Opinion of the European Economic and Social Committee on the ‘Proposal for a Directive of the European Parliament and of the Council relating to restrictions on the marketing and use of certain polycyclic aromatic hydrocarbons in extender oils and tyres (twenty-seventh amendment of Council Directive 76/769/EEC)’(COM(2004) 98 final – 2004/0036 (COD))
Date: 2004-09-21
Institutions: European Economic and Social Committee
Subjects: ESC opinion, approximation of laws, dangerous substance, marketing restriction, oil technology, pneumatic tyre, pollution, public health

C 120/30

EN

Official Journal of the European Union

20.5.2005

Opinion of the European Economic and Social Committee on the ‘Proposal for a Directive of the
European Parliament and of the Council relating to restrictions on the marketing and use of
certain polycyclic aromatic hydrocarbons in extender oils and tyres (twenty-seventh amendment
of Council Directive 76/769/EEC)’

(COM(2004) 98 final – 2004/0036 (COD))

(2005/C 120/07)

On 22 March 2004, the Council decided to consult the European Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the abovementioned proposal.

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing
the Committee's work on the subject, adopted its opinion on 21 September 2004. The rapporteur was Mr
Sears.

At its 412th plenary session of 27 and 28 October 2004 (meeting of 27 October 2004), the European
Economic and Social Committee adopted the following opinion by 154 votes to three, with seven absten-
tions.

1. Introduction

formed whenever

Polycyclic aromatic hydrocarbons (PAHs) are naturally-
1.1
occurring substances
carbon-containing
compounds are burned at low temperatures in uncontrolled
fires and volcanoes;
conditions. This happens in forest
in
human activities such as smoking;
in home heating, power
generation and driving using fossil fuels; in cooking food and
burning waste materials; and in a number of
industrial
processes. PAHs occur naturally in crude oil and coal and,
being easily formed and stable, accumulate during the early
stages of cracking and distillation.

This process of partial oxidation results in a mixture of
1.2
compounds with linked unsaturated five and six-member
carbon rings which can repeat
in virtually any direction.
Around 600 structures have been identified; only a few have
been characterised or isolated for use as intermediates. None
have been deliberately produced in significant quantities.
Further oxidation results in the formation of soot (i.e., impure
particles of carbon) with which PAHs are frequently associated.

1.3
As they always occur in undifferentiated groups, the
individual characteristics of PAHs cannot be easily determined
(and, for the same reason, are largely irrelevant). However, as
some can be shown to be carcinogenic to animals, it is reason-
able to classify the mixtures as likely to cause cancer in
humans. Oils and some other preparations known to contain
PAHs therefore require risk and safety labelling and appropriate
handling to ensure safety in the work place. Processes likely to
release PAHs into the environment should, where possible, be
controlled or avoided.

These oils, which may make up as much as 28 % of the tread,
confer the essential characteristic of grip which is not required
in the carcass. If the tread does not work as intended, or does
not remain coherent in use, then safety and performance are
compromised, with obvious consequences for the drivers of the
vehicles.

1.5
Technically the oils must be capable of dissolving the
natural and synthetic rubbers and other materials used in tyres,
must be long-lasting and stable, must distribute well and
remain bound in the rubber matrix, must function in different
conditions of temperature and humidity, and must be safe to
handle in manufacture and use. The oils must also be available
in large quantities, manufactured to globally agreed specifica-
tions, from a number of competing suppliers, at costs below
that of the rubber to reduce the overall cost of the tyres.

1.6
Highly aromatic oils meeting these specifications have
traditionally been supplied by leading oil producers under the
title of distillate aromatic extracts
(DAEs). The required
solvating power depends on the total aromaticity of the oils
which in turn depends on the presence of significant levels of
PAHs. As the tread of a tyre wears away, it must be assumed
that these PAHs are released to the environment. Whether or
not these releases are significant compared to other releases is
in dispute. However the process of change to other oils is
under way in Europe and needs to be brought to a satisfactory
conclusion.

1.4
One such process is the use of extender oils in tyres for
cars, goods vehicles, motorcycles, racing cars and aircraft.

1.7
This is especially important as the world-wide supply of
DAEs is also becoming limited, with refinery upgrades now
focusing on the production of higher value fully hydrogenated
(i.e. low aromatic and reduced solvating power) products and
on ‘clean’ gasoline and fuel products.

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1.8
Given that around 300 million tyres are produced each
year in Europe and the world market for extender and process
oils for the tyre industry is close to 1 million tonnes, to bring
this about in a cost-effective manner, whilst maintaining the
drive for safety and high performance at low or acceptable
cost, is a major challenge for oil suppliers, tyre manufacturers
and regulators alike.

listed are not high production volume (HPV) substances and
have not appeared on any of the four priority lists for the
assessment of existing substances. They are however regarded
as a group as being Persistent Organic Pollutants (POPs) under
the relevant UN ECE Protocol and Convention.

1.9
So far, two formulations for non-carcinogenic oils have
been proposed, requiring varying degrees of investment by the
oil suppliers and different reformulations by the tyre compa-
nies. These are known as mild extraction solvate (MES) and
treated distillate aromatic extract (TDAE) respectively. Other
oils may be developed by other suppliers outside Europe.

As far as can be determined (as details are not publicly
1.10
available in the extremely competitive tyre market), some
substitution has already taken place – for instance in winter
and truck tyres where wet traction for tread is less important.
However it is generally accepted that conversion of higher
performance summer tyres, let alone tyres for racing cars and
aircraft, will take much longer. Also there is a shortage of
installed capacity for MES and TDAE, in addition to the limita-
tions on DAE availability already mentioned.

representatives of

In order to bring about the desired changes, in a timely
1.11
manner and consistent with other EU legislation on both
competition and health and safety,
the
industry sectors (CONCAWE,
IISRP and BLIC) have worked
with the Commission and other regulatory bodies to agree the
appropriate manufacturing approach and regulatory frame-
work. Still outstanding in this are tests to define which oils are
acceptable for use in Europe, and tests for all tyres placed on
the market, whether manufactured in or outside of the EU, to
demonstrate that acceptable low-PAH oils are incorporated in
the finished articles.

is

classified

One specific PAH, benzo(a)pyrene (BaP, CAS number
2.2
50-32-8)
framework of Directive
in the
67/548/EEC as being carcinogenic, mutagenic and reprotoxic
Category 2, and is proposed here as a qualitative and quantita-
tive marker for the presence of other PAHs.

Extender oils may not be placed on the market and used
2.3
for the production of tyres if they contain more than 1mg/kg
BaP or more than 10mg/kg of the sum of all the listed PAHs.

The Commission recognises that a number of technical
2.4
problems still need to be overcome,
therefore the date of
general application is set at 1 January 2009. Racing car tyres
would be covered from 1 January 2012 and aircraft tyres at
some date in the future to be determined. The absence of rele-
vant harmonised test methods for the content of PAHs in
extender oils and tyres, e.g., from CEN or ISO, should not delay
the entry into force of the Directive.

The Commission notes that it has consulted the Scien-
2.5
tific Committee on Toxicity, Ecotoxicity and the Environment
(CSTEE) with respect to the scientific findings on the adverse
health effects of PAHs.

2.6 Member States will have one year to publish laws neces-
sary to comply with this Directive. This will be from the date
of entry into force of this proposal, after consulting, as required
by Article 95 of the Treaty, the European Economic and Social
Committee (EESC) and following the Co-decision Procedure
with the European Parliament.

2. Summary of the Commission's proposal

3. General comments

2.1
In July 2003 the Commission proposed a general restric-
tion on heavy metals and PAHs in ambient air. The EESC gave
its Opinion on this first proposal
in February 2004. The
current proposal, also published in February 2004, seeks to
establish an Internal Market as well as providing a high level of
protection to human health and the environment by adding
certain PAHs to Annex 1 of Directive 76/769/EEC. The PAHs

3.1
This proposal, which supplements other controls on
PAHs, is based on reports on the alleged health and environ-
mental effects of tyre debris from the German Umweltbunde-
samt (UBV) dated 18 March 2003 and the Swedish National
Chemicals Inspectorate (KEMI) dated 27 March 2003. These
were reviewed by the CSTEE, as reported in an Opinion
adopted at its 40th plenary session of 12-13 November 2003.

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3.2
THE CSTEE agreed, for the reasons given above, that
PAHs, as a group, should be considered as likely carcinogens
for man and that PAHs are emitted to the environment as a
result of tyre wear. It however gave only partial support to the
use of BaP as a qualitative and quantitative marker for other
PAHs and severely questioned the overall impact of this emis-
sion route.

3.7
Given the above, and the overlap with the earlier
Commission proposal on heavy metals and PAHs in ambient
air, it has been argued that this Directive is unnecessary and
should be withdrawn. The market has become fragmented,
with at least two products needed to replace the one previously
used. There is insufficient installed capacity to meet demands.
There are still concerns over the safety of the replacement
formulations; if treads made with low-PAH oils fail in use, real
deaths will replace the hypothetical deaths used to justify
precautionary action.

3.3
In summary, PAH emissions from tyre wear contribute
less than 2 % to total human exposure, with the sources
mentioned in 1.1 contributing the remaining 98+ %. This is
consistent with repeated WHO assessments that the primary
including
causes of air pollution and associated diseases,
cancer, are smoking and wood and coal burning for heat and
food preparation. The CSTEE therefore concluded that ‘a limita-
tion of PAHs in tyres will not considerably affect the PAHs
concentrations in ambient air and sediments’.

3.4
It follows that the routine statement that the Directive
‘will yield benefits in terms of providing a high level of protec-
tion to human health and the environment’ does not apply
strongly in this case. The extender oils are already labelled and
can be handled safely in the work place under existing legisla-
tion on Dangerous Substances. This proposal will therefore
bring no benefits in the work place and minimal benefits to the
environment.

3.5
It should be also noted that this proposal, as with the
twenty-sixth amendment of Council Directive 76/769/EEC in
its attempt to limit concentrations of naturally occurring chro-
mium VI in cement, on which the EESC delivered its Opinion
in March 2003, stretches the scope of the Directive to, or past,
its intended limits. PAHs are neither deliberately manufactured
nor placed on the market as such. This is recognised in the
Annex – where the limitations are, correctly, on products
containing PAHs – but not in the title, which should therefore
be amended.

3.8
The EESC understands these concerns however feels
strongly that the Directive must proceed, in close consultation
with the affected industries, to bring about a successful transi-
tion to the world-wide use of low-PAH extender oils in the
manufacture of tyres. These replacement oils must clearly meet
the same minimum standards of performance in all matters
relating to safety. The establishment of an effective, competitive
and reliable Internal Market in Europe in these new products is
therefore a sufficient and proper driving force for this proposal.

Crucial to this in terms of timing is agreement on the
3.9
tests to be used to determine which oils will be acceptable in
use. The present Annex suggests testing for the presence of
individual PAHs. This is inappropriate to continuous running
large scale refinery operations where the actual chemical consti-
tuents of specific streams vary with the crude oils being
processed. Other tests such as IP-346 from the Institute of
Petroleum (which controls total PAH content by measuring the
quantity of three to seven-member ring PAHs extractable by
the solvent DMSO) are in already in use in the oil industry as
an acceptable measure of carcinogenicity under Directive
67/548/EEC. Studies by CONCAWE for
industry
support the CSTEE Opinion that the single measurement of
BaP gives a poor correlation with overall potential carcinogeni-
city. The use of IP-346 for defining and testing the different
extender oils is therefore strongly recommended.

the oil

The title and the text are also confusing in the references
3.6
to ‘certain PAHs’ as a specific and meaningful group. Given
that, as the CSTEE notes, very few PAHs have been charac-
terised, and of these even fewer shown to be unlikely to be
carcinogens, it must be concluded that the entire class presents
risks where human exposures are possible. The restrictions on
marketing and use should therefore be on ‘oils rich in PAHs
used in the manufacture of tyres, and on tyres containing these
oils’.

3.10
In order to protect the tyre industry in Europe – and
the environment if such benefits exist – there must be a similar
test for the oils used in imported tyres. A draft standard from
the International Standards Organisation (ISO TC 45/SC 3 N
dated 29 October 2003) proposes, for review and comment, a
test method for the determination of oil
type in rubber
compounds. This work should be brought to a satisfactory
conclusion before this Directive is implemented.

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than MES. All of

Given the above, it should be possible to resolve the
3.11
for TDAE which
in particular
current supply restrictions,
requires higher levels of
this
investment
however takes time and the current requirement for the change
to be completed for all general purpose tyres by 1 January
2009 looks increasingly unrealistic. Given that the benefits of
this proposal are likely to be minimal, and the costs and risks
of unsuccessful
the EESC
proposes that this initial deadline should be extended by 12
months to 1 January 2010. Even this will entail considerable
negotiation between the various competing stakeholders. The
Commission will continue to have a key role in facilitating this
process within the constraints of EU law and eventually
bringing it to a successful conclusion.

reformulations are considerable,

4. Specific comments

In the light of the above, the title of this proposal and
4.1
subsequent wording should be consistent with the overall aim
of introducing restrictions on the marketing and use of ‘oils
rich in PAHs used in the manufacture of tyres, and on tyres
containing these oils’.

Brussels, 27 October 2004.

4.2
This should be reflected in the Annex with limitations
imposed on the marketing and use of oils used in the manufac-
ture of tyres having greater than 3 % DMSO extractables under
IP-346 and therefore classified as carcinogenic under Directive
67/548/EEC. All references to BaP as a marker and to other
individual PAHs should be deleted.

4.3
An international standard test method should be devel-
oped for the characterisation of oils in rubber compounds, in
particular tyres, and incorporated in this Directive.

4.4
Appropriate time should be given to the rubber and tyre
industries to complete the reformulation work under way, and
to the oil industry to invest in and supply the required raw
materials. At present it is believed that all the parties could
meet such requirements by 1 January 2010 and this date
should therefore be incorporated as the initial deadline in the
proposal. Derogations for tyres for racing cars, aircraft and
other high performance end uses should be agreed with the
stakeholders; in the light of the above, it is difficult to see any
measurable benefits from these changes compared to the
obvious risks of non-performance to all concerned.

The President

of the European Economic and Social Committee

Anne-Marie SIGMUND