Opinion of the European Economic and Social Committee on the Proposal for a Decision of the European Parliament and of the Council amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of certain dangerous substances and preparations (Dichloromethane) COM(2008) 80 final — 2008/0033 (COD)
Date: 2008-09-17
Institutions: European Economic and Social Committee
Subjects: ESC opinion, chemical product, health risk, marketing restriction, paints and varnishes

31.3.2009

EN

Official Journal of the European Union

C 77/29

Opinion of the European Economic and Social Committee on the ‘Proposal for a Decision of the
the Council amending Council Directive 76/769/EEC as regards
European Parliament and of
substances and preparations
restrictions on the marketing and use of certain dangerous

(Dichloromethane)’

COM(2008) 80 final — 2008/0033 (COD)

(2009/C 77/05)

On 10 March 2008, the Council decided to consult the European Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the

Proposal for a Decision of the European parliament and of the Council amending Council Directive 76/769/EEC as
regards restrictions on the marketing and use of certain dangerous substances and preparations (Dichloromethane).

The Section for Single Market, Production and Consumption, which was responsible for preparing the
Committee's work on the subject, adopted its opinion on 15 July 2008. The rapporteur was Mr Sears.

At its 447th plenary session, held on 17 and 18 September 2008 (meeting of 17 September), the European
Economic and Social Committee adopted the following opinion unanimously.

1. Summary and recommendations

not of the products or people concerned. Recommendations on
packaging and labelling are therefore made to rectify this
situation.

seeks

This proposal

to amend Council Directive
1.1
76/769/EEC by adding restrictions on the marketing and use of
dichloromethane (DCM) when used as a major component of
paint strippers for industrial, professional and consumer use.

1.2
This is the last such amendment of Council Directive
76/769/EEC before it is replaced on 1 June 2009 by Regulation
(EC) 1907/2006 (REACH).

1.6
Other problems are identified, most noticeably the
absence of agreed Occupational Exposure Limits and guidelines
or regulations on good industrial practice. The German TRGS
612 is considered an excellent model in this respect.

1.7
A number of other general points are made for consid-
eration by the Commission, European Parliament and Member
States in the hope that agreement can be reached. Failure to do
so will lead to a fracturing of the internal market. Users, in and
outside the work place, will remain at risk.

The EESC recognises the considerable scientific and poli-
1.3
tical difficulties faced by the Commission in proposing and
reaching agreement on a proportionate and cost effective
amendment which, as Directive 76/769/EEC requires, will
preserve the Internal Market and at the same time ensure a high
level of protection for human health and the environment.

2. Legal Basis

The EESC agrees that there is compelling evidence that,
1.4
where high concentrations of vapour occur due to the high
volatility of DCM, these can lead to unconsciousness and death.
These result from poor industrial practice, including inadequate
ventilation. The evidence for a serious ongoing risk to consu-
mers through occasional domestic use is less compelling. The
proposal for a ban on sales is therefore disproportionate and,
given the known but so far unquantified risks of the alternative
products and processes, seems unlikely to lead to any overall
reduction in the, rather low, rate of accidents being recorded.

As previously noted, Regulation (EC) No 1907/2006 of
2.1
18 December 2006 of the European Parliament and of the
Council concerning the Registration, Evaluation, Authorisation
and Restriction of Chemicals (REACH) will come into effect on
1 June 2009. This will repeal and replace a number of existing
Council and Commission Regulations and Directives, including
Council Directive 76/769/EEC of 27 July 1976 on the
marketing and use of
substances and
preparations.

certain dangerous

1.5
The EESC also notes, as did the consultants employed by
the Commission, that the special hazards of DCM are not fully
covered by existing pictograms or Risk and Safety phrases. The
same comment applies to the risks to children, more common
in a domestic setting. This is a failing of the labelling system,

2.2
Annex I of Council Directive 76/769/EEC sets out the
specific restrictions on the marketing and use of certain
dangerous substances and preparations that have been agreed
and put in place over the last 30 years. On 1 June 2009 these
will become the cornerstone of Annex XVII of Regulation (EC)
No 1907/2006 (REACH).

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2.3
Previous amendments to Council Directive 76/769/EEC
(i.e. to add further restrictive measures) have been in the form
of Directives requiring implementation by member states. This
proposal by the Commission is, however, for a Decision, which
will have immediate effect, rather than for a Directive. It will
not therefore require transposition into national
laws which
would also have to be repealed on 1 June 2009 when Regu-
lation (EC) No 1907/2006 (REACH) comes into force.

3.2
Although regarded as one of the safer low molecular
weight halogenated hydrocarbons, DCM must still be used with
care. It is classified in Europe as a Category 3 carcinogen, i.e. it
is ‘a substance that causes concern for man owing to possible
carcinogenic effects but for which the available information is
not adequate to make a satisfactory assessment’. It must there-
fore carry the R40 phrase (‘limited evidence of a carcinogenic
effect’). It is also a priority substance under the Water Frame-
work Directive.

All

subsequent proposals

2.4
restrictions on the
marketing and use of dangerous substances or preparations will
be under Regulation (EC) No 1907/2006 (REACH).

for

The substances (and any preparations containing them)
2.5
for which restrictions on marketing and use have been deemed
necessary have generally resulted from evaluations of certain
‘priority substances’ nominated by Member States and published
in four priority lists between 1994 and 2000 under Council
Regulation (EEC) No 793/93.

A number of substances not included in these lists have
2.6
also been assessed for their impact on human health and the
environment, and/or proposals made to restrict their marketing
and use, as new problems have been addressed at the request of
the Member States. DCM comes under this heading. A number
of Member States, for a variety of reasons, have already imposed
or sought to impose restrictions on its use, in particular as a
component of paint strippers. Other member states view these
measures as being disproportionate, costly and likely to lead to
less satisfactory outcomes for users. There is some evidence (or
a lack of evidence) to support or contradict both positions.

The first full review of the proposal

in Council took
2.7
place in early June. If a compromise can be found within the
coming months, then the proposal
is likely to go ahead as
planned. If this is not the case, then the proposal will fail. In
this case the Internal Market for DCM-based paint strippers will
remain fractured and may become more so. DCM would then in
due course be assessed under Regulation (EC) No 1907/2006
(REACH) — with its use in paint stripping being one of many
exposure routes to be considered. It is obviously unclear what
the outcome of this would be or when any final recommenda-
tion could be made.

3.3
Of greater concern however is that it is also a powerful
narcotic, depressing the central nervous system, and leading to
unconsciousness or death. This has led to a series of accidents
and fatalities, generally associated with unsafe working practices
and gross over-exposure, generally during open tank industrial
or large scale professional use. Usage in closed systems, where
this is feasible, removes these risks.

France,

Italy, Spain,

Production levels of DCM in Europe (from sites in
3.4
Germany,
the Netherlands, UK and
Romania) are declining slowly as other products become avail-
able. Of the approximately 240 000 tonnes currently manufac-
tured in Europe, approximately 100 000 tonnes are exported.
30-50 % of the remainder goes to the pharmaceutical industry
and 10-20 % for sale as ‘virgin’ DCM in paint strippers. Recycled
DCM from the pharmaceutical
industry provides a similar
tonnage. This proposal deals solely with the use of DCM in
paint stripping.

3.5
Paint stripping is familiar to most householders as an
essential process to conserve and decorate wood, metal, stone
and plaster objects and surfaces in and outside their properties.
There are also a number of more specialist markets, including
fine art restoration, graffiti removal and the repainting of large
mobile objects such as trains or planes.

Paint strippers are divided somewhat arbitrarily into
3.6
‘industrial’ (i.e., with on-site continuing high
three categories:
volume usage);
‘professional’ (multiple site specialists, builders
and decorators) and ‘consumers’ (individuals occasionally under-
taking home maintenance).

3. Background

3.1
DCM is a colourless low boiling halogenated aliphatic
hydrocarbon with a mild sweet odour. It has been widely used
for many years as a powerful solvent with low flammability in
the production of pharmaceuticals, aerosols and adhesives and
in other processes such as paint stripping, metal degreasing and
as an extraction solvent for foodstuffs.

The numbers of actual incidents for each group are hard
3.7
to determine. Given that the symptoms of a DCM overdose
resemble heart failure, there may (or may not) be some under-
reporting. The data presented to the Commission by consultants
RPA show 3-4 incidents per year in Europe due to the use of
DCM-based paint strippers over the last twenty years, of which
1 per year proved fatal. Fatalities were concentrated in
France (6), Germany (6) and the UK (5), non fatalities were
concentrated in the UK (36), Sweden (12) and France (6).

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In the south of Europe, only one incident has been recorded in
the period studied by RPA (1930-2007) — an industrial fatality
in Spain in 2000. Local climatic conditions and work practices
may well be relevant. In warm weather windows are always
open, good ventilation is achieved and the risks are negligible;
in colder climates, the reverse may be true.

3.8
Fatalities were split equally between industrial and profes-
sional users. The bulk of the non-fatal incidents were recorded
during use by operators classified as ‘professionals’. The causes
of the fatalities were recorded as being almost entirely inade-
quate ventilation and inadequate use of personal protective
equipment, especially in the presence of large open tanks.

3.9
A possible fatality reported for a consumer (or a profes-
sional) in France in 1993 cannot now be verified and this par-
ticular key piece of data has therefore been challenged. The only
other death reported for a consumer was in the Netherlands in
1960. Other factors may be relevant.

liquids or pastes, or

3.10
Alternatives to DCM-based chemical paint strippers of
course exist. These are generally grouped under three headings
— ‘physical/mechanical stripping’ (sanding, scraping, blasting);
‘pyrolitic or thermal stripping’ (in ovens, over hot fluidised beds
or using blow torches or heat guns); and ‘chemical stripping’
(using high power solvents, including DCM, or corrosive, gener-
ally strongly alkaline,
formic acid or
hydrogen peroxide based mixtures). Each process may work and
may be the preferred course under specific circumstances. All
pose risks of one sort or another, either due to particle impact,
heat, fire, explosion, eye or skin irritation or due to the compo-
sition of the coatings being removed, most notably lead from
paints applied prior to 1960. With multiple layers dating back
100 years or more in old but still usable or even highly desir-
able housing stock, or with sensitive surfaces that must not be
damaged, more than one approach and some degree of experi-
mentation will be required.

longer to work. For a consumer, short exposures are replaced by
longer exposures and potentially greater domestic disruption.
(The assumption by RPA that consumers are less time sensitive
‘because they usually carry out stripping in their leisure time’
should certainly be challenged.) For all users, new methods of
working and changes to work flow will become essential. For an
industrial user, any switch to water-based products decreases the
costs of ventilation but sharply increases the cost of tanks and
pipe work to minimise corrosion. Given all these variables,
predicting the effect of any restriction on any one route
becomes extremely difficult. Consumers are particularly at risk
under these circumstances, with little evidence, given conflicting
their choices of alternative
that
views at government
products or processes will be in their own best interest.

level,

One of the popular alternatives to DCM as a solvent,
3.13
methyl-2-pyrrolidone (NMP), has recently been classified as
‘toxic to reproduction Category 2’ which will eventually lead to
a ban on sales of formulations containing it to the general
public (but not
industrial users). Other
solvents, such as 1,3 dioxolane, are highly flammable.

to professional or

Systems based around dibasic esters (DBEs) — mixtures
3.14
of dimethyl adipate, succinate and glutarate — currently look to
be the most promising alternatives, with little to suggest that
there are any significant concerns for human health or the
environment. Dimethyl sulfoxide (DMSO) and benzyl alcohol
also appear to be relatively ‘safe’. Whether or not any of these
are regarded as cost effective by their users, however, depends
on many factors, and their eventual choice as widely used ‘safe’
alternatives cannot be guaranteed.

3.15
Overall it is clear that there is no single totally accep-
table approach — and that inappropriate action may well lead
to an increase in the current, relatively low, rate of recorded
incidents. The difficulty is to identify a solution which satisfies
all the parties, in particular member states with different experi-
ences and, quite reasonably, strongly held positions.

3.11
No data have been presented on the overall market
share of these various alternatives under all 3 headings or of the
different costs per square metre stripped. DCM is thought to be
still the most widely used solvent, in particular in the consumer
sector, with caustic soda based applications also popular. Even
within the chemicals group, comparative costings are difficult.
There is general agreement
that DCM-based paint strippers
appear cheaper than competing products on a volume basis.
This advantage is likely to disappear if the full costs of protec-
tive equipment (if used) and waste disposal
(if relevant) are
taken into account.

4. Summary of the Commission's proposal

4.1
The Commission's proposal seeks to protect human
health and the environment whilst preserving the Internal
Market for dichloromethane, in particular when used as a major
component of paint strippers for industrial, professional and
consumer use.

Total costs are also determined by through-put times.
3.12
Slower acting but more benign products and processes increase
the cost of work in progress and reduce profits. Higher boiling
solvents allow larger areas to be coated at one time but take

4.2
The proposal seeks to ban all sales of DCM-based paint
strippers to the general public and to professionals, other than
to those specially trained and licensed by competent authorities
in the member states. Sales to industrial installations would be
possible only where a series of protective measures, in particular
the
effective ventilation and the provision and use of

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appropriate personal protective equipment, are in place. All
DCM-based formulations should be indelibly marked as being
‘reserved for industrial and professional uses’ (and then presum-
ably only to those suitably licensed).

measures under the above Directive.
If a common position
between the member states and the European Parliament cannot
be agreed and the proposed Decision (or any variation to it)
adopted and implemented, there will be no further action until
DCM is assessed for all
its uses under Regulation (EC)
No 1907/2006 (REACH).

4.3
No new DCM-based paint strippers should be placed on
the market for supply to the general public or to professionals
within 12 months of the entry into force of the Decision. All
supplies to these two groups would be banned after a further
12 months.

4.4
The Decision would come into force on the third day
following that of its publication in the Official Journal of the EU.

The proposal is accompanied by an explanatory memor-
4.5
andum and a Commission staff working document
(impact
assessment report). Further material is available in impact assess-
ments prepared for the Commission by outside consultants
(RPA, TNO) or in reports on specific topics (ETVAREAD, on the
effectiveness of vapour retardants). These have been in turn
reviewed by the appropriate scientific committee (SCHER).
There is no formal EU Risk Assessment Report (RAR) as DCM
was not defined by any of the stakeholders to be a priority
substance despite concerns already being noted.

Some EU member states (and other major economies
4.6
and trading partners such as Switzerland and the US) have also
conducted studies to support particular — and often strongly
conflicting — regulatory and political positions. The concerned
industries have generated a wealth of data on the possible risks
and comparative benefits of different products and processes;
not surprisingly, these too conflict. Comments from other stake-
holders were recorded during the European Health and Safety
Week ‘Building in Safety’ in 2004 after a conference of experts
hosted by the Danish Painters Union. According to RPA in
April 2007, BEUC, EMCEF and the ETUC had not yet expressed
formal opinions.

5. General comments

the difficulties

The EESC recognises

5.1
faced by the
Commission in proposing a proportionate and cost effective
amendment
to Directive 76/769/EEC for DCM usage as a
solvent in paint stripping. There have been relatively few inci-
dents reported and verified. There may (or may not) have been
under-reporting. Existing legislation has not
always been
followed — and in respect to labelling, appears inadequate.
Alternative products and processes exist but these have not
been evaluated and all pose risks. There are good reasons why
the views of member states differ. There is no guarantee that the
overall outcome will be favourable to any of the groups most
likely to be affected.

5.2
constraints,

The EESC also recognises that, due to obvious time
the last opportunity to introduce any

this

is

5.3
The EESC strongly believes that such a delay is unneces-
sary and undesirable, with respect to protecting the environment
and the health of all users in or outside the work place. The
EESC would also deeply regret any fracturing of the internal
market over this, or any other, issue. The need to find a basis
for agreement should be obvious to all concerned. This should
to replace one hazard with
seek to manage the risks, not
another.

5.4
In this respect the EESC notes that DCM can be manufac-
tured, stored, transported and used safely in closed systems.
DCM is non-flammable and does not contribute to ground level
in open systems, for instance in
ozone formation. However,
paint stripping, DCM clearly presents problems due to its volati-
lity (it evaporates quickly), the density of the ensuing vapour (it
accumulates at the lowest point or where there is inadequate
ventilation), and its behaviour as a narcotic (it induces uncon-
sciousness and death). All of these contribute to increased risks
for children. DCM is also classified as a category 3 carcinogen
and it is this potential risk that dominates the labelling of any
product containing DCM.

this

RPA and others have all noted that

is both
5.5
misleading and inadequate to properly protect users in or
outside the workplace. There are no R (Risk), S (Safety) phrases
or pictograms under existing legislation, or their counterparts
under the revised UN Globally Harmonised System of Classifica-
tion and Labelling, which adequately warn against either
narcosis (and a subsequent risk of death) or, more surprisingly,
of the serious risk to children (which would of course apply to
many products and processes used in domestic situations).

5.6
The focus on the possible but so far unproven cancer
in their Opinion on the
risk is also misleading. SCHER,
ETVAREAD Report on vapour retardants noted that the meta-
bolic mechanism in a mouse for the end-point tested is not the
same as in a human and therefore DCM, on the basis of the
evidence presented, is unlikely to be a carcinogen. There is little
evidence based on actual usage. The results of two major epide-
miological studies on cohorts exposed to DCM in the US in
other industries are still awaited. Cohorts in the EU may have
been exposed to other known carcinogens such as styrene. RPA
did not present any evidence of actual risks under this heading
from exposures to DCM used in paint stripping. The required
R68 phrase (‘possible risk of irreversible effects’) is not the most
useful under the circumstances.

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It

the incident

should also be noted that

5.7
statistics
presented by RPA for the period 1930-2007 clearly demon-
strated the dangers of gross over-exposure to DCM, generally
through very poor working practices. The corresponding data
for alternative processes and products were not collected. The
extent to which these data can be extended to use by either
‘professionals’ or ‘consumers’
is
however questionable. Indications of chronic (long term) indus-
trial health effects may (or may not) indicate problems for acute
(short
term) consumer exposures; accident statistics, which
perhaps these are, are harder to pro-rate.

in a domestic environment

or maintain in real life. The only real difference is that single
site, high throughput, continuous paint stripping operations
require large open tanks of chemical agents into which products
are dipped; off-site operations generally do not depend on
dipping and therefore do not involve large open tanks. Single
sites are covered by other Directives, for instance on solvents
emissions and water waste quality which should be strictly
enforced; off-site operations depend more on the care and
common sense of the individual. Where there is an employer,
the duty of care of course rests with him or her to ensure the
best possible working environment for any employees involved.

5.8
The studies also highlighted the lack of consistent Occu-
pational Exposure Levels (OELs) for work places across the EU.
Limits vary considerably for a single substance (DCM) between
member states and between substances (DCM v DBE or DMSO,
for example). Manufacturers must recognise their duty of care to
their workers; regulators must provide a clear, consistent data-
based regulatory framework to achieve this.

5.13
The ‘professional’ category should also be split between
those engaged permanently in specialty cleaning operations
(e.g. graffiti removal, façade restoration, trains and planes) and
those having only an occasional need to strip paint (builders,
decorators and ‘consumers’) as a necessary but time-consuming
prelude to more profitable activity. The needs, capabilities and
vulnerabilities of this last group appear to be identical and they
should be treated equally.

In this respect the EESC took note in particular of the
5.9
Technical Rules for Hazardous Substances TRGS 612 for alterna-
tives to DCM-based paint strippers produced by the German
Federal Ministry of Labour and Social Affairs (BMAS), version
dated February 2006. This appears to be a model which others
could follow to help ensure work place safety and is consider-
ably more detailed than the current proposal
from the
Commission.

Finally, a proposal to train and license certain operators
5.14
has been introduced as a possible derogation to enable a
compromise between different views. It is however difficult to
equate the use of DCM-based paint strippers with, say, asbestos
removal or the handling of nuclear waste, for which licenses
most certainly are required. Given the high costs of installing
and monitoring such a system, it is difficult to see this proposal
as likely to meet anyone's needs.

5.10
The hierarchy of questions to be answered under the
above (a) can you make your process safer by substitution? (b) if not,
why not? and (c) have you taken all appropriate measures to make
your work place safe? should be followed in most cases. The
potential risks, as well as benefits, from alternative processes
and products should be fully recognised. Above all, there must
be some estimate of the likely outcomes of any decision to
remove a significant quantity of any material from any market;
what actually will users do and will their choice improve their
personal safety?

5.11
As an example, taken from a Member State that has
already implemented a ban on DCM-based products and applic-
able to industrial and professional users alike, this is a ban on
sales of products containing DCM, not on DCM itself. A
powerful paint stripper can still be made by mixing DCM with
methanol at the place of use. The resulting product is cheaper
but lacks the surfactants and vapour retardants which increase
both the effectiveness and the safety of the properly formulated
product. This is therefore an undesirable outcome.

5.12
As RPA and the Commission have noted, the distinc-
tions between the different categories of user are hard to justify

6. Specific comments

Given the above,

the EESC do not believe that

6.1
the
current proposal is either proportionate or, by itself, likely to
lead to fewer incidents in or outside the work place. Given the
wide actual and political differences between member states,
other approaches must be considered and implemented without
further delay.

6.2
This would include changes to the packaging and label-
ling of DCM-based paint strippers to minimise the risk of acci-
dent and to highlight the real dangers. Sales to anyone not
permanently engaged in paint-stripping, on or off-site, whether
regarded as being a ‘professional’ or a ‘consumer’ should be
limited to a maximum of 1L per container and purchase. The
containers should have child-proof seals as defined by the rele-
vant existing or new EU Regulations and Directives and/or
EN-ISO standards 8317:2004 and 862:2005. Narrow necks to
limit spillage would also be useful, although the consequent
need to decant before use with a brush limits their effect. Manu-
should actively work towards new and safer
facturers

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delivery systems if they wish to maintain the long term viability
of these products. Bulk sales to all other users for ‘industrial’ or
ongoing ‘professional’ use should be in quantities of not less
than 20 L. Manufacturers and suppliers should recognise their
duty of care under such circumstances and ensure that sufficient
information and training is provided to ensure safe handling
and disposal under all conditions of use.

New pictograms and R and S phrases for narcotics and
6.3
to warn of the dangers to children should be developed as a
matter of urgency to complement those already in use. For
DCM-based paint strippers (and other products with similar
effects) the appropriate wording for all users would be along the
‘Narcotic: high concentrations lead to unconsciousness and
lines of:
death’;
‘Do not use in the presence of children or vulnerable adults’;
‘Do not use in an enclosed space: heavy vapours asphyxiate’. These
seem to be justified by the evidence and are relevant to actual
needs. The phrases should not be lost in an array of less signifi-
cant warnings. An effective warning and unmistakeable picto-
gram on the need to protect children would be likely to have
more effect than many more complicated pieces of advice. The
current S2 phrase (‘Keep out of the reach of children’) is inade-
quate in this respect.

6.4
There is also a clear need for a standardised and intern-
ally consistent set of EU-wide Occupational Exposure Limits
(OELs) to further improve work place safety. This should be
considered as a useful output of the REACH programme over
the coming years.

Brussels, 17 September 2008.

6.5
Good working practice, and the close observance of all
existing controls, is obviously key to risk management, in and
outside the work place. Manufacturers and retailers share the
responsibility of providing good advice and ensuring that
recommendations can be followed by members of the general
public and others using hazardous materials or processes on an
infrequent basis. Safety advice and equipment
should be
promoted with the same enthusiasm and incentives as the
materials for which they are required.

6.6
The approach used in the German TRGS 612 should
form the basis of EU-wide controls. Additional technical advice
on ventilation or waste treatment can be added as necessary.
Best practices should be published and shared.

6.7
Ongoing studies in the US on the effects of long-term
exposure to DCM should be completed as quickly as possible
and the results presented to SCHER for evaluation. Opportu-
nities should be explored to identify any valid cohorts for study
in Europe.

6.8
A systematic evaluation of the risks associated with paint
stripping should also be undertaken so that all the products and
processes can be evaluated on a comparable basis. This would
lead to a better understanding of their relative performance
characteristics and risks and eventually the possibility of more
informed choices being made by users in and outside the work
these proposals should however delay the
place. Neither of
adoption of the control measures discussed above.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS