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The European Union has published a draft bill restricting the use of dimethyl fumarate.

2012-01-17

Taiwan – 28/11/11

The European Union has published a draft bill restricting the use of dimethyl fumarate.

No. 20/ 2011

The European Commission recently published a draft amendment to Annex 17 of the REACH Regulation, which would include dimethyl fumarate (DMF) as Article 61, thus restricting its use in consumer products.

DMF (dimethylformamide) has been used as a preservative in manufacturing until Directive 98/8/EC, but this directive did not restrict the import of DMF-treated goods into the EU. DMF is often contained in small pouches inside furniture or added to shoe boxes. DMF evaporates and seeps into products to prevent mold; however, it can also penetrate clothing and onto 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 Decision 2009/251/EC prohibiting the importation or production of goods containing DMF within the EU. Subsequently, Decision 2009/251/EC was extended to Decisions 2010/153/EU and 2011/135/EU, effective until March 15, 2012. If the draft amendment to Annex 17 of the REACH Regulation is adopted, the emergency restriction will become a permanent legal restriction.

If the draft is adopted at the REACH Committee meeting in November, the regulation will come into effect twenty days after its publication in the Official Journal of the European Union (OJ).

Key points of the draft regulations:

substance	scope	Limit	Effective Date
富馬酸二甲酯(Dimethylfumarate , DMF)	Goods or parts	≤ 0.1 mg/kg	Twenty days after being published in the Official Journal of the European Union

source

EU official draft (English version only)

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

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