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,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Regulation (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 Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 
93/67/EEC, 93/105/EC and 2000/21/EC (  1 ), and in particular 
Article 68(1) and Article 131 thereof,  
Whereas:  
(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 
the environment that is not adequately controlled and 
needs to be addressed, it shall prepare a dossier after 
notifying that intention to the European Chemicals 
Agency (the Agency).  
(2) France has prepared a dossier concerning the substance 
dimethylfumarate (DMF) which demonstrates that DMF 
contained in articles or parts thereof, in concentrations 
greater than 0,1 mg/kg, poses a risk to human health and 
that action on a Union-wide basis, beyond any measures 
already in place, is necessary. That dossier was submitted 
to the Agency in order to initiate the restriction process.  (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.  
(4) It was recognised that the health damage was caused by 
DMF, which is a biocide that prevents moulds that may 
deteriorate leather furniture or footwear during storage 
or transport in a humid climate. DMF was most often 
contained in little pouches fixed inside the furniture or 
added to the footwear boxes. It evaporated and 
impregnated the product, protecting it from moulds. 
However, it also affected consumers who were in 
contact with those products. DMF came into contact 
with consumers’ skin where it caused a number of 
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. 
Because of its potential for sensitisation, exposure to 
DMF can elicit adverse reactions at very low concen ­
trations in sensitised subjects.  
(5) The marketing and use of DMF in biocidal products is 
not permitted in the Union, according to 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 (  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 
European Parliament and of the Council concerning the 
placing of biocidal products on the market (  3 ). Therefore, 
articles produced in the Union may not be treated with 
DMF. However, Directive 98/8/EC does not foresee 
restricting the import into the Union of articles treated 
with biocides.EN 16.5.2012 Official Journal of the European Union L 128/1  
( 1 ) OJ L 396, 30.12.2006, p 1.  ( 2 ) OJ L 123, 24.4.1998, p. 1.  
( 3 ) OJ L 325, 11.12.2007, p. 3.(6) On the basis of Article 13 of Directive 2001/95/EC of 
the European Parliament and of the Council of 
3 December 2001 on general product safety (  1 ), the 
Commission has adopted Decision 2009/251/EC of 
17 March 2009 requiring Member States to ensure that 
products containing the biocide dimethylfumarate are not 
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 
situation of DMF could be evaluated under Regulation 
(EC) No 1907/2006.  
(7) The prohibition provided by Decision 2009/251/EC was 
subsequently prolonged by Commission Decision 
2010/153/EU (  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 ­
lation or 15 March 2013, whichever is the earlier.  
(8) In its opinion of 8 March 2011, the Committee for Risk 
Assessment of the Agency considers that prohibiting the 
use of DMF in articles or parts thereof at a concentration 
higher than 0,1 mg/kg, and the placing on the market of 
articles or parts thereof containing DMF at a concen ­
tration greater than 0,1 mg/kg, is the most appropriate 
Union-wide measure to address the identified risks in 
terms of the effectiveness in reducing the risks.  (9) In its opinion of 14 June 2011, the Committee for 
Socioeconomic Analysis considers that the proposed 
measure regarding DMF is the most appropriate Union- 
wide measure to address the identified risks in terms of 
the proportionality of its socioeconomic benefits to its 
socioeconomic costs.  
(10) The Agency has submitted to the Commission the 
opinions of the Committees for Risk Assessment and 
Socioeconomic Analysis.  
(11) The measures provided for in this Regulation are in 
accordance with the opinion of the Committee estab ­
lished under Article 133 of Regulation (EC) No 
1907/2006,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII to Regulation (EC) No 1907/2006 is amended in 
accordance with the Annex to this Regulation.  
Article 2  
This Regulation shall enter into force on the twentieth day 
following that of its publication in the  Official Journal of the 
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 BARROSOEN L 128/2 Official Journal of the European Union 16.5.2012  
( 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.ANNEX  
In the table of Annex XVII to Regulation (EC) No 1907/2006, the following entry 61 is added: 
‘61. Dimethylfumarate (DMF) 
CAS No 624-49-7 
EC 210-849-0  Shall not be used in articles or any parts thereof in concentrations greater 
than 0,1 mg/kg. 
Articles or any parts thereof containing DMF in concentrations greater than 
0,1 mg/kg shall not be placed on the market.’EN 16.5.2012 Official Journal of the European Union L 128/3