Safety of toys — Part 3: Migration of certain elements

1.1 This document specifies maximum acceptable levels and methods of sampling, extraction and determination for the migration of the elements antimony, arsenic, barium, cadmium, chromium, lead, mercury and selenium from toy materials and from parts of toys. 1.2 Maximum acceptable levels are specified for the migration of the elements listed in 1.1 from the following toy materials: — coatings of paints, varnishes, lacquers, printing inks, polymers and similar coatings (see 9.1); — polymeric and similar material, including laminates, whether textile-reinforced or not, but excluding other textiles and non-woven textiles (see 9.2); — paper and paperboard (see 9.3); — natural, artificial or synthetic textiles (see 9.4); — glass/ceramic/metallic materials, excepting lead solder when used for electrical connections (see 9.5); — other materials, whether mass-coloured or not (e.g. wood, fibreboard, hardboard, bone and leather) (see 9.6); — materials intended to leave a trace (e.g. the graphite materials in pencils and liquid ink in pens) (see 9.7); — pliable modelling materials, including modelling clays and gels (see 9.8); — paints to be used as such in the toy, including finger paints, varnishes, lacquers, glazing powders and similar material in solid or liquid form (see 9.9). 1.3 The requirements in this document apply to the following toys and toy components of toys and toy materials (see D.2.1): — all intended food and oral contact toys, cosmetic toys and writing instruments categorized as toys, irrespective of any age grading or recommended age labelling; — all toys intended for or suitable for children under 72 months of age; — accessible coatings, irrespective of any age grading or recommended age labelling; — accessible liquids, pastes and gels (e.g. liquid paints, modelling compounds), irrespective of any age grading or recommended age labelling. 1.4 Packaging materials are not included, unless they are intended to be kept, for example boxes and containers, or unless they form part of the toy or have intended play value (see D.2.2). NOTE No requirements are given for toys and parts of toys which, due to their accessibility, function, mass, size or other characteristics, are obviously unlikely to be sucked, licked or swallowed, bearing in mind the normal and foreseeable behaviour of children (e.g. the coating on the crossbeam of a swing set, the tyres of a toy bicycle).

Sécurité des jouets — Partie 3: Migration de certains éléments

General Information

Status
Published
Publication Date
15-Mar-2020
Current Stage
6060 - International Standard published
Start Date
16-Mar-2020
Completion Date
16-Mar-2020
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INTERNATIONAL ISO
STANDARD 8124-3
Third edition
2020-03
Safety of toys —
Part 3:
Migration of certain elements
Sécurité des jouets —
Partie 3: Migration de certains éléments
Reference number
ISO 8124-3:2020(E)
ISO 2020
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ISO 8124-3:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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Published in Switzerland
ii © ISO 2020 – All rights reserved
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ISO 8124-3:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

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

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Maximum acceptable levels ...................................................................................................................................................................... 3

4.1 Specific requirements ....................................................................................................................................................................... 3

4.2 Interpretation of results ................................................................................................................................................................. 4

5 Principle ........................................................................................................................................................................................................................ 4

6 Reagents ........................................................................................................................................................................................................................ 4

7 Apparatus ..................................................................................................................................................................................................................... 5

8 Selection of test portions ............................................................................................................................................................................. 5

9 Preparation and extraction of test portions ............................................................................................................................ 6

9.1 Coatings of paint, varnish, lacquer, printing ink, polymer and similar coatings ............................ 6

9.1.1 Test portion preparation ........................................................................................................................................... 6

9.1.2 Extraction procedure ................................................................................................................................................... 6

9.2 Polymeric and similar material, including laminates, whether textile-reinforced or

not, but excluding other textiles .............................................................................................................................................. 7

9.2.1 Test portion preparation ........................................................................................................................................... 7

9.2.2 Extraction procedure ................................................................................................................................................... 7

9.3 Paper and paperboard ...................................................................................................................................................................... 7

9.3.1 Test portion preparation ........................................................................................................................................... 7

9.3.2 Extraction procedure ................................................................................................................................................... 7

9.4 Natural, artificial or synthetic textiles ................................................................................................................................ 8

9.4.1 Test portion preparation ........................................................................................................................................... 8

9.4.2 Extraction procedure ................................................................................................................................................... 8

9.5 Glass/ceramic/metallic materials .......................................................................................................................................... 8

9.5.1 Test portion preparation ........................................................................................................................................... 8

9.5.2 Extraction procedure ................................................................................................................................................... 8

9.6 Other materials, whether mass-coloured or not (e.g. wood, fibreboard, bone and leather) 9

9.6.1 Test portion preparation ........................................................................................................................................... 9

9.6.2 Extraction procedures ................................................................................................................................................. 9

9.7 Materials intended to leave a trace ........................................................................................................................................ 9

9.7.1 Test portion preparation for materials in solid form ....................................................................... 9

9.7.2 Test portion preparation for materials in liquid form ..................................................................10

9.7.3 Extraction procedure for samples not containing grease, oil, wax or

similar material ..............................................................................................................................................................10

9.7.4 Extraction procedure for samples containing grease, oil, wax or similar

material .................................................................................................................................................................................10

9.8 Pliable modelling materials, including modelling clays and gels .............................................................11

9.8.1 Test portion preparation ........................................................................................................................................11

9.8.2 Extraction procedure for samples not containing grease, oil, wax or

similar material ..............................................................................................................................................................11

9.8.3 Extraction procedure for samples containing grease, oil, wax or similar

material .................................................................................................................................................................................12

9.9 Paints, including finger paints, varnishes, lacquers, glazing powders and similar

material in solid or liquid form ..............................................................................................................................................12

9.9.1 Test portion preparation for materials in solid form ....................................................................12

9.9.2 Test portion preparation for materials in liquid form ..................................................................12

9.9.3 Extraction procedure for samples not containing grease, oil, wax or

similar material ..............................................................................................................................................................13

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ISO 8124-3:2020(E)
9.9.4 Extraction procedure for samples containing grease, oil, wax or similar

material .................................................................................................................................................................................13

10 Elemental analysis ...........................................................................................................................................................................................13

10.1 Methods of analysis ..........................................................................................................................................................................13

10.2 Method detection limit (MDL) ................................................................................................................................................13

10.3 Calculation of results ......................................................................................................................................................................14

11 Test report ................................................................................................................................................................................................................14

Annex A (normative) Sieve requirements ....................................................................................................................................................15

Annex B (informative) Selection of procedure ........................................................................................................................................16

Annex C (informative) Methods for analysis of elements ............................................................................................................17

Annex D (informative) Background and rationale ..............................................................................................................................23

Bibliography .............................................................................................................................................................................................................................29

iv © ISO 2020 – All rights reserved
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ISO 8124-3:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

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

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/

iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 181, Safety of toys.

This third edition cancels and replaces the second edition (ISO 8124-3:2010), which has been technically

revised. It also incorporates the Amendments ISO 8124-3:2010/Amd.1:2014 and ISO 8124-3:2010/

Amd.2:2018. The main changes to the previous edition are as follows:

— two detailed dewaxing methods have been introduced to replace the original one;

— an ICP-OES method for determination of the elements is given in Annex C as informative content.

A list of all parts in the ISO 8124 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
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ISO 8124-3:2020(E)
Introduction

The requirements of this document are based on the bioavailability of certain elements resulting from

the use of toys, which should not, as an objective, exceed the following levels per day:

— 0,2 µg for antimony;
— 0,1 µg for arsenic;
— 25,0 µg for barium;
— 0,6 µg for cadmium;
— 0,3 µg for chromium;
— 0,7 µg for lead;
— 0,5 µg for mercury;
— 5,0 µg for selenium.

For the interpretation of these values, it has been necessary to identify an upper limit for the ingestion

of toy material. Very limited data have been available for identifying this upper limit. As a working

hypothesis, a summed average daily intake of the various toy materials has been gauged at the currently

accepted value of 8 mg/d, in the knowledge that in certain individual cases these values might be

exceeded.

By combining the daily intake with the bioavailability values listed above, limits have been obtained

for various toxic elements in micrograms per gram of toy material (milligrams per kilogram) and are

detailed in Table 1. The values obtained have been adjusted to minimize children's exposure to toxic

elements in toys and to ensure analytical feasibility, taking into account limits achievable under current

manufacturing conditions (see Annex D).
vi © ISO 2020 – All rights reserved
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INTERNATIONAL STANDARD ISO 8124-3:2020(E)
Safety of toys —
Part 3:
Migration of certain elements

WARNING — Persons applying this document should be familiar with laboratory practice for

chemical analysis. This document does not purport to address all of the safety problems, if any,

associated with its use. It is the responsibility of the user to establish appropriate safety and

health practices.

IMPORTANT — It is essential that the laboratory ensures that personnel have the competence to

perform laboratory activities for which they are responsible.
1 Scope

1.1 This document specifies maximum acceptable levels and methods of sampling, extraction and

determination for the migration of the elements antimony, arsenic, barium, cadmium, chromium, lead,

mercury and selenium from toy materials and from parts of toys.

1.2 Maximum acceptable levels are specified for the migration of the elements listed in 1.1 from the

following toy materials:

— coatings of paints, varnishes, lacquers, printing inks, polymers and similar coatings (see 9.1);

— polymeric and similar material, including laminates, whether textile-reinforced or not, but excluding

other textiles and non-woven textiles (see 9.2);
— paper and paperboard (see 9.3);
— natural, artificial or synthetic textiles (see 9.4);

— glass/ceramic/metallic materials, excepting lead solder when used for electrical connections

(see 9.5);

— other materials, whether mass-coloured or not (e.g. wood, fibreboard, hardboard, bone and leather)

(see 9.6);

— materials intended to leave a trace (e.g. the graphite materials in pencils and liquid ink in pens)

(see 9.7);
— pliable modelling materials, including modelling clays and gels (see 9.8);

— paints to be used as such in the toy, including finger paints, varnishes, lacquers, glazing powders and

similar material in solid or liquid form (see 9.9).

1.3 The requirements in this document apply to the following toys and toy components of toys and toy

materials (see D.2.1):

— all intended food and oral contact toys, cosmetic toys and writing instruments categorized as toys,

irrespective of any age grading or recommended age labelling;
— all toys intended for or suitable for children under 72 months of age;

— accessible coatings, irrespective of any age grading or recommended age labelling;

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ISO 8124-3:2020(E)

— accessible liquids, pastes and gels (e.g. liquid paints, modelling compounds), irrespective of any age

grading or recommended age labelling.

1.4 Packaging materials are not included, unless they are intended to be kept, for example boxes and

containers, or unless they form part of the toy or have intended play value (see D.2.2).

NOTE No requirements are given for toys and parts of toys which, due to their accessibility, function, mass,

size or other characteristics, are obviously unlikely to be sucked, licked or swallowed, bearing in mind the normal

and foreseeable behaviour of children (e.g. the coating on the crossbeam of a swing set, the tyres of a toy bicycle).

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.

ISO 3696, Water for analytical laboratory use — Specification and test methods

ISO 8124-1:2018, Safety of toys — Part 1: Safety aspects related to mechanical and physical properties

ISO 8124-6:2018, Safety of toys — Part 6: Certain phthalate esters in toys and children's products

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:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
base material
material upon which coatings (3.2) may be formed or deposited
3.2
coating

layers of material formed or deposited on the base material (3.1) of a toy, including paints, varnishes,

lacquers, inks, polymers or other substances of a similar nature, whether they contain metallic particles

or not, no matter how they have been applied to the toy, and which can be removed by scraping (3.7)

with a sharp blade
3.3
method detection limit
MDL

three times the standard deviation of the result obtained in the method blank by the laboratory

carrying out the analysis
3.4
mass-coloured material

material which has absorbed colouring matter without formation of a coating (3.2)

EXAMPLE Wood, fibreboard, hardboard, leather, bone and other porous substances.
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ISO 8124-3:2020(E)
3.5
paper

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

Note 1 to entry: If paper with polymeric lamination, or other treatments which may be resistant to wetting, no

longer presents the same properties as paper, then it is not treated as such.
[SOURCE: ISO 8124-1:2018, 3.46]
3.6
paperboard

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

excluding pressed wooden fibreboards such as medium density fibreboard (MDF), chipboard and

materials with similar properties

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

mass per unit area over 400 g/m .

Note 2 to entry: If paperboard with polymeric lamination, or other treatments which may be resistant to wetting,

no longer present the same properties as paper, then they are not treated as such.

[SOURCE: ISO 8124-1:2018, 3.85]
3.7
scraping
mechanical process for removal of coatings (3.2) down to the base material (3.1)
3.8
toy material
accessible material present in a toy
3.9
method blank

aliquot of extraction solvent that is treated exactly as a sample including exposure to glassware,

apparatus and conditions used for a particular test, but with no added sample
3.10
calibration blank
solution containing no analyte that is used to verify blank value
EXAMPLE 0,07 ± 0,005 mol/l hydrochloric acid solution (6.1).
3.11
instrument detection limit
IDL

three times the standard deviation of the result obtained by analysing calibration blank

3.12
calibration check solution

solution of known composition within the range of the calibration solutions, but prepared independently

4 Maximum acceptable levels
4.1 Specific requirements
See D.3.

Toys and parts of toys, as specified in Clause 1, are deemed to meet the requirements of this document

when the adjusted value of migration of elements from them conform with the maximum limits given in

Table 1 when tested in accordance with Clauses 8, 9 and 10.
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ISO 8124-3:2020(E)
4.2 Interpretation of results
See D.4.

Due to the precision of the methods specified in this document, an adjusted analytical result is required

to take into consideration the results of interlaboratory trials. The analytical results obtained in

accordance with Clauses 8, 9 and 10 shall be adjusted by subtracting the analytical correction in Table 2

to obtain an adjusted analytical result.

Materials are deemed to conform with the requirements of this document if the adjusted analytical

result for the migrated element is less than or equal to the value given in Table 1.

Table 1 — Maximum acceptable element migration from toy materials
Values in milligrams per kilogram of toy material
Element
Toy material
Sb As Ba Cd Cr Pb Hg Se
Any toy material given in Clause 1, except
60 25 1 000 75 60 90 60 500
modelling clay and finger paint
Modelling clay 60 25 250 50 25 90 25 500
Finger paint 10 10 350 15 25 25 10 50
Table 2 — Analytical correction
Element Sb As Ba Cd Cr Pb Hg Se
Analytical correction (%) 60 60 30 30 30 30 50 60

EXAMPLE An analytical result for lead of 120 mg/kg was obtained. The necessary analytical correction

taken from Table 2 is 30 %. Therefore, the adjusted analytical result is as shown in Formula (1).

120×30
120− =−120 36 (1)
100
= 84 mg/kg.

This is deemed to be conforming with the requirements of this document (maximum acceptable

migration of lead as given in Table 1 is 90 mg/kg).
5 Principle

Soluble elements are extracted from toy materials under conditions that simulate the material

remaining in contact with stomach acid for a period of time after swallowing. The concentrations of the

soluble elements are then determined quantitatively by inductively coupled plasma optical emission

spectrometry (ICP-OES) or other specified analytical methods with specified MDL.
6 Reagents

NOTE No recommendation is made for the reagents and materials necessary for carrying out elemental

analyses within the MDL specified in 10.2.
During the analyses, use only reagents of recognized analytical grade.
6.1 Hydrochloric acid solution, c(HCl) = (0,07 ± 0,005) mol/l.
6.2 Hydrochloric acid solution, c(HCl) = (0,14 ± 0,010) mol/l.
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ISO 8124-3:2020(E)
6.3 Hydrochloric acid solution, c(HCl) = approximately 1 mol/l.
6.4 Hydrochloric acid solution, c(HCl) = approximately 2 mol/l.
6.5 Hydrochloric acid solution, c(HCl) = approximately 6 mol/l.
6.6 General purpose reagent n-heptane, (C H ), 99 %.
7 16
6.7 Water of at least grade 3 purity, in accordance with ISO 3696.
7 Apparatus

NOTE No recommendation is made for the apparatus necessary for carrying out elemental analyses within

the MDL specified in 10.2.
See D.5.
Normal laboratory apparatus and the following:

7.1 Plain-weave wire-cloth stainless steel metal sieve, of nominal aperture 0,5 mm and tolerances

as indicated in Annex A, Table A.1.
7.2 Means of measuring pH to proper accuracy without cross-contamination

The accuracy of pH measurement shall be cautiously considered to make sure the pH value of the

mixture is in the range 1,0–1,5 (as specified in Clause 9). For example, when a pH measurement with

an accuracy of ± 0,2 pH units is used, the range shall be changed to 1,2–1,3 after considering the

uncertainty.
See D.5.1.
7.3 Membrane filter, of pore size 0,45 µm.
7.4 Centrifuge, capable of centrifuging at (5 000 ± 500) g .
See D.5.2.
7.5 Means of agitating the mixture, at a temperature of (37 ± 2) °C.

7.6 Series of containers, of gross volume between 1,6 × and 5,0 × that of the volume of hydrochloric

acid extractant.
See D.5.3.
7.7 Soxhlet extractor, according to ISO 8124-6:2018, Figure C.1.
7.8 Solvent extractor, according to ISO 8124-6:2018, Figure C.2.

7.9 High retention filter paper, for example quantitative slow flow rate filter paper.

8 Selection of test portions
See D.6.
1) 1 g = 9,806 65 m/s .
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ISO 8124-3:2020(E)

A laboratory sample for testing shall consist of a toy either in the form in which it is marketed or in

the form in which it is intended to be marketed. Test portions shall be taken from the accessible parts

(see ISO 8124-1) of a single toy sample. Identical materials in the toy may be combined and treated as

a single test portion, but additional toy samples shall not be used. Test portions may be composed of

more than one material or colour only if physical separation, such as dot printing, patterned textiles or

mass limitation reasons, precludes the formation of discrete specimens.

NOTE The requirement does not preclude the taking of test portions from materials used to manufacture

the toy, provided they are representative of the final toy.
Test portions of less than 10 mg of material shall not be tested.
9 Preparation and extraction of test portions

NOTE A guideline for the choice of procedure to be used for the various toy materials is provided in Annex B.

9.1 Coatings of paint, varnish, lacquer, printing ink, polymer and similar coatings

9.1.1 Test portion preparation

Remove the coating from the laboratory sample by scraping (see 3.7) at room temperature and

comminute it at a temperature not exceeding ambient. Collect enough coating to obtain a test portion of

preferably not less than 100 mg which will pass through a metal sieve of aperture 0,5 mm (7.1).

If only between 10 mg and 100 mg of comminuted uniform coating is available, extract this in accordance

with 9.1.2 and calculate the quantity of the appropriate elements as if a test portion of 100 mg had been

used. Report the mass of the test portion in accordance with Clause 11 e).

In the case of coatings that by their nature cannot be comminuted (e.g. elastic/plastic paint), remove a

test portion of coating from the laboratory sample without comminuting.
9.1.2 Extraction procedure

Using a container of appropriate size (7.6), mix the test portion prepared in 9.1.1 with 50 × its mass of

an aqueous HCl solution at (37 ± 2) °C of c(HCl) 0,07 mol/l (6.1). [Where the test portion has only a mass

of between 10 mg and 100 mg, mix the test portion with 5,0 ml of this solution (6.1) at (37 ± 2) °C.]

Shake for 1 min. Check the acidity of the mixture (7.2). If the pH is greater than 1,5, add dropwise,

while shaking the mixture, an aqueous solution of c(HCl) approximately 2 mol/l (6.4) until the pH of the

mixture is between 1,0 and 1,5.

Protect the mixture from light. Agitate the mixture continuously at (37 ± 2) °C (7.5) for 1 h and then

allow to stand for 1 h at (37 ± 2) °C.

Without delay, efficiently separate the solids from the solution, firstly by filtration using

...

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