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) (amendment of Council Directive 76/769/EEC) {SEC(2008) 192} {SEC(2008) 193}
Date: 2008-02-14
Institutions: European Commission
Subjects: chemical product, dangerous substance, health risk, marketing restriction, paints and varnishes

COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 14.2.2008 
COM(2008) 80 final 

2008/0033 (COD) 

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) 

(amendment of Council Directive 76/769/EEC) 

(presented by the Commission) 

{SEC(2008) 192} 
{SEC(2008) 193} 

EN 

   EN 

 
 
 
  
 
 
 
EXPLANATORY MEMORANDUM 

1. 

CONTEXT OF THE PROPOSAL 

Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations 
and administrative provisions of the Member States relating to restrictions on the marketing 
and  use  of  certain  dangerous  substances  and  preparations  establishes  a  framework  for 
harmonised rules throughout the European Union concerning the placing on  the market and 
use of dangerous substances and preparations. 

Directive 76/769/EEC is used to manage the risks to human health and the environment from 
dangerous substances. Dangerous substances and preparations listed in Annex I to Directive 
76/769/EEC may only be placed on the market and used under specific conditions. 

It  is  proposed  to  manage  the  risks  on  Dichloromethane  (DCM)  by  listing  this  substance  in 
Annex I of Directive 76/769/EEC. 

1.1. 

Dichloromethane, its chemical properties and its risks to human health 

Dichloromethane  (DCM),  CAS  number  75-09-2  and  EINECS  number  200-838-9,  is  a 
colourless, halogenated aliphatic hydrocarbon compound with a penetrating ether-like or mild 
sweet  odour.  It  is  mainly  used  in  the  production  of  pharmaceuticals,  solvent  and  auxiliary 
applications, paint strippers manufacture and adhesives. 

DCM  is  not  included  in  the  priority  lists  under  Regulation  (EEC)  No  793/93  of  23  March 
1993  on  the  evaluation  and  control  of  the  risks  of  existing  substances.  However  risks  from 
DCM  in  paint  strippers  have  been  assessed  in  several  studies1  which  concluded  that  risk 
reduction measures are required throughout the EU. Paint strippers are used to remove coats 
of  paints,  especially  blistered  or  cracked  coats  on  various  substrates,  particularly  metal  and 
wood and are applied by industrial and professional users, as well as consumers. 

The main risks from DCM to human health are related to its vapours and its toxic effects to 
the central nervous system. These effects associated with bad working/operational conditions 
(e.g. inadequate ventilation, inappropriate personal protective equipment) have contributed to 
a number of registered accidents and fatalities during the last 18 years in the EU. 

According  to  the  Scientific  Committee  on  Health  and  Environmental  Risks2  (SCHER), 
exposure to DCM released from paint strippers is of concern for human health especially for 
the more susceptible populations such as children due to a potential for higher exposure. The 

1 

2 

finalised 

in  November  1999.  http://ec.europa.eu/enterprise/chemicals/studies_en.htm 

Methylene  chloride:  Advantages  and  drawbacks  of  possible  market  restrictions  in  the  EU.  TNO-STB 
study 
; 
Effectiveness  of  vapour  retardants  in  reducing  risks  to  human  health  from  paint  strippers  containing 
dichloromethane  by  ETVAREAD  expert  group.  Final 
in  April  2004 
http://ec.europa.eu/enterprise/chemicals/studies_en.htm;  Impact  assessment  of  potential  restrictions  on 
the  marketing  and  use  of  dichloromethane  in  paint  stripper.  RPA  study  finalised  in  April  2007. 
http://ec.europa.eu/enterprise/chemicals/studies_en.htm 
Scientific  Committee  on  Health  and  Environmental  Risks  opinion  on  “Effectiveness  of  vapour 
retardants  in  reducing  risks  to  human  health  from  pain  stripper  containing  dichloromethane 
ETVAREAD final report April 2004. Adopted by SCHER during the 4th plenary session of 18 March 
2005. http://ec.europa.eu/health/ph_risk/committees/04_scher/scher_opinions_en.htm 

report  published 

EN 

2 

   EN 

 
                                                 
high  concentrations  of  DCM  measured  during  paint  removing  activity  are  unacceptable  for 
the risks to human health.  

Various  alternatives  to  DCM-based  paint  strippers  are  already  available  on  the  market: 
physical/mechanical  stripping,  pyrolitic/thermal  stripping,  and  chemical  stripping  involving 
other chemicals than DCM. The chemical alternative paint strippers are the most widely used, 
however they also have their own hazard profiles and, depending on their concentration in the 
formulation, they could pose other risks to the user. 

During  the  last  four  years  discussions  have  taken  place  between  the  Commission,  Member 
States and other stakeholders. Despite strongly divergent opinions on the risks associated with 
DCM  and  on  the  safety  of  alternatives,  an  agreement  has  been  reached  on  the  need  for 
marketing  and  use  restrictions  at  Community  level  under  Council  Directive  76/769/EEC  to 
limit the risks from DCM.  

1.2. 

Intended effects of EU legislation 

Due  to  the  fact  that  there  is  a  need  for  limiting  the  risks  during  industrial,  professional  and 
consumer  uses  of  DCM-based  paint  strippers,  certain  restrictions  on  placing  on  the  market 
and  use  should  be  applied.  The  present  Decision  would  amend  Annex  I  to  Directive 
76/769/EEC  by  adding  Dichloromethane.  This  will  ensure  harmonised  rules  applied  at 
Community wide level. 

The  most  significant  proportion  of  fatalities  associated  with  the  use  of  DCM-based  paint 
strippers in Europe over the last 18 years were linked to industrial and professional uses under 
conditions of inadequate ventilation and with inappropriate application of personal protective 
equipment. 

For the activities conducted in industrial installations some mandatory requirements should be 
applied such as: the use of appropriate protective gloves, the installation of local ventilation or 
independent air supply respiratory protective equipment, and modification of the strip tanks, 
to ensure reduction of exposure of workers. 

Professional uses should be banned in general, but Member States could opt to allow further 
use  on  their  territories  by  specifically  licensed  professionals  for  those  activities  where  they 
believe that the replacement of DCM is particularly difficult or inappropriate. Licenses should 
be subject to specific training requirements. 

A total ban of the placing on the market of paint strippers containing DCM for consumer uses 
should be applied as the only effective measure to eliminate the risks. 

2. 

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND 
IMPACT ASSESSMENT 

2.1. 

Consultations 

In  2004  the  Commission  started  discussions  at  the  meetings  of  the  Commission  Working 
Group responsible for the implementation of Directive 76/769/EEC (hereinafter referred to as 
the “Limitations Working Group”). In November 2005 the Commission organised a forum on 
“paint  stripping  agents”  with  the  involvement  of  the  manufacturers  of  DCM-based  paint 
strippers and of DCM alternatives. Due to the remaining divergent opinions of industry and 
authorities, the Commission contracted out another study to collect more information in order 

EN 

3 

   EN 

 
to  assess  the  impact  of  potential  restrictions  on  the  marketing  and  use  of  DCM-based  paint 
strippers at Community wide level. 

The  recommendations  of  this  study3  were  discussed  during  the  Limitations  Working  Group 
meeting on 3 July 2007. Representatives from companies in favour of continued use of DCM 
and  from  companies  in  favour  of  the  alternatives,  the  European  Consumers  Organisation 
(BEUC),  the  European  Mine,  Chemical  and  Energy  workers  federation  (EMCEF)  and  the 
European Trade Union Confederation (ETUC) attended this meeting or were consulted. 

2.2. 

Impact Assessment 

A detailed impact assessment has been prepared and was sent to the Impact assessment Board 
on 5 October 2007 which expressed its opinion on 9 November 2007. All the comments of the 
Board  (IA  quality  checklist  and  final  opinion)  have  been  included  in  the  final  impact 
assessment version4  

A number of options ranging from the 'No-Action' option, over voluntary actions by industry 
to legislative restrictions of various degrees have been evaluated and the most effective and 
efficient options for the three use categories are the following: 

– 

For industrial uses 

DCM–based paint strippers activities should be conducted only in industrial installations with 
mandatory  requirements  concerning  the  protection  of  personnel,  such  as  appropriate  gloves, 
exhaust  ventilation  or  air  respiratory  equipment  and  engineering  controls  for  strip  tanks. 
These  measures  will  further  support  the  enforceability  of  the  legislation  for  workers 
protection  by  effectively  reducing  exposure  to  DCM  and  thus  the  number  of  accidents  and 
fatalities. 

– 

For professional uses 

The use of DCM-paint strippers by professionals in non-industrial settings should be banned 
in general, but Member States could opt to allow further use on their territories by specifically 
licensed professionals for those activities where they believe that the replacement of DCM is 
particularly  difficult  or  inappropriate.  This  measure  will  give  Member  States  and  interested 
companies the full responsibility and the administrative burden of setting up and controlling a 
training  and  licensing  system  with  appropriate  measures.  The  number  of  accidents  and 
fatalities will be reduced. 

– 

For consumer uses 

A  ban  of  placing  on  the  market  of  DCM-based  paint  strippers  for  consumer  use  is  the  only 
effective  measure  to  eliminate  the  risk  to  consumers.  It  would  be  impossible  to 
comprehensively  monitor  consumer  behaviour  during  Do-It-Yourself  applications,  or  to 
ensure adequate training and use of the necessary protective equipment. 

3 

4 

EN 

3Impact  assessment  of  potential  restrictions  on  the  marketing  and  use  of  dichloromethane  in  paint 
stripper. RPA study finalised in April 2007. http://ec.europa.eu/enterprise/chemicals/studies_en.htm 
Commission  Staff  working 
document : 
http ://ec.europa.eu/chemicals/studies_en.htm  

« Impact  Assessment  Report » 

available 

at: 

4 

   EN 

 
                                                 
3. 

LEGAL ELEMENTS OF THE PROPOSAL 

3.1. 

Legal basis  

The legal basis of the Proposal is Article 95 of the Treaty. 

The  present  Decision  would  provide  rules  for  the  placing  on  the  market  and  use  of  DCM-
based paint strippers for the three categories of use (industrial, professional and consumer). 

It would also establish uniform rules for the circulation of DCM-based paint strippers and it 
would  avoid  obstacles  to  trade  because  of  differences  in  legislation  between  the  Member 
States. This proposed amendment to Directive 76/769/EEC would improve the conditions for 
the  functioning  of  the  Internal  Market  and  it  would  guarantee  a  high  level  of  protection  of 
human health. 

3.2. 

Subsidiarity and proportionality principles 

Council Directive 76/769/EEC relating to restrictions on the placing on the market and use of 
certain dangerous substances and preparations, seeks to establish harmonised rules throughout 
the EU and to avoid divergent national legislation, which is liable to cause barriers to intra-
community  trade.  This  cannot  be  achieved  by  leaving  the  responsibility  to  act  solely  to  the 
Member States. 

The measures proposed in the present Decision are also proportionate considering the overall 
costs  and  benefits  for  all  use  categories  in  relation  with  the  final  aim  of  improving  the 
protection of human health. 

3.3. 

Choice of instruments 

The Commission has chosen Council Directive 76/769/EEC as the best instrument to preserve 
the Internal Market and at the same time ensure a high level of protection of human health and 
the environment. It is therefore in conformity with Article 95(3) of the Treaty. 

Directive 76/769/EEC will be repealed on 1 June 2009 by Regulation (EC) No 1907/2006 of 
the  European  Parliament  and  of  the  Council  of  18  December  2006  concerning  the 
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing 
a  European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council 
Regulation  (EEC)  No  793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as 
Council  Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC, 
93/105/EC and 2000/21/EC. The amendment to be made to Annex I of Directive 76/769/EEC 
by this Decision will be applied after 1 June 2009 and will be introduced in Annex XVII of 
Regulation (EC) No 1907/2006. 

It is more appropriate to amend the Annex I of Directive 76/769/EEC using a Decision rather 
than  a  Directive  as  transposition  of  the  proposed  restrictions  into  national  law  would  be 
accomplished  only  a  few  months  before  Directive  76/769/EEC  is  repealed  or  even  only 
afterwards.  Transposition  will  therefore  not  serve  any  useful  purpose.  In  this  situation  a 
Decision is a more appropriate legal act than a Directive.  

4. 

BUDGETARY IMPLICATION 

There are no budgetary implications arising from the present Decision. 

EN 

5 

   EN 

 
2008/0033 (COD) 

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) 

(amendment of Council Directive 76/769/EEC) 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having regard to the Treaty establishing the European Community, and in particular Article 
95 thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Economic and Social Committee2, 

Acting in accordance with the procedure laid down in Article 251 of the Treaty3, 

Whereas: 

(1) 

The risks posed to human health by Dichloromethane (DCM) in paint strippers have 
been  assessed  in  several  studies4  which  concluded  that  risk  reduction  measures  are 
required  throughout  the  EU  to  reduce  the  risks  posed  to  human  health  during  the 
application of DCM at industrial, professional and consumer level. The results of those 
studies  were  evaluated  by  the  Commission’s  Scientific  Committee  on  Toxicity, 
Ecotoxicity  and  the  Environment  (CSTEE  -  later  named  SCHER)  which  confirmed 
that  the  exposure  to  DCM  released  from  paint  strippers  is  of  concern  for  human 
health5. 

1 
2 
3 
4 

5 

1999. 

finalised 

in  November 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
Methylene  chloride:  Advantages  and  drawbacks  of  possible  market  restrictions  in  the  EU.  TNO-STB 
study 
http://ec.europa.eu/enterprise/chemicals/studies_en.htm; 
Effectiveness  of  vapour  retardants  in  reducing  risks  to  human  health  from  paint  strippers  containing 
dichloromethane  by  ETVAREAD  expert  group.  Final 
in  April  2004 
http://ec.europa.eu/enterprise/chemicals/studies_en.htm;  Impact  assessment  of  potential  restrictions  on 
the  marketing  and  use  of  dichloromethane  in  paint  stripper.  RPA  study  finalised  in  April  2007. 
http://ec.europa.eu/enterprise/chemicals/studies_en.htm  
Scientific Committee on Health and Environmental Risks opinion on Effectiveness of vapour retardants 
in reducing risks to human health from paint strippers containing dichloromethane. ETVAREAD Final 
Report  01  April  2004.  Adopted  by  the  SCHER  during  the  4th  plenary  session  of  18  March  2005. 
http://ec.europa.eu/health/ph_risk/committees/04_scher/scher_opinions_en.htm 

report  published 

EN 

6 

   EN 

 
 
                                                 
(2) 

(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

In order to achieve a high level of health protection for all  use categories (industrial 
professional  and  consumer)  the  marketing  and  use  of  DCM-based  paint  strippers 
should be restricted. 

DCM-based paint strippers are used by consumers at home to remove paints, varnishes 
and lacquers both indoors and outdoors. The safe use of DCM by consumers cannot be 
ensured  by  training  or  monitoring.  Therefore,  the  only  effective  and  proportionate 
measure  to  eliminate  the  risks  for  consumers  is  a  ban  on  the  marketing  and  use  of 
DCM-based paint strippers. 

In  order  to  ensure  a  proportionate  enforceability  of  the  phase-out  along  the  supply 
chain of paint strippers containing DCM, different dates to prohibit the first placing on 
the market and the final supply to the general public and professionals should be fixed. 

As consumers, may have access to DCM-based paint stripper despite the ban through 
the distribution chain intended for professional and industrial users, a warning phrase 
should be included on the product. 

The fatalities registered in Europe over the last 18 years for industrial and professional 
uses  are  mainly  attributed  to  inadequate  ventilation,  the  inappropriate  personal 
protective equipment, the use of inadequate tanks and the long-term exposure to DCM. 
Therefore  restrictions  should  be  imposed  to  control  and  reduce  the  risks  involved  in 
professional and industrial uses. 

Professionals  are  generally  covered  by  the  provisions  of  the  legislation  for  workers 
protection.  However,  many  professional  activities  are  often  conducted  in  customers 
premises which often do not have all the appropriate measures to manage, control and 
reduce  the  risks  to  health.  Moreover,  self-employed  workers  are  not  covered  by  the 
provisions  of  the  worker  protection  legislation  and  would  require  adequate  training 
before conducting paint stripping activities based on DCM.  

The  placing  on  the  market  and  use  of  DCM-paint  strippers  by  professionals  should 
therefore  be  banned  in  order  to  protect  their  health  and  to  reduce  the  number  of 
fatalities  and  non-fatal  accidents.  Nevertheless,  when  the  replacement  of  DCM  is 
deemed to be particularly difficult or inappropriate, Member States should be able to 
allow further use of DCM by specially licensed professionals. Member States would 
be  responsible  for  granting  and  monitoring  such  licences,  which  should  be  based  on 
compulsory training with specific requirements.  

The number of fatalities and non-fatal accidents registered during industrial activities 
is an indication of inadequate enforcement of the workplace legislation. The exposure 
to DCM remains high and further risk reduction measures should apply to workers in 
industrial installations. Preventive measures such as good ventilation of the workplace, 
appropriate personal protective equipment and additional modification of tanks should 
be adopted. 

EN 

7 

   EN 

 
(10)  Personal  protective  equipment  should  comply  with  the  requirements  of  Council 
Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the 
Member States6. 

(11)  Directive 76/769/EEC should therefore be amended accordingly. 

for 

requirements 

(12)  This  Decision  is  without  prejudice  to  the  Community  legislation  laying  down 
minimum 
the  protection  of  workers,  such  as  Council 
Directive 89/391/EEC  of  12 June 1989  on  the  introduction  of  measures  to  encourage 
improvements in the safety and health of workers at work7 and individual Directives 
based thereon, in particular Directive 2004/37/EC of the European Parliament and of 
the  Council  of  29  April  2004  on  the  protection  of  workers  from  the  risks  related  to 
exposure  to  carcinogens  or  mutagens  at  work  (Sixth  individual  Directive  within  the 
meaning  of  Article  16(1)  of  Council  Directive  89/391/EEC)  (codified  version)8  and 
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety 
of  workers  from  the  risks  related  to  chemical  agents  at  work  (fourteenth  individual 
Directive within the meaning of Article 16(1) of Directive 89/391/EEC)9, 

HAVE ADOPTED THIS DECISION: 

Article 1 

Annex I to Directive 76/769/EEC is amended in accordance with the Annex to this Decision. 

This  Decision  shall  enter  into  force  on  the  third  day  following  that  of  its  publication  in  the 
Official Journal of the European Union.  

Article 2 

Article 3 

This Decision is addressed to the Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

6 
7 

8 
9 

OJ L 399, 30.12.1989, p. 18. 
OJ L 183,  29.6.1989,  p. 1.  Directive  as  amended  by  Regulation  (EC)  No  1882/2003  of  the  European 
Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). 
OJ L 158, 30.4.2004, p. 50. 
OJ L 131, 5.5.1998, p. 11. 

EN 

8 

   EN 

 
                                                 
In Annex I to Directive 76/769/EEC, the following point xx is added: 

ANNEX 

“(xx) 

Dichloromethane 

CAS N°: 75-09-2 

EINECS N°: 200-838-9 

(1) 

(2) 

(3) 

(4) 

strippers 

Paint 
containing 
dichloromethane  in  a  concentration 
equal  to  or  greater  than  0.1%  by 
mass  shall  not  be  placed  on  the 
market  for  the  first  time  after  [12 
months  after  the  entry  into  force  of 
the  Decision]  for  supply 
the 
general  public  or  to  professionals, 
and  shall  not  be  supplied  to  them 
after  [24  months  after  the  entry  into 
force of the Decision]. 

to 

By  way  of  derogation  to  paragraph 
(1),  Member  States  may  authorise 
strippers 
the 
containing 
to 
licensed professionals.  

supply  of  paint 

dichloromethane 

The  licence  referred  to  in  paragraph 
(2)  shall  be  granted  to  professionals 
trained  in  the  safe  use  of  paint 
containing 
strippers 
dichloromethane.  The  training  shall 
cover: 

(a) 

awareness,  evaluation  and 
management  of 
to 
health, 

risks 

(b) 

use of adequate ventilation, 

(c) 

use  of  appropriate  personal 
protective equipment1. 

strippers 

containing 
Paint 
dichloromethane 
in  concentrations 
equal  to  or  greater  than  0.1%  by 
mass  may  be  used  in  industrial 
installations  only  if  the  following 
conditions are met: 

(a) 

effective  exhaust  ventilation 
protective 
or 

respiratory 

1 

Such  personal  protective  equipment  shall  comply  with  the  requirements  of  Council  Directive 
89/686/EEC. 

EN 

9 

   EN 

 
                                                 
equipment 
independent air supply2, 

with 

an 

(b) 

(c) 

enclosed  strip  tanks  covered 
when not in use, 

appropriate  protective  gloves 
for operators.3 

(5)  Without 

to 

prejudice 

other 
Community 
legislation  concerning 
the  classification,  packaging  and 
labelling  of  dangerous  substances 
and  preparations,  paint  strippers 
containing  more  than  0.1%  by  mass 
of  dichloromethane  shall  be  legibly 
and  indelibly  marked  by  [24  months 
after  the  entry  into  force  of  the 
follows:
Decision] 
as 
and 
“Reserved 
professional uses”.” 

industrial 

for 

2 

3 

Such  respiratory  protective  equipment  shall  comply  with  the  requirements  of  Council  Directive 
89/686/EEC. 
Such protective gloves shall comply with the requirements of Council Directive 89/686/EEC. 

EN 

10 

   EN