SIST EN ISO 19577:2020

Footwear - Critical substances potentially present in footwear and footwear components - Determination of Nitrosamines (ISO 19577:2019)

This document specifies a method for the determination of the content of 12 kinds of Nitrosamines (see Annex A) in footwear and footwear components by using solvent extraction and Gas chromatography with mass selective detector (GC-MS).
This document is applicable to rubber in footwear materials.
NOTE  ISO/TR 16178 defines which materials are concerned by this

Schuhe - Möglicherweise in Schuhen oder Schuhbestandteilen vorhandene kritische Substanzen - Bestimmung von Nitrosaminen (ISO 19577:2019)

Dieses Dokument legt ein Verfahren zur Bestimmung des Gehalts von 12 Arten von Nitrosaminen (siehe Anhang A) in Schuhen und Schuhbestandteilen mittels Lösemittelextraktion und Gaschromatographie mit massenselektivem Detektor (GC-MS) fest.
Dieses Dokument ist anzuwenden für Gummi in Schuhwerkstoffen.
ANMERKUNG ISO/TR 16178 legt fest, welche Werkstoffe von dieser Bestimmung betroffen sind.

Chaussure - Substances critiques potentiellement présentes dans les chaussures et les composants de chaussure - Détermination des nitrosamines (ISO 19577:2019)

Le présent document spécifie une méthode de détermination de la présence de 12 types de nitrosamines (voir Annexe A) dans les chaussures et composants de chaussure, à l'aide de l'extraction par solvant et de la chromatographie en phase gazeuse couplée à un détecteur sélectif de masse (CPG-DSM).
Le présent document s'applique au caoutchouc présent dans les matériaux de chaussure.
NOTE       L'ISO/TR 16178 définit les matériaux concernés par cette détermination.

Obutev - Kritične snovi, ki so lahko v obutvi in delih obutve - Ugotavljanje prisotnosti nitrozaminov (ISO 19577:2019)

Ta standard določa metodo za določanje vsebnosti 12 vrst nitrozaminov (glej dodatek A) pri obutvi in njenih sestavnih delih na podlagi ekstrakcije s topilom in plinsko kromatografijo z masno selektivnim detektorjem (GC-MS). Ta dokument se uporablja za gumo v materialih obutve.

General Information

• Status: Published
• Publication Date: 16-Dec-2019
• ICS: 61.060 - Footwear
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 12-Dec-2019
• Due Date: 16-Feb-2020
• Completion Date: 17-Dec-2019
• Ref Project: EN ISO 19577:2019 - Footwear - Critical substances potentially present in footwear and footwear components - Determination of Nitrosamines (ISO 19577:2019)

Overview

EN ISO 19577:2019 - "Footwear - Critical substances potentially present in footwear and footwear components - Determination of Nitrosamines" specifies an analytical method for detecting and quantifying 12 nitrosamines (see Annex A of the standard) in footwear materials. Published by CEN/ISO in 2019, the procedure is applicable to rubber used in footwear components and uses solvent extraction followed by analysis with gas chromatography–mass spectrometry (GC‑MS).

Key topics and technical requirements

• Scope: Method targets 12 nitrosamines potentially present in footwear; full list in Annex A. Applicable primarily to rubber materials (ISO/TR 16178 gives material applicability).
• Sample preparation: Representative sample cut to <3 mm; typical test mass is 5.0 g. Extraction uses methanol with ultrasonic agitation (≈30 min) at temperatures not exceeding 40 °C.
• Concentration & cleanup: Methanol extracts are concentrated (rotary vacuum or nitrogen evaporator) to <2 ml, transferred to amber volumetric glassware, and purified using a solid‑phase extraction (SPE) column (500 mg/3 ml).
• Chromatographic analysis: GC‑MS is used - full scan mode for qualitative identification and selected ion monitoring (SIM) for quantitative determination with external (and internal) standards. Annexes provide GC‑MS parameters, chromatograms and SIM ions.
• Reagents & apparatus: Chromatographic‑grade methanol, amber glassware, ultrasonic bath (≈40 kHz), analytical balance, SPE device, centrifuge, 0.45 µm syringe filters and GC‑MS instrumentation.
• Safety note: Nitrosamines are hazardous; the standard warns about exposure risks and requires appropriate laboratory safety measures.
• Performance: The document includes procedures for calculating results, a section on limits of quantification, interlaboratory test results (informative) and confirmation criteria (normative).

Applications and who uses it

• Testing laboratories: Routine analysis and method validation for nitrosamines in footwear components.
• Footwear manufacturers and suppliers: Quality control of rubber components and incoming material screening.
• Regulatory and conformity assessors: Demonstrating compliance with safety requirements and limits for critical substances in consumer products.
• Importers/brand owners: Batch testing for product safety assurance and supplier audits.

Practical value: this standard provides a validated, GC‑MS‑based workflow-sample prep, cleanup, analysis and reporting-designed for reliable identification and quantification of nitrosamines in rubber footwear components.

Related standards

• ISO/TR 16178 - Defines which footwear materials are concerned by this determination.
• Annex E of EN ISO 19577:2019 - Notes alternative methods (informative/normative distinctions are in the standard).

Keywords: EN ISO 19577:2019, nitrosamines in footwear, GC‑MS nitrosamine method, footwear testing, rubber footwear components, solvent extraction, SPE cleanup.

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2020
Obutev - Kritične snovi, ki so lahko v obutvi in delih obutve - Ugotavljanje
prisotnosti nitrozaminov (ISO 19577:2019)
Footwear - Critical substances potentially present in footwear and footwear components
- Determination of Nitrosamines (ISO 19577:2019)
Schuhe - Möglicherweise in Schuhen oder Schuhbestandteilen vorhandene kritische
Substanzen - Bestimmung von Nitrosaminen (ISO 19577:2019)
Chaussure - Substances critiques potentiellement présentes dans les chaussures et les
composants de chaussure - Détermination des nitrosamines (ISO 19577:2019)
Ta slovenski standard je istoveten z: EN ISO 19577:2019
ICS:
61.060 Obuvala Footwear
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 19577
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2019
EUROPÄISCHE NORM
ICS 61.060
English Version
Footwear - Critical substances potentially present in
footwear and footwear components - Determination of
Nitrosamines (ISO 19577:2019)
Chaussure - Substances critiques potentiellement Schuhe - Möglicherweise in Schuhen oder
présentes dans les chaussures et les composants de Schuhbestandteilen vorhandene kritische Substanzen -
chaussure - Détermination des nitrosamines (ISO Bestimmung von Nitrosaminen (ISO 19577:2019)
19577:2019)
This European Standard was approved by CEN on 9 November 2019.

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
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 19577:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 19577:2019) 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 June 2020, and conflicting national standards shall be
withdrawn at the latest by June 2020.
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.
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 19577:2019 has been approved by CEN as EN ISO 19577:2019 without any modification.

INTERNATIONAL ISO
STANDARD 19577
First edition
2019-11
Footwear — Critical substances
potentially present in footwear
and footwear components —
Determination of Nitrosamines
Chaussure — Substances critiques potentiellement présentes dans
les chaussures et les composants de chaussure — Détermination des
nitrosamines
Reference number
ISO 19577:2019(E)
©
ISO 2019
ISO 19577:2019(E)
© ISO 2019
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: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 19577:2019(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 1
5 Reagents and materials . 1
6 Apparatus . 2
7 Preparation of test samples . 3
8 Procedure. 3
8.1 Extraction . 3
8.2 Purification . 3
8.3 Chromatographic analysis . 3
8.3.1 The chromatography parameters for GC-MS . 3
8.3.2 Qualitative and quantitative analysis by GC-MS . 4
9 Expression of results . 4
9.1 Calculation of results . 4
9.2 Limit of Quantification . 5
10 Test report . 5
Annex A (informative) Names of 12 kinds of Nitrosamines and the Standard selective GC-MS ions .6
Annex B (informative) The chromatography parameters for GC-MS . 7
Annex C (informative) GC-MS total ion current of Nitrosamine standard sample .8
Annex D (normative) Confirmation of detected Nitrosamines . 9
Annex E (normative) Alternative methods .10
Annex F (informative) Results of the interlaboratory tests .11
Bibliography .12
ISO 19577:2019(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.
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 2019 – All rights reserved

INTERNATIONAL STANDARD ISO 19577:2019(E)
Footwear — Critical substances potentially present in
footwear and footwear components — Determination of
Nitrosamines
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.
1 Scope
This document specifies a method for the determination of the content of 12 kinds of Nitrosamines (see
Annex A) in footwear and footwear components by using solvent extraction and Gas chromatography
with mass selective detector (GC-MS).
This document is applicable to rubber in footwear materials.
NOTE ISO/TR 16178 defines which materials are concerned by this determination.
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.
ISO 4787, Laboratory glassware — Volumetric instruments — Methods for testing of capacity and for use
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Principle
Extract Nitrosamines in the sample with methanol using an ultrasonic bath. The extract is concentrated
in a rotary vacuum evaporator and purified by passing through C solid-phase separation column. The
Nitrosamines in test solutions are analysed by GC-MS, using full scan detection mode for qualitative
analysis and selected ion monitoring (SIM) mode for quantitative analysis with an external standard
solution.
5 Reagents and materials
Unless otherwise specified, all the reagents used are chromatographic grade.
5.1 Methanol, CAS number: 67-56-1.
ISO 19577:2019(E)
5.2 C solid-phase extraction column, 500 mg/3 ml freshly made in lab or obtained from commercial
sources.
5.3 Standard stock-solution, prepare stock solutions containing 2
...