FprEN 71-15

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

Sécurité des jouets - Partie 15 : Formamide dans les matériaux-jouets en mousse

Le présent document spécifie des exigences et une méthode d’essai permettant de déterminer la teneur en formamide dans les matériaux -  jouets en mousse. Le document 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 - 15. del: Formamid v materialih za penaste igrače

General Information

• Status: Not Published
• Publication Date: 22-Apr-2025
• ICS: 97.190 - Equipment for children
• Technical Committee: CEN/TC 52 - Safety of toys
• Drafting Committee: CEN/TC 52/WG 15 - Appendix C test methods
• Current Stage: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Start Date: 23-Oct-2024
• Completion Date: 23-Oct-2024
• 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
• Mandate: M/589 - Safety of toys in support of Directive 2009/48/EC
• Mandate: M/XXX - Ecodesign requirements for servers and data storage products
• Ref Project: oSIST prEN 71-15:2023 - Safety of toys - Part 15: Formamide in foam toy materials

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2023
Varnost igrač - 15. del: Formamid v materialih za penaste igrače
Safety of toys - Part 15: Formamide in foam toy materials
Sicherheit von Spielzeug - Teil 15: Formamid in Spielzeugmaterial aus Schaumstoff
Sécurité des jouets - Partie 15 : Formamide dans les matériaux-jouets en mousse
Ta slovenski standard je istoveten z: prEN 71-15
ICS:
97.200.50 Igrače Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
prEN 71-15
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2023
ICS
English Version
Safety of toys - Part x: Formamide in foam toy materials
Sicherheit von Spielzeug - Teil xx: Formamid in
Spielzeugmaterial aus Schaumstoff
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 71-15:2023 E
worldwide for CEN national Members.

prEN 71-15:2023 (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 . 6
6 Reagents and Apparatus. 7
6.1 Reagents . 7
6.2 Standards . 7
6.2.1 Calibration standard . 7
6.2.2 Internal standard . 7
6.2.3 Stock solution of internal standard . 7
6.2.4 Solutions of calibration standard. 7
6.3 Apparatus . 8
7 Sample preparation . 8
8 Method of analysis . 8
8.1 General. 8
8.2 Chromatographic conditions . 9
9 Method performance . 9
9.1 Limit of quantification . 9
9.2 Precision . 9
10 Calculation of the result. 10
11 Test report . 10
Annex A (informative) Background and rationale. 11
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2009/48/EC aimed to be covered . 12
Bibliography . 13

prEN 71-15:2023 (E)
European foreword
This document (prEN 71-15:2023) 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 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 (under development) (the present document)
— Part bb: Certain chlorinated phosphorus flame retardants (TCEP, TCPP, TDCP) in toy materials (under
development)
— Part cc: Certain isothiazolinones (MIT, CIT, BIT) in aqueous toy materials (under development)
— Part dd: Phenol in aqueous (content) and polymeric (migration) toy materials (under development)
prEN 71-15:2023 (E)
— Part ee: 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, and
— 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 (under development)
— 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 71-15:2023 (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 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]). This European standard provides a test method to check compliance with the limit value
(cut-off limit based on content).
prEN 71-15:2023 (E)
1 Scope
This document specifies requirements and a test method for determining the content of formamide in
foam toy materials. The document is applicable to toys for use by children under 36 month 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
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 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
foam toy material
plastic 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]
3.2
sample
part of the foam toy material subject to testing
4 Requirements
The concentration of formamide in foam toy materials shall not exceed 200 mg/kg.
NOTE This limit corresponds to the limit value specified in Directive (EU) 2009/48 [1] which was introduced
by Commission Directive (EU) 2015/2115 [2].
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 selective detector (GC-MS).
prEN 71-15:2023 (E)
6 Reagents and Apparatus
6.1 Reagents
Unless otherwise specified, all reagents shall be of analytical grade or higher. For substances purchased
refer to the storage conditions and stability information specified by the supplier.
6.1.1 Acetone (CAS 67-64-1)
6.1.2 Extraction solution
Prepare an extraction solution containing 5 mg/l N,N-Dimethylformamide-d7 (6.2.2) by diluting the
stock solution of internal standard (6.2.3). For this purpose, 1 ml of the stock solution of internal standard
(6.2.3) is transferred to a 1 l volumetric flask, filled up to volume with acetone (6.1.1) and thoroughly
mixed. This solution can be stored in the absence of light at (5 ± 3) °C for 6 months.
6.2 Standards
6.2.1 Calibration standard
Formamide (CAS 75-12-7), with known purity of at least 99 %.
6.2.2 Internal standard
N,N-Dimethylformamide-d7 (CAS 4472-41-7).
6.2.3 Stock solution of internal standard
Prepare a stock solution containing 5 g/l N,N-Dimethylformamide-d7 (6.2.2) in acetone (6.1.1) by
dissolving 100 mg of N,N-Dimethylformamide-d7 (6.2.2) in a 20 ml volumetric flask (6.3.4) with acetone
(6.1.1) and diluting to volume with acetone (6.1.1). This solution shall be stored in the absence of light at
(5 ± 3) °C.
6.2.4 Solutions of calibration standard
6.2.4.1 Stock solution of formamide
Prepare a stock solution containing 1 000 mg/l formamide (6.2.1) by dissolving 10 mg of formamide
(6.2.1) in a 10 ml volumetric flask (6.3.4) in the extraction solution (6.1.2) and filling to volume with
extraction solution (6.1.2).
6.2.4.2 Intermediate solution of formamide
Prepare an intermediate solution containing 10 mg/l formamide (6.2.1) by diluting the stock solution of
formamide (6.2.4.1). 200 µl of the stock solution of formamide (6.2.4.1) are transferred to a 20 ml
volumetric flask (6.3.4) and filled up to volume with the extraction solution (6.1.2). This solution shall be
stored in the absence of light at (5 ± 3) °C.
6.2.4.3 Final calibration solutions
Prepare five calibration solutions by diluting the intermediate solution of formamide (
...