1、BSI Standards Publication PD CEN/TR 16417:2016 Footwear Footwear industry guideline for substances of very high concern (Annex XIV of REACH)PD CEN/TR 16417:2016 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of CEN/TR 16417:2016. It supersedes PD CEN/TR 16417:2
2、012 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee TCI/69, Footwear. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a con
3、tract. Users are responsible for its correct application. The British Standards Institution 2016. Published by BSI Standards Limited 2016 ISBN 978 0 580 83737 1 ICS 61.060 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the
4、authority of the Standards Policy and Strategy Committee on 31 January 2016. Amendments/corrigenda issued since publication Date Text affectedPD CEN/TR 16417:2016 TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT C E N / T R 1 6 4 1 7 J a n u a r y 2 0 1 6 ICS 61.060 Supersedes CEN/TR 16417:201
5、2 English Version Footwear - Footwear industry guideline for substances of very high concern (Annex XIV of REACH) Chaussures - Lignes directrice de lindustrie de la chaussure concernant les substances extrmement proccupantes (annexe XIV de REACH) Schuhe - Leitfaden fr die Schuhindustrie fr sehr bede
6、nkliche Substanzen (Anhang XIV von 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,
7、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 CO
8、MIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 worldwide for CEN national Members. Ref. No. CEN/TR 16417:2016 EPD CEN/TR 16417:2016 CEN/TR 16417:201
9、6 (E) 2 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 Annex A (informative) Available test methods for the identification of the substances of 3.3 SVHC include
10、d in the candidate list of Annex XIV of REACH 11 very high concern given in the future REACH Annex XIV . 29 Bibliography . 39 PD CEN/TR 16417:2016 CEN/TR 16417:2016 (E) 3 European foreword This document (CEN/TR 16417:2016) has been prepared by Technical Committee CEN/TC 309 “Footwear”, the secretari
11、at 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 compariso
12、n 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; th
13、e new substances of Tables 9 to 13 have been added in the annex. PD CEN/TR 16417:2016 CEN/TR 16417:2016 (E) 4 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,
14、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 Anne
15、x 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 members state, ECHA includes the substances in the
16、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 theref
17、ore, 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
18、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
19、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 i
20、nformation 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 whe
21、re 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 proce
22、dures. 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
23、, are identified as a category 1 chemical in CEN ISO/TR 16178. PD CEN/TR 16417:2016 CEN/TR 16417:2016 (E) 5 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 cri
24、teria 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 bioconcentrat
25、ion 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,
26、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-o
27、bserved 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 ident
28、ified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EECPD CEN/TR 16417:2016 CEN/TR 16417:2016 (E) 6 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 i
29、n 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 Report, in Annex XIV of REACH after the 17 thApril 2014. Table 1 Identification of substances of very hi
30、gh concern included in Annex XIV of REACH after the 17 thApril 2014 ID Substance name CAS number EC number Group Reason for inclusion Occurrence in footwear 1.1 5-tert-butyl-2,4,6-trinitro- m-xylene (musk xylene) 81-15-2 201-329-4 vPvB (article 57e) Not used in footwear or footwear components 1.2 4,
31、4- Diaminodiphenylmethane 101-77-9 202-974-4 Aryl amine Carcinogenic (article 57a) Not used as a free compound This substance can be detected after the degradation of: azo colorant, see Annex XVII of Reach) PU material, (false positive result is possible, generated as a marker in testing of PU mater
32、ial) 1.3 Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified ( HBCDD, -HBCDD, -HBCDD) 25637-99-4 and 3194-55-6 (134237-51-7, 134237-50-6, 134237-52-8) 247-148-4 and 221-695-9 PBT (article 57d) Not used in footwear or footwear components (flame retardant for electronics) 1.4 a Bi
33、s (2- ethyl(hexyl)phthalate) (DEHP) 117-81-7 204-211-0 Phthalate Toxic for reproduction (article 57c) Possible (concentration higher than 0,1 % possible) 1.5 a Benzyl butyl phthalate (BBP) 85-68-7 201-622-7 Phthalate Toxic for reproduction (article 57c) Possible (concentration higher than 0,1 % poss
34、ible) PD CEN/TR 16417: 2016 CEN/TR 16417:2016 (E) 7 ID Substance name CAS number EC number Group Reason for inclusion Occurrence in footwear 1.6 a Dibutyl phthalate (DBP) 84-74-2 201-557-4 Phthalate Toxic for reproduction (article 57c) Possible (concentration higher than 0,1 % possible) 1.7 2,4 Dini
35、trotoluene (2,4-DNT) 121-14-2 204-450-0 Aromatic hydrocarbons Carcinogenic (article 57a) Not used in footwear or footwear components 1.8 Tris(2- chloroethyl)phosphate (TCEP) 115-96-8 204-118-5 Tris(2- chloroethyl) phosphate (TCEP) Toxic for reproduction (article 57c) Not used in footwear or footwear
36、 components (flame retardant for furniture, plasticizer for PU-PVC) 1.9 Diarsenic pentaoxide 1303-28-2 215-116-9 Arsenic compounds Carcinogenic (article 57a) Not used in footwear or footwear components 1.10 Lead sulfochromate yellow (C.I. Pigment Yellow 34) 1344-37-2 215-693-7 Substances containing
37、lead Carcinogenic and toxic for reproduction (articles 57a and 57c) Possible pigment in certain surface coating 1.11 Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 12656-85-8 235-759-9 Substances containing lead Carcinogenic and toxic for reproduction (articles 57a and 57c) Possible pig
38、ment in certain surface coating 1.12 Diarsenic trioxide 1327-53-3 215-481-4 Arsenic compounds Carcinogenic (article 57a) Not used in footwear or footwear components 1.13 Lead chromate 7758-97-6 231-846-0 Substances containing chromate Carcinogenic and toxic for reproduction (articles 57a and 57c) Po
39、ssible pigment in certain surface coating 1.14 a Diisobutyl phthalate (DIBP) 84-69-5 201-553-2 phthalate Toxic for reproduction (article 57c) Possible (concentration higher than 0,1 % possible) PD CEN/TR 16417: 2016 CEN/TR 16417:2016 (E) 8 ID Substance name CAS number EC number Group Reason for incl
40、usion Occurrence in footwear 1.15 Trichloroethylene 79-01-6 201-167-4 Chlorinated aliphates Carcinogenic (article 57a) Solvent used in not flammable adhesive, volatile product can be present only as a residue More possible to detect in the footwear packaging than in the footwear 1.16 Chromium trioxi
41、de 1333-82-0 215-607-8 Substances containing chromium Carcinogenic and mutagenic (articles 57a and 57b) Not used in footwear or footwear components (Cr VI possible in leather at low concentration) 1.17 Chromic acid, Dichromic acid, Oligomers of chromic acid and dichromic acid 7738-94-5, 13530-68-2,
42、not yet assigned 231-801-5, 236-881-5, not yet assigned Substances containing chromium Carcinogenic (article 57a) Not used in footwear or footwear components (Cr VI possible in leather at low concentration) 1.18 Sodium dichromate 7789-12-0 and 10588-01-9 234-190-3 Substances containing chromate Carc
43、inogenic, mutagenic and toxic for reproduction (articles 57a, 57b and 57c) Not used in footwear or footwear components (Cr VI possible in leather at low concentration) 1.19 Potassium dichromate 7778-50-9 231-906-6 Substances containing chromate Carcinogenic, mutagenic and toxic for reproduction (art
44、icles 57a, 57b and 57c) Not used in footwear or footwear components (Cr VI possible in leather at low concentration) 1.20 Ammonium dichromate 7789-09-5 232-143-1 Substances containing chromate Carcinogenic, mutagenic and toxic for reproduction (articles 57a, 57b and 57c) Not used in footwear or foot
45、wear components (Cr VI possible in leather at low concentration) 1.21 Potassium chromate 7789-00-6 232-140-5 Substances containing chromate Carcinogenic and mutagenic (articles 57a and 57b) Not used in footwear or footwear components (Cr VI possible in leather at low concentration) PD CEN/TR 16417:2
46、016 CEN/TR 16417:2016 (E) 9 ID Substance name CAS number EC number Group Reason for inclusion Occurrence in footwear 1.22 Sodium chromate 7775-11-3 231-889-5 Substances containing chromate Carcinogenic, mutagenic and toxic for reproduction (articles 57a, 57b and 57c) Not used in footwear or footwear
47、 components (Cr VI possible in leather at low concentration) 1.23 Formaldehyde, oligomeric reaction products with aniline (technical MDA) 25214-70-4 500-036-1 aldehyde Carcinogenic (article 57a) Reaction products Not used in footwear or footwear components 1.24 Arsenic acid 7778-39-4 231-901-9 Arsen
48、ic compounds Carcinogenic article 57a) Not used in footwear or footwear components 1.25 Bis(2-methoxyethyl) ether 111-96-6 203-924-4 Dihydroxy ether Carcinogenic (article 57a) Not used in footwear or footwear components volatile product, traces can be present only as a residue 1.26 1,2-Dichloroethan
49、e; ethylene dichloride 107-06-2 203-458-1 Chlorinated aliphate Carcinogenic (article 57a) Solvent used in not flammable adhesive, volatile product can be present only as a residue More possible to detect in the packaging of footwear than in the footwear itself 1.27 2,2-dichloro-4,4- methylenedianiline (MOCA) 101-14-4 202-918-9 Aryl amine Carcinogenic (article 57a) Used as a curing agent in PU industry, Possible in certain technical PU Only low level residue will be expected (less than 0,1 %) 1.28 Dichromium tris(chromate) 24613-89-6 246-356-
