1、BRITISH STANDARD BS EN 14350-2:2004 Child use and care articles Drinking equipment Part 2: Chemical requirements and tests The European Standard EN 14350-2:2004 has the status of a British Standard ICS 97.190 BS EN 14350-2:2004 This British Standard was published under the authority of the Standards
2、 Policy and Strategy Committee on 26 November 2004 BSI 26 November 2004 ISBN 0 580 44910 6 National foreword This British Standard is the official English language version of EN 14350-2:2004. The UK participation in its preparation was entrusted to Technical Committee CW/42, Baby soothers, soother h
3、olders, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue und
4、er the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct app
5、lication. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed;
6、monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 21 and a back cover. The BSI copyright notice displayed in this document indicates when the document was
7、 last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN143502 August2004 ICS97.190 Englishversion ChilduseandcarearticlesDrinkingequipmentPart2: Chemicalrequirementsandtests ArticlesdepuricultureArticlespourlalimentationliquide Partie
8、2:Exigenceschimiquesetessais ArtikelfrSuglingeundKleinkinderArtikelfrflssige KindernahrungTeil2:ChemischeAnforderungenund Prfungen ThisEuropeanStandardwasapprovedbyCENon30April2004. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Stand
9、ardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytr
10、a nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,
11、Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Slovakia, Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2004CEN Allrightsofexploitationinanyf
12、ormandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN143502:2004:EEN 14350-2:2004 (E) 2 Contents page Foreword3 Introduction .4 1 Scope 6 2 Normative references 6 3 Terms and definitions .6 4 Requirements.8 4.1 General8 4.2 Chemical properties 8 4.3 Requirements by material.8 4.4 Migrat
13、ion of certain elements.8 4.5 N-Nitrosamines and N-Nitrosatables release9 4.6 2-mercaptobenzothiazole (MBT) release.9 4.7 Antioxidants release9 4.8 2,2-bis(4-hydroxyphenyl)propane Bisphenol A (BPA) release.10 4.9 Volatile compounds content.10 5 Test methods10 5.1 Sample preparation .10 5.2 Determina
14、tion of the migration of certain elements 10 5.2.1 Principle10 5.2.2 Apparatus .10 5.2.3 Reagents (analytical reagent grade unless otherwise specified).11 5.2.4 Selection of test portions11 5.2.5 Preparation of test portion11 5.2.6 Procedure .11 5.2.7 Determination of the quantity of migrated elemen
15、ts .11 5.3 Determination of N-Nitrosamines and N-Nitrosatables release11 5.4 Determination of 2-mercaptobenzothiazole (MBT) and antioxidants release .12 5.4.1 Principle12 5.4.2 Apparatus .12 5.4.3 Reagents: Chemicals (analytical reagent grade unless otherwise specified) 12 5.4.4 Reagents: authentic
16、samples (purity greater than 98 %) 12 5.4.5 Reagents: standard solutions 12 5.4.6 Procedure .13 5.4.7 Calculation13 5.5 Determination of 2,2-bis(4-hydroxyphenyl)propane Bisphenol A (BPA) release .14 5.5.1 Principle14 5.5.2 Apparatus .14 5.5.3 Reagents: chemicals (analytical reagent grade unless othe
17、rwise specified) .14 5.5.4 Reagents: authentic samples (purity greater than 98 %) 14 5.5.5 Reagents: standard solutions 14 5.5.7 Determination of the quantity of migrated BPA .15 5.6 Determination of volatile compounds content .15 Annex A (informative) Suitable HPLC apparatus, method and precision d
18、ata for the determination of 2-mercaptobenzothiazole (MBT) and/or antioxidants17 Annex B (informative) Suitable HPLC apparatus and method for the determination of 2,2-bis(4- hydroxyphenyl)propane Bisphenol A (BPA) 19 Bibliography 21 EN 14350-2:2004 (E) 3 Foreword This document (EN 14350-2:2004) has
19、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 February 2005, and conflic
20、ting national standards shall be withdrawn at the latest by February 2005. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Fin
21、land, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. This European Standard EN 14350 “Child use and care articles Drinking equipment” consis
22、ts of the following parts: Part 1: General and mechanical requirements and tests Part 2: Chemical requirements and tests EN 14350-2:2004 (E) 4 Introduction This document establishes minimum safety requirements and gives appropriate test methods for childrens drinking equipment. The complete document
23、 harmonises, for the first time, minimum safety requirements and test methods for childrens 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. It is not per
24、mitted to claim compliance with individual parts of this document. Any claim relates to all published parts. The use of this document may involve hazardous materials, operations and/or equipment. This document does not purport to address all the safety problems associated with its use. It is the res
25、ponsibility of the user of this document to establish appropriate health and safety practices and determine the applicability of regulatory limitations prior to its use. It is recommended that manufacturers and suppliers operate to EN ISO 9001 7 standard for quality management systems. Elastomeric a
26、nd rubber teats are regulated by the Commission Directive 93/11/EEC 1 concerning the release of N-Nitrosamine and N-Nitrosatable substances from elastomer or rubber teats and soothers. The current Directive provides in its annexes an outline method of analysis that has been published as EN 12868. A
27、limit for the release of 2-mercaptobenzothiazole (MBT) has been specified in the standard. This limit significantly reduces the level of this substance potentially released from childrens drinking equipment. The Scientific Committee for Food has concluded that the limit does not constitute a health
28、hazard. The limit for release of MBT will be reconsidered in light of future studies and recommendations. A limit for the release of 2,2-bis(4-hydroxyphenyl)propane Bisphenol A (BPA) has been specified in the standard. The Scientific Committee for Food has concluded that the (temporary) limit (t-TDI
29、) does not constitute a health hazard. The limit for release of BPA will be reconsidered in light of future studies and recommendations. It is noted that all plastics components of drinking equipment are regulated by the Commission Directive 2002/72/EC 2 relating to plastics materials and articles i
30、ntended to come into contact with foodstuff. Commission Decision 99/815/EC 3, with its subsequent extensions, has adopted (temporary) measures prohibiting the placing on the market of toys and childcare articles intended to be placed in the mouth by children under three years of age. The prohibition
31、 relates to such products made of soft PVC containing one or more of the substances di-iso-nonyl phthalate (DINP), di-(2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), di-iso-decyl phthalate (DIDP), di-n-octyl phthalate (DNOP) and butylbenzyl phthalate (BBP). At the time of preparing this do
32、cument a final decision was awaited. This document will be reviewed in the light of that decision. The Technical Committee has considered the issues relating to phthalate plasticiser migration from child use and care articles not intended to be placed in the mouth. Recognising the inadequacies of th
33、e only currently validated (static) test method for plasticiser migration from PVC 8, the Committee has developed an improved test to provide migration data under more realistic (dynamic) conditions of exposure. However, the Technical Committee will consider the official European method prior to its
34、 application to drinking equipment; such child use and care articles may require additional or alternative measures due to the mode of usage of drinking equipment and their potentially longer periods of exposure to babies and young children. After this consideration, an amendment to this document ma
35、y be made. Formaldehyde, caprolactam and colorants have each been considered by the Technical Committee. They have not been included in the document at this stage because of the lack of either adequate information for making a EN 14350-2:2004 (E) 5 satisfactory potential risk assessment, or validate
36、d test methods for the determination of their migration levels from relevant products. They will be reconsidered when further information becomes available. For similar reasons, latex protein allergy risk has also not been included in this document. There is an extremely low incidence of latex prote
37、in allergy amongst babies and young children. Nevertheless, provision for information for drinking equipment containing natural rubber latex has been made in Part 1 of this document. The issue of potential sensitisation and allergic reaction from rubber products will be reconsidered when further inf
38、ormation becomes available. EN 14350-2:2004 (E) 6 1 Scope This part of this document specifies limits for the release of certain chemicals from materials to be used for the manufacture of the following drinking equipment: Re-usable feeding teats and drinking accessories; Re-usable feeding bottles an
39、d drinking cups; Single-use feeding bottles, feeding teats, feeding bags and drinking accessories, which do not contain fluid when purchased. It includes test methods for the chemical safety requirements specified. It does not apply to drinking equipment designed for medical applications or for use
40、under medical supervision. This document is not applicable to soothers. Safety requirements and test methods for soothers are specified in EN 1400-1, EN 1400-2 and EN 1400-3. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated r
41、eferences, 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 - Methods for determining the release of N-Nitrosa
42、mines and N-Nitrosatable substances from elastomer or rubber teats and soothers. EN ISO 3696, Water for analytical laboratory use Specification and test methods (ISO 3696:1987). 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 feeding teat sub
43、stitute mothers nipple that when attached to a container permits a child to obtain fluid by suckling 3.2 drinking accessory any device other than a feeding teat which permits a child to obtain fluid from a container EXAMPLE feeding spout. 3.2.1 straw hollow tube drinking accessory through which flui
44、d is sucked 3.3 container either a feeding bottle, drinking cup or feeding bag EN 14350-2:2004 (E) 7 3.3.1 feeding bottle container which is capable of holding a fluid and incorporates a graduated scale suitable for visual measurement and is intended for feeding a child through a feeding teat or dri
45、nking accessory 3.3.2 drinking cup container other than a feeding bottle or feeding bag capable of holding a fluid intended for feeding a child 3.3.3 feeding bag bag capable of holding fluid and supported for use by a holder NOTE Feeding bags are also known as feeding liners. 3.4 locking ring compon
46、ent used to secure a feeding teat or drinking accessory to a container 3.5 sealing disc component used to create a seal between the container and the locking ring 3.6 protective cover component to cover a feeding teat or drinking accessory 3.7 matched components any of the above defined components w
47、hich are used together whilst feeding a child 3.8 numbered graduations numbered markings which indicate the volume of fluid within the container 3.9 single-use feeding teat, drinking accessory or container any item of drinking equipment sold for single use 3.10 re-usable component intended to be use
48、d again after first use 3.11 protrusions drinking accessory, feeding teat or spoon, excluding straws EN 14350-2:2004 (E) 8 4 Requirements 4.1 General Materials used for the manufacture of drinking equipment shall be subjected to the tests listed in Table 1 and shall conform to 4.4 to 4.9. NOTE 1 Additional information for the finished product can be obtained from Directives 82/711/EEC 4 and amendments 93/8/EEC and 97/48/EC, 85/572/EEC 5, 89/109/EEC 6, and 2002/72/EC 2. NOTE 2 It is recommended that manufacturers and s
