EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SCBP42-Doc.5.1 
[…](2014) XXX  draft 
  
COMMISSION IMPLEMENTING RE GULATION (EU) No …/.. 
of XXX  
approving clothianidin as an active substan ce for use in biocidal products for product-
type 18 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving clothianidin as an existing active  substance for use in biocidal products for 
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 av ailable 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 Regul ation (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 or inclusion into Annex I to Regulation (EU) No 528/2012.  
(2) That list includes clothianidin. 
(3) Clothianidin has been evaluated in accordan ce with Article 16(2) of Directive 98/8/EC 
of the European Parliament and of the Council3 for use in biocidal products for 
product-type 18, insecticides, acaricides and products to control other arthropods, as 
defined in Annex V to that  Directive, which correspond respectively to product-types 
18 and 19 as defined in Annex V to Regulation (EU) No 528/2012. 
(4) Germany was designated as evaluating competent authority and submitted the 
assessment reports, together with its r ecommendations, to the Commission on 27 May 
2009 in accordance with paragraphs 4 and 6 of Article 14 of Commission 
Regulation (EC) No 1451/20074. 
(5) In accordance with Article 7(1)(b) of Commission Delegate d Regulation (EU) 
No 1062/2014,5  the opinion of the European Chem icals Agency was formulated on 2 
                                                 
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). 
3 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).  
4 Commission Regulation (EC) No 1451 /2007 of 4 December 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the 
Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).  
5 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 Text with EEA relevance 
(OJ L 294, 10.10.2014, p. 1).   
EN 3   EN October 2014 by the Biocidal Product Committee, having regard to the conclusions of 
the evaluating competent authority.  
(6) According to thatopinion, biocidal products  used for product-type 18 and containing 
clothianidin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the European  Parliament and of the Council
6 provided that 
certain specifications an d conditions relating to its use are satisfied.  
(7) It is therefore appropriate to approve clot hianidin for use in biocidal products for 
product-type 18 subject to compliance with the specific conditi ons in the Annex.  
(8) The opinion concludes that the characteristics of clothianidin render it very persistent 
(vP) and toxic (T) in accordance with th e criteria laid down in Annex XIII to 
Regulation (EC) No 1907/2006 of the Eur opean Parliament and of the Council7.  
(9) Since pursuant to Article 90(2) of Regulat ion (EU) No 528/201, substances for which 
the Member States' evaluation has not been completed by 1 September 2013 should be approved in accordance with Directive 98/8/EC  , the period of approval should be 10 
years in accordance with the practice  established under that Directive.  
(10) For the purposes of Articl e 23 of Regulation (EU) No 528/2012 however, clothianidin 
meets the conditions of Artic le 10(1)(b) of that Regulation and should therefore be 
considered a candidate for substitution. 
(11) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit interested pa rties to take the preparatory measures 
necessary to meet th e new requirements.  
(12) 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 
Clothianidin is approved as an active substance for use in bioc idal products for product-type 
18, subject to the specifications a nd 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. 
                                                
 
6 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) . 
7 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/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1)  
EN 4   EN Done at Brussels, 
 For the Commission 
 The President