EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12067/2017 CIS 
(POOL/E4/2017/12067/12067 -EN 
CIS.doc)  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving penflufen as an active substance for use in biocidal products of product -
type 8 
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving penflufen 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 availab le on the market and use of biocidal 
products1, and in particular Article  9(1)(a) thereof,  
Whereas:  
(1) The evaluating competent authority of the United Kingdom  received on 7 July 2015  an 
application for the approval of the active substance penflufen  for use in biocidal 
products of product -type 8, wood preservatives , as described in Annex V to 
Regulation (EU) No  528/2012.  
(2) The evaluating competent authority of the United Kingdom submitted the assessment 
report together with its recommendations on 28 Fe bruary 2017  in accordance  with 
Article 8(1) of Regulation (EU) No  528/2012.  
(3) The opinion of the European Chemicals Agency was formulated on 14 December 
2017  by the Biocidal Products  Committee, having regard to the conclusions of the 
evaluating competent aut hority2. 
(4) According to that opinion, biocidal products of product -type 8 containing penflufen  
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 us e 
are complied with.  
(5) It is therefore  appropriate to approve penflufen  for use in  biocidal products of product -
type 8, subject to compliance with certain specifications and conditions . 
(6) Since  the opinion of the European Chemical Agency concludes that  penflufen  meets 
the criteria for being very persistent  (vP) in accordance with  Annex XIII to Regulation 
(EC) No 1907/2006  of the Europea n Parliament and of the Council3, treated articles 
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance 
Penflufen, Product type: 8, ECHA/BPC/184/2017, Adopted on 14 December 2017 . 
3 Regulation (EC) No 1907/2006 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 Council 
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) .  
EN 2  EN treated with or incorporating penflufen  should be labelled appropriat ely when placed 
on the market . 
(7) 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.  
(8) The measures provided for i n this Regulation are in accordance with the opinion of the 
Standing  Committee on Biocidal Product s, 
HAS ADOPTED THIS REGULATION:  
Article  1 
Penflufen is approved as an active substance for use in biocidal 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