oSIST prEN 71-18:2023
(Main)Safety of toys - Part 18: Phenol in aqueous and polymeric toy materials
Safety of toys - Part 18: Phenol in aqueous and polymeric toy materials
This document specifies requirements and test methods for phenol in aqueous (content limit) and polymeric (migration limit) toy materials.
Sicherheit von Spielzeug - Teil xx: 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 anwendbar auf Spielzeug, 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 et polymères
Le présent document spécifie des exigences et des méthodes d’essai permettant de déterminer la teneur en phénol dans les matériaux-jouets aqueux ainsi que la migration du phénol depuis les matériaux jouets. Il s’applique aux jouets destinés aux enfants de moins de trente-six mois ou 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 materialih za vodne igrače in igrače iz polimerov
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2023
Varnost igrač - 18. del: Fenol v materialih za vodne igrače in igrače iz polimerov
Safety of toys - Part 18: Phenol in aqueous and polymeric toy materials
Sicherheit von Spielzeug - Teil xx: Phenol in wässrigem (Gehalt) und polymerem
(Migration) Spielzeugmaterial
Sécurité des jouets - Partie 18 : Phénol dans les matériaux-jouets aqueux et polymères
Ta slovenski standard je istoveten z: prEN 71-18
ICS:
97.200.50 Igrače Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
prEN 71-18
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2023
ICS
English Version
Safety of toys - Part 18: Phenol in aqueous and polymeric
toy materials
Sicherheit von Spielzeug - Teil xx: Phenol in wässrigem
(Gehalt) und polymerem (Migration) Spielzeugmaterial
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 52.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 71-18:2023 E
worldwide for CEN national Members.
prEN 71-18:2023 (E)
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 Content method . 7
6 Reagents and apparatus . 7
6.1 Reagents . 7
6.2 Standards . 7
6.3 Apparatus . 8
7 Sample preparation . 9
7.1 Migration method . 9
7.1.1 General. 9
7.1.2 Sample area calculation. 9
7.1.3 Migration . 9
7.2 Content method . 10
8 Method of analysis . 10
8.1 General. 10
8.2 HPLC chromatographic conditions . 10
8.3 MS/MS conditions . 11
8.4 DAD and FLD detection . 11
9 Method performance . 12
9.1 Limit of quantification . 12
9.2 Precision . 12
10 Calculation of the result. 13
10.1 Identification of phenol . 13
10.2 Evaluating the concentration of phenol using HPLC-MS/MS . 13
10.3 Evaluating the concentration of phenol using HPLC-DAD/FLD . 13
10.4 Migration method . 13
10.5 Content method . 13
11 Test report . 14
Annex A (Informative) Background and rationale — Extraction and migration conditions 15
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2009/48/EC aimed to be covered . 16
Bibliography . 17
prEN 71-18:2023 (E)
European foreword
This document (prEN 71-18:2023) has been prepared by Technical Committee CEN/TC 52 “Safety of
toys”, the secretariat of which is held by DS.
This document is currently submitted to the CEN Enquiry.
This document has been prepared under a standardisation request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For 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.
This document constitutes the 18th 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 (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 (under development)
(the present document)
prEN 71-18:2023 (E)
— Part 19: Migration of bisphenol A from toy materials (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,
— CEN/TR 15371 (all parts), 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 (under development), and
— CEN ISO/TR 8124-8, Safety of toys — Part 8: Age determination guidelines.
NOTE 2 Words in italics (apart from document titles) are defined in Clause 3 (Terms and definitions).
prEN 71-18:2023 (E)
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.
prEN 71-18:2023 (E)
1 Scope
This document specifies requirements and test methods for determining the content of phenol in aqueous
toy materials and for migration of phenol from toy materials. This document is applicable to toys intended
for use by children under 36 months or 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 document (including any amendments) applies.
EN ISO 3696:1995, 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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
3.1
aqueous toy material
homogeneous toy material where water is one of the constituents to liquefy the material
3.2
sample (migration method)
part of the toy material subject to testing
Note 1 to entry: In the context of the content method (which is applied to aqueous toy material) sample is
understood as aliquot from an aqueous toy material subject to testing.
4 Requirements
The migration of phenol from toy materials shall not exceed 5 mg/l when tested according to the method
specified in 7.1 and clause 8.
The concentration of phenol in aqueous toy materials shall not exceed 10 mg/kg when tested according
to the method specified in 7.2 and clause 8.
NOTE The limit values correspond to the limit values specified in Directive 2009/48/EC [1] which were
introduced by Commission Directive (EU) 2017/774 [2].
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