oSIST prEN 71-19:2023
(Main)Safety of toys - Part 19: Migration of bisphenol A from toy materials
Safety of toys - Part 19: Migration of bisphenol A from toy materials
This document specifies requirements (migration limit) and a test method for bisphenol A in toy materials.
Sicherheit von Spielzeug - Teil xx: Migration von Bisphenol A aus Spielzeugmaterial
Dieses Dokument legt Anforderungen an und ein Prüfverfahren für die Migration von Bisphenol A aus Spielzeugmaterialien fest. Dieses Dokument ist anwendbar auf Spielzeug, das zur Verwendung durch Kinder unter 36 Monaten bestimmt ist, oder anderes Spielzeug, das dazu bestimmt ist, in den Mund genommen zu werden.
ANMERKUNG Die Leitlinie Nr. 11 der Europäischen Kommission zur Anwendung der Richtlinie 2009/48/EG über die Sicherheit von Spielzeug [3] enthält Hinweise, die bei der Einstufung von Spielzeug für Kinder unter 36 Monaten oder für Kinder ab 36 Monaten helfen.
Sécurité des jouets - Partie 19 : Migration du bisphénol A depuis les matériaux-jouets
Le présent document spécifie les exigences et une méthode d’essai permettant de déterminer la migration du bisphénol A depuis les matériaux-jouets destinés aux enfants de moins de trente-six mois ou destinés à être mis en bouche.
NOTE Le document d’orientation n° 11 de la Commission européenne concernant l’application de la Directive 2009/48/CE relative à la sécurité des jouets [3] fournit des lignes directrices qui aident à la classification des jouets destinés aux enfants de moins de 36 mois ou de 36 mois et plus.
Varnost igrač - 19. del: Migracija bisfenola A iz materialov za igrače
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2023
Varnost igrač - 19. del: Migracija bisfenola A iz materialov za igrače
Safety of toys - Part 19: Migration of bisphenol A from toy materials
Sicherheit von Spielzeug - Teil xx: Migration von Bisphenol A aus Spielzeugmaterial
Sécurité des jouets - Partie 19 : Migration du bisphénol A depuis les matériaux-jouets
Ta slovenski standard je istoveten z: prEN 71-19
ICS:
97.200.50 Igrače Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
prEN 71-19
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2023
ICS
English Version
Safety of toys - Part 19: Migration of bisphenol A from toy
materials
Sicherheit von Spielzeug - Teil xx: Migration von
Bisphenol A aus Spielzeugmaterial
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 52.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 71-19:2023 E
worldwide for CEN national Members.
prEN 71-19:2023 (E)
Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 6
5 Principle . 6
6 Reagents and apparatus . 7
6.1 Reagents . 7
6.2 Standards . 7
6.3 Apparatus . 8
7 Sample preparation and migration . 8
7.1 General. 8
7.2 Sample area calculation. 8
7.3 Migration . 9
8 Method of analysis . 9
8.1 General. 9
8.2 HPLC chromatographic conditions . 9
8.3 MS/MS conditions . 10
9 Method performance . 11
9.1 Limit of quantification . 11
9.2 Precision . 11
10 Calculation of the result. 11
11 Test report . 12
Annex A (informative) Background and rationale. 13
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2009/48/EC aimed to be covered . 15
Bibliography . 16
prEN 71-19:2023 (E)
European foreword
This document (prEN 71-19:2023) has been prepared by Technical Committee CEN/TC 52 “Safety of
toys”, the secretariat of which is held by DS.
This document is a working draft.
This document has been prepared under a standardisation request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States
For 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.
This document constitutes the 19th 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 (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 (under development)
— Part 19: Migration of bisphenol A from toy materials (under development) (the present document)
prEN 71-19:2023 (E)
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,
— CEN/TR 15371 (all parts), Safety of toys — Interpretations,
— CEN/TR 16918, Safety of toys — Children's mouthing behaviour in contact with toys, and
— 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 (under development)
— CEN ISO/TR 8124-8, Safety of toys — Part 8: Age determination guidelines.
NOTE 2 Words in italics (apart from document titles) are defined in Clause 3 (Terms and definitions).
prEN 71-19:2023 (E)
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 a specific limit value for bisphenol A in toys (see Commission Directive (EU) 2017/898 [2]).
This document provides a test method to check compliance with this limit value.
prEN 71-19:2023 (E)
1 Scope
This document specifies requirements and a test method for testing migration of Bisphenol A from toy
materials of toys intended for use by children under 36 month or 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 [3] 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 terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
3.1
sample
part of the toy material subject to testing
Note 1 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
Migration of Bisphenol A from toy materials shall not exceed 0,04 mg/l when tested according to the
method described in this European standard.
NOTE This limit corresponds to the limit value specified in Directive (EU) 2009/48 [1] which was introduced
by Commission Directive (EU) 2017/898 [2].
5 Principle
The migration of Bisphenol A 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 measured using HPLC-MS/MS.
NOTE More information on selection of simulant and migration conditions can be found in A.1.
prEN 71-19:2023 (E)
6 Reagents and apparatus
6.1 Reagents
Unless otherwise specified, all reagents shall be of analytical grade or higher. For substances purchased
refer to the storage conditions and stability information specified by the supplier.
6.1.1 Methanol (CAS 67-56-1)
6.1.2 Purified water, conforming to at least grade 3 of EN ISO 3696:1995.
6.2 Standards
6.2.1 Calibration standard
Bisphenol A (CAS 80-05-7) (BPA), neat substance or in solution, with known purity.
6.2.2 Internal standard
Bisphenol A-d16 (CAS 96210-87-6) (d16-BPA) or Bisphenol A-d8 (CAS 92739-58-7) (d8-BPA),
neat substance or in solution.
6.2.3 Solutions of internal standard
6.2.3.1 Stock solution of internal standard
When the internal standard (6.2.2) is purchased as a neat substance, prepare a stock solution containing
1 000 mg/l of the internal standard (6.2.2) in methanol (6.1.1) using appropriate pipettes and volumetric
flasks.
If the internal standard (6.2.2) is purchased as a solution this is the stock solution.
6.2.3.2 Intermediate solution of internal standard
Prepare the intermediate solution of the internal standard (6.2.2) by diluting the stock solution of the
internal standard (6.2.3.1) with methanol (6.1.1) to a concentration of 10 mg/l using appropriate pipettes
and volumetric flasks.
6.2.4 Calibration solutions
6.2.4.1 Stock solution
When BPA (6.2.1) is purchased as a neat substance, prepare a stock solution containing 1 000 mg/l BPA
(6.2.1) in methanol (6.1.1) using appropriate pipettes and volumetric flasks.
If BPA (6.2.1) is purchased as a solution this is the stock solution.
6.2.4.2 Intermediate solution 1
Prepare the intermediate solution 1 by diluting the stock
...
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