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The European Union extends the temporary ban on dimethyl fumarate (DMF).

2012-04-18

Taiwan – 15/02/12

The European Union extends the temporary ban on dimethyl fumarate (DMF).

No. 01/ 2012

In January 2012, the European Commission published Directive 2012/48/EU in the Official Journal (OJ), deciding to extend the temporary ban on dimethylfumarate (DMF).

DMF (dimethylformamide) was used as a preservative in manufacturing until Directive 98/8/EC was enacted. However, this directive did not restrict the import of DMF-treated goods into the EU. DMF is often contained in small bags inside furniture or added to shoe boxes. DMF evaporates and seeps into products to prevent mold growth; it can also penetrate clothing and reach consumers' skin, causing contact dermatitis, itching, irritation, redness, and burns. In some cases, it can even cause breathing difficulties. Therefore, the EU took emergency measures, with European Commission resolution 2009/251/EC prohibiting the importation or production of goods containing DMF within the EU. Subsequently, 2009/251/EC was extended to resolutions 2010/153/EU and 2011/135/EU, which were in effect until March 15, 2012.

This directive will officially take effect on March 15, 2012, and will remain in effect until March 15, 2013, or until the final revised version of REACH is released, in which case the DMF will be amended to Annex 17 of the REACH Regulation and permanently banned.

Key points of the regulations:

substance	scope	Limits under Decision 2011/135/EU	Current value under the new 2012/48/EU directive
富馬酸二甲酯(Dimethylfumarate； DMF)	Goods or parts	≤ 0.1 mg/kg Valid until March 15, 2012	≤ 0.1 mg/kg Those that were in effect before March 15, 2013, or were amended to become permanent under Annex 17 of the REACH Regulation, are prohibited from use.

Source: Decision 2012/48/EU (English version only)

For the full details, please refer to the original document.

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