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EN14350-2020儿童护理用品-饮水设备-安全要求和试验方法-英文版正版

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2021-02-09 04:05
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2021年2月9日发(作者:chock)



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


.


............................. .................................................. .................................................. ........................


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




9

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