Commission Regulation (EU) No 474/2014
of 8 May 2014
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’) as regards 1,4-dichlorobenzene
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
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 for DCB conforming to the requirements of Annex XV to that Regulation (hereinafter ‘the Annex XV dossier’).
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 deodoriser in toilets, homes, offices or other indoor public areas, 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 classification of a mixture as a category 2 carcinogen under Regulation (EC) No 1272/2008.
As indicated in the background document to the RAC opinion, reliable analytical methods to determine contents of DCB are available on the Union market.
In its assessment, RAC considered that carcinogenicity (mitogen, threshold carcinogen) is the end-point of greatest relevance to the human health. Based on data on inhalation exposure to DCB vapours, RAC proposed to reduce the identified risk to consumers when they use air fresheners and toilet deodorisers, containing DCB, continuously at home. That scenario was considered 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.
In analysing the scope of the restriction RAC considered the exposure of consumers to air fresheners and toilet deodorisers in households and in public toilets 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) where air fresheners containing DCB are used were also considered. Other professional or industrial uses were not considered.
On 5 June 2013, SEAC adopted by consensus its opinion 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 Union-wide measure to address the identified risks in terms of the proportionality of its socioeconomic benefits to its socioeconomic 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 restriction 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 involved, concluded that the measure may not be considered to be disproportionate.
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 were taken into consideration by RAC and SEAC.
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 equal to or greater than 1 % by weight, used as an air freshener or deodoriser in toilets, homes, offices or other indoor public areas. The Commission further considers that these risks need to be addressed on a Union-wide basis. The socioeconomic impacts of this restriction, including the availability of alternatives, have been taken into account.
It is appropriate to provide for a period of 12 months after the entry into force of this Regulation within which stakeholders should take measures to comply with it, including for air fresheners and deodorisers that are already in the supply chain or in stock.
Regulation (EC) No 1907/2006 should therefore be amended accordingly.
The measures provided for in this Regulation 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 1 June 2015.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 May 2014.
For the Commission
The President
José Manuel Barroso
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
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 placed on the market for use or used as an air freshener or deodoriser in toilets, homes, offices or other indoor public areas.’