EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/11868/2017 
(POOL/E3/2017/11868/11868 -EN.doc)  
[…](2017) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving azoxystrobin as an active substance for use in biocidal products of product -
types 7, 9 and 10  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving  azoxystrobin as an active substance for use in biocidal 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 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)(a) thereof,  
Whereas:  
(1) The United Kingdom  received on 13 April 2014  an application  for the approval  of the 
active substance azoxystrobin  for use in biocidal products of product -type 7, film 
preservatives , product -type 9, fibre, leather, rubber and polymerised materials 
preservatives , and product -type 10, construction material preservatives , as described in 
Annex V to Regulation (EU) No  528/2012.  
(2) The United Kingdom  submitted the assessment report s together with its 
recommendations on 1 December  2016 in accordance  with Article 8(1) of Regulation 
(EU) No  528/2012.  
(3) The opinion s of the European Chemicals Agency w ere formulated on 3 October 2017 
by the Biocidal Products Committee, having regard to the conclusions of the 
evaluating competent authority.  
(4) According to th ose opinion s, biocidal products of product -types 7, 9 and 10 containi ng 
azoxystrobin  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 use are complied with.  
(5) It is therefore appropriate to approve azoxystrobin  for use in  biocidal products of 
product -types 7, 9 and 10, subject to compliance with certain specifications and 
conditions . 
(6) The opinions conclude that azoxystrobin  meets the criteria for being a  very persistent 
(vP) and toxic (T)  substance  according to Annex XIII to Regulation (EC) No 
1907/2006 of the Europea n Parliament and of the Council2. Azoxystrobin  therefore 
                                                 
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 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/E EC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1) .  
EN 2  EN meets the conditions set out in point (d) of Article  10(1) of Regulation (EU) No 
528/2012  and should be considered a candidate for substitution.  
(7) Pursuant to  Article 10(4) of that Regulation, t he approval of an active substance that is 
considered as a candidate for substitution should be for a period not exceeding 7  years .  
(8) Since azoxystrobin  meets the criteria for being very persistent  (vP) according to 
Annex XIII to Regulation (EC) No 1907/2006 , treated articles treated with or 
incorporating azoxystrobin  should be appropriately labelled when placed on the 
market . 
(9) 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.  
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing  Committee on Biocidal Product s, 
HAS ADO PTED THIS REGULATION:  
Article  1 
Azoxystrobin  is approved as an active substance for use in biocidal products of product -types 
7, 9 and 10, subject to the specifications and conditions set out in the Annex.  
Article  2 
This Regulation shall enter into force o n 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