COMMISSION
COMMISSION DECISION
of 17 March 2009
requiring Member States to ensure that products containing the biocide dimethylfumarate are not
placed or made available on the market
(notified under document number C(2009) 1723)
(Text with EEA relevance)
(2009/251/EC)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European
Community,
Having regard to Directive 2001/95/EC of the European
Parliament and of the Council of 3 December 2001 ongeneral product safety (
1), and in particular Article 13 thereof,
Having consulted the Member States,Whereas:
(1) Pursuant to Directive 2001/95/EC producers are obliged
to place only safe consumer products on the market.
(2) Furniture and footwear available on the market in severalMember States have been identified as the cause ofdamage to the health of consumers in France, Poland,Finland, Sweden and the UK.
(3) According to clinical tests the health damage was causedby the chemical dimethylfumarate (DMF), a biocidepreventing moulds that may deteriorate leatherfurniture or footwear during storage or transport in ahumid climate.(4) DMF was most often contained in little pouches fixedinside the furniture or added to the footwear boxes. Itthus evaporated and impregnated the product, protectingit from moulds. However, it then also affected consumerswho were in contact with the products. DMF penetratedthrough the clothes onto consumers ’skin (
2) where it
caused painful skin contact dermatitis, including itching,irritation, redness, and burns; in some cases, acuterespiratory troubles were reported. The dermatitis wasparticularly difficult to treat. The presence of DMF isthus a serious risk.
(5) Under Article 13 of Directive 2001/95/EC, if theEuropean Commission becomes aware that certainproducts present a serious risk to the health and safetyof consumers, it may, subject to certain conditions, adopta decision requiring Member States to take measuresintended in particular to restrict or make subject tospecific conditions the availability on the market ofsuch products.
(6) Such a decision may be adopted if (a) Member Statesdiffer significantly on the approach adopted or to beadopted to deal with the risk concerned; (b) the riskcannot, in view of the nature of the safety issue, bedealt with in a manner compatible with the degree ofurgency of the case under other procedures laid down bythe specific Community legislation applicable to theproduct concerned; and (c) the risk can be eliminatedeffectively only by adopting appropriate measuresapplicable at Community level, in order to ensure aconsistent and high level of protection of the healthand safety of consumers and the proper functioning ofthe internal market.EN L 74/32 Official Journal of the European Union 20.3.2009
(1) OJ L 11, 15.1.2002, p. 4.(2) Williams J.D.L., et al. (2008), ‘An outbreak of furniture dermatitis in
the UK ’,British Journal of Dermatology 159: p. 233-234.(7) A clinical study on humans (1) (patch tests) with leather
furniture and patches of pure DMF showed strongreactions in the most severe case down to 1 mg/kg.On the basis of this study, France adopted a decree (
2)
which bans the importation and placing on the marketof seating and footwear containing DMF. The Frenchdecree also requires the recall of all seating andfootwear which visibly contains, or the packaging of
which visibly contains, DMF. The duration of the
decree is limited to 1 year. Belgium issued a decree (
3),
on the basis of the same study, which bans the placingon the market of all articles and products containingDMF. Spain issued measures (
4) banning DMF in all
consumer products coming into contact with the skin.
(8) Belgium, Spain and France are the only Member Stateshaving adopted specific regulatory measures to addressthe serious risk to consumer health from the biocideDMF.
(9) Under Article 2(1)(a) of Directive 98/8/EC of theEuropean Parliament and of the Council of 16 February1998 concerning the placing of biocidal products on themarket (the Biocides Directive) (
5), biocidal products are
defined as active substances and preparations containingone or more active substances, which are intended to
destroy, deter, render harmless, prevent the action of,
or otherwise exert a controlling effect on any harmfulorganism by chemical or biological means. Article 3(1) ofthe Biocides Directive requires Member States toprescribe that a biocidal product shall not be placed onthe market and used in their territory unless it has beenauthorised in accordance with the Directive; andArticle 5(1)(b)(iii) of the Directive provides thatMember States shall authorise a biocidal product onlyif, amongst other things, it has no unacceptable effectsitself or as a result of its residues, on human health,directly or indirectly. Thus, very high safety standardshave to be fulfilled before a biocidal product can beauthorised.
(10) Biocidal products containing DMF are not authorised inthe Community in accordance with the BiocidesDirective. Thus, biocidal products containing DMF are
not legally available in the Community for thetreatment of products against moulds, and thus noproduct manufactured in the EU can legally containDMF. However, there is no restriction when DMF ispresent in products (or raw materials of products) thatare imported into the Community.
(11) Any restriction of DMF to be put in place under Regu­lation (EC) No 1907/2006 of the European Parliamentand of the Council of 18 December 2006 concerning theRegistration, Evaluation, Authorisation and Restriction ofChemicals (REACH), establishing a European ChemicalsAgency, amending Directive 1999/45/EC and repealingCouncil Regulation (EEC) No 793/93 and CommissionRegulation (EC) No 1488/94 as well as CouncilDirective 76/769/EEC and Commission Directives91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (
6)
would be impossible in the short term and would thusnot suffice with regard to the urgency of the present riskmanagement need.
(12) In these circumstances, Member States should be requiredto ensure that no products containing DMF are placed ormade available on the market, in order to prevent theserious risk posed by these products to consumers, untila permanent solution becomes available.
(13) The presence of DMF in products should be determinedagainst the maximum limit of 0,1 mg DMF per kg ofproduct or part of the product. This is considered to besufficiently below the concentration of 1 mg/kg whichshowed a strong reaction in the patch tests mentionedabove. The maximum limit of 0,1 mg/kg thus appro­priately addresses the serious risk from DMF in products.
(14) Accordingly, the analytical method employed should beable to reliably quantify 0,1 mg DMF per kg of productor part of the product. This means that the method ’s
quantification limit should be 0,1 mg/kg or less.
(15) Member States must carry out market surveillance andenforcement activities to prevent risks posed by unsafeproducts to the health and safety of consumers.EN 20.3.2009 Official Journal of the European Union L 74/33
(1) Rantanen T. (2008), ‘The cause of the Chinese sofa/chair dermatitis
epidemic is likely to be contact allergy to dimethylfumarate, a novelpotent contact sensitizer. ’Concise communication, British Journal of
Dermatology 159: p. 218-221.
(
2) 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. JORF (French
Official Journal), 10 December 2008, Text 17 of 108.
(3) The Minister for Public Health and the Minister for Consumer
Protection, Ministerial Decree concerning the prohibition ofplacing articles and products containing DMF on the market.Belgisch Staatsblad/Moniteur belge (Belgian Official Journal),
12 January 2009.
(
4) Resolution of 22 December 2008 of the National Consumer
Institute BOE (Spanish Official Journal) No 18, 21 January 2009,Sec. V-B, p. 5474.
(
5) OJ L 123, 24.4.1998, p. 1.(6) OJ L 396, 30.12.2006, p. 1, as corrected by OJ L 136, 29.5.2007,
p. 3.(16) A short transition period is necessary in the interests of
both the Member States, who must ensure that thisDecision will be applied, and producers and distributorswho are subject to the obligation to make available onthe market only safe products. The shortest possible tran­sition period is appropriate, consistent with the need toprevent further incidents of serious damage to the healthand safety of consumers and to ensure proportionality.
(17) The measures provided for in this Decision are inaccordance with the opinion of the Committee estab­lished by Article 15 of Directive 2001/95/EC,
HAS ADOPTED THIS DECISION:
Article 1
Definitions
For the purposes of this Decision the following definitions shall
apply:
(a) ‘DMF ’means the chemical dimethylfumarate, with the
IUPAC name Dimethyl (E)-butenedioate, the CAS No624-49-7 and the Einecs No 210-849-0;
(b) ‘product ’means any product as defined in Article 2(a) of
Directive 2001/95/EC;
(c) ‘product containing DMF ’means any product or any part of
a product where either:
(i) the presence of DMF is declared, such as on one or
more pouches; or
(ii) the concentration of DMF is greater than 0,1 mg/kg of
the weight of the product or part of the product;
(d) ‘placing on the market ’means the first making available of a
product on the Community market;
(e) ‘made available on the market ’means supplied for distri­
bution, consumption or use on the Community market inthe course of a commercial activity, whether in return for
payment or free of charge.Article 2
Implementation
1. As of 1 May 2009 Member States shall ensure that
products containing DMF are prohibited from being placed ormade available on the market.
2. As of 1 May 2009 Member States shall ensure that
products containing DMF and already placed or madeavailable on the market are withdrawn from the market andrecalled from consumers, and that consumers are adequatelyinformed of the risk posed by such products.
3. Member States shall inform the Commission without
delay of the measures taken under this Article in accordancewith Article 12 of Directive 2001/95/EC.
Article 3
Information
Member States shall take the necessary measures to comply
with this Decision, publish those measures and inform theCommission thereof accordingly.
Article 4
Period of application
This Decision shall be applicable until 15 March 2010.
Article 5
Addressees
This Decision is addressed to the Member States.
Done at Brussels, 17 March 2009.
For the Commission
Meglena KUNEVA
Member of the CommissionEN L 74/34 Official Journal of the European Union 20.3.2009