CEN ISO/TR 16178:2021

SLOVENSKI STANDARD
01-december-2021
Nadomešča:
SIST-TP CEN ISO/TR 16178:2012
Obuvala - Nevarne snovi, ki so lahko prisotne v obuvalih in njihovih sestavnih
delih - Seznam kritičnih kemičnih snovi (ISO/TR 16178:2021)
Footwear - Critical substances potentially present in footwear and footwear components
- Lists of critical chemical substances (ISO/TR 16178:2021)
Schuhe - Möglicherweise in Schuhen und Schuhbestandteilen vorhandene kritische
Substanzen (ISO/TR 16178:2021)
Chaussures - Substances critiques potentiellement présentes dans la chaussure et les
composants de chaussures - Listes des substances chimiques critiques (ISO/TR
16178:2021)
Ta slovenski standard je istoveten z: CEN ISO/TR 16178:2021
ICS:
61.060 Obuvala Footwear
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN ISO/TR 16178
TECHNICAL REPORT
RAPPORT TECHNIQUE
October 2021
TECHNISCHER BERICHT
ICS 61.060 Supersedes CEN ISO/TR 16178:2012
English Version
Footwear - Critical substances potentially present in
footwear and footwear components - Lists of critical
chemical substances (ISO/TR 16178:2021)
Chaussures - Substances critiques potentiellement Schuhe - Möglicherweise in Schuhen und
présentes dans la chaussure et les composants de Schuhbestandteilen vorhandene kritische Substanzen
chaussures - Listes des substances chimiques critiques (ISO/TR 16178:2021)
(ISO/TR 16178:2021)
This Technical Report was approved by CEN on 26 July 2021. 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, 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. CEN ISO/TR 16178:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (CEN ISO/TR 16178:2021) 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.
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/TR 16178:2012.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
Endorsement notice
The text of ISO/TR 16178:2021 has been approved by CEN as CEN ISO/TR 16178:2021 without any
modification.
TECHNICAL ISO/TR
REPORT 16178
Third edition
2021-09
Footwear — Critical substances
potentially present in footwear and
footwear components — Lists of
critical chemical substances
Chaussures — Substances critiques potentiellement présentes dans la
chaussure et les composants de chaussures — Listes des substances
chimiques critiques
Reference number
ISO/TR 16178:2021(E)
©
ISO 2021
ISO/TR 16178:2021(E)
© 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.
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO/TR 16178:2021(E)
Contents Page
Foreword .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Presence of chemicals in footwear materials . 2
5 Critical substances potentially present in footwear and footwear components .8
5.1 Acrylonitrile . 8
5.1.1 General. 8
5.1.2 Potential risks . 8
5.1.3 Test methods . 8
5.2 Alkylphenols and Alkylphenol ethoxylates (NP, OP, NPEO, OPEO) . 8
5.2.1 General. 8
5.2.2 Potential risks . 9
5.2.3 Test methods . 9
5.3 Aromatic amines .10
5.3.1 General.10
5.3.2 Potential risks .11
5.3.3 Test methods .11
5.4 Benzene .11
5.4.1 General.11
5.4.2 Potential risks .11
5.4.3 Test methods .11
5.5 Biocides .12
5.5.1 Orthophenylphenol .12
5.5.2 2-(thiocyanatomethylthio)-1,3-benzothiazole (TCMTB) .12
5.5.3 2-octylisothiazol-3(2H)-one (OIT) .13
5.5.4 4-Chloro-3-methylphenol (CMK) .13
5.5.5 Triclosan.14
5.6 Bisphenol .15
5.6.1 General.15
5.6.2 Potential risks .15
5.6.3 Test methods .15
5.7 Cadmium – Cd .15
5.8 Chlorinated paraffins .15
5.8.1 General.15
5.8.2 Potential risks .16
5.8.3 Test methods .16
5.9 Chlorobenzenes and chlorotoluenes .16
5.9.1 General.16
5.9.2 Potential risks .17
5.9.3 Test methods .17
5.10 Chromium and Chromium VI .17
5.11 Colophony .18
5.11.1 General.18
5.11.2 Potential risks .18
5.11.3 Test methods .18
5.12 Dimethylformamide .18
5.12.1 General.18
5.12.2 Potential risks .19
5.12.3 Test methods .19
5.13 Dimethylfumarate (DMFu) .19
5.13.1 General.19
5.13.2 Potential risks .19
ISO/TR 16178:2021(E)
5.13.3 Test methods .20
5.14 Disperses dyes .20
5.14.1 General.20
5.14.2 Potential risks .21
5.14.3 Test methods .21
5.15 Flame retardants .21
5.15.1 General.21
5.15.2 Potential risks .22
5.15.3 Test methods .22
5.16 Formaldehyde .22
5.16.1 General.22
5.16.2 Potential risks .22
5.16.3 Test methods .23
5.17 Heavy metals .23
5.17.1 General.23
5.17.2 List of heavy metals .23
5.17.3 Potential risks .23
5.17.4 Test methods .25
5.17.5 Special cases .25
5.18 Mercaptobenzothiazole .26
5.18.1 General.26
5.18.2 Potential risks .27
5.18.3 Test methods .27
5.19 N-ethylphenylamine .27
5.19.1 General.27
5.19.2 Potential risks .27
5.19.3 Test methods .27
5.20 N methyl-2-pyrrolidone (NMP) .27
5.20.1 General.27
5.20.2 Potential risks .28
5.20.3 Test methods .28
5.21 N,N-dimethylacetamide .28
5.21.1 General.28
5.21.2 Potential risks .28
5.21.3 Test methods .28
5.22 Nickel – Ni .28
5.23 Nitrosamines.28
5.23.1 General.28
5.23.2 Potential risks .29
5.23.3 Test methods .29
5.24 Organotins compounds .29
5.24.1 General.29
5.24.2 Potential risks .30
5.24.3 Test methods .30
5.25 PAHs (Polycyclic aromatic hydrocarbons) .31
5.25.1 General.31
5.25.2 Potential risks .31
5.25.3 Test methods .32
5.26 Paraphenylene diamine .32
5.26.1 General.32
5.26.2 Potential risks .32
5.26.3 Test methods .32
5.27 Pesticides .32
5.27.1 General.32
5.27.2 Potential risks .32
5.27.3 Test methods .33
5.28 Perfluorinated and polyfluorinated chemicals-PFC .33
5.28.1 Different substances .33
iv © ISO 2021 – All rights reserved

ISO/TR 16178:2021(E)
5.28.2 Potential risks .36
5.29 pH .36
5.29.1 General.36
5.29.2 Potential risks .37
5.29.3 Test methods .37
5.30 Phenol .37
5.30.1 General.37
5.30.2 Potential risks .37
5.30.3 Test methods .37
5.31 Phenyl mercury .37
5.31.1 General.37
5.31.2 Potential risks .38
5.31.3 Test methods .38
5.32 Phthalates .38
5.32.1 General.38
5.32.2 Potential risks .40
5.32.3 Test methods .40
5.33 Polychlorophenols .40
5.33.1 General.40
5.33.2 Potential risks .42
5.33.3 Test methods .42
5.34 Paratertiary butyl phenol formaldehyde (PTBF) .42
5.34.1 General.42
5.34.2 Potential risks .42
5.34.3 Test methods .42
5.35 Quinoline .42
5.35.1 General.42
5.35.2 Potential risks .43
5.35.3 Test methods .43
5.36 Thiuram and thiocarbamate.43
5.36.1 General.43
5.36.2 Potential risks .43
5.36.3 Test methods .43
5.37 Volatile organic compounds (VOC) .44
5.37.1 General.44
5.37.2 Potential risks .44
5.37.3 Test methods .44
Bibliography .46
ISO/TR 16178:2021(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/
iso/ foreword .html.
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 third edition cancels and replaces the second edition (ISO/TR 16178:2012), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— new Table 1 including a new system of grading;
— withdrawn substances:
proteins in latex, substances destroying ozone layer, polychlorobiphenyls, polychloroprene, vinyl
chloride;
— added substances:
benzene, bisphenol, NMP, DMAC, phenyl mercury, quinoline, VOC;
— biocides are grouped together (CMK, OIT, OPP, TCMTB);
[67]
— Annex A is now in ISO 21061 ;
— Annex B is now Clause 5;
— bibliography, updated.
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.
vi © ISO 2021 – All rights reserved

TECHNICAL REPORT ISO/TR 16178:2021(E)
Footwear — Critical substances potentially present in
footwear and footwear components — Lists of critical
chemical substances
1 Scope
This document defines lists of critical chemical substances potentially present in footwear and footwear
components.
This document describes the critical chemical substances, their potential risks of nocuousness, in which
materials they could be found, and which test method(s) can be used to quantify them.
The test methods listed indicate the state of the art. For some substances, a test method is not available.
This document is applicable to any kind of footwear and footwear components.
2 Normative references
There are no normative references in this document.
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:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
allergen
substance that is capable of inducing an allergic reaction
3.2
allergy
immunologically mediated response to certain specific substances (allergens)
Note 1 to entry: Type-1 allergy (respiratory allergy) is mediated by IgE antibodies, can cause asthma, rhinitis,
urticaria. Type-4 allergy (dermal allergy) is mediated by T-cells, can cause dermatitis.
3.3
limit of detection
value from which a substance is considered as detectable
Note 1 to entry: 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.
3.4
critical substances
chemical substance that can be found in footwear or footwear components and can have an effect on
the wearer and/or environmental impact due to its chemical reactivity
Note 1 to entry: The effects caused by critical substances vary. It can be carcinogenic or mutagenic effects,
allergy, reaction to toxics, etc.
ISO/TR 16178:2021(E)
3.4.1
critical substances category 1
substances with proven dangerous effect on the wearer
Note 1 to entry: These substances are widely restricted by national regulation in several countries.
3.4.2
critical substances category 2
substances with dangerous effect on the wearer
Note 1 to entry: These substances are restricted by national regulation in a limited number of countries.
3.4.3
critical substances category 3
substances that are highly suspected to have an effect on the wearer
Note 1 to entry: These substances might not be restricted by regulation at the time of publication but they are
frequently requested by the market stakeholders.
3.4.4
critical substances category 4
substances that are suspected to have an effect on the wearer
Note 1 to entry: These substances might not be restricted by regulation. Substances known to have an allergenic
effect on the wearer are included in category 4 for reference.
4 Presence of chemicals in footwear materials
A number of chemicals are present in footwear materials. Table 1 lists the following:
a) in which materials they are supposed to be. The possible materials potentially used in the footwear
[67]
industry are given in ISO 21061:2021 , Annex C.
b) a list of critical chemicals, (see Clause 5 for information);
c) test methods that can be used to quantify them (see Bibliography);
d) the potential risks associated with their use, assessed by the use of the critical substances’ category
scale
1) stand for “critical substances category 1”;
2) stand for “critical substances category 2”;
3) stand for “critical substances category 3”;
4) stand for “critical substances category 4”.
For composite materials, the tests should be conducted on the entire component.
EXAMPLE 1 Coated textile (cotton + PVC coating). Test on PVC and test on cellulosic natural fibres should be
done.
EXAMPLE 2 Mixed textile (PES + cotton). Test on cellulosic natural textile and test on PES textile should be
done.
2 © ISO 2021 – All rights reserved

ISO/TR 16178:2021(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   4   4  4
ISO 18218-1
Alkylphenols( OP, NP) and Alkylpheno-
3 3 3
lethoxylates, (OPEO, NPEO)
ISO 18218-2
ISO 18254-1
Alkylphenols( OP, NP) and Alkylpheno-
2 2 2 2 2 2  2
lethoxylates, (OPEO, NPEO)
ISO 21084
AZO - arylamines ISO 17234-1 1 1 1
When 4-aminoa-
AZO - arylamines zobenzene is sus- ISO 17234-2 1 1 1
pected
AZO - arylamines ISO 14362-1    1 1 1 1 1 1  1
When 4-aminoa-
AZO - arylamines zobenzene is sus- ISO 14362-3    1 1 1 1 1 1  1
pected
Benzene     1 1 1 1 1 1 2
ISO 13365-1
Biocides
and ISO 13365- 4 4 4 4  4 4 4 4 4 4 4 4  4
(TCMTB, OIT, CMK)
ISO 13365-1
Biocides (OPP) and ISO 13365- 2 2 2 2  2 2 2 2 2 2 2 2  2
Biocides (triclosan) EN 17134 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
Bisphenol 2 2 2
All plastics
Cadmium EN 1122 1 1 1 1 1 1     1
(mainly PVC)
Chlorinated paraffin’s (Short chained
ISO 18219-1 2 2 2 2 2 2 2 2 2 2  2
[C10-C13])
Leather
Coated leather
Leather board
PVC
EVA
Rubber
PU –
TPU elastane
PE-T PP
Polyester
Polyamide
Chloride fibre
Polyacrylic
Latex
Cellulosic natu-
ral textile
Proteinic natural
textile
Wood - cork
Adhesives
Metal hardware
Prints for textile
Cellulose
ISO/TR 16178:2021(E)
4 © ISO 2021 – All rights reserved
Table 1 (continued)
Leather Synthetic material Natural material Miscellaneous
Substance
Test method
(see Annex B)
Chlorinated paraffin’s (Middle chained
ISO 18219-2 3 3 3 3 3 3 3 3 3 3  3
[C14-C17])
Chlorobenzene and chlorotoluene EN 17137    2
Chlorobenzene and chlorotoluene (tetra-
chorotoluene, trichlorotoluene, αchlo- EN 17137    2 2 2 2 2 2
rotoluene)
ISO 17075-1
Chromium VI 1 1 1
ISO 17075-2
Chromium VI With ageing ISO 10195 3 3 3
Colophony         4
Dimethylformamide (DMF) ISO 16189 2  2
Dimethylfumarate (DMFu) ISO 16186 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
ISO 16373-2
Disperses dyes and dyestuffs    2 2 2 2 2 2  2
ISO 16373-3
Flame retard-
ant
ISO 17881-1
Only for product claim-
(Phosphorated 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1
ing FR properties
ISO 17881-2
and brominat-
ed)
ISO 17226-1
Formaldehyde 2 2 2
ISO 17226-2
EN 120
Formaldehyde        2  2
EN 717-3
Formaldehyde ISO 27587        3
Formaldehyde ISO 14184-1    1 1 1 1 1 1  1
Leather
Coated leather
Leather board
PVC
EVA
Rubber
PU –
TPU elastane
PE-T PP
Polyester
Polyamide
Chloride fibre
Polyacrylic
Latex
Cellulosic natu-
ral textile
Proteinic natural
textile
Wood - cork
Adhesives
Metal hardware
Prints for textile
Cellulose
ISO/TR 16178:2021(E)
Table 1 (continued)
Leather Synthetic material Natural material Miscellaneous
Substance
Test method
(see Annex B)
Extractible
ISO 17072-1
3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3
(Sb – As –Cd – Cr – Co –
EN 16711-2
Cu – Ni – Hg – Zn)
E x t r a c t i b le
Footwear for children
less than 36 months ISO 17072-1
2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
Heavy
...