EN 71-18:2024

SLOVENSKI STANDARD
01-julij-2025
Varnost igrač - 18. del: Fenol v igračah iz materialov na vodni osnovi (vsebnost) in
igračah iz polimerov (migracija)
Safety of toys - Part 18: Phenol in aqueous (content) and polymeric (migration) toy
materials
Sicherheit von Spielzeug - Teil 18: Phenol in wässrigem (Gehalt) und polymerem
(Migration) Spielzeugmaterial
Sécurité des jouets - Partie 18 : Phénol dans les matériaux-jouets aqueux (teneur) et
polymères (migration)
Ta slovenski standard je istoveten z: EN 71-18:2024
ICS:
97.200.50 Igrače Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN 71-18
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2024
EUROPÄISCHE NORM
ICS 97.190
English Version
Safety of toys - Part 18: Phenol in aqueous (content) and
polymeric (migration) toy materials
Sécurité des jouets - Partie 18 : Phénol dans les Sicherheit von Spielzeug - Teil 18: Phenol in wässrigem
matériaux-jouets aqueux (teneur) et polymères (Gehalt) und polymerem (Migration) Spielzeugmaterial
(migration)
This European Standard was approved by CEN on 1 December 2024.

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, Türkiye 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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 71-18:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 6
5 Principle . 7
5.1 Migration method . 7
5.2 Extraction method . 7
6 Reagents, standards and apparatus . 7
6.1 Reagents . 7
6.2 Standards . 7
6.3 Apparatus . 9
7 Sample preparation . 10
7.1 Migration method . 10
7.1.1 Sample preparation . 10
7.1.2 Sample surface area calculation . 10
7.1.3 Migration . 10
7.2 Extraction method . 11
8 Method of analysis . 11
8.1 General. 11
8.2 Chromatographic conditions . 12
8.3 Mass spectrometer settings . 12
8.4 DAD and FLD detection . 13
9 Method performance . 13
9.1 Limit of quantification . 13
9.2 Precision . 13
10 Calculation of the result. 14
10.1 Evaluating the concentration of phenol using LC-MS/MS . 14
10.2 Evaluating the concentration of phenol using HPLC-DAD, HPLC-DAD/FLD and HPLC-
FLD . 14
10.3 Migration method . 14
10.4 Extraction method . 15
11 Test report . 15
Annex A (informative) Background and rationale . 16
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2009/48/EC aimed to be covered . 18
Bibliography . 19
European foreword
This document (EN 71-18:2024) 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 June 2025, and conflicting national standards shall be
withdrawn at the latest by June 2025.
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 has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
Additional information on the background and rationale for various requirements are given in Annex A.
th
This document constitutes the 18 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;
— 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 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;
— Part 15: Formamide in foam toy materials (content) (under development);
— Part 16: Certain chlorinated phosphorus flame retardants (TCEP, TCPP, TDCP) in toy materials (under
development);
— Part 17: Certain isothiazolinones (MIT, CIT, BIT) in aqueous toy materials (under development);
— Part 18: Phenol in aqueous (content) and polymeric (migration) toy materials (this document);
— Part 19: Migration of bisphenol A from toy materials;
— Part 20: Microbiological safety of toys containing accessible aqueous media (under development).
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 deliverables have been published:
— CEN/TR 15071, Safety of toys — National translations of warnings and instructions for use in the EN 71
series;
— the CEN/TR 15371 series, Safety of toys — Interpretations;
— CEN/TR 16918, Safety of toys — Children's mouthing behaviour in contact with toys;
— CEN/TR 17695, Safety of toys — Mechanical and physical properties — Guidance on categorisation of
projectile toys within EN 71-1;
— CEN/TS 17973, Safety of toys — Categorization of slime type materials; and
— CEN ISO/TR 8124-8, Safety of toys — Part 8: Age determination — First age grade for the appropriate
play of toys (ISO/TR 8124-8).
NOTE 2 Words in italics (apart from document titles) are defined in Clause 3 (Terms and definitions).
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the United
Kingdom.
Introduction
According to article 46 of Directive 2009/48/EC on the safety of toys [1] the “Commission may adopt
specific limit values for chemicals used in toys intended for use by children under 36 months or in other
toys intended to be placed in the mouth”.
In May 2017, the European Commission amended Appendix C to Annex II to this Directive accordingly
and adopted specific limit values for phenol in toys (see Commission Directive (EU) 2017/774 [2]). The
limit values take into account the SCHER Opinion on “CEN's response to the opinion of the CSTEE on the
assessment of CEN report on the risk assessment of organic chemicals in toys” [3].
This document provides test methods to check compliance with these limit values.
WARNING — The application of the test method specified in this document can involve hazardous
materials, operations and equipment. The document does not purport to address all of the safety or
environmental problems associated with its use.
1 Scope
This document specifies requirements and test methods for determining the concentration of phenol in
aqueous toy materials and for migration of phenol from polymeric toy materials. This document is
applicable to toys intended for use by children under 36 months or other toys intended to be placed in
the mouth.
NOTE The European Commission Guidance Document No 11 on the Application of Directive 2009/48/EC on
the Safety of Toys [4] provides guidelines to help on the classification of toys intended for children under 36 months
of age or of 36 months and over.
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 ISO 3696:1995, Water for analytical laboratory use — Specification and test methods (ISO 3696:1987)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1
aqueous toy material
toy material formulated with water
Note 1 to entry: Formulated with water means the material has added water or water containing ingredients
during the manufacturing process and excludes materials that have absorbed water, unintentionally.
3.2
sample
part of the toy material subject to testing
Note 1 to entry: In the context of the extraction method (which is applied to aqueous toy material), sample is
understood as aliquot from an aqueous toy material subject to testing.
Note 2 to entry: A sample can consist of more than one material if the materials cannot be separated (e.g. coatings
on a base material).
4 Requirements
The migration of phenol from toy materials shall not exceed 5 mg/l when tested according to the method
specified in 7.1 and Clause 8.
The content of phenol in aqueous toy materials shall not exceed 10 mg/kg when tested according to the
method specified in 7.2 and Clause 8.
NOTE The limit values correspond to the limit values specified in Directive 2009/48/EC [1], which were
introduced by Commission Directive (EU) 2017/774 [2].
5 Principle
5.1 Migration method
The migration of phenol from toy material is tested by using water as simulant. Migration conditions are
shaking the sample at 37 °C for 3 h. The migration solution is analysed using a liquid chromatography
system coupled with a tandem mass spectrometer (LC-MS/MS) in multiple reaction monitoring (MRM)
mode or a high performance liquid chromatography system with a Diode Array Detector (DAD) and/or a
Fluorescence Detector (FLD) (HPLC-DAD, HPLC-DAD/FLD, HPLC-FLD).
NOTE More information on migration conditions can be found in Clause A.1.
5.2 Extraction method
The sample of an aqueous toy material is mixed with methanol by shaking at room temperature for a
specified time. The solution is filtered, and the extract analysed using LC-MS/MS in multiple reaction
monitoring (MRM) mode, HPLC-DAD/FLD or HPLC-FLD.
NOTE More information on extraction conditions can be found in Clause A.1.
6 Reagents, standards and apparatus
6.1 Reagents
Unless otherwise specified, all reagents shall be at least analytical grade. Reagents shall be stored as
specified by the supplier.
6.1.1 Methanol (CAS No. 67-56-1)
6.1.2 Purified water, conforming to at least grade 3 of EN ISO 3696:1995.
6.2 Standards
The following calibration standard and internal standard can either be neat substances or solutions of
known purity. Standards shall be stored as specified by the supplier.
The scheme for preparing the calibration solutions may be modified as long as the calibration solutions
correspond to those specified in 6.2.4.4.
6.2.1 Calibration standard
Phenol (CAS No. 108-95-2)
6.2.2 Internal standard for LC-MS/MS detection
d5-phenol (CAS No. 4165-62-2)
6.2.3 Internal standard solutions for LC-MS/MS detection
6.2.3.1 Internal standard stock solution
Prepare a stock solution containing d5-phenol (6.2.2) in methanol (6.1.1) at a concentration of
1 000 mg/l.
6.2.3.2 Internal standard intermediate solution
Prepare the internal standard intermediate solution by diluting the internal standard stock solution
(6.2.3.1) with methanol (6.1.1) to a concentration of 20 mg/l d5-phenol.
6.2.3.3 Extraction solution for LC-MS/MS detection
Prepare the extraction solution by diluting the internal standard stock solution (6.2.3.1) with methanol
(6.1.1) to a concentration of 0,5 mg/l d5-phenol.
6.2.4 Calibration standard solutions
6.2.4.1 Calibration standard stock solution
Prepare a stock solution containing phenol (6.2.1) in methanol (6.1.1) at a concentration of 1 000 mg/l.
6.2.4.2 Calibration standard intermediate solution for extraction method
Prepare the calibration standard intermediate solution for the extraction method by diluting the
calibration standard stock solution (6.2.4.1) with methanol (6.1.1) to a concentration of 10 mg/l phenol.
6.2.4.3 Calibration standard intermediate solution for migration method
Prepare the calibration standard intermediate solution for the migration method by diluting the
calibration standard stock solution (6.2.4.1) with water (6.1.2) to a concentration of 10 mg/l phenol.
6.2.4.4 Calibration solutions
6.2.4.4.1 HPLC-DAD/FLD and HPLC-FLD detection, extraction method
Prepare a minimum of five calibration solutions by diluting the calibration standard
intermediate solution for extraction method (6.2.4.2) with methanol (6.1.1). The phenol concentrations
of the calibration solutions shall range from 0,05 mg/l to 2,0 mg/l.
NOTE The calibration range can be extended by using additional calibration solutions.
6.2.4.4.2 HPLC-DAD, HPLC-DAD/FLD and HPLC-FLD detection, migration method
Prepare a minimum of five calibration solutions by diluting the calibration standard intermediate
solution for migration method (6.2.4.3) with water (6.1.2). The phenol concentrations of the calibration
solutions shall range from 0,05 mg/l to 2,0 mg/l.
NOTE The calibration range can be extended by using additional calibration solutions.
6.2.4.4.3 LC-MS/MS detection, extraction method
Prepare at least five calibration solutions by diluting the calibration standard intermediate solution for
extraction method (6.2.4.2) and the internal standard intermediate solution (6.2.3.2) with methanol
(6.1.1). The phenol concentrations of the calibration solutions shall range from 0,05 mg/l to 2,0 mg/l.
Each solution shall contain 0,5 mg/l d5-phenol (6.2.2).
NOTE The calibration range can be extended by using additional calibration solutions.
6.2.4.4.4 LC-MS/MS detection, migration method
Prepare at least five calibration solutions by diluting the calibration standard intermediate solution for
migration method (6.2.4.3) with water (6.1.2). The concentrations of the calibration solutions shall range
from 0,05 mg/l to 2,0 mg/l. Transfer 1 ml of each calibration solution in a LC vial and add 25 µl of the
internal standard intermediate solution (6.2.3.2) to each calibration solution. Close the vials and shake to
homogenize the solutions.
NOTE The calibration range can be extended by using additional calibration solutions.
6.3 Apparatus
Standard laboratory equipment and the following shall be used.
6.3.1 Horizontal shaker, capable of maintaining a temperature of (37 ± 2) °C and 150 ( ± 10) strokes
per minute.
EXAMPLE This can be a horizontal shaker placed in an oven, an incubator with a permanently installed shaker
or a shaking water bath.
6.3.2 Laboratory round bottle, narrow neck, with screw cap, with a concave (curved inward) bottom,
nominal volume 250 ml.
EXAMPLE GL 45 Laboratory Bottle, clear, with screw cap and pouring ring, PP, blue, capacity 250 ml, diameter
70 mm, height 143 mm
NOTE When the bottom of the bottle is not totally flat (e.g. concave), it is usu
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