2009/251/EC: 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)
Date: 2009-03-17
Institutions: European Commission
Subjects: Finland, France, Poland, Sweden, United Kingdom, chemical product, health risk, market approval, product safety

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Official Journal of the European Union

20.3.2009

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,

(4)

Having regard to the Treaty
Community,

establishing the European

the European
Having regard to Directive 2001/95/EC of
Parliament and of
the Council of 3 December 2001 on
general product safety (1), and in particular Article 13 thereof,

DMF was most often contained in little pouches fixed
inside the furniture or added to the footwear boxes. It
thus evaporated and impregnated the product, protecting
it from moulds. However, it then also affected consumers
who were in contact with the products. DMF penetrated
through the clothes onto consumers’ skin (2) where it
caused painful skin contact dermatitis, including itching,
irritation,
in some cases, acute
respiratory troubles were reported. The dermatitis was
particularly difficult to treat. The presence of DMF is
thus a serious risk.

redness, and burns;

Having consulted the Member States,

(5)

Whereas:

(1)

Pursuant to Directive 2001/95/EC producers are obliged
to place only safe consumer products on the market.

aware

if
the
Under Article 13 of Directive 2001/95/EC,
European Commission becomes
certain
that
products present a serious risk to the health and safety
of consumers, it may, subject to certain conditions, adopt
a decision requiring Member States to take measures
intended in particular to restrict or make subject
to
specific conditions the availability on the market of
such products.

(2)

(3)

Furniture and footwear available on the market in several
Member States have been identified as the cause of
damage to the health of consumers in France, Poland,
Finland, Sweden and the UK.

According to clinical tests the health damage was caused
by the chemical dimethylfumarate (DMF), a biocide
preventing moulds
leather
that may
furniture or footwear during storage or transport in a
humid climate.

deteriorate

(1) OJ L 11, 15.1.2002, p. 4.

(6)

Such a decision may be adopted if (a) Member States
differ significantly on the approach adopted or to be
adopted to deal with the risk concerned;
(b) the risk
cannot,
in view of the nature of the safety issue, be
dealt with in a manner compatible with the degree of
urgency of the case under other procedures laid down by
the specific Community legislation applicable to the
product concerned; and (c) the risk can be eliminated
appropriate measures
effectively only by
adopting
in order to ensure a
applicable at Community level,
the health
consistent and high level of protection of
and safety of consumers and the proper functioning of
the internal market.

(2) Williams J.D.L., et al. (2008), ‘An outbreak of furniture dermatitis in

the UK’, British Journal of Dermatology 159: p. 233-234.

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(7)

(8)

(9)

A clinical study on humans (1) (patch tests) with leather
furniture and patches of pure DMF showed strong
reactions 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 market
of seating and footwear containing DMF. The French
decree also requires
seating and
footwear 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 placing
on the market of all articles and products containing
DMF. Spain issued measures (4) banning DMF in all
consumer products coming into contact with the skin.

recall of all

the

Belgium, Spain and France are the only Member States
having adopted specific regulatory measures to address
the serious risk to consumer health from the biocide
DMF.

Under Article 2(1)(a) of Directive 98/8/EC of
the
European Parliament and of the Council of 16 February
1998 concerning the placing of biocidal products on the
market (the Biocides Directive) (5), biocidal products are
defined as active substances and preparations containing
one or more active substances, which are intended to
destroy, deter, render harmless, prevent the action of,
or otherwise exert a controlling effect on any harmful
organism by chemical or biological means. Article 3(1) of
the Biocides Directive
to
prescribe that a biocidal product shall not be placed on
the market and used in their territory unless it has been
and
authorised in accordance with the Directive;
Article 5(1)(b)(iii) of
that
the Directive provides
Member States shall authorise a biocidal product only
if, amongst other things, it has no unacceptable effects
itself or as a result of its residues, on human health,
directly or indirectly. Thus, very high safety standards
have to be fulfilled before a biocidal product can be
authorised.

requires Member States

(10)

Biocidal products containing DMF are not authorised in
in accordance with the Biocides
the Community

(1) Rantanen T. (2008), ‘The cause of the Chinese sofa/chair dermatitis
epidemic is likely to be contact allergy to dimethylfumarate, a novel
potent 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
the prohibition of
placing articles and products containing DMF on the market.
Journal),
Belgisch
belge
12 January 2009.

Staatsblad/Moniteur

(Belgian Official

concerning

(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.

legally

available

in the Community

Directive. Thus, biocidal products containing DMF are
not
the
treatment of products against moulds, and thus no
product manufactured in the EU can legally contain
there is no restriction when DMF is
DMF. However,
present in products (or raw materials of products) that
are imported into the Community.

for

(11) Any restriction of DMF to be put in place under Regu­
lation (EC) No 1907/2006 of the European Parliament
and of the Council of 18 December 2006 concerning the
Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH), establishing a European Chemicals
Agency, amending Directive 1999/45/EC and repealing
Council Regulation (EEC) No 793/93 and Commission
as Council
Regulation (EC) No 1488/94 as well
Directive
76/769/EEC and Commission Directives
91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (6)
would be impossible in the short term and would thus
not suffice with regard to the urgency of the present risk
management need.

(12)

In these circumstances, Member States should be required
to ensure that no products containing DMF are placed or
made available on the market,
in order to prevent the
serious risk posed by these products to consumers, until
a permanent solution becomes available.

(13)

The presence of DMF in products should be determined
against the maximum limit of 0,1 mg DMF per kg of
product or part of the product. This is considered to be
sufficiently below the concentration of 1 mg/kg which
showed a strong reaction in the patch tests mentioned
above. The maximum limit of 0,1 mg/kg thus appro­
priately addresses the serious risk from DMF in products.

(14) Accordingly, the analytical method employed should be
able to reliably quantify 0,1 mg DMF per kg of product
or 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 and
enforcement activities to prevent risks posed by unsafe
products to the health and safety of consumers.

(6) OJ L 396, 30.12.2006, p. 1, as corrected by OJ L 136, 29.5.2007,

p. 3.

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(16) A short transition period is necessary in the interests of
both the Member States, who must ensure that
this
Decision will be applied, and producers and distributors
who are subject to the obligation to make available on
the market only safe products. The shortest possible tran­
sition period is appropriate, consistent with the need to
prevent further incidents of serious damage to the health
and safety of consumers and to ensure proportionality.

(17)

in this Decision are in
The measures provided for
accordance with the opinion of the Committee estab­
lished 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
IUPAC name Dimethyl
624-49-7 and the Einecs No 210-849-0;

the chemical dimethylfumarate, with the
the CAS No

(E)-butenedioate,

(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

Article 2

Implementation

1.
As of 1 May 2009 Member States shall ensure that
products containing DMF are prohibited from being placed or
made available on the market.

containing DMF

As of 1 May 2009 Member States shall ensure that
2.
and already placed or made
products
available on the market are withdrawn from the market and
recalled from consumers, and that consumers are adequately
informed of the risk posed by such products.

3. Member States shall
inform the Commission without
delay of the measures taken under this Article in accordance
with 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 the
Commission thereof accordingly.

Article 4

Period of application

This Decision shall be applicable until 15 March 2010.

Article 5

Addressees

(ii) the concentration of DMF is greater than 0,1 mg/kg of
the weight of the product or part of the product;

This Decision is addressed to the Member States.

(d) ‘placing on the market’ means the first making available of a

product on the Community market;

Done at Brussels, 17 March 2009.

(e)

‘made available on the market’ means supplied for distri­
bution, consumption or use on the Community market in
the course of a commercial activity, whether in return for
payment or free of charge.

For the Commission

Meglena KUNEVA
Member of the Commission