EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10085/2016 
(POOL/E4/2016/10085/10085-EN.doc) 
[…](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving Copper, granulated, as  an active substance for use in biocidal products of 
product-type 8 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving Copper, granulated, as an active substance for use in biocidal products of 
product-type 8 
(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 avai lable on the market and use of biocidal 
products
1, and in particular the third subpa ragraph of Article 90(2) thereof, 
Whereas: (1) France received on 30 August 2013 an applicati on, in accordance with Article 11(1) of 
Directive 98/8/EC  of the European Parliament and of the Council
2, for the inclusion of 
the active substance C opper, granulated, in Annex I of that Directive for use in 
products of product-type 8, wood preservati ves, as described in Annex V to that 
Directive, which correspond to product-type  8 as described in Annex V to Regulation 
(EU) No 528/2012.  
(2) France submitted the assessment report together with its recommendations on 3 April 
2015 in accordance  with Article 90(2) of Regulation (EU) No 528/2012. 
(3) The opinion of the European Chemicals Agency was formulated on 9 December 2015 
by the Biocidal Products Committee, havi ng regard to the conclusions of the 
evaluating competent authority. 
(4) According to that opinion, biocidal pr oducts of product-type 8 and containing Copper, 
granulated, may be expected to satisfy th e criteria of Article 19(1)(b) of Regulation 
(EU) No 528/2012, provided that certain spec ifications and conditions concerning 
their use are complied with. 
(5) It is therefore appropriate to approve Copper, granulated, for use in biocidal products 
of product-type 8, subject to compliance w ith certain specifications and conditions. 
(6) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interested parties to take the preparatory measures 
necessary to meet th e new requirements. 
(7) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 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 (OJ L 123, 24.4.1998, p. 1) .  
EN 3   EN HAS ADOPTED THIS REGULATION: 
Article 1 
Copper, granulated, is approved as an active subs tance for use in biocid al products of product-
type 8, subject to the specifications  and conditions set out in the Annex. 
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, 
 For the Commission 
 The President  Jean-Claude JUNCKER