EN 71-12-2013 2500 Safety of toys - Part 12 N-Nitrosamines and N-nitrosatable substances《玩具安全 第12部分 亚硝胺和前体物》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 71-12:2013Safety of toysPart 12: N-Nitrosamines and N-nitrosatablesubstancesCopyright European Committee for Standardization Provided by IHS under license with CENNot for R

2、esaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 71-12:2013 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 71-12:2013.The UK participation in its preparation was entrusted to TechnicalCommittee CW/15, Safety of toys.A list of orga

3、nizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013I

4、SBN 978 0 580 77754 7ICS 97.200.50Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2013.Amendments issued since publicationDate Text affectedCopyright Europ

5、ean Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 71-12:2013EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 71-12 June 2013 ICS 97.200.50 English Version Safety of toys - Part 12: N-Ni

6、trosamines and N-nitrosatable substances Scurit des jouets - Partie 12: N-Nitrosamines et substances N-nitrosables Sicherheit von Spielzeug - Teil 12: N-Nitrosamine und N-nitrosierbare Stoffe This European Standard was approved by CEN on 29 May 2013. CEN members are bound to comply with the CEN/CENE

7、LEC 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 o

8、r 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 off

9、icial 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

10、, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitatio

11、n in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 71-12:2013: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 71-12:2013EN 71-12:2013

12、 (E) 2 Contents Page Foreword . 4 Introduction 6 1 Scope 7 2 Normative references . 7 3 Terms and definitions 7 4 Requirements . 8 4.1 Requirements for finger paints 8 4.2 Requirements for elastomers 8 5 Principle 9 6 Reagents and apparatus 9 6.1 Reagents . 9 6.2 Standards . 10 6.3 Apparatus . 10 7

13、Sample preparation 11 7.1 General . 11 7.2 Finger paints 11 7.2.1 N-nitrosamines . 11 7.2.2 N-nitrosatable substances . 11 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 o

14、f 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 . 13 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

15、.1 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 Quality 19 10.1 Finger paints 19 10.1.1 Repeatability, reproducibility and measurement uncertain

16、ty 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 11 Test report 20 Annex A (informative) Background and rationale for this European Standard 22

17、 A.1 Requirements for finger paints (see 4.1) . 22 Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 71-12:2013EN 71-12:2013 (E) 3 A.2 Requirements for elastomers (see 4.2) 2

18、2 A.3 Avoidance N-nitrosamines in finger paints . 22 A.4 Explanation for decision to do static migration for elastomers . 22 A.5 Reference to other standards and relevant deviations . 23 A.6 Conditions for nitrosation 23 A.7 NDELA in balloons . 23 A.8 Selection of N-nitrosamines specified in this st

19、andard 23 Annex B (informative) Sample storage conditions 24 Annex C (informative) A-deviations 25 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 2009/48/EC 26 Bibliography 27 Copyright European Committee for Standardization Provided

20、 by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 71-12:2013EN 71-12:2013 (E) 4 Foreword This document (EN 71-12:2013) has been prepared by Technical Committee CEN/TC 52 “Safety of toys”, the secretariat of which is held by DS. Thi

21、s 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 2013, and conflicting national standards shall be withdrawn at the latest by December 2013. Attention is drawn to the possibility that some of

22、 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 has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and sup

23、ports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. This European Standard constitutes the 12thpart of the European Standard on safety of toys. This European Standard for safety of toys consists

24、 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) other than experimental sets; Part 7: Finger paints Requirements and test met

25、hods; 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; Part 12: N-nitrosamines and N-nitrosatable substances; Part 13: Olfactory boa

26、rd games, gustative board games, cosmetic kits and gustative kits; Part 14: Trampolines for domestic use. NOTE 1 In addition to the above parts of EN 71, the following guidance documents have been published: CEN Report, CR 14379, Classification of toys Guidelines, CEN Technical Report CEN/TR 15071,

27、Safety of toys National translations of warnings and instructions for use in EN 71, and CEN Technical Report CEN/TR 15371, Safety of toys Replies to requests for interpretation of EN 71-1, EN 71-2, and EN 71-8. NOTE 2 Words in italics are defined in Clause 3 (Terms and definitions). Copyright Europe

28、an Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 71-12:2013EN 71-12:2013 (E) 5 According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following count

29、ries 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, Pol

30、and, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 71-12:2013EN 71-12:20

31、13 (E) 6 Introduction There are ongoing developments in the following area: the influence of the mouthing behaviour (mouthing time and sucking/chewing) on the migration out of teethers and other elastomers than balloons. WARNING N-nitrosamines can endanger human health owing to their toxicity. Perso

32、ns using this European Standard should be familiar with normal laboratory practice. This European Standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user to establish appropriate safety and health practices and to ensure

33、compliance with any national regulatory conditions. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 71-12:2013EN 71-12:2013 (E) 7 1 Scope This European Standard specifies t

34、he 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

35、 months. EXAMPLES Examples of toys made from elastomers are balloons and teethers. 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 und

36、ated references, the latest edition of the referenced document (including any amendments) applies. EN ISO 3696, Water for analytical laboratory use Specification and test methods (ISO 3696) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 fing

37、er paint paste and/or jelly like, coloured mixture specially designed for children to apply directly to suitable surfaces with the fingers and hands Note 1 to entry: In addition to water, finger paints essentially consist of colorants, binders, preservatives and embittering agent and may additionall

38、y contain extenders, humectants and surfactants. SOURCE: prEN 71-7:2012, 3.1 3.2 elastomer material which undergoes substantial, elastic (fully) reversible) deformation when put under stress and consisting of three-dimensional networks of cross-linked flexible polymers Note 1 to entry: The cross-lin

39、ks can be chemical bonds in rubbers (like natural rubber, synthetic rubber and silicones) or physical, thermo-reversible fixation points in thermoplastic elastomers (TPE) or the combination of both (TPE-V). 3.3 N-nitrosamine substance characterised by the -N-N=O functional group, usually formed by t

40、he reaction of an amine with a nitrosating agent at acidic pH Note 1 to entry: The reacting amines primarily are secondary amines. Note 2 to entry: An example for a nitrosating agent is nitrite. 3.4 N-nitrosatable substance substance which when released into the test solution undergoes nitrosation t

41、o form a N-nitrosamine under specified conditions Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 71-12:2013EN 71-12:2013 (E) 8 4 Requirements 4.1 Requirements for finger p

42、aints 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/kg of toy mat

43、erial, calculated as sum of all detected N-nitrosamines after nitrosation. At least the substance in Table 1 shall be tested in finger paint. If there are indications of the presence of other N-nitrosamines, they should also be tested. Table 1 List of N-nitrosamines in finger paints Name of the subs

44、tance CAS number Abbreviation N-nitrosodiethanolamine 1116-54-7 NDELA 4.2 Requirements for elastomers The migration of N-nitrosamines from toys intended for use by children under 36 months or in other toys or parts of toys intended to be placed into the mouth shall not exceed 0,05 mg/kg of toy mater

45、ial when tested in accordance with 7.3 and Clause 8, calculated as sum of all detected N-nitrosamines according to 9.2. The migration of N-nitrosatable substances from toys intended for use by children under 36 months or in other toys or parts of toys intended to be placed into the mouth shall not e

46、xceed 1 mg/kg of toy material, calculated as sum of all detected N-nitrosamines after nitrosation. At least the substances in Table 2 shall be tested in elastomers. If there are indications of the presence of other N-nitrosamines they should also be tested. Table 2 List of N-nitrosamines in elastome

47、rs Name of the substance CAS number Abbreviation N-nitrosodiethanolamine 1116-54-7 NDELA N-nitrosodimethylamine 62-75-9 NDMA N-nitrosodiethylamie 55-18-5 NDEA N-nitrosodipropylamine 621-64-7 NDPA N-nitrosodiisopropylamine 601-77-4 NDiPA N-nitrosodibutylamine 924-16-3 NDBA N-nitrosodiisobutylamine 99

48、7-95-5 NDiBA N-nitrosodiisononylamine 1207995-62-7 NDiNA N-nitrosomorpholine 59-89-2 NMOR N-nitrosopiperidine 100-75-4 NPIP N-nitrosodibenzylamine 5336-53-8 NDBzA N-nitroso-N-methyl-N-phenylamine 614-00-6 NMPhA N-nitroso-N-ethyl-N-phenylamine 612-64-6 NEPhA Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN 71-12:2013EN 71-12:2013 (E) 9 5 Principle N-nitrosamines and N-nitrosatable substances migrate into a t