CEN/TR 16417:2012
(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 authorisation, 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 member states and a first enquiry is carried out 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 authorisation 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, every 6 months. This revision interval is difficult to follow by the standardization procedures.
Therefore, this document reflects the situation at the date of 20th December 2011. 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 directrices pour l’industrie de la chaussure relatives aux substances extrêmement préoccupantes (Annexe XIV du 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 est une liste des substances extrêmement préoccupantes (SVHC), produits chimiques qui sont en cours d’évaluation par l’ECHA (Agence européenne des produits chimiques), qui supervise la mise en œuvre du Règlement REACH.
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.
L’Agence européenne des produits chimiques, ECHA, met à jour l’Annexe XIV et la liste candidate de l’Annexe XIV du REACH tous les 6 mois. 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 du 20 décembre 2011. 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.
NOTE Les produits chimiques qui sont soumis à une restriction au titre de l’Annexe XVII sont identifiés comme des produits chimiques de catégorie 1 dans le CEN ISO/TR 16178.
Obutev - Smernica za obutveno industrijo za snovi, ki zelo zbujajo skrb (Dodatek XIV iz REACH)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2014
Obutev - Smernica za obutveno industrijo za snovi, ki zelo zbujajo skrb (Dodatek
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 (Anhnag IV
von REACH)
Chaussures - Lignes directrices pour l’industrie de la chaussure relatives aux substances
extrêmement préoccupantes (Annexe XIV du REACH)
Ta slovenski standard je istoveten z: CEN/TR 16417:2012
ICS:
61.060 Obuvala Footwear
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
TECHNICAL REPORT
CEN/TR 16417
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
October 2012
ICS 61.060
English Version
Footwear - Footwear industry guideline for substances of very
high concern (Annex XIV of REACH)
Chaussures - Lignes directrices pour l'industrie de la Schuhe - Leitfaden für die Schuhindustrie für sehr
chaussure relatives aux substances extrêmement bedenkliche Substanzen (Anhang XIV von REACH)
préoccupantes (Annexe XIV du REACH)
This Technical Report was approved by CEN on 27 August 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/TR 16417:2012: E
worldwide for CEN national Members.
Contents Page
Foreword .3
1 Scope .4
2 Terms and definitions .4
3 SVHC potentially present in the footwear industry .5
3.1 General .5
3.2 SVHC included in Annex XIV of REACH .6
3.3 SVHC included in the candidate list of Annex XIV of REACH .7
Annex A (informative) Available test methods for the identification of the substances of very high
concern given in the future REACH- Annex XIV . 16
Bibliography . 22
Foreword
This document (CEN/TR 16417:2012) 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.
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 (Registration, Evaluation, Authorisation
and Restriction 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
authorisation, 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 member states and a first enquiry is carried out 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 authorisation 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 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, every 6 months. This revision interval is difficult to
follow by the standardization procedures.
th
Therefore, this document reflects the situation at the date of 20 December 2011. 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 days, or
2) the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or
3) the half-life in soil is higher than 180 days.
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 days, or
2) the half-life in fresh- or estuarine water is higher than 40 days, or
3) the half-life in marine sediment is higher than 180 days, or
4) the half-life in fresh- or estuarine water sediment is higher than 120 days, or
5) the half-life in soil is higher than 120 days.
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 Technical
Report, in Annex XIV of REACH (see Regulation (EU) N° 143/2011 of February 2011).
Table 1 — Identification of substances of very high concern included in Annex XIV of REACH
th
Regulation (EU) N°143/2011 17 February 2011
EC Reason for Occurrence in
ID Substance name CAS number Group
number inclusion Footwear
5-tert-butyl-2,4,6-trinitro-m- Not used in footwear or
1.1 81-15-2 201-329-4 vPvB (article 57e)
xylene (musk xylene) footwear components
Not used as a free
compound
This substance can be
detected after the
degradation of:
azo colorant, see
Carcinogenic
Annex XVII of
1.2 4,4’- Diaminodiphenylmethane 101-77-9 202-974-4 Aryl amine
(article 57a)
Reach)
PU material, (false
positive result is
possible, generated
as a marker in
testing of PU
material)
25637-99-4
Hexabromocyclododecane
Not used in footwear or
and 3194-55-6
247-148-4
(HBCDD) and all major
footwear components
and
1.3 diastereoisomers identified PBT (article 57d)
(134237-51-7,
(flame retardant for
(α – HBCDD, β-HBCDD, γ-
221-695-9
134237-50-6,
electronics)
HBCDD)
134237-52-8)
Possible
Toxic for
Bis (2-ethyl(hexyl)phthalate)
a
1.4 117-81-7 204-211-0 phthalate reproduction
(concentration higher
(DEHP)
(article 57c)
than 0,1 % possible)
Possible
Toxic for
a
1.5 Benzyl butyl phthalate (BBP) 85-68-7 201-622-7 phthalate reproduction
(concentration higher
(article 57c)
than 0,1 % possible)
Possible
Toxic for
a
1.6 Dibutyl phthalate (DBP) 84-74-2 201-557-4 phthalate reproduction
(concentration higher
(article 57c)
than 0,1 % possible)
a
These substances are especially important for footwear and footwear components.
3.3 SVHC included in the candidate list of Annex XIV of REACH
The following tables include the substances of very high concern included, at the moment of publication of this
Technical Report, in the candidate list of Annex XIV of REACH. Different tables have been drafted to identify
the date of inclusion in the candidate list.
Table 2 — Identification of substances of very high concern included in the candidate list for
th
Annex XIV of REACH Date of inclusion 28 October 2008
ID Substance name CAS Number EC Group Reason for Occurrence in
Number inclusion Footwear
2.1 Bis(tributyltin) oxide (TBTO) 56-35-9 200-268- Substances PBT (article 57d) Not used in footwear or
0 containing tin footwear components
Use in the past as a
preservative agent
a
2.2 Anthracene 120-12-7 204-371- PAHs PBT (article 57d) PAH compound
1 Possible contaminant
(recycled materials or
leather fat liquor)
2.3 Lead hydrogen arsenate 7784-40-9 232-064- Arsenic Carcinogenic and Not used in footwear or
2 compounds toxic for footwear components
reproduction
(articles 57 a
and 57 c)
2.4 Triethyl arsenate 15606-95-8 427-700- Arsenic Carcinogenic Not used in footwear or
2 compounds (article 57a) footwear components
2.5 Diarsenic pentaoxide 1303-28-2 215-116- Arsenic Carcinogenic Not used in footwear or
9 compounds (article 57a) footwear components
2.6 Diarsenic trioxide 1327-53-3 215-481- Arsenic Carcinogenic Not used in footwear or
4 compounds (article 57a) footwear components
2.7 Sodium dichromate 7789-12-0 234-190- Substances Carcinogenic, Not used in footwear or
and 10588- 3 containing mutagenic and footwear components
01-9 chromate toxic for (Cr VI possible in
reproduction leather at low
(articles 57a, 57b concentration)
and 57c)
a
2.8 Alkanes, C10-13,chloro [Short 85535-84-8 287-476- Chlorinated PBT and vPvB Possible
Chain Chlorinated paraffins] 5 aliphates (articles 57 d (flame retardant for
(SCCP) and 57 e) textile or fat liquor for
leather)
a
These substances are especially important for footwear and footwear components.
Table 3 — Identification of substances of very high concern included in the candidate list for
th
Annex XIV of REACH Dates of inclusion 13 January 2010
ID Substance name CAS EC Group Reason for Occurrence in
Number Number inclusion Footwear
3.1 Coal tar pitch, high 65996- 266-028-2 PAHs Carcinogenic, PBT Not used in footwear or
temperature 93-2 and vPvB (articles footwear components
57a, 57d and 57e)
a
3.2 Diisobutyl phthalate 84-69-5 201-553-2 Phthalates Toxic for reproduction Possible
(article 57c)
(concentration higher
than 0,1 % possible)
3.3 Tris(2- 115-96-8 204-118-5 Tris(2- Toxic for reproduction Not used in footwear or
chloroethyl)phosphate chloroethyl)pho (article 57c) footwear components
(TCEP) sphate (TCEP)
(flame retardant for
furniture, plasticiser for
PU-PVC)
Table 3 — Identification of substances of very high concern included in the candidate list for
th
Annex XIV of REACH Dates of inclusion 13 January 2010 (continued)
ID Substance name CAS EC Group Reason for Occurrence in
Number Number inclusion Footwear
3.4 2,4-Dinitrotoluene 121-14-2 204-450-0 Aromatic Carcinogenic Not used in footwear or
hydrocarbons (article 57a) footwear components
3.5 Anthracene oil 90640- 292-602-7 PAHs Carcinogenic[1], PBT Not used in footwear or
80-5 and vPvB (articles footwear components
57a, 57d and 57e)
3.6 Anthrace
...
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