EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10093/2016 
(POOL/E4/2016/10093/10093-EN.doc) 
[…](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving copper flakes (coated with aliphatic acid) as an existing active substance for 
use in biocidal products of product-type 21 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving copper flakes (coated with aliphatic acid) as an existing active substance for 
use in biocidal products of 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 avai lable 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 existing 
active substances to be evaluated for thei r possible approval for use in biocidal 
products. That list includes copper, to be named copper flakes (coated with aliphatic 
acid) as a result of its evaluation. 
(2) Copper flakes (coated with aliphatic acid) has been evaluated for use in products of 
product-type 21, antifouling products, as desc ribed in Annex V to Regulation (EU) 
No 528/2012. 
(3) France was designated as evaluating competent authority and submitted the 
assessment report together with its  recommendations on 31 October 2014. 
(4) In accordance with Article 7(2) of De legated Regulation (EU) No 1062/2014, the 
opinion of the European Chemicals Agen cy was formulated on 9 December 2015 by 
the Biocidal Products Committee, having rega rd to the conclusions of the evaluating 
competent authority. 
(5) According to that opinion, biocidal products  of product-type 21 and containing copper 
flakes (coated with aliphatic acid) may be  expected to satisfy the criteria of 
Article 19(1)(b) of Regulati on (EU) No 528/2012, provided th at certain specifications 
and conditions concerning their use are complied with. 
(6) The acceptability of the risks related to th e use of antifouling products, as well as the 
suitability of the proposed risk mitigation measures, should however 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 all those substa nces should be the same. 
                                                
 
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).  
EN 3   EN (7) It is therefore appropriate to approve copper flakes (coated with a liphatic acid) for use 
in biocidal products of product-type 21, subject to compliance with certain 
specifications and conditions. 
(8) 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. 
(9) 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 flakes (coated with aliphatic acid) is  approved as an active substance for use in 
biocidal products of product-t ype 21, subject to the specificati ons 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