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 toluene and trichlorobenzene (twenty-eighth amendment of Council Directive 76/769/EEC)’(COM(2004) 320 final - 2004/0111 (COD))
Date: 2004-10-27
Institutions: European Economic and Social Committee
Subjects: ESC opinion, dangerous substance, health risk, marketing restriction, scientific committee (EU), toxic substance

C 120/6

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
toluene and trichlorobenzene (twenty-eighth amendment of Council Directive 76/769/EEC)’

(COM(2004) 320 final - 2004/0111 (COD))

(2005/C 120/02)

On 11 May 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 the Single Market, Production and Consumption, which was responsible for preparing the
Committee's work on the subject, adopted its opinion on 6 October 2004. The rapporteur was Mr Sears.

At its plenary session of 27 and 28 October 2004 (meeting of 27 October), the European Economic and
Social Committee adopted the following opinion by 165 votes to 1, with 5 abstentions:

1. Introduction

1.1
‘Existing’ substances are substances deemed to have been
on the European Community market between 1 January 1971
and 18 September 1981. 100,195 such substances were identi-
fied and listed in the European Inventory of Existing Commer-
cial Chemical Substances (EINECS) published in the Official
Journal in 1990 (1). Substances placed on the market after 18
September 1981 are defined to be ‘new’ and require pre-
marketing notification under the relevant European Union
legislation.

Risks to human health and the environment of these
1.2
existing substances have been routinely assessed under Council
Regulation (EEC) 793/93 (2). To date,
four priority lists for
assessment have been established, for implementation by the
competent authorities in Member States. The last of these was
dated 25 October 2000 (3). These identified 141 substances
where some risk might be expected either due to their specific
structures and known or anticipated biochemical interactions,
or where their high production volumes (HPV) gave rise to
concern.

1.3 Member States assess each substance at all stages of
manufacture and use for both hazard and exposure to deter-
mine whether or nor there are indeed risks to health and the
environment and if there are, what risk reduction measures
might be required. If it is determined that, despite being on a
priority list for assessment, there are no or very low risks in
any actual or planned use, control measures are either not
required or are likely to be low in both impact and benefit.

(CSTEE). If the CSTEE agrees with the conclusions and supports
the overall assessment process, risk reduction measures,
if
required, can be proposed as amendments to Annex 1 of the
Council Directive on the marketing and use of certain
dangerous substances and preparations 76/769/EEC (4). The
present proposal is the twenty-eighth such amendment.

The two substances

1.5
(toluene and trichlorobenzene)
referred to in the proposal have been assessed in accordance
with the above procedure. Both were included in the second
list of priority substances published as Commission Regulation
EC 2268/95 of 27 September 1995 (5). Both were awarded to
Denmark for the process of assessment. The CSTEE substan-
tially agreed with and supported the subsequent RARs in
Opinions delivered at its 24th and 25th plenary meetings on 12
June 2001 and 20 July 2001 respectively.

This proposal sets out risk reduction measures for the
1.6
two substances to be implemented by Member States within
eighteen months of the entry into force of the Directive. The
Commission published the proposal on 28 April 2004. After
following due procedures, and if agreement can be reached on
any changes required, it should take effect in Member States by
no later than June 2006.

2. Summary of the Commission's proposal

1.4
Completed Risk Assessment Reports (RARs) from the
Member States have in turn been evaluated by the Scientific
Committee on Toxicity, Ecotoxicity and the Environment

The proposal seeks to protect human health and the
2.1
environment, as well as establishing (or preserving) the Internal
Market for these two substances. It is believed that this can be
done at little or no cost as uses in the specified applications
have already declined and alternative products are believed to
be readily available.

(1) OJ C 146A of 15.6.1990
(2) OJ L 84 of 5.4.1993
(3) OJ L 273 of 26.10.2000

(4) OJ L 262 of 27.9.1976
(5) OJ L 231 of 28.9.1995

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2.2
In the case of toluene, recognised as a versatile HPV
substance used as an essential raw material for chemical synth-
esis and as a solvent in many industrial and consumer applica-
tions, restrictions are to be placed on any use above 0,1 % by
mass in adhesives and spray paints for sale to the general
public. This does not apply to any industrial applications and is
intended to protect consumer health.

2.3
In the case of trichlorobenzene, with a more limited use
as an intermediate for certain herbicides and as a process
solvent in closed systems, restrictions are to be placed on any
use above 0,1 % by mass in any use except as an intermediate.
This restricts any possible sales to the general public and
provides additional protection to health in the work place.

2.4
The two products to which this amendment applies are
defined by their CAS Numbers 108-88-3 120-82-1 in the
Annex to the proposal. Restrictions on usage will be added to
Annex 1 of Directive 76/769/EEC.

2.5 Member States will have one year to publish laws neces-
sary to comply with this Directive, with the controls to be
effective within a further six months. 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.

3. General comments

emissions from volcanoes and forest fires, and can be deliber-
ately manufactured in very large quantities from coal or crude
oil.

4.2
According to industry sources, worldwide capacity and
production levels for deliberately produced toluene in 2002
were 20 million tonnes and 14 million tonnes respectively.
75 % of this capacity is located in the US, Asia and Japan. The
CSTEE Opinion quotes EU production in 1995 at 2,6 million
tonnes. Much larger quantities result from the routine manufac-
ture of gasoline and contribute to overall exposures; these are
not included in these totals (3).

4.3
Toluene is used primarily as the raw material in closed
systems for the deliberate manufacture of benzene, urethane
foams and other chemical products, and,
in much smaller
quantities, as a solvent carrier in paints, inks, adhesives, phar-
maceutical products and cosmetics. Its effects on human health
and the environment have been widely studied and generally
accepted by all those concerned. There is a clear need to mini-
mise any unnecessary actual or theoretical uncontrolled expo-
in particular where alternative products, with similar
sure,
solvating power, exist.

4.4
The two end uses specified in this proposal fall into this
latter category. The usage of toluene as the solvent for adhe-
sives and spray paints for sale to the general public is neither
necessary nor supported by its manufacturers in Europe. Actual
sales are currently believed to be low or nil to these two end
uses. This is therefore a largely precautionary measure, with
little anticipated effect on manufacturers' costs or on consu-
mers' choice or health.

3.1
As with the twenty-sixth amendment of Council Direc-
tive 76/769/EEC (restrictions on the marketing and use of
nonylphenol, nonylphenol ethoxylates and cement) (1), on
which the EESC delivered its Opinion in March 2003 (2), this
proposal deals with unrelated substances which, for clarity, will
be discussed separately.
intervening twenty-seventh
(The
amendment on polycyclic aromatic hydrocarbons in extender
oils and tyres has been published but is still under review.)

4.5
The EESC recognises that the prime requirement is to
ensure that toluene can be safely handled in large quantities in
closed systems in the work place. This proposal ensures that
members of the general public, outside of a controlled work
environment, will be adequately protected, both now and in
the future,
from unnecessary exposure. The EESC therefore
supports this part of the proposal.

4. Toluene

5. Trichlorobenzene

4.1
Toluene is a clear colourless liquid with a distinctive
smell. Also known as methyl benzene, it has the second, after
benzene, most simple aromatic structure – a six-member
carbon ring with a one member (alkyl) carbon chain attached.
It occurs naturally in crude oil, in some plants and trees, and in

5.1
The situation for trichlorobenzene differs significantly
from the above and some amendments and clarifications are
required to the proposal.

(1) OJ L 178 of 17.7.2003
(2) OJ C 133 of 6.6.2003

(3) Data from the APA (Aromatics Producers Association), a member of

CEFIC (European Chemical Industry Council)

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5.2
‘Trichlorobenzene’ is a deliberately made chemical which does not occur in nature, other than by
the degradation of other chlorinated aromatic compounds. There are three different isomers, depending on
the location of the chlorine atoms around the six-member carbon ring. Each has (marginally) different
physical properties and biochemical interactions, for instance as measured by their LD50 values. Each has
a different CAS and EINECS Number. In addition there is an entry in both CAS and EINECS registers for
‘trichlorobenzene’ in general. All are commercially available in the US and elsewhere. 1,3,5-Trichloroben-
zene is no longer believed to be manufactured in Europe. Details of the listings are as follows (1):

EINECS Number

201-757-1

204-428-0

203-686-6

234-413-4

CAS Number

Isomer

Form

87-61-6

1,2,3-

120-82-1

108-70-3

12002-48-1

1,2,4-

1,3,5-

-

White flakes

Clear liquid

White flakes

Clear liquid

Melting Point ° C

Oral, rat LD50 mg/kg

UN Number

52-55

1830

2811

17

756

2321

63-65

800

2811

-

-

-

5.3
The RAR and CSTEE Opinion refer specifically to 1,2,4-
Trichlorobenzene, with EINECS and CAS Numbers as above.
The present proposal confirms this single CAS Number (and
therefore the one isomer that has been studied) in the Annex –
but not in the title or text.

restricted to the isomers 1,2,4-TCB and 1,2,3-TCB for use only
as intermediates, with this being confirmed in pre-delivery
written use statements from each customer.

5.4
The different isomers are manufactured to high degrees
of purity as intermediates in closed systems for the synthesis of
certain herbicides, pesticides, dyes and other specialist chemi-
cals. Where the specific isomeric structure is less important, a
mixture of isomers can be used in closed systems as a solvent
carrier for dyes or as process regulators or heat transfer media,
in sprays as a corrosion inhibitor and in metal working fluids.

5.5
In the EU (and elsewhere) the prime usage is of 1,2,4-
in varying degrees of purity.
Trichlorobenzene (1,2,4-TCB),
Production is believed to have declined steadily since the
1980s. Data presented to the OSPAR Commission for the
protection of the marine environment estimated 1994 produc-
tion of 1,2,4-TCB as being between 7-10 thousand tonnes;
1,2,3-TCB as less than 2 thousand tonnes; and 1,3,5-TCB as
less than 200 tonnes (2). In June 2000 OSPAR added all three
isomers as individual entries to its list of Hazardous Substances
for Priority Action. The CSTEE Opinion of July 2001 also
quotes 7 thousand tonnes production in Europe in 1994/95.
Production levels have continued to decline and are currently
believed to be around half these levels, with the greater part
being for export (3).

A limited number of other closed system uses are
5.7
known and recognised by the Commission and CSTEE,
for
instance as process solvents with no release to the external
environment. As this proposal
is intended to allow essential
manufacture but severely restrict emissions due to open use, it
would seem reasonable to add this to the permitted uses in the
Annex to this proposal.

5.8
The EESC believes that, subject to the specific points
made above, this proposal should provide increased protection
in the work place and remove altogether any risks of exposure
outside the work place. Manufacturers and users of trichloro-
benzene and of competing products seem to have largely
anticipated this proposal. There should,
therefore, be only
minor impacts on manufacturers' and users' costs. The EESC
therefore supports this part of the proposal.

6. Specific comments

5.6
producer

At present there is believed to be only one remaining
in the EU/OSPAR region. Sales are said to be

(1) European Chemicals Bureau Website (http://ecb.jrc.it)
(2) Data from Eurochlor, a member of CEFIC.
(3) CSTEE opinions are available at the DG SANCO website.

6.1
The EESC notes, as above, that this proposal has to be
based on the relevant RAR and CSTEE Opinion and therefore
has to refer solely to 1,2,4-TCB. This should be made clear in
the title and text. Happily the effect of the restrictions on usage
will remain the same, as this isomer is the principal constituent
of mixed-isomer TCBs previously sold for use in solvents or
sprays.

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6.2
Other closed system uses should be permitted, by the
addition of the words ‘or in other closed systems where no
release to the environment is possible’ at the conclusion of the
relevant restriction.

6.3
As with previous amendments to Council Directive
76/769/EEC, the EESC regrets the linking of unrelated products
in a single text which may require specific and continuing
amendments to match external realities. This does not support
good,
follows from
resource limitations during this final and critical stage of
agreeing specific risk reduction measures,
these limitations
should be overcome as quickly as possible.

timely and effective governance.

If

it

6.4
The EESC notes that the last list of priority substances
for assessment was published in October 2000. The EESC
regrets that this approach seems to have been abandoned long
before other procedures such as REACH can be implemented.
This loss of momentum is regretted.

6.5
The EESC notes the key role played by the CSTEE in the
past and trusts that adequate provision has been made for
continuing this
role in the future, despite the recently
announced changes to the structure and responsibilities of the
scientific committees.

Brussels, 27 October 2004.

6.6
The EESC shares the generally expressed concerns over
the time taken to evaluate substances under the present system.
For these two products close to 11 years will have elapsed
before the legislation comes into effect. Five years of this will
be after the CSTEE pronounced the RARs to be satisfactory.
When the legislation does come into force,
there will be
virtually no costs – or measurable health or environmental
benefits – for anyone concerned.
In the absence of further
information, it is impossible to say whether this is good (i.e.,
the market has adapted under pressure of the continuing risk
assessments) or bad (the process has achieved very little, at
considerable cost to all concerned) – or how to make any
desired improvements.

6.7
The EESC therefore believes that, as a complement to
other proposals such as REACH and to ensure that they will
indeed improve rather than detract from the existing processes,
reasons for the slow progress should be evaluated without
further delay. This should be in parallel with other studies now
in progress to measure impacts, costs and benefits for all the
stakeholders in these processes designed to benefit health and
the environment, within the framework of a successful and
competitive knowledge-based European economy.

The President

of the European Economic and Social Committee

Anne-Marie SIGMUND