CEN TR 16417-2016 Footwear - Footwear industry guideline for substances of very high concern (Annex XIV of REACH).pdf

1、BSI Standards PublicationPD CEN/TR 16417:2016Footwear Footwear industryguideline for substances ofvery high concern (Annex XIVof REACH)PD CEN/TR 16417:2016 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of CEN/TR 16417:2016. It supersedes PD CEN/TR 16417:2012 whi

2、ch is withdrawn.The UK participation in its preparation was entrusted to Technical Committee TCI/69, Footwear.A list of organizations represented on this committee can be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 contract. Use

3、rs are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 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 authority of

4、the Standards Policy and Strategy Committee on 31 January 2016.Amendments/corrigenda issued since publicationDate Text affectedPD CEN/TR 16417:2016TECHNICAL REPORT RAPPORT TECHNIQUE TECHNISCHER BERICHT CEN/TR 16417 January 2016 ICS 61.060 Supersedes CEN/TR 16417:2012English Version Footwear - Footwe

5、ar 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 sehrbedenkliche Substanzen (Anhang XIV von R

6、EACH) 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 Macedoni

7、a, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISC

8、HES 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 16417:2016 (E) 2 Contents Page European forewo

9、rd . 3 1 Scope 4 2 Terms and definitions . 5 3 SVHC potentially present in the footwear industry 6 3.1 General . 63.2 SVHC included in Annex XIV of REACH. 6Annex A (informative) Available test methods for the identification of the substances of 3.3 SVHC included in the candidate list of Annex XIV of

10、 REACH 11very high concern given in the future REACH Annex XIV . 29 Bibliography . 39 PD CEN/TR 16417:2016CEN/TR 16417:2016 (E) 3 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

11、 drawn to the possibility that some of the elements of this document may be the subject ofpatent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patentrights. This document supersedes CEN/TR 16417:2012. In comparison with the previous edition, the most signif

12、icant 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

13、 added in the annex. PD CEN/TR 16417:2016CEN/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, Evaluation andAuthorisation of Chemicals) and

14、their usage and presence in the footwear industry. The Annex XIV, overseen by the ECHA (European Chemicals Agency), is a list of substances subject toauthorization, substances of very high concern (SVHC). Before the inclusion of a substance in theAnnex XIV, the procedure is strictly fixed: A Europea

15、n 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 tothe candidate list of Annex XIV. After the agreement of the members state, ECHA includes the substances in the candidate list toAnnex XIV. As soon as a substance

16、 has been included in the candidate list, it should be taken intoaccount exactly as a SVHC. ECHA prioritizes the substances from the Candidate List to determine which ones should beincluded in the Authorisation List (Annex XIV of REACH) and therefore, subject to authorization.ECHA regularly submits

17、recommendations to the European Commission, who will decide on thesubstances to be included in the Authorisation List. Following the evaluation of the Annex XIV substances, ECHA can take the decision to restrict thesubstances. This restriction may take the form of an authorization for use, an author

18、ization only forspecific 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 regulationrequires that the user shall be informed if one or more of these substances are p

19、resent in any part of thearticle in quantity over 0,1 % by weight. This Technical Report shows which of these chemicals may be present in footwear materials and thefootwear industry in order to help shoe manufacturers to collect mandatory information from suppliersregarding the content of these chem

20、icals and, at same time, allow them to provide accurate informationto their customers. The test methods reported in Annex A are informative only to identify where these chemicals may befound and control the use along the supply chain where their suppliers are not under the jurisdiction ofthe REACH R

21、egulation. Taking into account final decision of the European Commission, ECHA, implements the Annex XIV andthe candidate list to Annex XIV of REACH, regularly. This revision interval is difficult to follow by thestandardization procedures. Therefore this document reflects the situation at the date

22、of June 2014. This document will be annually revised. This Technical Report does not concern the substances for which restriction have been already enactedunder Annex XVII of REACH. NOTE Chemicals that are restricted under Annex XVII, are identified as a category 1 chemical inCEN ISO/TR 16178. PD CE

23、N/TR 16417:2016CEN/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 substancevPvB substance that fulfils the criteria of both the sections below: a) Persistence1) the half-life in ma

24、rine, fresh- or estuarine water is higher than 60 d, or2) the half-life in marine, fresh- or estuarine water sediment is higher than 180 d, or3) the half-life in soil is higher than 180 db) Bioaccumulation1) the bioconcentration factor is greater than 5 0002.2 Persistent, Bioaccumulative and Toxic s

25、ubstancePBT substance that fulfils all three of the criteria of the sections below: a) Persistence1) the half-life in marine water is higher than 60 d, or2) the half-life in fresh- or estuarine water is higher than 40 d, or3) the half-life in marine sediment is higher than 180 d, or4) the half-life

26、in fresh- or estuarine water sediment is higher than 120 d, or5) the half-life in soil is higher than 120 db) Bioaccumulation1) the bioconcentration factor (BCF) is higher than 2 000c) Toxicity1) the long-term no-observed effect concentration (Noec) for marine or freshwater organisms isless than 0,0

27、1 mg/l, or2) the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2) ortoxic for reproduction (category 1, 2, or 3), or3) there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48according to Directive 67/548/EECPD CEN/TR

28、 16417:2016CEN/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 befound in the footwear or in the footwear components. 3.2 SVHC included in Annex XIV of REACH Table 1

29、 includes the substances of very high concern included, at the moment of publication of thisTechnical Report, in Annex XIV of REACH after the 17thApril 2014. Table 1 Identification of substances of very high concern included in Annex XIV of REACH after the 17thApril 2014 ID Substance name CAS number

30、 EC number Group Reason forinclusion Occurrence infootwear 1.1 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) 81-15-2 201-329-4 vPvB(article 57e) Not used infootwear orfootwearcomponents 1.2 4,4-Diaminodiphenylmethane 101-77-9 202-974-4 Aryl amine Carcinogenic(article 57a) Not used as a freecomp

31、ound This substance canbe detected afterthe degradation of: azo colorant,see Annex XVIIof Reach) PU material,(false positiveresult ispossible,generated as amarker in testing of PUmaterial) 1.3 Hexabromocyclododecane(HBCDD) and all majordiastereoisomers identified( HBCDD, -HBCDD, -HBCDD) 25637-99-4 a

32、nd 3194-55-6 (134237-51-7, 134237-50-6,134237-52-8) 247-148-4 and 221-695-9 PBT(article 57d) Not used infootwear or footwearcomponents (flame retardant forelectronics) 1.4 aBis (2-ethyl(hexyl)phthalate)(DEHP) 117-81-7 204-211-0 Phthalate Toxic forreproduction(article 57c) Possible(concentrationhighe

33、r than 0,1 %possible) 1.5 aBenzyl butyl phthalate(BBP) 85-68-7 201-622-7 Phthalate Toxic forreproduction(article 57c) Possible(concentrationhigher than 0,1 %possible) PD CEN/TR 16417: 2016CEN/TR 16417:2016 (E) 7 ID Substance name CAS number EC number Group Reason forinclusion Occurrence infootwear 1

34、.6 aDibutyl phthalate (DBP) 84-74-2 201-557-4 Phthalate Toxic forreproduction(article 57c) Possible(concentrationhigher than 0,1 %possible) 1.7 2,4 Dinitrotoluene(2,4-DNT) 121-14-2 204-450-0 Aromatichydrocarbons Carcinogenic (article 57a) Not used infootwear orfootwearcomponents 1.8 Tris(2-chloroeth

35、yl)phosphate(TCEP) 115-96-8 204-118-5 Tris(2-chloroethyl)phosphate(TCEP) Toxic forreproduction(article 57c) Not used infootwear or footwearcomponents(flame retardant forfurniture, plasticizer forPU-PVC) 1.9 Diarsenic pentaoxide 1303-28-2 215-116-9 Arseniccompounds Carcinogenic (article 57a) Not used

36、 infootwear orfootwearcomponents 1.10 Lead sulfochromate yellow (C.I. Pigment Yellow 34) 1344-37-2 215-693-7 Substances containing lead Carcinogenicand toxic for reproduction (articles 57aand 57c) Possible pigment in certain surface coating 1.11 Lead chromate molybdate sulphate red (C.I. Pigment Red

37、 104) 12656-85-8 235-759-9 Substances containing lead Carcinogenicand toxic for reproduction (articles 57aand 57c) Possible pigment in certain surface coating 1.12 Diarsenic trioxide 1327-53-3 215-481-4 Arseniccompounds Carcinogenic (article 57a) Not used infootwear orfootwearcomponents 1.13 Lead ch

38、romate 7758-97-6 231-846-0 Substances containing chromate Carcinogenicand toxic for reproduction (articles 57aand 57c) Possible pigment in certain surface coating 1.14 aDiisobutyl phthalate(DIBP) 84-69-5 201-553-2 phthalate Toxic forreproduction(article 57c) Possible(concentrationhigher than 0,1 %po

39、ssible) PD CEN/TR 16417: 2016CEN/TR 16417:2016 (E) 8 ID Substance name CAS number EC number Group Reason forinclusion Occurrence infootwear 1.15 Trichloroethylene 79-01-6 201-167-4 Chlorinatedaliphates Carcinogenic (article 57a) Solvent used in notflammable adhesive, volatileproduct can bepresent on

40、ly as aresidue More possible todetect in the footwear packagingthan in the footwear 1.16 Chromium trioxide 1333-82-0 215-607-8 Substancescontainingchromium Carcinogenic and mutagenic(articles 57a and 57b) Not used infootwear or footwearcomponents (Cr VI possible in leather at lowconcentration) 1.17

41、Chromic acid, Dichromicacid, Oligomers of chromicacid and dichromic acid 7738-94-5,13530-68-2, not yet assigned 231-801-5, 236-881-5,not yet assigned Substancescontainingchromium Carcinogenic (article 57a) Not used infootwear or footwearcomponents (Cr VI possible in leather at lowconcentration) 1.18

42、 Sodium dichromate 7789-12-0 and 10588-01-9 234-190-3 Substancescontainingchromate Carcinogenic,mutagenic and toxic forreproduction (articles 57a,57b and 57c) Not used infootwear or footwearcomponents (Cr VI possible in leather at lowconcentration) 1.19 Potassium dichromate 7778-50-9 231-906-6 Subst

43、ancescontainingchromate Carcinogenic,mutagenic and toxic forreproduction (articles 57a,57b and 57c) Not used infootwear or footwearcomponents (Cr VI possible in leather at lowconcentration) 1.20 Ammonium dichromate 7789-09-5 232-143-1 Substancescontainingchromate Carcinogenic,mutagenic and toxic for

44、reproduction (articles 57a,57b and 57c) Not used infootwear or footwearcomponents (Cr VI possible in leather at lowconcentration) 1.21 Potassium chromate 7789-00-6 232-140-5 Substancescontainingchromate Carcinogenic and mutagenic(articles 57a and 57b) Not used infootwear or footwearcomponents (Cr VI

45、 possible in leather at lowconcentration) PD CEN/TR 16417:2016CEN/TR 16417:2016 (E) 9 ID Substance name CAS number EC number Group Reason forinclusion Occurrence infootwear 1.22 Sodium chromate 7775-11-3 231-889-5 Substancescontainingchromate Carcinogenic,mutagenic and toxic forreproduction (article

46、s 57a,57b and 57c) Not used infootwear or footwearcomponents (Cr VI possible in leather at lowconcentration) 1.23 Formaldehyde, oligomeric reaction products with aniline (technical MDA) 25214-70-4 500-036-1 aldehyde Carcinogenic (article 57a) Reaction productsNot used in footwear or footwearcomponen

47、ts 1.24 Arsenic acid 7778-39-4 231-901-9 Arseniccompounds Carcinogenic article 57a) Not used infootwear orfootwearcomponents 1.25 Bis(2-methoxyethyl) ether 111-96-6 203-924-4 Dihydroxyether Carcinogenic(article 57a) Not used infootwear or footwearcomponents volatileproduct, traces can be present onl

48、y as aresidue 1.26 1,2-Dichloroethane;ethylene dichloride 107-06-2 203-458-1 Chlorinatedaliphate Carcinogenic (article 57a) Solvent used in notflammable adhesive, volatileproduct can bepresent only as aresidue More possible todetect in thepackaging of footwear than in thefootwear itself 1.27 2,2-dic

49、hloro-4,4-methylenedianiline(MOCA) 101-14-4 202-918-9 Aryl amine Carcinogenic (article 57a) Used as a curingagent in PUindustry, Possible in certain technical PU Only low levelresidue will be expected (less than0,1 %) 1.28 Dichromiumtris(chromate) 24613-89-6 246-356-2 Substancescontainingchromium Carcinogenic (article 57a) Not used infootwear or footwearcomponents (Cr VI possible in leather at lowconcentration) PD CEN/TR 16417:2016CEN/TR 16417:2016 (E) 10 ID Substance name CAS number EC number Group Reason forinclusion Occurrence infootwear 1