SIST-TP CEN/TR 18217:2026

SLOVENSKI STANDARD
kSIST-TP FprCEN/TR 18217:2025
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
kSIST-TP FprCEN/TR 18217:2025 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

kSIST-TP FprCEN/TR 18217:2025
kSIST-TP FprCEN/TR 18217:2025
FINAL DRAFT
TECHNICAL REPORT
FprCEN/TR 18217
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.

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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

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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.
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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
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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
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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 ion from the polymer surface
3) Solvation of the metal ion into the solution.
In this process diffusion is the determining step.
4.2.4 Diffusion through the polymer
The atomic motion is called diffusion [6]. It refers to the spontaneous motion of particles that move from
higher to lower concentration. The irregular mass motion of atoms or molecules is based on Brownian
motion [7].
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Mass motion and diffusion are temperature dependent, the higher the temperature, the faster the
movement of the particles. Diffusion is defined by the first Fick’s law [8].
2 2
For example, the diffusion coefficient (D) of gaseous CO in air is D ≈ 16 mm /s ≡ 5,8 m /h and in water
2 2
D ≈ 0,0016 mm /s ≡ 138 mm /day [9]. The following table shows further examples for diffusion
coefficients [10].
Table 1 – Diffusion coefficients
Molecule in medium Coefficient Temperature
[°C]
O2 in air 1,5 m²/day 25
H O in air 2,4 m²/day 25
H in iron 0,05 cm²/day 10
H in iron 3,9 cm²/day 100
-13
Al in copper 4 x 10 µm²/day 20
Even for gas molecules in air the diffusion coefficients are rather low. Typical diffusion coefficients for
-13 2
metal-ions (atoms) in a solid object at 298,15 K (25°C) are around 1 x 10 cm /s. In general diffusion
-11 -13
coefficient for metals in solid objects are a factor 10 to 10 times lower in comparison to diffusion
coefficients in gas.
-8
For a metal ion diffusing in a polymer this would mean a maximum velocity of 36 x 10 µm/h. This would
only apply, if it was a purely linear diffusion, which is usually not the case.
4.2.5 Desorption
Desorption is the process, in which particles detach from a surface [11]. Sorption describes the adhesion
of a particle to the surface. It is divided into physisorption and chemisorption. The physisorption
(physical binding) describes the “Van-der-Waals“-forces that exist between the adsorbate and the
substrate. This creates several layers on the substrate, which adhere by weak interactions. Chemisorption
(chemical adsorption) is based on covalent bonds. The adsorbate is bound in a single layer (one-layer) to
the substrate [12].
In the case of sorption, energy is released. The enthalpy is < 50 kJ/mol for physisorption and > 200 kJ/mol
for chemisorption. By implication desorption of the adsorbate requires an equivalent energy input. In
solutions, this is called solvation enthalpy.
4.2.6 Solvation
In aqueous solutions, a hydration sphere is formed around a metal ion. In this case the partial negative
charge of the oxygen atom is oriented towards the positive metal ion. The result is the formation of a
solvation sphere of water molecules. Depending on the charge different amounts of water molecules will
surround the ion [13].
This case describes the solution behaviour of polar compounds in polar solvents. In this context the
theory “similar dissolves similar” applies. Non-polar compounds are dissolved in non-polar solvents, but
not in polar, and vice versa.
Metal ions in polymers are embedded in a polymer matrix. Therefore, this molecule-part reduces the
solubility in a polar solvent such as water.
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4.2.7 Necessary requirements for migration to occur
The metal ion must diffuse through the network of carbon chains to get to the outside boundary of the
polymeric matrix. Due to the diffusion coefficient, this diffusion takes so long that no measurable diffusion
of metal ions is expected in the 2-hour migration-time in accordance with EN 71-3.
If a molecule does manage to diffuse to the surface of the polymer within 2 h, it will require desorption.
This means that desorption energy needs to be put in. In the case of ideal wetting this is favoured.
Incomplete moistening impedes desorption.
Assuming the metal ion has diffused to the polymer surface and suitable conditions for desorption are
present, solvation of the metal ion can occur. In polymers however, metal ions are usually bound to non-
polar or embedded, organic molecules that cannot dissolve in polar solvents, which is the reason that
solvation does not occur even though the metal ions have already diffused to the edge of the polymer.
Since migration of metal ions (diffusion, desorption, and solvation) does not happen in an aqueous
solution, testing in accordance with EN 71-3 cannot detect any relevant amounts of metal ions released
from polymers in the migration solution.
The literature and scientific evidence suggest/indicate, that significant migration of elements listed in EN
71-3 is improbable from polymers.
5 Material
An ABS masterbatch (Shore A hardness of 70 to 80) was used.
In this masterbatch, a fine-grained ABS granulate, metals were added in form of pigments and salts,
homogenized by mechanical agitation before being extruded.
To confirm homogeneity and stability several measurements of the metal total content were taken
throughout a period of 6 months.
To evaluate the content as well as the stability and homogeneity of the spiked polymer, the matrix was
completely digested via microwave-assisted decomposition in nitric acid, and the metals were retrieved
in the acid in accordance with EN 13346. The incorporated levels of metals are listed below in Table 2.
The selected Ions were chosen as representatives for all ions in question showing a range of charge from
1-6+.
Table 2 – Nominal concentrations
Concentration
Element
mg/kg
Aluminum (Al) 5 400
Antimony (Sb) 3 600
Arsenic (As) 0
Barium (Ba) 70
Boron (B) 100
Cadmium (Cd) 0
Chromium, Cr 1 900
Cobalt (Co) 0
Copper (Cu) 210
Lead (Pb) 0
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Concentration
Element
mg/kg
Manganese (Mn) 70
Mercury (Hg) 0
Nickel (Ni) 40
Selenium (Se) 0
Strontium (Sr) 0
Tin (Sn) 1 900
Zinc (Zn) 120
6 Experiments and methodology
Members of CEN/TC 52/WG 5/TG 5 were requested to submit empirical data to evaluate if metal ions
possibly migrate or not from polymers specially toy materials.
The test results of EN 71-3 tests of polymers were reviewed and reported by 9 notified body labs (8
participants on the round robin test and one lead lab). The scope of testing of EN 71-3:2013 refers to the
expanded scope of testing of 18 metals (formerly 8). The test results show that in the period from 2012
to 2015 no toy product made of polymers failed the migration testing on metals in accordance with EN
71-3.
The spiked ABS sample was submitted to the selected eight laboratories for testing in accordance with
EN 71-3:2013 and total metal content in accordance with EN 13346. Furthermore, an analytical
determination of the different metals was performed.

Figure 3 – Photo of polymer
This polymer contains more than 13 000 mg/kg heavy metals.
The polymer was tested in accordance with EN 71-3:2013.
7 Results and discussion
The results of the international laboratory test show that none of the testing facilities could determine
the elements present in the material in amounts above the limit of quantification [see Annex A].
These results are in accordance with the reported test data provided by EU and Asian notified bodies.
Considering the physico-chemical background of diffusion of ions within a polymer, the temperature
influence, the polarity, the wetting at the surface and their solvation / solubility it is unlikely that amounts
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above the limits specified in EN 71-3 can migrate from certain polymer matrices, even if this polymer
comprises small particles (1 x2 mm) and containing a sum of 13 410 mg/kg of elements.
Furthermore, the 10 elements tested in the interlaboratory trial can be regarded as representative for all
elements listed in EN 71-3 due to their comparable atomic size and charge.
Physico-chemical data which confirm the transferability of the results from ABS to other polymers (like
polyethylene, polypropylene, polystyrene and polycarbonate) can be found in scientific literature [see
Bibliography].
8 Conclusions
The
...