EN    EN  
 EUROPEAN COMMISSION 
Brussels, XXX 
[…](2011) XXX draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council on the Registration, E valuation, Authorisation and Restriction of 
Chemicals ("REACH") 
 
(Text with EEA relevance) 
  
EN 2   EN Draft 
COMMISSION REGULATION (EU) No …/.. 
of XXX 
amending Annex XVII to Regulation (EC)  No 1907/2006 of the European Parliament 
and of the Council on the Registration, Eval uation, Authorisation and Restriction of 
Chemicals ("REACH") 
 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Regi stration, Evaluation, Authorisation and 
Restriction of Chemicals (REA CH), 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
1, and in particular Article 
68(1) and Article 131 thereof,  
Whereas: 
(1) Regulation (EC) No 1907/2006 pr ovides that, if a Member State considers that the 
manufacture, placing on the ma rket or use of a substance on its own, in a mixture or in 
an article poses a risk to human health or  the environment that is not adequately 
controlled and needs to  be addressed, it shall prepar e a dossier after notifying that 
intention to the European Chem icals Agency (the Agency). 
(2) France has prepared a dossier concerning  the substance dimethylfumarate (DMF) 
which demonstrates that DMF c ontained in articles or parts thereof, in concentrations 
greater than 0.1 mg/kg, poses a risk to human  health and that action on a Union-wide 
basis, beyond any measures already in place, is necessary. That dossier was submitted to the Agency in order to init iate the restriction process.  
(3) Furniture and footwear available on the mark et in several Member States have been 
identified as the cause of damage to th e health of consumers in France, Poland, 
Finland, Sweden and the United Kingdom. 
                                                
 
1 OJ L 396, 30.12.2006, p 1.  
EN 3   EN (4) It was recognised that the h ealth damage was caused by DMF, which is a biocide that 
prevents moulds that may deteriorate leathe r furniture or footw ear during storage or 
transport in a humid climate. DMF was most  often contained in little pouches fixed 
inside the furniture or added to the footw ear boxes. It evaporated and impregnated the 
product, protecting it from moulds. However, it also a ffected consumers who were in 
contact with those products. DMF came into contact with consumers’ skin where it 
caused a number of cases of sensitisation (c ontact dermatitis), resulting in a painful 
condition. In some cases, acute respiratory tr oubles were also reported. Dermatitis is 
particularly difficult to treat and the sens itisation is irreversible. Because of its 
potential for sensitisation, exposure to DMF can elicit adverse reactions at very low 
concentrations in se nsitised subjects.  
(5) The use of DMF as a biocidal active subs tance is not authorized in the Union, 
according to Directive 98/8/EC of the Eur opean Parliament and of the Council of 16 
February 1998 concerning the placing of biocidal products on the market2. Therefore, 
articles produced in the Union may not be  treated with DMF. However, Directive 
98/8/EC does not restrict the import of DMF-treated articles into the Union.  
(6) On the basis of Article 13 of Directive 2001/ 95/EC of the European Parliament and of 
the Council of 3 December 2001 on general product safety3, the Commission has 
adopted Decision 2009/251/EC of 17 March 2009 requiring Member States to ensure 
that products containing the biocide dime thylfumarate are not placed or made 
available on the market4, which restricts the placing on the market of products 
containing DMF, as an emergency measur e until the situation of DMF could be 
evaluated under Regulation (EC) No 1907/2006. 
(7) The prohibition provided by Decision 2009/ 251/EC was subsequently prolonged by 
Commission Decision 2010/153/EU5 and Commission Decision 2011/135/EU6 and is 
applicable until 15 March 2012.  
(8) In its opinion of 8 March 2011, the Committ ee for Risk Assessment (RAC) of the 
Agency considers that prohibiting the use of  DMF in articles or parts thereof at a 
concentration higher than 0.1 mg/kg, and the placing on the market of articles or parts 
thereof containing DMF at a concentratio n greater than 0.1 mg/kg, is the most 
appropriate Union-wide measure to addre ss the identified risks in terms of the 
effectiveness in reducing the risks. 
(9) In its opinion of 14 June 2011, the Committee for Socio-economic Analysis considers 
that the proposed measure regarding DMF is the most appropriate Union-wide 
measure to address the identified risks in terms of the proportionality of its socio-
economic benefits to its socio-economic costs. 
(10) The Agency has submitted to the Commission the opinions of the Committees for Risk 
Assessment and Socio-economic Analysis. 
                                                 
2 OJ L 123, 24.4.1998, p. 1. 
3 OJ L 11, 15.1.2002, p. 4. 
4 OJ L 74, 20.3.2009, p. 32. 
5 OJ L 63, 12.3.2010 p.21. 
6 OJ L 57 2.3.2011 p.43.   
EN 4   EN (11) The measures provided for in this Regulati on are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to 
this Regulation.  
Article 2  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
 For the Commission 
 The President     
EN 5   EN ANNEX  
In the table of Annex XVII to Regulati on (EC) No 1907/2006, the following entry 61 is 
added:  
61. Dimethylfumarate (DMF) 
CAS No 624-49-7 
EC 210-849-0 Shall not be used in articles or any parts 
thereof in concentrations greater than 0.1 mg/kg. 
 Articles or any parts thereof containing DMF 
in concentrations greater than 0.1mg/kg shall not be placed on the market.