The EU extends the ban on dimethyl fumarate. The Official Journal of the European Union published European Commission resolution 2011\/135\/EU on March 2, 2011, extending the validity of resolution 2009\/251\/EC, which prohibits the placement of all products containing dimethyl fumarate (DMF) on the EU market. In France, Poland, Finland, Sweden, and the UK, consumers reported severe allergic reactions, and investigations found that DMF was the cause. Subsequently, in March 2009, the EU adopted resolution 2009\/251\/EC, requiring member states to ensure that products containing DMF are not placed on the market and to recall products containing DMF from the market from May 1, 2009. Dimethyl fumarate (DMF) is a biocidal agent used in the manufacture of shoe covers, furniture, and packaging for electronic products to prevent leather parts or objects from developing mold and spoiling due to moisture during storage and transport. While foreign manufacturers could still use DMF in products exported to the EU until the adoption of EU Directive 2009\/251\/EC in 2009, EU Directive 98\/8\/EC prohibited its use in products manufactured in the EU. In 2009, due to the ineffectiveness of existing monitoring mechanisms in protecting consumers from DMF, the EU first implemented a ban on DMF under Article 13 of Directive 2001\/95\/EC. Article 13 stipulates that the ban is valid for one year, but can be extended, but not for more than one year at a time.
Due to the failure to reach a definitive solution, the European Commission adopted resolution 2011\/135\/EU on March 1, 2011, extending the ban again until March 15, 2012. However, this ban is expected to continue until the EU adopts a permanent regulatory solution.
France has submitted a report to the Risk Assessment Committee (RAC) and the Socio-Economic Analysis Committee (SEAC) of the European Chemicals Agency (ECHA), recommending that the current temporary restrictions should be made permanent under the REACH Regulation. The report was open for public consultation from September 21 to December 21, 2010. The two committees were required to provide their final opinions by June 2011. Subsequently, the European Commission would decide whether to convert the temporary restrictions into permanent restrictions under the REACH Regulation.
EU member states must comply with this resolution by March 15, 2011, extending the ban for another year in their own countries. Resolution 2011\/135\/EU is available at: http:\/\/eur-lex.europa.eu\/LexUriServ\/LexUriServ.do?uri=OJ:L:2011:057:0043:0043:EN:PDF The French report recommending the conversion of temporary restrictions into permanent measures is available at: http:\/\/echa.europa.eu\/doc\/restrictions\/annex_xv_restriction_report_DMFu_en.pdf
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