DIN EN 71-12-2017 Safety of toys - Part 12 N-Nitrosamines and N-nitrosatable substances German version EN 71-12 2016《玩具安全性 第12部分 N-亚硝胺及其前体物 德文版本EN 71-12-2016》.pdf

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1、March 2017 English price group 15No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 97.200.50!%c+“2640804www.din.deDIN

2、 EN 71-12Safety of toys Part 12: NNitrosamines and Nnitrosatable substances;English version EN 7112:2016,English translation of DIN EN 71-12:2017-03Sicherheit von Spielzeug Teil 12: NNitrosamine und Nnitrosierbare Stoffe;Englische Fassung EN 7112:2016,Englische bersetzung von DIN EN 71-12:2017-03Scu

3、rit des jouets Partie 12: Nnitrosamines et substances Nnitrosables;Version anglaise EN 7112:2016,Traduction anglaise de DIN EN 71-12:2017-03SupersedesDIN EN 7112:201307www.beuth.deDocument comprises 35 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be co

4、nsidered authoritative.03.17 DIN EN 71-12:2017-03 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2017-03-01. National foreword This standard includes safety requirements. This document (EN 71-12:2017) has been prepared by Technical Committe

5、e CEN/TC 52 “Safety of toys” (Secretariat: DS, Denmark). The responsible German body involved in its preparation was DIN-Normenausschuss Sicherheitstechnische Grundstze (DIN Standards Committee Safety Design Principles), Working Committee NA 095-05-01-02 AK Sicherheit von Spielzeug Chemische Eigensc

6、haften. The DIN Standard corresponding to the International Standard referred to in this document is as follows: ISO 29941 DIN ISO 29941 Amendments This standard differs from DIN EN 71-12:2013-07 as follows: a) the introduction has been deleted and the warning notice which had been in the introducti

7、on has been transferred to 6.2; b) a note stating that with regard to elastometers, up to now N-nitrosamines and N-nitrosatable substances have mainly been detected in vulcanized materials has been added; c) the definition of elastomer (3.2) has been revised; d) in 4.1 and 4.2, the German translatio

8、n of “should” (sollte) has been replaced by the German translation of “shall” (sind zu) in the last sentence respectively; e) furthermore, the limit values for N-nitrosamines and N-nitrosatable substances in elestomers have been revised; f) in 6.1, CAS numbers for the reagents have been added and th

9、e requirement that saliva test solution that has been kept for more than five days shall not be used has been added; g) an additional subclause 6.2.6.3 on “Calibration solutions for elastomers” has been added; h) in 6.3, glass balls and conical flasks have been added as additional apparatus and poro

10、us graphitic carbon has been added as an alternative HPLC column; i) in 7.3.2, the “Sample preparation for other toys or parts of toys than balloons” has been revised; j) in 8.2, it has been permitted to adjust the injection volume in order to achieve a limit of quantification (LOQ) of 0,000 2 mg/l

11、for each N-nitrosamine; DIN EN 71-12:2017-03 3 k) in 8.4, high resolution mass spectrometry has been added as an alternative confirmation method for N-nitrosamines; l) in 10.1.2, the limits of detection (LOD) and quantification (LOQ) have been lowered; m) in Annex A.1, a rationale for the definition

12、 of elastomer has been added; n) in Annex A.3, the rationale for the requirements on elastomers has been extended to include additional information on the specified migration time and in Annex A.5, additional information on the migration time defined in the standard has been added in the rationale;

13、o) the content of the former informative Annex B “Sample storage conditions” has been transferred to 7.1 (Sample preparation General) and the annex has been deleted; p) in Annex C, the A-deviation has been updated in order to reflect modifications introduced in this revision of EN 71-12; q) DIN 3264

14、5 1, EN 71-10 3, CEN/TR 16918 8 and Resolution 2012/160/EU 13 have been added to the Bibliography. Previous editions DIN EN 71-12: 2013-07 National Annex NA (informative) Bibliography DIN ISO 29941, Condoms Determination of nitrosamines migrating from natural rubber latex condoms DIN EN 71-12:2017-0

15、3 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 71-12 December 2016 ICS 97.200.50 Supersedes EN 71-12:2013English Version Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances Scurit des jouets - Partie 12: N-nitrosamines et substances N-nit

16、rosables Sicherheit von Spielzeug - Teil 12: N-Nitrosamine und N-nitrosierbare Stoffe This European Standard was approved by CEN on 30 October 2016. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status o

17、f 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

18、). 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,

19、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

20、 Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 71

21、-12:2017 E2 Contents Page European foreword . 4 1 Scope 6 2 Normative references 6 3 Terms and definitions . 6 4 Requirements . 7 4.1 Requirements for finger paints 7 4.2 Requirements for elastomers . 7 5 Principle . 8 6 Reagents and apparatus . 8 6.1 Reagents . 8 6.2 Standards . 9 6.3 Apparatus 10

22、7 Sample preparation . 11 7.1 General . 11 7.2 Finger paints 11 7.2.1 N-nitrosamines 11 7.2.2 N-nitrosatable substances 12 7.3 Elastomers 12 7.3.1 Sample preparation for balloons 12 7.3.2 Sample preparation for other toys or parts of toys than balloons . 12 7.3.3 Nitrosation 13 7.3.4 Preparation of

23、solution for determination of N-nitrosamines by HPLC-MS/MS . 13 8 Methods of analysis . 13 8.1 General . 13 8.2 HPLC chromatographic conditions 14 8.3 MS/MS conditions 14 8.4 Confirmation of detected N-nitrosamines . 15 9 Calculation of results for N-nitrosamines and N-nitrosatable substances 16 9.1

24、 Finger paint 16 9.1.1 General . 16 9.1.2 N-nitrosamines 16 9.1.3 N-nitrosatable substances 17 9.2 Elastomers 17 9.2.1 General . 17 9.2.2 N-nitrosamines 18 9.2.3 N-nitrosatable substances 18 10 Method performance 19 10.1 Finger paints 19 10.1.1 Repeatability, reproducibility and measurement uncertai

25、nty . 19 10.1.2 Limits of detection (LOD) and quantification (LOQ) . 19 10.2 Elastomers 19 10.2.1 Repeatability, reproducibility and measurement uncertainty . 19 10.2.2 Limits of detection and quantification . 20 EN 71-12:2016 (E) DIN EN 71-12:2017-03 3 11 Test report 21 Annex A (informative) Backgr

26、ound and rationale for this European Standard . 22 A.1 Definition of elastomer . 22 A.2 Requirements for finger paints (see 4.1) . 22 A.3 Requirements for elastomers (see 4.2) 23 A.4 Avoidance N-nitrosamines in finger paints . 24 A.5 Explanation for decision to do static migration for elastomers and

27、 for the specified migration times . 24 A.6 Reference to other standards and relevant deviations 25 A.7 Conditions for nitrosation . 25 A.8 NDELA in balloons 26 A.9 Selection of N-nitrosamines specified in this standard 26 Annex B (informative) Significant technical changes between this European Sta

28、ndard and the previous version 27 Annex C (informative) Adeviations . 29 Annex ZA (informative) Relationship between this European Standard and the essential requirements of EU Directive 2009/48/EC aimed to be covered . 30 Bibliography . 31 EN 71-12:2016 (E) DIN EN 71-12:2017-03 4 European foreword

29、This document (EN 71-12:2017) has been prepared by Technical Committee CEN/TC 52 “Safety of toys”, the secretariat of which is held by DS. 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 June 2017

30、, and conflicting national standards shall be withdrawn at the latest by June 2017. 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 sup

31、ersedes EN 71-12:2013. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive 2009/48/EC. For relationship with EU Directive 2009/48/EC, see informative Annex ZA, which is an

32、 integral part of this document. Additional information on the rationale for various requirements is given in Annex A. Annex B provides details of significant technical changes between this European Standard and the previous edition. This European Standard constitutes the 12th part of the European S

33、tandard on safety of toys. This European Standard for safety of toys consists of the following parts: Part 1: Mechanical and physical properties; Part 2: Flammability; Part 3: Migration of certain elements; Part 4: Experimental sets for chemistry and related activities; Part 5: Chemical toys (sets)

34、other than experimental sets; Part 7: Finger paints Requirements and test methods; Part 8: Activity toys for domestic use; Part 9: Organic chemical compounds Requirements; Part 10: Organic chemical compounds Sample preparation and extraction; Part 11: Organic chemical compounds Methods of analysis;

35、Part 12: N-nitrosamines and N-nitrosatable substances; Part 13: Olfactory board games, gustative board games, cosmetic kits and gustative kits; Part 14: Trampolines for domestic use. EN 71-12:2016 (E) DIN EN 71-12:2017-03 5 NOTE 1 In addition to the above parts of EN 71, the following guidance docum

36、ents have been published: CEN Technical Report CEN/TR 15071, Safety of toys National translations of warnings and instructions for use in EN 71, and CEN Technical Report CEN/TR 15371 (all parts), Safety of toys Interpretations. NOTE 2 Words in italics are defined in Clause 3 (Terms and definitions).

37、 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, Ge

38、rmany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. EN 71-12:2016 (E) DIN EN 71-12:2017-03 6 1 Scope This European Standard specifies the

39、requirements and test methods for N-nitrosamines and N-nitrosatable substances for: toys and parts of toys made from elastomers and intended for use by children under 36 months; toys and parts of toys made from elastomers and intended to be placed in the mouth; finger paints for children under 36 mo

40、nths. EXAMPLE Examples of toys made from elastomers are balloons and teethers. NOTE With regard to elastomers, up to now N-nitrosamines and N-nitrosatable substances have mainly been detected in vulcanized materials. 2 Normative references The following documents, in whole or in part, are normativel

41、y 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. EN ISO 3696, Water for analytical laboratory use - Specification an

42、d test methods (ISO 3696) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 finger paint aqueous semi-solid or liquid, coloured mixture specially designed for children to apply directly to suitable surfaces with the fingers and hands SOURCE: EN

43、 71-7:2014, definition 3.1 3.2 elastomer flexible cross-linked macro-molecular material which returns rapidly to approximately its initial dimensions and shape after substantial deformation by stress and release of the stress at room temperature Note 1 to entry: Not all elastomers are likely to cont

44、ain N-nitrosamines and N-nitrosatable substances. For further guidance on possible sources of N-nitrosamines and N-nitrosatable substances in elastomers the term elastomer and other related aspects see A.1. SOURCE: EN ISO 472:2013, 2.327, modified: the phrases “flexible cross-linked”, “approximately

45、” and “at room temperature” and note 1 to entry added and the phrase “a weak” deleted 3.3 N-nitrosamine substance characterised by the -N-N=O functional group, usually formed by the reaction of an amine with a nitrosating agent at acidic pH Note 1 to entry: The reacting amines primarily are secondar

46、y amines. Note 2 to entry: An example for a nitrosating agent is nitrite. EN 71-12:2016 (E) DIN EN 71-12:2017-03 7 3.4 N-nitrosatable substance substance which when released into the test solution undergoes nitrosation to form a N-nitrosamine under specified conditions 4 Requirements 4.1 Requirement

47、s for finger paints The concentration of N-nitrosamines in finger paints shall not exceed 0,02 mg/kg when tested in accordance with 7.2 and Clause 8, calculated as sum of all detected N-nitrosamines according to 9.1. The migration of N-nitrosatable substances from finger paints shall not exceed 1 mg

48、/kg of toy material, calculated as sum of all detected N-nitrosamines after nitrosation. At least the substance in Table 1 shall be determined in finger paint. If there are indications of the presence of other N-nitrosamines, they shall also be determined. Table 1 List of N-nitrosamines in finger pa

49、ints Name of the substance CAS number Abbreviation N-nitrosodiethanolamine 1116547 NDELA 4.2 Requirements for elastomers The migration of N-nitrosamines (calculated as sum of all detected N-nitrosamines according to 9.2) and of N-nitrosatable substances (calculated as sum of all detected N-nitrosamines after nitrosation) from toys or parts of toys shall not exceed the limit values specified in Table 2 when tested i