Brussels, 30 April 2009
The biocide dimethylfumarate (DMF) has caused severe allergic reactions, including skin itching, irritation, redness, burns and, in some cases, acute respiratory difficulties, in hundreds of consumers in the EU because of its use in imported every day consumer products such as couches and shoes. There has even been one case of a soft toy for small children. On May 1, a European Commission Decision comes into force to ensure that no consumer product containing the strongly sensitising DMF is placed on the market in the EU. If already on the market, these products will have to be recalled and withdrawn without delay, and consumers will have to be informed about the serious risk. The Commission Decision is an EU wide emergency measure, pending the adoption of a more permanent regulatory solution.
EU Consumer Affairs Commissioner Meglena Kuneva, said: "I am very pleased to see that the RAPEX system is working well to ensure that dangerous goods containing DMF are quickly removed from the market. But we need to go further with urgent EU action to tackle the problem at source.”
The risk from DMF
Dimethylfumarate (DMF) is used by producers as a biocide to kill moulds that may cause products such as furniture or shoes to deteriorate during storage or transportation in a humid climate. Placed in "Desiccant" sachets inside the furniture or footwear boxes, DMF evaporates and impregnates the product, protecting it from moulds. However, it has been found to seriously affect consumers who were in contact with the products. DMF penetrated through the clothes onto the skin of consumers, where it caused painful dermatitis. The fact that in serious cases the dermatitis is particularly difficult to treat adds to the damage. The presence of DMF is thus a serious risk.
The dangerous chemical initially raised concerns when notified by a number of Member State authorities through the EU rapid alert system for dangerous non-food consumer products (RAPEX). The notifications related to imported sofas, armchairs and shoes, and clinical tests later confirmed that the dermatitis suffered by consumers in contact with these products was caused by DMF. France, Belgium and Spain subsequently put national bans in place which, however, were differing in scope. The new Decision adopted today will cover all Member States and ensure a ban of DMF in all consumers products (maximum limit value: 0.1 mg/kg) across the EU.
The existing rules
DMF is not legally available for use in the manufacture of goods in the EU, since biocidal products containing DMF are not authorised under the Biocides Directive (98/8/EC). However, manufacturers outside the EU may use these unauthorised biocides and then export their products to the EU if they cause no risks.
The Decision therefore protects EU consumers from the risk of DMF in imported products in the same way as they are protected at home.
Background - RAPEX
RAPEX is the EU rapid alert system for dangerous non-food consumer products, providing a rapid exchange of information between Member States and the Commission to prevent marketing or use of products posing a serious risk to the health and safety of consumers.
For further information see:
 Williams JDL, et al (2008) An outbreak of furniture dermatitis in the U.K. . British Journal of Dermatology 159: 233-234.
 Rantanen T (2008) The cause of the Chinese sofa/chair dermatitis epidemic is likely to be contact allergy to dimethylfumarate, a novel potent contact sensitizer. Concise communication. British Journal of Dermatology 159: 218-221.