EU Member States Vote to Ban Certain Products Containing Dimethyl Fumarate from the EU Market
On January 29, 2009, EU member states voted in favour of a draft European Commission Decision for an emergency EU wide measure to ensure that
consumer products, such as leather furniture or footwear, containing dimethyl fumarate are not placed on the EU market. If already on the market, these products will have to be recalled and withdrawn without delay.
This decision is pending the adoption of a more permanent regulatory
Chemical Structure of
solution by the European Parliament. Some consumer products containing dimethyl
dimethyl fumarate
fumarate are already banned from being placed on the French market as per
December’s French Arrêté and on the Belgian Market as per January’s Belgian Decree.
Background
Dimethyl fumarate has been found to be an allergic sensitizer at very low concentrations, producing extensive, pronounced eczema that is difficult to treat. Concentrations as low as 1 ppm may produce allergic reactions. There are only a few equally as potent sensitizers. Dimethyl fumarate, having antifungal properties, is used to limit mould growth during rainy periods such as the monsoon. In recent months, however, it has provoked allergic reactions resulting in serious rashes that have hospitalised several people in the European Union. As a result, numerous products have been recalled with negative media interest. Characteristics / Identifiers: • CAS number: 624-49-7
• EINECS number: 210-849-0
• Molecular formula: C6H8O4
• Toxicology: Harmful in contact with skin. Severe eye irritant - eye contact may lead to
serious damage. May act as a sensitizer through skin contact.
Regulation
Dimethyl fumarate is not authorised under the Biocides Directive (98/8/EC). However, this
Overview
applies primarily to it being used as a preparation or substance in a sachet. With
manufacturers outside the EU often spraying a product or its packaging with dimethyl fumarate and then exporting it to the EU, these restrictions will help protect consumers. To view the recent Europa release on dimethyl fumarate: http://tinyurl.com/c4y6sh
• Recent Member State actions include: In December 2008, France adopted a decree that
bans the importation and placing on the market of seating and footwear containing dimethly fumarate for one year. The French decree also requires the recall of all seating and footwear which visibly contains, or the packaging of which visibly contains, dimethyl fumarate.
• In January 2009, Belgium issued a decree that bans the placing on the market of all
articles and products containing dimethyl fumarate.
• Spain is considering introducing a similar measure.
Now What?
To reduce risk and protect your reputation, you need to act now to consider what impact these developments might have on your business, and then develop an effective compliance approach. Bureau Veritas has facilities worldwide and experienced professionals who can advise on the regulatory framework and perform dimethyl fumarate testing on your products.
Contact Information: Please contact your customer service representative or: Contact Information: Europe-France/Germany: [email protected], [email protected],
If you have any comments and/or questions, please contact your customer service representative or email:
Asia-Hong Kong: [email protected], or [email protected]
Bureau Veritas Consumer Products Services, Inc. (“BVCPS”) provides the information in this client bulletin as a resource of general information. It does not replace any applicable legal or regulatory requirements and is provided “as is.” BVCPS will not be liable for any indirect, special, punitive, consequential or other damages (including without limitation lost profits) of any kind in connection with this client bulletin. BVCPS DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, IN CONNECTION WITH THIS CLIENT BULLETIN. Copyright 2009 Bureau Veritas Consumer Products Services, Inc. All Rights Reserved. February 2009, Bulletin 09B-107
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EU Member States Vote to Ban Certain Products