Safety of toys - Part 3: Migration of certain elements

This document specifies requirements and test methods for the migration of aluminium, antimony, arsenic, barium, boron, cadmium, Chromium (III), Chromium (VI), cobalt, copper, lead, manganese, mercury, nickel, selenium, strontium, tin, organic tin and zinc from toy materials and from parts of toys.
Packaging materials are not considered to be part of the toy unless they have intended play value.
NOTE 1   See the European Commission guidance document no. 12 on the application of the Directive on the safety of toys - packaging [2].
The standard contains requirements for the migration of certain elements from the following categories of toy materials:
-   Category I: Dry, brittle, powder like or pliable materials;
-   Category II: Liquid or sticky materials;
-   Category III: Scraped-off materials.
The requirements of this document do not apply to toys or parts of toys which, due to their accessibility, function, volume or mass, clearly exclude any hazard due to sucking, licking or swallowing or prolonged skin contact when the toy or part of toy is used as intended or in a foreseeable way, bearing in mind the behaviour of children.
NOTE 2   For the purposes of this document, for the following toys and parts of toys the likelihood of sucking, licking or swallowing toys is considered significant (see H.2 and H.3):
-   All toys intended to be put in the mouth or to the mouth, cosmetics toys and writing instruments categorized as toys can be considered to be sucked, licked or swallowed;
-   All the accessible parts and components of toys intended for children up to 6 years of age can be considered to come into contact with the mouth. The likelihood of mouth contact with parts of toys intended for older children is not considered significant in most cases (see H.2).

Sicherheit von Spielzeug - Teil 3: Migration bestimmter Elemente

Dieses Dokument legt Anforderungen an und Prüfverfahren für die Migration von Aluminium, Antimon, Arsen, Barium, Bor, Cadmium, Chrom(III), Chrom(VI), Cobalt, Kupfer, Blei, Mangan, Quecksilber, Nickel, Selen, Strontium, Zinn, Organozinn und Zink aus Spielzeugmaterialien und Teilen von Spielzeug fest.
Verpackungsmaterialien werden nicht als Teil des Spielzeugs angesehen, es sei denn, sie haben einen beab-sichtigten Spielwert.
ANMERKUNG 1   Siehe hierzu Leitlinie Nr. 12 der Europäischen Kommission zur Anwendung der Richtlinie über die Sicherheit von Spielzeug - Verpackungen [2].
Die Norm enthält Anforderungen an die Migration bestimmter Elemente aus den folgenden Kategorien von Spielzeugmaterialien:
-   Kategorie I: Trockene, brüchige, staubförmige oder geschmeidige Materialien;
-   Kategorie II: Flüssige oder haftende Materialien;
-   Kategorie III: Abgeschabte Materialien.
Die Anforderungen dieses Dokumentes gelten nicht für Spielzeug oder Teile von Spielzeug, das/die bei bestimmungsgemäßem oder vorhersehbarem Gebrauch und unter Berücksichtigung des Verhaltens von Kindern wegen seiner/ihrer Zugänglichkeit, Funktion, Volumens oder Masse jegliche Gefährdung durch Saugen, Lecken oder Verschlucken oder längeren Hautkontakt eindeutig ausschließt/ausschließen.
ANMERKUNG 2   Für die Zwecke dieses Dokuments wird für folgendes Spielzeug und Teile von Spielzeug die Wahrscheinlichkeit von Saugen, Lecken oder Verschlucken an/von Spielzeug als wesentlich angesehen (siehe Abschnitt H.2 und Abschnitt H.3):
-   bei jedem Spielzeug, das dazu bestimmt ist, in oder an den Mund genommen zu werden, sowie bei Kosmetik-spielzeug und Schreibgeräten, die als Spielzeug eingestuft sind, kann davon ausgegangen werden, dass sie gesaugt, geleckt oder verschluckt werden;
-   bei allen zugänglichen Teilen und Bestandteilen von Spielzeug, das für Kinder bis zu 6 Jahren vorgesehen ist, kann von Mundkontakt ausgegangen werden. Die Wahrscheinlichkeit des Mundkontakts mit Teilen von Spielzeug, das für ältere Kinder vorgesehen ist, wird in den meisten Fällen als nicht signifikant angesehen (siehe Abschnitt H.2).

Sécurité des jouets - Partie 3: Migration de certains éléments

Le présent document spécifie les exigences et les méthodes d’essai applicables à la migration de l’aluminium, de l’antimoine, de l’arsenic, du baryum, du bore, du cadmium, du chrome (III), du chrome (VI), du cobalt, du cuivre, du plomb, du manganèse, du mercure, du nickel, du sélénium, du strontium, de l’étain, de l’étain organique et du zinc à partir de matériaux-jouet et de parties de jouets.
Les matériaux d’emballage ne sont pas considérés comme des parties de jouets, sauf s’ils ont une valeur ludique.
NOTE 1 Voir le document d’orientation no 12 de la Commission européenne sur l’application de la Directive relative à la sécurité des jouets - Emballage [2].
La présente norme contient des exigences relatives à la migration de certains éléments à partir des catégories de matériaux-jouet suivantes :
- Catégorie I : matériaux secs, friables, poudreux ou souples ;
- Catégorie II : matériaux liquides ou collants ;
- Catégorie III : matériaux grattés.
Les exigences du présent document ne s’appliquent pas aux jouets ou parties de jouets qui, en raison de leur accessibilité, fonction, volume ou masse, excluent manifestement tout danger par succion, léchage, ingestion ou contact prolongé avec la peau lorsque le jouet ou la partie de jouet est utilisé(e) conformément à son usage prévu ou d’une manière prévisible, en gardant le comportement des enfants à l’esprit.
NOTE 2 Pour les besoins du présent document, pour les jouets et parties de jouets suivants, la probabilité de succion, léchage ou ingestion des jouets est considérée comme significative (voir H.2 et H.3) :
- tous les jouets destinés à être mis dans la bouche ou portés à la bouche, les jouets cosmétiques et les articles d’écriture classés comme jouets peuvent être considérés comme étant sucés, léchés ou ingérés ;
- toutes les parties accessibles et tous les composants de jouets destinés aux enfants jusqu’à l’âge de 6 ans peuvent être considérés comme entrant en contact avec la bouche. La probabilité de contact oral avec des parties de jouets destinés à des enfants plus âgés n’est pas jugée significative dans la plupart des cas (voir H.2).

Varnost igrač - 3. del: Migracija določenih elementov (vključuje dopolnilo A1)

General Information

Status
Published
Publication Date
14-Jun-2021
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
06-May-2021
Due Date
11-Jul-2021
Completion Date
15-Jun-2021

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SLOVENSKI STANDARD
SIST EN 71-3:2019+A1:2021
01-julij-2021
Nadomešča:
SIST EN 71-3:2019
Varnost igrač - 3. del: Migracija določenih elementov (vključuje dopolnilo A1)
Safety of toys - Part 3: Migration of certain elements
Sicherheit von Spielzeug - Teil 3: Migration bestimmter Elemente
Sécurité des jouets - Partie 3: Migration de certains éléments
Ta slovenski standard je istoveten z: EN 71-3:2019+A1:2021
ICS:
97.200.50 Igrače Toys
SIST EN 71-3:2019+A1:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 71-3:2019+A1:2021
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SIST EN 71-3:2019+A1:2021
EN 71-3:2019+A1
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2021
EUROPÄISCHE NORM
ICS 97.200.50 Supersedes EN 71-3:2019
English Version
Safety of toys - Part 3: Migration of certain elements

Sécurité des jouets - Partie 3: Migration de certains Sicherheit von Spielzeug - Teil 3: Migration bestimmter

éléments Elemente

This European Standard was approved by CEN on 8 April 2019 and includes Amendment 1 approved by CEN on 2 February

2021.

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, Turkey 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

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 71-3:2019+A1:2021 E

worldwide for CEN national Members.
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SIST EN 71-3:2019+A1:2021
EN 71-3:2019+A1:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 5

Introduction .................................................................................................................................................................... 7

1 Scope .................................................................................................................................................................... 8

2 Normative references .................................................................................................................................... 8

3 Terms and definitions ................................................................................................................................... 8

4 Requirements ................................................................................................................................................... 9

4.1 Toy material categories (see H.4) ............................................................................................................. 9

4.2 Specific requirements ................................................................................................................................. 10

5 Principle .......................................................................................................................................................... 11

6 Reagents and apparatus ............................................................................................................................ 12

6.1 Reagents .......................................................................................................................................................... 12

6.2 Apparatus ........................................................................................................................................................ 12

7 Sampling and sample preparation ......................................................................................................... 12

7.1 Selection of test portions ........................................................................................................................... 12

7.2 Sample preparation ..................................................................................................................................... 13

7.2.1 General ............................................................................................................................................................. 13

7.2.2 Sampling .......................................................................................................................................................... 13

7.2.3 Dewaxing (see H.11) ................................................................................................................................... 15

8 Migration methodology ............................................................................................................................. 16

8.1 Preparation of test portions before migration testing ................................................................... 16

8.1.1 General ............................................................................................................................................................. 16

8.1.2 Category I: Dry, brittle, powder like or pliable materials and Category II: Liquid or

sticky materials............................................................................................................................................. 16

8.1.3 Category III: Scraped-off materials ........................................................................................................ 16

8.2 pH adjustment (see H.10).......................................................................................................................... 17

8.2.1 General ............................................................................................................................................................. 17

8.2.2 pH adjustment – no buffering effect by toy material ....................................................................... 17

8.2.3 pH adjustment – buffering effect by toy material ............................................................................. 17

8.3 Migration procedure ................................................................................................................................... 18

8.3.1 Migration ......................................................................................................................................................... 18

8.3.2 Filtration (see H.8) ....................................................................................................................................... 19

9 Stabilization and analysis of migration solutions ............................................................................ 19

9.1 General ............................................................................................................................................................. 19

9.2 General elements ......................................................................................................................................... 19

9.3 Chromium (VI) .............................................................................................................................................. 19

9.4 Organic tin ...................................................................................................................................................... 20

10 Calculation of results .................................................................................................................................. 20

10.1 Calculation of migration ............................................................................................................................ 20

10.1.1 General ............................................................................................................................................................. 20

10.1.2 Calculation of Chromium (III) .................................................................................................................. 20

10.2 Interpretation of results ............................................................................................................................ 21

11 Method performance .................................................................................................................................. 21

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SIST EN 71-3:2019+A1:2021
EN 71-3:2019+A1:2021 (E)

11.1 Repeatability and reproducibility .......................................................................................................... 21

11.2 Estimation of bias ......................................................................................................................................... 23

11.3 Limit of detection (LOD) and limit of quantification (LOQ) .......................................................... 23

12 Test report ...................................................................................................................................................... 24

Annex A (informative) Significant technical changes between this document and the

previous version ........................................................................................................................................... 25

Annex B (informative) Information on method validation........................................................................... 27

B.1 General ............................................................................................................................................................. 27

B.2 Samples of interlaboratory comparison .............................................................................................. 27

B.3 Selection of material category/element combinations .................................................................. 28

Annex C (informative) Estimation of reproducibility ..................................................................................... 29

Annex D (informative) Toy material visual particle size comparison materials.................................. 31

Annex E (normative) Method of analysis for general elements .................................................................. 33

E.1 Principle ........................................................................................................................................................... 33

E.2 Working solutions ........................................................................................................................................ 33

E.2.1 Stock solution (M ) ...................................................................................................................................... 33

E.2.2 Diluted stock solution (M ) ...................................................................................................................... 34

E.2.3 Working solutions ........................................................................................................................................ 34

E.2.4 Internal standard stock solution ............................................................................................................ 34

E.3 Procedure ........................................................................................................................................................ 34

E.4 Analysis ............................................................................................................................................................ 34

E.5 Calculation....................................................................................................................................................... 35

E.5.1 Calibration curve .......................................................................................................................................... 35

E.5.2 Calculation of migration ............................................................................................................................. 35

Annex F (normative) Method of analysis for Chromium (VI) ...................................................................... 36

F.1 Principle ........................................................................................................................................................... 36

F.2 Reagents ........................................................................................................................................................... 36

F.3 Apparatus ........................................................................................................................................................ 37

F.4 Procedure ........................................................................................................................................................ 38

F.5 Analysis ............................................................................................................................................................ 38

F.5.1 General ............................................................................................................................................................. 38

F.5.2 Chromatographic conditions .................................................................................................................... 38

F.5.3 Limit of detection and quantification .................................................................................................... 39

F.6 Calculation....................................................................................................................................................... 39

F.6.1 Calibration curve .......................................................................................................................................... 39

F.6.2 Calculation of migration ............................................................................................................................. 40

Annex G (normative) Method of analysis for organic tin (see H.9) ........................................................... 41

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SIST EN 71-3:2019+A1:2021
EN 71-3:2019+A1:2021 (E)

G.1 Principle .......................................................................................................................................................... 41

G.2 Reagents .......................................................................................................................................................... 42

G.3 Apparatus ........................................................................................................................................................ 45

G.4 Procedure........................................................................................................................................................ 45

G.4.1 Sample derivatisation ................................................................................................................................. 45

G.4.2 Calibration standards ................................................................................................................................. 47

G.5 Analysis ............................................................................................................................................................ 47

G.5.1 General ............................................................................................................................................................. 47

G.5.2 Example of GC conditions .......................................................................................................................... 49

G.5.3 Example of MS conditions ......................................................................................................................... 49

G.5.4 Limit of detection and quantification ................................................................................................... 49

G.5.5 Example of a GC-MS chromatogram....................................................................................................... 50

G.6 Calculation ...................................................................................................................................................... 51

G.6.1 Calibration curve .......................................................................................................................................... 51

G.6.2 Standard addition ........................................................................................................................................ 51

G.6.3 Calculation of migration of organic tin ................................................................................................. 51

Annex H (informative) Rationale ........................................................................................................................... 53

H.1 General ............................................................................................................................................................. 53

H.2 Mouthing behaviour of children (see Clause 1) ................................................................................ 53

H.3 Skin contact (see Clause 1) ....................................................................................................................... 54

H.4 Toy categories (see 4.1) ............................................................................................................................. 54

H.5 Test portions (see Clause 7) ..................................................................................................................... 54

H.6 Size of test pieces (see 7.2) ....................................................................................................................... 54

H.7 Stability of Chromium (VI) in the migration solution (see 9.3) ................................................... 55

H.8 Filtration of migration solutions (see 8.3.2) ...................................................................................... 55

H.9 Organic tin (see Annex G) .......................................................................................................................... 55

H.10 pH value (see 8.2 and 8.3.1.2) .................................................................................................................. 57

H.11 De-waxing (see 7.2.3) ................................................................................................................................. 57

Annex ZA (informative) !Relationship between this European Standard and the essential

requirements of EU Directive 2009/48/EC aimed to be covered ............................................... 58

Bibliography ................................................................................................................................................................. 59

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SIST EN 71-3:2019+A1:2021
EN 71-3:2019+A1:2021 (E)
European foreword

This document (EN 71-3:2019+A1:2021) 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 October 2021, and conflicting national standards shall

be withdrawn at the latest by October 2021.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document includes Amendment 1 approved by CEN on 2 February 2021.
This document supersedes !EN 71-3:2019".

The start and finish of text introduced or altered by amendment is indicated in the text by tags !".

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive 2009/48/EC.

For relationship with EU Directive 2009/48/EC, see informative Annex ZA, which is an integral part of

this document.

The significant changes from the previous edition of this standard are detailed in Annex A.

!This document constitutes the third 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 (this document);
— 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 9: Organic chemical compounds — Requirements;
— 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;
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SIST EN 71-3:2019+A1:2021
EN 71-3:2019+A1:2021 (E)
— Part 14: Trampolines for domestic use.

!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 technical reports have been published:

— CEN/TR 15071, Safety of toys — National translations of warnings and instructions for use in EN 71 series;

— CEN/TR 15371 (parts 1 and 2), Safety of toys — Interpretations;

— CEN/TR 16918, Safety of toys — Children’s mouthing behaviour in contact with toys;

— CEN ISO/TR 8124-8, Safety of toys — Age determination guidelines."
NOTE 2 Words in italics are defined in Clause 3 (Terms and definitions).

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, Turkey and the United

Kingdom.
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SIST EN 71-3:2019+A1:2021
EN 71-3:2019+A1:2021 (E)
Introduction

The Toy Safety Directive (2009/48/EC) [1] specifies maximum migration limits for three categories of

toy materials. Certain limit values have been amended (see [4, 5, 6, 7]). The limits for the migration of

certain elements are expressed in milligram per kilogram toy material and are detailed in Table 2. The

purpose of the limits is to minimize children’s exposure to certain potentially toxic elements.

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SIST EN 71-3:2019+A1:2021
EN 71-3:2019+A1:2021 (E)
1 Scope

This document specifies requirements and test methods for the migration of aluminium, antimony,

arsenic, barium, boron, cadmium, Chromium (III), Chromium (VI), cobalt, copper, lead, manganese,

mercury, nickel, selenium, strontium, tin, organic tin and zinc from toy materials and from parts of toys.

Packaging materials are not considered to be part of the toy unless they have intended play value.

NOTE 1 See the European Commission guidance document no. 12 on the application of the Directive on the safety

of toys – packaging [2].

The standard contains requirements for the migration of certain elements from the following categories

of toy materials:
— Category I: Dry, brittle, powder like or pliable materials;
— Category II: Liquid or sticky materials;
— Category III: Scraped-off materials.

The requirements of this document do not apply to toys or parts of toys which, due to their accessibility,

function, volume or mass, clearly exclude any hazard due to sucking, licking or swallowing or prolonged

skin contact when the toy or part of toy is used as intended or in a foreseeable way, bearing in mind the

behaviour of children.

NOTE 2 For the purposes of this document, for the following toys and parts of toys the likelihood of sucking,

licking or swallowing toys is considered significant (see H.2 and H.3):

— All toys intended to be put in the mouth or to the mouth, cosmetics toys and writing instruments categorized

as toys can be considered to be sucked, licked or swallowed;

— All the accessible parts and components of toys intended for children up to 6 years of age can be considered

to come into contact with the mouth. The likelihood of mouth contact with parts of toys intended for older

children is not considered significant in most cases (see H.2).
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 71-1:2014+A1:2018, Safety of toys — Part 1: Mechanical and physical properties

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 http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
base material
material upon which coatings can be formed or deposited
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SIST EN 71-3:2019+A1:2021
EN 71-3:2019+A1:2021 (E)
3.2
coating

layer of material formed or deposited on a base material which can be removed by scraping

Note 1 to entry: Coatings can include paints, varnishes, lacquers, inks, polymeric coatings or other substances of

a similar nature, whether they contain metallic particles or not, and irrespective of the manner of application.

3.3
paper

sheet formed by irregularly intervened fibres with a mass per unit area of 400 g/m or less

3.4
paper board

sheet formed by irregularly intervened fibres with a mass per unit area over 400 g/m

Note 1 to entry: The term paper board also includes materials commonly referred to as card or cardboard with a

mass per unit area over 400 g/m .
3.5
scraping
mechanical removal of coatings down to but not including the base material
3.6
toy material

material present in toys and accessible as determined in accordance with EN 71-1:2014+A1:2018, 8.10

3.7
sample
toy or material subject to testing
3.8
laboratory sample
material taken from a sample
4 Requirements
4.1 Toy material categories (see H.4)

Table 1 contains a list of common toy materials and their respective categories. Toy materials not

specifically listed in Table 1 shall be assigned to one of the categories.
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SIST EN 71-3:2019+A1:2021
EN 71-3:2019+A1:2021 (E)
Table 1 — Cross-reference table for determining category
Toy Material Category I Category II Category III
Coatings of paints, varnishes, lacquers, printing inks,
X
polymers, foams and similar coatings
Polymeric and similar materials, including laminates,
X
whether textile reinforced or not, but excluding other textiles
Paper and paper board X
Textiles, whether natural or synthetic X
Glass, ceramic, metallic materials X
Wood, fibre board, hard board, bone, leather and other solid
X
materials
Compressed paint tablets, materials intended to leave a trace
or similar materials in solid form appearing as such in the toy X
(e.g. the cores of colouring pencils, chalk, crayons)
Pliable modelling materials, including modelling clays and
plaster
Liquid paints, including finger paints, varnishes, lacquers,
liquid ink in pens and similar materials in liquid form X
appearing as such in the toy (e.g. slimes, bubble solution)
Glue sticks X
4.2 Specific requirements

The migration of elements from toy materials categorized in accordance with 4.1 shall not exceed the

migration limits given in Table 2 when tested in accordance with Clause 7 (sampling and sample

preparation), Clause 8 (migration
...

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