SIST EN 71-18:2025
(Main)Safety of toys - Part 18: Phenol in aqueous (content) and polymeric (migration) toy materials
Safety of toys - Part 18: Phenol in aqueous (content) and polymeric (migration) toy materials
This document specifies requirements and test methods for determining the concentration of phenol in aqueous toy materials and for migration of phenol from polymeric toy materials. This document is applicable to toys intended for use by children under 36 months or other toys intended to be placed in the mouth.
NOTE The European Commission Guidance Document No 11 on the Application of Directive 2009/48/EC on the Safety of Toys [4] provides guidelines to help on the classification of toys intended for children under 36 months of age or of 36 months and over.
Sicherheit von Spielzeug - Teil 18: Phenol in wässrigem (Gehalt) und polymerem (Migration) Spielzeugmaterial
Dieses Dokument legt Anforderungen an und Prüfverfahren für die Bestimmung der Konzentration von Phenol in wässrigem Spielzeugmaterial und für die Migration von Phenol aus polymerem Spielzeugmaterial fest. Dieses Dokument ist auf Spielzeug anwendbar, das zur Verwendung durch Kinder unter 36 Monaten bestimmt ist, oder anderes Spielzeug, das dazu bestimmt ist, in den Mund genommen zu werden.
ANMERKUNG Die Leitlinie Nr. 11 der Europäischen Kommission zur Anwendung der Richtlinie 2009/48/EG über die Sicherheit von Spielzeug [4] enthält Hinweise, die bei der Einstufung von Spielzeug für Kinder unter 36 Monaten oder für Kinder ab 36 Monaten helfen.
Sécurité des jouets - Partie 18 : Phénol dans les matériaux-jouets aqueux (teneur) et polymères (migration)
Le présent document spécifie des exigences et des méthodes d’essai permettant de déterminer la concentration de phénol dans les matériaux-jouets aqueux ainsi que la migration du phénol depuis les matériaux-jouets polymères. Le présent document s’applique aux jouets destinés aux enfants de moins de 36 mois ou autres jouets destinés à être mis en bouche.
NOTE Le document d’orientation n° 11 de la Commission européenne concernant l’application de la Directive 2009/48/CE relative à la sécurité des jouets [4] fournit des lignes directrices qui aident à la classification des jouets destinés aux enfants de moins de 36 mois ou de 36 mois et plus.
Varnost igrač - 18. del: Fenol v igračah iz materialov na vodni osnovi (vsebnost) in igračah iz polimerov (migracija)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2025
Varnost igrač - 18. del: Fenol v igračah iz materialov na vodni osnovi (vsebnost) in
igračah iz polimerov (migracija)
Safety of toys - Part 18: Phenol in aqueous (content) and polymeric (migration) toy
materials
Sicherheit von Spielzeug - Teil 18: Phenol in wässrigem (Gehalt) und polymerem
(Migration) Spielzeugmaterial
Sécurité des jouets - Partie 18 : Phénol dans les matériaux-jouets aqueux (teneur) et
polymères (migration)
Ta slovenski standard je istoveten z: EN 71-18:2024
ICS:
97.200.50 Igrače Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 71-18
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2024
EUROPÄISCHE NORM
ICS 97.190
English Version
Safety of toys - Part 18: Phenol in aqueous (content) and
polymeric (migration) toy materials
Sécurité des jouets - Partie 18 : Phénol dans les Sicherheit von Spielzeug - Teil 18: Phenol in wässrigem
matériaux-jouets aqueux (teneur) et polymères (Gehalt) und polymerem (Migration) Spielzeugmaterial
(migration)
This European Standard was approved by CEN on 1 December 2024.
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, 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, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 71-18:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 6
5 Principle . 7
5.1 Migration method . 7
5.2 Extraction method . 7
6 Reagents, standards and apparatus . 7
6.1 Reagents . 7
6.2 Standards . 7
6.3 Apparatus . 9
7 Sample preparation . 10
7.1 Migration method . 10
7.1.1 Sample preparation . 10
7.1.2 Sample surface area calculation . 10
7.1.3 Migration . 10
7.2 Extraction method . 11
8 Method of analysis . 11
8.1 General. 11
8.2 Chromatographic conditions . 12
8.3 Mass spectrometer settings . 12
8.4 DAD and FLD detection . 13
9 Method performance . 13
9.1 Limit of quantification . 13
9.2 Precision . 13
10 Calculation of the result. 14
10.1 Evaluating the concentration of phenol using LC-MS/MS . 14
10.2 Evaluating the concentration of phenol using HPLC-DAD, HPLC-DAD/FLD and HPLC-
FLD . 14
10.3 Migration method . 14
10.4 Extraction method . 15
11 Test report . 15
Annex A (informative) Background and rationale . 16
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2009/48/EC aimed to be covered . 18
Bibliography . 19
European foreword
This document (EN 71-18:2024) 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 2025, and conflicting national standards shall be
withdrawn at the latest by June 2025.
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 has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Additional information on the background and rationale for various requirements are given in Annex A.
th
This document constitutes the 18 part of the EN 71 series of standards on safety of toys.
EN 71, 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 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, cosmetic kits and gustative games;
— Part 14: Trampolines for domestic use;
— Part 15: Formamide in foam toy materials (content) (under development);
— Part 16: Certain chlorinated phosphorus flame retardants (TCEP, TCPP, TDCP) in toy materials (under
development);
— Part 17: Certain isothiazolinones (MIT, CIT, BIT) in aqueous toy materials (under development);
— Part 18: Phenol in aqueous (content) and polymeric (migration) toy materials (this document);
— Part 19: Migration of bisphenol A from toy materials;
— Part 20: Microbiological safety of toys containing accessible aqueous media (under development).
It is up to the user of the standard to determine whether or not a toy is included in the scope of several of
the above parts of the EN 71 series, and to apply each applicable standard accordingly. Normative
references from one part of the EN 71 series to another, are therefore normally not provided in the
individual parts.
NOTE 1 In addition to the above parts of EN 71, the following deliverables have been published:
— CEN/TR 15071, Safety of toys — National translations of warnings and instructions for use in the EN 71
series;
— the CEN/TR 15371 series, Safety of toys — Interpretations;
— CEN/TR 16918, Safety of toys — Children's mouthing behaviour in contact with toys;
— CEN/TR 17695, Safety of toys — Mechanical and physical properties — Guidance on categorisation of
projectile toys within EN 71-1;
— CEN/TS 17973, Safety of toys — Categorization of slime type materials; and
— CEN ISO/TR 8124-8, Safety of toys — Part 8: Age determination — First age grade for the appropriate
play of toys (ISO/TR 8124-8).
NOTE 2 Words in italics (apart from document titles) are defined in Clause 3 (Terms and definitions).
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the United
Kingdom.
Introduction
According to article 46 of Directive 2009/48/EC on the safety of toys [1] the “Commission may adopt
specific limit values for chemicals used in toys intended for use by children under 36 months or in other
toys intended to be placed in the mouth”.
In May 2017, the European Commission amended Appendix C to Annex II to this Directive accordingly
and adopted specific limit values for phenol in toys (see Commission Directive (EU) 2017/774 [2]). The
limit values take into account the SCHER Opinion on “CEN's response to the opinion of the CSTEE on the
assessment of CEN report on the risk assessment of organic chemicals in toys” [3].
This document provides test methods to check compliance with these limit values.
WARNING — The application of the test method specified in this document can involve hazardous
materials, operations and equipment. The document does not purport to address all of the safety or
environmental problems associated with its use.
1 Scope
This document specifies requirements and test methods for determining the concentration of phenol in
aqueous toy materials and for migration of phenol from polymeric toy materials. This document is
applicable to toys intended for use by children under 36 months or other toys intended to be placed in
the mouth.
NOTE The European Commission Guidance Document No 11 on the Application of Directive 2009/48/EC on
the Safety of Toys [4] provides guidelines to help on the classification of toys intended for children under 36 months
of age or of 36 months and over.
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 documen
...
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