EU Dimethyl Fumarate (DMF) Ban Becomes Permanent
The EU rolling temporary ban on products containing dimethyl fumarate (DMF) now becomes permanent through a further amendment to REACH Annex XVII by Regulation (EU) No 412/2012. This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Substance
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CAS
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EC
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Restriction
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Dimethylfumarate
(DMF)
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624-49-7
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210-849-0
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1) Shall not be used in articles or any parts thereof in concentrations greater than 0,1 mg/kg.
2) Articles or any parts thereof containing DMF in concentrations greater than 0,1 mg/kg shall not be placed on the market.
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The Challenge:
Dimethyl fumarate (CAS No 624-49-7, EC No 210-849-0) has been used as a fungicide to prevent mould-growth on leather goods, such as furniture, footwear and leather accessories; typically added in small pouches from which DMF evaporates and impregnates the leather. However DMF can also penetrate through clothing onto consumers’ skin where it may cause sensitization and painful skin contact dermatitis. The symptoms of which can include itching, irritation, redness, burns and in severe cases acute respiratory difficulties have been reported. The sensitization is permanent and this type of dermatitis has been particularly difficult to treat. Injuries involving furniture and footwear have been reported in France, Poland, Finland, Sweden and the United Kingdom.
Hence the presence of DMF was considered to pose a serious risk and products containing it were banned from being placed on the EU market by an emergency rolling temporary ban, initiated by Decision 2009/251/EC. This followed national restrictions in Belgium, Spain and France along with reported incidents linked to DMF in many other EU Member States. The original restrictions were taken under the fast-track provisions in Article 13 of the General Product Safety Directive 2001/95/EC, which remained valid for a maximum of 12 months and have been continually renewed until these permanent restrictions.
Our Solution:
Intertek has developed precise analytical methods to verify the concentration of DMF in leather. By leveraging our local services and global network, we enable our customers to dedicate their primary energies to their core business activities. We offer comprehensive programs and services which draw on our industry specific knowledge and technical expertise. Please contact your local Intertek laboratory for further details of this and our other services.