EN
16.5.2012 Official
Journal
of
the
European
Union L
128/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION REGULATION (EU) No 412/2012
of 15 May 2012
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(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 United Kingdom.
Having regard to the Treaty on the Functioning of the European
Union,
(4) It
was
recognised
that
the
health
damage
was
caused
by
Having regard to Regulation (EC) No 1907/2006 of the
DMF, which is a biocide that prevents moulds that may
European Parliament and of the Council of 18 December
deteriorate leather furniture or footwear during storage
2006 concerning the Registration, Evaluation, Authorisation
or transport in a humid climate. DMF was most often
and Restriction of Chemicals (REACH), establishing a
contained in little pouches fixed inside the furniture or
European Chemicals Agency, amending Directive 1999/45/EC
added to the footwear boxes. It evaporated and
and repealing Council Regulation (EEC) No 793/93 and
impregnated the product, protecting it from moulds.
Commission Regulation (EC) No 1488/94 as well as Council
However, it also affected consumers who were in
Directive 76/769/EEC and Commission Directives 91/155/EEC,
contact with those products. DMF came into contact
93/67/EEC, 93/105/EC and 2000/21/EC ( 1 ), and in particular
with consumers’ skin where it caused a number of
Article 68(1) and Article 131 thereof,
cases of sensitisation (contact dermatitis), resulting in a
painful condition. In some cases, acute respiratory
troubles were also reported. Dermatitis is particularly
difficult to treat and the sensitisation is irreversible.
Whereas:
Because of its potential for sensitisation, exposure to
DMF can elicit adverse reactions at very low concen
trations in sensitised subjects.
(1) Regulation
(EC)
No
1907/2006
provides
that,
if
a
Member State considers that the manufacture, placing
on the market or use of a substance on its own, in a
mixture or in an article poses a risk to human health or
(5) The
marketing
and
use
of
DMF
in
biocidal
products
is
the environment that is not adequately controlled and
not permitted in the Union, according to Directive
needs to be addressed, it shall prepare a dossier after
98/8/EC of the European Parliament and of the Council
notifying that intention to the European Chemicals
of 16 February 1998 concerning the placing of biocidal
Agency (the Agency).
products on the market ( 2 ) and to Commission Regu
lation (EC) No 1451/2007 of 4 December 2007 on
the second phase of the 10-year work programme
referred to in Article 16(2) of Directive 98/8/EC of the
(2) France
has
prepared
a
dossier
concerning
the
substance
European Parliament and of the Council concerning the
dimethylfumarate (DMF) which demonstrates that DMF
placing of biocidal products on the market ( 3 ). Therefore,
contained in articles or parts thereof, in concentrations
articles produced in the Union may not be treated with
greater than 0,1 mg/kg, poses a risk to human health and
DMF. However, Directive 98/8/EC does not foresee
that action on a Union-wide basis, beyond any measures
restricting the import into the Union of articles treated
already in place, is necessary. That dossier was submitted
with biocides.
to the Agency in order to initiate the restriction process.
( 2 ) OJ L 123, 24.4.1998, p. 1.
( 1 ) OJ L 396, 30.12.2006, p 1.
( 3 ) OJ L 325, 11.12.2007, p. 3.

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L 128/2
EN
Official Journal of the European Union
16.5.2012
(6)
On the basis of Article 13 of Directive 2001/95/EC of
(9) In
its
opinion
of
14
June
2011,
the
Committee
for
the European Parliament and of the Council of
Socioeconomic Analysis considers that the proposed
3 December 2001 on general product safety ( 1 ), the
measure regarding DMF is the most appropriate Union-
Commission has adopted Decision 2009/251/EC of
wide measure to address the identified risks in terms of
17 March 2009 requiring Member States to ensure that
the proportionality of its socioeconomic benefits to its
products containing the biocide dimethylfumarate are not
socioeconomic costs.
placed or made available on the market ( 2 ), which
restricts the placing on the market of products
containing DMF, as an emergency measure until the
(10) The Agency has submitted to the Commission the
situation of DMF could be evaluated under Regulation
opinions of the Committees for Risk Assessment and
(EC) No 1907/2006.
Socioeconomic Analysis.

(11) The
measures
provided
for
in
this
Regulation
are
in
(7) The
prohibition
provided
by
Decision
2009/251/EC
was
accordance with the opinion of the Committee estab
subsequently prolonged by Commission Decision
lished under Article 133 of Regulation (EC) No
2010/153/EU (
1907/2006,

3 ), Commission Decision 2011/135/EU ( 4 )
and Commission Implementing Decision 2012/48/EU ( 5 )
and is applicable until the entry into force of this Regu
HAS ADOPTED THIS REGULATION:
lation or 15 March 2013, whichever is the earlier.
Article 1
(8) In
its
opinion
of
8
March
2011,
the
Committee
for
Risk Annex XVII to Regulation (EC) No 1907/2006 is amended in
Assessment of the Agency considers that prohibiting the
accordance with the Annex to this Regulation.
use of DMF in articles or parts thereof at a concentration
higher than 0,1 mg/kg, and the placing on the market of
Article 2
articles or parts thereof containing DMF at a concen
tration greater than 0,1 mg/kg, is the most appropriate
This Regulation shall enter into force on the twentieth day
Union-wide measure to address the identified risks in
following that of its publication in the Official Journal of the
terms of the effectiveness in reducing the risks.
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 May 2012.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 11, 15.1.2002, p. 4.
( 2 ) OJ L 74, 20.3.2009, p. 32.
( 3 ) OJ L 63, 12.3.2010, p. 21.
( 4 ) OJ L 57, 2.3.2011, p. 43.
( 5 ) OJ L 26, 28.1.2012, p. 35.

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EN
16.5.2012 Official
Journal
of
the
European
Union L
128/3
ANNEX
In the table of Annex XVII to Regulation (EC) No 1907/2006, the following entry 61 is added:
‘61. Dimethylfumarate (DMF)
Shall not be used in articles or any parts thereof in concentrations greater
CAS No 624-49-7
than 0,1 mg/kg.
EC 210-849-0
Articles or any parts thereof containing DMF in concentrations greater than
0,1 mg/kg shall not be placed on the market.’

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Document Outline

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