EN    EN EN 
  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
C(2009) final 
Draft 
COMMISSION DECISION 
of 
requiring Member States to ensure that  products containing the biocide 
dimethylfumarate are not placed or  made available on the market  
EN 2   EN Draft 
COMMISSION DECISION 
of 
requiring Member States to ensure that  products containing the biocide 
dimethylfumarate are not placed or  made available on the market 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community, 
Having regard to Directive 2001/95/EC of the European Parliament and of the Council of 
3 December 2001 on general product safety1, and in particular Article 13 thereof, 
Having consulted the Member States,  Whereas: (1) Pursuant to Directive 2001/95/EC producers are obliged to place only safe consumer 
products on the market. 
(2) 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 UK.  
(3) According to clinical tests the health  damage was caused by the chemical 
dimethylfumarate (DMF), a biocide preventi ng moulds that may deteriorate leather 
furniture or footwear during storage or transport in a humid climate. 
(4) DMF was most often contained in little pouche s fixed inside the furniture or added to 
the footwear boxes. It thus evaporated a nd impregnated the product, protecting it from 
moulds. However, it then also affected consumers who were in contact with the 
products. DMF penetrated through the clothes onto consumers' skin
2 where it caused 
painful skin contact dermatitis including itc hing, irritation, redness, and burns; in some 
cases, acute respiratory troubles were re ported. The dermatitis was particularly 
difficult to treat. The presence of  DMF is thus a serious risk. 
(5) Under Article 13 of Directive 2001/95/EC , if the European Commission becomes 
aware that certain products pres ent a serious risk to the hea lth and safety of consumers, 
                                                 
1 OJ L 11, 15.1.2002, p. 4. 
2 Williams JDL, et al (2008) An outbreak of furniture dermatitis in the U.K. . British Journal of 
Dermatology 159: 233-234.  
EN 3   EN it may, subject to certain conditions, adopt a decision requiring Memb er States to take 
measures intended in particular to restrict or make subject to sp ecific conditions the 
availability on the market of such products. 
(6) Such a decision may be adopted if (a) Me mber States differ significantly on the 
approach adopted or to be adopt ed to deal with the risk co ncerned; (b) the risk cannot, 
in view of the nature of the safety issue, be dealt with in a manner compatible with the 
degree of urgency of the case under other procedures laid down by the specific 
Community legislation applicable to the pr oduct concerned; and (c) the risk can be 
eliminated effectively only by adopting appropriate measures applicable at Community level, in order to ensure a cons istent and high level of protection of the 
health and safety of consumers and the proper functioning of the internal market. 
(7) A clinical study on humans
3 (patch tests) with leather furniture and patches of pure 
DMF showed strong reactions in the most severe case down to 1 mg/kg. On the basis 
of this study, France adopted a decree4 which bans the importation and placing on the 
market of seating and footwear containing DMF. The French decree also requires the 
recall of all seating and footwear which vi sibly contains, or the packaging of which 
visibly contains, DMF. The duration of th e decree is limited to 1 year. - Belgium 
issued a decree5, on the basis of the same study, whic h bans the placing on the market 
of all articles and products contai ning DMF. – Spain issued measures6 banning DMF 
in all consumer products coming into contact with the skin. 
(8) Belgium, Spain and France are the only Me mber States having adopted specific 
regulatory measures to addre ss the serious risk to consum er health from the biocide 
DMF. 
(9) Under Article 2(1)(a) of Dir ective 98/8/EC of the Europe an Parliament and of the 
Council of 16 February 1998 conc erning the placing of bi ocidal products on the 
market ("the Biocides Directive")7, biocidal products are defi ned as active substances 
and preparations containing one or more active substances, which are intended to 
destroy, deter, render harmless, prevent th e action of, or otherw ise exert a controlling 
effect on any harmful organism by chemical or biological means. Article 3(1) of the 
Biocides Directive requires Member States to prescribe that a biocidal product shall 
not be placed on the market and used in thei r territory unless it has been authorised in 
accordance with the Directive; and Article 5(1)(b)( iii) of the Directive provides that 
Member States shall authorise a biocidal product only if, amongst ot her things, it has 
no unacceptable effects itself or as a result of its residues, on human health, directly or 
                                                 
3 Rantanen T (2008) The cause of the Chinese sofa/chair dermatitis epidemic is likely to be contact 
allergy to dimethylfumarate, a novel potent cont act sensitizer. Concise communication. British Journal 
of Dermatology 159: 218-221. 
4 Ministry for the Economy, Indu stry and Employment, Decree of  4 December 2008 suspending the 
placing on the market of seats and footwear containing DMF from the market. French Official Journal, 
10 December 2008, Text 17 of 108. 
5 The Minister for Public Health and the Minist er for Consumer Protec tion, Ministerial Decree 
concerning the prohibition of placing articles and products containing DMF on the market. Belgian 
Official Journal, 12.1.2009 
6 Resolution of 22 December 2008 of the National Cons umer Institute. Spanish O fficial Journal no 18, 21 
January 2009, Sec. V-B. Pág. 5474 
7 OJ L 123, 24.4.1998, p. 1.  
EN 4   EN indirectly. Thus, very high safety standard s have to be fulfilled before a biocidal 
product can be authorised. 
(10) Biocidal products containing DMF are not authorised in the Community in accordance 
with the Biocides Directive. Thus, biocid al products containing DMF are not legally 
available in the Community for the treatment  of products against moulds, and thus no 
product manufactured in the EU can legally  contain DMF. However, there is no 
restriction when DMF is pres ent in products (or raw mate rials of products) that are 
imported into the Community. 
(11) Any restriction of DMF to be put in pl ace under Regulation (EC) No 1907/2006 of the 
European Parliament and of the C ouncil of 18 December 2006 concerning the 
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Ag ency, amending Directive 1999/45/EC and 
repealing Council Regulation (EEC) No 793/ 93 and Commission Re gulation (EC) No 
1488/94 as well as Council Di rective 76/769/EEC and Commission Directives 
91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006)8 would 
be impossible in the short term and would t hus not suffice with regard to the urgency 
of the present risk management need. 
(12) In these circumstances, Member States should  be required to ensure that no products 
containing DMF are placed or made availabl e on the market, in order to prevent the 
serious risk posed by these products to cons umers, until a permanent solution becomes 
available. 
(13) The presence of DMF in products should be determined against the maximum limit of 
0.1 mg DMF per kg of product or part of th e product. This is considered to be 
sufficiently below the concentration of 1 mg /kg which showed a strong reaction in the 
patch tests mentioned above. The maximu m limit of 0.1 mg/kg thus appropriately 
addresses the serious risk  from DMF in products. 
(14) Accordingly, the analytical method employe d should be able to reliably quantify 0.1 
mg DMF per kg of product or part of the product. This means that the method's 
quantification limit should be 0.1 mg/kg or less. 
(15) Member States must carry out market surveillance and enforcement activities to 
prevent risks posed by unsafe products to the health and safety of consumers. 
(16) A short transition period is necessary in the interests of both the Member States, who 
must ensure that this Decision will be a pplied, and producers and distributors who are 
subject to the obligation to make availa ble on the market only safe products. The 
shortest possible transition peri od is appropriate, consistent with the need to prevent 
further incidents of serious damage to the h ealth and safety of consumers and to ensure 
proportionality. 
(17) The measures provided for in this Decision are in accordance with the opinion of the 
Committee established by Article  15 of Directive 2001/95/EC. 
                                                 
8 OJ L 136, 29.5.2007, p. 3.  
EN 5   EN HAS ADOPTED THIS DECISION:  
Article 1 
Definitions 
For the purposes of this Decision the following definitions shall apply: 
(a) "DMF" means the chemical dimethylfuma rate, with the IUPAC name Dimethyl (E)-
butenedioate, the CAS number 624-49- 7 and the EINECS number 210-849-0; 
(b) “product” means any product as defined in article 2(a) of Directive 2001/95/EC; 
(c) "product containing DMF" means any produc t or any part of a product where either: 
(i) the presence of DMF is declared, such as on one or more pouches, or 
(ii) the concentration of DMF is greate r than 0.1 mg/kg of the weight of the 
product or part of the product; 
(d) “placing on the market” means the fi rst making available of a product on the 
Community market; 
(e) “made available on the market” means s upplied for distribution, consumption or use 
on the Community market in the course of a commercial activity, whether in return for payment or free of charge. 
Article 2 
Implementation 
1. As of 1 May 2009 Member States shall en sure that products containing DMF are 
prohibited from being placed or made available on the market. 
2. As of 1 May 2009 Member States shall en sure that products containing DMF and 
already placed or made available on the ma rket are withdrawn from the market and 
recalled from consumers, and that consumer s are adequately informed of the risk 
posed by such products. 
3. Member States shall inform the Commissi on without delay of the measures taken 
under this Article in accordance with  Article 12 of Directive 2001/95/EC.  
Article 3 
Information 
Member States shall take the necessary measures  to comply with this  Decision, publish those 
measures and inform the Commission thereof accordingly .  
EN 6   EN Article 4 
Period of application 
This Decision shall be applicable until 15 March 2010. 
Article 5 
Addressees 
This Decision is addressed to the Member States. 
Done at Brussels, […] 2009 
 For the Commission 
 Meglena KUNEVA  Member of the Commission