The allergenic anti-mould agent dimethylfumarate (DMF), which in contact with skin may give rise to skin itching, irritation and burns, is prohibited in Swedish articles from 1 May 2009. 

Articles containing DMF in concentrations exceeding a maximum limit of 0.1 mg/kg must be withdrawn from the market and recalled from consumers. It is therefore necessary that companies ensure that the articles they handle (for example furniture and shoes) do not contain DMF. Consumers who have bought an article containing a concentration of DMF that is greater than 0,1 mg/kg of the weight of the product or part of the product should be allowed to return the product and be recompensated by the seller.

The ban is based on an EU decision of 17 March 2009, stating that all member states should make sure that DMF is not placed or made available on the market. The decision was made pursuant to the General Product Safety Directive (2001/95/EC) and implemented in Swedish legislation by Sections 15 a-c in Ordinance (1998:944). 

The Commission decision also contains obligations that consumers be adequately informed of any content of DMF in a product and of the risk posed by such products.  The decision does not contain detailed provisions with regard to the person obliged to provide information and how the information should be submitted. It is therefore important that concerned companies co-operate on this issue in order for the implementation to be as smooth as possible.

The Swedish Chemicals Agency (KemI) is the responsible authority for enforcing compliance with the decision.

Facts on the substance

Dimethylfumarate (DMF) is an ester between methanol and organic fumaric acid. DMF is a white, solid substance that readily evaporates in room temperature and with melting point above 100° C. The substance contains a reactive double binding and could therefore be irritating in contact with skin and eyes.

DMF has been used for treatment of psoriasis and as a preservative against mould. DMF is not contained in Swedish chemical products according to the products register or as an ingredient in pharmaceuticals according to the Swedish pharmaceuticals register.

Regulations

2009/251/EG: Commission Decision of 17 March 2009 requiring Member States to ensure that products containing the biocide dimethylfumarate are not placed or made available on the market.

The Chemical Products (Handling, Import, and Export Prohibitions) Ordinance (1998:944). PDF, 190 kB. Last amendment: 2009:654.

Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety.

Contact:

Christina Larsson, Inspector
Tel: +46-8-519 41 194

Eva Nilsson, Legal Officer
Tel: +46-8-519 41 164