EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11722/2016 
(POOL/E4/2016/11722/11722 -EN.doc)  
[…](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving dichlofluanid 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 dichlofluanid 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 Functionin g 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 
products1, and in particular the third subparagraph of Arti cle 89(1) thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU) No  1062/20142 establishes a list of existing 
active substances to be evaluated for their possible approval for use in biocidal 
products.  That list includes dichlofluanid . 
(2) Dichlofluanid  has be en evaluated for use in products of product -type 21, antifouling 
products , as d escribed  in Annex  V to Regulation (EU) No  528/2012 . 
(3) The United Kingdom  was designated as evaluating competent authority and submitted 
the assessment report to gether with its rec ommendations  on 22 October 2015 . 
(4) In accordance with Article 7( 2) of Delegated Regulation  (EU) No  1062/2014, the 
opinion  of the European Chemicals Agency w as formulated on  11 October  2016  by 
the Biocidal Product s Committee, having regard to the conclusions of the evaluating 
competent authority.  
(5) According to th at opinion, biocidal products of product -type 21 containing 
dichlofluanid  may be expected to satisfy the criteria  of Article  19(1)(b) of Regulation 
(EU) No 528/2012 , provided that certain specifications  and conditions concerning 
their use are complied with . 
(6) The acceptability of the risks related to the use of antifouling products, as well as the 
suitability of the proposed risk mitigation measures, should however be further 
confirmed. In order to facilit ate, 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 mitigation measures applied, the expiry date of 
approval of all those  substances should be the same.  
(7) It is therefore appropriate to approve dichlofluanid  for use in  biocidal products of 
product -type 21, subject to compliance with certain specifications and conditions . 
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 Commission Delegated Regula tion (EU) No 1062 /2014 of 4 August 2014  on the work programme for 
the systematic examination of all existing active s ubstances 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 (8) Since dichlofluanid  meets the criteria for classificatio n as skin sensitiser category 1 as 
defined in Annex I to Regulation (EC) No  1272/2008 of the European Parliament and 
of the Council3, treated articles  treated  with or incorporating dichlofluanid  should be 
appropriately labelled when placed on the market.  
(9) 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 the new requirements.  
(10) The measures provided for in this Regulation are in accorda nce with the opinion of the 
Standing  Committee on Biocidal Product s, 
HAS ADOPTED THIS REGULATION:  
Article  1 
Dichlofluanid  is approved as an active substance for use in biocidal products of product -
type 21, subject to the specifications and conditions set o ut 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 S tates.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER  
                                                 
3 Regulation (EC) No  1272/2008 of the European Parliament and of the Council of 16  December 2008  on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No  1907/2006 (OJ L 353, 31.12.2008, 
p. 1).