EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11145/2016 (POOL/E4/2016/11145/11145-EN.doc) […](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving epsilon -Momfluorothrin as an active substance for use in biocidal products of 
product-type 18 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving epsilon -Momfluorothrin as an active substance for use in biocidal products of 
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 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 Article 90(2) thereof, 
Whereas: (1) The United Kingdom received on 29 May 2013 an application, in accordance with 
Article 11(1) of Directive 98/8/EC of th e European Parliament and of the Council
2, for 
the inclusion of the active substance epsilon -Momfluorothrin, in Annex I to that 
Directive for use in products of product-t ype 18, insecticides, acaricides and products 
to control other arthropods, as described in Annex V to  that Directive, which 
correspond to product-type 18 as descri bed in Annex V to Regulation (EU) 
No 528/2012. 
(2) The United Kingdom submitted the assessment report together with its 
recommendations on 6 October 2015 in accordance  with Article 90(2) of Regulation 
(EU) No 528/2012. 
(3) The opinion of the European Chemicals Agency was formulated on 16 June 2016 by 
the Biocidal Products Committee, having rega rd to the conclusions of the evaluating 
competent authority. 
(4) According to that opinion, biocidal pr oducts of product-type 18 and containing 
epsilon -Momfluorothrin may be expected to satis fy the 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. 
(5) It is therefore appropriate to approve epsilon -Momfluorothrin for use in biocidal 
products of product-type 18, subject to co mpliance with certai n specifications and 
conditions. 
(6) 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. 
(7) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 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).  
EN 3   EN HAS ADOPTED THIS REGULATION: 
Article 1 
epsilon -Momfluorothrin is approved as an active s ubstance for use in biocidal products of 
product-type 18, subject to th e specifications and conditi ons 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