Footwear - Critical substances potentially present in footwear and footwear components (ISO/TR 16178:2012)

This Technical Report establishes a list of critical chemical substances potentially present in footwear and footwear components.
This Technical Report describes the critical chemical substances, their potential risks, the materials in which they can be found and the test method(s) which can be used to quantify them. It does not include requirements; it is the responsibility of the user of this Technical Report to fix his/her level of acceptance, for instance using a defined concentration or detection limit or quantification limit.
NOTE The proposed test methods indicate the state of the art. Some substances do not include a test method, as no test method is available at the time of publication of this Technical Report. If possible, it is intended to include a test method in a revision of this Technical Report.
This Technical Report applies to any kind of footwear and footwear components.

Schuhe - Möglicherweise in Schuhen und Schuhbestandteilen vorhandene kritische Substanzen (ISO/TR 16178:2012)

Chaussures - Substances critiques potentiellement présentes dans la chaussure et les composants de chaussures (ISO/TR 16178:2012)

Le présent Rapport technique établit une liste de substances chimiques critiques potentiellement présentes dans les chaussures et les composants de chaussures.
Le présent Rapport technique décrit les substances chimiques critiques, leurs risques potentiels, les matériaux dans lesquels on peut les trouver, ainsi que la ou les méthodes d'essai permettant de les quantifier. Il ne comprend aucune exigence; la responsabilité de fixer les niveaux d'acceptation, par exemple en utilisant une concentration définie, une limite de détection ou une limite de quantification, etc., incombe à l'utilisateur du présent Rapport technique.
NOTE Les méthodes d'essai proposées reflètent l'état de la technique. Aucune méthode d'essai n'est indiquée pour certaines substances dans la mesure où aucune méthode d'essai normative n'est disponible au moment de la publication du présent Rapport technique. Si possible, une méthode sera intégrée dans une future version du présent Rapport technique.
Le présent Rapport technique s'applique à tout type de chaussure et de composant de chaussure.

Obuvala - Nevarne snovi, ki so lahko prisotne v obuvalih in njihovih sestavnih delih (ISO/TR 16178:2012)

V tem tehničnem poročilu je naveden seznam nevarnih kemičnih snovi, ki so lahko prisotne v obuvalih in njihovih sestavnih delih. V tem tehničnem poročilu so opisane nevarne kemične snovi, možna tveganja v zvezi z njimi, vrste materialov, v katerih so lahko prisotne, in preskusne metode, ki jih je mogoče uporabiti za njihovo oceno. V poročilu ni navedenih zahtev; določitev sprejemljive stopnje, npr. uporaba opredeljene meje koncentracije, zaznavnosti ali količinske določitve itd., je odgovornost uporabnika tega tehničnega poročila. V predlaganih preskusnih metodah je navedeno stanje tehnike. Nekatere snovi ne vključujejo preskusne metode, ker v času objave tega tehničnega poročila ni na voljo nobene normativne preskusne metode. Če je mogoče, bo vključena v prihodnji reviziji tehničnega poročila.
To tehnično poročilo velja za vse vrste obuval in njihove sestavne dele.

General Information

Status
Withdrawn
Publication Date
04-Sep-2012
Withdrawal Date
05-Oct-2021
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
06-Oct-2021

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SLOVENSKI STANDARD
01-november-2012
1DGRPHãþD
kSIST-TP FprCEN ISO/TR 16178:2010
Obuvala - Nevarne snovi, ki so lahko prisotne v obuvalih in njihovih sestavnih
delih (ISO/TR 16178:2012)
Footwear - Critical substances potentially present in footwear and footwear components
(ISO/TR 16178:2012)
Schuhe - Möglicherweise in Schuhen und Schuhbestandteilen vorhandene kritische
Substanzen (ISO/TR 16178:2012)
Chaussures - Substances critiques potentiellement présentes dans la chaussure et les
composants de chaussures (ISO/TR 16178:2012)
Ta slovenski standard je istoveten z: CEN ISO/TR 16178:2012
ICS:
61.060 Obuvala Footwear
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

TECHNICAL REPORT
CEN ISO/TR 16178
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
September 2012
ICS 61.060 Supersedes CEN ISO/TR 16178:2010
English Version
Footwear - Critical substances potentially present in footwear
and footwear components (ISO/TR 16178:2012)
Chaussures - Substances critiques potentiellement Schuhe - Möglicherweise in Schuhen und
présentes dans la chaussure et les composants de Schuhbestandteilen vorhandene kritische Substanzen
chaussures (ISO/TR 16178:2012) (ISO/TR 16178:2012)

This Technical Report was approved by CEN on 30 July 2012. It has been drawn up by the Technical Committee CEN/TC 309.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TR 16178:2012: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Foreword
This document (CEN ISO/TR 16178:2012) has been prepared by Technical Committee CEN/TC 309
“Footwear", the secretariat of which is held by AENOR, in collaboration with Technical Committee ISO/TC 216
"Footwear".
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes CEN ISO/TR 16178:2010.
TECHNICAL ISO/TR
REPORT 16178
Second edition
2012-07-15
Footwear — Critical substances
potentially present in footwear and
footwear components
Chaussures — Substances critiques potentiellement présentes dans la
chaussure et les composants de chaussures
Reference number
ISO/TR 16178:2012(E)
©
ISO 2012
ISO/TR 16178:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO/TR 16178:2012(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Terms and definitions . 1
3 Presence of chemicals in footwear materials . 2
Annex A (informative) Materials used in the footwear industry . 7
Annex B (informative) Critical substances potentially present in footwear and footwear components .13
Bibliography .40
ISO/TR 16178:2012(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In exceptional circumstances, when a technical committee has collected data of a different kind from that
which is normally published as an International Standard (“state of the art”, for example), it may decide by a
simple majority vote of its participating members to publish a Technical Report. A Technical Report is entirely
informative in nature and does not have to be reviewed until the data it provides are considered to be no longer
valid or useful.
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.
ISO/TR 16178 was prepared by Technical Committee ISO/TC 216, Footwear.
ISO/TR 16178 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 309, Footwear, in collaboration with ISO Technical Committee TC 216, Footwear, in accordance with
the Agreement on technical cooperation between ISO and CEN (Vienna agreement).
This second edition cancels and replaces the first edition (ISO/TR 16178:2010), which has been technically revised.
iv © ISO 2012 – All rights reserved

TECHNICAL REPORT ISO/TR 16178:2012(E)
Footwear — Critical substances potentially present in footwear
and footwear components
1 Scope
This Technical Report establishes a list of critical chemical substances potentially present in footwear and
footwear components.
This Technical Report describes the critical chemical substances, their potential risks, the materials in which
they can be found and the test method(s) which can be used to quantify them. It does not include requirements;
it is the responsibility of the user of this Technical Report to fix his/her level of acceptance, for instance using
a defined concentration or detection limit or quantification limit.
NOTE The proposed test methods indicate the state of the art. Some substances do not include a test method, as no
test method is available at the time of publication of this Technical Report. If possible, it is intended to include a test method
in a revision of this Technical Report.
This Technical Report applies to any kind of footwear and footwear components.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
allergen
substance that is capable of inducing an allergic reaction
2.2
allergy
immunologically mediated response to certain specific substances
NOTE 1 The specific substances are allergens.
NOTE 2 Type-1 allergy (respiratory allergy) is mediated by IgE antibodies and can cause asthma, rhinitis and urticaria.
NOTE 3 Type-4 allergy (dermal allergy) is mediated by T-cells and can cause dermatitis.
2.3
detection limit
value from which a substance is considered detectable
NOTE This means that the signal associated to the substance is three times bigger than the background noise signal.
The limit of detection is determined experimentally by the laboratory for each substance.
2.4
quantification limit
value from which a substance is considered measurable
NOTE It is the value where the uncertainty of measurement is equal to 50 % of the determined value.
2.5
absence of a chemical
state in which a chemical is lacking from a material, where the test method is unable to detect it
NOTE The amount of the chemical is smaller than the detection limit of the test method.
ISO/TR 16178:2012(E)
2.6
critical substance
chemical substance that can be found in footwear or footwear components and that can have an effect on the
wearer and/or environmental impact due to its chemical reactivity
NOTE 1 The effects caused by critical substances vary. They can be carcinogenic or mutagenic effects, allergy,
reaction to toxics, etc.
NOTE 2 Legislations can change; this Technical Report gives the information available at the time of publication. It is
the responsibility of the user of this Technical Report to ensure that no changes have occurred.
2.6.1
critical substances category 1
substances with proven dangerous effect on the wearer
NOTE These substances are restricted by regulation at European level.
2.6.2
critical substances category 2
substances with dangerous effect on the wearer
NOTE These substances are restricted by regulation at national level in some countries.
2.6.3
critical substances category 3
substances with environmental impact
NOTE These substances are mentioned in European Ecolabel.
2.6.4
critical substances category 4
substances that are highly suspected to have an effect on the wearer
NOTE Possibly, these substances are not restricted by regulation at the time of publication of this Technical Report.
2.6.5
critical substances category 5
substances that are suspected to have an effect on the wearer
NOTE Possibly, these substances are not restricted by regulation at the time of publication of this Technical Report.
3 Presence of chemicals in footwear materials
A number of chemicals are present in footwear materials. Table 1 gives:
a) materials in which they are supposed to be (for information, see Annex A);
b) the list of the critical chemicals, (for information, see Annex B);
c) test methods which can be used to provoke and quantify them;
d) the potential risk associated with and assessed by the use of the critical substances category scale (see 2.6).
For composite materials, the tests should be conducted on the entire component.
EXAMPLE 1 Coated textile (cotton plus PVC coating): the test on PVC and the test on cellulosic natural fibres should
be carried out.
EXAMPLE 2 Mixed textile (PES plus cotton): the test on cellulosic natural textile and the test on PES textile should
be carried out.
2 © ISO 2012 – All rights reserved

ISO/TR 16178:2012(E)
Table 1 — Critical chemicals potentially present in footwear and footwear components
Leather Synthetic material Natural material Miscellaneous

Substance
Test method
(see Annex B)
Acrylonitrile   5   5  5
AZO - arylamines ISO 17234-1 1 1 1
When 4-aminoazobenzene
AZO - arylamines ISO 17234-2 1 1 1
is suspected
AZO - arylamines EN 14362-1     1 1 1 1 1  1
AZO - arylamines EN 14362-2    1     1
When 4-aminoazobenzene
AZO - arylamines EN 14362-3    1 1 1 1 1 1  1
is suspected
Cadmium All plastics (mainly PVC) EN 1122 1 1 1 1 1 1     1
Chloroorganic carriers DIN 54232    3
Chromium VI
ISO 17075 2 2 2
Colophony         5
Dimethylformamide (DMF)  4  4
Dimethylfumarate (DMFU)
ISO/TS 16186 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
Disperses dyes and dyestuffs DIN 54231    2 2 2 2 2 2
Only for product claiming
Flame retardant 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
FR properties
ISO 17226-1 and
Formaldehyde 2 2 2
ISO 17226-2
Leather
Coated leather
Leather fibre board
PVC
EVA
Rubber
PU – TPU elasthan
PE- PP
Polyester
Polyamide
Chloride fibre
Polyacrylic
Latex
Cellulosic natural textile
Proteinic natural textile
Wood - cork
Adhesives
Metal hardware
Prints for textile
Cellulosic materials
ISO/TR 16178:2012(E)
4 © ISO 2012 – All rights reserved
Table 1 (continued)
Leather Synthetic material Natural material Miscellaneous

Substance
Test method
(see Annex B)
Formaldehyde EN 120 EN 717-3        2  2
Formaldehyde ISO 14184-1    2 2 2 2 2 2
Extractible
ISO 17072-1 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4
(Sb – As – Pb – Cd – Cr –
Co – Cu – Ni – Hg – Zn)
Extractible
Footwear for children less
than 36 months old
ISO 17072-1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
(Sb – As – Pb – Cd – Cr
Heavy metals
– Co – Cu – Ni – Hg – Zn
– Ba – Se)
Total content
ISO 17072-2 4 4 4 4 4 4 4 4 4
...

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