SIST EN 71-17:2025
(Main)Safety of toys - Part 17: Certain isothiazolinones (MIT, CIT, BIT) in aqueous toy materials
Safety of toys - Part 17: Certain isothiazolinones (MIT, CIT, BIT) in aqueous toy materials
This document specifies requirements (content limit) and a test method for isothiazolinones in aqueous toy materials.
Sicherheit von Spielzeug - Teil 17: Isothiazolinone in wässrigem Spielzeugmaterial
Sécurité des jouets - Partie 17 : Certaines isothiazolinones (MIT, CIT, BIT) dans les matériaux-jouets aqueux
Le présent document spécifie des exigences et une méthode d’essai permettant de déterminer la teneur en isothiazolinones spécifiques dans les matériaux-jouets aqueux 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 [4] 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 - 17. del: Določeni izotiazolinoni (MIT, CIT, BIT) v igračah iz materialov na vodni osnovi
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2025
Varnost igrač - 17. del: Določeni izotiazolinoni (MIT, CIT, BIT) v igračah iz
materialov na vodni osnovi
Safety of toys - Part 17: Certain isothiazolinones (MIT, CIT, BIT) in aqueous toy materials
Sicherheit von Spielzeug - Teil 17: Isothiazolinone in wässrigem Spielzeugmaterial
Sécurité des jouets - Partie 17 : Certaines isothiazolinones (MIT, CIT, BIT) dans les
matériaux-jouets aqueux
Ta slovenski standard je istoveten z: EN 71-17:2025
ICS:
97.200.50 Igrače Toys
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN 71-17
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2025
EUROPÄISCHE NORM
ICS 97.190
English Version
Safety of toys - Part 17: Certain isothiazolinones (MIT, CIT,
BIT) in aqueous toy materials
Sécurité des jouets - Partie 17 : Isothiazolinones dans Sicherheit von Spielzeug - Teil xx: Isothiazolinone in
les matériaux-jouets aqueux wässrigem Spielzeugmaterial
This European Standard was approved by CEN on 29 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 71-17:2025 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 . 7
5 Principle . 7
6 Reagents, standards and apparatus . 7
6.1 Reagents . 7
6.2 Standards . 8
6.3 Apparatus . 9
7 Sample preparation . 9
8 Method of analysis . 10
8.1 General. 10
8.2 Chromatographic conditions . 10
8.3 Mass spectrometer settings . 11
9 Method performance . 11
9.1 Limit of quantification . 11
9.2 Precision . 11
10 Calculation of the results. 12
11 Test report . 13
Annex A (informative) Background and rationale. 14
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 2009/48/EC aimed to be covered . 15
Bibliography . 16
European foreword
This document (EN 71-17:2025) 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 August 2025, and conflicting national standards shall be
withdrawn at the latest by August 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 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 17 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) (the
present document)
— Part 18: Phenol in aqueous (content) and polymeric (migration) toy materials (under development)
— Part 19: Migration of bisphenol A from toy materials (under development)
— 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,
— CEN/TR 15371 (all parts), 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 categorization 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 guidelines - First age grade for the appropriate
play of toys.
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 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 document provides a test method 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 a test method for determining the concentration of certain
isothiazolinones in aqueous (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
aliquot taken from the aqueous toy material for testing
4 Requirements
The content 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].
Table 1 — Limit values for certain isothiazolinones in aqueous toy materials
Compound(s) CAS registry number Requirement/limit
[mg/kg]
1,2-benzisothiazol-3(2H)-one (BIT) 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 (CIT) 26172–55–4 0,75
2-methylisothiazolin-3(2H)-one (MIT) 2682–20–4 0,25
5 Principle
The sample is mixed with methanol containing a known concentration of deuterated isothiazolinones by
shaking at room temperature for a specified time. The solution is filtered, and the extract analysed using
a liquid chromatography system coupled with a tandem mass spectrometer (LC-MS/MS) in multiple
reaction monitoring (MRM) mode.
6 Reagents, standards and apparatus
6.1 Reagents
Unl
...
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