kSIST-TP FprCEN/TR 18325:2026

SLOVENSKI STANDARD
01-marec-2026
Gumeni materiali iz izrabljenih avtomobilskih gum - Smernice za skladnost z
uredbama CLP in REACH - Granulati in praški
Rubber materials obtained from EndofLife Tyres - Guidelines for the compliance to CLP
and REACH regulations - Granulates and powders
Leitlinien für die REACH-Konformität von aus ELT hergestellten Materialien
Matériaux caoutchouc issus des PUNR (Pneus Usagés Non Réutilisables) - Guide pour
la conformité aux réglementations CLP et REACH - Granulats et poudrettes
Ta slovenski standard je istoveten z: FprCEN/TR 18325
ICS:
83.080.01 Polimerni materiali na Plastics in general
splošno
83.160.01 Avtomobilske pnevmatike na Tyres in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

FINAL DRAFT
TECHNICAL REPORT
RAPPORT TECHNIQUE
TECHNISCHER REPORT
January 2026
ICS
English Version
Rubber materials obtained from EndofLife Tyres -
Guidelines for the compliance to CLP and REACH
regulations - Granulates and powders
Matériaux caoutchouc issus des PUNR (Pneus Usagés Leitlinien für die REACH-Konformität von aus ELT
Non Réutilisables) - Guide pour la conformité aux hergestellten Materialien
réglementations CLP et REACH - Granulats et
poudrettes
This draft Technical Report is submitted to CEN members for Vote. It has been drawn up by the Technical Committee CEN/TC
366.
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, Türkiye 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: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TR 18325:2026 E
worldwide for CEN national Members.

Contents Page
European foreword. 3
Introduction . 4
1 Scope. 5
2 Normative references. 5
3 Terms and definitions . 5
4 Classification Labelling and Packaging Regulation (CLP): Identification of the
relevant hazardous substances expected in ELT derived rubber . 7
5 Registration, Evaluation, Authorisation and Restriction of Chemicals regulation
(REACH) . 8
5.1 Registration obligation and exemption . 8
5.2 Authorization . 9
6 Other Applicable Regulations . 9
7 Communication . 10
7.1 Safety Data Sheet (SDS) . 10
Annex A (informative) Non-exhaustive list of applications. 11
Annex B (informative) CLP Hazard assessment methodology. 14
Annex C (informative) Scientific elements supporting the sameness condition of REACH
registration exemption under art.2.7(d) for ELT derived Rubber . 24
Annex D (informative) Authorization argumentation . 30
Bibliography . 31

European foreword
This document (FprCEN/TR 18325:2026) has been prepared by Technical Committee CEN/TC 366
"Materials obtained from End-of-Life Tyres (ELT)", the secretariat of which is held by UNI.
This document is currently submitted to the Vote on TR.
Introduction
According to its article 2.2, Regulation (CE) 1907/2006 of the European Parliament and the council and
subsequent amendments concerning the Registration, Evaluation, Authorization and Restriction of
Chemicals (hereinafter REACH or REACH Regulation) does not apply to Waste. However as soon as ELT
derived materials have ceased to be waste following a recycling or other recovery operation they fall,
like any material containing chemicals, within the scope of both CLP (Regulation (CE) 1272/2008
concerning the classification, labelling and packaging of chemical substances and mixtures) and REACH.
According to the REACH guidance on waste and recovered substances, substances are recovered either
on their own or as part of a mixture.
At the point they cease to be waste ELTs derived granulates and powders also referred to in this
document as ELT derived rubbers are considered mixtures by ECHA .
This document aims to bring in a single document the existing data on both the nature and the
concentrations of relevant hazardous substances expected in ELT derived rubbers based on of the
substances used in the tyre supply chain and their impurities, their reaction species, their intrinsic
hazard in order to help their hazard classification under CLP and substantiate the exemption from
REACH registration requirements as provided by article 2.7(d) to REACH. The approach essentially
relies on the guidelines given in the REACH guidance on waste and recovered substances .
This document needs to be reviewed periodically to assess the potential need for update depending on
the regulatory developments on individual substances.

As per the European Commission opinion presented at the CARACAL conference of 29 June/1 July 2016

(CA/30/2016),
European Chemicals Agency (ECHA), "Guidance on waste and recovered substances," Version 2.0, European
Chemicals Agency, Helsinki, 2010, available at:
https://echa.europa.eu/documents/10162/23036412/waste_recovered_en.pdf/657a2803-710c-472b-8922-
f5c94642f836
1 Scope
This document compiles scientific and technical information on the composition of ELT derived rubbers
aiming at helping ELT recyclers and producers of ELT derived rubbers complying with the main
requirements of the European CLP and REACH regulations.
This document builds on existing literature data and on the REACH guidance on waste and recovered
substances to:
— identify the relevant hazardous substances expected in ELT derived rubbers and the expected
concentration ranges;
— assess the hazardous classification of the material according to the CLP Regulation;
— support the exemption from REACH registration requirements as provided by article 2.7(d) to
REACH.
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 terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1
article
object which, during production, is given a specific shape, surface or design that determines its function
to a greater degree than its chemical composition
[SOURCE ECHA, https://echa.europa.eu]
3.2
chemical safety assessment (CSA)
process determining the risk posed by a substance and, as part of the exposure assessment, developing
exposure scenarios including risk management measures to control the risks
[SOURCE ECHA, https://echa.europa.eu]
3.3
end-of-life tyre (ELT) derived rubber
rubber recovered/recycled from end-of-life tyres
Note 1 to entry: this includes granulates and powders
Note 2 to entry: please refer to the definition of end-of-life tyre in 3.10
3.4
granulate
end-of-life tyre derived rubber with particle sizes typically ranging from 0.8 mm to 20 mm obtained
from a granulation process
3.5
granulation process
successive shredding, crushing, fragmentation, sorting, and sieving of ELTs in order to separate the
textile and metal reinforcements from the rubber matrix
3.6
mixtures
mixture or solution composed of two or more substances
Note 1 to entry: under the EU chemicals legislation, mixtures are not considered substances
3.7
persistent, Bioaccumulative and Toxic (PBT)
substances recognized for their long-lasting presence in the environment, their accumulation in living
organisms, and their harmful effects on health and ecosystems
3.8
powder
end-of-life tyre derived rubber with particle size typically less than 0.8 mm obtained from a granulation
process
3.9
safety data sheet (SDS)
document listing information relating to environment, health and safety for the use of substances and
mixtures
Note 1 to entry: : SDS information often encompasses instructions for the safe use of a material or product,
potential hazards associated with it, and procedures for handling spills
3.10
End-of-Life Tyre
tyres no longer suitable for use for its original purpose
3.11
vPvB
substances that are very persistent and very bioaccumulate
3.12
carcinogenic, mutagenic, and reprotoxic chemicals (CMR)
substance or mixture which meets the criteria for classification as carcinogen or germcell mutagen or
toxic for reproduction
3 CLP
, https://eur-lex.europa.eu/eli/reg/2008/1272/oj/eng
Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (1)
4 Classification Labelling and Packaging Regulation (CLP): Identification of the
relevant hazardous substances expected in ELT derived rubber
This section deals with the assessment of the intrinsic chemical hazards of ELT derived rubber as per
the Classification Labelling and Packaging Regulation (CLP) (Regulation (EC) No 1272/2008 of the
European parliament and of the council). The approach is based on a screening of the substances these
materials may contain considering both the knowledge of the substances used in the tyre
manufacturing supply chain and their potential derived substances or impurities and a literature
review reporting qualitative and quantitative information on these substances.
Attention was paid to substances with known hazards or substances deemed of concern because of
their toxicological profile and related scientific or regulatory debates (phthalates for example).
The vast majority of published data on substances in ELT derived rubbers are about granulates and
specifically those used as infill material in artificial turfs. Nevertheless, as only size reduction processes
and no chemical reactions are involved in the production of these materials, it is assumed for the
purpose of this screening that the data available on granulates also apply to powders. The details of the
approach are given in Annex B.
As a summary of this screening exercise attention is drawn mainly to five substances: 6PPD, Silica, Zinc,
DPG and BPH (Table 1).
Table 1 — List of Substances with CAS Numbers
Substances CAS Number
6PPD 793-24-8
Silica 7631-86-9
Zinc 7440-66-6
DPG 102-06-7
BPH 119-47-1
6PPD has been voluntarily classified as Reprotoxic cat 1B in 2019 by its lead registrant under EU
REACH regulation (harmonized classification process launched November 2021, expected timeline late
Q1 2026). This substance is a protection agent added in tyre rubber compounds to protect them against
oxidation and ozone. The typical concentration of the substance in fresh tyre compounds is close to 1 %,
but this concentration is expected to decrease because of its reaction with oxygen and oxidated species.
The reported concentration ranges of 6PPD are under the 0,3 % European reprotoxic classification but
close to it. The 6PPD content is measurable through a standardized test method [24], particularly
considering that this content varies with the age of the feedstock.
Silica has been the subject of a notification for a classification as STOT RE Cat 1 (H372), following an
evaluation concluded in 2021.
The regulatory process is ongoing, with several steps remaining. At this moment, drawing a conclusion
on the outcome of the process remains premature. Consequently, there is a need to closely monitor the
process and adapt the classification of ELT derived rubber, if necessary, in the event of a STOT RE 1
classification. Such a classification would entail a classification of ELT derived rubber as STOT RE 1 or
STOT RE 2 depending on the silica content in the material. The classification thresholds are 1 % and 10
% for Cat1 and Cat 2, respectively. It is advisable to consider classifying based on real measurements of
silica content rather than paper studies estimates. The expected timeline for the regulatory process to
be completed is 2027.
Zinc (Zn) is generally reported at concentration above the classification threshold.
Reported concentrations for Zinc would lead to a H412 (aquatic chronic cat 3) classification. However,
published ecotoxic tests [13] have not revealed any short-term or long-term ecotoxic effects. This
provides grounds for non-ecotoxic classification by virtue of article 12 paragraph (b) to the CLP
regulation which provides that tests data prevail over calculation rules.
DPG is classified as Reprotoxic cat 2 (H361f) by the REACH consortium.
However, the reported concentrations for DPG are always well under the classification threshold.
BPH has recently been the subject of a harmonized classification as reprotoxic 1B (H360f) and has been
included in the REACH candidate list. According to sector knowledge on how BPH is used (volumes and
applications) it is highly likely that the concentration of this substance in ELT derived rubber is far
lower than many of the substances investigated in our screening, i.e., well below the classification
threshold concentration.
In conclusion, from the relatively comprehensive literature screening study and according to the
regulatory status of the individual substances expected in ELT derived rubbers, it appears that most
likely, At the time of drafting of this document, there is no need to classify ELT derived materials as
hazardous according to CLP. This assessment will be subjected to periodic revisions to consider the
regulatory development on individual substances.
5 Registration, Evaluation, Authorisation and Restriction of Chemicals
regulation (REACH)
5.1 Registration obligation and exemption
In principle, according to the REACH regulation, manufacturers of mixtures, such as those derived from
End-of-Life Tyres (ELT), are expected to register all chemicals in mixtures produced in quantities of 1
ton or more per year. For substances produced in quantities of 10 tons or more annually, conducting a
Chemical Safety Assessment (CSA) and creating a Chemical Safety Report (CSR) with detailed
recommended risk management measures are part of the process. REACH Article 2.7. d provides for an
exemption of registration if the three following conditions are cumulatively met:
— the recovery occurs within the EU;
— the substance that results from the recovery process is the same as a substance that has been
already registered under REACH;
— the information required by Articles 31 or 32 relating to the substance that has been registered in
accordance with Title II is available to the establishment undertaking the recovery.
According to the discussion presented in Annex C, ELT derived material are mixtures of substances in
which only carbon black needs to be assessed for the purpose of complying with article 2.7(d).
The discussion of Annex C highlights the fact that there are no expected chemical reactions involving
carbon black in the vulcanization process, the interaction between carbon black and the rest of the
rubber compound being mainly physical. Consequently, the chemical nature of carbon black inside the
rubber compound is unaltered comparable to the one of the raw materials before its introduction and
process into the rubber compound. This supports the claim for the sameness with already registered
carbon blacks without further chemical analysis.
In their normal operations, recyclers typically lack access to safety data sheets (SDS) for two main
reasons. First, there are no requirements for safety data sheets for articles under REACH, which is the
case for tyres. Secondly ELTs are wastes and REACH does not apply to waste. In accordance with the
ECHA guidelines ("Guidance on waste and recovered substances"), the information on the ECHA
website and published in accordance with art. 119 to REACH or, if available, SDS of a registered carbon
black are usable for the purpose of fulfilling the third condition of article 2.7(d).
5.2 Authorization
Based on the information available on individual substances expected in ELT derived rubbers, at the
time we draft this technical report no authorization is applicable to these materials. Regulated
Substances and Concentration Limits.
Table 2 – Maximum Concentrations in specific application using ELT-Derived Rubbers
Substance Regulatory Reference Maximum Concentration
Polycyclic Aromatic Reg. 1907/2006, Annex XVII, ≤ 1 mg/kg for rubber articles in
Hydrocarbons (PAHs) Entry 50 direct skin contact
Reg. 1907/2006, Annex XVII,
Lead (Pb) ≤ 0,1 % (1000 mg/kg)
Entry 63
Reg. 1907/2006, Annex XVII,
Cadmium (Cd) ≤ 0,01 % (100 mg/kg)
Entry 23
Phthalates (DEHP, DBP, BBP, Reg. 1907/2006, Annex XVII,
≤ 0,1 % (1000 mg/kg)
DIBP) Entries 51, and 52
Carcinogenic, mutagenic, and
reprotoxic chemicals (CMR) Reg. 1907/2006, Annex XVII, Subject to substance-specific
Substances (Categories 1A and Entries 28, 29, 30 limits
1B)
NOTE For the complete list of CMR and SVHC substances and the relevant concentration limits that trigger
mixture classification, consult the European Chemicals Agency (ECHA) website:
https://echa.europa.eu/candidate-list-table
6 Other Applicable Regulations
COMMISSION REGULATION (EU) 2021/1199 of 20 July 2021 amending Annex XVII to Regulation (EC)
No 1907/2006 of the European Parliament and of the Council as regards polycyclic-aromatic
hydrocarbons (PAHs) in granules or mulches used as infill material in synthetic turf pitches or in loose
form on playgrounds or in sport applications.
COMMISSION REGULATION (EU) 2023/2055 of 25 September 2023 amending Annex XVII to Regulation
(EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards synthetic polymer
microparticles Annex XVII to Regulation (EC) No 1907/2006 – Entry 78.
ELT -derived rubber (granulates and powder) are Synthetic Polymer Microparticles as per the
definition of this regulation also known as entry 78 of Annex XVII to REACH, and as such, the use is
governed by the provisional paragraphs 78.4(a), 78.5(a) and 78.5(c) and the corresponding reporting
obligations laid down in in paragraphs 7, 8 10, 11, 12 and 14 of that restriction. In particular, the use of
the material is restricted to the following uses:
— use at industrial sites (entry 78.4(a));
— use in conditions where the material is contained by technical means so that releases to the
environment are prevented when used in accordance with the instructions for use during the
intended end use (entry 78.5(a));
— conditions where the material is permanently incorporated into a solid matrix during intended end
use (entry 78.5(C)).
The following chart summarizes the exemptions provided under this restriction (numbers in brackets
are paragraphs of Entry 78).
NOTE The above-mentioned regulations represent a non-comprehensive list that potentially applies to the
material. Depending on the local context where the material enters the market and its intended application,
certain sector or product-specific regulations potentially apply.
Figure 1 — Summary of entries 78 exemptions
7 Communication
7.1 Safety Data Sheet (SDS)
End-of-Life Tyre (ELT) derived rubber is generally considered a non-hazardous mixture. Under the
provisions of Article 31 and Annex II of Regulation (EC) No. 1907/2006 (REACH), producers of ELT-
derived rubber materials typically provide a Safety Data Sheet (SDS) only when requested by a
downstream user.
According to Article 31.c.3 of REACH and Annex II of REACH producers have obligation to provide an
SDS upon request when:
a) the material contains hazardous substances in concentrations that require classification under the
CLP Regulation (EC) No. 1272/2008;
b) the material contains substances of very high concern (SVHC) in concentrations above
0,1 % (w/w).
Although not mandatory provision of an SDS is encouraged as a best practice to ensure transparency
and regulatory compliance.
Annex A
(informative)
Non-exhaustive list of applications
Summary of Data and List of Different Applications
As per the German association:
Category and Application:
Animal Welfare:
— Stable Mats
— Rubber Bricks
Building/Construction:
— Acoustic Insulation
— Vibration Damping
— Flooring for Shops
— Building Protection
Infrastructure:
— Railroad Crossings
— Acoustic/Vibration Insulation
— Sub-ballast Mats
Loading Safety:
— Load Securing Anti-Slip Mats
Play + Landscaping:
— Safety Tiles
— Seamless Safety Flooring
— Bordering, Palisades
— Design & Play-Elements
— Lawn Grating
— Rubber Bricks
— Growth Inhibiting Mats
Sport:
— Athletic Tracks
— Multi-Purpose Halls and Fields
— Shooting Ranges
— Fitness Flooring
— Sport HallsClimbing Hall FloorsWinter Sports Floors
— Shockpads
— Infill
Urban:
— Ramps
— Urban Furniture and Decorative Products
— Speed Breaker
— Lane Segregation
Asphalt:
— Rubber Modified Asphalt
Civil Engineering:
— Replacement Aggregate
— Floor Boarding
— Street Furniture (e.g., Seating and Signposts)
— Railway Crossing Surface Matting
As per the UK’s End-of-Waste (EoW) criteria:
— Civil engineering (unbound and bound applications)
— Replacement aggregate in the construction and building industry (e.g., block fabrication)
— Bound rubberized product (e.g., wall and floor boarding, street furniture, railway crossing surface
matting)
— Bituminous composite materials (e.g., modified bitumen, bituminous or cement conglomerates)
— Foaming agents for steelworks
— Industrial and consumer applications (bound applications)
— Automotive (e.g., new, and remolded tyres, mats, and molded parts)
— Street furniture and road surface matting (e.g., level crossings)
— Rubber matting (e.g., livestock mats and mattresses)
— Building products (e.g., rubberized tiles and insulation mats, rubberized adhesives, and mastics)
— Consumer products (e.g., footwear and stationery)
— Carpet underlay rubbery conglomerates, rubber compounds, and rubber-plastic provided for
structural and finishing elements for construction, industrial mechanics, components of means of
transport outside the passenger compartment, construction and railway infrastructures, signs and
traffic, weights and counterweights
As per the Spanish EoW regulation:
— Use exclusively in:
— Artificial turf pitches and shock pads for sport fields
— Pavements for playgrounds, sports courts, and safety pavements
— Molded parts and rubber articles
— Bituminous mixtures
As per the Italian EoW criteria:
— Production of articles and/or components of rubber articles, rubbery conglomerates, rubber
compounds, and rubber-plastic for structural and finishing elements for construction, industry
mechanics, components of means of transport outside the passenger compartment, construction
and railway infrastructures, signs and traffic, weights, and counterweights
— Lower layers of sports play surfaces
— Bituminous composite materials (e.g., modified bitumen, bituminous membranes, asphalt-based
additives rubber, sealing mastics, bituminous or cement conglomerates)
— Foaming agents for steelworks
NOTE The above list of applications is not comprehensive.
Annex B
(informative)
CLP Hazard assessment methodology
B.1 Example of a table
The ELTs which the granulates and powders are recovered from are waste. As no EU harmonized End-
of-Waste criteria have been defined for ELT derived rubbers, they are deemed to be waste unless it is
demonstrated that they meet specific national or case-by-case End of waste criteria. As of today,
national End of Waste criteria are defined in Spain, Italy, and Portugal Only.
At the point they cease to be waste, ELT derived rubbers are considered “mixtures” by ECHA.
Consequently, the EU regulatory framework requires that the precise composition of these mixtures is
described, and the classification of their intrinsic hazards is assessed according to the CLP regulation. In
case where the mixture is classified as hazardous as a result of this assessment, a notification to the CLP
inventory is necessary.
B.2 Specific restrictions applicable to tyre
All tyres commercialized in the European market are covered by the European Union’s regulation on
Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH Regulation (EC) No
1907/2006 of the European Parliament and of the Council), which restricts the use of high-aromatic
content oils in tyres produced from January 2010. According to this restriction, extender oils, used for
the production of tyres or parts of tyres, shall not contain more than 1 mg/kg of benzo[a]pyrene, or
more than 10 mg/kg of the sum of benzo[a]pyrene, benzo[e]pyrene, benzo[a]anthracene, chrysene,
benzo[b]fluoranthene, benzo[j]fluoranthene, benzo[k]fluoranthene and dibenzo[a, h]anthracene.
This regulation is important as far as it leads to a minimization of PAH levels in new tyres and
ultimately in End-of-Life Tyres.
B.3 Screening Methodology
As a starting point it is important to bear in mind that most of the studies on the composition of ELT
derived materials are about rubber granulates because they are more widely used and they have been
the subject of regulatory scrutiny in the past recent years, particularly those used as infill material for
artificial turf.
The basic idea supporting the extension of the validity of the approach used in this report to all types of
ELT derived rubbers is the fact that they are all produced through mechanical recycling processes. As
no chemical reactions are involved in these processes, it is likely that the chemical composition of all
ELT derived rubbers is the same [17]
A literature review was conducted to search for substances and corresponding expected concentrations
in ELT derived rubber granulates. The results are summarized in the Table B.1, where only substances
likely to originate from tyres and/or ELTs (i.e. substances used as rubber chemicals or potentially
generated during the process and the ageing) are retained, especially those reported in both the US EPA
study [25] [26], the ECHA study [29], the Dutch RIVM study [19] and the European Risk Assessment
Study on Synthetic Turf Rubber infill (ERASSTRI) [10][11][12].
B.4 List of substances with reported concentrations
The Table B.1 below provides a comprehensive list of substances expected in ELT derived rubbers as
reported in the literature, with the corresponding hazard classifications and expected concentration
ranges.
Table B.1 — Substances expected in ELT derived rubbers
Hazard
Classification
Expected
Comments.
Substances of concentration
(N/A meaning no
CAS# Classification Reference(s)
interest in ELT derived
hazard
consequences
rubbers
classification
existing)
No metallic
impurity
leading to a
Metals   classification
Pyr. Sol. 1
Carc. 1B – H350
Muta. 2 – H341
Repr. 2 – H361fd
Acute Tox. 2 * - H330
STOT RE 1 – H372
Exits as
Aquatic Acute 1 –
impurity in
H400 Lim 2012 [27],
ZnO. No
7440- Aquatic Chronic 1 - incidence on Marsili 2014
Cadmium5 43-9 H410 0,74-2,68 ppm classification [28]

Pyr. Sol. 1 - H250 1.5 % would
lead to
Water-react. 1 - H260
classification
Aquatic Acute 1 -
of aquatic
H400
chronic cat 3
Aquatic Chronic 1 -
H412
H410
according to
CLP
1,5 % on
calculation
average
rules, however
recently
published
ecotoxic tests
[13] support a
non- Ruffino 2013
7440- classification [29], Anses
Zinc 66-6 decision 2018 [30]
Hazard
Classification
Expected
Comments.
Substances of concentration
(N/A meaning no
CAS# Classification Reference(s)
interest in ELT derived
hazard
consequences
rubbers
classification
existing)
Chromium 7440- 4-50 ppm No incidence Lim 2012 [27],

47-3; on Menicchini et
16065- classification Boca 2009 [31]
83-
1(CrIII);
18540-
29-9
(CrVI)
Carc. 2 – H351
No incidence Lim 2012 [27]
STOT RE 1 – H372
7440- on Marsili 2014
Nickel 02-0 Skin Sens. 1 H317 5-26 ppm classification [28]
Repr. 1A - H360 Lim 2012 [27],
Marsili 2014
Lact. - H362
[28] Menichini
Aquatic Acute 1 -
Exists as 2011 [32],
H400
impurity in Ruffino 2013
Aquatic Chronic 1 -
ZnO. No [29], ERASSTRI
H410
7439- incidence on 2020 [10] [11]
Lead 92-1 STOT RE 1 – H372 9-55 ppm classification [12]
Pyr. Sol. 1 - H250 Menicchi 2011
[32], ERASSTRI
Water-react. 2 - H261
7429- 2020 [10] [11]
Aluminum 90-5 700-1000 ppm No incidence [12]
Carc. 1B - H350
Form cobalt
Muta. 2 - H341
salts used for
Repr. 1B - H360F
metallic sheets
Resp. Sens. 1 - H334
adhesion. No
Menicchi 2011
Skin Sens. 1 - H317
incidence on [32], ERASSTRI
classification
7440- Aquatic Chronic 4 - 2020 [10] [11]
Cobalt 48-4 H413 11-186 ppm [12]
Copper 7440- Aquatic Chronic 2 - 2-84 ppm No incidence Menicchi 2011
50-8 H411 on [32]
classification
Iron 7439- N/A 400-7000 ppm No incidence Menicchi 2011
89-6 on [32]
classification
Phatalates    No incidence
in terms of
classification
Hazard
Classification
Expected
Comments.
Substances of concentration
(N/A meaning no
CAS# Classification Reference(s)
interest in ELT derived
hazard
consequences
rubbers
classification
existing)
Di- 84-69-5 Repr. 1B - H360Df 2-7 ppm  RIVM 2017
isobutylphtalate [19], Celeiro
2018 [33]
Di-2-ethylexyl- 117-81- Repr. 1B - H360FD 27-17 ppm References to RIVM 2017
phtalate 7 where the [19], Celeiro
value was 2018 [33]
taken.
Repr. 1B - H360Df
Aquatic Acute 1 - Celeiro 2018
Di-butylphtalate 84-74-2 H400 16 ppm  [33]
Bis(2-ethylexyl- 103-23- N/A 1-251-0,47 ppm  RIVM 2017

adipate) 1 [19], Celeiro
2018 [33], Lim
2012 [27]
Di-ethylphtalate 84-66-2 N/A 11 ppm  Celeiro 2018

[33]
BTEX    No incidence
in terms of
classification
Flam. Liq. 2 – H225
Carc. 1A – H350
Muta. 1B – H340
Asp. Tox. 1 – H304
STOT RE 1 – H372
Skin Irrit. 2 – H315
Ruffino 2013
Benzene 71-43-2 Eye Irrit. 2 – H319 0,64 µg/kg  [29]
Flam. Liq. 2 – H225
Repr. 2 – H361
Asp. Tox. 1 – H304
STOT SE 3 – H336
STOT RE 2 * - H373
108-88- Ruffino 2013
Toluene 3 Skin Irrit. 2 – H315 449 µg/kg  [29]
Flam. Liq. 3 - H226
Acute Tox. 4 * - H332
Acute Tox. 4 * - H312
1330- Ruffino 2013
Xylene 20-7 Skin Irrit. 2 - H315 975 µg/kg  [29]
Hazard
Classification
Expected
Comments.
Substances of concentration
(N/A meaning no
CAS# Classification Reference(s)
interest in ELT derived
hazard
consequences
rubbers
classification
existing)
Butylhydroxytol 128-37- N/A 56 µg/kg  Celeiro 2018
uene 0 [33]
Phenols    No incidence
in terms of
classification
Repr. 2 - H361f
Skin Irrit. 2 - H315
Celeiro 2018
Eye Dam. 1 - H318
[33], ERASSTRI
4-ter- 2020 [10] [11]
Aquatic Chronic 1 -
butylphénol 98-54-4 H410 0,076 ppm  [12]
Skin Irrit. 2 - H315
Eye Dam. 1 - H318
Aquatic Acute 1 -
RIVM 2017
H400
[19], ERASSTRI
140-66- Aquatic Chronic 1 - 2020 [10] [11]
4-ter octylphénol 9 H410 22,4 ppm  [12]
STOT SE 3 - H335
Eye Dam. 1 - H318
Skin Sens. 1 - H317
Aquatic Acute 1 –
H400
Celeiro 2018
Aquatic Chronic 1- [33], RIVM
BPA 80-05-7 H410 2,5-1,7 ppm  2017 [19]
2-4 ter-di- 108-95- N/A 0,8-4 ppm  ERASSTRI
butylphénol 2 2020 [10] [11]
[12]
BPH 119-47- BPH has recently  According to
1 been the subject of a our knowledge
2,2'-Methylene-
harmonized of how BPH is
bis(4-methyl-6-
classification as used (volumes
tert-
reprotoxic 1B (H- and
butylphenol)
360F) and has been applications) it
included in the is very likely
REACH candidate list. that the
This substance, concentration
which is known to be of this
present in the tyre substance in
manufacturing the ELT
supply chain was not derived rubber
investigated in most would be
of the studies lower than
Hazard
Classification
Expected
Comments.
Substances of concentration
(N/A meaning no
CAS# Classification Reference(s)
interest in ELT derived
hazard
consequences
rubbers
classification
existing)
considered in this many of the
review substances
investigated in
this report, i.e.,
well below the
classification
threshold
concentration
Benzothiazole    No incidence
family in terms of
classification
Acute Tox. 3: H301
Acute Tox. 3: H311
Acute Tox. 4: H332
ERASSTRI
STOT RE cat 2: H373
2020 [10] [11]
Benzothiazole 95-16-9 Eye Irrit. 2: H319 14-90 ppm  [12]
Skin Sens. 1 - H317
Aquatic Acute 1 -
H400
2- ERASSTRI
mercaptobenzot 149-30- Aquatic Chronic 1 - 2020 [10] [11]
hiazole 4 H410 5-94 ppm  [12]
2- 934-34- N/A 7-58 ppm  ERASSTRI
hydroxybenzothi 9 2020 [10] [11]
azole [12]
Overall,
whatever the
study, the sum
of the
regulated
PAHs does not
exceed 51
mg/kg. In
PAHs
consequence
they have no
impact on a
potential
classification
of the ELT
derived
rubber.
Hazard
Classification
Expected
Comments.
Substances of concentration
(N/A meaning no
CAS# Classification Reference(s)
interest in ELT derived
hazard
consequences
rubbers
classification
existing)
Sum of total  N/A 19,8 mg/kg, 4-9  RIVM 2017
PAHs 8 regulated mg: kg [19], ERASSTRI
by REACH 2020 [10] [11]
[12]
Carc. 1B - H350
Muta. 1B - H340
Repr. 1B - H360FD
Skin Sens. 1 - H317
ERASSTRI
Aquatic Acute 1 -
2020 [10] [11]
H400
[12], RIVM
Aquatic Chronic 1 - [19], Celeiro
Benzo[a]pyrene 50-32-8 H410 0,79-1,52 ppm  2018 [33]
Carc. 1B - H350
Aquatic Acute 1 -
H400
ERASSTRI
Benzo[a]anthrac Aquatic Chronic 1 - 2020 [10] [11]
ene 56-55-3 H410 0,9 ppm  [12]
Carc. 1B - H350
Muta. 2 - H341
Aquatic Acute 1 -
H400
ERASSTRI
218-01- Aquatic Chronic 1 - 2020 [10] [11]
Chrysene 9 H410 0,2-1,2 ppm  [12]
Carc. 1B - H350
Aquatic Acute 1 -
H400
ERASSTRI
0,9-1,2
Benzo[k]fluorant 207-08- Aquatic Chronic 1 - 2020 [10] [11]
hene 9 H410 ppm  [12]
Other substances
of concern
Hazard
Classification
Expected
Comments.
Substances of concentration
(N/A meaning no
CAS# Classification Reference(s)
interest in ELT derived
hazard
consequences
rubbers
classification
existing)
Self-classified R1B by
the REACH Lead
Values from
registrant in 2019.
different studies
are:
Other self-
classification in the
65-570 ppm,
ERASSTRI
No incidence
REACH dossier: 1039ppm,
2020 [10] [11]
in terms of
649ppm,
Acute Tox. 4 : H302
[12], Nilsson
classification
727ppm
Skin sens 1 : H317 2008 [34],
in EU.
(reported by
ECHA [20]
Repro 1B: H360F
ECHA following
Aquatic Acute 1:
a publication by
H400
Nilsson in
2008)
Aquatic Chronic 1:
6PPD 793-24-8 H410
proposal for a 21
harmonized
classification as R2,
as a result of
substance evaluation
completed in 2020.
Repr. 2 - H361f ***
Acute Tox. 4 * - H302
STOT SE 3 - H335
Skin Irrit. 2 - H315
Eye Irrit. 2 - H319 ERASSTRI
No incidence
102-06- Aquatic Chronic 2 - in terms of
DPG 7 12-50 ppm classification. [10] |11] [12]
H411
Carc. 2 – H351
Muta. 2 – H341
Acute Tox. 3 * - H311
Acute Tox. 3 * - H331
Acute Tox. 3 * - H301
STOT RE 1 – H372
Eye Dam. 1- H318
Skin Sens. 1 – H317
3,8 ppm
Aquatic Acute 1 – (average) 7,2
Aniline 62-53-3 ppm(max)  US EPA
H400
Hazard
Classification
Expected
Comments.
Substances of concentration
(N/A meaning no
CAS# Classification Reference(s)
interest in ELT derived
hazard
consequences
rubbers
classification
existing)
Flam. Liq. 3 - H226
Acute Tox. 4 * - H312
Italia _
Acute Tox. 4 * - H302
108-91- CONFOREACH
cyclohexylamine 8 Skin Corr. 1B - H314 41 ppm  Study
Acute Tox. 4 * - H302
Skin Corr. 1B - H314
Aquatic Acute 1 -
H400
Italia _
dicyclohexylami 101-83- Aquatic Chronic 1 - CONFOREACH
ne 7 H410 175 ppm  Study
Silica has been the
7631- subject of a From 1 % to 10
Silica
86-9 notification for a %
STOT RE 2 – H373
B.5 Findings
Each one of the substances or group of substances was considered and the findings are below:
— metals potentially present are not reported concerning concentration with regards to a potential
classification except Zinc;
— when it comes to Zinc, the reported in concentrations would lead to a H412 classification (aquatic
chronic cat 3) according to CLP calculation rules. However, published ecotoxic tests [13] have not
revealed any ecotoxic effect either for short term or for long term. This provides grounds for non-
ecotoxic classification by virtue of article 12 paragraph (b) to the CLP regulation which provides
that tests data prevail over calculation rules;
— Silica is not triggering any classification at the time we draft this report. However, the ongoing
regulatory process to a harmonized STOT RE 1 classification, could lead to a classification of ELT
derived rubbers as STOT RE 1 or STOT RE2 depending on the silica content, from the strict
application of CLP calculation rules. The classification thresholds are 1 % and 10 % for Cat1 and Cat
2, respectively;
— widely reported phthalates are not expected to be at a concerning level either;
— BTEX are present at a very low level and in any case at concentration well below classification
thresholds;
— concentrations of phenols are not concerning;
— regarding BPH, based on our knowledge of the use of this substance given the limited volumes
within the tyre supply chain it is likely that the BPH content will not lead to any classification;
— the benzothiazole derivates are not present at classifying concentrations;
— PAHs are not present at concentration that would entail a classification;
— reported 6PPD concentrations are below the European classification threshold.
B.6 Conclusion
It appears from this relatively comprehensive review of published data at the time of drafting this
report that there is no need to classify ELT-derived materials as hazardous according to the CLP
regulation. This assessment will be subjected to periodic revisions to take into account the regulatory
developments on individual substances.
Annex C
(informative)
Scientific elements supporting the sameness condition of REACH
registration exemption under art.2.7(d) for ELT derived Rubber
C.1 Introduction
Article 2.7(d) to REACH (Regulation (EC) No 1907/2006 of the European Parliament and of the Council)
provides for an exemption of registration for substances recovered from waste provided that the
following conditions are cumulatively met:
— the recovery is done within the EU;
— the substance that results from the recovery process is the same as a substance that has been
already registered under REACH;
— the information required by Articles 31 or 32 relating to the substance that has been registered is
available to the establishment undertaking the recovery.
This Annex focuses on the second condition, on the sameness. According to the REACH Guidance on
waste and recovered substances [4], the sameness with an already registered substance must be
supported by analytical tests as per the recommendation of the registrants. We build on our expertise in
rubber chemistry and the existing scientific elements suggesting the sameness without analytical tests.
The approach taken is pragmatic and helps overcome the chemical complexity due to the vulcanization
reaction. Indeed because of the
...