EN 71-3:2019
(Main)Safety of toys - Part 3: Migration of certain elements
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 dieser Norm wird für folgendes Spielzeug und Teile von Spielzeug die Wahrschein-lichkeit 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, das 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 signifi¬kant 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, des composés organostanniques 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 de la présente norme, 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
Ta evropski standard določa zahteve in preskusne metode za migracijo aluminija, antimona, arzena, barija, bora, kadmija, kroma (III), kroma (VI), kobalta, bakra, svinca, mangana, živega srebra, niklja, selena, stroncija, kositra, organskega kositra in cinka iz materialov igrač in delov igrač.
Materiali, ki se uporabljajo za embalažo, se ne upoštevajo kot del igrače, razen če imajo igralni namen.
OPOMBA 1: Glej dokument z napotki Evropske komisije št. 12 [2] o uporabi direktive o varnosti igrač – embalaže.
Ta standard vsebuje zahteve za migracijo določenih elementov iz naslednjih kategorij materialov igrač:
– Kategorija I: Suhi, lomljivi, prahasti ali prožni materiali;
– Kategorija II: Tekoči ali lepljivi materiali;
– Kategorija III: Materiali, postrgani s površine igrače.
Zahteve za ta standard ne veljajo za igrače ali dele igrač, ki zaradi svoje dostopnosti, funkcije, velikosti ali teže jasno izključujejo nevarnost zaradi sesanja, lizanja ali zaužitja oz. podaljšanega stika s kožo, kadar se igrača ali del igrače uporablja v skladu s predvideno uporabo ali na predvidljiv način, pri čemer je pri tem treba upoštevati vedenje otrok.
OPOMBA 2: Pri naslednjih igračah in delih igrač, omenjenih v tem standardu, je verjetnost sesanja, lizanja ali zaužitja igrače zelo velika (glej točki H.2 in H.3):
– vse igrače, namenjene dajanju v usta ali na usta, igralna kozmetika in pisalne potrebščine je mogoče kategorizirati za sesanje, lizanje ali zaužitje;
– za vse dostopne dele in komponente igrač, namenjene za otroke do 6. leta starosti, je mogoče predvidevati, da lahko pridejo v stik z usti. Verjetnost, da deli igrač, namenjenih za starejše otroke, pridejo v stik z usti, v večini primerov ni bistvena (glej točko H.2).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2019
Nadomešča:
SIST EN 71-3:2013+A3:2018
Varnost igrač - 3. del: Migracija določenih elementov
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
ICS:
97.200.50 Igrače Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 71-3
EUROPEAN STANDARD
NORME EUROPÉENNE
April 2019
EUROPÄISCHE NORM
ICS 97.200.50 Supersedes EN 71-3:2013+A3:2018
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.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 71-3:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 5
Introduction . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Requirements . 9
5 Principle . 11
6 Reagents and apparatus . 12
7 Sampling and sample preparation . 12
8 Migration methodology . 16
9 Stabilization and analysis of migration solutions . 19
10 Calculation of results . 20
11 Method performance . 21
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 . 26
B.1 General . 26
B.2 Samples of interlaboratory comparison . 26
B.3 Selection of material category/element combinations . 27
Annex C (informative) Estimation of reproducibility . 28
Annex D (informative) Toy material visual particle size comparison materials . 30
Annex E (normative) Method of analysis for general elements . 32
E.1 Principle . 32
E.2 Working solutions . 32
E.2.1 Stock solution (M ) . 32
E.2.2 Diluted stock solution (M ) . 33
E.2.3 Working solutions . 33
E.2.4 Internal standard stock solution . 33
E.3 Procedure. 33
E.4 Analysis . 33
E.5 Calculation . 34
E.5.1 Calibration curve . 34
E.5.2 Calculation of migration . 34
Annex F (normative) Method of analysis for Chromium (VI) . 35
F.1 Principle . 35
F.2 Reagents . 35
F.3 Apparatus . 36
F.4 Procedure . 37
F.5 Analysis . 37
F.5.1 General . 37
F.5.2 Chromatographic conditions . 37
F.5.3 Limit of detection and quantification . 38
F.5.3.1 General . 38
F.5.3.2 Example of chromatogram . 38
F.6 Calculation. 38
F.6.1 Calibration curve . 38
F.6.2 Calculation of migration . 39
Annex G (normative) Method of analysis for organic tin (see H.9) . 40
G.1 Principle . 40
G.2 Reagents . 41
G.3 Apparatus . 44
G.4 Procedure . 44
G.4.1 Sample derivatisation . 44
G.4.1.1 Derivatisation . 44
G.4.1.2 Category I and III materials . 45
G.4.1.3 Category II materials . 45
G.4.1.4 Standard addition method . 45
G.4.2 Calibration standards . 46
G.5 Analysis . 46
G.5.1 General . 46
G.5.2 Example of GC conditions . 48
G.5.3 Example of MS conditions . 48
G.5.4 Limit of detection and quantification . 48
G.5.5 Example of a GC-MS chromatogram . 49
G.6 Calculation. 50
G.6.1 Calibration curve . 50
G.6.2 Standard addition . 50
G.6.3 Calculation of migration of organic tin . 50
Annex H (informative) Rationale . 52
H.1 General . 52
H.2 Mouthing behaviour of children (see Clause 1) . 52
H.3 Skin contact (see Clause 1) . 53
H.4 Toy categories (see 4.1) . 53
H.5 Test portions (see Clause 7) . 53
H.6 Size of test pieces (see 7.2) . 53
H.7 Stability of Chromium (VI) in the migration solution (see 9.3) . 54
H.8 Filtration of migration solutions (see 8.3.2) . 54
H.9 Organic tin (see Annex G) . 54
H.10 pH value (see 8.2 and 8.3.1.2) . 56
H.11 De-waxing (see 7.2.3) . 56
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of EU Directive 2009/48/EC aimed to be covered . 57
Bibliography . 58
European foreword
This document (EN 71-3:2019) 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 2019, and conflicting national standards shall
be withdrawn at the latest by October 2019.
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 supersedes EN 71-3:2013+A3:2018.
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.
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;
— Part 14: Trampolines for domestic use.
NOTE 1 In addition to the above parts of EN 71, the following guidance documents have been published:
CEN/TR 15071, Safety of toys — National translations of warnings and instructions for use in EN 71, and
CEN/TR 15371 (all parts), Safety of toys — Interpretations.
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, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
the United Kingdom.
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.
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
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.
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
X
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 procedure) and Clause 9 (stabilization and analysis of migration
solutions).
Table 2 — Migration limits from toy materials
Migration limit
Element
Category I Category II Category III
mg/kg mg/kg mg/kg
Aluminium 5 625 1 406 70 000
Antimony 45 11,3 560
Arsenic 3,8 0,9 47
Barium 1 500 375 18 750
Boron 1 200 300 15 000
Cadmium 1,3 0,3 17
Chromium (III) 37,5 9,4 460
a
Chromium (VI) 0,02 0,005
0,2 / 0,053
Cobalt 10,5 2,6 130
Copper 622,5 156 7 700
Lead 2,0 0,5 23
Manganese 1 200 300 15 000
Mercury 7,5 1,9 94
Nickel 75 18,8 930
Selenium 37,5 9,4 460
Strontium 4 500 1 125 56 000
Tin 15 000 3 750 180 000
Organic tin 0,9 0,2 12
Zinc 3 750 938 46 000
a
The migration limit for Chromium (VI) for Category III toy material (scraped-off toy material) has been
amended by Commission Directive (EU) 2018/725 [7]. The new limit value (0,053 mg/kg) applies from 2019-
11-18. Before this date the limit value 0,2 mg/kg applies.
5 Principle
Soluble elements are extracted from toy materials using conditions which simulate the material
remaining in contact with gastric juices for a period of time after swallowing. The concentrations of the
soluble elements are determined quantitatively by three different methods:
— method for determining general elements: Aluminium, Antimony, Arsenic, Barium, Boron, Cadmium,
Chromium, Cobalt, Copper, Lead, Manganese, Mercury, Nickel, Selenium, Strontium, Tin and Zinc;
— method for determining Chromium (VI);
— method for determining organic tin.
6 Reagents and apparatus
6.1 Reagents
All reagents, including water, used for analysis shall be of analytical grade or, if unavailable, technical
grade reagents which have been determined to have acceptably low levels of impurity to allow the
analysis to be performed.
6.1.1 Hydrochloric acid solution, c(HCl) = (0,07 ± 0,005) mol/l.
6.1.2 Hydrochloric acid solution, c(HCl) = (0,14 ± 0,010) mol/l.
6.1.3 Hydrochloric acid solution, c(HCl) = approximately 1 mol/l.
6.1.4 Hydrochloric acid solution, c(HCl) = approximately 2 mol/l.
6.1.5 Hydrochloric acid solution, c(HCl) = approximately 6 mol/l.
6.1.6 Isooctane, (C H ), 99 %.
8 18
6.2 Apparatus
Standard laboratory equipment and the following shall be used.
6.2.1 Equipment for measuring pH, calibrated and sufficiently accurate for the purposes of this
European Standard.
NOTE H.10 contains additional information on equipment for measuring pH.
6.2.2 Centrifuge, capable of centrifuging at high speed to separate the solids (see H.8).
6.2.3 A means to agitate the mixture, at a temperature of (37 ± 2) °C.
An orbital or linear shaker or shaking water bath capable of maintaining the migration solution in
constant motion relative to the sample.
6.2.4 Plastic containers of gross volume, between 1,6 times and 5,0 times the volume of hydrochloric
acid extract.
6.2.5 High retention filter-paper, ashless filter paper, particle retention in liquids 2,5 µm.
6.2.6 Membrane filters with pore sizes of 0,45 µm and 0,02 µm.
Syringe filters made with a cellulose acetate membrane are recommended for the 0,45 µm filter.
7 Sampling and sample preparation
7.1 Selection of test portions
A sample for testing shall consist of one toy in the form in which it will be marketed. Test portions shall
be taken from toy materials of the 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 to prepare larger test portions.
Test portions are taken from each colour of each toy material. Test portions may be composed of more
than one toy material or colour only when discrete specimens cannot be separated physically, e.g. dot
printing, patterned textiles, multi-coloured printed surfaces etc. Such test portions shall be
representative of the whole material.
NOTE This requirement does not preclude the preparation of test portions which represent the material and
any base material upon which it is deposited.
Analysis of toy materials present in amounts less than 0,010 g is not required (see H.5).
The above does not preclude the testing of toy materials before they are used to manufacture a toy (raw
materials). In these cases, the manufacturing process shall be assessed in order to ensure that it does not
influence the migration of elements from the toy materials.
7.2 Sample preparation
7.2.1 General
Appropriate blank solutions shall be analysed so that appropriate corrections can be made when
necessary (e.g. contamination of reagents and materials). If the blank result exceeds half of the lowest
value the laboratory intends to report (laboratory’s reporting limit) at least two blank solutions shall be
analysed and the analytical result shall be corrected by the average value of the blank solutions.
7.2.2 Sampling
Whenever possible obtain a test portion of not less than 0,100 g of each toy material of the laboratory
sample using the appropriate sampling method specified in Table 3.
Table 3 — Sampling methods
Toy material Category Sampling method
(Table 1)
Liquid paints, including finger paints, II Mix the laboratory sample. Ink in pens should
varnishes, lacquers, liquid ink in pens be removed from the pen’s refill before
and similar materials in liquid form mixing.
appearing as such in the toy (e.g. slimes,
bubble solutions)
NOTE 1 Paper or paper board samples with
Coatings of paints, varnishes, lacquers, III
paint, varnish, lacquer, printing ink, adhesive or
printing ink, polymers, foams and similar
similar material applied to their surfaces are not
coatings
subjected to this sampling method but are treated
according to the sampling method for paper or
paper board.
Remove the coating from the laboratory
sample by scraping at room temperature,
taking care to avoid the inclusion of the base
material. Obtain particles of approximately
0,5 mm. The use of pre-prepared materials for
visual size comparison is recommended (see
Annex D).
In case of a thick layer or one which is difficult
to remove (e.g. pliable or plasticised layers),
the coating can be cut off and tested as
polymeric material.
For coatings deposited on a non-polymeric
base material, it is permissible to add a few
drops of solvent, such as acetone/ethanol
(1:1) mixture, methylene chloride or
tetrahydrofuran to soften the coating and
assist in its removal from the base material. If
Toy material Category Sampling method
(Table 1)
a solvent is used, remove the traces of solvent
only by evaporation prior to migration. This
procedure shall not be used if there are
indications that the use of solvents can affect
the migration of an element from the coating.
NOTE 2 The use of scraping tools made of plastic
materials helps to prevent the removal of base
material after applying the solvent.
This solvent assisted procedure may be used
for verifying previous high results which
might have been caused by the release of
elements from scraped off base materials
underlying the coating, e.g. high release of zinc
from a coating scraped off from a base
material containing zinc.
Paper and paper board III Prepare a test portion by cutting the
laboratory sample using suitable tools. Take
care to produce clean cut edges. Each
dimension of the test pieces shall be as near to
6 mm as possible (see H.6). The use of pre-
prepared materials for visual size comparison
is recommended (see Annex D).
If a paper or paper board sample has paint,
varnish, lacquer, printing ink, adhesive or
similar material applied to its surface, test
portions of the coating shall not be taken
separately. In such cases test portions shall be
taken from the toy material so that they also
include representative parts of the coated
area.
Toys and removable components which III Apply the migration procedure to the whole
fit entirely within the small parts cylinder component including any coatings.
(see EN 71-1:2014+A1:2018, 8.2) Components, the coatings of which have been
containing accessible glass, ceramic, removed for analysis, shall not be used. A
metallic materials separate unchanged component shall be used.
Compressed paint tablets, materials I
intended to leave a trace or similar
materials in solid form appearing as such
in the toy (e.g. the cores of colouring
Prepare a test portion by cutting the
pencils, chalk, crayons)
laboratory sample using suitable tools. Take
care to produce clean cut edges. Each
Pliable modelling materials, including I
dimension of the test pieces shall be as near to
modelling clays and plaster
6 mm as possible (see H.6). The use of pre-
Glue sticks II
prepared materials for visual size comparison
is recommended (see Annex D).
Polymeric and similar materials,
including laminates, whether textile
III
reinforced or not, but excluding other
textiles
Toy material Category Sampling method
(Table 1)
Textiles, whether natural or synthetic,
III
including textile threads
Wood, fibre board, hard board, bone,
III
leather and other solid materials
NOTE No sampling procedure for inaccessible toy materials or glass, ceramic and metallic toy components
which do not fit within the small parts cylinder is specified as they are not within the scope of this European
Standard. The exposure to certain elements from inaccessible materials and larger hard components, which cannot
be swallowed, is not considered significant.
If a test portion of 0,1 g or more cannot be obtained, a test portion shall be obtained from each toy material
present in the sample in a mass greater than 0,010 g. If the weight of the test portion obtained is between
0,010 g and 0,100 g, this shall be indicated in the report (see Clause 12 h)). In this case the analytical
results shall be calculated as though 0,100 g of the test portion had been used (Wtp = 0,100 g, see H.5).
7.2.3 Dewaxing (see H.11)
7.2.3.1 General
If there are indications that the test portion contains grease, oil, wax or similar material dewax the test
portion according to 7.2.3.2.
Category II test portions which can be dispersed in 0,07 mol/l HCL shall not be dewaxed.
De-waxing shall not be carried out on test portions prepared for organic tin analysis.
NOTE There are certain sample types known to contain grease, oil, wax or similar material. See H.11 for more
information on which samples contain wax and, consequently, would need to be dewaxed.
7.2.3.2 Dewaxing procedure
Use a high-retention filter paper (see 6.2.5) which should be as small as possible without risking loss of
the test portion during the de-waxing procedure. Weigh the test portion, to the nearest 0,001 g, onto the
filter paper (Wtp). Use this mass of the test portion for the calculation of the results of the test. For
category II samples containing grease, oil, wax or similar material, dry the test portion at (37 ± 2) °C for
approximately 4 h. Fold the filter paper carefully to enclose the test portion without loss. Put the filter
paper into the thimble of a Soxhlet extractor. Add an amount of isooctane appropriate for the equipment
into the boiling flask of the extractor and extract for at least 60 min with no less than 10 reflux cycles per
hour. If after 60 min there are indications of residual grease, oil, wax or similar material continue the
extraction as necessary.
After extraction, dry the folded filter paper containing the dewaxed test portion at (80 ± 2) °C for
approximately 1 h to remove the residual solvent. Weigh the dried filter paper parcel, to the nearest
0,001 g (Wfp). Use Wfp to calculate the volume of water and 0,14 mol/l HCl used in the migration
procedure (see 8.1.2.1, samples containing grease, oil, wax or similar material).
The use of a dewaxing step shall be reported (see Clause 12 h)).
8 Migration methodology
8.1 Preparation of test portions before migration testing
8.1.1 General
For the purposes of the following subclauses the density of the water and hydrochloric acid solution can
be assumed to be 1,0 g/ml and the solutions can be added volumetrically using suitable dispensers
accurate to the nearest 0,05 ml.
The volume of simulant (V) added shall be recorded for the purpose of calculation of results.
8.1.2 Category I: Dry, brittle, powder like or pliable materials and Category II: Liquid or sticky
materials
8.1.2.1 Samples containing grease, oil, wax or similar material
After dewaxing (see 7.2.3), weigh to the nearest 0,05 g Wfp × 25 of water at (22 ± 3) °C into the
appropriate sized container (see 6.2.4) containing the filter paper parcel.
Using a suitable mechanical means (e.g. a glass rod, a pestle or similar implement) homogenize the filter
paper containing the dewaxed test portion in the water.
Add to the nearest 0,05 g Wfp x 25 of 0,14 mol/l hydrochloric acid solution (see 6.1.2) at (22 ± 3) °C and
mix.
Proceed without any delay with the appropriate pH adjustment procedure specified in 8.2 (pH
adjustment).
8.1.2.2 Samples not containing grease, oil, wax or similar material
Weigh the test portion to the nearest 0,001 g (Wtp) into the appropriate sized container (see 6.2.4). Add
to the nearest 0,05 g Wtp x 50 of an aqueous solution of 0,07 mol/l HCl (see 6.1.1) at (22 ± 3) °C.
For test portions of mass between 0,010 g and 0,100 g, add 5,0 ml of 0,07 mol/l HCl (see 6.1.1) at
(22 ± 3) °C.
Proceed without any delay with the appropriate pH adjustment procedure specified in 8.2 (pH
adjustment).
8.1.3 Category III: Scraped-off materials
8.1.3.1 Glass, ceramic and metallic materials
Weigh the toy or component to the nearest 0,001 g (Wtp) into a 50 ml container with nominal height
60 mm and nominal diameter 40 mm.
Add sufficient amount of an aqueous solution of 0,07 mol/l HCl (see 6.1.1) at (22 ± 3) °C to just cover the
toy or component.
NOTE This size of container can contain components/toys that fit inside the small parts cylinder.
Proceed without any delay with the appropriate pH adjustment procedure specified in 8.2 (pH
adjustment).
8.1.3.2 Paper and paper board
Weigh the test portion to the nearest 0,001 g (Wtp) into the appropriate sized container (see 6.2.4).
Add to the nearest 0,05 g Wtp × 25 g of water at (22 ± 3) °C.
Using a suitable mechanical means (e.g. a glass rod, a pestle or similar implement) homogenize the test
portion in the water.
Add to the nearest 0,05 g Wtp × 25 g of 0,14 mol/l hydrochloric acid solution (see 6.1.2) at (22 ± 3) °C
and mix.
Proceed without any delay with the appropriate pH adjustment procedure specified in 8.2 (pH
adjustment).
8.1.3.3 Other materials
Weigh the test portion to the nearest 0,001 g (Wtp) into the appropriate sized container (see 6.2.4).
Add to the nearest 0,05 g Wtp x 50 g of an aqueous solution of 0,07 mol/l HCl (see 6.1.1) at (22 ± 3) °C.
For test portions of mass between 0,010 g and 0,100 g, add 5,0 ml of 0,07 mol/l HCl (see 6.1.1) at
(22 ± 3) °C.
Proceed without any delay with the appropriate pH adjustment procedure specified in 8.2 (pH
adjustment).
8.2 pH adjustment (see H.10)
8.2.1 General
Before starting the migration procedure adjust pH as specified in:
— 8.2.2 (pH adjustment – no buffering effect by toy material) if the test portion is not expected to
contain a significant quantity of alkaline/buffering materials; or
— 8.2.3 (pH adjustment – buffering effect by toy material) if the test portion is expected to contain a
significant quantity of alkaline/buffering materials.
Sample types for which close pH control is most important include chalk, finger paints, crayons, pigments,
paints, solid paint tablets and, in particular, paper and paper board.
For each batch of test portions (i.e. test portions taken through the migration procedure at the same time),
the pH control check measurement shall be performed on at least one solution from each material type
within the batch. If the pH measured is less than 1,10 or more than 1,30 the remaining solutions in the
batch for test portions of that type shall also be checked.
8.2.2 pH adjustment – no buffering effect by toy material
8.2.2.1 Following the addition of diluted of hydrochloric acid as specified in the relevant subclause
of 8.1 (preparation of test portions before migration testing), shake the mixture gently for approximately
1 min to mix the contents.
8.2.2.2 Measure the pH of the mixture at (22 ± 3) °C.
8.2.2.3 If the pH is greater than 1,30 add 2 mol/l HCl (see 6.1.4) dropwise whilst mixing until the pH
is within the range 1,10 to 1,30. Proceed to the migration steps (see 8.3, migration procedure).
8.2.3 pH adjustment – buffering effect by toy material
8.2.3.1 Shake the mixture gently to mix the contents.
+2
8.2.3.2 Allow the mixture to stand at (22 ± 3) °C for 5 min.
8.2.3.3 Measure the pH of the mixture at (22 ± 3) °C (pH ).
a
If pH is within the range 1,10 – 1,20 proceed with the migration procedure (8.3, migration procedure).
a
If pH is greater than 1,20, add 6 mol/l HCl (see 6.1.5) dropwise whilst mixing until the pH is within the
a
range 1,10 – 1,20.
+2
8.2.3.4 Allow the mixture to stand at (22 ± 3) °C for min.
8.2.3.5 Measure the pH of the mixture at (22 ± 3) °C (pH ).
b
If pH is within the range 1,10 – 1,20 proceed with the migration procedure (8.3, migration procedure).
b
If pH is greater than 1,20, add 6 mol/l HCl (see 6.1.5) dropwise whilst mixing until the pH is within the
b
range 1,10 – 1,20.
+2
8.2.3.6 Allow the mixture to stand at (22 ± 3) °C for min.
8.2.3.7 Measure the pH of the mixture at (22 ± 3) °C (pH ).
c
If pH is within the range of 1,10 – 1,20 proceed with the migration procedure (8.3, migration procedure).
c
If pHc is greater than 1,20, add 6 mol/l HCl (see 6.1.5) dropwise whilst mixing until the pH is within the
range 1,10 – 1,20.
+2
8.2.3.8 Allow the mixture to stand at (22 ± 3) °C for 10 min.
8.2.3.9 Measure the pH of the mixture at (22 ± 3) °C (pH ).
d
If pH is within the range of 1,10 – 1,20 proceed with the migration procedure (8.3, migration procedure).
d
If pH is greater than 1,20, add 6 mol/l HCl (see 6.1.5) dropwise whilst mixing until the pH is within the
d
range 1,10 – 1,20. Then proceed with the migration procedure (8.3, migration procedure).
8.3 Migration procedure
8.3.1 Migration
8.3.1.1 Migration conditions
For glass, ceramic and metallic materials, cover the container and allow the contents to stand for
+10
min at (37 ± 2) °C.
+5
For all other materials, close the container (see 6.2.4) and agitate the mixture at (37 ± 2) °C for 60 min
-1
with a speed of (150 ± 10) min . Stop the agitation and leave the containers to stand for a further
+5
min at (37 ± 2) °C.
8.3.1.2 pH control after migration (see H.10)
After completing migration the pH shall be checked in order to ensure that the correct pH has been
maintained throughout the migration procedure. If it is possible to demonstrate that there is no variation
of the pH for certain materials (e.g. plastic) it is not necessary to control the pH for that material after
migration.
Migration solutions with a pH less than 1,10 or greater than 1,30 which have been adjusted according to
8.2.2 (pH adjustment – no buffering effect by toy material) shall be discarded and a new test por
...
Frequently Asked Questions
EN 71-3:2019 is a standard published by the European Committee for Standardization (CEN). Its full title is "Safety of toys - Part 3: Migration of certain elements". This standard covers: 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).
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).
EN 71-3:2019 is classified under the following ICS (International Classification for Standards) categories: 97.200.50 - Toys. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 71-3:2019 has the following relationships with other standards: It is inter standard links to EN 71-3:2013+A3:2018, EN 71-3:2013+A3:2018, EN 71-3:2019+A1:2021, EN 71-3:2019+A1:2021/prA2, EN 71-3:2019/prA1, EN 71-3:2013+A2:2017, EN 71-3:2013+A1:2014. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 71-3:2019 is associated with the following European legislation: EU Directives/Regulations: 2009/48/EC; Standardization Mandates: M/445. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN 71-3:2019 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
기사 제목: EN 71-3:2019 - 장난감의 안전성 - 제 3부: 일부 원소의 이동 기사 내용: 이 문서는 장난감 재료와 장난감 부품으로부터 알루미늄, 안티모니, 비소, 바륨, 붕소, 카드뮴, 색(III), 크롬(IV), 코발트, 구리, 납, 망간, 수은, 니켈, 셀렌, 스트론튬, 주석, 유기주석, 아연의 이동에 대한 요구 사항과 시험 방법을 규정합니다. 포장재는 의도된 놀이 가치가 없는 한 장난감의 일부로 간주되지 않습니다. 참고 1 - 장난감 안전 지침서인 유럽 위원회 지침서 번호 12에 대하여 참조해주세요. 이 표준은 다음 범주의 장난감 재료로부터 일부 원소의 이동에 대한 요구 사항을 포함하고 있습니다: - 1 범주: 건조, 깨지기 쉬운, 가루 같은 또는 유연한 재료 - 2 범주: 액체 또는 끈적거리는 재료 - 3 범주: 벗겨지는 재료 이 문서의 요구 사항은 접근성, 기능, 크기 또는 질량 등으로 인해 장난감 또는 장난감의 일부가 의도된대로 사용되거나 예측 가능한 방식으로 사용될 때, 아이들의 행동을 고려하면 빨아들이거나 핥거나 삼키거나 피부와의 장기간 접촉으로 인한 어떠한 위험도 제외합니다. 참고 2- 이 문서의 목적을 위해, 다음 장난감과 장난감의 일부에 대해 빨아들이거나 핥거나 삼키는 확률이 상당히 높다고 간주됩니다 (H.2 및 H.3 참조). - 입에 넣거나 입에 대려고 하는 모든 장난감, 화장 장난감 및 장난감으로 분류되는 필기 도구는 빨아들이거나 핥거나 삼켜진다고 간주될 수 있습니다 - 6세 이하의 어린이를 위해 제작된 장난감의 모든 접근 가능한 부분과 부품은 입과 접촉한다고 간주됩니다. 어린이의 입이 접촉할 가능성이 있는 장난감 부분은 대부분의 경우 중요하지 않습니다 (H.2 참조).
The article discusses the EN 71-3:2019 standard, which focuses on the safety of toys in relation to the migration of certain elements. It specifies requirements and test methods for the migration of various elements, such as aluminium, antimony, arsenic, and lead, from toy materials and parts. Packaging materials are not considered part of the toy unless they have intended play value. The standard categorizes toy materials into dry, brittle, powder-like or pliable materials, liquid or sticky materials, and scraped-off materials. The requirements of the standard do not apply to toys or parts of toys that are not accessible or pose no hazard when sucked, licked, swallowed, or in prolonged skin contact when used as intended. The article also provides examples of toys and parts that are likely to be sucked, licked, or swallowed, such as toys intended for the mouth, cosmetics toys, and certain writing instruments. Contact with the mouth is considered significant for toys intended for young children, but not necessarily for older children.
記事タイトル：EN 71-3:2019 - おもちゃの安全性 - 第3部：特定の元素の移行 記事内容：この文書では、おもちゃの材料およびおもちゃの部品からアルミニウム、アンチモン、ヒ素、バリウム、ホウ素、カドミウム、クロム(III)、クロム(VI)、コバルト、銅、鉛、マンガン、水銀、ニッケル、セレン、ストロンチウム、スズ、有機スズ、亜鉛の移行に関する要件と試験方法を規定しています。 パッケージ材料は、意図された遊びの価値がない限り、おもちゃの一部とは見なされません。 注記1：おもちゃの安全性に関する指令の適用に関する欧州委員会のガイダンス文書12を参照してください。 この基準には、おもちゃ材料の以下のカテゴリからの特定の元素の移行に対する要件が含まれています： - カテゴリI：乾燥、もろい、粉状または柔軟な材料 - カテゴリII：液体または粘着性のある材料 - カテゴリIII：削り取られる材料 この文書の要件は、おもちゃまたはおもちゃの部品が、吸ったり舐めたり飲み込んだり、または予測可能な方法で使用される場合に、吸ったり舐めたり飲み込んだり、または長時間の皮膚接触による危険が明らかに除外される場合には適用されません。なお、この場合は児童の行動を考慮します。 注記2：この文書の目的のため、次のおもちゃやおもちゃの一部の場合、吸ったり舐めたり飲み込む可能性が高いと見なされます（H.2およびH.3を参照）： - 口に入れるか、口にすることを意図したすべてのおもちゃ、化粧品のおもちゃ、おもちゃとして分類される筆記具は吸ったり舐めたり飲み込んだりされるものと見なされます。 - 6歳以下の子供向けに作られたおもちゃのすべてのアクセス可能な部分と部品は、口と接触するものと見なされます。年長の子供向けのおもちゃの部分は、口との接触がほとんど重要ではないとされています（H.2を参照）。
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