Child use and care articles — Soothers for babies and young

Transcription

BS EN 1400:2013
BSI Standards Publication
Child use and care articles —
Soothers for babies and young
children — Safety requirements
and test methods
NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW
raising standards worldwide™
BS EN 1400:2013
BRITISH STANDARD
National foreword
This British Standard is the UK implementation of EN 1400:2013.
It supersedes BS EN 1400-1:2002, BS EN 1400-2:2002 and BS EN
1400-3:2002 which are withdrawn.
The UK participation in its preparation was entrusted to Technical
Committee CW/1/4, Feeding, drinking and mouthing.
A list of organizations represented on this committee can be
obtained on request to its secretary.
This publication does not purport to include all the necessary
provisions of a contract. Users are responsible for its correct
application.
© The British Standards Institution 2013. Published by BSI Standards
Limited 2013
ISBN 978 0 580 75432 6
ICS 97.190
Compliance with a British Standard cannot confer immunity from
legal obligations.
This British Standard was published under the authority of the
Standards Policy and Strategy Committee on 30 April 2013.
Amendments issued since publication
Date
Text affected
BS EN 1400:2013
EN 1400
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2013
ICS 97.190
Supersedes EN 1400-1:2002, EN 1400-2:2002, EN 14003:2002
English Version
Child use and care articles - Soothers for babies and young
children - Safety requirements and test methods
Articles de puériculture - Sucettes pour nourrissons et
jeunes enfants - Exigences de sécurité et méthodes d'essai
Artikel für Säuglinge und Kleinkinder - Schnuller für
Säuglinge und Kleinkinder - Sicherheitstechnische
Anforderungen und Prüfverfahren
This European Standard was approved by CEN on 12 January 2013.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN
All rights of exploitation in any form and by any means reserved
worldwide for CEN national Members.
Ref. No. EN 1400:2013: E
BS EN 1400:2013
EN 1400:2013 (E)
Contents
Page
Foreword .......................................................................................................................................................3
Introduction ..................................................................................................................................................4
1
Scope ................................................................................................................................................5
2
Normative references .......................................................................................................................5
3
Terms and definitions ......................................................................................................................5
4
Description of a soother ..................................................................................................................7
5
Test equipment............................................................................................................................... 11
6
General ........................................................................................................................................... 18
7
Printing and decals ........................................................................................................................ 21
8
Construction properties and tests ................................................................................................ 21
9
Mechanical properties.................................................................................................................... 34
10
Chemical requirements and test methods .................................................................................... 41
11
Teat protectors ............................................................................................................................... 48
12
Consumer packaging ..................................................................................................................... 50
13
Product information ....................................................................................................................... 50
14
Test report ...................................................................................................................................... 53
Annex A (normative) Warnings .................................................................................................................. 55
Annex B (informative) Rationale ................................................................................................................. 60
Annex C (informative) Information for products resembling a soother .................................................... 71
Annex D (informative) Some examples of suitable fixing devices ............................................................ 73
Annex E (informative) Soothers — Assessment of compliance with standard — Sampling plan
and compliance levels for freshly manufactured samples........................................................... 76
Annex F (informative) A suitable HPLC apparatus and method for determination of 2Mercaptobenzothiazole (MBT) and antioxidants BHT, 2246, Cyanox 425, Wingstay L and
Irganox 1520 ................................................................................................................................... 77
Annex G (informative) Graphical representation for determining puncture resistance of a teat ............ 80
Annex H (informative) A–deviations ........................................................................................................... 81
Bibliography................................................................................................................................................ 82
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EN 1400:2013 (E)
Foreword
This document (EN 1400:2013) has been prepared by Technical Committee CEN/TC 252 “Child use and 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 September 2013, and conflicting national standards shall be
withdrawn at the latest by March 2014.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 1400-1:2002, EN 1400-2:2002 and EN 1400-3:2002.
This document has been prepared under a mandate (M/264) given to CEN by the European Commission and
the European Free Trade Association.
This standard is linked to the General Product Safety Directive (GPSD) but no Annex ZA is needed because
GPSD is not a New Approach Directive and does not include Essential Requirements to which such an annex
should refer.
The most significant change from EN 1400:2002 is that the three parts of that standard have been combined
into one single document.
In addition, improvements to several of the testing equipment have been made, including the shield template
and probes for ventilation holes and finger traps.
A number of common migration rules have been adopted as has the concept of allocating only a proportion of
TDI's when setting migration limits.
For the first time, requirements have been set for teat protectors as has supply chain information for products
that contain vulcanised rubber.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
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EN 1400:2013 (E)
Introduction
Soothers are widely used throughout Europe to satisfy non-nutritive sucking needs and to pacify children.
They are designed to be in the mouths of babies and young children for long periods. Accidents, some of
which have been fatal, have occurred in the past and a prime purpose of this standard is to reduce the risk of
accidents occurring in the future. It is stressed that this European Standard cannot eliminate all possible risks
to babies and young children using such a product and that parental or guardian control is of paramount
importance. It is essential that all warnings and instructions specified in this standard are given clearly by the
manufacturer, to allow the consumer to ensure that the soother is used correctly and safely.
This European Standard harmonises minimum safety requirements and test methods for soothers. Most of the
provisions have been taken from other existing national and European Standards.
It is recommended that manufacturers and suppliers operate to EN ISO 9001, the standard for quality
management systems [1]. It is also recommended that laboratories operate to ISO/IEC 17025, General
requirements for the competence of testing and calibration laboratories [4].
In addition, it is recognised that some organisations require reference testing. A suggested sampling plan and
compliance levels for freshly manufactured soothers are provided in Annex E (informative). This procedure
can be used as a voluntary type approval procedure.
Latex protein allergy risk has not been included in this standard. Nevertheless, provision for packaging
information for soothers containing natural rubber has been made in this standard. There is no published
information that sensitisation is caused by soother teats. In addition, there is an extremely low incidence of
latex protein allergy among young children and babies. However, the issue of subsequent allergic reaction
from rubber teats will be reconsidered when further information becomes available.
Phthalates have not been included in this standard because the use of phthalates in childcare articles is
restricted by Annex XVII of REACH Regulation [5].
A normative annex has been included which contains translations of warning phrases into the main European
languages.
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EN 1400:2013 (E)
1
Scope
This European Standard specifies safety requirements relating to the materials, construction, performance,
packaging and product information for soothers.
This European Standard is applicable to products that resemble or function as a soother. Some soothers may
be marketed with other functions. This standard is applicable to these products (some examples are given in
Annex C).
This European Standard does not apply to products designed for specialist clinical medical applications, e.g.
those relating to Pierre-Robin Syndrome or premature babies (see Annex C).
The standard is not applicable to feeding teats. Safety requirements and test methods for feeding teats are
included in all parts of EN 14350 [2], [3].
2
Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
DIN 53160-1, Determination of the colourfastness of articles for common use — Part 1: Test with artificial
saliva
EN 71-1, Safety of toys — Part 1: Mechanical and physical properties
EN 71-3, Safety of toys — Part 3: Migration of certain elements
EN 71-11:2005, Safety of Toys — Part 11: Organic chemical compounds — Methods of analysis
EN 12868, Child use and care articles — Methods for determining the release of N-Nitrosamines and NNitrosatable substances from elastomer or rubber teats and soothers
EN 20105-A03, Textiles — Tests for colour fastness — Part A03: Grey scale for assessing staining
(ISO 105-A03)
EN ISO 1302, Geometrical Product Specifications (GPS) — Indication of surface texture in technical product
documentation (ISO 1302)
EN ISO 3696, Water for analytical laboratory use — Specification and test methods (ISO 3696)
ISO 188, Rubber, vulcanized or thermoplastic — Accelerated ageing or heat resistance tests
3
Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
soother
article which includes a teat and which is intended to satisfy the non-nutritive sucking need of children
Note 1 to entry: Soothers are also known as pacifiers or babies' dummies.
3.2
teat
part of the soother designed to be placed in the mouth
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3.3
shield
structure positioned at the rear of the teat to reduce the likelihood of the soother being drawn entirely into the
child's mouth
3.4
ring
structure positioned adjacent to or on the shield to facilitate handling of the soother
Note 1 to entry: The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is
attached to the shield or plug
Note 2 to entry: See Figure 1.
3.5
knob
structure positioned adjacent to or on the shield to facilitate gripping of the soother
attached to the shield or plug.
3.6
plug
device located within the neck of the teat that secures the teat to the shield
3.7
cover
device that prevents open access to the plug
3.8
ventilation hole (see B.7)
any shape of hole in the shield or teat protector that is large enough to allow sufficient passage of air to
sustain life
Note 1 to entry: See also 8.4.1 and 11.3.1.
3.9
teat protector
device that can be attached to and detached from the soother to cover the teat
3.10
outer packaging
any packaging used for storage of the product by a retailer, not including the packaging intended for the
consumer
3.11
major axis of the soother
major axis of the soother goes at right angles to the shield and through the centre of the teat, where the teat
enters the shield
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3.12
major axis of the shield
major axis of the shield is parallel to the longest dimension of the shield and in the middle of the width
4
Description of a soother
A soother, as shown in Figures 1, 2, 3 and 4, normally consists of:
 a teat,
 a shield, and
 either a ring or knob,
and can include:
 a plug, and
 a cover.
NOTE 1
Similar components are marked with the same number in Figures 1 to 4.
NOTE 2
Some or all of the components may be manufactured from the same material which may result in the
components not being separately distinguishable.
NOTE 3
The ring, knob or cover can be integral with the shield or plug or it can be a separate component that is
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Key
1
2
3
5
7
8
teat
shield
ring
cover
sucking face of shield
rear face of shield
Figure 1 — Example of a soother with ring
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Key
1
2
4
6
teat
shield
plug
knob
Figure 2 — Example of a soother with knob
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Key
1
2
4
5
6
7
8
teat
shield
plug
cover
knob
sucking face of shield
rear face of shield
Figure 3 — Example of a soother with plug and cover
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EN 1400:2013 (E)
Key
1
2
4
6
teat
shield
plug
knob
Figure 4 — Example of a soother with a combined plug and knob
5
Test equipment
5.1
Shield template
The shield template shall be made from Polyoxymethylene (POM), standard (natural, non pigmented, unfilled),
E-modulus: 3000 MPa to 3300 MPa, hardness: 80 to 90 Shore D, Surface roughness: lower than Ra 2,2.
NOTE
Extruded sheets of POM normally meet the surface roughness requirement.
The dimensions shall be as shown in Figure 5.
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EN 1400:2013 (E)
Dimensions in millimetres
Key
1
2
enlarged part section A – A
permanent marks for major and minor axes
Figure 5 — Shield template
5.2
Test spheres
Test spheres A, B, C and D, shall be made from stainless steel of diameters given in Table 1.
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EN 1400:2013 (E)
Table 1 — Test sphere diameters
5.3
Test sphere
Diameter
mm
A
4,0+−00,1
B
5,5 +−00,1
C
12 +−00,1
D
14 +−00,1
Indentor
The indentor is made from H13 high chrome tool steel or equivalent and hardened to a minimum of
50 Rockwell C and shall have dimensions as shown in Figure 6. All dimensions with a tolerance are machined
.The larger diameter of the indentor has not been specified, as it should be
as in EN ISO 1302 to
of a size to fit into the equipment for applying the necessary force specified in the test methods.
Key
a
This face is flat and has dimensions of (3,0 x 0,20) mm
Figure 6 — Indentor
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5.4
Cutting board
The cutting board is made from a polymeric material of (70 ± 5) Shore D hardness with a stop made from any
suitable material to the dimensions as shown in Figure 7. All dimensions shall have a tolerance of ± 2 mm
except where indicated. A centre line and point of puncture is to be marked onto the surface as shown in
Figure 7.
Key
1
2
3
stop for cut edge of teat
position of teat
point of puncture
Figure 7 — Cutting board
5.5
Bite endurance jaws
The jaws are made from H13 high chrome tool steel or equivalent and hardened to (45 to 50) Rockwell C and
shall have dimensions as shown in Figure 8.
All dimensions with a tolerance are machined as in EN ISO 1302 to
and bottom jaws are identical.
14
. All dimensions for the top
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EN 1400:2013 (E)
Figure 8 — Bite endurance jaws
5.6
Impact mass
A flat stainless steel weight with radiused edges (2 ± 0,5) mm and a mass of (1 ± 0,02) kg, distributed over an
area of diameter (80 ± 2) mm, see Figure 9.
Key
a
radius (2 ± 0,5) mm
Figure 9 — Impact mass
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5.7
Guides
Guides 1, 2 and 3 with dimensions as shown in Figures 10, 11 and 12.
Figure 10 — Guide 1
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6
General
6.1
Tolerances for construction and mechanical properties
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:
± 2º of the nominal angle;

Duration of forces for durability tests:
± 1 s;
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
Duration of forces for static load tests:
± 2 s.
The tests are described in terms of the application of forces. Masses can however be used. 1 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 adversely
affect the results.
6.2
Order of tests for construction and mechanical properties
The tests shall be carried out in the order given in Table 2.
Table 2 — Order of testing for construction and mechanical properties
Order of
Testing
Test
Clause
6.3.1
6.3.2
6.3.3
1
2
Samples taken direct from
manufacturer prior to being
placed on the market
All Other samples
Pre-treatment
No pre-treatment
Boiling
Conditioning
6.3.4
A sample used in any of the tests below shall not be used in any
further tests
8.1 - 8.9
9.1.2
7
9.7.2.3
Construction properties and tests
Impact resistance
followed by
Tensile test along the major axis
(see Annex D, Figure D.1)
Puncture resistance of teat
Tear resistance of teat
followed by
Tensile test
at right angles to the major axis
Knob, plug and/or cover retention
Bite endurance of elastomeric components
followed by
Tensile test
Tensile tests for single components and pairs of components
8
9.7.2
Integrity
9.7.2.2
3
4
9.2.2.1
9.3.2.1
9.7.2.2
5
6
9.4.2
9.5.2
9.7.2.2
Additional requirements for soothers with knobs made of flexible
materials
9
10
9.2.2.2
9.3.2.2
9.7.2.2
11
9.5.2
9.7.2.2
Puncture resistance of knob made of flexible materials
Tear resistance of knob made of flexible materials
followed by
Tensile test
Bite endurance of elastomeric components
followed by
Tensile test
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Order of
Testing
Test
Clause
Samples taken direct from
manufacturer prior to being
placed on the market
All Other samples
Additional tests for soothers where a part rotates inside the teat
(See 9.6)
12
9.6.2
9.7.2.2
Rotation endurance
followed by
Tensile test
along the major axis
6.3
Preparation of samples for construction and mechanical tests
6.3.1
Pre-treatment
Only samples taken directly from the manufacturer (see B.4.1) prior to being placed on the market shall be
artificially aged for (7 days) ± 2 h in a cabinet 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) at a temperature of
(70 ± 2) °C and conditioned as described in 6.3.3.
6.3.2
Boiling
All samples 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 and removed (see B.4.2). Afterwards, allow the samples to cool to
room temperature.
6.3.3
Conditioning
All samples shall be conditioned before the tests. The conditioning of the samples shall be performed for at
least 40 h in 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.
6.3.4
New samples
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) or for each testing orientation, unless otherwise stated.
6.4
Preparation of samples for chemical tests
6.4.1
General
The sample preparation (6.4.2) applies to all tests except N-Nitrosamines and N-Nitrosatable substances
release; see 10.4.
Samples and test portions shall only be handled with suitable (for example, non-rubber) gloves and shall only
be stored in securely fastened, migration free containers and protected from the light.
6.4.2
Boiling
All samples 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 and removed. Store in a closed container; a desiccator for example
is ideal for this purpose. This is to reduce the risk of contamination.
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6.4.3
New samples
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.
7
Printing and decals
There shall be no printing on the sucking face of the shield.
Adhesive decals and labels shall not be attached to any part of the soother. No decorations shall be attached
to any part of the soother by glue.
A soother may be decorated, including moulded in, imprinting and printing. Imprinting may include techniques
such as stamping and laser etching. No form of decoration shall be removed during the boiling stage
(see 6.3.2).
8
Construction properties and tests
8.1
General
The soother shall be free from any sharp points or edges and free of flash and burrs.
The soother shall have no removable parts other than a teat protector (see Clause 11).
Soothers have been known to become lodged in a child's mouth. Attention should therefore be made to the
design of all soother components to allow the assembled soother to be gripped as easily as possible, thereby
facilitating removal of the soother from the child's mouth.
Attention should also be made to the design of the soother to ensure that it may be cleaned as easily and as
efficiently as possible (see B.3).
8.2
Teat (see B.5)
8.2.1
Requirements
When tested in accordance with 8.2.2, the effective penetration of the teat shall not be greater than 35 mm.
The teat shall not include any hole in front of the sucking face side of the shield.
Any hollow section of the teat shall not contain solid, fluid or gaseous substances (except air) nor shall it
contain any inserts except for the plug.
8.2.2
Test method for effective penetration
The effective penetration is the distance from the tip of the teat to where the teat enters the shield along the
major axis, see Figure 13, and shall be measured using a suitable measuring device with an accuracy of
0,1 mm.
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Figure 13 — Measurement of teat penetration
8.3
Shield (see B.6)
8.3.1
Requirements
The soother shall incorporate a shield.
When tested in accordance with 8.3.2, the shield shall not pass through the shield template.
8.3.2 Test method
The shield template, see 5.1, shall be supported horizontally so that it remains firm and horizontal throughout
the test and there is no lateral movement of the shield template.
NOTE
It will assist the test if the shield is marked with its major and minor axes on both the sucking face and the rear
face. These marked axes can then be lined up with the permanent marks on the shield template (see Figure 5).
Immerse the soother for at least 10 s in an aqueous solution of a wetting agent. A 2 % (V/V) solution of
polyoxyethylene (20) sorbitan mono-oleate is suitable.
Position the wet soother with the sucking face of the shield against the opening in the template; such that the
major axis of the soother goes through the intersection of the axes marked on the template (see Figure 14).
Orientate the soother, until the major axis of the shield (see Figure 15) is parallel to the major axis of the
template.
At a crosshead speed of (100 ± 5) mm per min, apply a tensile force of (10 ± 0,5) N to the teat along the
direction of the major axis of the soother, ensuring that there is no lateral movement causing a pendulum
effect. That is, the major axis of the soother shall always be aligned with the centre of the template throughout
the test. Maintain the load for (10 ± 0,5) s (see Figure 16 a)).
Reverse the soother and repeat the test by pulling on the ring or the knob, using a suitable device (see
Figure 16 b)).
If the design or position of the soother ring or knob makes this impossible, or if the shield slides sideways
through the template during the test then cut off the teat and repeat the test with the soother reversed over the
template. The force is applied from above through a rod centred in the hole left by the teat and along the
major axis (see Figure 16 c)). The rod shall be a little larger in diameter than the size of the hole left by the
teat.
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EN 1400:2013 (E)
With some soothers (e.g. full rubber or full silicone soothers) using this rod may not be possible. In these
instances a tube with an internal diameter of (15 ± 0/1) mm and a wall thickness of (1 ± 0,1) mm shall be used
(see Figure 16d)). The teat shall be cut off as far as necessary to accommodate the tube.
Key
a
b
c
d
major axis of soother
intersection of major and minor axes of shield template
shield template (side view)
shield template (top view)
Figure 14 — Major axis of soother in relation to the intersection of the axes marked on the shield
template
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Key
w half of shield width
a-a major axis of shield
Figure 15 — Example of the major axis of a shield
Key
a)
b)
c)
d)
force applied to the teat
force applied to the ring or knob
force applied from above through a rod centred in the hole left by the teat
force applied from above through a tube
Figure 16 — Examples of positions of a soother on the shield template
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8.4
Shield ventilation (see B.7)
8.4.1 Requirements
The shield shall be provided with at least two ventilation holes (see 3.8) each of which shall include a circular
2
area of at least 4 mm diameter and a minimum area of 20 mm .
When tested in accordance with 8.4.2.1, each ventilation hole shall allow the unhindered passage of test
sphere A, see 5.2, even when the ring, if present, is in contact with the shield. In this respect, "unhindered"
means that the test sphere falls through the hole under its own weight, even if it touches the edges of the hole
or other parts of the soother, such as the ring.
When tested in accordance with 8.4.2.2, each ventilation hole shall have a minimum area of 20 mm2.
If any part of the soother, in any position, is equal to or more than 1,3 mm from the entrance to the hole then
the hole shall be considered to be unobstructed and area measurement shall be made on the complete hole
(see Figures 17 a) and Figure 17 b)).
An obstructed hole is when any part of the soother, for example the ring, covers part of the hole in at least one
position and when the obstruction is less than 1,3 mm at its closest point to the surface of the hole (see
Figures 17 c) and Figure 17 d)).
If a ring or other part of the soother obstructs a ventilation hole it shall be the unobstructed part of this
ventilation hole that is tested.
Additional holes in any position, even if smaller than ventilation holes, may be provided and shall comply with
the requirements of 8.9.
The centres of two of the ventilation holes shall be at least 15 mm apart and located either side of the minor
axis of the shield, see Figure 18.
The edges of two ventilation holes shall be at least 5 mm from the edge of the shield.
The minimum diameter of a ventilation hole is 4mm, however it is recommended that ventilation holes are as
large as possible, but consistent with the requirement for openings (see 8.9).
Certain types of ventilation holes have given rise to finger injuries. Non-circular holes should avoid acute Vshaped angles or inward facing angles that are not well rounded, as both these features can lead to fingers
becoming caught and injured. See also 8.9.
NOTE
The shape of the edge of the shield and the size, shape and position of ventilation holes affect the ease with
which the shield can be gripped in the event of the soother becoming lodged in a child’s mouth.
25
BS EN 1400:2013
EN 1400:2013 (E)
Key
O
S
H
L
T
obstructing part
soother shield
ventilation hole
lateral view
top view showing examples of permissible measurement areas (shaded)
Figure 17 — Examples of obstructed and unobstructed holes in the shield
26
BS EN 1400:2013
EN 1400:2013 (E)
Key
A
B
C
minor axis
major axis
shaded area – no mandatory holes
Figure 18 — Examples of permissible positions for mandatory ventilation holes
8.4.2
8.4.2.1
Test Methods
Minimum diameter
The ventilation hole to be tested shall be orientated so that the entry to the hole shall be horizontal. Any part of
the soother whether it obstructs or does not obstruct the hole (see 8.4.1) shall be in its most onerous position.
Place test sphere A, see 5.2, on the hole so that its mass allows it to pass through the ventilation hole.
Check whether the sphere passes completely through the hole.
27
BS EN 1400:2013
EN 1400:2013 (E)
8.4.2.2
Minimum area
Measurement of the area of the hole may be made by any suitable method including graph paper, shadow
technology etc. Any part of the soother whether it obstructs or does not obstruct the hole (see 8.4.1) shall be
in its most onerous position.
If the hole is unobstructed (any part of the soother, in any position, is equal to or more than 1,3 mm from the
entrance to the hole) then the area measurement shall be made on the complete hole (see Figure 17 a) and
Figure 17 b)).
If the hole is obstructed then the measurement of area shall be made by including the area occupied by the
2
Test Sphere A (12,57mm ) plus the area immediately surrounding Test Sphere A (see Figure 17 c) and
Figure 17 d)).
8.5
Ring (see B.8)
8.5.1
Requirements
A flow chart for ring requirements is shown in Table 3.
Table 3 — Flow chart for ring requirements
Rings made of non-flexible
materials
Rings made of flexible
materials
8.5.1
8.8.1
If rings made of non-flexible
materials fail any of the
requirements then treat as if
it is a knob made from nonflexible materials; see 8.7.1
Rings made of flexible materials shall comply with the requirements of 8.8.1.
Rings made of non-flexible materials shall comply with the following requirements.
 When tested in accordance with 8.5.2, the effective penetration, dimension A, which is the distance from
the tip of the ring to the rear face of the shield, shall not be greater than 35 mm (see Figure 19).
 Dimension A shall not be greater than 1,4 times dimension B, the widest width of the ring, see Figure 19,
8.5.2.2 and B.8.
 When tested in accordance with 8.5.2.3 the opening in the ring shall allow test sphere D, see 5.2, to pass
through, see Figure 19.
 When tested in accordance with 8.5.2.4 the ring shall collapse to 16 mm or less above the shield (see
B.9).
Soothers fitted with rings that do not meet all the above requirements shall be treated as if they are fitted with
a knob made from non-flexible materials, see 8.7.
28
BS EN 1400:2013
EN 1400:2013 (E)
Key
A
B
1
effective penetration of ring = Dimension ‘A’
widest width of ring = Dimension ‘B’
test sphere D
Figure 19 — Ring dimension nomenclature
8.5.2
Test methods
8.5.2.1 Effective penetration of ring
The dimension A from the tip of the ring to the rear face of the shield, see Figure 19, along the major axis shall
be measured using a suitable measuring device with an accuracy of 0,1 mm.
8.5.2.2 Width of ring
The dimension B, the maximum width of the ring, see Figure 19, shall be measured using a suitable
measuring device with an accuracy of 0,1 mm.
8.5.2.3 Size of opening in the ring
Position the ring 90° to the shield, see Figure 19, and check that test sphere D passes through the opening in
the ring.
29
BS EN 1400:2013
EN 1400:2013 (E)
8.5.2.4 Collapse of ring
Support the soother so that the movement of the ring is not restricted.
Apply a (10 ± 0,5) N force along the major axis of the ring through a test plate as shown in Figure 20. Measure
the distance between the rear face of the shield and the face of the test plate along the major axis of the
soother, as shown in Figure 20, using a suitable measuring device with an accuracy of 0,1 mm.
If necessary, the ring shall be offset slightly from the 90° position, before applying the force, to ensure it does
not lock in the 90° position.
Key
1
2
3
position of ring following application of the 10 N force
test plate
rear face of shield along the major axis
Figure 20 — Collapse of ring measurement
8.6
Plug (see B.10)
8.6.1
Requirement
A plug shall not project more than 3 mm beyond the sucking face of the shield, see Figure 21.
30
BS EN 1400:2013
EN 1400:2013 (E)
Key
a
b
sucking face of shield with teat removed
exposed plug
Figure 21 — Section through soother showing measurement of the projection of the plug
8.6.2
Test Method
Carefully cut off the teat. If the plug projects beyond the sucking face of the shield, measure from the end of
the plug to the sucking face of the shield using a suitable device with an accuracy of 0,1 mm .
8.7
Knobs, plugs and/or covers made from non-flexible materials (see B.11)
8.7.1
Requirements
A knob, plug or cover made from non-flexible materials, whichever projects furthest beyond the rear face of
the shield, shall not be less than 10 mm and not more than 16 mm, see Figure 22, unless the soother is fitted
with a ring that meets requirement 8.5.1.
Requirement 8.7.1 shall also apply to a ring made of non-flexible materials that does not meet requirement
8.5.1.
8.7.2
Test Method
The distance from the tip of the knob, plug or cover to the shield template (see 5.1), down the central axis,
see Figure 21, shall be measured using a suitable measuring device with an accuracy of 0,1 mm. The
thickness of the shield template shall be added to the length measured to give the effective projection. The
knob, plug and/or cover shall be tested in all orientations about the major axis of the soother relative to the
intersection of the major and minor axes of the shield template.
31
BS EN 1400:2013
EN 1400:2013 (E)
Key
b
c
d
e
f
g
M
knob
cover
shield template
dimension to be measured
effective penetration
thickness of shield template
major axis of soother
Figure 22 — Measurement of effective penetration of knob, plug and/or cover made from non-flexible
materials using the shield template
8.8
Rings, knobs, plugs and/or covers made of flexible materials (see B.12)
8.8.1
Requirement
If made of flexible materials, the effective penetration of the ring knob, plug and/or cover shall not be less than
10 mm and not more than 35 mm when tested in accordance with 8.8.2.
8.8.2
Test method
The distance from the tip of the ring, knob, plug and/or cover to the shield template (see 5.1), down the central
axis, see Figure 23, shall be measured using a suitable measuring device with an accuracy of 0,1 mm. The
thickness of the shield template shall be added to the length measured to give the overall effective penetration
length. The ring, knob, plug and/or cover shall be tested in all orientations about the major axis of the soother
relative to the intersection of the major and minor axes of the shield template.
32
BS EN 1400:2013
EN 1400:2013 (E)
Key
a
b
c
d
e
f
g
M
ring
knob
cover
shield template
dimension to be measured
effective penetration
thickness of shield template
major axis of the soother
Figure 23 — Measurement of effective penetration of ring, knob, plug and/or cover made of flexible
materials using the shield template
8.9
8.9.1
Openings (see B.13)
Requirement
When tested in accordance with 8.9.2, there shall be no openings that allow test sphere B, see 5.2, to enter
and penetrate at least the complete size of test sphere B (5,5 mm), unless test sphere C, see 5.2, enters the
opening at least the same depth that test sphere B penetrated.
This requirement only applies to components made of materials with a Shore A hardness of more than 60.
Circular holes not meeting this requirement present a risk of restricting circulation. Non-circular holes with
acute V-shaped angles or inward facing angles that are not well rounded are to be avoided.
8.9.2
Test method
The opening to be tested shall be orientated so that the entry to the opening is horizontal. Place test sphere C,
see 5.2, on the hole so that its mass allows it to pass through the opening. If test sphere C does not pass
through any opening, check whether test sphere B, see 5.2, enters 5,5 mm into the opening. This test shall be
repeated from the other side of the opening.
33
BS EN 1400:2013
EN 1400:2013 (E)
9
Mechanical properties
9.1
Impact resistance
9.1.1
Requirements
When tested in accordance with 9.1.2 no part of the soother shall break, tear or separate. Subsequently when
tested in accordance with 9.7.2.2, tensile test, no part of the same soother shall break, tear or separate.
9.1.2
Test method
Place the soother to be tested unsupported on a flat, horizontal steel surface. Drop the impact mass, see 5.6,
from a height of (100 ± 2) mm above the highest point of the soother so that the centre of the impact mass is
the first point to contact the soother. The test shall be carried out five times on the same sample with, as far as
it is practical, each impact carried out with the soother in a different stable orientation, see Figure 24.
NOTE
To align the impact mass before dropping, a ring just bigger than the diameter of the impact mass clamped at a
corresponding height to a retort stand has been found to be useful when carrying out this test.
Key
A
B
impact mass centre line
steel surface
Figure 24 — Examples of positions of the soother for the impact test
The subsequent tensile test, 9.7.2.2, shall be conducted along the major axis of the soother. For a soother
with a ring, apply the force between the ring and the teat. For a soother with a knob which can be gripped, the
force shall be applied between the knob and the teat. For a soother with a plug, cover or knob, which cannot
be held by a fixture device, the force shall be applied between the shield and the teat.
9.2
Puncture resistance (see B.14)
9.2.1
Requirements
9.2.1.1
When tested in accordance with 9.2.2.1 a force greater than 30 N shall be required to cut completely through
one wall of the teat, or for a solid teat through the whole of the teat.
34
BS EN 1400:2013
EN 1400:2013 (E)
9.2.1.2
When tested in accordance with 9.2.2.2 soothers fitted with a knob made of flexible materials, shall require a
force greater than 30 N to cut completely through one wall of the knob, or for a solid knob made of flexible
materials, through the whole of the knob.
9.2.2
9.2.2.1
Test methods
Before use, the tip of the indentor, see 5.3, shall be inspected visually for any damage such as burrs or chips.
Only undamaged indentors shall be used as otherwise the results of the test will be affected.
Without pulling, cut off the teat at right angles to the major axis from the complete soother as close as possible
to the shield and place the teat on the cutting board, see 5.4 and Figure 25.
Key
a
b
c
d
indentor (see 5.3)
teat
cutting board (see 5.4)
stop for cut edge of teat
Figure 25 — Positioning of indentor on the teat
Place the indentor, see 5.3, with the 3 mm edge of the indentor centred over and at right angles to the major
axis of the teat and (5 ± 0,5) mm from the cut edge of the teat using the markings on the cutting board, see
5.4.
35
BS EN 1400:2013
EN 1400:2013 (E)
In the case of teats not having a circular cross section, the indentor shall be positioned over the flattest
surface of the neck of the teat.
At a cross-head speed of (10 ± 1) mm/min, apply a load until the indentor cuts completely through the upper
wall of the teat. The upper wall of the teat is completely cut when the first maximum load has been detected.
See Annex G for an example of a graph produced during the puncture resistance test, showing the first point
of maximum load.
The force shall be applied at right angles to the cutting board using a tensile-testing machine.
For solid teats there is only one wall and a piece of similar material to the teat should be placed under the teat.
9.2.2.2
If the soother is fitted with a knob made of flexible materials repeat the puncture resistance test on the knob in
a similar manner to that described in 9.2.2.1.
For solid knobs made of flexible materials there is only one wall and a piece of similar material to the flexible
knob should be placed under the flexible knob.
9.3
Tear resistance (see B.15)
9.3.1
Requirements
9.3.1.1
When tested in accordance with 9.3.2.1 the teat shall not break or separate during the subsequent tensile test
in accordance with 9.7.2.2.
9.3.1.2
Tear resistance of knob made of flexible materials
If the soother is fitted with a knob made of flexible materials, when tested in accordance with 9.3.2.2 the knob
shall not break or separate during the tensile test in accordance with 9.7.2.2.
9.3.2
9.3.2.1
Test methods
Using a complete new soother sample, place the indentor, see 5.3, with the 3 mm edge of the indentor
centred over and at right angles to the major axis of the soother and (7,5 ± 0,5) mm from where the teat enters
the shield in the sucking face of the shield.
Apply a load ensuring that the indentor cuts completely through the teat and approximately 1 mm into an
undamaged area of a cutting board, see 5.4. When assessing solid teats, if the indentor has not cut through
with a force of 300 N, stop this test and conduct the tensile test in accordance with 9.7.2.2.
The subsequent tensile test, 9.7.2.2, with the teat at right angles to the major axis of the soother, shall be
conducted with the clamp applied to the teat at a distance of (12 ± 2) mm from the shield and with the shield
attached to a suitable fixture (see Annex D 1). The clamp holding the teat shall not cover or come into contact
with the punctured holes.
9.3.2.2
Tear resistance of knob made from flexible materials
If the soother is fitted with a knob made from flexible materials, repeat the tear resistance test on the knob in a
similar manner to that described in 9.3.2.1.
36
BS EN 1400:2013
EN 1400:2013 (E)
9.4
Knob, plug and/or cover retention (see B.16)
9.4.1
Requirement
When tested in accordance with 9.4.2, no part of the soother shall break or separate when checked by visual
inspection.
9.4.2
Test method
The rear face of the shield shall be supported as in Figure 26. The support shall be close to the knob, plug
and/or cover, but it shall not touch the plug, knob and/or cover. Certain soothers fitted with rings require slots
in the soother support in order to achieve a good fit on the rear face of the shield, see Figure 26.
Cut the tip off the teat at (5 to 10) mm from the teat/shield junction. Place a 5 mm diameter rod with a flat end
into the teat until it rests on the plug or the combined plug and cover. Apply a force of (90 ± 5) N at a
crosshead speed of (10 ± 1) mm/min and maintain for (10 ± 0,5) s.
If the soother is fitted with a separate plug and knob or cover then all parts shall be tested. Apply the force to
the underside of the knob or cover e.g. by drilling a hole in the centre of the plug to allow access for the test
rod, or by such other means as the design of the soother might allow.
Key
A
B
C
D
E
rod
teat
plug
cover
soother support
Figure 26 — Example of positioning of the soother for the knob, plug and/or cover retention test
In cases where a 5 mm diameter rod is not satisfactory, an alternative rod having a round or flattened cross
section of a suitable size shall be used.
37
BS EN 1400:2013
EN 1400:2013 (E)
9.5
Bite endurance of elastomeric components (see B.17)
9.5.1
Requirement
When tested in accordance with 9.5.2, no elastomeric component of the soother shall break, tear or separate
by visual inspection. When subsequently tested in accordance with 9.7.2.2, tensile test, no elastomeric
component of the soother shall break, tear or separate.
9.5.2
Test method
Place the elastomeric component of the soother to be tested between the bite endurance jaws, see 5.5 and
Figure 27, such that the full force is applied by the biting edges to the most onerous position on the
elastomeric component of the soother. Apply a minimum load of (200 ± 10) N to hold the elastomeric
component of the soother. Apply a maximum load of (400 ± 10) N and minimum load of (200 ± 10) N as the
upper jaw cycles up and down 50 times at a crosshead speed of (10 ± 1) mm/min.
Figure 27 — Positioning of the soother teat, knob and shield for the bite endurance of elastomeric
components test
After this treatment, the soother shall be tested in accordance with 9.7.2.2 for tensile strength by holding the
shield in a suitable fixture and by applying the force to the teat at right angles to the major axis of the soother.
It is essential that the biting edges do not move out of line during the bite endurance tests. Guide bars can be
provided in order to ensure that this is achieved.
9.6
Rotation endurance (see B.18)
9.6.1
Requirement
If any part is capable of being rotated (360°) within the teat of the soother when a torque of (1 ± 0,2) Nm is
applied, the teat when tested in accordance with 9.6.2 and followed by 9.7.2.2, shall not tear or separate.
38
BS EN 1400:2013
EN 1400:2013 (E)
9.6.2
Test method
Clamp the shield securely and rotate the knob, plug, cover or ring at a speed of (50 ± 5) rev/min 250
revolutions in a clockwise direction, then 250 revolutions in a counter clockwise direction.
After this test, carry out the tensile test in accordance with 9.7.2.2 applying the force between the shield and
the teat along the major axis of the soother.
9.7
Integrity (see B.19)
9.7.1
Requirements
When tested in accordance with 9.7.2.2 and 9.7.2.3 no part of the soother shall break, tear or separate when
checked by visual inspection.
Additional tests shall be carried out to ensure the integrity of all components not already examined as part of
9.1 to 9.6.
9.7.2
9.7.2.1
Test methods
General instructions for all tensile tests
Clamp the teat (12 ± 2) mm from the shield.
Rings shall be held by a clamp, rod or by a hook. Two rods or hooks can be used if the shape of the ring
prevents it from being held securely in the required position. Each rod or hook shall have a diameter of at least
5 mm and have a circular cross section.
All other components shall be held by clamps or other devices.
Examples of some suitable devices are given in Annex D (informative).
Clamps or other devices shall hold the components securely during the test without giving rise to damage
which might affect the test result. Any results where such damage occurs shall be disregarded.
If, after several attempts, the test cannot be performed without damaging the teat because the material of the
teat is so weak it shall be recorded as a non-compliance. This also applies to any other test where the teat is
clamped.
9.7.2.2
Tensile test
The tensile force shall be applied to one component of the soother whilst another part is firmly held. 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 (200 ± 5) mm/min and maintained at that level for (10 ± 0,5) s.
NOTE
The force used is not applicable for the reference test method given in Annex E.
In some cases the design of the soother makes it impossible to apply a force exactly at right angles to its
major axis, e.g. when the side of the teat contacts the edge of the shield. In such cases, the force shall be
applied as near as is practical to a right angle, whilst ensuring that any residual contact between the two parts
shall not significantly reduce the force actually applied to their junction.
When the force is applied at right angles to the axis, to a component which does not have a circular section
about the main axis of the soother, then the test shall be carried out on two samples. The force shall be
applied, once to each sample, 90° apart, and as far as possible in line with the extremes of the section.
39
BS EN 1400:2013
EN 1400:2013 (E)
9.7.2.3
Tensile tests for single components and pairs of components
The tensile force specified in 9.7.2.2 shall be applied along the major axis and at right angles to the major axis
of the soother, as described below to the soother and its components.
All single components shall be tested, and also every possible combination of pairs of components, where this
has not been carried out in other tests.
As the purpose of this series of tensile tests is to reduce the risk of the soother coming apart, the forces shall
be applied in the most onerous position.
The following are additional examples of the likely suitable combinations which need to be tested dependent
on the design of the soother:
a)
ring/ring;
b)
ring/shield;
c)
knob/cover/plug – shield;
d)
shield/shield (2-component shield e. g. rattle shield);
e)
knob/cover/plug - knob/cover/plug (2-components).
This is not an exhaustive list of such additional tests. Other constructions/designs could have other pairs of
components which shall be tested.
Some examples of suitable tests are shown in Figure 28.
40
BS EN 1400:2013
EN 1400:2013 (E)
Key
1 major axis
2 clamping device
A ring - ring
B ring - shield
C knob/cover/plug – shield
D ring – shield (2-component rattle shield)
NOTE
The hatched boxes indicate the component part is fixed or clamped in place.
Figure 28 — Examples of additional tests on soother components
10 Chemical requirements and test methods
10.1
General (see B.20)
Materials used for manufacturing soothers shall be subjected to the sample preparation as specified in 6.4
and the tests listed in Table 4.
The chemicals mentioned below do not represent a definitive list. The following requirements cover the current
known issues.
In addition, soothers shall be produced from grades of materials with quality standards that ensure that there
is no increased risk from chemicals either specified or not in this standard.
10.2
Materials
Soothers or components of soothers shall be subjected to the tests marked with an x in Table 4.
41
BS EN 1400:2013
EN 1400:2013 (E)
Volatile compound
content
Colour Fastness
Bisphenol A release
Formaldehyde release
Antioxidants release
2Mercaptobenzothiazole
release
N-Nitrosamines and
N-Nitrosatables release
Migration of certain
elements
Table 4 — Requirements and Tests on materials
Requirement
Clause
10.3.1
10.4.1
10.5.1
10.5.1
10.5.1
10.6. 1 a
10.7.1
10.8.1
Test Clause
10.3.2
10.4.2
10.5.2
10.5.2
10.5.2
10.6.2
10.7.2
10.8.2
Vulcanised rubber
x
x
x
x
x
x
Silicone rubber
x
x
x
x
Thermoplastics
x
TPEs
x
All Decorations
x
x
x
x
x
x
x
a Bisphenol A Migration should only be carried out on thermoplastics that use Bisphenol A in their
manufacture, such as polycarbonates. Bisphenol A is not used in the production of other common
thermoplastics, such as polypropylene and polyethylene.
10.3
Migration of certain elements (see B.21)
10.3.1 Requirement
When tested in accordance with 10.3.2 the migration of elements from any material used in the manufacture
of soothers 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 considered to be part of the material on which they are printed.
42
BS EN 1400:2013
EN 1400:2013 (E)
Table 5 — Limits of element migration from soothers
Element
Limit
mg/kg
Aluminium, Al
1 430
Antimony, Sb
60
Arsenic, As
2,5
Barium, Ba
200
Boron, B
1 600
Cadmium, Cd
1,8
Chromium, Cr
50
Cobalt, Co
14
Copper, Cu
830
Lead, Pb
2,5
Manganese, Mn
300
Mercury, Hg
10
Nickel, Ni
100
Selenium, Se
50
Strontium, Sr
6 000
Tin, Sn
20 000
Zinc, Zn
5 000
10.3.2 Method for the determination of the migration of certain elements
The migration of certain elements shall be determined using EN 71-3.
10.3.3 Determination of the quantity of migrated elements
Methods having a detection limit of at least 0,1 times the values of the limits to be measured shall be used to
determine their quantity.
10.4
N-Nitrosamines and N-Nitrosatable substances release (see B.22)
10.4.1 Requirement
When tested in accordance with 10.4.2 the total release of N-Nitrosamines and N-Nitrosatable substances
from any elastomer or rubber component shall not exceed the limits given in Table 6.
Test results not complying with this requirement shall be verified with a second sample by a laboratory fully
accredited for EN 12868.
43
BS EN 1400:2013
EN 1400:2013 (E)
Table 6 —N-Nitrosamines and N-Nitrosatable substances release and tolerance
Substance
Limit a
mg/kg
Tolerance
mg/kg
N-Nitrosamines
0,01
0,01
N-Nitrosatables
0,1
0,1
a
a Limits and tolerances are expressed as amount of substances migrating from 1 kg of
elastomer or rubber component.
10.4.2 Determination of N-Nitrosamines and N-Nitrosatable substances release
The levels of N-Nitrosamines and N-Nitrosatable substances released from a soother teat shall be determined
using EN 12868.
The sample preparation given in 6.4.1 does not apply to samples for N-Nitrosamines and N-Nitrosatable
substances release determination. All possible precautions shall be taken to avoid contamination of the
samples.
NOTE 1
The weight of sample taken for analysis is a significant factor in reporting N-Nitrosamine and N-Nitrosatable
results. For this test, at least ten pieces of whole, uncut soother teats have been shown to be necessary.
NOTE 2 The method given in EN 12868 is highly sensitive. The analytical tolerances given in Table 6 only apply if the
procedures laid down in EN 12868 are strictly followed, preferably by experienced laboratories.
10.5 2-Mercaptobenzothiazole (MBT), Antioxidant and Formaldehyde release (see B.20.5
and B.23, B.24, B.25)
10.5.1 Requirements
When vulcanised rubber components of soothers are tested in accordance with 10.5.2, the migration of
2-mercaptobenzothiazole or 2(3H)-benzothiazolethione shall not exceed the limit given in Table 7.
Table 7 — MBT release limit (see B.23)
Compound
2-mercaptobenzothiazole or 2(3H)benzothiazolethione (MBT)
a
CAS number
Limita
149-30-4
8 mg/kg
Limits are expressed as amount of substance migrating from 1 kg of rubber.
When tested in accordance with 10.5.2, the migration of the following chemicals from vulcanised rubber
components of the soother shall not exceed the limits given in Table 8.
Table 8 — Antioxidant release limits (see B.24)
Chemical name
2,6-bis(1,1-dimethylethyl)-4-methylphenol (BHT)
2,2’-methylenebis(4-ethyl-6-tert-butylphenol) (Cyanox 425)
2,2'-methylenebis(6-(1,1-dimethylethyl)-4-methylphenol) (Antioxidant 2246)
Butylated reaction product of p-cresol & dicyclopentadiene (Wingstay L)
2,4-bis(octylthiomethyl)-6-methylphenol (Irganox1520)
a
CAS
number
128-37-0
000088-24-4
119-47-1
68610-51-5
110553-27-0
Limitsa
(mg/l)
0,3125
0,0625b
0,25
0,25c
Limits are expressed as amount of substance per litre of simulant.
b This limit is the sum of Cyanox 425 and Antioxidant 2246.
c This limit is the sum of Irganox 1520 and Irganox 1726 - 2,4-bis(dodecylthiomethyl)-6-methylphenol),
CAS 110675-26-8.
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When tested in accordance with 10.5.2, the migration of formaldehyde from vulcanised rubber and silicone
rubber components of the soother shall not exceed the limit given in Table 9.
Table 9 — Formaldehyde migration (See B.25)
Compound
CAS number
Formaldehyde
a
50-00-0
Limita
mg/l
0,375
Limits are expressed as amount of substance per litre of simulant (see EN 71-11).
10.5.2 Determination
10.5.2.1 Principles
MBT, its metal-salts and the antioxidants listed in Table 8, are quantitatively determined following extraction
into an aqueous migration liquid. MBT and the antioxidants are identified and determined by High
Performance Liquid Chromatography (HPLC) and UV-detection at specific wavelength, either by fluid-fluid
extraction or in a concentrated solution. The identification is confirmed by comparing the UV-spectra of the
sample peaks produced by a diode array detector with the spectra of the peaks of authentic samples [6] [7].
Migrated formaldehyde shall be analysed using 5.5.3.1 to 5.5.3.6 specified in EN 71-11:2005.
10.5.2.2 Apparatus and reagents for the determination of antioxidants and MBT
10.5.2.2.1
Stainless steel tweezers.
10.5.2.2.2 Extraction bottles, approximate volume 250 ml with flat base, a screw neck and provided with a
PTFE-lined rubber septum.
10.5.2.2.3 Bottle rotator, capable of holding and rotating the extraction bottles in head-over-heels motion at
a constant speed.
The distance from the centre of the rotating axis to the centre of the extraction bottle shall be approximately
150 mm.
10.5.2.2.4 HPLC, with a suitable injection loop and diode array detector connected to an integrator or
personal computer with chromatography software.
10.5.2.2.5 HPLC-column, capable of separating MBT from the antioxidants and fully resolving the
antioxidants such that the peaks do not overlap by more than 1 % peak area with each other and with
interferences arising from other sample ingredients.
10.5.2.3 Reagents
10.5.2.3.1
Distilled water.
10.5.2.3.2
Dichloromethane (Residue analysis grade).
10.5.2.3.3
Anhydrous sodium sulphate.
10.5.2.3.4
Methanol (HPLC grade).
10.5.2.4 Procedure
Take one soother and cut off the teat as close to the shield as possible. Cut the teat into two pieces along the
major axis and weigh.
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Place the pieces into the extraction bottle (10.5.2.2.2) using tweezers (10.5.2.2.1). Add (100 ± 1) ml distilled
water (10.5.2.3.1) at (20 ± 2) °C. Close the extraction bottle and secure to the rotator (10.5.2.2.3). Rotate the
-1
bottle at (60 ± 5) min for (95 ± 5) min (see B.20.5).
Filter the aqueous migrate in the bottle through a plug of glass wool or filter paper with pore size 22 µm.
After filtration, divide the aqueous migrate into two parts:
One part of the migrant (70 ml) is used for MBT and antioxidants determination after a concentration step. The
concentration step can be done with (see Annex F):
a)
an SPE column using methanol for elution. The extract is concentrated under N2 to 0,5ml in an
evaporation step then analysed with HPLC,
or
b)
fluid-fluid extraction in dichloromethane. Shake the aqueous migration liquid with two 50 ml aliquots of
dichloromethane (10.5.2.3.2). The combined organic phases are dried over anhydrous sodium sulphate
(10.5.2.3.3), and evaporated carefully to dryness. The residue is then re-dissolved in 5 ml of methanol
(10.5.2.3.4) and analysed with HPLC.
The other part of the migrant (30 ml) is used for determination of Formaldehyde as specified in EN 71-11:2005.
NOTE
Annex F.
A suitable method of determination of MBT and Antioxidants and data on detection limits are described in
10.5.2.5 Calculation of MBT and Antioxidants
Using calibration curves (see Annex F) calculate the amounts of migrated MBT and individual antioxidants
found in terms of mg/l simulant. The amount of MBT determined in mg/l is converted to mg/kg rubber by using
the weight of the teats used in 10.5.2.4.
10.6
Bisphenol A release (see B.20.5, B.26 and Annex H)
10.6.1 Requirement
When tested in accordance with 10.6.2, the migration of Bisphenol A shall not exceed the limit given in
Table 10.
Table 10 — Monomers (migration) - see B.26
Compound
Bisphenol A (2,2-bis(4hydroxyphenyl)propane)a
a
CAS number
80-05-7
a
Limit
mg/l
0,125
Limits are expressed as amount of substance per litre of simulant (see EN 71-11).
10.6.2 Migration of Monomers including BPA
Use a single soother after cutting off the teat as close to the shield as possible. Other than cutting off the teat,
the soother shall not be further disassembled.
Place the soother into an extraction bottle (10.5.2.2.2) using tweezers (10.5.2.2.1). Add (100 ± 1) ml distilled
water (10.5.2.3.1) at (20 ± 2) oC. Close the extraction bottle and secure to the rotator (10.5.2.2.3). Rotate the
-1
bottle at (60 ± 5) min for (95 ± 5) min (see B.20.5).
Filter the aqueous migrate in the bottle through a plug of glass wool or filter paper with pore size 22 µm.
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Analyse the aqueous migrate using 5.5.2.2.3.2, 5.5.2.4.1.2, 5.5.2.4.2 and 5.5.2.5 specified in EN 71-11:2005.
10.7
Colour Fastness (see B.27)
10.7.1 Requirement
When all parts are tested in accordance with 10.7.2, colour fastness to saliva shall be > 4 on the grey scale as
defined in EN 20105-A03.
10.7.2 Determination of colour fastness
Colour fastness to saliva shall be tested in accordance with DIN 53160-1.
10.8
Volatile compounds content (see B.27)
10.8.1 Requirement
When silicone rubber components of soothers are tested in accordance with 10.8.2, and the results calculated
in accordance with 10.8.2.3, the volatile compounds content shall not exceed 0,5 % (m/m).
10.8.2 Determination of volatile compounds content
10.8.2.1 Apparatus
10.8.2.1.1
Balance, capable of weighing to ± 0,1 mg.
10.8.2.1.2
Oven, capable of maintaining a temperature of (100 ± 5) ºC and (200 ± 5) ºC.
This oven shall have a mechanical air circulation system to provide an average air change of as near to 50
changes per hour as possible.
10.8.2.1.3
Desiccator, with fresh anhydrous calcium chloride or fresh self indicating silica gel.
10.8.2.1.4
Watch glass 125 mm diameter
10.8.2.2 Method
o
Preheat the watch glass (10.8.2.1.4) in the oven (10.8.2.1.2) maintained at (100 ± 5) C for (60 ± 5) min.
Remove from the oven and cool in a desiccator (10.8.2.1.3) for (60 ± 5) min. After cooling, weigh the watch
glass and record as Weight A.
Remove the teats from the soother samples (see 6.4) by cutting as close to the shield as possible. Cut the
teats in half along the major axis. No further cutting of the teats shall be undertaken. Place the cut teats in the
watch glass.
It is recommended to use four or five teats, weighing approximately 10 g.
Place the watch glass with the sample teats in the oven at (100 ± 5)°C for (60 ± 5) min. Remove from oven
and cool in the desiccator for (60 ± 5) min. After cooling, weigh the watch glass and sample and record as
Weight B.
Replace the watch glass and sample in the oven at (200 ± 5) °C for 4 h ± 5 min. Place the watch glass and
sample in the desiccator to cool for 2 h ± 5 min and re-weigh; record as Weight C.
10.8.2.3 Calculation of results
The volatile compounds content is calculated from the percentage weight difference between Weight B and
Weight C, after deducting the weight of the watch glass (Weight A), as follows:
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{ (B − C ) ÷ (B − A) }× 100
(1)
where
A
is Weight A (g);
B
is Weight B (g);
C
is Weight C (g).
It is recommended that the test be carried out at least in duplicate.
Any volatile compounds content result above the limit specified in 10.8.1 shall be subjected to an analytical
tolerance of 0,3 %.
Examples of applying the analytical tolerance are shown in Table 11.
Table 11 — Volatile compounds content — Examples for applying the analytical tolerance to analytical
results
Analytical Result (%)
Analytical Tolerance
(%)
Calculated Analytical
Result (%)
Complies with 10.8.1?
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.28).
The Test report (see 14) should show both the analytical and the calculated analytical results.
11 Teat protectors
11.1
General (see B.29)
Teat protectors are marketed by some manufacturers to protect the teat while the soother is not being used by
the child. If present, the following requirements and tests shall apply.
11.2
Visual/tactile
The teat protector shall be free from any sharp points or edges and free of flash and burrs.
11.3
Size
11.3.1 Requirement
When tested in accordance with 11.3.2, the protective cover shall not pass completely through Guide 3
(see Figure 12).
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11.3.2 Test method
Position and clamp Guide 3 so that the slot is horizontal and unobstructed at its top and bottom openings.
Orientate the teat protector in a position that would most likely permit the entry of it through the slot in the
guide. Place the part in the slot so that the only force on the teat protector is the force due to its mass.
Observe whether the teat protector passes completely past the base of the guide.
11.4
Ventilation holes
11.4.1 Requirements
The following ventilation hole requirements shall be met:
If the teat protector on its own passes through Guide 1 (see Figure 10) using the test method outlined in
11.3.2, the teat protector shall be provided with at least two unobstructed ventilation holes, each of which
shall include a circular area of at least 4 mm diameter and a minimum area of 20 mm2, when tested in
accordance with 11.4.2.
If the combined product (soother plus teat protector) passes through Guide 1 then the combined product shall
be provided with at least two unobstructed ventilation holes each of which shall include a circular area of at
2
least 4 mm diameter and a minimum area of 20 mm , when tested in accordance with 11.4.3.
11.4.2 Test method for ventilation holes in teat protectors
The ventilation hole to be tested shall be orientated so that the entry to the hole is horizontal. Place test
sphere A, see 5.2, on the hole so that its mass allows it to pass through the ventilation hole.
Check whether the sphere passes completely through the hole.
technology etc.
11.4.3 Test method for ventilation holes in combined product (soother plus teat protector)
Attach the teat protector to the soother. The ventilation hole to be tested shall be orientated so that the entry
to the hole is horizontal. Place test sphere A, see 5.2, on the hole so that its mass allows it to pass through the
ventilation hole, that is through both the teat protector and the soother.
Check whether the sphere passes completely through the hole in the teat protector and the corresponding
hole in the soother shield.
To assist passage through the ventilation holes, the assembly may be tilted from the horizontal.
technology etc.
11.5
Openings
When tested in accordance with 8.9.2, there shall be no openings in the teat protector that allow test sphere B,
see 5.2, to penetrate more than 5,5 mm unless test sphere C, see 5.2, passes through.
This requirement only applies to components made of materials with a Shore A hardness of more than 60.
Circular holes not meeting this requirement present a risk of restricting circulation. Non-circular holes with
acute V-shaped angles or inward facing angles, that are not well rounded, should be avoided.
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11.6
Cup-shaped teat protectors
If any part of the teat protector is cup-shaped or bowl-shaped, having a nearly round, oval or elliptical opening
with the minor and major outer diameters between 64 mm and 102 mm, and a volume of less than 177 ml and
a depth greater than 13 mm, then the Hemispheric shaped toys requirements of EN 71-1 shall be met.
11.7
Impact Resistance
11.7.1 Requirements
All teat protectors shall be tested for impact resistance in accordance with 11.7.2 and no part shall break, tear
or separate during this test.
11.7.2 Test Method
Place the teat protector to be tested unsupported on a flat, horizontal steel surface. Drop the impact mass,
see 5.6, from a height of (100 ± 2) mm above the highest point of the teat protector so that the centre of the
impact mass is the first point to contact the teat protector. The test shall be carried out five times on the same
sample with, as far as it is practical, each impact carried out with the teat protector in a different stable
orientation (see also Figure 24).
NOTE
To align the impact mass before dropping, a ring just bigger than the diameter of the impact mass clamped at
a corresponding height to a retort stand has been found to be useful when carrying out this test.
12 Consumer packaging
Soothers shall be sold in a clean condition in closed packs.
The pack as received by the consumer shall include clear, legible instructions for use and hygienic care of the
soother.
These instructions shall be given as described in 13.3 and may be included on a separate leaflet placed inside
the packaging.
It is recommended that consumer packaging should not contaminate the product in any way.
Manufacturers when designing consumer packaging should consider environmental issues, such as disposal
instructions and recycling.
13 Product information
13.1
General
The text shall be printed in the official language or at least one of the official languages of the country of retail
sale. If other languages are included, they shall be easy to distinguish, e.g. by separate presentation.
The text shall be clearly legible. Sentences shall be short and of simple construction. The words used shall be
uncomplicated and in everyday use.
It is recommended that products or packaging be batch coded.
13.2
Purchase information
13.2.1 Visible at point of retail sale
The following information shall be visible at the point of retail sale on the outside of the packaging:
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 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 standard;
 for products containing natural rubber latex, the following information shall be given: “Produced from
natural rubber latex”.
It is recommended that more information relating to possible allergic reactions should be given.
13.2.2 Visible at point of internet sale or mail order
It is recommended that the purchase information (see 13.2.1) be visible at the point of internet sale or mail
order.
13.3
Instructions for use
13.3.1 General
The following information shall be provided either on the packaging or in a leaflet:
 information on the safe use of the product;
 at least one method of cleaning;
 unsuitable common methods of cleaning, storage and use which might damage the soother.
13.3.2 Warnings in a set form and order
The following warnings shall be provided in the form and order given:
For your child's safety
WARNING!
Inspect carefully before each use. Pull the soother in all directions. Throw away at the first signs of
damage or weakness.
Only use dedicated soother holders tested to EN 12586. Never attach other ribbons or cords to a soother,
your child may be strangled by them.
NOTE
Translations of these warnings into other languages are given in Annex A (normative).
13.3.3 Warning not in set form
The following warning shall be given although alternative wording is permitted.
Do not leave a soother in direct sunlight or near a source of heat, or leave in disinfectant ("sterilising
solution") for longer than recommended, as this may weaken the teat.
13.3.4 Warning if applicable
The following warning shall be given if applicable (see 3.9):
Keep the removable teat protector away from children to avoid suffocation.
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13.3.5 Other instructions for use
The following instructions shall be provided although alternative wording is permitted. Further instructions may
also be provided.
 Before first use, place the soother in boiling water for 5 min, allow to cool, and squeeze out any trapped
water from the soother. This is to ensure hygiene.
 Clean before every use.
 Never dip the teat in sweet substances or medication, your child may get tooth decay.
 Replace the soother between one and two months of use, for safety and hygiene reasons.
 In the event that the soother becomes lodged in the mouth, DO NOT PANIC; it cannot be swallowed and
is designed to cope with such an event. Remove from the mouth with care, as gently as possible.
13.4
Supply chain information for products that contain vulcanised rubber
13.4.1 Requirements
The following information shall be provided on any outer packaging (see 3.10) 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 13.4.2, in the local language, and/or the symbol given in 13.4.3,
Figure 29 shall be visible on the outside of the packaging at least once.
Text and symbols should be readily readable.
13.4.2 Text
Alternative wording is permitted:
 Keep away from sunlight and heat
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13.4.3 Symbol
0624
Figure 29 — Symbol indicating keep away from sunlight
NOTE
The symbol shown in Figure 29 is taken from ISO 7000:2004 [8].
14 Test report
Each test report shall include at least the following information, unless the laboratory has valid reasons for not
doing so:
a)
title (e.g. “Test Report”);
b)
name and address of the laboratory, and the location where the tests were carried out, if different from
the address of the laboratory;
c)
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 recognised as a part of the test report, and a clear identification of the
end of the test report;
d)
name and address of the customer;
e)
reference to this standard (EN 1400) and the date of its publication;
f)
description of, the condition of, and unambiguous identification of the item(s) tested;
g)
date of receipt of the test item(s) and the date(s) of performance of the test(s);
h)
test results with, where appropriate, the units of measurement and relevant clauses;
i)
compliance or non-compliance to the requirements tested;
j)
deviations from any test method used, if appropriate;
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k)
name(s), function(s) and signature(s) or equivalent identification of person(s) authorising the test report;
l)
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.1 shall be used for the relevant country of retail sale for the warnings given
in 13.3.2 in the form given.
Translation into languages not listed shall be made and the national standardisation body informed.
Table A.1 — Translation of warning phrases
English
For your child's safety
WARNING!
Inspect carefully before each use. Pull the soother in all directions. Throw away at the first
signs of damage or weakness.
Bulgarian
Only use dedicated soother holders tested to EN 12586. Never attach other ribbons or cords to
a soother, your child may be strangled by them.
За безопасността на Вашето дете
ВНИМАНИЕ!
Проверявайте старателно преди всяка употреба. Дръпнете биберона във всички посоки.
Изхвърлете при първите признаци на повреда или дефект.
Croatian
Използвайте само специалните държачи за залъгалки, изпитвани съгласно EN 12586.
Никога не окачвайте други панделки или шнурове на залъгалката, защото детето Ви
може да се удуши с тях
Za sigurnost vašeg djeteta
UPOZORENJE!
Pažljivo pregledati dudu varalicu prije svake upotrebe. Rastegnuti je u svim smjerovima. U
slučaju znakova oštećenja ili istrošenosti, dudu varalicu baciti.
Koristiti samo namjenske držače za dudu varalicu ispitane prema EN 12568.
Nikada ne pričvršćivati vrpcu ili konopac na dudu varalicu jer se dijete time može zadaviti.
Czech
Pro bezpečnost vašeho dítěte
UPOZORNĚNÍ!
Před každým použitím výrobek pečlivě zkontrolujte. Natáhněte dudlík do všech směrů.
V případě jakýchkoli známek poškození nebo opotřebení jej vyhoďte.
Používejte pouze držáky dudlíků, které byly testovány v souladu s normou EN 12586. Na
dudlík nikdy nepřipínejte jiné šňůrky nebo stuhy. Mohlo by dojít k udušení dítěte.
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Danish
For dit barns sikkerhed
ADVARSEL!
Kontroller altid produktet før brug. Træk sutten i alle retninger. Smid den ud ved første tegn på
skader eller slitage
Dutch
Burg kun de dertil beregnede sutteholdere, som er testet i henhold til EN 12586. Fastgør aldrig
andre bånd eller snore på en sut, da dit barn kan blive kvalt i dem
Voor de veiligheid van uw kind
WAARSCHUWING!
Controleer de fopspeen nauwkeurig voor elk gebruik. Trek er in alle richtingen aan. Gooi de
fopspeen weg zodra u beschadigingen of zwakke plekken ziet.
Estonian
Gebruik alleen speciale fopspeenhouders getest volgens EN 12586. Bevestig nooit andere
linten of koorden aan een fopspeen. Uw kind kan zich erdoor verwurgen."
Teie lapse ohutuseks
HOIATUS!
Kontrollige lutti enne igat kasutamist ning tõmmake seda igas suunas. Visake lutt ära esimeste
kahjustuste või kulumise märkide ilmnemisel.
Kasutage üksnes spetsiaalseid lutihoidjaid, mida on katsetatud standardi EN 12586 kohaselt.
Ärge kunagi siduge luti külge muid paelu ega nööre, need võivad seada teie lapse
lämbumisohtu.
Finnish
Lapsesi turvallisuuden tähden
VAROITUS!
Tarkista tutti huolellisesti ennen jokaista käyttöä ja vedä tuttia kaikkiin suuntiin. Heitä tutti pois
heti jos huomaat siinä merkkejä huonokuntoisuudesta tai vaurioista.
French
Käytä ainoastaan sellaisia tutinpidikkeitä, jotka ovat standardin EN 12586 mukaisia. Älä kiinnitä
tuttiin muita nauhoja tai naruja, koska ne voivat aiheuttaa lapselle kuristumisvaaran.
Pour la sécurité de votre enfant
AVERTISSEMENTS !
Avant
chaque
utilisation,
examinez
soigneusement
la
sucette
dans tous les sens. Jetez-la au moindre signe de détérioration ou de fragilité.
et
tirez-la
Utilisez uniquement des attaches-sucettes testés selon la norme EN 12586.
Pour éviter tout risque d'étranglement, n'attachez jamais de rubans ou un cordons à une
sucette.
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German
Für die Sicherheit Ihres Kindes
VORSICHT!
Kontrollieren Sie den Schnuller vor jedem Gebrauch. Ziehen Sie den Schnuller in alle
Richtungen. Werfen Sie ihn beim ersten Anzeichen von Beschädigungen oder Mängeln sofort
weg.
Greek
Verwenden Sie nur spezielle Schnullerbänder, die der EN 12586 entsprechen. Befestigen Sie
niemals andere Bänder oder Schnüre an einem Schnuller, Ihr Kind kann sich mit ihnen
strangulieren.
Για την ασφάλεια του παιδιού σας
ΠΡΟΣΟΧΗ!
Ελέγχετε προσεκτικά το προϊόν πριν από κάθε χρήση. Τραβήξτε δυνατά τη θηλή προς κάθε
κατεύθυνση. Αντικαταστήστε την πιπίλα μόλις παρατηρήσετε κάποιο σημάδι φθοράς ή
αδυναμίας.
Hungarian
Χρησιμοποιείτε μόνο ειδικές κορδέλες στήριξης πιπίλας, ελεγμένες κατά το πρότυπο EN
12586. Ποτέ μη δένετε απλές κορδέλες ή κορδόνια στην πιπίλα του μωρού. Κίνδυνος
στραγγαλισμού.
Gyermeke biztonságáért
FIGYELEM!
Minden egyes használat előtt vizsgálja meg alaposan, és húzogassa meg a cumit minden
irányba. Ha az anyag gyengülését vagy sérülését észleli, azonnal dobja el.
Italian
Kizárólag az EN 12586 szabványnak megfelelő funkcionális cumitartót használjon. Ne tegyen
egyéb szalagot vagy zsinórt a cumira, mert a gyermek megfulladhat tőle.
Per la sicurezza del vostro bambino
AVVERTENZA!
Controllare attentamente prima di ogni uso. Tirare il succhietto in tutte le direzioni. Sostituirlo al
primo segno di usura o danneggiamento.
Latvian
Utilizzare solamente trattieni succhietti conformi alla EN 12586. Non fissare il succhietto a
nastri o cordini, il vostro bambino potrebbe strangolarsi.
Jūsu mazuļa drošībai!
BRĪDINĀJUMS!
Pirms katras lietošanas reizes rūpīgi pārbaudiet. Pavelciet knupīti visos virzienos. Izmetiet
knupīti, tiklīdz pamanāt bojājumu vai trūkumu pazīmes.
Izmantojiet tikai paredzētos knupīšu turētājus, kas testēti atbilstoši standartam EN 12586.
Nekad nepievienojiet knupītim citas lentes vai vadus, jo jūsu bērns var ar tiem nožņaugties.
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Lithuanian
Jūsų vaiko saugumui užtikrinti
ĮSPĖJIMAS!
Prieš kiekvieną naudojimą čiulptuką atidžiai apžiūrėti. Patampyti čiulptuką visomis kryptimis.
Išmesti, jei atsirado pirmi apgadinimo arba netvirtumo požymiai.
Norwegian
Naudoti tik specialius čiulptuko laikiklius, išbandytus pagal EN 12586. Prie čiulptuko niekada
netvirtinti juostelių arba virvelių, nes jūsų vaikas gali jomis pasismaugti.
For barnets sikkerhet
ADVARSEL!
Undersøk nøye før hver bruk. Dra smokken i alle retninger. Kast den ved første tegn på skade
eller svakhet.
Polish
Bruk kun egne smokkeholdere som er testet i henhold til EN 12586. Ikke fest andre bånd eller
snorer til en smokk ettersom dette kan føre til at barnet kveles.
Dla bezpieczeństwa Twojego dziecka
OSTRZEŻENIE!
Przed każdym użyciem dokładnie sprawdź produkt. Pociągnij smoczek we wszystkich
kierunkach. W przypadku jakichkolwiek oznak uszkodzeń wyrzuć produkt.
Używaj wyłącznie dedykowanych uchwytów do smoczka zgodnych z normą EN 12586. Nigdy
nie przywiązuj do smoczka wstążek ani pasków, gdyż może to spowodować uduszenie się
dziecka.
Portuguese
Pela segurança do seu filho
ATENÇÃO!
Verifique cuidadosamente antes de cada utilização. Puxe a chupeta em todas as direcções.
Elimine ao primeiro sinal de danos ou deterioração.
Romanian
Utilize apenas clipes porta-chupetas dedicados testados de acordo com a EN 12586. Nunca
prenda outras fitas ou fios a uma chupeta, o seu filho pode ser estrangulado.
Pentru siguranţa copilului dvs.
AVERTISMENT!
Înaintea fiecărei utilizări, verificaţi cu atenţie. Trageţi de suzetă din toate direcţiile. Aruncaţi-o la
primele semne de deteriorare sau slăbire.
Russian
Utilizaţi numai suporturi de suzetă dedicate, testate în conformitate cu EN 12586. Pentru a
evita strangularea, nu ataşaţi niciodată funde sau cordoane de suzetă.
Для безопасности вашего ребёнка
ПРЕДУПРЕЖДЕНИЕ!
Перед каждым использованием. Потяните соску пустышки во всех направлениях.
Используйте только специальные держатели пустышек, протестированные согласно EN
12586. Никогда не прикрепляйте другие ленты или к пустышке, ваш ребёнок может.
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Slovakian
Pre bezpečnosť Vášho dieťaťa!
UPOZORNENIE!
Pred každým použitím dôkladne skontrolujte. Potiahnite cumlík všetkými smermi. Pri prvom
náznaku poškodenia či opotrebovania ho odhoďte.
Slovenian
Používajte iba výhradne určené držiaky cumlíkov testované podľa normy EN 12586. K cumlíku
nikdy nepriväzujte iné stužky ani šnúrky, mohlo by dôjsť k uškrteniu dieťaťa!
Za varnost vašega otroka
OPOZORILO!
Dudo pred vsako uporabo natančno preglejte. Dudo potegnite v vse smeri. Ob prvih znakih
poškodb ali obrabljenosti jo takoj zavrzite.
Spanish
Uporabljajte samo namenska držala za dude, ki so bila preskušena v skladu z EN 12586. Na
dudo ne pritrjujte drugih trakov ali vrvic, ker se otrok z njimi lahko zadavi.
Para la seguridad de su bebé
¡ADVERTENCIA !
Inspecciónelo atentamente antes de cada uso. Tire del chupete en todas las direcciones.
Deseche el chupete al primer signo de deterioro o fragilidad.
Utilice sólo broches para chupetes probados según la norma EN 12586. Nunca unir el chupete
a otras cintas o cordeles, su bebé podría estrangularse con ellas.
Swedish
För ditt barns säkerhet
VARNING!
Kontrollera nappen före varje användning. Dra i den åt olika håll. Kasta nappen så fort den
visar tecken på skador eller slitage.
Använd bara napphållare som är avsedda för ändamålet och testade enligt EN 12586. Fäst
aldrig andra band eller snören i en napp, barnet kan strypas av dem.
Turkish
Çocuğunuzun güvenliği için
UYARI!
Her kullanımdan önce ürünü dikkatlice inceleyin. Kontrol için emziği tüm yönlere doğru
çekiştirin. İlk hasar ya da zedelenme belirtisinde ürünü atın.
Yalnızca EN 12586 standartlarında test edilmiş uygun emzik tutacaklarını kullanın. Emziğe
kesinlikle başka kurdele ya da ip bağlamayın, çocuğunuz boğulabilir.
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Annex B
(informative)
Rationale
B.1
Introduction
This informative annex has been included with the purpose of providing the rationale for the inclusion of some
of the requirements given in this standard.
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. A rationale also provides 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
Soothers are used by a wide age range: newborns, neonates (0 - 4 weeks of life), infants, toddlers and young
children for long periods. Accidents, some of which have been fatal, have occurred in the past and a prime
purpose of this standard is to reduce the risk of accidents occurring in the future. It is stressed that this
European Standard cannot eliminate all possible risks to babies and young children using such a product and
that parental or guardian control is of paramount importance. It is essential that all warnings and instructions
specified in this standard are given clearly by the manufacturer, to allow the carer to ensure that the soother is
used correctly and safely.
B.3
Cleanliness (see 8.1)
Attention should be made to the design of the soother to ensure that it may be cleaned easily and efficiently.
There are no viable tests to compare one soother model with another in terms of whether one can be more
easily cleaned than another. Therefore, the standard can at this stage merely highlight the problem and
ensure that manufacturers include sufficient warnings and instructions about cleaning (see 13.3.5).
B.4
Preparation of samples
B.4.1
Pre-treatment (6.3.1)
Samples 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.4.2
Boiling (6.3.2 and 6.4.2)
Samples are boiled prior to testing to remove the surface coating arising from the manufacturing processes.
Immersion of the soother in boiling water will also indicate the stability of materials to cleaning processes that
may undermine the integrity of the soother which is tested in the mechanical section.
B.5
Teat (see 8.2)
The maximum penetration of the teat is specified to ensure the teat does not cause choking or initiate the gag
reflex. The committee considered existing international standards and a literature review relating to lengths of
babies’ thumbs and fingers and decided the maximum length of 35 mm used in EN 1400:2002 is still
appropriate.
A hole in the teat in front of the shield, which allows the ingress of air or liquid into the hollow section of the
teat, is considered a potential source for a biological hazard.
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The requirement for no solid, fluid or gaseous substances (other than air) contained in the hollow section of
the teat is to avoid ingestion of these materials in the event that the teat splits or breaks.
The Technical Committee was unable to define the ideal flexibility of the teat; therefore a wide range of
materials could be used. However, this European Standard only addresses the vast majority of teats currently
used in the market - made from vulcanised rubber, silicone rubber and thermoplastic elastomers. If other
materials are used then the manufacturer shall show with an appropriate risk assessment that they are safe.
B.6
Shield (see 8.3)
The minimum size of the soother shield has been specified to reduce the risk of the child getting the whole of
the soother in the mouth. This minimum size follows previously published requirements (EN 1400:2002) and
regulations (CPSC 16 CFR Ch. II), which have been shown to dramatically reduce this hazard, whilst at the
same time allowing for the distance between the child’s lips and nasal septum. Given these physical
constraints of a child’s face, it is not possible to completely avoid the risk of the soother entering the mouth.
The test procedure (8.3.2) involves the use of a wetting agent to simulate a shield covered with saliva.
B.7
Shield ventilation (see 8.4)
This European Standard contains both a definition for ventilation holes (see 3.7) and specific requirement for
the number and size of the holes (see 8.4.1). Medical literature suggests that a single hole of 3 mm to 3,5 mm
diameter will sustain life if the mouth or throat of a young child is blocked. This hole also provides assistance
for the extraction of the object with a surgical instrument and prevents a build up of negative pressure.
However, in case one hole becomes blocked, two ventilation holes each having a minimum diameter of 4 mm
2
and a minimum area of 20 mm are required. These minimum dimensions follow previously published
requirements which have been shown to dramatically reduce this hazard. In addition, the placement of the
ventilation holes in the shield is carefully controlled to reduce the risk of blockage.
Attention has been paid to those soothers which may have a part, for example the ring, which partly obstructs
one or more of the ventilation holes.
The primary requirement given in 8.4.1 states that "The shield shall be provided with at least two ventilation
holes (see 3.8) each of which shall include a circular area of at least 4 mm diameter and a minimum area of
20 mm2."
The shortest circumference of a hole with an area of 20 mm2 is 15,8 mm. Given these measurements, the
2
minimum distance of an obstruction can be calculated to be 1,3 mm above the hole (15,8 x 1,3 = 20,5 mm ).
Therefore, if any part of the soother, in any position, is more than 1,3 mm from the entrance to the hole then
the hole shall be considered to be unobstructed and area measurement shall be made on the complete hole.
However, in all cases the requirement for a minimum circular area of 4 mm diameter applies.
This European Standard now requires ventilation holes and other openings to be tested using stainless steel
spheres (see 5.2). The adoption of test spheres has been decided to avoid the practical difficulties of
assessing the amount of force to be applied when using test rods.
B.8
Ring (see 8.5)
The maximum effective penetration (35 mm; the same as the maximum penetration of the teat) and relative
shape of any ring is specified to reduce the risk of the soother becoming stuck in the child’s mouth, to reduce
the risk of gagging if the soother becomes reversed, to allow air flow, and to aid the removal of the soother
from a child’s mouth.
Although the maximum effective penetration of the ring has been specified for the first time in this standard,
the requirement for the length of the ring to be no greater than 1,4 of its width, avoiding a long thin "stick-like"
ring shape which might present a gagging hazard, has been retained.
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B.9
Collapse of rings made of non-flexible material (see 8.5.1)
The requirement for the collapse of rings made of non-flexible material has been made to reduce the chance
of the ring damaging the child’s face or nose in the event that child suffers a fall with the soother in his mouth.
B.10
Plug (see 8.6)
The maximum size requirement for the plug projecting beyond the sucking face of the shield has been set to
reduce any damage the plug might inflict on the teat when it is bitten.
B.11
Knob, plug and cover made of non-flexible materials (see 8.7)
The minimum projection of a knob, plug or cover made of non-flexible materials, whichever projects furthest
beyond the rear face of the shield, has been set to assist the handling of the soother and its removal from the
child’s mouth.
The maximum projection requirement equates with the height of a collapsed ring (see 8.5.1) and is to reduce
the chance of injury to the child’s face, mouth or nose if the child suffers a fall with the soother in his mouth.
B.12
Rings, knobs, plugs and/or covers made of flexible materials (see 8.8)
The minimum penetration of a knob, plug and/or cover made of flexible materials is to assist the handling of
the soother and its removal from the child’s mouth.
The maximum penetration of a knob, plug and/or cover made of flexible materials at 35 mm is the same as the
maximum length of a soother teat (see B.5) to allow for the eventuality that a child might suck on the knob.
B.13
Openings (see 8.9)
The size of openings and depth of penetration are specified to reduce the risk of a child’s finger becoming
stuck in an opening and reducing the flow of blood to the finger. There is evidence that circular holes not
meeting the requirement present a risk of restricting circulation.
B.14
Puncture resistance (see 9.2)
The puncture resistance requirement sets an acceptable level of integrity for the teat or a knob made of
flexible materials.
The puncture resistance test has been studied by the Technical Committee with a series of Round Robin
trials; and it has been found that the use of the standardised cutting board (see 5.4) reduces interlaboratory
variation.
B.15
Tear resistance (see 9.3)
The tear resistance of a teat or knob made of flexible materials is assessed to reduce the risk of a child tearing
the teat after causing a puncture. This tearing might result in a piece separating from the teat which may
cause a choking hazard.
B.16
Knob, plug and/or cover retention (see 9.4)
The retention of the knob, plug and/or cover is assessed to reduce the risk of one of these parts
disassembling, which could then become a choking hazard.
B.17
Biting endurance of elastomeric components (see 9.5)
The requirements, test equipment and test method for bite endurance have been set to assess the ability of
the teat and other parts of the soother to withstand a child biting on them repeatedly prior to and after teething.
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B.18
Rotation endurance (see 9.6)
When any component (such as a plug) can be rotated 360° inside the teat, the rotation endurance is assessed
to reduce the risk of a component part being damaged during rotation such that it will become detached which
could result in a choking hazard.
B.19
Integrity (see 9.7)
The soother is assessed for integrity to reduce the risk of a part of the soother being detached when a child
bites and pulls on the soother at the same time, which could result in a choking hazard.
The forces for tensile strength (90 N) stated in this standard have been based on other standards, such as
BS 5239 and EN 71-1 and these forces have been accepted as appropriate to ensure a soother has sufficient
integrity.
If during any test, the soother or any part of the soother breaks, tears or separates, it is considered to be a
failure. Therefore there is no need for any detached part to be tested using a small parts cylinder.
B.20
Chemical requirements and test methods (see Clause 10)
B.20.1 General
Chemicals other than those mentioned in this standard can be used provided they have, either on the original
chemical and any reaction product, toxicological evidence which demonstrates that no increased risk is posed
when they are used in soothers, adopting the same principles and methodology as shown in this standard.
Appropriate analytical test procedures for determining migration levels shall also be provided.
A soother is not an article intended to come into contact with foodstuffs, even though it may include materials
of construction that are suitable for food contact.
The Technical Committee has adopted a risk approach to calculate the migration limits for certain chemicals
identified as hazards found in materials used in the construction of soothers. Unless already specified, the
migration limits have been calculated using the tolerable daily intake (TDI) values for the chemical, the
duration of mouthing of the soother, the amount of material that may be ingested, the age of the child and
contribution of the chemical hazard from other sources. The principles are described in the report for the EU
Commission Chemicals in Toys - A general methodology for assessment of chemical safety of toys with a
focus on elements - RIVM/SIR Advisory Report 0010278A01 [9].
Caprolactam, platinum, organo-tin and chromium VI have been considered by the Technical Committee. They
have not been included in the standard at this stage because of the lack of sufficient information to make a
satisfactory risk assessment or because there is no existing validated test method. They will be reconsidered
when further information becomes available.
The Technical Committee has identified methods in the toy standards as appropriate for determining the
elements (EN 71-3) and organic chemicals (EN 71-10 [33] and EN 71-11) in soother materials. These
methods have been adopted and the migration limits recalculated for a child mouthing a soother or ingesting
material scraped or bitten off a soother.
B.20.2 Weight of a child mouthing the soother
This standard covers soothers for children from birth to 36 months of age. Accordingly, body weights in this
age range vary widely from about 2 kg to over 18 kg. However, a significant proportion of soothers are used
by newborn babies and therefore the Technical Committee has decided to use birth weight as the measure for
the weight of the baby in the migration formulae given in this standard.
There are numerous growth charts published by individual countries and recently by the World Health
Organisation. Some comparison of the available data has been carried out; however, the Technical
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Committee decided to follow a more pragmatic approach, that is, to consider a healthy newborn term baby
who is not defined as “low birth weight”.
The generally accepted definition of low birth weight is a baby less than 2,5 kg. It has been estimated that
about 94 % of all birth weights in Europe are at least 2,5 kg. Accordingly, this weight has been used
throughout the calculations involving migration data.
B.20.3 Amount of material that can be bitten/scraped off a soother
There are no definitive studies providing information on the amounts of material that may be ingested when
mouthing a soother. Examination of used soothers has shown the most likely source of ingested material is
the teat where older children with teeth have been able to puncture the teat forming small particles typically
1 mm3 to 2 mm3 weighing approximately 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.20.4 Allocation of TDI
Following from the RIVM/SIR Advisory Report 0010278A01 [9], it is not acceptable that the (daily) systemic
exposure from soothers would fill up the total 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.
RIVM has recommended that not more than 30 % of the TDI of any element should be allowed in toys. As a
comparison it should be noted that in other regulatory frameworks, limit values for elements are also related to
a fraction of the TDI. One of the most prominent examples is the setting of limit values for drinking water as
used by WHO for their drinking water guidelines. Limit values for drinking water are derived by allocating a
maximum of 10 % of the TDI for drinking water and an intake of two litres of water.
The Technical Committee decided to use mainly a 10 % allocation of TDI where applicable in the standard. It
is also noted that the 2010 SCHER report [10] recommends 10 % allocation for all chemical elements.
However, Directive 2009/48/EC on the Safety of Toys [11] 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.
B.20.5 Common migration rules
The Technical Committee has adopted a number of common migration techniques and rules:
 The migration (see 10.5) of 2-Mercaptobenzothiazole, antioxidant release, and Formaldehyde release are
carried out dynamically on a single soother teat using the head-over-heels technique outlined in EN 71-10
[33]. To avoid air becoming trapped inside the teat during the migration stage, the teat is cut into two
pieces along the major axis.
 In the case of Bisphenol A migration (see 10.6) the Technical Committee has tried to simulate a child
sucking or licking on all parts of the soother, which might contain Bisphenol A. Therefore, a single, whole
soother (excluding the teat) is used for the dynamic head-over-heels migration stage.
 There are very few peer-reviewed studies evaluating the daily length of time sucking on a soother.
However, Juberg et alia [12] showed that the average mouthing times during the day on a soother for
different aged children are 3-6 months; (94,9 min), 6-18 months; (27,3 min), 12-18 months; (17,3 min)
and 18-36 months (20,8 min)
 The Technical Committee decided to use this 3-6 month data and have adopted a migration time of
95 min for 2-Mercaptobenzothiazole, antioxidants, formaldehyde and Bisphenol A.
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 For all these four migrations, the simulant used is 100 ml water.
B.21
Migration of certain elements (see 10.3)
The presence of certain elements may be found in the raw materials used in the manufacture of soothers such
as inks, pigments, fillers, anti-oxidants etc or through inadvertent contamination during the production process.
Although these elements may present a hazard, the risk of exposure is minimal as the element is usually
retained within the matrix of the material especially a polymer even when the material is ingested, sucked or
licked. The recent literature has been consulted and TDI values have been used from a variety of sources
given in Table B.1.
Using a defined method such as EN 71-3 which simulates the effect of ingestion, a maximum migration limit
can be calculated on the weight of sample ingested and absorbed into the body. Using the allocated
percentage of the TDI (see B.20.4), the weight of a child (see B.20.2), and the amount of material that may be
bitten/scraped off the soother and ingested (see B.20.3), the migration limit in terms of mg element/kg material,
can be expressed in the following formula:
{ (T
× A ×W ) ÷ B
}× 1000
(B.1)
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 or scraped off a soother (mg);
1 000
is the multiplication factor.
For example, using the TDI value shown in Table B.1, the migration limit for antimony (Sb) can be calculated
as follows:
{ (6 × 0,1 × 2,5) ÷ 25 }× 1000
= 60 mg /kg
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Using the same approach, the following migration limits have been calculated:
Table B.1 — TDI Values for certain elements and calculated migration limits
Element
Symbol
TDI
µg/kg body
weight/day
Allocation
of TDI
Sources of TDI
Migration limits
mg/kg
Aluminium
Al
143
0,10
[13]
1 430
Antimony
Sb
6
0,10
[14]
60
Arsenic
As
1
0,05
[15]
2,5
Barium
Ba
20
0,10
[16]
200
Boron
B
160
0,10
[17]
1 600
Cd
0,36
0,05
[18]
1,8
a
0,10
[17]
50
Cadmium
Chromium
Cr
5
Cobalt
Co
1,4
0,10
[17]
14
Copper
Cu
83
0,10
[17]
830
Lead
Pb
0,5
0,05
[11], [19]
2,5
Manganese
Mn
30
0,10
[17]
300
Mercury
Hg
2
0,05
[17]
10
Nickel
Ni
10
0,10
[17]
100
Selenium
Se
5
0,10
[17]
50
Strontium
Sr
600
0,10
[17]
6 000
Tin
Sn
2 000
0,10
[17]
20 000
Zinc
Zn
500
0,10
[17]
5 000
a
B.22
based on Cr (III)
N-Nitrosamines and N-Nitrosatable substances release (see 10.4)
The European Commission Scientific Committee for Food in 1993 indicated that N-Nitrosamines and
N-Nitrosatable substances may endanger human health owing to their carcinogenicity. Levels of these
substances should therefore be maintained as low as practically achievable.
Commission Directive 93/10/EEC regulates the release of N-Nitrosamine and N-Nitrosatable substances from
elastomer or rubber teats and soothers [20].
The levels of N-Nitrosamines and N-Nitrosatable substances present in the soother are determined using
EN 12868, which is the only validated test method; EN 12868 is currently under revision.
B.23
Mercaptobenzothiazole (MBT) release (see 10.5)
The European Commission Scientific Committee on Food (SCF) [21] in 2000 and the Scientific Committee on
Consumer Products (SCCP) [22] 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 standard.
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B.24
Antioxidant release (see 10.5)
Antioxidants are used in vulcanised rubber soother teats to prevent degradation of the rubber over time which
may affect the integrity of the material. However, certain antioxidants have varying degrees of toxicity
requiring migration limits to be set to ensure there is no harm to health. Certain antioxidants have been
identified by the Technical Committee as being used in rubber soother teats and limits have been calculated
using TDI values taken or derived from various sources shown in Table B.2.
An allocation of 10 % of the TDI has been used for the majority of antioxidants. However for
2,6-Di-t-butyl-4-methylphenol (BHT) it was decided to reduce this to 5 % because this antioxidant is widely
used as a food additive.
Using a defined method such as EN 71-10 [33] (see B.20.5) which simulates the effect of mouthing, a
maximum migration limit can be calculated on the amount of the migration solution volume. Using the
allocated percentage of the TDI, the migration solution volume (see B.20.5 Common migration rules), and the
weight of a child (see B.20.2), the migration limit can be expressed in the following formula:
{ (T
× A ×W ) ÷ S
}× 1000
(B.2)
where:
T
is the TDI in milligram per kilogram body weight per day;
A
is the allocation of TDI as a decimal;
W
is the weight of the child (kg);
S
is the migration solution volume (ml);
1 000
is the multiplication factor to convert millilitres to litres.
For example using the TDI value shown in Table B.2, the migration limit for BHT can be calculated as follows:
{ (0,25 × 0,05× 2,5)÷ 100 }×1000 = 0,3125 mg/l
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Table B.2 — TDI values for antioxidants and calculated migration limits
Antioxidant
CAS No.
TDI
mg/kg
body
weight/day
2,6-Di-t-butyl-4-methylphenol
000128-37-0
Allocation
of TDI
Sources
of TDI
Migration
Limit
mg/l
0,25
0,05
[23]
0,3125
0,025
0,10
[24]
0,0625a
68610-51-5
0,10b
0,10
[25]
0,25
110553-27-0
0,10
c
0,10
[26]
0,25
BHT
2,2’-methylenebis(4-ethyl-6tert-butylphenol)
000088-24-4
Cyanox 425
2,2′-methylene bis(4-methyl6-tertbutylphenol)
00119-47-1
Antioxidant 2246 or A22M46
Butylated reaction product of
p-cresol & dicyclopentadiene
Wingstay L
2,4-bis(octylthiomethyl)-6methylphenol
Irganox 1520
a
This migration limit is the sum of Cyanox 425 and Antioxidant 2246.
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 Irganox1520 and Irganox 1726, for which both a TDI and SML are published.
c
The TDI is for the sum of Irganox 1520 and Irganox 1726 (2,4-bis(dodecylthiomethyl)-6-methylphenol), CAS
110675-26-8. Irganox 1726 was not considered as a relevant antioxidant for soothers.
B.25
Formaldehyde release (see 10.5)
Formaldehyde may be found in silicone and rubber components, and therefore the Technical Committee
decided to set a limit for formaldehyde release.
The World Health Organisation (WHO) derived a drinking-water guideline value for formaldehyde of 900 μg/l
based on a tolerable daily intake (TDI) value of 0,15 mg/kg bw/day [27], [28], which has been adopted.
maximum migration limit can be calculated on the amount of the migration solution volume. Using an
allocation of 10 % of the TDI (see B.20.4), the migration solution volume (see B.20.5), and the weight of a
child (see B.20.2), the migration limit can be calculated with the same formula used in B.24. That is,
0,375 mg/l.
B.26
Bisphenol A release (see 10.6)
Bisphenol A - 2,2-Bis(4-hydroxyphenyl)propane (“BPA”) is commonly used in the manufacture of
polycarbonate and some polysulphones, but not in other thermoplastics such as polypropylenes and
polyethylenes.
68
BS EN 1400:2013
EN 1400:2013 (E)
There is currently a strong debate within the scientific community relating to the potential hazard and
associated risk effects of Bisphenol A (BPA) in humans. A comprehensive human risk assessment of BPA has
been completed and is continuously being reviewed by the European Food Safety Authority (EFSA). In 2006
the EFSA established a full TDI of 0,05 mg BPA/kg bw per day, derived by applying a 100-fold uncertainty
factor to the overall NOAEL of 5 mg/kg bw/day [29]. This TDI was reconfirmed in a 2010 EFSA Opinion [30].
However, the EU has temporarily banned the use of BPA in infant bottles (for children less than one year old)
as from 1 May 2011 [31], [32] but this does not apply to soothers. The EU Directive states the EFSA Opinion
on BPA is still valid and therefore the Technical Committee has included a requirement for BPA in soothers
based on the TDI from the EFSA Opinions.
maximum migration limit can be calculated on the amount of the migration solution volume. Using the
allocated percentage of the TDI (see B.20.4), the migration solution volume (see B.20.5 Common migration
rules), and the weight of a child (see B.20.2), the migration limit can be calculated with the same formula used
in B.24, which is 0,125 mg/l.
Therefore, the weight of the soother plays no part in the calculation of the migration limit and the weighing of
the soother in 10.6.2 has been excluded.
B.27
Colourants (see 10.7)
Pigments and dyes are used in the materials that form the different components of soothers. These are
usually retained in the matrix of the material particularly where thermoplastics are used for the shield, ring and
knob, and rarely in elastomeric teats. A colour fastness test method is used to ensure these colourants are not
released.
B.28
Volatile compounds content (see 10.8)
The volatiles compound content is a measure of the cleanliness and the degree of curing of the silicone, which
might affect properties such as the tear and puncture resistance of the soother teat. The Technical Committee
was unable to find any evidence that the volatile compounds normally found in silicone soother teats for
example constitute a health hazard.
The test procedure has been extensively studied by the Technical Committee with the aid of two 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 relatively low volatility of the compounds normally found in silicone teats and also
the variation between ovens.
However, it was felt that the test should remain in this standard as a measure to avoid silicone teats that had
not been post-cured from entering the market.
A further round robin trial was carried out on post-cured and uncured teats manufactured from the same
moulding batches and the results indicated that with a high degree of probability soother teats having volatile
compounds content of up to 0,8 % were satisfactorily post-cured.
Therefore it was decided to leave the requirement at 0,5 % but to apply an analytical tolerance of 0,3 %, which
is to be subtracted from any analytical result that exceeds 0,5 %. By this means, both the issue of uncured
teats and the reproducibility problems are addressed.
In addition, a number of significant changes have been made to the test procedure as compared with
EN 1400:2002 series.
B.29
Teat protectors (see 11)
Teat protectors are marketed by some manufacturers to protect the teat while the soother is not being used by
the child.
69
BS EN 1400:2013
EN 1400:2013 (E)
The Technical Committee considers that it is foreseeable that a teat protector whether fixed to the soother or
not, may be mouthed by the child. Accordingly, requirements have been set for size, ventilation holes and
impact resistance.
The requirement for cup-shaped teat protectors (see 11.6) is intended to address the asphyxiation hazards
associated with certain shapes (e.g. cup-shape, bowl-shape or one half of an egg-shape) that can be placed
over a young child's nose and mouth forming an airtight seal.
In addition, a requirement for adding a warning to the instructions for use has been made.
70
BS EN 1400:2013
EN 1400:2013 (E)
Annex C
(informative)
Information for products resembling a soother
C.1
General
In this European Standard a soother is defined as "article which includes a teat and which is intended to
satisfy the non-nutritive sucking need of children" (see 3.1). However, it is clear that there are many products
which either resemble a soother or function as a soother as well as having another function, or functions. In
addition, some soothers are specially designed for dedicated applications, such as for premature babies.
There are also some products which although clearly resembling a soother, are kept out of the scope of this
standard as they are covered by the Medical Device Directive.
These products can be summarised under the following headings:
 resemble a soother but are not designed or do not function as a soother for children;
 resemble a soother but having another minor function;
 resemble a soother but having another major function;
 specialised applications;
 medical devices.
C.2
Resemble a soother but are not designed or do not function as a soother for children
These are products that resemble a soother but are designed for other purposes, such as decoration or
ornaments.
It is recommended that all such products be labelled with a statement saying that the product is not a soother
and that it shall be kept away from young children.
C.3
Resemble a soother but having another minor function
An example of this type of product is a soother with soft edges on the shield for chewing or as a teething aid. It
is recommended that such products should fulfil all the requirements of this standard.
C.4
Resemble a soother but having another major function
This category includes products for example that are marketed as teething rings but resemble a soother in
shape and appearance. Similarly, some temperature sensors can have a teat to allow measurement within the
mouth.
It is recommended that unless specifically covered by the Medical Device Directive or by other standards
(such as the Toy Standard) these products should fulfil all the requirements of this standard.
C.5
Specialised applications
These are products that are designed to deal with specific medical problems and will be used under qualified
medical supervision. Examples are soothers for Pierre Robin Syndrome and for premature babies. It is
recognised that many of these extremely important products will not fulfil all the requirements of this standard
(for example size of shield) and they are excluded from the scope.
71
BS EN 1400:2013
EN 1400:2013 (E)
However, it is recommended that these products should fulfil as many of the requirements as is practicable. It
is also recommended that such products be labelled with a statement that the product is not for general sale.
C.6
Medical devices
In the event that these products do not meet the requirements of this standard, the manufacturer can argue
that they meet the requirements of the Medical Device Directive.
It is recommended that when conducting a risk assessment all the requirements of this standard are taken into
account.
In addition, a prominent warning regarding the inadvisability of using the product as a soother, when it is being
used for its medical purposes, should be provided.
72
BS EN 1400:2013
EN 1400:2013 (E)
Annex D
(informative)
Some examples of suitable fixing devices
Key
A
B
front view
side view
Figure D.1 — Examples of suitable fixing devices for tensile tests along the major axis
73
BS EN 1400:2013
EN 1400:2013 (E)
Key
A
B
front view
side view
Figure D.2 — Example of a suitable fixing device for tensile tests at right angles to the major axis
74
BS EN 1400:2013
EN 1400:2013 (E)
Key
1, 6 -y axial movement
2, 7 +y axial movement
3 translation tables
4, 8 - x axial movement
5, 9 +x axial movement
10 tensile force (front view)
11 tensile force (side view)
Figure D.3 — Example of an axial auto-centring system for assisting alignment of soother teat when
tensile testing at right angles to major axis
75
BS EN 1400:2013
EN 1400:2013 (E)
Annex E
(informative)
Soothers — Assessment of compliance with standard — Sampling plan
and compliance levels for freshly manufactured samples
E.1
General
This annex does not apply to samples purchased in stores.
If a party wishes to establish, by inspection and testing of samples of the final product, whether a batch of
soothers produced to EN 1400 complies with the requirements, the sampling plans in E.2, the compliance
level in E3, and test methods and procedures in E.4 to E.5 can be applied. For example:
a)
type-testing of product;
b)
for contractual purposes by a purchaser;
c)
by a national inspection authority.
This annex takes into account the inevitable variation which occurs in the manufacturing processes. However,
if any test produces a single result lower than the minimum requirement (90 N) given in the body of the
standard, the soother shall be deemed to have failed. The tests are designed to be carried out until the
sample(s) break and therefore a higher threshold value has been used than in the standard.
E.2
Sampling
A single or double sampling plan can be used.
Each lot should be sampled in accordance with ISO 2859-1 [34], special inspection level S-4.
NOTE 1
It is necessary to know the batch size in order to derive from ISO 2859-1 the number of samples to be tested.
The batch size will vary between manufacturers and is regarded as part of the process and quality controls used by the
manufacturer.
NOTE 2
If the size of the batch from which the soothers in question were derived is unknown, it should be assumed
that the batch size is between 35 001 and 150 000.
E.3
Compliance level
AQL of 1,0 for 120 N.
E.4
Test methods and procedure
The soother is to be tested in accordance with Clauses 8 and 9 of EN 1400:2013.
NOTE
The requirements given in EN 1400 for mechanical properties are intended to be applied to soothers at the
time of sale and even after they have been in stock for some time. Therefore an oven treatment procedure (artificial
ageing) intended to simulate the effect of normal storage is included for freshly made soothers.
9.1.2, 9.3.2.1, 9.5.2, and 9.6.2
The final tensile strength tests are to be carried out to failure.
9.4.2, 9.7.2.3
The tests are to be carried out to failure.
76
BS EN 1400:2013
EN 1400:2013 (E)
Annex F
(informative)
A suitable HPLC apparatus and method for determination of 2Mercaptobenzothiazole (MBT) and antioxidants BHT, 2246, Cyanox 425,
Wingstay L and Irganox 1520
F.1
Apparatus
F.1.1
HPLC (HP 1090 or Agilent 1000 system), with a diode array detector connected to personal
computer with chromatography software (ChemStation).
F.1.2
SPE column for concentration.
F.2
Standards
The standards shown in Table F.1 have been found to be suitable.
Table F.1 — Standards
F.3
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
Antioxidant 2246
109-47-1
80,2
Irganox 1520
100553-27-0
>97
Kuo Ching Chemical Co
Column
A Spherisorb S5C8, 4,6 μm 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 0,005 M, pH 8 ± 0,01.
 Mobile phase (Eluent B): Methanol.
 If required, degas the mobile phase.
A suitable gradient programme is given in Table F.2.
Table F.2 — Gradient programme
Time (min)
Eluent A (%)
Eluent B (%)
1
16
21
30
36
85
5
5
0
0
15
95
95
100
100
77
BS EN 1400:2013
EN 1400:2013 (E)
 Flow rate: 1 ml/min.
 Detection:200 nm to 400 nm (280 nm, 320 nm).
 Column Compartment temperature: 40 °C.
 Injection volume: 25 µl (or more if necessary).
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.
F.4
Detection
a)
MBT: UV 320 nm, Diode array spectrum from 240 nm to 360 nm. Detector programming from time 5 min
to 15 min;
b)
Antioxidants: UV 280 nm, Diode array spectrum from 240 nm to 360 nm, Detector programming from time
12 min to time 25 min.
F.5
Retention Times
Typical chromatograms of the standard solution containing MBT and the antioxidants are shown in Figure F.1.
Key
1
2
3
4
5
6
MBT: approximately 12,4 min (max absorbance 320 nm)
antioxidant BHT: approximately 18,7 min (max absorbance 280 nm)
antioxidant 2246: approximately 19,4min (max absorbance 280 nm)
antioxidant Cyanox 425: approximately 19,7 min (max absorbance 280 nm)
Wingstay L: approximately 20,1 min (max absorbance 280 nm)
Irganox 1520: approximately 20,7 min (max absorbance 280 nm)
Figure F.1 — Typical Chromatograms of MBT and antioxidants
78
BS EN 1400:2013
EN 1400:2013 (E)
F.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 six chemicals. The concentration ranges were between quantitative detection limits (LOQ)
(see Table F.3) and twenty times the migration limits, to have at least six concentration points. A calibration
curve for each chemical was determined.
Table F.3 — Detection Limits of Quantification (LOQ)
LOQ (µg/ml)
LOQ calculated (mg/l
simulant)
LOQ
(mg/kg rubber)
MBT
2,07
0,015
0,65
BHT
0,99
0,007
Antioxidant 2246
0,97
0,007
Cyanox 425
1,03
0,007
Wingstay L
6,18
0,044
Irganox 1520
1,98
0,014
Compound
79
BS EN 1400:2013
EN 1400:2013 (E)
Annex G
(informative)
Graphical representation for determining puncture resistance of a teat
Key
N
mm
3
force
extension
point where one wall of teat has been punctured = puncture resistance to be recorded
Figure G.1 — Example of a graph produced during the puncture resistance test (see 9.2.2.1)
80
BS EN 1400:2013
EN 1400:2013 (E)
Annex H
(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 national member.
This European Standard does not fall under any Directive of the EU. 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
Country
National Regulation
Austria
Austrian Federal Law from the Ministry of Health
Regulation No 327 of 6 October 2011 prohibiting the
use of Bisphenol A in Soothers and teething rings
Sub-Clause 10.6.1
§ 1 (2)
The requirement for
applicable in Austria.
Bisphenol
A
cannot
be
"It is prohibited to produce soothers and teethers with
Bisphenol A or putting them on the market."
81
BS EN 1400:2013
EN 1400:2013 (E)
Bibliography
[1] EN ISO 9001, Quality management systems — Requirements (ISO 9001)
[2] EN 14350-1, Child use and care articles — Drinking Equipment — Part 1: General and mechanical
requirements and tests
[3] EN 14350-2, Child use and care articles — Drinking equipment — Part 2: Chemical requirements and
tests
[4] ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories
[5] 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
[6] G. Blosczyk and H-J.Dömling, Lebensmittelchemie und Gerichtl. Chemie (1982), 36, 90
[7] G. Blosczyk, Deutsche Lebensmittel Rundschau (1992), 88, 392
[8] ISO 7000:2004, Graphical symbols for use on equipment — Index and synopsis
[9] Chemicals in Toys — A general methodology for assessment of chemical safety of toys with a focus on
elements, RIVM/SIR Advisory Report 0010278A01 (August 2006)
[10] Scientific Committee on Health and Environmental Risks (SCHER). Evaluation of the Migration Limits for
Chemical Elements in Toys. Opinion adopted 1 July 2010
[11] Commission Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the
safety of toys (Recital 22)
[12] An Observational Study of Object Mouthing Behavior by Young Children, Daland R. Juberg, Kathleen
Alfano, Robert J. Coughlin and Kimberly M. Thompson, Pediatrics (2001);107;135-142
[13] EFSA Journal (2008), 754, 1
[14] WHO (2003), Antimony in Drinking Water, World Health Organisation. Geneva
[15] EFSA Journal (2009), 7, 1351
[16] WHO (2001), Concise International Chemical Assessment Document 33, World Health Organisation.
Geneva
[17] Chemicals in Toys — A general methodology for assessment of chemical safety of toys with a focus on
elements. RIVM Report 320003001, National Institute for Public Health and the Environment, The
Netherlands, 20081)
[18] EFSA Journal (2011), 9, 1975
[19] EFSA Journal (2010), 8, 1570
1) This report is a revision of citation [9].
82
BS EN 1400:2013
EN 1400:2013 (E)
[20] Commission Directive 93/11/EEC of 15 March 1993 concerning release of N-Nitrosamines and NNitrosatable substances from elastomer or rubber teats and soothers
[21] 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)
[22] Scientific Committee on Consumer Products Opinion on 2-Mercaptobezothiazole, SCCP/0883/05,
adopted 21 June 2005
[23] EFSA Journal (2012), 10, 2588
[24] RIVM Documentation Toxicology, Summary 300/418 of April 1983, National Institute for Public Health and
the Environment, The Netherlands
[25] Opinion of the Scientific Committee on Food on the 18th additional list of monomers and additives for food
th
contact materials (expressed on 24 September 2002)
[26] Commission Directive 2005/79/EC of 18th November amending Directive 2002/72/EC relating to plastic
materials and articles intended to come into contact with food
[27] WHO (1993) Guidelines for drinking-water quality. Second Edition. World Health Organisation. Geneva
[28] WHO (2004) Guidelines for drinking-water quality. Third Edition. World Health Organisation. Geneva
[29] EFSA Journal (2006) 428, 1
[30] EFSA Journal (2010) 8, 1829
[31] Commission Directive 2011/8/EU of 28 January 2011 amending Directive 2002/72/EC as regards the
restriction of use of Bisphenol A in plastic infant feeding bottles
[32] Commission implementing Regulation (EU) No 321/2011 of 1 April 2011 amending Regulation (EU) No
10/2010 as regards the restriction of use of Bisphenol A in plastic infant feeding bottles
[33] EN 71-10, Safety of Toys — Part 10: Organic chemical compounds — Sample preparation and extraction
[34] ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
83
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Child use and care articles — Soothers for babies and young

Transcription

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