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BSEN 14350:2020

Child care articles — Drinking equipment —


Safety requirements and test methods

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BS EN 14350:2020

EUROPEAN STANDARD EN14350


NORME EUROPEENNE

EUROPAISCHE NORM June 2020

ICS 97.190 Supersedes EN 14350-1:2004, EN 14350-2:2004

English Version

Child care articles - Drinking equipment - Safety


requirements and test methods
Articles de puericulture - Articles pour Falimentation Artikel fur Sauglinge und Kleinkinder - Artikel fur
liquide - Exigences en matiere de securite et methodes fliissige Kindernahrung - Sicherheitstechnische
d'essai Anforderungen und Priifverfahren

This European Standard was approved by CEN on 14 March 2020.

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.

EUROPEAN COMMITTEE FOR STANDARDIZATION


COMITE EUROPEEN DE NORMALISATION
EUROPAISCHES KOMITEE FUR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 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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8.9 Migration of primary aromatic amines (see B.23) 45


8.10 Migration of lead and cadmium from glass (see B.17) 45
8.11 Migration of elements from metal (see B.18) 46
9 Consumer packaging 46
10 Product information 46
10.1 General 46
10.2 Purchase information 46
10.3 Warnings ..................................................... 47
10.4 Instructions for use 48
10.5 Supply chain information for products that contain vulcanised rubber 49
Annex A (normative) Warnings...., •••••••••••••• ••••••• 52
Annex B (informative) Rationales
B.l Introduction
B.2 General 62
B.3 Preparation of samples for construction and mechanical tests (see 6.1) 62
Pre-treatment (see 6.3)
B.4 63
B.5 Boiling (see 6.4) 63
B.6 Decoration, inscription and decals (see 7.2) 63
Additional requirements for sealing discs (see 7.5)
B.7 ••••••• ••••••• 63
B.8 Volumetric labelling and accuracy requirements (see 7.6.1. and 7.6.2) ••••••• 63
B.9 Tear resistance test (see 7.7.1) 64
B.10 Print adhesion of markings and decorations (see 7.6.3) 64
B.ll Protective covers (see 7.8) 64
B.12 Push-pull valves (see 7.7.2) 65
B.13 Handles and clips (see 7.9) 65
Volatile compounds content (see 8.4)...
B.14 65
B.15 Colourants (see 8.8) 66
Migration of certain elements (see 8.6)
B.16 •••••••• •••••• •••••••• 66
Migration of lead and cadmium from glass (see 8.10)
B.17 •••••• ••••••• 68
B.18 Migration of elements from metal (see 8.11) ••••••• 68
Antioxidant release (see 8.7)
B.19 69
B.20 Formaldehyde release (see 8.7) 71
B.21 Cr VI limit (see 8.6) . 71
B.22 Mercaptobenzothiazole (MBT) release (see 8.7) •••••• •••••••• 71
B.23 Migration of primary aromatic amines (see 8.9) •••••••• 71
B.24 Migration conditions for elastomeric materials , 72
(informative)
AnnexCand antioxidantsMethod forinthe
specified determination
Table 7 of 2-mercaptobenzothiazole (MBT)
••••••• ••••••••• •••••••• 73

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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
/

C.7 Retention times 76


C.8 Calculation of MBT and antioxidants ..77
Annex D (informative) A-Deviations •••••• •••••• ••••••• .78
Annex E (informative) Good practice for visibility and legibility 79
E.l General ••••••••• •••••• •••••• 79
Warnings
E.2
E.3 Font.... 79
E.4 Multi-languages.... •••••• ••••••••• •••••• it 79
Bibliography. •••••• •••••• 80

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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.

This document supersedes EN 14350-1:2004 and EN 14350-2:2004.

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.

— Introduction: Completely reworded and references to European regulations were renewed.

— Clause 3: Completely restructured and partly described in more detail. Definitions for completely
new parts were added.

— Clause 4: Several completely new parts were added.

— Clause 5: This clause is completely new.

— Clause 6: This clause is completely new.

— 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.

— Clause 10: Revised and partly reworded.

— Clause 11: This clause on Test report is completely new.

— Annex A: This normative annex with translations of warnings into 24 languages is completely new.

— Annex B: This informative annex with rationales is completely new.

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— Annex C: This informative annex on Method for the determination of 2-mercaptobenzothiazole


(MBT) and antioxidants specified in Table 7 was revised and enlarged.

— 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;

— Single-use containers and drinking accessories sold with these containers;

— Single-use feeding teats;

— Ready to use feeding teats.

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 Terms and definitions


For the purposes of this document, the following terms and definitions apply.
ISO and 1EC maintain terminological databases for use in standardization at the following addresses:
• I EC Electropedia: available at http://www.electropedia.org/

• ISO Online browsing platform: available at https://www.iso.org/obp/ui

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.

Note 2 to entry: See definitions 3.2 to 3.9.

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

Note 1 to entry: A push-pull valve is also known as a “sports cup spout”.

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

Note 1 to entry: Feeding bags are also known as feeding liners.

3.3.4
feeding bag holder
support for a feeding bag

Note 1 to entry: see Figure 4 No 8.

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

Figure 1 — Design features of a feeding teat

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Figure 2 — Examples of feeding teats

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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

Figure 3 — Examples of other drinking accessories

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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

Figure 4 — Examples of containers with feeding teats

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Key
1 drinking cup
2 drinking accessory
3 handle

Figure 5 — Example of container with drinking accessory

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a)

b)
Key
a closed position
b open position

Figure 6 — Example of a push-pull valve

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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

Figure 7 — Examples of protective covers

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Figure 8 — Examples of handles

Figure 9 — Example of a clip

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Figure 10 — Examples of loops

5 Test equipment and tolerances


5.1 Small parts cylinder
Dimensions in millimetres

Figure 11 — Small parts cylinder

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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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5.3 Fixture for security/retention test

ft
Key
A direction of tensile force

Figure 13 — Fixture for security/retention test

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

Figure 14 — Probes for holes (finger traps) test method

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5.5 Templates A and B


Dimensions in millimetres

04
+1
m
r*-

73 ±2

Figure 15 — Template A and B


5.6 Tolerances

Unless otherwise stated, the following tolerances apply:


— Forces: ± 5 % of the nominal force;

— Masses: ± 0,5 % of the nominal mass;

— Dimensions: ±1,0 mm of the nominal dimension;

— Angles: ± 2C of the nominal angle;

— Duration of forces for durability tests: ± 1 s;

— Duration of forces for static load tests: ± 2 s.

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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6 Construction and mechanical properties - General and sample preparation


6.1 Sample preparation for construction and mechanical properties

Samples of single-use products shall be conditioned (6.5) before testing.


Samples of re-usable products shall be boiled (6.4) and conditioned (6.5) before testing.
Samples of any products containing vulcanized rubber shall be pre-treated (6.3) before being submitted
to the above sample preparation.
6.2 General

All samples shall be at least 3 days post-production (see B.3).


6.3 Pre-treatment (see B.4)

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.

7 Construction and mechanical requirements and tests


7.1 Order of testing for construction and mechanical properties

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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Table 1 — Order of testing for construction and mechanical properties

7.2 Decoration, inscription and decals

7.3 Visual and tactile examination

7.4 Small parts

7.5 Sealing discs

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 )

7.7 Drinking accessories


7.7.1 Resistance to tearing
7.7.2. Push-pull valves

7.8 Protective covers


7.8.1 Size of detachable protective cover
7.8.2 Size of permanent protective cover
7.8.3 Security of permanent protective cover

7.9 Handles and clips

7.10 Finger traps

7.11 Protruding parts


7.11.1 Maximum length of protruding parts
7.11.2 Flexibility of protruding parts
7.11.3 Security/retention test for protruding
parts

7.12 Cords and loops

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7.2 Decoration, inscription and decals (see B.6)

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)

7.6.2 Volumetric accuracy

7.6.2.1 Volumetric accuracy requirements (see B.8)

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 %;

— all graduations < 100 ml: ± 5 ml.

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

7.6.3.2.1 Adhesive tape

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

A non-abrasive eraser shall be used.


7.6.3.3 Test procedure

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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EN 14350:2020 (E)

Key
A container
B adhesive tape
C printed graduations
D direction of adhesive tape removal

Figure 16 — Removal of adhesive tape from the printed graduations

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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EN 14350:2020 (E)

240 — 240 - 240 — 240 - I /■

200 4 2no -Z 200 4 200 4


l
160 4 160 4 160 4 160 4

120 4 120 4 120 4 120 4

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

Figure 17 — Examples of graduations after tape removal

7.6.4 Thermal shock

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

110 1 g J min. The sample shall be examined for cracks.

7.7 Requirements and tests for drinking accessories


7.7.1 Tear resistance test (see B.9)

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.

— testing the punctured sample with a tensile test (see 7.7.1.4]

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.

Figure 18 — Position of teat for making the puncture

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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)

7.7.2.1 Integrity after simulated use

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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Figure 19 — Example of opening and dosing mechanism for cycle test

7.7.2.4 Tensile strength test procedure

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.

7.8 Protective covers (see B.l 1)


7.8.1 Size of detachable protective cover

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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7.8.3.3 Test procedure

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.

Figure 20 — Test of permanent protective cover

7.9 Handles and clips (see B.13)


7.9.1 Requirement

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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EN 14350:2020 (E)

Key
Arrows show the direction of force

Figure 21 — Examples of test with different designs of handles and clips

7.10 Finger traps


7.10.1 Requirement

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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7.11.1.2 Test procedure

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

Figure 22 — Example of flexibility test

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EN 14350:2020 (E)

7.11.3 Security/retention test of protruding parts

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

Cords and loops shall meet the requirements of 7.12.2


7.12.2 Requirement

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 Chemical requirements and test methods

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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EN 14350:2020 (E)

Table 2 — Food contact components

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

Migration from glass


Antioxidants release
Migration of certain
N-nitrosamines and

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

3.3.1 Feeding bottle and glass X

and drinking cup


3.3.2
plastic 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

Migration from glass


Antioxidants release
Migration of certain
N-nitrosamines and

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

3.4 Locking ring plastic X X

3.5 Sealing disc plastic X X

silicone rubber X X X X

TPE X X X X

3.6 Protective cover plastic X X

TPE X X X X

3.7 Handle and clip plastic X X

3.8
TPE X X X

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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

8.4.2.1.1 Balance with an accuracy of ± 0,1 mg

8.4.2.1.2 Oven, capable of maintaining a temperature of (100 ± 5] °C and (200 ± 5) °C.

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

8.4.2.1.4 Watch glass

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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EN 14350:2020 (E)

8.4.2.3 Calculation of results

The volatile compounds content is calculated as follows:


Volatiles content [%] = j [B -C}^(B - A] j x 100

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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Table 5 — Limits of element migration from drinking equipment


Element Limit
mg/kg
Aluminium, Al 6000

Antimony, Sb 120

Arsenic, As 10

Barium, Ba 4 000

Boron, B 3 200

Cadmium, Cd 3,6

Chromium, Cr III 100

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

Organic Tin 2,5

Zinc, Zn 10 000

a If the result is below the Limit of Quantification of EN 71-3,


the sample is to be considered passed. See B.21

8.6.2 Method for the determination of the migration of certain elements

The migration of certain elements shall be determined using EN 71-3.

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8.7 2-mercaptobenzothiazole (MBT), antioxidant and formaldehyde release (see B.19,


B.20, B.24)
8.7.1 Requirements

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

8.8.3.2.1 Oven, capable of maintaining a temperature of (50 ± 2] °C

8.8.3.2.2 Filter paper for qualitative analysis

8.8.3.2.3 Colourless adhesive tape

8.8.3.2.4 Household wrapping polyethylene foil, impermeable and self-adherent (clingfilm /


Frischhaltefolie)

NOTE Alternatively, a zip-locked PE bag can be used

8.8.3.2.5 Household aluminium foil

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8.8.3.3 Reagents

8.8.3.3.1 Acetic acid (3 %)

8.8.3.3.2 Coconut fat

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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8.11 Migration of elements from metal (see B.18)


8.11.1 Requirement

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.

Annex E contains information on good practice for visibility and legibility.


The manufacturer or distributor shall provide a statement advising the user to retain product
information for future use.
10.2 Purchase information
The following information shall be visible at the point of sale:
— the name, trademark or other means of identification and the address of the manufacturer,
distributor or retailer, including where applicable a website address. The particulars may be
abbreviated provided that the abbreviation enables the manufacturer, the distributor or the retailer
to be identified and easily contacted;

— the number of this document;

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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.

NOTE 2 For sentences in quotation marks alternative wording is permitted.

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.

— Always check food temperature before feeding.

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— Throw away at the first signs of damage or weakness.

— Keep components not in use out of the reach of children.

— Never attach to cords, ribbons, laces or loose parts of clothing. The child can be strangled.

10.3.3 Additional warnings

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.

— Always use this product with adult supervision.

For glass containers:


— Glass containers may break.

— Always use this product with adult supervision.

For single-use products:


— Single-use only.

For products containing cords/loops:


— Due to strangulation hazard do not extend cords or loops.

For feeding bags and holders for feeding bags:


— For use with breast milk only. Not to be used for mixing formula milk.

10.4 Instructions for use


10.4.1 General

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.

— Before each subsequent use clean carefully to ensure hygiene.

— Instruction for at least one suitable method ofcleaning.

— 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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For feeding teats:

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

10.4.3 Single use products (see 3.11)

— information that it is a single use product which shall be disposed of after first use;

— instructions on how to prepare the product for safe use;

— if applicable, information on unsuitable common methods for heating and storage which might
damage the product.

10.4.4 Ready to use products (see 3.13)

— 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)

For products with volumetric graduations:


— information of the method to assemble the feeding bag and/or holder for a feeding bag to achieve a
graduation accuracy of at least ± 15 %.

— 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.

10.4.6 Microwaveable drinking equipment

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

Alternative wording is permitted:


— Keep away from sunlight and heat

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EN 14350:2020 (E)

10.5.3 Symbol

Figure 23 — Symbol indicating keep away from sunlight

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");

b) name and address of the laboratory;

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;

e) name and address of the customer;

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;

j) compliance or non-compliance to the requirements tested;

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k) deviations from any test method used, if appropriate;

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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EN 14350:2020 (E)

Croatian Za sigurnost i zdravlje vasega djeteta


UPOZORENJE!
Uvijek koristite proizvod pod nadzorom odrasle osobe.
Nikada nemojte koristiti sisac kao dudu varalicu.
Kontinuirano i produzeno pijenje moze uzrokovati karijes.
Uvijek provjerite temperature hrane prije hranjenja.
Staklene bocice se mogu slomiti.
Dijelove koji nisu u upotrebi drzite izvan dohvata djece.
Bacite prilikom prvih znakova ostecenja i istrosenosti.
Sarno za jednokratnu upotrebu.
Zbog opasnosti od gusenja nemojte produzivati vrpce i vezice.
Nikada nemojte pricvrscivati na kablove, vezice ili labave dijelove odjece. Dijete se moze
ugusiti.
Sarno za koristenje izdojenog mlijeka. Ne smije se koristiti za mijesanje razlicitog mlijeka.
Czech Pro bezpecnost a zdravi Vaseho ditete
UPOZORNENI!
Pouzivejte tento vyrobek vzdy pod dohledem dospelych.
Nikdy nepouzfvejte dudlik na krmeni jako bezny dudlik.
Neustale a dlouhodobe sani tekutin tekutin zpusobuje zubni kaz.
Pred krmenim vzdy zkontrolujte teplotu jidla.
Ski enene lahve se mohou rozbit.
Nepouzivane soucasti vyrobku uchovavejte mimo dosah deti.
Pri prvnfrn naznaku poskozenf nebo opotrebeni vyrobek vyhod’te.
Urceno pouze na jednorazove pouziti.
Z duvodu nebezpecf uskrceni neprodluzujte snury ani smycky,
Nikdy nespojujte se snurami, stuhami, tkanickami nebo s volnymi castmi oblecenf, mohlo
by dojit k uskrceni ditete.
Pouzivejte jen na materske mleko. Nepouzfvejte na pripravu mleka z prasku.
Danish For dit barns sikkerhed og sundhed
ADVARSEL!
Brug altid dette produkt under overvagning af en voksen
Brug aidrig en flaskesut som sut
Vedvarende og laengerevarende sugning af vaesker kan forarsage tandskader
Kontroller altid madens temperatur f0r madning (Always check food temperature before
feeding)
Glasflasker kan ga i stykker
Opbevar altid dele, der ikke er i brug, uden for b0rns raekkevidde
Smid den ud ved fbrste tegn pa skader eller svaghed
Kun til engangsbrug
Forlaeng ikke snore/band og ltfkker pa grund af risiko for kvaelning
Bind aidrig produktet fast til snore/ band eller l0se dele af t0jet. Barnet kan blive kvalt
Ma kun anvendes til modermaelk. Ma ikke anvendes til maelkeerstatning

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EN 14350:2020 (E)

Dutch Voor de veiligheid en welzijn van uw kind


WAARSCHUWING!
Dit product alleen gebruiken onder toezicht van een volwassene.
Flessenspenen nooit gebruiken als fopspeen.
Het voortdurend en langdurig zuigen van vloeistoffen veroorzaakt tandbederf.
Controleer voor het voeden altijd de temperatuur van de voeding.
Glazen flessen kunnen breken.
Houd onderdelen die niet gebruikt worden buiten bereik van kinderen.
Weggooien bij de eerste tekenen van beschadigingen of verzwakking.
Slechts voor eenmalig gebruik.
Verleng niet koorden of lussen vanwege wurgingsgevaar.
Bevestig nooit met koorden, linten, veters of losse delen van kleding. Het kind kan
hierdoor worden gewurgd.
Voor het gebruik van borstvoedingsmelk alleen. Niet gebruiken voor het mixen van
melkpoeder voor baby's.
Estonian Teie lapse ohutuse huvides: HOIATUS!
Kasutage seda toodet alati taiskasvanu jarelvalve all.
Arge kasutage pudelilutti imemisluti asemel.
Pidev kontakt vedelikega, eriti mahlad voi puuviljahapped, pohjustavad kaariese teket.
Kontrollige enne toitmist alati toidu temperatuuri.
Klaaspudel voib puruneda kildudeks.
Kui pudel ei ole kasutuses, hoidke seda lastele kattesaamatus kohas.
Vahimategi rebendite voi nahtava vananemise korral vahetage lutt valja.
Individuaalseks kasutamiseks.
Poomisohu valtimiseks arge kinnitage kunagi luti kulge paelu voi nodre.
Arge kunagi kinnitage toodet noori, paela, pitsi ega riiete kulge. Kagistusoht!
Kasutamiseks ainult rinnapiima jaoks. Ei ole moeldud kasutamiseks piimasegude jaoks.
Finnish Lapsesi turvallisuuden tahden
VAROITUS!
Kayta tata tuotetta aina aikuisen valvonnassa.
Ala koskaan kayta pullotuttia huvituttina.
Jatkuva, pitkaaikainen nesteiden imeminen aiheuttaa kariesta.
Tarkista aina ruoan lampotila ennen syottamista.
Lasipullo saattaa rikkoutua.
Sailyta kaikki osat, jotka eivat ole kaytossa, lapsen ulottumattomissa.
Havita tuote heti, mikali huomaat siina merkkeja vaurioista tai huonokuntoisuudesta.
Kertakayttoinen.
Kuristumisvaaran vuoksi ala pidenna nyoria tai lenkkia.
Ala koskaan kiinnita nauhoihin, naruihin, pitseihin tai vaatteiden irrallisiin osiin. Lapsi
saattaa kuristua.
Kaytettava vain aidinmaidon kanssa. Ei saa kayttaa pulverista tehdyn aidinmaidon
sekoittamiseen.

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French Pour la securite et la sante de votre enfant


AVERTISSEMENT!
Ce produit doit toujours etre utilise sous la surveillance d'un adulte.
Ne jamais utiliser une tetine de biberon en guise de sucette.
La tetee continue et proIongee de liquides peut entrainer Tapparition de caries dentaires.
Toujours verifier la temperature de 1'aliment avant de donner le biberon.
Les biberons en verre peuvent se casser.
Garder tous les elements non utilises hors de portee des enfants.
Jeter au moindre signe de deterioration ou de fragilite.
A usage unique seulement.
Ne pas rallonger les cordons ou boucles, dangers de strangulation.
Ne jamais attacher a des cordons, rubans, lacets ou des elements vestimentaires laches.
Votre enfant pourrait s'etrangler.
A utiliser avec du lait maternel uniquement. Ne pas utiliser pour preparer le lait infantile.
German Zur Sicherheit und Gesundheit Ihres Kindes
ACHTUNG!
Dieses Produkt darf nur unter Aufsicht von Erwachsenen verwendet werden.
Andauerndes und langeres Saugen von Fliissigkeiten verursacht Karies.
Immer die Temperatur des Nahrungsmittels vor dem Fiittern iiberprufen.
Werfen Sie das Produkt bei ersten Anzeichen von Beschadigungen oder Mangein sofort
weg
Alle nicht verwendeten Einzelteile miissen aufierhalb der Reichweite von Kindern
aufbewahrt werden.
Bringen Sie niemals Schniire, Bander, Schniirsenkel oder Teile von Kleidungsstiicken an
das Produkt an. Strangulationsgefahr!
Ernahrungssauger dur fen niemals als Schnuller verwendet werden.
Glasflaschen konnen zerbrechen.
Nur fur den einmaligen Gebrauch.
Verlangern Sie Bander, Schniire und Schleifen nicht, Strangulationsgefahr!
Nur zur Verwendung mit Muttermilch. Nicht zum Anmischen von Babynahrung
verwenden.

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EN 14350:2020 (E)

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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EN 14350:2020 (E)

Italian Per la sicurezza e la salute del Vostro bambino


AWERTENZA!
Utilizzare sempre questo prodotto sotto la sorveglianza di un adulto
Non utilizzare mai le tettarelle da biberon come un succhietto
Il continuo e prolungato succhiare di liquidi pud causare carie
Controllare sempre la temperatura dell’alimento prima di alimentare il bambino
Il biberon di vetro pud rompersi
Tenere tutti i componenti non utilizzati fuori dalla portata dei bambini
Sostituire al primo segno di usura o danneggiamento.
Utilizzare solamente una volta
Non allungare corde o lacci, potrebbero crearsi dei pericoli di strangolamento
Non attaccare mai a corde, nastri, lacci o estremita libere dei vestiti. Il bambino potrebbe
strangolarsi
Utilizzare solamente con latte materno.
Non utilizzare per preparare latte in polvere.
Latvian brIdinAjumss
Vienmer lietojiet so pruduktu pieaugusa uzraudziba.
Nekad nelietojiet knupisus maneklisu vieta.
Nepartraukta un pagarinata skidrumu suksana var izraisit zobu bojasanos.
Vienmer parbaudiet ediena temperaturu pirms barosanas.
Stikla pudeles var plTst.
Neizmantotos piederumus turiet bernam nepieejama vieta.
Izmetiet produktu pie pirmajam bojajumu vai vajuma pazimem.
Tikai vienreizejai lietosanai.
Noznaugsanas briesmu del, nepagariniet auklas vai cilpas.
Nekad nepievienojiet auklas, lentes vai valigas apgerba dalas. Berns var noznaugties.
Lietosanai tikai ar kruts pienu. Nelietot piena formulas jauksanai.
Lithuanian Jusq vaiko sveikatos saugumui
fspejimas!
gaminj visada naudokite suaugusiesiems priziurint.
Niekada nenaudokite maitinimui skirto ciulptuko kudikiui nuraminti.
Nuolatinis ir ilgalaikis naudojimas gali sukelti dantq eduoni
Pries maitinant visada patikrinkite maisto temperaturq
Stikliniai buteliukai gali duzti,
Nenaudojamas dalis laikyti vaikams neprieinamoje vietoje.
Pasirodzius pirmiesiems pazeidimo ar susilpnejimo pozymiams gaminj ismeskite.
Vienkartinio naudojimo
Neprailginkite virveliq ar kilpq, gali kilti gresme pasismaugti.
Niekada neriskite juosteliq, virveliq, kaspineliq ar kilpq, nes vaikas gali pasismaugti.

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EN 14350:2020 (E)

Norwegian For barnets sikkerhet og helse


ADVARSEL!
Bruk alltid dette produktet med tilsyn av voksne.
Bruk aldri flaskesmokken som smokk.
Kontinuerlig og langvarig suging av va?ske vil forarsake tannrate.
Kontroller alltid temperatur pa maten for mating.
Glassflasker kan knuse.
Oppbevar komponenter som ikke er i bruk utilgjengelig for barn.
Kast ved forste tegn pa skade eller svakhet.
Kun til engangsbruk.
Pa grunn av kvelningsfare utvid ikke snorer eller sloyfer.
Fest aldri til snorer, band, snoreband eller til lose deler av klierne. Barnet kan bli kvalt.
Kun til bruk med brystmelk. Skal ikke brukes for blanding av morsmelkerstatning.
Polish Dla bezpieczenstwa i zdrowia twojego dziecka
OSTRZEZENIE!
Zawsze uzywac wyrobu pod nadzorem doroslych.
Nigdy nie uzywac smoczkow na butelki jako smoczkow do uspokajania.
Ciqgte i przedluzone ssanie ptyndw moze powodowac prochnic^.
Zawsze sprawdzac temperature pokarmu przed karmieniem.
Buteika szklana moze ulec stluczeniu.
Nieuzywane cz^sci przechowywac w miejscu niedost^pnym dla dzieci.
Wyrzucic przy pierwszych oznakach uszkodzenia lub zuzycia.
Wytqcznie do jednorazowego uzytku.
Z uwagi na niebezpieczeristwo uduszenia nie przedluzac paskow ani uchwytow
Nigdy nie przypinac do sznurkow, wstqzek, koronekani luznych cz^sci ubranka. Dziecko
moze sie u du sic.
Przeznaczone wylqcznie do mleka matki. Nie uzywac do przygotowania mleka
modyfikowanego.
Portuguese Para a seguran^a da sua crian^a
ADVERTENCIA!
Utilizar este produto sempre sob vigilancia de um adulto
Nunca utilizar uma tetina de biberao como se fosse uma chupeta.
A succao continua e prolongada de hquidos pode causar caries dentarias.
Verificar sempre a temperatura dos lfquidos antes de dar de beber ao bebe
Os biberdes de vidro podem-se partir
Manter todos os componentes que nao usar for a do alcance das criang:as.
Deita-la fora ao primeiro sinal de que esta danificada ou fragilizada
Producto de um unico uso.
Devido a perigo de estrangulamento, nao esticar as cordas ou la^os.
Nunca amarre corddes, fitas, la^os ou peda^os soltos de pano. A crian^a pode estrangular-
se.
Para uso apenas com Leite Materno. Nao deve ser usado com leite de formula de mistura.

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Romanian Pentru siguranta §i sanatatea copilului dumneavoastra


AVERTIZARE!
Utilizati intotdeauna acest produs cu supraveghere de adult.
Nu folositi niciodata biberon de hranire ca suzeta.
Sugerea continua $i prelungita a lichidelor cauza degradarea dinfilor.
Inainte de hranire intotdeauna verificafi temperatura alimentelor.
Buteliile de sticla se pot sparge.
Nu lasati componentele inafara de uz la indemana copiilor.
Aruncati-o la primele semne de deteriorare sau slabire.
Pentru o singura utilizare
Pentru evitarea pericolului de strangulare, nu extindets corzile sau buclele.
Nu legati niciodata de corzi, panglict ?ireturi sau parti de imbracaminte volante. Copilul
poate fi strangulate
Utilizare numai cu lapte materna. Nu se utilizeaza pentru amestecarea laptelui formula
Icelandic Fyrir dryggi og heilsu barnsins {jins
VIDVORUN!
bessa voru skal alltaf nota undir eftirliti fullorbinna.
Aldrei skal nota pelatuttu sem snub
Stbbugt og langvarandi sog a vokva veldur tannskemmdum.
Alltaf skal athuga hitastiga matvaelum abur en er hann er framdreiddur.
Glerpelar geta brotnab.
Geymib ihluti sem ekki eru f notkun |jar sem born na ekki til.
Hendib vid fyrstu ummerki um skemmdir eba veikleika.
Einungis einnota.
Varub hengingarhsetta. Ekki lengja snurur eba lykkjur.
Aldrei hengja vib snurur, reimar eba annan lausan fatnab, getur J^rengt ab halsi.
Til notkunar meb einungis brjostamjolk. Ekki skal nota fyrir blandaba formulu.
Slovakian Pre bezpecnost a zdravie Vasho diet'at’a
UPOZORNENIE!
Pouzfvajte tento vyrobok vylucne pod dohladom dospelych.
Nikdy nepouzfvajte cumlfk na krmenie ako bezny cumlfk.
Nepretrzite a dlhodobe sanie tekutin sposobuje zubny kaz.
Vzdy skontrolujte teplotu potravy pred podanfm.
Sklenene fl'ase sa mozu rozbit’.
Pocas nepouzivania udrzujte komponenty mimo dosah deti.
Pri prvom naznaku poskodenia ci opotrebovania produkt odhod'te.
Iba na jednorazove pouzitie.
Kvoli nebezpecenstvu uskrtenia nepredlzujte snury ani slucky.
Nikdy nespajajte so snurami, stuzkami, snurkami, alebo s vol'nymi cast'ami odevu, mohlo
by dojst' k uskrteniu dietata.
Pouzivajte len s materskym mliekom. Nepouzivajte na pripravu mlieka z prasku.

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Slovenian Za varnost in zdravje vasega otroka.


OPOZORILO!
Izdelek vedno uporabljajte pod nadzorom odrasle osebe.
Cuclja za hranjenje nikoli ne uporabljajte kot tolazilno dudo.
Pogosto in dolgotrajno sesanje tekocin povzroca zobno gnilobo.
Pred hranjenjem vedno preverite temperaturo hrane.
Steklenicke iz stekla se lahko razbijejo.
Vse sestavne dele, ki jih ne uporabljate, hranite zunaj dosega otrok.
Ob prvih znakih poskodb ali obrabe izdelek nemudoma zavrzite.
Samo za enkratno uporabo.
Zaradi nevarnosti zadavitve ne podaljsujte trakov, vrvic ali zank.
Izdelka nikoli ne pripenjajte na vrvice, trakove, vezalke ali podobne dele oblacil. Otrok se
lahko zadavi.
Uporabljajte samo za materino mleko. Ne uporabljajte za pripravo nadomestkov
materinega mleka (formul).
Spanish Para la seguridad de su bebe
jADVERTENCIA!
Usar siempre este producto bajo la supervision de un adulto.
Nunca usar la tetina como chupete.
La succion continua y prolongada de liquidos puede causar caries.
Comprobar siempre la temperatura de la comida antes de dar el alimento.
Los biberones de vidrio se pueden romper
Mantener fuera del alcance de los ninos todos los componentes que no esten en uso
Desechar en los primeros signos de dano o rotura
Producto de un solo uso
No alargar con cordones o cintas, por riesgo de estrangulamiento.
Nunca unirlo a cordones, cintas, lazos o partes sueltas de la ropa. Su nino podria
estrangularse.
Usar exclusivamente con leche materna. No utilizar con leche de formula.
Swedish For ditt barns sakerhet
VARNING!
Produkten ska alltid anvandas under uppsikt av en vuxen.
Anvand aidrig dinapparna som trostnappar.
Att dricka ur nappflaska oavbrutet och under lang tid kan ge upphov till karies.
Kontrollera alltid vatskans temperatur innan matning.
Glasflaskor kan ga sonder.
Forvara alia komponenter som inte anvands utom rackhall for barn.
Kasta vid forsta tecken pa skador elier slitage.
Endast for engangsbruk.
Forlang aidrig bandet elier oglan. Det kan innebara stryprisk.
Satt aidrig fast i band elier losa delar pa kladerna. Det kan innebara stryprisk.
Endast anpassad till anvandning av brbstmjolk. Ska inte anvandas for
modermjolksersattning.

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Turkish £ocugunuzun giiveligi ifin


UYARILAR!
Bu uriinu her zaman yeti^kin gozetiminde kullanimz.
Biberon emziklerini asla emzik olarak kullanmayin.
Uzun sureli sivi emilimi di$ ?uruklerine sebep olabilir.
Bebeginizi beslemeden once her zaman gida sicakhgim kontrol ediniz.
Cain biberonlar kirilabilir.
Kullanilmadigi zamanlarda iirun parfalanm focuklann ula^amayacagi yerlerde saklayiniz.
Zayiflama veya hasar belirtisi gordugiinuz anda kullanmayi birakmiz.
Tek bir bebek / cocuk icin kullanilmahdir.
Dolanma ve bogulma tehlikesinden dolayi kablo ve kordonlan uzatmayiniz.
Asia ip, kordon, kurdele ya da serbest hareket edebilen kiyafet par^alarma tutturmayiniz.,
Qocugunuz dolanabilir.
Sadece anne sutii ile kullanilmahdir. Devam sutii veya mamasi ile kullamma uygun
degildir.

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EN 14350:2020 (E)

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.4 Pre-treatment (see 6.3)


Samples made from vulcanised rubber (silicone is exempted) taken directly from the manufacturer
prior to being placed on the market are artificially aged for seven days to simulate the ageing between
the manufacturing process and retail sale.

B.5 Boiling (see 6.4)


The purpose of boiling all samples, excluding single-use products, is to simulate cleaning before first
use. Boiling is recognized as a common method in households to ensure hygiene. Boiling removes any
surface coating on the components and has the additional benefits of checking whether there is any
removal of printing. Boiling also identifies the likelihood of deformation and loss of integrity of the
product leading to products that may fail subsequent tests or might impair assembly.

B.6 Decoration, inscription and decals (see 7.2)


The Technical Committee accepted printing on surface areas intended to be in contact with food in case
a functional barrier according to EU/10/2011 [2] is present preventing transfer of printing ingredients
to the food.
However, since the functional barrier on mouthed areas can be damaged by teeth, no printing is
allowed on mouthable parts of any drinking accessory (3.2).
In the case of a drinking cup (3.3.2) which does not have a drinking accessory (3.2) such as an open
drinking cup or for drinking accessory (3,2) that could have a function as a drinking cup or a similar
product where the child's mouth can contact the outside of the drinking cup the Technical Committee
has referred to ISO 7086 [17] [18] for guidance that restricts the printing or decoration to a specific
distance from the rim. The Technical Committee considered printing at a smaller distance as 20 mm
from the rim as a risk even when protected by a functional barrier. It decided to maintain the general
ban of printing in the area to 20 mm from the rim because the functional barrier could be damaged by
teeth.
Decorations attached by glue, labels or adhesive decals may be detached during use and represent a
small part or other risks, which is why they are not allowed on drinking equipment.

B.7 Additional requirements for sealing discs (see 7.5)


A sealing disc (see 3.5) used to create a seal between the container (usually a feeding bottle) and the
locking ring, is not normally in the vicinity of the child when feeding. However, circumstances are
foreseeable when a sealing disc may be in the proximity of a child. The requirement for a minimum
diameter of 35 mm for a sealing disc was set in the previous standard EN 14350-1:2004 to avoid the
foreseeable risk of choking. As no accidents have been reported, the Technical Committee has decided
to maintain this requirement.

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.

B.9 Tear resistance test (see 7.7.1)


The requirements, test equipment and test method for the tear resistance test have been set to assess
the ability of drinking accessories to withstand a child biting on them repeatedly prior to and after
teething. If the child mouths a punctured accessory and it comes apart, it can lead to a choking hazard.
Due to their dimensions straws normally do not withstand the tear resistance test. However, since
silicone straws are established in the market as drinking accessories for drinking equipment and
because the Technical Committee is not aware of incidents due to small pieces of straws being bitten off,
it was decided to include straws in this document and apply as much requirements as possible.
Consequently, silicone straws need to withstand the tensile test without being punctured.

B.10 Print adhesion of markings and decorations (see 7.6.3)


The Technical Committee had a great deal of difficulty finding a validated test for print adhesion,
bearing in mind the generally curved surfaces of the container and the range of materials commonly
used. EN 14350-1:2004 included a test based on EN ISO 2409 (paints and varnishes - cross cut test]
[37] but enquiries at a number of laboratories showed that testing containers according to this method
was sometimes not feasible.
Therefore, it was decided that a test employing adhesive tape on an unscratched surface would be more
suitable.
It was also decided that the critical factor was the adhesion of numbered graduations as removal of
these markings might have a detrimental effect on the usability of the container (see B.8).

B.ll Protective covers (see 7.8)


The Technical Committee considered the requirement for the Hemispheric shaped toys requirements of
EN 71-1 [9] but this would require a provision for ventilation holes in some cases, which could negate
the essential function of this component.
Virtually every feeding bottle and many drinking cups are provided with a protective cover mounted to
the locking ring and covering the drinking accessory to avoid ingress of dirt and germs. In some cases, it
is also used to seal the drinking accessory and to prevent leakage. Clearly the provision of ventilation
holes would negate these benefits.
A protective cover is not used during feeding and therefore the Technical Committee has added a
Warning (see 10.3.2):
"Keep componen ts not in use out of the reach of children"

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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.

B.12 Push-pull valves (see 7.7.2)


Push-pull valves are commonly opened by children with their front teeth (incisors). To avoid dental
damage to the teeth the Technical Committee has set a maximum limit 45 N on the force required to
open the valve.
The General Product Safety Directive requires that the duration of use has to be considered. Push-pull
valves are subject to wear during the period of use which might result in lower forces required to
pulling out the valve from the container. The Technical Committee has therefore investigated and
introduced a durability test (Cycle Test - see 7.7.2.3), followed by a tensile test (see 7.7.2.4).
The number of open-close cycles (1000) is intended to simulate over 7 months of daily use. Tests have
shown that if a push-pull valve fulfilled this requirement and the subsequent tensile strength test, then
it would also maintain its integrity for 2000 cycles.

B.13 Handles and clips (see 7.9)


After an extensive review of products on the market, the Technical Committee came to the conclusion
that the main possible mechanical hazard associated with handles and clips is breakage in use.
Therefore, the test procedure is carried out in the assembled state.

B.14 Volatile compounds content (see 8.4)


The volatiles compound content can be a measure of the degree of curing of the silicone, which might
affect properties such as the tear and puncture resistance of a drinking accessory. The Technical
Committee was unable to find any evidence that the volatile compounds normally found in silicone
feeding teats for example constitute a health hazard.
The test procedure has been extensively studied by the Technical Committee with the aid of three
round robin trials. It was found that repeatability and reproducibility were far poorer than that
required for a validated test method, possibly due to the variation between ovens and sample
preparation. In order to improve repeatability and reproducibility a number of significant changes have
been made to the test procedure as compared with EN 14350-2:2004.
Changes in the test procedure mean that sources for variability have been significantly reduced.
However, an analytical tolerance of 0,3 % is still considered necessary.
Differing from certain national regulations, the method in this document contains a (60 ± 5) min
(100 ± 5) °C drying step, included in order to remove any moisture absorbed by the watch glass or by
the silicone material during pre-boiling.

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B.15 Colourants (see 8.8)


Pigments and dyes are used in the materials that form the different components of drinking equipment.
These are usually retained in the matrix of the material particularly where thermoplastics are used, and
are found rarely in elastomeric teats. However, a colour fastness test method is used to ensure these
colourants are not released.

B.16 Migration of certain elements (see 8.6)


B.16.1 General

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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B.16.4 Amount of material that can be bitten/scraped off

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

B.17 Migration of lead and cadmium from glass (see 8.10)


European Directive 84/500/EEC stipulates specific migration limits and basic rules for determining the
migration of lead and cadmium from ceramic articles in food contact, e.g. drinking cups, but is not
harmonized. European legislation exists for the glass or crystal sector. The Technical Committee
considered the potential release of lead and cadmium from glass baby bottles and cups, the two
relevant groups of articles within the scope of this document, as important safety issue and used the
limits from the "German Ordinance on the quality of water intended for human consumption" [38]. A
suitable method for determination is given in EN ISO 17294-2 [15].

B.18 Migration of elements from metal (see 8.11)


Metals are a potential source of food contamination. Migration of substances from metal drinking
bottles and cups to food shall not occur in amounts that endanger human health or bring about an
unacceptable change of the composition or of the organoleptic characteristics of the food.

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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.

B.19 Antioxidant release (see 8.7)


Antioxidants are used in vulcanised rubber components to prevent or delay degradation which may
affect the integrity of the material. However, as antioxidants have certain degrees of toxicity migration
limits are set to ensure that there is no harm to health. Certain antioxidants have been identified by the
Technical Committee as being used in rubber teats and limits have been calculated using TDI values
taken or derived from the sources shown in Table B.2.
The Technical Committee decided to use higher TDI - allocation factors for the feeding teats and other
drinking accessories than for soother teats due to the bigger product surfaces when compared to
soothers. Therefore an allocation of 20 % of the TDIs was set for the majority of antioxidants and 10 %
for 2,6-Di-t-butyl-4-methylphenol (BHT] as this latter antioxidant is a widely used food additive.
The allocated TDIs are multiplied by 2,5 kg, also accounting for very low body weights (worst case
scenario] yielding the allocated tolerable daily doses (TDDs]. TDDs are directly taken as the maximum
permissible release from a rubber teat.
The latter is determined in a worst case migration scenario assuming that every day a new teat is being
used for 1 day (24 h migration at 40 °C, no account of repeated use, i.e. only the first migrate is being
used].
In order to express the specific migration limits (SML) in mg/L, the migration ratio was set as 0,150 L
simulant per teat, so that the SMLs are calculated as:
SML [mg/L] = 20 % (or 10 %] * TDI [mg/kg/day] * 2,5kg*l/0,150 L.

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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

Butylated reaction product of p-


cresol and dicyclopentadiene 68610-
0,10 b 20 [31] 0,34
51-5
Wingstay L

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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B.20 Formaldehyde release (see 8.7)


Formaldehyde may be found in polymeric materials (silicone, rubber and TPE components) and
therefore the Technical Committee decided to set a limit for formaldehyde release.
The World Health Organization (WHO) derived a drinking-water guideline value for formaldehyde of
900 pg/1 based on a tolerable daily intake (TDI) value of 0,15 mg/kg bw/day [32], [33], which has been
adopted.
By using an allocation of 20 % and applying the same principles as above, an SML of 0,5 mg/L was
derived.

B.21 Cr VI limit (see 8.6)


The migration of certain elements shall be tested based on EN 71-3 (see Clause 8.6.2).
Technical Committee is aware that the limit of quantification achievable with the procedure established
by EN 71-3:2019 does not permit the determination of Chromium VI at the level of the proposed limit
(see Table 5). The opinion of the Technical Committee is that the proposed limit shall be maintained
because it is based on toxicologically relevant data and calculated by applying the same pragmatic
approach as for all other elements in the standard (see B.16).
In the special case of Cr VI, the technical specificities have to be considered and it is suggested that the
actual limit of quantification of the EN 71-3 test method shall be applied. This means that whenever the
Cr VI level measured in the sample is below the limit of quantification of the valid version of EN 71-3,
the sample is to be considered passed.

B.22 Mercaptobenzothiazole (MBT) release (see 8.7)


The European Commission Scientific Committee on Food (SCF) [34] in 2000 and the Scientific
Committee on Consumer Products (SCCP) [35] in 2005 concluded that the potential oral exposure to
MBT resulting from materials in compliance with the proposed CEN limit of 8 mg/kg rubber migrated
over a 24 h period does not constitute a health hazard. Accordingly, this limit has been used in this
document.

B.23 Migration of primary aromatic amines (see 8.9)


Primary aromatic amines (PAA) can occur in materials used in the manufacture of drinking equipment.
PAA can be impurities in the substances used or are reaction or degradation products of colorants,
adhesives or fillers. As certain PAA are known carcinogens, they should not migrate in detectable
amounts into food or food simulant. The Technical Committee has considered fixing a list of PAA to be
tested. However, this is not feasible because the number of substances under discussion is constantly
changing.

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B.24 Migration conditions for elastomeric materials


Regardless of the somewhat conflicting recommendations for the temperature to be used for
preparation of infant formula (WHO vs. ESPGHAN CoN or Afssa] it is the opinion of the Technical
Committee that specific to elastomeric articles designed to be mouthed (for example feeding teats]
contact with temperatures in excess of 40 will be extremely limited, if any.
The Technical Committee has considered the application of hot fill condition, and came to the
conclusion that the only scenario when this has to be applied is for an elastomeric container (silicone
container) when testing for Formaldehyde. However, testing for Formaldehyde is technically not
feasible due to the volatility of this substance.
Since the 4th amendment of EU/2002/72 50 % ethanol is the official migration liquid to simulate
contact of plastic materials and articles with milk. However, use of 50 % ethanol for testing of
elastomers has shown to significantly overestimate migration in milk and is thus not appropriate for
testing of teats.
Therefore, for the migration of elastomeric articles designed to be mouthed, the Technical Committee
decided to use aqueous simulants only and to apply migration conditions of 40 °C for 24 h, not
accounting for repeated use. These latter conditions are a worst case scenario and are taken over from
the previous revision of this document. They also align with the recommendation of BfR XXI [36].
The previous revision of this document required to use water and 3 % acetic acid to simulate contact
with milk and juices, resp. In order to limit the test effort to the necessary, the Technical Committee
decided to use only 3 % acetic acid, because all available data show that migration in water is never
higher than it is in 3 % acetic acid.

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Annex C
(informative)

Method for the determination of 2-mercaptobenzothiazole (MBT) and


antioxidants specified in Table 7

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;

— Equilibration: 4 ml water (deionised);

— The pH of the migrate should be set to pH of 2 (by using Hydrochloric acid) before loading;

— Load the migrate;

— Dry the column;

— Elute: 3 times 3 ml 0,1 % formic acid in methanol;

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

— Mobile phase (Eluent B): Methanol

If required, degas the mobile phase


A suitable gradient programme is given in Table C.l.
Table C.l — Gradient programme
Time (min) Eluent A (%) Eluent B (%)
1 85 15
10 30 70
20 2 98
22 0 100
26 0 100
— Flowrate: 1 ml/min.

— Detection: 200-400 nm (280 nm, 320 nm)

— Column Compartment temperature: 40 °C

— Injection volume: 25 pl (or more if necessary)

— Post time: 5 min

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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Table C.2 — Calibration Standards

Compound CAS Number Purity (%) Suggested source


MBT 149-30-4 99,5 Sigma-Aldrich 63720
BHT 128-37-0 99,9 Sigma-Aldrich 34750
Cyanox 425 88-24-4 81,5 Sigma-Aldrich 413143
Wingstay L 68610-51-5 46,6 wt% p-cresol Sigma-Aldrich 473146
Antioxidant 109-47-1 80,2 Sigma-Aldrich 413135
2246
Irganox 1520 100553-27-0 >99 BASF
Irganox 1726 110675-26-8 >95 BASF
NOTE BASF products are suggested as at the time of publication of this document there are no know sources
of certified standards for Irganox 1520 and Irganox 1726

C.6 Preparation of standard solutions of MBT and antioxidants


Standard stock solutions of 5 mg/ml in methanol were prepared, then diluted with methanol to obtain
relevant concentration of the 6 chemicals. The concentration ranges were between quantitative
detection limits [LOQJ [see Table C.3] and twenty times the migration limits, to have at least 6
concentration points. A calibration curve for each chemical was determined.

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C.7 Retention times


Typical chromatograms of the standard solution containing MET and the antioxidants are shown in
Figure C.l.

Current Chrorr.-ar CKjram ( £ I


□ADI A, Ro(-iibo,1oo (1B4JlooACXSICksoola D)

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)

Figure C.l — Typical chromatograms of MBT and antioxidants


■l

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Table C.3 — Limits of Quantification (LOQ)

LOQ LOQ calculated


LOQ calculated
(Standard with fluid-fluid
with SPE
solution) extraction Requirement
Component (100 ml
(100 ml
simulant)
simulant)
Hg/ml mg/I simulant mg/1 simulant
MBT 1 0,01 0,02 8 mg/kg rubber
0,420 mg/1
BUT 1 0,01 0,02
simulant
Cyanox 425 1 0,01 0,02 0,080 mg/1
simulant
Antioxidant (sum of the two
1 0,01 0,02
2246 components)
0,340 mg/1
Wingstay L 2 0,02 0,05
simulant
Irganox 1520 2 0,02 0,05 0,340 mg/1
Irganox 1726 2 0,02 0,05 simulant

C.8 Calculation of MBT and antioxidants


Using calibration curves (see Annex C) calculate the amounts of migrated MBT and individual
antioxidants found in terms of mg/1 simulant. The amount of MBT determined in mg/1 is converted to
mg/kg rubber by using the weight of the rubber used in 8.7.2.

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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;

b) Batch number or equivalent reference;

c) Commercial name of the soother or bottle teat."

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Annex E
(informative]

Good practice for visibility and legibility

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.

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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
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[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

[4] EN ISO 9001, Quality management systems - Requirements (ISO 9001:2015)

[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 -
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[7] EN 14372:2004, Child use and care articles - Cutlery and feeding utensils - Safety requirements and
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[8] EN ISO 1302, Geometrical Product Specifications (GPS) - Indication of surface texture in technical
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[9] EN 71-l:2014+Al:2018, Safety of toys - Part 1: Mechanical and physical properties

[10J Commission Directive 93/11/EEC Commission Directive of 15 March 1993 concerning release of
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[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:
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Farblassigkeit"]

[13] Simoneau et al, JRC Scientific and Technical Report "Suitability of new sources of olive oil
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[14] Technical guidelines on testing the migration of primary aromatic amines from polyamide
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[15] EN ISO 17294-2:2016, Water quality - Application of inductively coupled plasma mass
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[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
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[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:
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[22] SCHER opinion on tolerable intake of aluminium with regards to adapting the migration limits
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[23] EFSAJ. 2010, 8 p. 1570

[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
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[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

[27] SCHER opinion on chromium VI in toys, 15.01.2015

[28] EFSA Panel on Contaminants in the Food Chain [CONTAM] opinion. EFSA J. 2015,13 [2] p. 4002

[29] EFSAJ. 2012,10 p. 2588

[30] RIVM Documentation Toxicology, Summary 300/418 of April 1983, National Institute for Public
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[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,
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[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)

[35] Scientific Committee on Consumer Products Opinion on 2-Mercaptobezothiazole,


SCCP/0883/05, adopted 21 June 2005

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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

[39] Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing


practice for materials and articles intended to come into contact with

[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

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