Child care articles - Drinking equipment - Safety requirements and test methods

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.

Artikel für Säuglinge und Kleinkinder - Artikel für flüssige Kindernahrung - Sicherheitstechnische Anforderungen und Prüfverfahren

Dieses Dokument legt sicherheitstechnische Anforderungen an die Materialien, Konstruktion, Ausführung, und Verpackung sowie an die Produktinformationen für Artikel für flüssige Kindernahrung fest, die für Kinder im Alter von 0 Monaten bis 48 Monaten (siehe B.2) vorgesehen sind:
-   wiederverwendbare Behälter und wiederverwendbare Trinkhilfen;
-   Behälter für den einmaligen Gebrauch und mit diesen Behältern verkaufte Trinkhilfen;
-   Ernährungssauger für den einmaligen Gebrauch;
-   gebrauchsfertige Ernährungssauger.
Dieses Dokument enthält keine Anforderungen an die Sauberkeit von gebrauchsfertigen Produkten und von Produkten für den einmaligen Gebrauch.
Dieses Dokument gilt nicht für Produkte, die für klinisch medizinische Spezialanwendungen vorgesehen sind, z. B. solche für den Einsatz im Falle einer Lippenkiefergaumenspalte.
Dieses Dokument gilt nicht für Artikel aus Keramik, die für flüssige Kindernahrung vorgesehen sind.
Dieses Dokument gilt nicht für nur zu Aufbewahrungszwecken vorgesehene Beutel.
Dieses Dokument gilt nicht für Artikel für flüssige Kindernahrung, die bereits beim Verkauf Flüssigkeiten oder Flüssignahrung enthalten, und nicht für an ihnen angebrachte Trinkhilfen.
Dieses Dokument gilt nicht für Schnuller. Sicherheitstechnische Anforderungen an Schnuller und entsprechende Prüfverfahren sind in EN 1400 [6] festgelegt.
Dieses Dokument ist nicht auf Besteck und Geschirr anwendbar. Sicherheitstechnische Anforderungen an Besteck und sonstige Ausrüstungsteile zum Füttern sowie entsprechende Prüfverfahren sind in EN 14372 [7] festgelegt.
Für Artikel für flüssige Kindernahrung, die nicht in den Anwendungsbereich fallen, sind nach Möglichkeit die anwendbaren Anforderungen dieses Dokuments zu berücksichtigen.

Articles de puériculture - Articles pour l’alimentation liquide - Exigences en matière de sécurité et méthodes d’essai

Le présent document spécifie les exigences de sécurité relatives aux matériaux constitutifs, à la construction, à la performance, à l’emballage et aux informations relatives au produit des articles destinés aux enfants âgés de 0 à 48 mois (voir B.2) :
-   récipients réutilisables et accessoires pour l’alimentation liquide réutilisables ;
-   récipients à usage unique et accessoires pour l’alimentation liquide vendus avec ;
-   tétines pour l’alimentation liquide à usage unique ;
-   tétines pour l’alimentation liquide prêtes à l’emploi.
Le présent document n’inclut pas les exigences relatives à la propreté des produits prêts à l’emploi et à usage unique.
Le présent document n’est pas applicable aux produits destinés à des applications médicales cliniques spécialisées, tels que ceux destinés aux fentes labiales et palatines.
Le présent document ne s’applique pas aux articles pour l’alimentation liquide fabriqués en céramique.
Le présent document ne s’applique pas aux sachets destinés à la conservation uniquement.
Le présent document ne s’applique pas aux articles pour l’alimentation liquide contenant des liquides ou des denrées alimentaires au moment de l’achat, ni aux accessoires pour l’alimentation liquide qui y sont fixés.
Le présent document ne s’applique pas aux sucettes. Les exigences en matière de sécurité et les méthodes d’essai relatives aux sucettes sont spécifiées dans l’EN 1400 [6].
Le présent document ne s’applique pas aux couverts et à la vaisselle. Les exigences en matière de sécurité et les méthodes d’essai relatives aux couverts et autres articles de vaisselle sont spécifiées dans l’EN 14372 [7].
En ce qui concerne les articles pour l’alimentation liquide exclus du domaine d’application du présent document, tenir compte, dans la mesure du possible, des exigences applicables du présent document.

Izdelki za otroke - Pripomočki za pitje - Varnostne zahteve in preskusne metode

General Information

Status
Withdrawn
Publication Date
02-Jun-2020
Withdrawal Date
08-Aug-2023
Current Stage

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SLOVENSKI STANDARD
SIST EN 14350:2020
01-september-2020
Nadomešča:
SIST EN 14350-1:2005
SIST EN 14350-2:2005
Izdelki za otroke - Pripomočki za pitje - Varnostne zahteve in preskusne metode
Child care articles - Drinking equipment - Safety requirements and test methods
Artikel für Säuglinge und Kleinkinder - Artikel für flüssige Kindernahrung -
Sicherheitstechnische Anforderungen und Prüfverfahren
Articles de puériculture - Articles pour l’alimentation liquide - Exigences en matière de
sécurité et méthodes d’essai
Ta slovenski standard je istoveten z: EN 14350:2020
ICS:
97.190 Otroška oprema Equipment for children
SIST EN 14350:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 14350:2020

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SIST EN 14350:2020


EN 14350
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2020
EUROPÄISCHE NORM
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 puériculture - Articles pour l'alimentation Artikel für Säuglinge und Kleinkinder - Artikel für
liquide - Exigences en matière de sécurité et méthodes flüssige Kindernahrung - Sicherheitstechnische
d'essai Anforderungen und Prüfverfahren
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
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR 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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SIST EN 14350:2020
EN 14350:2020 (E)
Contents Page
European foreword . 5
Introduction . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 9
4 Description . 11
5 Test equipment and tolerances . 19
5.1 Small parts cylinder . 19
5.2 Indentor. 20
5.3 Fixture for security/retention test . 21
5.4 Probes for holes (finger traps) test . 21
5.5 Templates A and B . 22
5.6 Tolerances . 22
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) . 23
6.4 Boiling (see B.5) . 23
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.11) . 31
7.9 Handles and clips (see B.13) . 32
7.10 Finger traps . 33
7.11 Protruding parts. 33
7.12 Cords or loops . 35
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 . 36
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
2

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SIST EN 14350:2020
EN 14350:2020 (E)
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 . 62
B.1 Introduction . 62
B.2 General . 62
B.3 Preparation of samples for construction and mechanical tests (see 6.1) . 62
B.4 Pre-treatment (see 6.3) . 63
B.5 Boiling (see 6.4) . 63
B.6 Decoration, inscription and decals (see 7.2) . 63
B.7 Additional requirements for sealing discs (see 7.5) . 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.11 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
B.14 Volatile compounds content (see 8.4) . 65
B.15 Colourants (see 8.8) . 66
B.16 Migration of certain elements (see 8.6) . 66
B.17 Migration of lead and cadmium from glass (see 8.10) . 68
B.18 Migration of elements from metal (see 8.11) . 68
B.19 Antioxidant release (see 8.7) . 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
Annex C (informative) Method for the determination of 2-mercaptobenzothiazole (MBT)
and antioxidants specified in Table 7 . 73
3

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SIST EN 14350:2020
EN 14350:2020 (E)
C.1 Apparatus . 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.1 General. 79
E.2 Warnings . 79
E.3 Font . 79
E.4 Multi-languages . 79
Bibliography . 80

4

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SIST EN 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.
5

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SIST EN 14350:2020
EN 14350:2020 (E)
— 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.
6

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SIST EN 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].
7

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SIST EN 14350:2020
EN 14350:2020 (E)
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)
IEC 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
8

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SIST EN 14350:2020
EN 14350:2020 (E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC 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"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
9

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SIST EN 14350:2020
EN 14350:2020 (E)
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
detach
...

SLOVENSKI STANDARD
oSIST prEN 14350:2018
01-november-2018
,]GHONL]DRWURNH3ULSRPRþNL]DSLWMH9DUQRVWQH]DKWHYHLQSUHVNXVQHPHWRGH
Child care articles - Drinking equipment - Safety requirements and test methods
Artikel für Säuglinge und Kleinkinder - Artikel für flüssige Kindernahrung -
Sicherheitstechnische Anforderungen und Prüfverfahren
Ta slovenski standard je istoveten z: prEN 14350
ICS:
97.190 Otroška oprema Equipment for children
oSIST prEN 14350:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN 14350:2018

---------------------- Page: 2 ----------------------
oSIST prEN 14350:2018


DRAFT
EUROPEAN STANDARD
prEN 14350
NORME EUROPÉENNE

EUROPÄISCHE NORM

November 2018
ICS 97.190 Will supersede EN 14350-1:2004, EN 14350-2:2004
English Version

Child care articles - Drinking equipment - Safety
requirements and test methods
 Artikel für Säuglinge und Kleinkinder - Artikel für
flüssige Kindernahrung - Sicherheitstechnische
Anforderungen und Prüfverfahren
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 252.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14350:2018 E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------
oSIST prEN 14350:2018
prEN 14350:2018 (E)
Contents Page
European foreword . 5
Introduction . 6
1 Scope . 7
2 Normative references . 7
3 Terms and definitions . 8
4 Description . 10
5 Test equipment and Tolerances . 19
5.1 Small parts cylinder . 19
5.2 Indentor. 19
5.3 Fixture for security/retention test . 21
5.4 Probe for holes (finger traps) test . 21
5.5 5.5 Templates A and B . 22
5.6 Tolerances . 22
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) . 23
6.4 Boiling (see B.5) . 23
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.11) . 30
7.9 Handles and clips (see B.13) . 31
7.10 Finger traps . 32
7.11 Protruding parts. 33
7.12 Cords or Loops . 35
8 Chemical requirements and test methods . 35
8.1 General. 35
8.2 Preparation of samples for chemical tests . 36
8.3 Requirements by component and material . 36
8.4 Volatile compounds content of silicone components intended to be put in the mouth
or in contact with food (See B.14) . 38
8.5 N-nitrosamines and N-nitrosatable substance release . 39
8.6 Migration of certain elements (see B.16 and B.21) . 39
8.7 2-Mercaptobenzothiazole (MBT), Antioxidant and Formaldehyde release (See B.19,
B.20, B.24). 41
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8.8 Colour Fastness (see B.15) . 42
8.9 Migration of primary aromatic amines (see B.23) . 43
8.10 Migration of lead and cadmium from glass (see B.17) . 43
8.11 Migration of elements from metal (see B.18) . 44
9 Consumer packaging . 44
10 Product information . 44
10.1 General . 44
10.2 Purchase information . 44
10.3 Warnings . 45
10.4 Instructions for use . 46
10.5 Supply chain information for products that contain vulcanised rubber . 48
11 Test report . 48
Annex A (normative) Warnings . 50
Annex B (informative) Rationales . 59
B.1 Introduction . 59
B.2 General . 59
B.3 Preparation of samples for construction and mechanical tests (see 6.1) . 59
B.4 Pre-treatment (see 6.3) . 59
B.5 Boiling (See 6.4) . 59
B.6 Decoration, Inscription and Decals (see 7.2) . 60
B.7 Additional requirements for sealing discs (see 7.5) . 60
B.8 Volumetric Labelling and Accuracy Requirements (see 7.6.1. and 7.6.2) . 60
B.9 Tear Resistance Test (see 7.7.1) . 61
B.10 Print adhesion of markings and decorations (see 7.6.3) . 61
B.11 Protective Covers (see 7.8) . 61
B.12 Push-Pull valves (see 7.7.2) . 62
B.13 Handles and Clips (see 7.9) . 62
B.14 Volatile compounds content (see 8.4) . 62
B.15 Colourants (see 8.8) . 62
B.16 Migration of certain elements (see 8.6) . 62
B.16.1 General . 62
B.16.2 Calculation of migration limits . 63
B.16.3 Weight of a child . 63
B.16.4 Amount of material that can be bitten/scraped off . 63
B.16.5 Allocation of TDI . 63
B.17 Migration of lead and cadmium from glass (see 8.10) . 64
B.18 Migration of elements from metal (see 8.11) . 65
B.19 Antioxidant release (see 8.7) . 65
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B.20 Formaldehyde release (see 8.7) . 67
B.21 Cr VI Limit (see 8.6) . 67
B.22 Mercaptobenzothiazole (MBT) release (see 8.7) . 67
B.23 Migration of primary aromatic amines (see 8.9) . 67
B.24 Migration Conditions for elastomeric materials . 67
Annex C (informative) Method for the determination of 2-Mercaptobenzothiazole (MBT) and
antioxidants specified in Table 7 . 69
C.1 Apparatus . 69
C.2 Procedure . 69
C.3 Column . 70
C.4 Detection . 70
C.5 Standards . 70
C.6 Preparation of standard solutions of MBT and antioxidants . 71
C.7 Retention Times . 71
C.8 Calculation of MBT and Antioxidants . 73
Annex D (informative) A-Deviations . 74
Annex E (informative) Good Practice for Visibility and Legibility . 75
E.1 General. 75
E.2 Warnings . 75
E.3 Font . 75
E.4 Multi-languages . 75
Bibliography . 76

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European foreword
This document (prEN 14350:2018) has been prepared by Technical Committee CEN/TC 252 “Child use
and care articles”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 14350-1:2004 and EN 14350-2:2004.
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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 Documents 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 other drinking accessory
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.
All food contact materials and articles are regulated by European Regulation (EC) 1935/2004 [1] and
relevant implementation measures, at European or national level. Therefore, for example, the Bisphenol
A requirement has not been included.
All plastics components of drinking equipment are specifically regulated by the Commission Regulation
(EU) 10/2011 [2] on plastic materials and articles intended to come into contact with food.
Phthalates in childcare articles is restricted by Annex XVII of REACH Regulation [3] and has not been
included in this standard.
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
standard.
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 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 equipment marketed for children of 0 to 48 months (see B.2) of
age to drink:
— Re-usable drinking accessories
— Re-usable feeding bottles and drinking cups
— Single-use feeding bottles, feeding bags and drinking accessories sold with these bottles
— 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.
This document is not applicable to soothers. Safety requirements and test methods for soothers are
specified in EN 1400 [6].
Safety requirements and test methods for Cutlery and other feeding equipment are specified in
EN 14372- Cutlery and feeding utensils [7].
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 – Part3: Migration of certain elements
EN 12868, Child use and care articles - Methods 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)
IEC 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 IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
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 3.2-3.9
3.2
drinking accessory
device which permits a child to obtain fluid from a container
3.2.1
feeding teat
elastic device other than a straw that when attached to a container permits a child to obtain fluid
3.2.2
drinking spout
non-elastic device other than a straw that when attached to a container permits a child to obtain fluid
3.2.3
push-pull valve
valve on a container or drinking accessory 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 on a container
3.3
container
feeding bottle, drinking cup or feeding bag
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 feeding teat or other suitable drinking
accessory
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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
detachable protective cover or parts intended to be detachable.
Note 1 to entry: After being detached they can be reassembled in the original state.
3.6.2
permanent protective cover
permanent cover intended to be attached to other components of the product.
Note 1 to entry: It can only be detached by using a tool or force and cannot be reassembled afterwards.
3.7
handle
component designed to assist the handling of a container during drinking
3.8
clip
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.
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3.10
products in food contact
product consisting of a container already filled with food, including feeding accessories fixed to it
3.11
graduations
markings which indicate the volume of fluid within the container, numbered or unnumbered
3.12
single-use drinking accessory or container
product intended to be used without the need to clean and to be disposed of after first use
3.13
re-usable
component intended to be used again after first use
3.14
ready to use product
product intended to be used without the need to clean before first use, but maybe reusable
3.15
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 – 7 illustrate typical examples of different items of drinking equipment and their design
features.

Key
1 nipple
2 feeding hole/holes
Figure 1 — Design features of a feeding teat
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a)

b)

c)

d)
Figure 2 — Examples of feeding teats
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a)

b)

c)
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d)
Key
1 feeding spout
2 trainer spout
3 straw
4 trainer spoon
Figure 3 — Examples of drinking accessories
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Key
1 protective cover 5 feeding bottle
2 locking ring 6 feeding bag
3 feeding teat 7 numbered graduations
4 sealing disc 8 holder for feeding bag
Figure 4 — Examples of containers with feeding teats
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Key
1 drinking cup
2 drinking accessory/feeding spout
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
b permanent protective cover
Figure 7 — Examples of protective covers

Figure 8 — Examples of handles
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Figure 9 — Example of a clip

Figure 10 — Examples of loops
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