EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 14.2.2008 
COM(2008) 80 final 
2008/0033 (COD)   
Proposal for a  
DECISION OF THE EUROPEAN P ARLIAMENT AND OF THE COUNCIL 
amending Council Directive 76/769/EEC as re gards 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 2   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 St ates relating to restrictions on the marketing 
and use of certain dangerous substances an d preparations estab lishes a framework for 
harmonised rules throughout the European Unio n 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 lis ted 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 Dichlo romethane (DCM) by listi ng this substance in 
Annex I of Directive 76/769/EEC. 
1.1. Dichloromethane, its chemical prop erties and its risks to human health 
Dichloromethane (DCM), CAS number 75-09-2  and EINECS number 200-838-9, is a 
colourless, halogenated alipha tic hydrocarbon compound with a pene trating ether-like or mild 
sweet odour. It is mainly used in the producti on of pharmaceuticals, solvent and auxiliary 
applications, paint strippers manufacture and adhesives. 
DCM is not included in the priority lists und er 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 b een 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 subs trates, particularly metal and 
wood and are applied by industrial and prof essional users, as well as consumers. 
The main risks from DCM to human health are re lated to its vapours and its toxic effects to 
the central nervous system. These effects associ ated with bad working/operational conditions 
(e.g. inadequate ventilation, ina ppropriate personal protective e quipment) have contributed to 
a number of registered accidents and fatali ties during the last 18 years in the EU. 
According to the Scientific Committee on Health and Environmental Risks2 (SCHER), 
exposure to DCM released from pa int strippers is of concern fo r human health especially for 
the more susceptible populations such as child ren due to a potential for higher exposure. The 
                                                 
1 Methylene chloride: Advantages and drawbacks of possible market restrictions in the EU. TNO-STB 
study finalised in November 1999. http://ec.europa.eu/enterprise/chemicals/studies_en.htm ; 
Effectiveness of vapour retardants in reducing risk s to human health from paint strippers containing 
dichloromethane by ETVAREAD expert group. Final report published 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 
2 Scientific Committee on Health and Environmenta l 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   
EN 3   EN high concentrations of DCM measured during paint removing activity are unacceptable for 
the risks to human health.  
Various alternatives to DCM-based paint st rippers are already available on the market: 
physical/mechanical stripping, pyr olitic/thermal stri pping, and chemical stripping involving 
other chemicals than DCM. The chemical alterna tive paint strippers are the most widely used, 
however they also have their own hazard prof iles and, depending on their concentration in the 
formulation, they could pos e other risks to the user. 
During the last four years discussions have  taken place between the Commission, Member 
States and other stakeholders. De spite strongly diverg ent 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 Dir ective 76/769/EEC to 
limit the risks from DCM.  
1.2. Intended effects of EU legislation 
Due to the fact that th ere 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 De cision would amend Annex I to Directive 
76/769/EEC by adding Dichloromethane. This will ensure harmonise d rules applied at 
Community wide level. 
The most significant proportion of fatalities a ssociated with the use of DCM-based paint 
strippers in Europe over the last  18 years were linked to indust rial and professional uses under 
conditions of inadequate ventil ation and with inappr opriate application of  personal protective 
equipment. 
For the activities conducted in i ndustrial 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 eq uipment, and modificati on of the strip tanks, 
to ensure reduction of exposure of workers. 
Professional uses should be banne d in general, but Member Stat es 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 particular ly difficult or inapprop riate. Licenses should 
be subject to specific training requirements. 
A total ban of the placing on th e market of paint strippers co ntaining DCM for consumer uses 
should be applied as the only effectiv e measure to eliminate the risks. 
2. RESULTS OF CONSULTATIONS WI TH THE INTEREST ED PARTIES AND 
IMPACT ASSESSMENT 
2.1. Consultations 
In 2004 the Commission started di scussions at the meetings of the Commission Working 
Group responsible for the implementation of Direc tive 76/769/EEC (hereinafter referred to as 
the “Limitations Working Group”). In Novemb er 2005 the Commission organised a forum on 
“paint stripping agents” with  the involvement of the manuf acturers of DCM-based paint 
strippers and of DCM a lternatives. Due to the remaining divergent opinions of industry and 
authorities, the Commission contract ed out another study to collect  more information in order  
EN 4   EN to assess the impact of potential restrictions  on the marketing and us e of DCM-based paint 
strippers at Commun ity wide level. 
The recommendations of this study3 were discussed during the Limitations Working Group 
meeting on 3 July 2007. Representatives from co mpanies in favour of continued use of DCM 
and from companies in favour of the altern atives, 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-Ac tion' option, over voluntary actions by industry 
to legislative restrictions of various degrees have been evalua ted 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 c onducted only in industria l installations with 
mandatory requirements concerning the protection of personnel, such as appropriate gloves, 
exhaust ventilation or air respiratory equipm ent and engineering cont rols for strip tanks. 
These measures will further support the en forceability of the le gislation for workers 
protection by effectively reduc ing 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 allo w further use on their terri tories by specifically 
licensed professionals for those activities where they believe that the replacement of DCM is 
particularly difficult or inappropr iate. This measure will give Member States and interested 
companies the full responsibility and the admi nistrative burden of setting up and controlling a 
training and licensing system with appropria te measures. The number of accidents and 
fatalities will be reduced. 
– For consumer uses  
A ban of placing on the market of DCM-based pa int strippers for consum er 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 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  
4 Commission Staff working document : « Impact Assessment Report » available at: 
http ://ec.europa.eu/chem icals/studies_en.htm   
EN 5   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 pr ovide rules for the placing on the market and use of DCM-
based paint strippers for the th ree categories of use (industrial,  professional and consumer). 
It would also establish uniform rules for the circulation of DCM-base d paint strippers and it 
would avoid obstacles to trade because of di fferences in legislation between the Member 
States. This proposed amendment to Directiv e 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 propor tionality principles 
Council Directive 76/769/EEC rela ting to restrictions on the pl acing on the market and use of 
certain dangerous substances and preparations , seeks to establish harmonised rules throughout 
the EU and to avoid divergent na tional legislation, which is liab le to cause ba rriers to intra-
community trade. This cannot be achieved by l eaving the responsibility to act solely to the 
Member States. 
The measures proposed in the present Decision ar e 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 protecti on of human health and 
the environment. It is therefore in conf ormity 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 Rest riction of Chemicals (R EACH), establishing 
a European Chemicals Agency, amending Di rective 1999/45/EC an d repealing Council 
Regulation (EEC) No 793/93 a nd Commission Regulation (E C) No 1488/94 as well as 
Council Directive 76/769/EEC and Commi ssion 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 applie d 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 propo sed restrictions into national law would be 
accomplished only a few months before Direc tive 76/769/EEC is repealed or even only 
afterwards. Transposition will therefore not se rve 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 6   EN 2008/0033 (COD) 
Proposal for a  
DECISION OF THE EUROPEAN P ARLIAMENT AND OF THE COUNCIL 
amending Council Directive 76/769/EEC as re gards 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 CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty esta blishing the European Communit y, and in particular Article 
95 thereof, 
Having regard to the proposal from the Commission1, 
Having regard to the opinion of the Eu ropean 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 Dich loromethane (DCM) in paint strippers have 
been assessed in several studies
4 which concluded that ri sk reduction measures are 
required throughout the EU to reduce the ri sks posed to human health during the 
application of DCM at industria l, professional and consumer level. The results of those 
studies were evaluated by the Commissi on’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 OJ C , , p. . 
2 OJ C , , p. . 
3 OJ C , , p. . 
4 Methylene chloride: Advantages and drawbacks of possible market restrictions in the EU. TNO-STB 
study finalised in November 1999. http://ec.europa.eu/enterprise/chemicals/studies_en.htm ; 
Effectiveness of vapour retardants in reducing risk s to human health from paint strippers containing 
dichloromethane by ETVAREAD expert group. Final report published 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   
5 Scientific Committee on Health and Environmental Ri sks 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   
EN 7   EN (2) In order to achieve a high level of health  protection for all use categories (industrial 
professional and consumer) the marketing and use of DCM-base d paint strippers 
should be restricted. 
(3) 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 mon itoring. Therefore, the only effective and proportionate 
measure to eliminate the risks for consum ers is a ban on the marketing and use of 
DCM-based paint strippers. 
(4) In order to ensure a proportionate enfor ceability of the phase-out along the supply 
chain of paint strippers containing DCM, di fferent dates to prohi bit the first placing on 
the market and the final supply to the genera l public and professi onals should be fixed. 
(5) As consumers, may have access to DCM-ba sed paint stripper despite the ban through 
the distribution chain intende d for professional and industr ial users, a warning phrase 
should be included on the product. 
(6) The fatalities registered in Europe over th e 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 ri sks involved in 
professional and industrial uses. 
(7) Professionals are generally covered by the provisions of the legislation for workers 
protection. However, many professional activ ities are often conducted in customers 
premises which often do not have all the a ppropriate measures to manage, control and 
reduce the risks to health. Moreover, self-employed workers are not covered by the provisions of the worker protection legisla tion and would require adequate training 
before conducting paint strippi ng activities based on DCM.  
(8) The placing on the market and use of DC M-paint strippers by pr ofessionals should 
therefore be banned in orde r to protect their health and to reduce the number of 
fatalities and non-fatal accidents. Neverthe less, 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 licen sed professionals. Member States would 
be responsible for granting and monitoring such licences, which should be based on 
compulsory training with specific requirements.  
(9) The number of fatalities and non-fatal accid ents registered duri ng industrial activities 
is an indication of in adequate enforcement of the workplace legislation. The exposure 
to DCM remains high and further risk reduc tion measures should apply to workers in 
industrial installations. Preventi ve measures such as good ve ntilation of the workplace, 
appropriate personal protective equipment and additional modification of tanks should be adopted.  
EN 8   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. (12) This Decision is with out prejudice to the Commun ity legislation laying down 
minimum requirements for the protecti on 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 work
7 and individual Directives 
based thereon, in particular Directive 2004/37/EC of the Eu ropean 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 chemi cal agents at work (fourteenth individual 
Directive within the meaning of Ar ticle 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. 
Article 2 
This Decision shall enter into force on the third day following that of its publication in the 
Official Journal of the European Union .  
Article 3 
This Decision is addressed to the Member States. 
Done at Brussels,  
For the European Parliament For the Council 
The President The President 
                                                 
6 OJ L 399, 30.12.1989, p. 18. 
7 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). 
8 OJ L 158, 30.4.2004, p. 50. 
9 OJ L 131, 5.5.1998, p. 11.  
EN 9   EN ANNEX  
In Annex I to Directive 76/769/EEC, the following point xx is added: 
“(xx) 
Dichloromethane CAS N°: 75-09-2 EINECS N°: 200-838-9 (1) Paint strippers 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 to the 
general public or to professionals, and shall not be supplied to them 
after [ 24 months after the entry into 
force of the Decision ]. 
(2) By way of derogation to paragraph 
(1), Member States may authorise the supply of paint strippers 
containing dichloromethane to licensed professionals.  
(3) The licence referred to in paragraph 
(2) shall be granted to professionals trained in the safe use of paint strippers containing dichloromethane. The training shall cover: 
(a) awareness, evaluation and 
management of risks to health, 
(b) use of adequate ventilation, 
(c) use of appropriate personal 
protective equipment
1. 
(4) Paint strippers containing 
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 
or respiratory protective 
                                                 
1 Such personal protective equipment shall comply with the requirements of Council Directive 
89/686/EEC.  
EN 10   EN equipment with an 
independent air supply2, 
(b) enclosed strip tanks covered 
when not in use, 
(c) appropriate protective gloves 
for operators.3 
(5) Without prejudice to other 
Community legisl ation 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 
Decision ] as follows:
“Reserved for industrial and professional uses”.” 
 
                                                                                                                                                         
2 Such respiratory protective equi pment shall comply with the requirements of Council Directive 
89/686/EEC. 
3 Such protective gloves shall comply with the requirements of Council Directive 89/686/EEC.