EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1198/2022 
(POOL/E4/2022/1198/1198 -EN.docx)  
[…](2022) XXX  draft 
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving epsilon -metofluthrin as an active substance for use in biocidal products of 
product -type 19 in accordance with Regulation (EU) No 528/2012 of the European 
Parliament and of the Council  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving epsilon -metofluthrin as an active substance for use in biocidal products of 
product -type 19 in accordance with Regulation (EU) No 528/2012 of the European 
Parliament and of the Council  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulatio n (EU) No 528/2012 of the European Parliament and of the 
Council of 22 May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular Article 9(1), point (b), thereof,  
Whereas:  
(1) Pursuant to Article 11(1) of Directive  98/8/EC of the Europea n Parliament and of the 
Council2, an application for approval of epsilon -metofluthrin  for use in biocidal 
products of product -type 1 9, repellents and attractants , as described in Annex V  of that 
Directive , corresponding to product -type 1 9, repellents and attractants , as described in 
Annex V to Regulation (EU) No 528/2012 , was in January 2011 submitted to the 
competent authority of the United Kingdom, replaced by the competent authority of 
Spain as of 1 February 2020.  
(2) Pursuan t to Article 90(2), first subparagraph, of Regulation (EU) No 528/2012, 
applications submitted for the purposes of Directive 98/8/EC for which the Member 
States’ evaluation in accordance with Article 11(2) of Directive 98/8/EC has not been 
completed by 1 S eptember 2013 are to be evaluated by the competent authorities in 
accordance with the provisions of that Regulation.  
(3) On 24 October 2019, during the preparation of the opinion on the approval by the 
European Chemicals Agency, the applicant withdrew its appl ication and no longer 
requests the approval of epsilon -metofluthrin as an active substance for use in biocidal 
products of product -type 19.  
(4) Epsilon -metofluthrin is not included for product -type 1 9 in Annex II to Commission 
Delegat ed Regulation (EU) No 1062 /20143, which lists the active substance/product -
type combinations included in the work programme for the examination of existing 
biocidal active substances contained in biocidal products. Biocidal products of 
product -type 1 9 containing epsilon -metofluthri n are therefore not covered by the 
                                                 
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).  
3 Commission Delegated Regulation (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).  
EN 2  EN transitional provisions laid down in Article 89(2) of Regulation (EU) No 528/2012 and 
may therefore not be made available or used on the Union market.  
(5) However, in accordance with the transitional provision set out in Art icle 94(1), point 
(a), of Regulation (EU) No 528/2012, a treated article treated with or intentionally 
incorporating one or more biocidal products containing only active substances that are 
under examination for the relevant product -type in the work progra mme referred to in 
Article 89(1) of that Regulation on 1 September 2016 or for which an application for 
approval for the relevant product -type is submitted by that date, or containing only a 
combination of such substances and active substances included in the list drawn up in 
accordance with Article 9(2) of that Regulation for the relevant product -type and use 
or included in Annex I, may be placed on the market until the date falling 180 days 
after a decision not to approve one of the active substances for the relevant use, when 
such decision is adopted after 1 September 2016.  
(6) As the applicant has withdrawn the application for approval of epsilon -metofluthrin 
for use in biocidal products of product -type 1 9, there is no biocidal product to be 
evaluated. Conse quently, the European Chemicals Agency did not prepare an opinion. 
Finally, as there is no biocidal product of product -type 1 9 containing epsilon -
metofluthrin that may be expected to meet the criteria laid down in Article 19(1), point 
(b), of Regulation (E U) No 528/2012, the conditions laid down in Article 4(1) of that 
Regulation are not met. Considering also the need to ensure that treated articles treated 
with or intentionally incorporating epsilon -metofluthrin for product -type 1 9 are no 
longer placed on the Union market, it is appropriate not to approve epsilon -
metofluthrin for use in biocidal products of product -type 1 9. 
(7) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee on Biocidal Products,  
HAS ADOPT ED THIS DECISION:  
Article 1  
Epsilon -metofluthrin (CAS No: 240494 -71-7) is not approved as an active substance for use 
in biocidal products of product -type 19. 
Article 2 
This Decision shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN