CEN/TR 16417:2016
(Main)Footwear - Footwear industry guideline for substances of very high concern (Annex XIV of REACH)
Footwear - Footwear industry guideline for substances of very high concern (Annex XIV of REACH)
This Technical Report is intended to provide information on the chemicals listed in the Candidate List / Annex XIV of the Regulation (EC) 1907/2006, also known as REACH (Regulation, Evaluation and Authorisation of Chemicals) and their usage and presence in the footwear industry.
The Annex XIV, overseen by the ECHA (European Chemicals Agency), is a list of substances subject to authorization, substances of very high concern (SVHC). Before the inclusion of a substance in the Annex XIV, the procedure is strictly fixed:
- A European member state shall propose it to ECHA.
- ECHA inform all the members’ state and a first enquiry is done in order to include the substance to the candidate list of Annex XIV.
- After the agreement of the member’s state, ECHA includes the substances in the candidate list to Annex XIV. As soon as a substance has been included in the candidate list, it should be taken into account exactly as a SVHC.
- ECHA prioritises the substances from the Candidate List to determine which ones should be included in the Authorisation List (Annex XIV of REACH) and therefore, subject to authorisation. ECHA regularly submits recommendations to the European Commission, who will decide on the substances to be included in the Authorisation List.
Following the evaluation of the Annex XIV substances, ECHA can take the decision to restrict the substances. This restriction may take the form of an authorization for use, an authorisation only for specific applications in specified fields or, in some cases, a complete ban on the use of the substance.
During the evaluation process, these chemicals are not forbidden or limited in use. The regulation requires that the user shall be informed if one or more of these substances are present in any part of the article in quantity over 0,1 % by weight.
This Technical Report shows which of these chemicals may be present in footwear materials and the footwear industry in order to help shoe manufacturers to collect mandatory information from suppliers regarding the content of these chemicals and, at same time, allow them to provide accurate information to their customers.
The test methods reported in Annex 1 are informative only to identify where these chemicals may be found and control the use along the supply chain where their suppliers are not under the jurisdiction of the REACH Regulation.
Taking into account final decision of the European Commission, ECHA, implements the Annex XIV and the candidate list to Annex XIV of REACH, regularly. This revision interval is difficult to follow by the standardization procedures.
Therefore this document reflects the situation at the date of June 2014. This document will be annually revised.
This Technical Report does not concern the substances for which restriction have been already enacted under Annex XVII of REACH.
NOTE Chemicals that are restricted under Annex XVII, are identified as a category 1 chemical in CEN ISO/TR 16178.
Schuhe - Leitfaden für die Schuhindustrie für sehr bedenkliche Substanzen (Anhang XIV von REACH)
Chaussures - Lignes directrice pour l’industrie de la chaussure relatives aux substances extrêmement préoccupantes (annexe XIV de REACH)
Le présent Rapport technique est destiné à fournir des informations sur les produits chimiques figurant dans la liste candidate / Annexe XIV du Règlement (CE) n° 1907/2006, également connu sous le nom de REACH (enregistrement, évaluation et autorisation des substances chimiques, ainsi que restrictions applicables à ces substances), ainsi que sur leur usage et leur présence dans l’industrie de la chaussure.
L’Annexe XIV, supervisée par l’ECHA (Agence européenne des produits chimiques), est une liste des substances soumises à autorisation et des substances extrêmement préoccupantes (SVHC). Avant d’inclure une substance dans l’Annexe XIV, le mode opératoire à suivre est établi de manière stricte :
— Un État membre européen doit la proposer à l’ECHA.
— L’ECHA en informe tous les États membres et une première enquête est menée afin d’inclure la substance à la liste candidate de l’Annexe XIV.
— Après accord des États membres, l’ECHA inclut la substance à la liste candidate de l’Annexe XIV. Dès qu’une substance a été incluse à la liste candidate, il convient de la prendre en compte exactement de la même manière qu’une SVHC.
— L’ECHA hiérarchise les substances de la liste candidate afin de déterminer celles qu’il convient d’inclure à la liste d’autorisation (Annexe XIV du REACH) et qui sont donc soumises à autorisation. L’ECHA soumet régulièrement des recommandations à la Commission européenne, qui décide ensuite des substances à inclure à la liste d’autorisation.
Après évaluation des substances figurant dans l’Annexe XIV, l’ECHA peut prendre la décision de limiter lesdites substances. Cette restriction peut prendre la forme d’une autorisation d’utilisation, d’une autorisation uniquement pour des applications spécifiques dans des domaines spécifiés ou, dans certains cas, d’une interdiction totale d’utilisation de la substance.
Au cours du processus d’évaluation, ces produits chimiques ne sont pas interdits ni leur utilisation limitée. Le règlement exige que l’utilisateur soit informé si une ou plusieurs de ces substances sont présentes dans une partie quelconque de l’article en quantité supérieure à 0,1 % en masse.
Le présent Rapport technique indique lesquels de ces produits chimiques peuvent être présents dans les matériaux de chaussures et dans l’industrie de la chaussure, afin d’aider les fabricants de chaussures à recueillir les informations obligatoires auprès des fournisseurs en ce qui concerne la teneur de ces produits chimiques et, dans le même temps, leur permettre de fournir des informations exactes à leurs clients.
Les méthodes d’essai mentionnées dans l’Annexe A sont informatives uniquement et servent à identifier où ces produits chimiques peuvent être présents et à maîtriser leur utilisation le long de la chaîne d’approvisionnement lorsque leurs fournisseurs ne sont pas sous la juridiction du Règlement REACH.
En tenant compte de la décision finale de la Commission européenne, l’ECHA met régulièrement à jour l’Annexe XIV et la liste candidate de l’Annexe XIV du REACH. Cet intervalle de révision est difficile à appliquer dans le cadre des procédures de normalisation.
Par conséquent, le présent document reflète la situation à la date de juin 2014. Le présent document sera révisé annuellement.
Le présent Rapport technique ne concerne pas les substances pour lesquelles une restriction est déjà en vigueur au titre de l’Annexe XVII du REACH.
Obutev - Smernica, namenjena obutveni industriji, o snoveh, ki zelo zbujajo skrb (Priloga XIV iz REACH)
To tehnično poročilo zagotavlja informacije o kemikalijah, navedenih na seznamu kandidatnih snovi/dodatku XIV Uredbe (ES) 1907/2006, poimenovane tudi REACH (Regulation, Evaluation and Authorisation of Chemicals; Registracija, evalvacija in avtorizacija kemikalij), ter o njihovi uporabi in prisotnosti v obutveni industriji.
Dodatek XIV, ki je pod nadzorom Evropske agencije za kemikalije (ECHA), je seznam snovi, ki čakajo na avtorizacijo, pri čemer gre za snovi, ki vzbujajo veliko zaskrbljenost (SVHC). Postopek vključitve snovi na seznam v dodatku XIV je strogo določen:
Država članica EU snov predlaga Evropski agenciji za kemikalije.
Evropska agencija za kemikalije obvesti vse države članice in izvede se prva raziskava za vključitev snovi na seznam kandidatnih snovi v dodatku XIV.
Evropska agencija za kemikalije po dogovoru z državo članico snovi vključi na seznam kandidatnih snovi v dodatku XIV. Takoj, ko je snov vključena na seznam kandidatnih snovi, naj bi jo obravnavali kot snov, ki vzbuja veliko zaskrbljenost.
Evropska agencija za kemikalije dodeljuje prednost snovem na seznamu kandidatnih snovi, da ugotovi, katere naj bi vključili na seznam za avtorizacijo (dodatek XIV uredbe REACH) in jih posledično avtorizirali. Evropska agencija za kemikalije svoja priporočila redno posreduje Evropski komisiji, ki odloči, katere snovi bodo vključene na seznam za avtorizacijo.
Po analizi snovi iz dodatka XIV Evropska agencija za kemikalije lahko sprejme sklep o omejitvah za snov. Ta omejitev je lahko implementirana kot avtorizacija za uporabo, avtorizacija zgolj za določene vrste in področja uporabe, ali v nekaterih primerih kot popolna prepoved za uporabo snovi.
V času analize kemikalij slednje niso prepovedane oziroma njihova uporaba ni omejena. Uredba zahteva, da je treba uporabnika obvestiti, če je ena ali več teh snovi prisotna v katerem koli delu izdelka v količini, večji od 0,1 % glede na težo izdelka.
To tehnično poročilo navaja, katere od teh kemikalij so lahko prisotne v materialu za obutev in obutveni industriji, s čimer proizvajalcem čevljev pomaga pri zbiranju obveznih informacij od dobaviteljev v zvezi z vsebnostjo teh kemikalij in jim obenem omogoča, da strankam zagotovijo natančne informacije.
Preskusne metode, navedene v dodatku A, so zgolj informativne narave in pomagajo določiti mesta prisotnosti teh kemikalij ter omogočajo nadzor uporabe v dobavni verigi, v kateri dobavitelji teh kemikalij niso v pristojnosti uredbe REACH.
Evropska agencija za kemikalije ob upoštevanju končne odločitve Evropske komisije redno implementira dodatek XIV in seznam kandidatnih snovi v dodatku XIV uredbe REACH. Standardizacijski postopki le stežka upoštevajo ta interval revizije,
zato ta dokument odraža položaj iz junija 2013. Ta dokument bo letno revidiran.
To tehnično poročilo ne zajema snovi, za katere je bila omejitev v skladu z dodatkom XVII uredbe REACH že uzakonjena.
OPOMBA: Kemikalije, omejene na podlagi dodatka XVII, so v standardu CEN ISO/TR 16178 opredeljene kot kemikalije 1. kategorije.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
kSIST-TP FprCEN/TR 16417:2014
01-november-2014
Obutev – Smernica, namenjena obutveni industriji, o snoveh, ki zelo zbujajo skrb
(Priloga XIV iz REACH)
Footwear - Footwear industry guideline for substances of very high concern (Annex XIV
of REACH)
Schuhe - Leitfaden für die Schuhindustrie für sehr bedenkliche Substanzen (Anhang XIV
von REACH)
Chaussures - Lignes directrice de l’industrie de la chaussure concernant les substances
extrêmement préoccupantes (annexe XIV de REACH)
Ta slovenski standard je istoveten z: FprCEN/TR 16417
ICS:
61.060 Obuvala Footwear
kSIST-TP FprCEN/TR 16417:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
kSIST-TP FprCEN/TR 16417:2014
kSIST-TP FprCEN/TR 16417:2014
TECHNICAL REPORT
FINAL DRAFT
FprCEN/TR 16417
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
September 2014
ICS 61.060 Will supersede CEN/TR 16417:2012
English Version
Footwear - Footwear industry guideline for substances of very
high concern (Annex XIV of REACH)
Chaussures - Lignes directrice de l'industrie de la Schuhe - Leitfaden für die Schuhindustrie für sehr
chaussure concernant les substances extrêmement bedenkliche Substanzen (Anhang XIV von REACH)
préoccupantes (annexe XIV de REACH)
This draft Technical Report is submitted to CEN members for Technical Committee Approval. 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.
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.
Warning : This document is not a Technical Report. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a Technical Report.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TR 16417:2014 E
worldwide for CEN national Members.
kSIST-TP FprCEN/TR 16417:2014
FprCEN/TR 16417:2014 (E)
Contents Page
Foreword .3
1 Scope .4
2 Terms and definitions .5
3 SVHC potentially present in the footwear industry .6
3.1 General .6
3.2 SVHC included in Annex XIV of REACH .6
3.3 SVHC included in the candidate list of Annex XIV of REACH . 10
Annex A (informative) Available test methods for the identification of the substances of very high
concern given in the future REACH- Annex XIV . 29
Bibliography . 41
kSIST-TP FprCEN/TR 16417:2014
FprCEN/TR 16417:2014 (E)
Foreword
This document (FprCEN/TR 16417:2014) has been prepared by Technical Committee CEN/TC 309
“Footwear”, the secretariat of which is held by AENOR.
This document is currently submitted to the Technical Committee Approval.
This document will supersede CEN/TR 16417:2012.
kSIST-TP FprCEN/TR 16417:2014
FprCEN/TR 16417:2014 (E)
1 Scope
This Technical Report is intended to provide information on the chemicals listed in the Candidate List /
Annex XIV of the Regulation (EC) 1907/2006, also known as REACH (Regulation, Evaluation and
Authorisation of Chemicals) and their usage and presence in the footwear industry.
The Annex XIV, overseen by the ECHA (European Chemicals Agency), is a list of substances subject to
authorization, substances of very high concern (SVHC). Before the inclusion of a substance in the Annex XIV,
the procedure is strictly fixed :
A European member state shall propose it to ECHA.
ECHA inform all the members’ state and a first enquiry is done in order to include the substance to the
candidate list of Annex XIV.
After the agreement of the member’s state, ECHA includes the substances in the candidate list to Annex XIV.
As soon as a substance has been included in the candidate list, it should be taken into account exactly as a
SVHC.
ECHA prioritizes the substances from the Candidate List to determine which ones should be included in the
Authorisation List (Annex XIV of REACH) and therefore, subject to authorization. ECHA regularly submits
recommendations to the European Commission, who will decide on the substances to be included in the
Authorisation List.
Following the evaluation of the Annex XIV substances, ECHA can take the decision to restrict the substances.
This restriction may take the form of an authorization for use, an authorization only for specific applications in
specified fields or, in some cases, a complete ban on the use of the substance.
During the evaluation process, these chemicals are not forbidden or limited in use. The regulation requires
that the user shall be informed if one or more of these substances are present in any part of the Article in
quantity over 0,1% by weight.
This Technical Report shows which of these chemicals may be present in footwear materials and the footwear
industry in order to help shoe manufacturers to collect mandatory information from suppliers regarding the
content of these chemicals and, at same time, allow them to provide accurate information to their customers.
The test methods reported in Annex A are informative only to identify where these chemicals may be found
and control the use along the supply chain where their suppliers are not under the jurisdiction of the REACH
Regulation.
Taking into account final decision of the European Commission, ECHA, implements the Annex XIV
and the candidate list to Annex XIV of REACH, regularly. This revision interval is difficult to follow by
the standardization procedures.
Therefore, this document reflects the situation at the date of June 2013. This document will be
annually revised.
This Technical Report does not concern the substances for which restriction have been already enacted under
Annex XVII of REACH.
NOTE Chemicals that are restricted under Annex XVII, are identified as a category 1 chemical in
CEN ISO/TR 16178.
kSIST-TP FprCEN/TR 16417:2014
FprCEN/TR 16417:2014 (E)
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
Very Persistent and Very Bioaccumulative substance
vPvB
substance that fulfils the criteria of both the sections below:
a) Persistence
1) the half-life in marine, fresh- or estuarine water is higher than 60 d, or
2) the half-life in marine, fresh- or estuarine water sediment is higher than 180 d, or
3) the half-life in soil is higher than 180
b) Bioaccumulation
1) the bioconcentration factor is greater than 5 000
2.2
Persistent, Bioaccumulative and Toxic substance
PBT
substance that fulfils all three of the criteria of the sections below:
a) Persistence
1) the half-life in marine water is higher than 60 d, or
2) the half-life in fresh- or estuarine water is higher than 40 d, or
3) the half-life in marine sediment is higher than 180 d, or
4) the half-life in fresh- or estuarine water sediment is higher than 120 d, or
5) the half-life in soil is higher than 120 d
b) Bioaccumulation
1) the bioconcentration factor (BCF) is higher than 2 000
c) Toxicity
1) the long-term no-observed effect concentration (Noec) for marine or freshwater organisms is less
than 0,01 mg/l, or
2) the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2) or toxic for
reproduction (category 1, 2, or 3), or
3) there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48
according to Directive 67/548/EEC
kSIST-TP FprCEN/TR 16417:2014
FprCEN/TR 16417:2014 (E)
3 SVHC potentially present in the footwear industry
3.1 General
The following subclauses contain tables with the substances of very high concern (SVHC) that could be found
in the footwear or in the footwear components.
3.2 SVHC included in Annex XIV of REACH
Table 1 includes the substances of very high concern included, at the moment of publication of this Technical
th
Report, in Annex XIV of REACH (see Regulation (EU) N°348/2013 17 April 2013).
Table 1 — Identification of substances of very high concern included in Annex XIV of REACH —
th
Regulation (EU) N°348/2013 17 April 2013
CAS EC Reason for Occurrence
Substance name Group
number number inclusion in Footwear
Not used in
5-tert-butyl-2,4,6-trinitro- 201-329- vPvB (Article footwear or
1.1 81-15-2
m-xylene (musk xylene) 4 57e) footwear
components
Not used as a
free
compound
This
substance
can be
detected after
the
degradation
of:
4,4’- 202-974- Carcinogenic
azo colorant,
1.2 101-77-9 Aryl amine
Diaminodiphenylmethane 4 (Article 57a)
see Annex
XVII of
Reach)
PU material,
(false positive
result is
possible,
generated as
a marker in
testing of PU
material)
25637-
99-4 and
Not used in
3194-55-
Hexabromocyclododecane
247-148- footwear or
(HBCDD) and all major
4 footwear
diastereoisomers PBT (Article
and components
(134237-
1.3
identified 57d)
51-7,
221-695- (flame
(α – HBCDD, β-HBCDD,
134237-
9 retardant for
γ-HBCDD)
50-6,
electronics)
134237-
52-8)
kSIST-TP FprCEN/TR 16417:2014
FprCEN/TR 16417:2014 (E)
CAS EC Reason for Occurrence
Substance name Group
number number inclusion in Footwear
Possible
Bis (2- Toxic for
(concentration
204-211-
a
1.4 ethyl(hexyl)phthalate) 117-81-7 phthalate reproduction
higher than
(DEHP) (Article 57c)
0,1%
possible)
Possible
Toxic for
(concentration
Benzyl butyl phthalate 201-622-
a
1.5 85-68-7 phthalate reproduction
higher than
(BBP) 7
(Article 57c)
0,1%
possible)
Possible
Toxic for
(concentration
201-557-
a
1.6 Dibutyl phthalate (DBP) 84-74-2 phthalate reproduction
higher than
(Article 57c)
0,1%
possible)
Not used in
2,4 – Dinitrotoluene (2,4- 204-450- Aromatic Carcinogenic footwear or
1.7 121-14-2
DNT) 0 hydrocarbons (Article 57a) footwear
components
Not used in
footwear or
footwear
components
Tris(2- Tris(2- Toxic for
204-118-
1.8 chloroethyl)phosphate 115-96-8 chloroethyl)phosphate reproduction
(flame
(TCEP) (TCEP) (Article 57c)
retardant for
furniture,
plasticizer for
PU-PVC)
Not used in
1303-28- 215-116- Carcinogenic footwear or
1.9 Diarsenic pentaoxide Arsenic compounds
2 9 (Article 57a) footwear
components
Carcinogenic possible
and toxic for pigment in
Lead sulfochromate yellow 1344-37- 215-693- Substances
a
1.10 reproduction certain
(C.I. Pigment Yellow 34) 2 7 containing lead
(Articles 57 a surface
and 57 c) coating
Carcinogenic possible
Lead chromate molybdate and toxic for pigment in
12656- 235-759- Substances
a
1.11 sulphate red (C.I. Pigment reproduction certain
85-8 9 containing lead
Red 104) (Articles 57 a surface
and 57 c) coating
Not used in
1327-53- 215-481- Carcinogenic
footwear or
1.12 Diarsenic trioxide Arsenic compounds
3 4 (Article 57a) footwear
components
Carcinogenic possible
a 7758-97- 231-846- Substances
1.13 Lead chromate
and toxic for pigment in
6 0 containing chromate
reproduction certain
kSIST-TP FprCEN/TR 16417:2014
FprCEN/TR 16417:2014 (E)
CAS EC Reason for Occurrence
Substance name Group
number number inclusion in Footwear
(Articles 57 a surface
and 57 c) coating
Possible
Toxic for
(concentration
a Diisobutyl phthalate 201-553-
1.14 84-69-5 phthalate reproduction
higher than
(DIBP) 2
(Article 57c)
0,1%
possible)
Solvent used
in not
flammable
adhesive,
volatile
product can
be present
201-167- Carcinogenic
only as a
1.15 Trichloroethylene 79-01-6 Chlorinated aliphates
4 (Article 57 a)
residue.
More possible
to detect in
the packaging
of footwear
than in the
footwear itself
Not used in
footwear or
Carcinogenic
footwear
and
1333-82- 215-607- Substances components
1.16 Chromium trioxide mutagenic
0 8 containing chromium (Cr VI
(Articles 57a
possible in
and 57b)
leather at low
concentration)
Not used in
7738-94- footwear or
231-801-
5, footwear
Chromic acid, Dichromic 5, 236-
Substances Carcinogenic
13530- components
1.17 acid, Oligomers of chromic 881-5,
68-2, not containing chromium (Article 57a) (Cr VI
acid and dichromic acid not yet
yet possible in
assigned
assigned leather at low
concentration)
Not used in
Carcinogenic, footwear or
7789-12-
mutagenic footwear
0 and 234-190- Substances and toxic for components
1.18 Sodium dichromate
10588- 3 containing chromate reproduction (Cr VI
01-9 (Articles 57a, possible in
57b and 57c) leather at low
concentration)
Carcinogenic, Not used in
mutagenic footwear or
7778-50- 231-906- Substances
and toxic for footwear
1.19 Potassium dichromate
9 6 containing chromate
reproduction components
(Articles 57a, (Cr VI
57b possible in
kSIST-TP FprCEN/TR 16417:2014
FprCEN/TR 16417:2014 (E)
CAS EC Reason for Occurrence
Substance name Group
number number inclusion in Footwear
and 57c) leather at low
concentration)
Not use
...
SLOVENSKI STANDARD
01-marec-2016
1DGRPHãþD
SIST-TP CEN/TR 16417:2014
Obutev - Smernica, namenjena obutveni industriji, o snoveh, ki zelo zbujajo skrb
(Priloga XIV iz REACH)
Footwear - Footwear industry guideline for substances of very high concern (Annex XIV
of REACH)
Schuhe - Leitfaden für die Schuhindustrie für sehr bedenkliche Substanzen (Anhang XIV
von REACH)
Chaussures - Lignes directrice de l’industrie de la chaussure concernant les substances
extrêmement préoccupantes (annexe XIV de REACH)
Ta slovenski standard je istoveten z: CEN/TR 16417:2016
ICS:
61.060 Obuvala Footwear
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN/TR 16417
TECHNICAL REPORT
RAPPORT TECHNIQUE
January 2016
TECHNISCHER BERICHT
ICS 61.060 Supersedes CEN/TR 16417:2012
English Version
Footwear - Footwear industry guideline for substances of
very high concern (Annex XIV of REACH)
Chaussures - Lignes directrice de l'industrie de la Schuhe - Leitfaden für die Schuhindustrie für sehr
chaussure concernant les substances extrêmement bedenkliche Substanzen (Anhang XIV von REACH)
préoccupantes (annexe XIV de REACH)
This Technical Report was approved by CEN on 24 August 2015. 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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 16417:2016 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
1 Scope . 4
2 Terms and definitions . 5
3 SVHC potentially present in the footwear industry . 6
3.1 General . 6
3.2 SVHC included in Annex XIV of REACH. 6
3.3 SVHC included in the candidate list of Annex XIV of REACH . 11
Annex A (informative) Available test methods for the identification of the substances of
very high concern given in the future REACH — Annex XIV . 29
Bibliography . 39
European foreword
This document (CEN/TR 16417:2016) has been prepared by Technical Committee CEN/TC 309
“Footwear”, the secretariat of which is held by AENOR.
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/TR 16417:2012.
In comparison with the previous edition, the most significant changes are:
— inclusion of the new substances (Tables 9 to 13) published in the candidate list of Annex XIV of
REACH after January 2012;
— substances from Tables 2 to 8 have been transferred to table after their final inclusion in Annex XIV
of REACH;
— the new substances of Tables 9 to 13 have been added in the annex.
1 Scope
This Technical Report is intended to provide information on the chemicals listed in the Candidate List /
Annex XIV of the Regulation (EC) 1907/2006, also known as REACH (Regulation, Evaluation and
Authorisation of Chemicals) and their usage and presence in the footwear industry.
The Annex XIV, overseen by the ECHA (European Chemicals Agency), is a list of substances subject to
authorization, substances of very high concern (SVHC). Before the inclusion of a substance in the
Annex XIV, the procedure is strictly fixed:
— A European member state shall propose it to ECHA.
— ECHA inform all the members’ state and a first enquiry is done in order to include the substance to
the candidate list of Annex XIV.
— After the agreement of the member’s state, ECHA includes the substances in the candidate list to
Annex XIV. As soon as a substance has been included in the candidate list, it should be taken into
account exactly as a SVHC.
— ECHA prioritizes the substances from the Candidate List to determine which ones should be
included in the Authorisation List (Annex XIV of REACH) and therefore, subject to authorization.
ECHA regularly submits recommendations to the European Commission, who will decide on the
substances to be included in the Authorisation List.
Following the evaluation of the Annex XIV substances, ECHA can take the decision to restrict the
substances. This restriction may take the form of an authorization for use, an authorization only for
specific applications in specified fields or, in some cases, a complete ban on the use of the substance.
During the evaluation process, these chemicals are not forbidden or limited in use. The regulation
requires that the user shall be informed if one or more of these substances are present in any part of the
article in quantity over 0,1 % by weight.
This Technical Report shows which of these chemicals may be present in footwear materials and the
footwear industry in order to help shoe manufacturers to collect mandatory information from suppliers
regarding the content of these chemicals and, at same time, allow them to provide accurate information
to their customers.
The test methods reported in Annex A are informative only to identify where these chemicals may be
found and control the use along the supply chain where their suppliers are not under the jurisdiction of
the REACH Regulation.
Taking into account final decision of the European Commission, ECHA, implements the Annex XIV and
the candidate list to Annex XIV of REACH, regularly. This revision interval is difficult to follow by the
standardization procedures.
Therefore this document reflects the situation at the date of June 2014. This document will be annually
revised.
This Technical Report does not concern the substances for which restriction have been already enacted
under Annex XVII of REACH.
NOTE Chemicals that are restricted under Annex XVII, are identified as a category 1 chemical in
CEN ISO/TR 16178.
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
Very Persistent and Very Bioaccumulative substance
vPvB
substance that fulfils the criteria of both the sections below:
a) Persistence
1) the half-life in marine, fresh- or estuarine water is higher than 60 d, or
2) the half-life in marine, fresh- or estuarine water sediment is higher than 180 d, or
3) the half-life in soil is higher than 180 d
b) Bioaccumulation
1) the bioconcentration factor is greater than 5 000
2.2
Persistent, Bioaccumulative and Toxic substance
PBT
substance that fulfils all three of the criteria of the sections below:
a) Persistence
1) the half-life in marine water is higher than 60 d, or
2) the half-life in fresh- or estuarine water is higher than 40 d, or
3) the half-life in marine sediment is higher than 180 d, or
4) the half-life in fresh- or estuarine water sediment is higher than 120 d, or
5) the half-life in soil is higher than 120 d
b) Bioaccumulation
1) the bioconcentration factor (BCF) is higher than 2 000
c) Toxicity
1) the long-term no-observed effect concentration (Noec) for marine or freshwater organisms is
less than 0,01 mg/l, or
2) the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2) or
toxic for reproduction (category 1, 2, or 3), or
3) there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48
according to Directive 67/548/EEC
3 SVHC potentially present in the footwear industry
3.1 General
The following subclauses contain tables with the substances of very high concern (SVHC) that could be
found in the footwear or in the footwear components.
3.2 SVHC included in Annex XIV of REACH
Table 1 includes the substances of very high concern included, at the moment of publication of this
th
Technical Report, in Annex XIV of REACH after the 17 April 2014.
Table 1 — Identification of substances of very high concern included in Annex XIV of REACH —
th
after the 17 April 2014
Reason for Occurrence in
ID Substance name CAS number EC number Group
inclusion footwear
Not used in
5-tert-butyl-2,4,6-trinitro- vPvB footwear or
1.1 81-15-2 201-329-4
m-xylene (musk xylene) (article 57e) footwear
components
Not used as a free
compound
This substance can
be detected after
the degradation of:
— azo colorant,
see Annex XVII
4,4’- Carcinogenic
of Reach)
1.2 101-77-9 202-974-4 Aryl amine
Diaminodiphenylmethane (article 57a)
— PU material,
(false positive
result is
possible,
generated as a
marker in
testing of PU
material)
Not used in
Hexabromocyclododecane 25637-99-4 and
footwear or
(HBCDD) and all major 3194-55-6 247-148-4
PBT footwear
1.3 diastereoisomers identified (134237-51-7, and
(article 57d) components
(α – HBCDD, β-HBCDD, 134237-50-6, 221-695-9
(flame retardant for
γ-HBCDD) 134237-52-8)
electronics)
Possible
Bis (2- Toxic for
(concentration
a
1.4 ethyl(hexyl)phthalate) 117-81-7 204-211-0 Phthalate reproduction
higher than 0,1 %
(DEHP) (article 57c)
possible)
Possible
Toxic for
Benzyl butyl phthalate (concentration
a
1.5 85-68-7 201-622-7 Phthalate reproduction
(BBP) higher than 0,1 %
(article 57c)
possible)
Reason for Occurrence in
ID Substance name CAS number EC number Group
inclusion footwear
Possible
Toxic for
(concentration
a
1.6 Dibutyl phthalate (DBP) 84-74-2 201-557-4 Phthalate reproduction
higher than 0,1 %
(article 57c)
possible)
Not used in
2,4 – Dinitrotoluene Aromatic Carcinogenic footwear or
1.7 121-14-2 204-450-0
(2,4-DNT) hydrocarbons (article 57a) footwear
components
Not used in
footwear or
Tris(2- footwear
Tris(2- Toxic for
chloroethyl) components
1.8 chloroethyl)phosphate 115-96-8 204-118-5 reproduction
phosphate (flame retardant for
(TCEP) (article 57c)
(TCEP) furniture,
plasticizer for
PU-PVC)
Not used in
Arsenic Carcinogenic footwear or
1.9 Diarsenic pentaoxide 1303-28-2 215-116-9
compounds (article 57a) footwear
components
Carcinogenic
Substances and toxic for Possible pigment in
Lead sulfochromate yellow
1.10 1344-37-2 215-693-7 containing reproduction certain surface
(C.I. Pigment Yellow 34)
lead (articles 57a coating
and 57c)
Carcinogenic
Lead chromate molybdate Substances and toxic for Possible pigment in
1.11 sulphate red (C.I. Pigment 12656-85-8 235-759-9 containing reproduction certain surface
Red 104) lead (articles 57a coating
and 57c)
Not used in
Arsenic Carcinogenic footwear or
1.12 Diarsenic trioxide 1327-53-3 215-481-4
compounds (article 57a) footwear
components
Carcinogenic
Substances and toxic for Possible pigment in
1.13 Lead chromate 7758-97-6 231-846-0 containing reproduction certain surface
chromate (articles 57a coating
and 57c)
Possible
Toxic for
Diisobutyl phthalate (concentration
a
1.14 84-69-5 201-553-2 phthalate reproduction
(DIBP) higher than 0,1 %
(article 57c)
possible)
Reason for Occurrence in
ID Substance name CAS number EC number Group
inclusion footwear
Solvent used in not
flammable
adhesive, volatile
product can be
present only as a
Chlorinated Carcinogenic
1.15 Trichloroethylene 79-01-6 201-167-4
residue
aliphates (article 57a)
More possible to
detect in the
footwear packaging
than in the footwear
Not used in
footwear or
Carcinogenic
Substances footwear
and mutagenic
1.16 Chromium trioxide 1333-82-0 215-607-8 containing components
(articles 57a
chromium (Cr VI possible in
and 57b)
leather at low
concentration)
Not used in
footwear or
231-801-5,
Chromic acid, Dichromic 7738-94-5, Substances footwear
236-881-5, Carcinogenic
1.17 acid, Oligomers of chromic 13530-68-2, not containing components
not yet (article 57a)
acid and dichromic acid yet assigned chromium (Cr VI possible in
assigned
leather at low
concentration)
Not used in
Carcinogenic,
footwear or
mutagenic and
Substances footwear
7789-12-0 and toxic for
1.18 Sodium dichromate 234-190-3 containing components
10588-01-9 reproduction
chromate (Cr VI possible in
(articles 57a,
leather at low
57b and 57c)
concentration)
Not used in
Carcinogenic,
footwear or
mutagenic and
Substances footwear
toxic for
1.19 Potassium dichromate 7778-50-9 231-906-6 containing components
reproduction
chromate (Cr VI possible in
(articles 57a,
leather at low
57b and 57c)
concentration)
Not used in
Carcinogenic,
footwear or
mutagenic and
Substances footwear
toxic for
1.20 Ammonium dichromate 7789-09-5 232-143-1 containing components
reproduction
chromate (Cr VI possible in
(art
...
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