.
Deviation
Danish deviation in accordance with Danish Statutory Order from the Ministry of the Environment No. 5
of 05/01//2016 on soothers and bottle teats
§3 "All manufacturers, importers and retailers shall provide the sales packaging of soothers and bottle
teats with easy legible, visible and permanent marking stating:
a) Name/company name and address or registered trademark;
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Annex E
(informative]
E.l General
After considering a large sample of products from the market and other relevant standards and
guidelines, the Technical Committee recommend the following for visibility and legibility of warnings,
product and purchase information and instructions for use.
E.2 Warnings
Emphasize warnings, for example, by placing them in a prominent position on the product, on a leaflet
and/or on the packaging. The prominent position does not necessarily mean the front panel of the
packaging.
The text of the warnings on the packaging should be conspicuous and reasonably related to the font,
visibility, legibility and size of other printed matter on the packaging.
Avoid mixing safety information with commercial information.
The colour of the warning should be in sharp contrast with the background. Avoid using similar
foreground and background colours such as white text on yellow background. Dark ink on bright paper
or bright ink on dark paper provides good contrast
For the background of the warning avoid strong background patterns or images that may interfere with
the warning and avoid red-green and blue-yellow colour combinations, as these may create problems
for persons with colour-vision deficiency.
E.3 Font
Preferably use sans-serif font types, for example Arial, Verdana and Tahoma. Avoid the use of different
font types in the warning text.
Use font sizes that allow all target groups, including those with corrected vision, to read the warning. It
is recommended that the minimum size of capital letters is 1,3 mm. This equates to a font size of
approximately 4,5.
E.4 Multi-languages
In multi-language text, clearly separate the individual languages, for example by a flag, spacing, country
code or other means.
79
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BS EN 14350:2020
EN 14350:2020 (E)
Bibliography
[1] Commission Regulation (EC) No 1935/2004 of 27 October 2004 on materials and articles
intended to come into contact with food
[2] Commission Regulation (EU) 10/2011 of 14 January 2011 on plastic materials and articles
intended to come into contact with food
[3] Commission Regulation (EC) No 552/2009 of 22 June 2009 amending Regulation (EC) No
1907/2006 of the European Parliament and of the Council on the Registration, Evaluation,
Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII
[5] EN ISO/IEC 17025:2017, General requirements for the competence of testing and calibration
laboratories (ISO/IEC 17025:2017)
[6] EN 1400:2013+A2:2018, Child use and care articles - Soothers for babies and young children -
Safety requirements and test methods
[7] EN 14372:2004, Child use and care articles - Cutlery and feeding utensils - Safety requirements and
tests
[8] EN ISO 1302, Geometrical Product Specifications (GPS) - Indication of surface texture in technical
product documentation (ISO 1302:2002)
[10J Commission Directive 93/11/EEC Commission Directive of 15 March 1993 concerning release of
N-Nitrosamines and N-Nitrosatable substances from elastomer or rubber teats and soothers
[11] EN 71-11:2005, Safety of toys - Part 11: Organic chemical compounds - Methods of analysis
[12] Franck R., ed. „Kunststoffe im Lebensmittelverkehr", ISBN 978-3-452-16045-4, Part B II / IX:
„Priifung von eingefarbten Bedarfsgegenstanden aus Kunststoffen und anderen Polymeren auf
Farblassigkeit"]
[13] Simoneau et al, JRC Scientific and Technical Report "Suitability of new sources of olive oil
intended to be used as simulant D in migration testing", EUR 23395 EN-2008
[14] Technical guidelines on testing the migration of primary aromatic amines from polyamide
kitchenware and of formaldehyde from melamine kitchenware. JRC Scientific and Technical
reports, Annex 1, 2011
[15] EN ISO 17294-2:2016, Water quality - Application of inductively coupled plasma mass
spectrometry (ICP-MS) - Part 2: Determination of selected elements including uranium isotopes
(ISO 17294-2:2016)
[16] Metals and Alloys used in food contact materials and articles, European Directorate for the
Quality of Medicine and Health Care, Committee of Experts on Packaging Materials for Food and
Pharmaceutical Products (P-SC-EMB), Council of Europe, Strasbourg 2013
80
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BS EN 14350:2020
EN 14350:2020 (E)
[17] ISO 7086-1, Glass hollowware in contact with food — Release of lead and cadmium — Part 1: Test
method
[18] ISO 7086-2, Glass hollowware in contact with food — Release of lead and cadmium — Part 2:
Permissihie Iimits
[19] Chemicals in Toys — A general methodology for assessment of chemical safety of toys with a
focus on elements. RIVM Report 320003001, National Institute for Public Health and the
Environment, The Netherlands, 20081] incl. erratum 26/1/2015
[20] SCHER opinion on evaluation of the migration limits for chemical elements in toys, 1 July 2010
[21] Commission Directive 2009/48/EC of the European Parliament and of the Council of 18 June
2009 on the safety of toys (Recital 22]
[22] SCHER opinion on tolerable intake of aluminium with regards to adapting the migration limits
for aluminium in toys, 28 September 2017
[24] Council Directive (EU) 2017/738 of 27 March 2017 amending, for the purpose of adapting to
technical progress, Annex II to Directive 2009/48/EC of the European Parliament and of the
Council on the safety of toys, as regards lead
[25] SCHER opinion on assessment of the tolerable daily intake of barium, 22.03.2012
[26] Commission Directive 2012/7/EU of 2 March 2012 amending, for the purpose of adaptation to
technical progress, part III of Annex II to Directive 2009/48/EC of the European Parliament and
of the Council relating to toy safety
[28] EFSA Panel on Contaminants in the Food Chain [CONTAM] opinion. EFSA J. 2015,13 [2] p. 4002
[30] RIVM Documentation Toxicology, Summary 300/418 of April 1983, National Institute for Public
Health and the Environment, The Netherlands
[31] Opinion of the Scientific Committee on Food on the 18th additional list of monomers and
additives for food contact materials (expressed on 24th September 2002]
[32] WHO Guidelines for drinking-water quality. World Health Organisation, Geneva, Second Edition,
1993
[33] WHO Guidelines for drinking-water quality. World Health Organisation, Geneva, Third Edition,
2004
[34] Opinion of the Scientific Committee on Food on the 11th additional list of monomers and
additives for food contact materials (expressed on 19th October 2000)
81
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BS EN 14350:2020
EN 14350:2020 (E)
[36] German Federal Institute for Risk Assessment BfR XXI. Commodities based on Natural and
Synthetic Rubber, as of 01.07.2016
[37] EN ISO 2409, Paints and varnishes - Cross-cut test (ISO 2409}
[38] Ordinance on the quality of water intended for human consumption, Annex 2, March 10, 2016,
Ministery of Health, Germany
[40] Commision Implementing Regulation (EU) No 321/2011 of 1 April 2011 amending Regulation
(EU) No 10/2011 as regards the restriction of use of Bisphenol A in plastic infant feeding bottles
82
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