EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10474/2017 
(POOL/E4/2017/10474/10474-EN.doc) 
[…](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving fludioxonil as an active  substance for use in biocida l products of product-
types 7, 9 and 10 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING  REGULATION (EU) …/... 
of XXX  
approving fludioxonil as an active  substance for use in biocida l products of product-
types 7, 9 and 10 
(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 Pa rliament and of the 
Council of 22 May 2012 concerning the making available on the m arket and use of biocidal 
products1, and in particular Article 7(1) thereof, 
Whereas: (1) Denmark received on 8 October 20 14 an application for the appro val of the active 
substance fludioxonil for use in biocidal products of product-t ype 7, film 
preservatives, product-type 9, fibre, leather, rubber and polym erised materials 
preservatives, and product-type 10, construction material prese rvatives, as described in 
Annex V to Regulation (EU) No 528/2012. 
(2) Denmark submitted the assessment reports together with its reco mmendations on 
5 April 2016 in accordance  with Article 8(1) of Regulation (EU) No 528/2012. 
(3) The opinions of the European Chemicals Agency were formulated o n 2 March 2017 
by the Biocidal Products Committee, having regard to the conclu sions of the 
evaluating competent authority. 
(4) According to those opinions, bioc idal products of product-types  7, 9 and 10 and 
containing fludioxonil may be exp ected to satisfy the criteria of Article 19(1)(b) of 
Regulation (EU) No 528/2012, provi ded that certain specificatio ns and conditions 
concerning their use are complied with. 
(5) It is therefore appropriate to approve fludioxonil for use in b iocidal products of 
product-types 7, 9 and 10, subject to compliance with certain s pecifications and 
conditions. 
(6) Since fludioxonil meets the crite ria in Regulation (EC) No 1907 /2006 of the European 
Parliament and of the Council
2 for being very persistent, treated articles treated with or 
incorporating fludioxonil should be  appropriately labelled when  placed on the market. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Regulation (EC) No 1907/2006 of the European Parliament and of  the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Rest riction of Chemicals (REACH), 
establishing a European Chemical s Agency, amending Directive 19 99/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 14 88/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/6 7/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1).  
EN 3   EN (7) A reasonable period should be allowed to elapse before an activ e substance is 
approved in order to permit interested parties to take the prep aratory measures 
necessary to meet the new requirements. 
(8) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Fludioxonil is approved as an active substance for use in bioci dal products of product-types 7, 
9 and 10, subject to the specifica tions and conditions set out in the Annex. 
Article 2 
This Regulation shall enter into force on the twentieth day fol lowing that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding i n its entirety and directly a pplicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER