EN EN
EUROPEAN
COMMISSION
Brussels, XXX
CA-July13-Doc.3.8
[…](2013) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
to approve copper sulfate pentahydrate as an existing active substance for use in 
biocidal products for product -type 2
(Text with EEA relevance)EN 2 ENCOMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
to approve copper sulfate pentahydrate as an existing active substance for use in 
biocidal products for product -type 2
(Text with EEA relevance)
THE EUROPEAN COMMI SSION,
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 
Counc il of 22 May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular the third sub paragraph of Article 89(1) thereof ,
Whereas:
(1) Commission Regulation (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 concer ning the placing of biocidal 
products on the market2establishes 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. That list 
includes copper sulfate pentahy drate .
(2) Pursuant to Regu lation (EC) No 1451/2007, copper sulfate pentah ydrate 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 
defin ed in Annex V t o that Directive, which corresponds to product -type 2as defined 
in Annex V to Regulation (EU) No 528/2012.
(3) France was designated as Rapporteur Member State and submitted the competent 
authority report, together with a recomm endation, to the Commission on 5 April 2011
in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
(4) The competent authority report was reviewed by the Member States and the 
Commission. I n accordance with Article 15(4) of Regulation (EC) No 1451/2007, the 
findings of th e review were incorporated, within the Standing Committee on Biocidal 
Products on 27 September 2013 ,in an assessment report.
(5) It appears from the evaluations that biocidal products used for product -type 2and 
containing copper sulfate pentah ydrate maybe expected to satisfy the requirements 
laid down in Article 5 of Directive 98/8/EC . Italso appears from the report that such 
biocidal products maybe expected to satisfy the requirements laid down in Article 19 
of Regulation (EU) No 528/2012, provided that t he conditions specified in the Annex 
to this Regulation are satisfied.
(6) It is therefore appropriate to approve copper sulfate for use in biocidal products for 
product -type 2.
  
1OJ L 167, 27. 6.2012, p. 1.
2OJ L 325, 11.12.2007, p. 3.EN 3 EN(7) Since the evaluation did not a ddress nanomaterials, the approval should not cover such 
materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.
(8) 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 .
(9) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Biocidal Products ,
HAS ADOPTED THIS REGULATION:
Article 1
Copper sulfate pentah ydrate 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 
to this Regulation .
Article 2
This Regulation shall enter into force on the twentieth dayfollowing th at 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, 
For the Commission
The President
José Manuel BARROSOEN 4 ENANNEX 
Common 
NameIUPAC Name
Identification NumbersMinimum 
degree of 
purity of 
the active 
substance3Date of 
approvalExpiry date 
of approvalProduct 
typeSpecific condit ions4
Copper 
sulfate
pentahyd
rateIUPAC Name : Copper sulfate pentahydrate
EC No: 231-847-6
CAS No: 7758 -99-8990 g/kg 1 July 
2015 30 June 
20252The product assessment shall pay particular 
attention to the exposures, the risks and the 
efficacy linked to any uses covered by an 
application for authorisation, but not 
addressed in the Union level risk
assessment of the active substance .
Authorisations are subject to the following 
condition :
For industrial or professional users, safe 
operational procedures and appropriate 
organizational measures shall be 
established. Only where exposure cannot 
be reduce d to an acceptable level by other 
means, products shall be used w ith 
appropriate personal protective equipment. .
  
3The purity indicated in this column was the minimum degree of purity of the ac tive substance used for the evaluation made in accordance with Article 8 of Regulation (EU) 
No 528/2012 . The active substance in the product placed on the market can be of equal or different purity if it has been proven technica lly equivalent with the eval uated 
active substance.
4For the implementation of the common principles of Annex VI of Regulation (EU) No 528/2012 , the content and conclusions of assessment reports are available on the 
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm