SIST EN 71-15:2025
(Main)Safety of toys - Part 15: Formamide in foam toy materials (content)
Safety of toys - Part 15: Formamide in foam toy materials (content)
This document specifies requirements for formamide in foam toy materials and a test method for determining the content of formamide in foam toy materials. This document is applicable to toys intended for use by children under 36 month or other toys intended to be placed in the mouth.
NOTE 1 The document provides a test method to determine if the total content of formamide in foam toy materials is below the 200 mg/kg cut-off limit. Foam toy materials exceeding this limit are subject to the emission limit specified in Appendix C to Annex II to Directive 2009/48/EC.
NOTE 2 The European Commission Guidance Document No 11 on the Application of Directive 2009/48/EC on the Safety of Toys [3] 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 15: Formamid in Spielzeugmaterial aus Schaumstoff (Gehalt)
Dieses Dokument legt Anforderungen an Formamid in Spielzeugmaterial aus Schaumstoff und ein Prüfverfahren zur Bestimmung des Formamid-Gehaltes in Spielzeugmaterial aus Schaumstoff 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 1 Das Dokument enthält ein Prüfverfahren, um festzustellen, ob der Gesamtgehalt an Formamid in Spielzeugmaterial aus Schaumstoff unterhalb des Schwellenwertes von 200 mg/kg liegt. Spielzeugmaterialien aus Schaumstoff, die diesen Schwellenwert überschreiten, unterliegen dem in Richtlinie 2009/48/EG, Anhang II, Anlage C, festgelegten Emissionsgrenzwert.
ANMERKUNG 2 Die Leitlinie Nr. 11 der Europäischen Kommission zur Anwendung der Richtlinie 2009/48/EG über die Sicherheit von Spielzeug [3] enthält Hinweise, die bei der Einstufung von Spielzeug für Kinder unter 36 Monaten oder für Kinder ab 36 Monaten helfen.
Sécurité des jouets - Partie 15 : Formamide dans les matériaux-jouets en mousse (teneur)
Le présent document spécifie des exigences relatives au formamide dans les matériaux-jouets en mousse et une méthode d’essai permettant de déterminer la teneur en formamide dans les matériaux-jouets en mousse. Il s’applique aux jouets destinés aux enfants de moins de 36 mois ou autres jouets destinés à être mis en bouche.
NOTE 1 Le présent document fournit une méthode d’essai permettant de déterminer si la teneur totale en formamide dans les matériaux-jouets en mousse est inférieure à la valeur seuil de 200 mg/kg. Les matériaux-jouets en mousse dépassant cette limite sont soumis à la limite d’émission spécifiée à l’annexe II, appendice C, de la Directive 2009/48/CE.
NOTE 2 Le document d’orientation no 11 de la Commission européenne concernant l’application de la Directive 2009/48/CE relative à la sécurité des jouets [3] 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 - 15. del: Formamid v materialih za igrače iz penastih polimerov (vsebnost)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2025
Varnost igrač - 15. del: Formamid v materialih za igrače iz penastih polimerov
(vsebnost)
Safety of toys - Part 15: Formamide in foam toy materials (content)
Sicherheit von Spielzeug - Teil 15: Formamid in Spielzeugmaterial aus Schaumstoff
(Gehalt)
Sécurité des jouets - Partie 15 : Formamide dans les matériaux-jouets en mousse
(teneur)
Ta slovenski standard je istoveten z: EN 71-15:2025
ICS:
97.200.50 Igrače Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 71-15
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2025
EUROPÄISCHE NORM
ICS 97.190
English Version
Safety of toys - Part 15: Formamide in foam toy materials
(content)
Sécurité des jouets - Partie 15 : Formamide dans les Sicherheit von Spielzeug - Teil 15: Formamid in
matériaux-jouets en mousse (teneur) Spielzeugmaterial aus Schaumstoff (Gehalt)
This European Standard was approved by CEN on 25 February 2025.
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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 71-15:2025 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 . 6
6 Reagents, standards and apparatus . 7
6.1 Reagents . 7
6.2 Standards . 7
6.3 Apparatus . 8
7 Sample preparation . 8
8 Method of analysis . 9
8.1 General. 9
8.2 Chromatographic conditions . 9
8.3 Mass spectrometer settings . 9
9 Method performance . 10
9.1 Limit of quantification . 10
9.2 Precision . 10
10 Calculation of the result. 10
11 Test report . 11
Annex A (informative) Background and rationale. 12
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2009/48/EC aimed to be covered . 13
Bibliography . 14
European foreword
This document (EN 71-15:2025) 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 August 2025, and conflicting national standards shall be
withdrawn at the latest by August 2025.
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 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 15th 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) (the present document)
— Part 16: Certain chlorinated phosphorus flame retardants (TCEP, TCPP, TDCP) in toy materials
— Part 17: Certain isothiazolinones (MIT, CIT, BIT) in aqueous toy materials
— Part 18: Phenol in aqueous (content) and polymeric (migration) toy materials
— 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,
— 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 categorization 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.
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 November 2015 the European Commission amended Appendix C to Annex II to this Directive
accordingly and adopted a specific limit value for formamide in toys (see Commission Directive (EU)
2015/2115 [2]):
“20 μg/m (emission limit) after a maximum of 28 days from commencement of the emission testing of
foam toy materials containing more than 200 mg/kg (cut-off limit based on content)”.
For more information about the legal limit value see A.2.
This document provides a test method to determine if the total content of formamide in foam toy
materials is below the 200 mg/kg cut-off limit.
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 for formamide in foam toy materials and a test method for
determining the content of formamide in foam toy materials. This document is applicable to toys intended
for use by children under 36 month or other toys intended to be placed in the mouth.
NOTE 1 The document provides a test method to determine if the total content of formamide in foam toy
materials is below the 200 mg/kg cut-off limit. Foam toy materials exceeding this limit are subject to the emission
limit specified in Appendix C to Annex II to Directive 2009/48/EC.
NOTE 2 The European Commission Guidance Document No 11 on the Application of Directive 2009/48/EC on
the Safety of Toys [3] 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
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1
foam toy material
polymeric material whose density is reduced by the presence of numerous small cavities (cells),
interconnected or not, dispersed throughout the material
[SOURCE: IEC Electropedia, definition 212-15-24; modified: “plastic” replaced by “polymeric material”]
3.2
sample
representative, homogenous part of the foam toy material subject to testing
4 Requirements
The emission of formamide from foam toy materials shall not exceed 20 μg/m (emission limit) after a
maximum of 28 days from commencement of the emission testing. Emission testing is not necessary
when the formamide content does not exceed 200 mg/kg (cut-off limit based on content) when tested
according to Clauses 7 and 8.
NOTE The “emission limit” (20 μg/m ) and the “cut-off limit based on content” (200 mg/kg) are specified in
Directive 2009/48/EC [1], and were introduced by Commission Directive (EU) 2015/2115 [2]. Foam toy material
containing more than 200 mg/kg (cut-off limit based on content) are subject to the emission limit (20 μg/m after
a maximum of 28 days from commencement of the emission testing).
5 Principle
The sample is cut into small pieces and subsequently extracted with acetone at 70 °C using an ultrasonic
bath. The extract is analysed by gas chromatography with mass spectrometer (GC-MS).
6 Reagents, standards and apparatus
6.1 Reagents
Unless otherwise specified, all reagents shall be at least analytical grade. Reagents shall be stored as
specified by the supplier.
6.1.1 Acetone (CAS No. 67-64-1)
6.2 Standards
The following calibration standard and internal standard can either be a neat substance or solution of
known purity. Standards shall be stored as specified by the
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