25.10.2013 EN Official Journal of the European Union L 283/25
COMMISSION IMPLEMENTING REGULATION (EU) No 1033/2013
of 24 October 2013
approving copper sulphate pentahydrate as an existing active substance for use in biocidal products for product-type 2
(Text with EEA relevance)
THE EUROPEAN COMMISSION
,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
(1) Commission Regulation (EC) No 1451/2007 (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council (3). That list includes copper sulphate.
(2) Copper sulphate has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 2, private area and public health area disinfectants and other biocidal products, as defined in Annex V to that Directive, which corresponds to product-type 2 as defined in Annex V to Regulation (EU) No 528/2012.
(3) The data submitted for the purpose of the evaluation allowed conclusions to be drawn only regarding a certain form of copper sulphate, i.e. copper sulphate pentahydrate CAS No 7758-99-8. The evaluation did not allow conclusions to be drawn regarding any other substance complying with the definition of copper sulphate CAS 7758-99-7 in the abovementioned list of active substances in Regulation (EC) No 1451/2007. Therefore, only copper sulphate pentahydrate should be covered by the approval.
(4) France was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 5 April 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
(5) The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report.
(6) It appears from that report that biocidal products used for product-type 2 and containing copper sulphate pentahydrate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
(7) It is therefore appropriate to approve copper sulphate for use in biocidal products for product-type 2.
(8) Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.
(9) A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed.
(10) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
Copper sulphate pentahydrate shall be approved as an active substance for use in biocidal products for product-type 2, subject to the specifications and conditions set out in the Annex.
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.