EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10085/2015 
(POOL/E3/2015/10085/10085 -EN.doc)  
[…](2015) XXX  draft  
  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving hexaflumuron as an existing active substance for use in biocidal products for 
product -type 18  
(Text with EEA relevance)    
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving hexaflumuron as an existing active substance for use in biocidal products for 
product -type 18  
(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 Parliame nt 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 subparagraph of Article 89(1)  thereof , 
Whereas:  
(1) Commission Delegated Regulation (E U) 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 hexaflumuron . 
(2) Hexaflumuron has been evaluated in accordance with Article  16(2) of Directive 
98/8/EC of the Europea n Parliament and of the Council3 for use in product -type 18, 
insecticides, acaricides and products to control other arthropods , as defined in 
Annex  V to that Directive, which correspond to product -type 18, as defined in Annex 
V to Regulation (EU) No  528/20 12. 
(3) Portugal  was designated as evaluating competent authority and submitted the 
assessment report, together with its recommendations, to the Commission on 11 July 
2011  in accordance with paragraphs 4 and 6 of Article 14 of Commission 
Regulation  (EC) No 145 1/20074. 
(4) In accordance with Article 7(1)(b) of Delegated  Regulation (EU) No  1062/2014 , the 
opinion of the European Chemicals Agency w as formulated on 3 December 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 18 and containing 
hexaflumuron  may be expected to satisfy the requirements laid down in Article 5 of 
Directive  98/8/EC  provided that certain conditions concerning  its use are complied 
with.  
                                                 
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 substances 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 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). 
4 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 concerning the placing of biocidal products on the market  (OJ L 325, 11.12.2007, p. 3 ).  
EN 3   EN (6) It is therefore appropriate to approve hexaflumuron for use in biocidal products for 
product -type 18 subject to compliance with certain specifications and conditions .  
(7) The opinion  concludes that the characteristics of hexaflumuron  render it very 
persistent (vP), very bioaccumulative (vB) and toxic (T)  in accordance with the criteria 
laid down in Annex XIII to Regulation (EC) No 1907/2006 of the Europea n 
Parliament and of the Counci l5.  
(8) Since , pursuant to Article  90(2) of Regulation (EU) No 528/2012 , substances for 
which the Member States' evaluation has been completed by 1  September 2013 should 
be approved in accordance with Directive  98/8/EC , the period of approval should 
therefore  be five years  in accordance  with the practice established under Directive 
98/8/EC . 
(9) For the purpose s of Article  23 of Regulation (EU) No  528/2012 h owever, 
hexaflumuron  meets the conditions of Article 10(1)(a) and (d) of that Regulation  and 
should therefore  be considered a candidate for substitution . 
(10) 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 .  
(11) The measure s provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Biocidal  Products , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Hexaflumuron is approved as an active substance for use in biocidal products for product -type 
18, su bject 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  
                                                 
5 Regulation (EC) No 1 907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Co uncil 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1).