Sgs-safeguards 06409- eu bans dimethyl fumarate in products -en-09
SAFEGUARDS SGS CONSUMER TESTING SERVICES
HARDLINES, SOFTLINES, ELECTRICAL & ELECTRONIC
EUROPEAN MARKET CONCERNS PART 4 EU BANS DIMETHYL FUMARATE
The European Union has officially banned the use of the anti-fungal agent dimethyl fumarate (DMF) in products. From May 2009, Member States shall ensure that products containing DMF are prohibited from being placed or made available on the market and any products available on the market to be withdrawn and recalled from consumers.
In January 2009, Member States of the European Union (EU) voted in
(DMF) in consumer products 1. In the EU, the restriction on the usage of DMF in products is governed by Commission Decision 2009/251/EC of 17 March 2009 2. From 1 May 2009, a product or part of the product containing DMF in a concentration of greater than 0.1 mg/kg is prohibited from being placed or made available on the market. Furthermore, Member States shall ensure products containing DMF and already placed or made available on the market are withdrawn from the market and recalled from consumers.
February 2009, Safeguard 30/09 and references therein
2.Commission Decision 2009/251/EC of 17 March 2009 ‘requiring Member States to Ensure that
Products Containing the Biocide Dimethyl Fumarate are not Place or made available on the Market’, L 74/32 – L74/34, Official Journal of the European Union, 20 March 2009.
HARDLINES, SOFTLINES, ELECTRICAL & ELECTRONIC
Belgium, France and Spain are the only Member States to have adopted specific regulatory measures to address DMF. In December 2008, France adopted a decree banning the importation and placing on the market of seating and footwear containing DMF for 1 year. The French Decree also requires the recall of all seating and footwear which visibly contains, or the packaging of which visibly contains, DMF. In January 2009, Belgium issued a Decree to ban all articles containing DMF on the market. In January 2009, Spain officially published 1229 Resolution of 22 December 2008 to ban DMF in
Dimethyl fumarate was most often used in sachets / pouches fixed inside the
furniture or added to footwear boxes. The substance evaporated and
impregnated the product, protecting it from moulds. This also affected
consumers who were in contact with the products. Dimethyl fumarate
penetrated through the clothes onto the skin of consumers where it caused
painful skin contact dermatitis, including itching, irritation, redness, burns and
Since 2008, 25 RAPEX notifications have been published for products containing dimethyl fumarate for the below countries: Spain with 16 notifications, France with 7 notifications, Finland and Poland with 1 notification each4.
On March, 23rd 2009, the French Health Ministry published a report on skin manifestations associated with possible exposure to dimethyl fumarate.
Between 1 January 2008 and 10 January 2009, 134 skin manifestations were reported to French poison centers. Exposure to dimethyl fumarate was identified as a possible cause of the symptoms reported for 97 of these alerts. Exposure to dimethyl fumarate has been confirmed with certainty in 28 cases.
3.1229 ‘Resolución de 22 de diciembre de 2008, del Instituto Nacional del Consumo, por la
que se acuerda la publicación del acuerdo de iniciación de procedimiento para prohibir la comercialización de calzado, sillones y cualquier articulo que por su uso va a estar en contacto con la piel que contenga dimetilfumarato’, Nŭm. 18, Dec. V-B. pág. 5474-5476, Miércoles 21 de enero de 2009, Boletín Oficial Del Estado,
4 SGS collects for you the notifications of unsafe products in the US, the European market
and Australia on consumer products in SGS publication PRODUCT RECALLS. If you would like to receive future publications of PRODUCT RECALLS, you can subscribe on
line. Several subscription-period options with competitive fees are offered,
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Substance JurisdictionScope RequirementRegulation
Decision 2009/251/EC of 17 March 2009 Effective date = 1 May 2009
Minister for Public health and the Minister for Consumer
Protection, Ministerial Decree concerning the prohibition of placing articles and products containing DMF on the market, Belgian Official Journal, 12 January 200912 Jan 2009
Ministry for the Economy, Industry and Employment, Decree of
4 December 2008 suspending the placing on the market of seats and footwear containing DMF from the Market, French Official Journal, Text 17 of 108 10 December 2008
1229 ‘Resolución de 22 de diciembre de 2008, del Instituto
Nacional del Consumo, por la que se acuerda la publicación del
acuerdo de iniciación de procedimiento para prohibir la comercialización de calzado, sillones y cualquier articulo que por su uso va a estar en contacto con la piel que contenga dimetilfumarato’ Spanish Official Journal ‘Boletín Oficial Del Estado’, 21 January 2009
SGS will follow and inform interested parties as development on international
Throughout our global network of laboratories, we are able to provide a range of services, including analytical testing and consultancy for dimethyl fumarate in a wide range of consumer products for the EU and worldwide markets. Please do not hesitate to contact us for further information.
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Belgium, France and Spain are the only Member States to have adopted specific regulatory measures to address DMF. In December 2008, France adopted a decree banning the importation and placing on the market of seating and footwear containing DMF for 1 year. The French Decree also requires the recall of all seating and footwear which visibly contains, or the packaging of which visibly contains, DMF. In January 2009, Belgium issued a Decree to ban all articles containing DMF on the market. In January 2009, Spain officially published 1229 Resolution of 22 December 2008 to ban DMF in
Dimethyl fumarate was most often used in sachets / pouches fixed inside the
furniture or added to footwear boxes. The substance evaporated and
impregnated the product, protecting it from moulds. This also affected
consumers who were in contact with the products. Dimethyl fumarate
penetrated through the clothes onto the skin of consumers where it caused
painful skin contact dermatitis, including itching, irritation, redness, burns and
Since 2008, 25 RAPEX notifications have been published for products containing dimethyl fumarate for the below countries: Spain with 16 notifications, France with 7 notifications, Finland and Poland with 1 notification each4.
On March, 23rd 2009, the French Health Ministry published a report on skin manifestations associated with possible exposure to dimethyl fumarate.
Between 1 January 2008 and 10 January 2009, 134 skin manifestations were reported to French poison centers. Exposure to dimethyl fumarate was identified as a possible cause of the symptoms reported for 97 of these alerts. Exposure to dimethyl fumarate has been confirmed with certainty in 28 cases.
3.1229 ‘Resolución de 22 de diciembre de 2008, del Instituto Nacional del Consumo, por la
que se acuerda la publicación del acuerdo de iniciación de procedimiento para prohibir la comercialización de calzado, sillones y cualquier articulo que por su uso va a estar en contacto con la piel que contenga dimetilfumarato’, Nŭm. 18, Dec. V-B. pág. 5474-5476, Miércoles 21 de enero de 2009, Boletín Oficial Del Estado,
4 SGS collects for you the notifications of unsafe products in the US, the European market
and Australia on consumer products in SGS publication PRODUCT RECALLS. If you 
HARDLINES, SOFTLINES, ELECTRICAL & ELECTRONIC
Substance Jurisdiction Scope