Footwear - Critical substances potentially present in footwear and footwear components - Determination of dimethyl fumarat (DMFU) (ISO 16186:2021)

This document specifies a method for the determination of the content of dimethyl fumarate (DMFU) by gas chromatograph with single quadrupole mass spectrometer (GC-MS) or tandem quadrupole mass spectrometer (GC-MS/MS).
This document is applicable to all types of footwear and footwear components except metal parts.

Schuhe - Möglicherweise in Schuhen und Schuhbestandteilen vorhandene kritische Substanzen - Bestimmung von Dimethylfumarat (DMFU) (ISO 16186:2021)

Dieses Dokument legt ein Verfahren zur Bestimmung des Gehaltes an Dimethylfumarat (DMFU) mit einem Gaschromatographen mit Single-Quadrupol-Massenspektrometer (GC-MS) oder Tandem-Quadrupol-Massen¬spektrometer (GC-MS/MS) fest.
Dieses Dokument ist anzuwenden für alle Arten von Schuhen und Schuhbestandteilen mit Ausnahme von Metallteilen.
WARNUNG - Die Verwendung dieses Dokuments kann gefährliche Materialien, Arbeitsabläufe oder Geräte einschließen. Es bezweckt nicht, sämtliche in Zusammenhang mit seiner Anwendung stehenden Sicherheits- oder Umweltprobleme zu behandeln. Es liegt in der Verantwortung der Anwender dieses Dokuments, die geeigneten Maßnahmen zu ergreifen, um den Sicherheits- und Gesundheitsschutz des Personals und der Umwelt vor Anwendung des Dokuments sicherzustellen und die zu diesem Zweck anwendbaren gesetzlichen Beschränkungen zu bestimmen.

Chaussures - Substances critiques potentiellement présentes dans les chaussures et les composants de chaussures - Détermination du fumarate de diméthyle (DMFU) (ISO 16186:2021)

Le présent document spécifie une méthode de détermination de la teneur en fumarate de diméthyle (DMFU) au moyen d’un chromatographe en phase gazeuse avec un spectromètre de masse à simple quadripôle (GC-MS) ou avec un spectromètre de masse à quadripôle en tandem (GC-MS/MS).
Le présent document est applicable à tous les types de chaussures et de composants de chaussures, sauf les parties métalliques.

Obutev - Kritične snovi, ki so lahko v obutvi in delih obutve - Ugotavljanje dimetil fumarata (DMFU) (ISO 16186:2021)

General Information

Status
Published
Publication Date
15-Jun-2021
Withdrawal Date
30-Dec-2021
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-Jun-2021
Completion Date
16-Jun-2021

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SLOVENSKI STANDARD
SIST EN ISO 16186:2021
01-september-2021
Nadomešča:
SIST-TS CEN ISO/TS 16186:2012
Obutev - Kritične snovi, ki so lahko v obutvi in delih obutve - Ugotavljanje dimetil
fumarata (DMFU) (ISO 16186:2021)
Footwear - Critical substances potentially present in footwear and footwear components
- Determination of dimethyl fumarat (DMFU) (ISO 16186:2021)
Schuhe - Möglicherweise in Schuhen und Schuhbestandteilen vorhandene kritische
Substanzen - Bestimmung von Dimethylfumarat (DMFU) in Schuhwerkstoffen (ISO/FDIS
16186:2021)
Chaussures - Substances critiques potentiellement présentes dans les chaussures et les
composants de chaussures - Détermination du diméthylformamide (DMF) (ISO
16186:2021)
Ta slovenski standard je istoveten z: EN ISO 16186:2021
ICS:
61.060 Obuvala Footwear
SIST EN ISO 16186:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16186:2021

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SIST EN ISO 16186:2021


EN ISO 16186
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2021
EUROPÄISCHE NORM
ICS 61.060 Supersedes CEN ISO/TS 16186:2012
English Version

Footwear - Critical substances potentially present in
footwear and footwear components - Determination of
dimethyl fumarat (DMFU) (ISO 16186:2021)
Chaussures - Substances critiques potentiellement Schuhe - Möglicherweise in Schuhen und
présentes dans les chaussures et les composants de Schuhbestandteilen vorhandene kritische Substanzen -
chaussures - Détermination du diméthylformamide Bestimmung von Dimethylfumarat (DMFU) in
(DMF) (ISO 16186:2021) Schuhwerkstoffen (ISO 16186:2021)
This European Standard was approved by CEN on 17 May 2021.

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, 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16186:2021 E
worldwide for CEN national Members.

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SIST EN ISO 16186:2021
EN ISO 16186:2021 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 16186:2021
EN ISO 16186:2021 (E)
European foreword
This document (EN ISO 16186:2021) has been prepared by Technical Committee ISO/TC 216
"Footwear" in collaboration with Technical Committee CEN/TC 309 “Footwear” the secretariat of which
is held by UNE.
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 December 2021, and conflicting national standards
shall be withdrawn at the latest by December 2021.
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 CEN ISO/TS 16186:2012.
According to the CEN-CENELEC Internal Regulations, the national standards organizations 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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 16186:2021 has been approved by CEN as EN ISO 16186:2021 without any modification.

3

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SIST EN ISO 16186:2021

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SIST EN ISO 16186:2021
INTERNATIONAL ISO
STANDARD 16186
First edition
2021-05
Footwear — Critical substances
potentially present in footwear
and footwear components —
Determination of dimethyl fumarate
(DMFU)
Chaussures — Substances critiques potentiellement présentes dans
les chaussures et les composants de chaussures — Détermination du
fumarate de diméthyle (DMFU)
Reference number
ISO 16186:2021(E)
©
ISO 2021

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SIST EN ISO 16186:2021
ISO 16186:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

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SIST EN ISO 16186:2021
ISO 16186:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 Reagents and materials . 2
6 Apparatus . 2
7 Sampling . 3
8 Procedure. 3
8.1 Standard procedure . 3
8.2 Procedure for complex matrix . 3
8.2.1 Extraction . 3
8.2.2 Clean-up . 4
8.3 Preparation of calibration solutions . 4
8.4 Determination of dimethyl fumarate . 4
9 Expression of results . 4
9.1 Calculation of dimethyl fumarate in the sample . 4
9.2 Limit of quantification (LOQ) . 5
10 Test report . 5
Annex A (informative) The chromatography parameters (GC-MS) . 6
Annex B (informative) The chromatography parameters (GC-MS/MS) . 8
Annex C (informative) Rationale for excluding methanol as extraction solvent .10
Annex D (informative) Reliability of the method .11
Bibliography .12
© ISO 2021 – All rights reserved iii

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SIST EN ISO 16186:2021
ISO 16186:2021(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
is o/ f or ewor d . ht m l .
This document was prepared by Technical Committee ISO/TC 216, Footwear, in collaboration with
the European Committee for Standardization (CEN) Technical Committee CEN/TC 309, Footwear, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This first edition of ISO 16186 cancels and replaces ISO/TS 16186:2012, which has been technically
revised.
The main changes compared to the previous edition are as follows:
— new Clause 3, 6.6, 6.8, 6.9;
— gas chromatograph with tandem quadrupole mass spectrometer (GC-MS/MS);
— in Clause 7, desiccant treated as a note;
— in 8.2.2, new clean up procedure;
— new Annexes A, B and C;
— Tabled D.1 aligned with Table D.2;
— bibliography added.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved

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SIST EN ISO 16186:2021
ISO 16186:2021(E)

Introduction
Dimethyl fumarate (DMFU) has been found to be a sensitizer at very low concentrations, producing
extensive, pronounced eczema, which is difficult to treat.
There are regulations that limit the use of DMFU. For example in the EU, products, or any parts thereof,
[3]
containing DMFU in concentrations greater than 0,1 mg/kg are not authorized on the market .
© ISO 2021 – All rights reserved v

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SIST EN ISO 16186:2021

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SIST EN ISO 16186:2021
INTERNATIONAL STANDARD ISO 16186:2021(E)
Footwear — Critical substances potentially present in
footwear and footwear components — Determination of
dimethyl fumarate (DMFU)
WARNING — The use of this document can involve hazardous materials, operations and
equipment. It does not purport to address all of the safety or environmental problems associated
with its use. It is the responsibility of users of this document to take appropriate measures
to ensure the safety and health of personnel and the environment prior to application of the
document, and to determine the applicability of regulatory limitations for this purpose.
1 Scope
This document specifies a method for the determination of the content of dimethyl fumarate (DMFU)
by gas chromatograph with single quadrupole mass spectrometer (GC-MS) or tandem qua
...

SLOVENSKI STANDARD
oSIST prEN ISO 16186:2020
01-april-2020
Obutev - Kritične snovi, ki so lahko v obutvi in delih obutve - Ugotavljanje
dimetilformamida (DMF) v obutvenih materialih (ISO/DIS 16186:2020)
Footwear - Critical substances potentially present in footwear and footwear components
- Determination of Dimethylformamide (DMF) in footwear materials (ISO/DIS
16186:2020)
Schuhe - Möglicherweise in Schuhen und Schuhbestandteilen vorhandene kritische
Substanzen - Bestimmung von Dimethylfumarat (ISO/DIS 16186:2020)
Chaussures - Substances critiques potentiellement présentes dans les chaussures et les
composants de chaussures - Détermination du diméthylformamide (DMF) dans les
matériaux de chaussures (ISO/DIS 16186:2020)
Ta slovenski standard je istoveten z: prEN ISO 16186
ICS:
61.060 Obuvala Footwear
oSIST prEN ISO 16186:2020 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 16186:2020

---------------------- Page: 2 ----------------------
oSIST prEN ISO 16186:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16186
ISO/TC 216 Secretariat: UNE
Voting begins on: Voting terminates on:
2020-02-19 2020-05-13
Footwear — Critical substances potentially present in
footwear and footwear components — Determination of
Dimethylformamide (DMF) in footwear materials
Chaussures — Substances critiques potentiallement présentes dans les chaussures et les componsants des
chaussures — Détermination des dimethylfumarate
ICS: 61.060
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 16186:2020(E)
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. ISO 2020

---------------------- Page: 3 ----------------------
oSIST prEN ISO 16186:2020
ISO/DIS 16186:2020(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST prEN ISO 16186:2020
ISO/DIS 16186:2020(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Method principle . 1
5 Reagents . 2
6 Equipment . 2
7 Preparation of sample . 3
7.1 Sampling . 3
7.2 Extraction . 3
8 Determination with GC-MS . 3
8.1 Calibration standard . 3
8.2 Examples of instrumental method . 3
9 Expression of results . 4
9.1 Calibration curve . 4
10 Performance of the method . 4
11 Test report . 5
Annex A (informative) Suggested parameters for GC-MS determination of DMF .6
Bibliography . 7
© ISO 2020 – All rights reserved iii

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oSIST prEN ISO 16186:2020
ISO/DIS 16186:2020(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 216, Footwear.
This second edition cancels and replaces the first edition (ISO/TS 16186:2012), which has been
technically revised.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2020 – All rights reserved

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oSIST prEN ISO 16186
...

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