EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10091/2016 
(POOL/E4/2016/10091/10091-EN.doc) 
[…](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving tolylfluanid as an existing active substance for use in biocidal products of 
product-type 7 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving tolylfluanid as an existing active  substance for use in biocidal products of 
product-type 7 
(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 in cludes tolylfluanid. 
(2) Tolylfluanid has been evaluated for us e in products of product-type 7, film 
preservatives, as described in A nnex V to Regulation (EU) No 528/2012. 
(3) Finland was designated as evaluating competent authority and submitted the 
assessment reports together with its recommendations on 17 March 2015. 
(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 pr oducts of product-type 7 and containing 
tolyfluanid may be expected to satisfy th e criteria of Article 19(1)(b) of Regulation 
(EU) No 528/2012, provided that certain spec ifications and conditions concerning 
their use are complied with. 
(6) It is therefore appropriate to approve tolylfluanid for use in biocidal products of 
product-type 7, subject to compliance with certain sp ecifications and conditions. 
                                                 
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) Since tolylfluanid meets the cr iteria for classification 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 incorpora ting tolylfluanid should be 
appropriately labelled when placed on the market. 
(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 
Tolylfluanid is approved as an active substance for use in biocid al products of product-type 7, 
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  
                                                
 
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).