EN 71-12:2016

Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances

This European Standard specifies the 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 months.
EXAMPLES   Examples of toys made from elastomers are balloons and teethers.

Sicherheit von Spielzeug - Teil 12: N-Nitrosamine und N-nitrosierbare Stoffe

Diese Europäische Norm legt die Anforderungen und Prüfverfahren zu N-Nitrosaminen und N-nitrosierbaren Stoffen für folgendes Spielzeug fest:
   Spielzeug und Spielzeugteile aus Elastomeren, die für die Verwendung durch Kinder unter 36 Monaten vorgesehen sind;
   Spielzeug und Spielzeugteile aus Elastomeren, die in den Mund genommen werden sollen;
   Fingermalfarben für Kinder unter 36 Monaten.
BEISPIEL   Luftballons und Beißringe sind Beispiele für Spielzeug aus Elastomeren.
ANMERKUNG   Im Hinblick auf Elastomere wurden N-Nitrosamine und N-nitrosierbare Stoffe bis jetzt hauptsächlich in vulkanisierten Materialien nachgewiesen.

Sécurité des jouets - Partie 12 : N-Nitrosamines et substances N-nitrosables

La présente Norme européenne spécifie les exigences et les méthodes d’essai relatives aux N nitrosamines et aux substances N-nitrosables pour :
   les jouets et parties de jouets en élastomères et destinés à être utilisés par des enfants de moins de 36 mois ;
   les jouets et parties de jouets en élastomères et destinés à être mis en bouche ;
   les peintures au doigt destinées aux enfants de moins de 36 mois.
EXEMPLES   Les ballons de baudruche et les anneaux de dentition sont des exemples de jouets en matériaux élastomères.
NOTE   Concernant les élastomères, les N-nitrosamines et les substances N-nitrosables ont été jusqu’à présent principalement détectées dans des matériaux vulcanisés.

Varnost igrač - 12. del: N-nitrozamini in N-nitrozabilne snovi

Ta evropski standard določa zahteve in preskusne metode za N-nitrozamine in N-nitrozabilne snovi za: igrače in dele igrač, izdelane iz elastomerov in namenjene uporabi s strani otrok, mlajših od 36 mesecev; igrače in dele igrač, izdelane iz elastomerov in namenjene vstavljanju v usta; prstne barve za otroke, mlajše od 36 mesecev. PRIMERI   Igrače, ki so narejene iz elastomerov, so baloni in grizala.

General Information

• Status: Published
• Publication Date: 20-Dec-2016
• ICS: 97.200.50 - Toys
• Technical Committee: CEN/TC 52 - Safety of toys
• Drafting Committee: CEN/TC 52/WG 5 - Safety of toys - Chemical toys
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 15-Jul-2022
• Directive: 2009/48/EC - DIRECTIVE 2009/48/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 June 2009 on the safety of toys
• Mandate: M/445 - Standardisation mandate addressed to CEN and CENELEC within the framework of Directive 2009/48/EC revising Directive 88/378/EEC concerning the safety of Toys
• Ref Project: SIST EN 71-12:2017 - Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances

Relations

• Replaces: EN 71-12:2013 - Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances
• Effective Date: 28-Dec-2016

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2017
1DGRPHãþD
SIST EN 71-12:2013
9DUQRVWLJUDþGHO1QLWUR]DPLQLLQ1QLWUR]DELOQHVQRYL
Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable substances
Sicherheit von Spielzeug - Teil 12: N-Nitrosamine und N-nitrosierbare Stoffe
Sécurité des jouets - Partie 12 : N-Nitrosamines et substances N-nitrosables
Ta slovenski standard je istoveten z: EN 71-12:2016
ICS:
97.200.50 ,JUDþH Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 71-12
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2016
EUROPÄISCHE NORM
ICS 97.200.50 Supersedes EN 71-12:2013
English Version
Safety of toys - Part 12: N-Nitrosamines and N-nitrosatable
substances
Sécurité des jouets - Partie 12 : N-Nitrosamines et Sicherheit von Spielzeug - Teil 12: N-Nitrosamine und
substances N-nitrosables 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 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 or 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 official 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, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR 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 Ref. No. EN 71-12:2017 E
worldwide for CEN national Members.

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
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 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 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 uncertainty . 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 . 21
Annex A (informative) Background 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 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 Standard and
the previous version . 27
Annex C (informative) A–deviations . 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
European foreword
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, 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 supersedes 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 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 Standard 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) 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;
— 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.
NOTE 1 In addition to the above parts of EN 71, the following guidance documents 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).
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 o
...