-
BS EN 14350:2020
EN 14350:2020 (E)
8.9
8.10
8.11
9
10
10.1
10.2
10.3
10.4
10.5
Migration of
primary aromatic amines (see B.23) ...............
..................................................
.......... 45
Migration of lead and
cadmium from glass (see B.17)
.
< br>............................................... .................... 45
Migration of
elements from metal (see B.18)
.
..............................................
...................................... 46
Consumer packaging ....................
..................................................
..................................................
........... 46
Product information
.
...............................
..................................................
..................................................
46
General ............................
..................................................
..................................................
............................. 46
Purchase information ..................
..................................................
..................................................
........... 46
Warnings ...............
..................................................
..................................................
...................................... 47
Instructions for use
.
.............................................
..................................................
...................................... 48
Supply chain information for products
that contain vulcanised rubber
.
................................. 49
Annex A
(normative)
Warnings
.
.......
..................................................
..................................................
.................. 52
Annex B
(informative)
Rationales ...
..................................................
..................................................
.................. 62
B.1
B.2
B.3
B.4
B.5
B.6
B.7
B.8
B.9
Introduction
..................................................
..................................................
............................................... 62
General ...............................
..................................................
..................................................
.......................... 62
Preparation of samples for construction
and mechanical tests (see 6.1)
.
............................... 62
Pre-treatment (see 6.3)
.
..........................................
..................................................
................................. 63
Boiling (see 6.4) .....................
..................................................
..................................................
................... 63
Decoration,
inscription and decals (see 7.2) .................
..................................................
................... 63
Additional
requirements for sealing discs (see 7.5)
.
....................................
................................... 63
Volumetric labelling and accuracy
requirements (see 7.6.1. and 7.6.2)
.................................. 63
Tear resistance test (see 7.7.1) ......
..................................................
..................................................
..... 64
B.10
Print adhesion of markings and
decorations (see 7.6.3) ..........................
..................................... 64
B.11
Protective
covers (see 7.8)
.
..........
..................................................
..................................................
......... 64
B.12
Push-pull valves (see 7.7.2) ..........
..................................................
..................................................
........ 65
B.13
Handles and clips (see 7.9) ...........
..................................................
..................................................
........ 65
B.14
Volatile compounds content (see 8.4)...
..................................................
.............................................. 65
B.15
Colourants
(see 8.8)
.
.................
..................................................
..................................................
............... 66
B.16
Migration of certain elements (see 8.6)
..................................................
............................................. 66
B.17
Migration of
lead and cadmium from glass (see 8.10) ...........
..................................................
....... 68
B.18
Migration of elements from metal (see
8.11)
.
.....................
..................................................
............. 68
B.19
Antioxidant release (see 8.7) .........
..................................................
..................................................
...... 69
B.20
Formaldehyde release (see 8.7)
< br>.
...................................
..................................................
........................ 71
B.21
Cr VI limit
(see 8.6) ........................................
..................................................
............................................ 71
B.22
Mercaptobenzothiazole (MBT) release
(see 8.7)
.
.................
..................................................
.......... 71
B.23
Migration of primary aromatic amines
(see 8.9)
.
.................
..................................................
.......... 71
B.24
Migration conditions for elastomeric
materials ........................................
....................................... 72
Annex C
(informative)
Method for the determination of
2-mercaptobenzothiazole (MBT)
and
antioxidants specified in Table 7 ................
..................................................
................................. 73
3
BS EN
14350:2020
EN 14350:2020 (E)
C.1
C.2
C.3
C.4
C.5
C.6
C.7
C.8
Apparatus ...
..................................................
..................................................
.................................................
7
3
Procedure ....
..................................................
..................................................
................................................
7
3
Column
.
..................................
..................................................
..................................................
.......................
7
4
Detection
.
......
..................................................
..................................................
...............................................
7
4
Standards
.
...............................
..................................................
..................................................
.....................
7
4
Preparation of standard solutions of
MBT and antioxidants..............................
..........................
7
5
Retention
times ............................................
..................................................
...............................................
7
6
Calculation of
MBT and antioxidants
.
......
..................................................
............................................
7
7
Annex D
(informative)
A-Deviations <
/p>
.
............................
..................................................
......................................
7
8
Annex E
(informative)
Good practice
for visibility and legibility
.
< br>............................................... ...............
7
9
E.1
E.2
E.3
E.4
General .....
..................................................
..................................................
..................................................
..
7
9
Warnings
p>
.
.............................
..................................................
..................................................
........................
7
9
Font
.
...........
..................................................
..................................................
..................................................
..
7
9
Multi-
languages
.
.................
..................................................
..................................................
.......................
7
9
Bibliography ..........................
..................................................
..................................................
...................................
8
0
4
BS EN 14350:2020
EN 14350:2020 (E)
European
foreword
This document (EN 14350:2020)
has been prepared by Technical Committee
CEN/
TC 252 “Child care
articles”, the secretariat of which is
held by AFNOR.
This
European
Standard
shall
be
given
the
status
of
a
national
standard,
either
by
publication
of
an
identical
text
or
by
endorsement,
at
the
latest
by
December 2020, and
conflicting
national
standards
shall be withdrawn
at the latest by June 2021.
Attention is drawn to the possibility
that some of the elements of this document may be
the subject of
patent rights. CEN shall
not be held responsible for identifying any or all
such patent rights.
This
document supersedes EN 14350-1:2004 and EN
14350-2:2004.
The main changes compared
to the previous edition are listed below:
—
The standard
has been completely renewed and a new structure
was given. The former two parts
were
joined
together
into
one
standard.
A
whole
series
of
new
aspects
had
to
be
considered,
following changes in the market and the
regulatory background.
—
Introduction:
Completely reworded and references to European
regulations were renewed.
—
Clause 3:
Completely restructured and partly described in
more detail. Definitions for completely
new parts were added.
—
Clause 4:
Several completely new parts were added.
—
Clause 5: This clause is completely
new.
—
Clause 6: This clause is completely
new.
—
Clause
7:
The
whole
clause
has
been
divided
into
several
sub-paragraphs
for
individual
components of drinking equipment and
the associated tests to improve the clarity of the
sequence.
Several paragraphs for new
items and their tests were added.
—
Clause
8:
This
clause
was
completely
restructured
and
subdivided.
The
requirements
and
test
conditions
have
been
set
with
the
consideration
of
the
likely
chemical
exposure:
food
contact,
mouthing or ingestion. Chemical
requirements and test methods were set for
materials (like rubber,
silicon,
TPE,
metal,
glass)
and
exposures
(mouthing
and
swallowing)
which
are
recently
not
covered
by
harmonised
legislations.
Requirements
for
substances
(e.g.
Phthalates
and
BPA)
covered by harmonised
regulation (like REACH, (EU) 10/2011 or its
amendments) have not been
included.
—
Clause 10: Revised and partly reworded.
—
Clause 11: This clause on Test report
is completely new.
—
Annex A: This
normative annex with translations of warnings into
24 languages is completely
n
ew.
—
Annex B: This
informative annex with rationales is completely
new.
5
BS EN 14350:2020
EN 14350:2020 (E)
—
Annex C: This
informative annex on Method for the determination
of 2-mercaptobenzothiazole
(MBT) and
antioxidants specified in Table 7 was revised and
enlarged.
—
Annex E: This informative annex on good
practice for visibility and legibility is
completely new.
This
document has been prepared under a mandate M/264
given to CEN by the European Commission
and
the
European
Free
Trade
Association.
The
standard
is
developed
in
support
of
the
EU
Directive
2001/95/EC (GPSD).
According
to
the
CEN-CENELEC
Internal
Regulations,
the
national
standards
organisations
of
the
following countries are
bound to implement this European Standard:
Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland,
Italy,
Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Republic of North
Macedonia,
Romania,
Serbia,
Slovakia,
Slovenia,
Spain,
Sweden,
Switzerland,
Turkey
and
the
United
Kingdom.
6
BS EN
14350:2020
EN 14350:2020
(E)
Introduction
This
document
harmonises
minimum
safety
requirements
and
test
methods
for
children’s
drinking
equipment.
Some
of
the
provisions
have
been
taken
from
other
existing
national
and
European
Standards and for
these provisions the Technical Committee has
relied on previous validation.
A
significant choking hazard can arise if the
component parts of drinking equipment become
separated
during use. This hazard is
addressed in this document by the inclusion of a
security test. However, as
the
fixing
of
such
products
to
the
container
is
user-dependent,
the
risk
of
an
accident
cannot
be
completely
eliminated.
This
document
sets
out
labelling
requirements
stating
that
parents
or
carers
should not leave children unattended
whilst being fed with a product containing a
feeding teat or using
a container made
of glass and that children should not be allowed
to use feeding teats as a
s
oother.
The
Technical
Committee
considered
the
possibility
of
standardizing
both
sizes
of
feeding
teats
and
ranges
of
flow
rates.
However,
it
was
decided
that
the
many
combinations
of
container
systems
precluded
being
standardized.
It
is
recommended
that
all
container
and
drinking
accessory
combinations are matched components.
Providing meaningful flow rate information is
difficult because
of
several
factors
including
hole
diameter,
teat
thickness,
hole
shape/type
of
feed,
and
also
how
individual infants
suck
the
teat.
Accordingly, it
was
decided
not
to
include a
test for
flow
rate
but
to
recommend that
manufacturers provide information on flow rate and
hole size that is appropriate to
their
particular product.
This document sets
chemical requirements and test methods for
materials (like rubber, silicon, TPE etc)
and
exposures
(mouthing
and
swallowing)
not
covered
by
harmonised
legislations.
Where
this
document
sets
migration
limits
for
substances
also
covered
by
legislation,
the
requirements
of
this
document with stated
test conditions must be regarded as additional.
Materials and chemical risks included
in the standard (Table 3) do not present a
definitive list but the
considered
opinion of the Technical Committee based on
current knowledge of likely risks.
All
food contact materials and articles are regulated
by Regulation (EC) No 1935/2004 [1], Regulation
(EC) No 2023/2006 [39] and relevant
implementation measures, at European or national
level.
All plastics components of
drinking equipment intended to come into contact
with food are specifically
regulated by
the Regulation (EU) 10/2011 [2] on plastic
materials and articles intended to come into
contact with food and its amendments.
Therefore, for example the Bisphenol A
- requirement has not been included in this
document. [40]
Phthalates in childcare
articles are restricted by Annex XVII of the REACH
Regulation [3] and have not
been
included in this document.
Latex
protein allergy risk has not been included in this
document. There is no published information
that
sensitization is
caused
by
feeding
teats and
there is an
extremely
low
incidence
of
latex
protein
allergy among young children and
babies. Nevertheless, provision for packaging
information for feeding
teats made from
natural rubber latex has been included in this
document.
It
is
recommended
that
manufacturers
and
suppliers
operate
to
EN
ISO
9001
standard
for
quality
management
systems
[4].
It
is
also
recommended
that
laboratories
operate
to
EN
ISO/IEC
17025,
General requirements
for the competence of testing and calibration
laboratories [5].
7
BS EN 14350:2020
EN 14350:2020 (E)
1
Scope
This
document
specifies
safety
requirements
relating
to
the
materials,
construction,
performance,
packaging and product information for
drinking equipment intended for children of 0 to
48 months (see
B.2) of age:
—
Re-usable
containers and re-usable drinking accessories;
—
Single-use containers and drinking
accessories sold with these containers;
—
Single-use feeding teats;
—
Ready to use
feeding teats.
This
document does not include requirements for the
cleanliness of ready to use and single use
products.
This document does
not apply to products designed for specialist
clinical medical applications, e.g.
those relating to cleft lip palates.
This document does not apply to
drinking equipment made from ceramics.
This document does not apply to bags
intended for storage only.
This
document does not apply to drinking equipment
which is supplied with fluids or food when
purchased and to feeding accessories
fixed to it.
This document is not
applicable to soothers. Safety requirements and
test methods for soothers are
specified
in EN 1400 [6].
This document is not
applicable for cutlery and other feeding utensils.
Safety requirements and test
methods
for Cutlery and other feeding equipment are
specified in EN 14372 [7].
For drinking
equipment excluded from the scope, consider the
applicable requirements of this
document whenever possible.
2
Normative
references
The
following
documents
are
referred
to
in
the
text
in
such
a
way
that
some
or
all
of
their
content
constitutes
requirements
of
this
document.
For
dated
references,
only
the
edition
cited
applies.
For
undated references, the latest edition
of the referenced document (including any
amendments) applies.
EN 71-3,
Safety of toys - Part 3: Migration of
certain elements
EN 12868,
Child use and care articles - Method
for determining the release of N-nitrosamines and
N-
nitrosatable substances from
elastomer or rubber teats and soothers
EN ISO 3696,
Water for
analytical laboratory use - Specification and test
methods (ISO
3
696)
IEC 60454-2,
Pressure-sensitive adhesive tapes for
electrical purposes, Part 2: Methods of test
ISO 188:2011,
Rubber, vulcanized or thermoplastic
—
Accelerated ageing and
heat resistance tests
8
BS EN 14350:2020
EN 14350:2020 (E)
3
Terms and
definitions
For the purposes of this
document, the following terms and definitions
apply.
ISO and IEC maintain
terminological databases for use in
standardization at the following addresses:
?
IEC
Electropedia: available at
/
ISO Online browsing platform: available
at
/obp/ui
?
3.1
matched components
components which are intended to be
used together whilst feeding a child
Note 1 to entry: Their dimensions are
matched to fit together and fulfil the relevant
safety requirements.
Note 2 to entry:
See definitions 3.2 to 3.9.
3.2
drinking accessory
device
fitted to a container which permits a child to
obtain fluid from it
3.2.1
feeding teat
elastic
drinking accessory other than a straw
Note 1 to entry: there is no accepted
scientific definition for the word “elastic”. The
Technical Committee intended
to
describe by
3.2.2
drinking spout
non-elastic
drinking accessory other than a straw
3.2.3
push-pull valve
drinking accessory equipped with a
valve designed to be manually operated by a push-
pull, twist or
similar action
Note 1 to entry: A push-
pull valve is also know
n as a “sports
cup spout”.
3.2.4
straw
drinking accessory consisting of a
cylindrical hollow tube which is in contact with
the mouth and
through which fluid is
sucked
3.2.5
protruding part
drinking
accessory when assembled for its intended use on a
container
3.3
container
feeding bottle, drinking cup or feeding
bag
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