EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
[…](2013) XXX  draft 
  
COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council on the Registration, E valuation, Authorisation and Restriction of 
Chemicals ("REACH") as re gards 1,4-dichlorobenzene 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION REGULATION (EU) No …/.. 
of XXX  
amending Annex XVII to Regulation (EC)  No 1907/2006 of the European Parliament 
and of the Council on the Registration, Eval uation, Authorisation and Restriction of 
Chemicals ("REACH") as regards 1,4-dichlorobenzene 
(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 Regi stration, Evaluation, Authorisation and 
Restriction of Chemicals (REA CH), 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) thereof, 
Whereas: (1) A risk assessment on 1,4 dichlorobenzene (hereinafter ‘DCB’) was carried out by the 
French authorities in accordance wi th Council Regulation (EEC) No 793/93
2 on the 
evaluation and control of the risks of th e existing substances appearing in the 
European Inventory of Existing Commer cial Substances. The final report was 
published in 2004 on the European Chemicals Bureau website (EC, 2004)3.  
(2) In February 2008, the Commission communication4 on the results of the risk 
evaluation and the risk reduction stra tegies for DCB was published in the Official 
Journal of the European Union . That communication recommended that, in order to 
limit the risk for consumers, marketing a nd use restrictions in Council Directive 
76/769/EEC5 should be considered for the use of DCB in air fresheners, moth 
repellents and toilet blocks. Restrictions on the use of DCB as a moth repellent, as 
recommended by that communication in 2008, are already covered by Commission 
                                                 
1 OJ L 396, 30.12.2006, p 1. 
2 Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of 
existing substances (OJ C 146, 15.6.1990, p. 1). 
3 EU Risk Assessment Report on 1,4-dichlorobenzene. European Chemicals Bureau, Existing substances, 
Volume 48.  
4 Commission communication on the results of the risk evaluation and the risk reduction strategies for the 
substances: Piperazine; Cyclohexane; Methylenediphenyl diisocyanate; But-2yne-1,4-diol; 
Methyloxirane; Aniline; 2-Ethylhexylacrylate; 1,4-Di chlorobenzene; 3,5-din itro-2,6-dimethyl-4-tert-
butylacetophenone; Di-(2-ethyl hexyl)phthalate; Phenol; 5-tert-butyl -2,4,6-trinitro-m-xylene (OJ C 34, 
7.2.2008, p. 1). 
5  Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and 
administrative provisions of the Member States relating to restrictions on the marketing and use of 
certain dangerous substances and preparations (OJ L 262, 27.9.1976, p. 201 ).  
EN 3   EN Decision 2007/565/EC6 (product type 19 - Repellents and attractants) and therefore 
restriction under Regulation (EC) No 1907/2006 is not necessary for that use. 
(3) For DCB, the deadline imposed by the transitional measure in Article 137(1)(a) of 
Regulation (EC) No 1907/2006 was not achieved and in November 2011, in 
accordance with Article 69(1) of that Regulation, the Commission requested the 
European Chemicals Agency (hereinafter ‘the  Agency’) to prepare a restriction dossier 
conforming to the requirements of Annex XV  to that Regulation (hereinafter ‘the 
Annex XV dossier’) for this substance.  
(4) In its request the Commission specifically as ked the Agency to address the exposure 
of consumers at home and in public toilet s, including the exposur e of professionals 
attending or cleaning such toilets, taking in to account the most recent and relevant 
information in scientific literature and the decline of the use of DCB in Europe. The report
7 on the socio-economic impacts of a restriction of DCB, commissioned by the 
Commission was also to be cons idered in this assessment.  
(5) DCB is listed in part 3 of Annex VI to Regulation (EC) No 1272/2008 of the European 
Parliament and of the Council8 as a carcinogen in hazard category 2, as well as for its 
eye irritation properties and its high toxic ity to aquatic organisms, with long lasting 
effects. It is estimated that  approximately 800 tonnes per y ear of DCB are used in the 
Union, for the manufacturing of air fresheners  and toilet deodoriser  products, of which 
10 % is destined for domestic uses and the rest for professional uses (essentially as 
deodorisers in public toilets). 
(6) On 19 April 2012, the Agency submitted to its Committee for Risk Assessment 
(hereinafter ‘RAC’) and to its Committee fo r Socio-Economic Analysis (hereinafter 
‘SEAC’) the Annex XV dossier. In that dossier9, it was demonstrated that the placing 
on the market and use of DCB-based air fr esheners and toilet  blocks should be 
restricted for both domestic and professional us es as risks associated with them are not 
adequately controlled and th e benefits arising from the re striction outweigh the costs. 
The dossier further demonstrated that ac tion on a Union-wide basis is necessary. 
(7) On 8 March 2013, RAC adopted by consensus its opinion on the restriction proposed 
in the Annex XV dossier. According to the RAC opinion, the restriction is the most 
appropriate Union-wide measure to address the identified risks posed by DCB used as 
an air freshener or as a deodoriser in to ilets, both in terms of effectiveness and 
practicability. However, RAC proposed to modify the restriction for enforceability 
reasons, specifying a concentration limit of  1 % by weight for DCB in such products, 
thereby avoiding products containing DCB as  an impurity being unduly affected. That 
concentration corresponds to the limit value which triggers classi fication of a mixture 
as a category 2 carcinogen under Regulation (EC) No 1272/2008.  
                                                 
6  Commission Decision 2007/565/EC of 14 August 2007 concerning the non-inclusion in Annex I, IA or 
IB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of 
biocidal products on the market of certain substances to be examined under the 10-year work 
programme referred to in Article 16(2) thereof (OJ L 216, 21.8.2007, p. 17 ). 
7 RPA – Risk & Policy Analysts Limited (2010) Socio-Economic Evaluation arising from a Proposal for 
Risk Reduction Measures related to Restrictions on 1,4-Dichlorobenzene, Final Report – June 2010. 
http://ec.europa.eu/enterprise/sectors/chem icals/documents/reach/studies/index_en.htm   
8 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1). 
9 http://echa.europa.eu/documents/10162/3f467af2-66e0-468d-8366-f650f63e27d7   
EN 4   EN (8) As indicated in the background document to the RAC opinion, reliable analytical 
methods to determine contents of D CB are available on the Union market.  
(9) In its assessment, RAC considered th at carcinogenicity (mitogen, threshold 
carcinogen) is the end-point of greatest rele vance to the human health. Based on data 
on inhalation exposure to DCB vapours, RAC proposed to re duce the identified risk to 
consumers when they use air fresheners and toilet deodorise rs, containing DCB, 
continuously at home. That scenario was c onsidered to represent reasonable worst-
case conditions of exposure. In addition, the RAC opinion stated that exposure of professional toilet attendants and cleaners needs to be reduced as risk has been 
identified where toilets are poorly ventilated.  
(10) In analysing the scope of the restriction RA C considered the exposure of consumers to 
air fresheners and toilet deodorisers in house holds and in public to ilets as well as of 
professionals who work in public toilets, including toilet attendants and cleaners, but 
also other groups such as maintenance personnel. Consumers and professionals who visit and work in indoor areas  (other than toilets) wher e air fresheners containing DCB 
are used were also considered. Other professional or industrial uses were not considered.  
(11) On 5 June 2013, SEAC adopted by consensus its opi nion on the restriction proposed in 
the Annex XV dossier. According to the SEAC  opinion, the restriction, as modified by 
RAC and SEAC, is the most appropriate Unio n-wide measure to address the identified 
risks in terms of the proportionality of its socio-economic benefits to its socio-
economic costs. Based on the RAC conclusion  that exposures to DCB need to be 
reduced for domestic and professional users and some evidence that use of toilet 
blocks and air fresheners containing DCB will persist in the absence of any intervention, SEAC agreed that a restric tion is an appropriate and an effective 
measure. Concerning proportionality of a restriction on domestic use, SEAC 
concluded that the measure is proportionate . Concerning the proportionality of a joint 
restriction on domestic and professional use, SEAC, taking account of the inferred 
health benefits and the scale of costs invol ved, concluded that the measure may not be 
considered to be disproportionate. 
(12) The Forum for Exchange of Information on Enforcement was consulted during the 
restrictions process and their comments on the wording of the conditions of the 
restriction and on the transitional period we re taken into consideration by RAC and 
SEAC.  
(13) On 17 June 2013, the Agency submitted to the Commission the opinions of RAC and 
SEAC, based on which the Commission concludes that an unacceptable risk to human health arises from the placing on the market  and use of DCB, as a substance or as a 
constituent of mixtures in a concentration e qual to or greater than 1 % by weight, used 
as an air freshener or as a deodoriser in toilets. The Comm ission further considers that 
these risks need to be addressed on a Un ion-wide basis. The socio-economic impacts 
of this restriction, including the availabil ity of alternatives, ha ve been taken into 
account.  
(14) It is appropriate to provide for a period of 12 months after the entry into force of this 
Regulation within which stakeholders shoul d take measures to comply with it, 
including for air fresheners and deodorisers th at are already in the supply chain or in 
stock. 
(15) Regulation (EC) No 1907/2006 should th erefore be amended accordingly.   
EN 5   EN (16) The measures provided for in this Regulati on are in accordance with the opinion of the 
Committee established 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 .  
It shall apply from (first day of the 13th month after the entry into force). 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  
EN 6   EN ANNEX  
In Annex XVII to Regulation (EC) No 1907/2006, the following entry is added:  
64. 1,4-dichlorobenzene  
CAS No 106-46-7  EC No 203-400-5   
 
 1. Shall not be placed on the market, or used, 
as a substance or as a constituent of mixtures in a concentration equal to or greater than 1 % by weight where the substance or the mixture is used as an air freshener or as a deodoriser in toilets, homes, offices or other indoor public areas. 
2. Paragraph 1 shall apply from {first day of 
the 13
th month  after the date of the entry into 
force }.