FprCEN/TR 18217

SLOVENSKI STANDARD
01-oktober-2025
Varnost igrač - Migracija določenih elementov iz trdih polimerov
Safety of toys - Migration of certain Elements from "Hard" polymers
Sicherheit von Spielzeug - Migration bestimmter Elemente aus (Hart-) Polymeren
Sécurité des jouets - Migration de certains éléments à partir de polymères "durs"
Ta slovenski standard je istoveten z: FprCEN/TR 18217
ICS:
97.200.50 Igrače Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

FINAL DRAFT
TECHNICAL REPORT
RAPPORT TECHNIQUE
TECHNISCHER REPORT
June 2025
ICS
English Version
Safety of toys - Migration of certain elements from
polymers
Sécurité des jouets - Migration de certains éléments à Sicherheit von Spielzeug - Migration bestimmter
partir de polymères "durs" Elemente aus (Hart-) Polymeren

This draft Technical Report is submitted to CEN members for Vote. It has been drawn up by the Technical Committee CEN/TC 52.

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 Technical Report. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a Technical Report.

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. FprCEN/TR 18217:2025 E
worldwide for CEN national Members.

FprCEN TR 18217:2025(E)
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Theory . 5
4.1 Toy Safety Directive . 5
4.2 Polymers . 5
4.2.1 General. 5
4.2.2 Structure and interaction within a polymer . 6
4.2.3 Prerequisite for a potential migration of metal ions from polymers . 6
4.2.4 Diffusion through the polymer . 6
4.2.5 Desorption . 7
4.2.6 Solvation. 7
4.2.7 Necessary requirements for migration to occur . 8
5 Material . 8
6 Experiments and methodology . 9
7 Results and discussion . 9
8 Conclusions . 10
Annex A (informative) Result of laboratory testing . 11
Annex B (informative) Test results from original toy samples reported by test laboratories
................................................................................................................................................................... 15
Annex C (informative) Tin organic compounds . 21
Bibliography . 23

FprCEN TR 18217:2025 (E)
European foreword
This document (FprCEN/TR 18217:2025) 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 Vote on TR.
FprCEN TR 18217:2025(E)
Introduction
The Toy Safety Directive 2009/48/EC sets out limits for the migration of certain elements (Annex II,
chapter III, clause 13). This requirement is implemented by the European standard EN 71-3 which
includes a specified test method.
This document addresses a lot of different material groups and materials, like polymers and other solid
materials, liquids as well as scraped-off materials like coatings and specifies sample preparation and
analytical test methods for these materials.
Toys or toy components containing accessible glass, ceramic or metallic materials are tested as a whole
if they fit entirely within the small parts cylinder specified in EN 71-1. Glass, ceramic and metallic toy
components which do not fit within the small parts cylinder do not need to be tested. They cannot be
swallowed and due to their hardness are unlikely to release ingestible fragments. The exposure to certain
elements from such components is, therefore, not considered significant.
Experience has shown that also the migration from polymers is neglectable because a migration from
those materials appears scientifically not relevant due to insignificant diffusion of elements in solid
matter (see annex B).
The review of a data set collected from several laboratories showed that testing of polymeric toy
materials does, in practice, not result in any significant migration (see Annex B for representative test
results of real toy samples collected from several test institutes).
Based on these observations the responsible working group CEN/TC 52/WG 5 "Safety of toys - Chemical
properties" established task group CEN/TC 52/WG 5/TG 5 “Migration of certain elements regarding hard
polymers” in order to investigate whether the migration from hard polymers can also be considered as
negligible.
This document summarizes the results of the task group and provides a view on the behaviour of
polymeric material during the migration in 0,07 mol/l hydrochloric acid in accordance with to EN 71-3.
Literature research regarding the theoretical background of the movement and diffusion of ionic
molecules within solid matter was conducted. The empirical data were evaluated focussing on certain
polymeric materials. Based on the results of the literature study a controlled interlaboratory comparison
test was designed to prove the theoretical findings engaging nine accredited laboratories (notified
bodies) in Europe and Asia.
The aim was to assess whether elements could exceed the migration limits specified in EN 71-3 in a
migration test with certain spiked polymers. Hard polymers are defined in this context as those with a
Shore A hardness >55 and are therefore unlikely to release ingestible fragments as a result of biting or
chewing by children. In this study, the expert group found that the hardness of the polymers had no
influence on the migration results. Because on the one hand migration of elements within polymers is
negligible and is not related to the hardness of a polymer but on physical properties described below.
Therefore, the expert group decided to address certain polymers used as toy materials, for example ABS,
PP, PE, Polystyrene, Polycarbonate. Based on results of the literature research (see 4.2) it was realized
that the diffusion behaviour of the mentioned polymers is comparable.
The comparison test was conducted with a polymer granulate (ABS) containing in total 13 410 mg/kg of
certain elements.
In accordance with literature the release of metal ions from the polymers in discussion appear negligible
due to the physico-chemical properties of the material and the low diffusion rates. Therefore, it can be
assumed that no relevant amounts of metal ions migrate from polymers under the specified conditions.
In all analyses after migration (in accordance with EN 71-3:2013) metal ions were not detectable or found
below the limit of quantification. Based on these results it can be concluded that measurable amounts of
FprCEN TR 18217:2025 (E)
soluble metals do not migrate from polymers within the two hours specified in the test method and
therefore testing for migration of metals from polymers appears not to be necessary.
The results can be applied to toy materials made from, among others, the polymers ABS, PP, PE,
polystyrene, and polycarbonate containing no more than 20% additives. In conclusion these data can be
used to support a risk assessment in accordance with to Directive 2009/48/EC.
1 Scope
This document provides information on the migration behaviour of certain elements from polymers. The
document can in particular assist manufacturers of toys in performing risk assessments.
Information on organic tin compounds can be found in Annex C.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.
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/
4 Theory
4.1 Toy Safety Directive
In accordance with Article 19 of the Toy Safety Directive (Directive 2009/48/EC, [1]) toy manufacturers
can declare compliance for a toy by applying the relevant harmonised standards or applying a specific
risk assessment.
EN 71-3 currently defines exemptions for glass, ceramics and metal parts, not fitting into the small parts
cylinder, based on exposure and risk-based evaluations. These considerations can potentially be applied
to other materials, like polymers.
4.2 Polymers
4.2.1 General
In accordance with Regulation (EC) 1907/2006 polymer means a substance consisting of molecules
characterised by the sequence of one or more types of monomer units. Such molecules are distributed
over a range of molecular weights wherein differences in the molecular weight are primarily attributable
to differences in the number of monomer units.
A polymer comprises the following additional conditions:
a) a simple weight majority of molecules containing at least three monomers mainly carbon-based units
which are covalently bound to at least one other monomer unit or another reactant.
b) less than a simple weight majority of molecules of the same molecular weight.
c) a maximum of 20% additives
FprCEN TR 18217:2025(E)
4.2.2 Structure and interaction within a polymer
A polymer consists of long carbon chains [2]. The carbon atoms are covalently bound and exhibit a
lipophilic and non-polar character [3]. Therefore, the polymers of common toy material like PVC, ABS,
polystyrene, polyethylene, and polypropylene are not soluble in water or acids. Even PVC, which contains
a high number of powerful electronegative substituents, is practically insoluble in water, but soluble in
tetrahydrofurane and partly in further organic solvents. The strong covalent bonds between the carbon
atoms have a bonding strength of 600 kJ/mol – 1000 kJ/mol [4].
As the carbon chain of a polymer itself is non-polar, there is, in principle no interaction with polar
solvents, especially with water.
A polymer generally used in toys is polypropylene [5] (see Figure 1).

Figure 1 – Polypropylene
Aqueous acid solutions are strongly polar. Water consists of many small water-molecules (H O), which
form intermolecular interactions via the rather weak force of hydrogen bonding (Bonding strength < 50
kJ/mol) [4]. Reduction of the pH-value by addition of acid increases the polar character or the hydrogen
bonding found in aqueous media. Addition of acid or salts, for instance to simulate sweat or saliva does
not influence the solubility of polymers in aqueous media.

Figure 2 – Water with interactions
The non-polar surface of polymeric material constitutes a clear phase boundary and therefore the wetting
by aqueous media is strongly limited.
4.2.3 Prerequisite for a potential migration of metal ions from polymers
Certain conditions must be met for the practical migration of a metal ion through the surface of a polymer
material into an aqueous medium:
1) Diffusion of the metal ion from the interior of the polymer to the polymer surface.
2) Desorption of the metal
...