EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SCBP42-Doc.XX […](2014) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving copper pyrithione as an active s ubstance for use in biocidal products for 
product-type 21 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving copper pyrithione as an active s ubstance for use in biocidal products for 
product-type 21 
(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 av ailable on the market and use of biocidal 
products
1, and in particular the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Delegated Re gulation (EU) No 1062/2014
2 establishes a list of active 
substances to be evaluated with a view to  their possible approval for use in biocidal 
products or inclusion into A nnex I to Regulation (EU) No  528/2012. That list includes 
copper pyrithione. 
(2) Copper pyrithione has been evaluated in acco rdance with Article 90(2) of Regulation 
(EU) No 528/2012 for use in biocidal pr oducts for product-t ype 21, antifouling 
products, as defined in Annex V to Regulation (EU) No 528/2012. 
(3) Sweden was designated as evaluating competent authority and submitted an 
assessment report, together with its r ecommendations, to the Commission on 28 
January 2011 in accordance with paragraphs  4 and 6 of Article 14 of Commission 
Regulation (EC) No 1451/20073. 
(4) The opinion of the European Chemicals Agen cy was formulated on 3 October 2014 by 
the Biocidal Product Committee, having regard  to the conclusions of the evaluating 
competent authority.  
(5) According to that opinion, biocidal products used for product-type 21 and containing 
copper pyrithione may be expected to satisf y the requirements la id down in Article 5 
of Directive 98/8/EC of the Europe an Parliament and of the Council4 provided that 
certain specifications an d conditions relating to its use are satisfied.  
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for 
the systematic examination of all existing active substan ces contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 
1). 
3 Commission Regulation (EC) No 1451/2007 of 4 Decem ber 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 concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3). 
4 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 (6) Nevertheless, the acceptability of the risks re lated to the use of antifouling products, as 
well as the suitability of th e proposed risk mitigation meas ures, needs to be further 
confirmed. In order to facilitate, at the time of the renewal of the approvals of existing 
antifouling active substances, the review and comparison of the risks and benefits of 
those substances as well as of the risk m itigation measures applied, the expiry date of 
approval of those substances should be the same. 
(7) It is therefore appropriate to approve coppe r pyrithione for use in biocidal products for 
product-type 21 subject to compliance with  certain specifications and conditions.  
(8) Since the evaluations did not address nanom aterials, the approva l should not cover 
such materials in accordance with Arti cle 4(4) of Regula tion (EU) No 528/2012. 
(9) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit interested pa rties to take the preparatory measures 
necessary to meet th e new requirements.  
(10) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Copper pyrithione shall be approve d as an active substance for us e in biocidal products for 
product-type 21, subject to th e specifications and conditi ons 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