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SLOVENSKI STANDARD
01-december-2023
Varnost igrač - 17. del: Izotiazolinon v materialih za vodne igrače
Safety of toys - Part 17: Isothiazolinones in aqueous toy materials
Sicherheit von Spielzeug - Teil xx: Isothiazolinone in wässrigem Spielzeugmaterial
Sécurité des jouets - Partie 17 : Isothiazolinones dans les matériaux-jouets aqueux
Ta slovenski standard je istoveten z: prEN 71-17
ICS:
97.200.50 Igrače Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
EUROPEAN STANDARD
prEN 71-17
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2023
ICS
English Version
Safety of toys - Part 17: Isothiazolinones in aqueous toy
materials
Sicherheit von Spielzeug - Teil xx: Isothiazolinone in
wässrigem 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 71-17:2023 E
worldwide for CEN national Members.
prEN 71-17:2023 (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 . 7
6 Reagents and apparatus . 7
6.1 Reagents . 7
6.2 Standards . 7
6.3 Apparatus . 9
7 Sample preparation . 9
8 Method of analysis . 9
8.1 General. 9
8.2 HPLC chromatographic conditions . 10
8.3 MS/MS conditions . 10
9 Method performance . 11
9.1 Limits of quantification . 11
9.2 Precision . 11
10 Calculation of the results. 12
11 Test report . 12
Bibliography . 15
prEN 71-17:2023 (E)
European foreword
This document (prEN 71-17:2023) has been prepared by Technical Committee CEN/TC 52 “Safety of
toys”, the secretariat of which is held by DS.
This document is currently submitted to the CEN Enquiry.
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 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 xth 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 flame retardants in toy materials (under development)
— Part 17: Certain isothiazolinones (MIT, CIT, BIT) in aqueous (toy) materials (under development) (the
present document)
— Part XXX: Phenol in aqueous and polymeric toy materials (under development)
— Part XXX: Migration of bisphenol A from toy materials (under development)
prEN 71-17:2023 (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 categorization 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 71-17:2023 (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 November 2015 the European Commission amended Appendix C to Annex II to this Directive
accordingly and adopted specific limit values for certain isothiazolinones in toys (see Commission
Directive (EU) 2015/2116 [2] and Directive (EU) 2015/2117 [3]). This European standard provides a
test method to check compliance with these limit values.
prEN 71-17:2023 (E)
1 Scope
This document specifies requirements and a test method for determining the content of certain
isothiazolinones in aqueous (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 [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 terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at
• ISO Online browsing platform: available at
3.1
aqueous toy material
homogeneous toy material where water is one of the constituents to liquefy the material
3.2
sample
aliquot from an aqueous toy material subject to testing
4 Requirements
The concentration of certain isothiazolinones in aqueous toy materials shall not exceed the limits
specified in Table 1.
NOTE The limit values in Table 1 correspond to the limit values specified in Directive 2009/48/EC [1] which
were introduced by Commission Directive (EU) 2015/2116 [2] as well as Commission Directive (EU) 2015/2117
[3].
prEN 71-17:2023 (E)
Table 1 — Limit values for certain isothiazolinones in aqueous toy materials
Compound(s) CAS Requirement/limit
[mg/kg]
1,2-benzisothiazol-3(2H)-one 2634–33–5 5
reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3- 55965–84–9 1
one [EC no. 247–500–7] and 2-methyl-2H-isothiazol-
3-one [EC no. 220–239–6] (3:1)
5-Chloro-2-methyl-isothiazolin-3(2H)-one 26172–55–4 0,75
2-methylisothiazolin-3(2H)-one 2682–20–4 0,25
5 Principle
The sample of an aqueous toy material is extracted with methanol by shaking at room temperature. The
extract is analysed using HPLC-MS/MS.
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
6.1.3 Formic acid (CAS 64-18-6)
6.1.4 Eluent A: 0,1 % (volume fraction) formic acid in water
6.1.5 Eluent B: 0,1 % (volume fraction) formic acid in methanol
6.1.6 Extraction solution
Methanol (6.1.1) containing 0,05 mg/l d3-MIT (6.2.2.1) and d3-CIT (6.2.2.2).
This solution can for example be prepared by adding 0,5 ml intermediate solution 1 of the internal
standards (6.2.3.2) to methanol (6.1.1) in a 2 l-volumetric flask and fill up the solution with methanol
(6.1.1) to the mark.
6.2 Standards
6.2.1 Calibration standards
The following calibration standards can be purchased either as neat substance or in solution, each with
known purity.
6.2.1.1 2-methylisothiazolin-3(2H)-one (CAS 2682-20-4) (MIT),
prEN 71-17:2023 (E)
6.2.1.2 5-Chloro-2-methyl-isothiazolin-3(2H)-one (CAS 26172-55-4) (CIT),
6.2.1.3 1,2-benzisothiazol-3(2H)-one (2634-33-5) (BIT),
6.2.2 Internal standards
6.2.2.1 2-Methyl-3-isothiazolone-d3 Hydrochloride (CAS 1329509-49-0) (d3-MIT),
6.2.2.2 5-Chloro-2-methyl-3-isothiazolone-d3 (1329611-34-8) (d3-CIT),
6.2.3 Solutions of internal standards
6.2.3.1 Stock solution of internal standards
When d3-MIT (6.2.2.1) and/or d3-CIT (6.2.2.2) are purchased as a neat substance, prepare a stock
solution for each substance containing 1 000 mg/l in methanol (6.1.1) using appropriate pipettes and
volumetric flasks.
If d3-MIT (6.2.2.1) and/or d3-CIT (6.2.2.2) are purchased as solutions these are the stock solutions.
6.2.3.2 Intermediate solution 1 of internal standards
Prepare the intermediate solution 1 of the internal standards containing 200 mg/l d3-MIT (6.2.1.1) and
d3-CIT (6.2.2.2) by diluting the stock solutions of the internal standards (6.2.3.1) with methanol (6.1
...